Fla. Admin. Code tit. 59 | Fla. Admin. Code Title 59 — Agency for Health Care Administration

Division 59C Certificate of Need

Chapter 59C-1 PROCEDURES FOR THE ADMINISTRATION OF SECTIONS 408.031-408.045, FLORIDA STATUTES, HEALTH FACILITY AND SERVICES DEVELOPMENT ACT

Fla. Admin. Code R. 59C-1.001 Purpose

History

Rulemaking Authority 408.034(5), 408.15(8) FS. Law Implemented 408.031-.045 FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-25-80, 2-1-81, Formerly 10-5.01, Amended 11-17-87, Formerly 10-5.001, Repealed 10-31-96.

Fla. Admin. Code R. 59C-1.002 Definitions

(1) “Applicant” means any individual, partnership, limited liability company, corporation, or governmental entity which has filed an application for a Certificate of Need with the Agency.

(2) “Application” means the forms supplied by the Agency to an applicant which are to be completed in order to be eligible to be considered for a Certificate of Need.

(3) “Audited financial statement” means all pages of the financial statements of the applicant, or the applicant’s parent corporation if financial statements of the applicant do not exist, that have been examined by an independent certified public accountant in accordance with generally accepted auditing standards as set forth in Statements on Auditing Standards published by the American Institute of Certified Public Accountants, on which the certified public accountant expresses an opinion as to the fairness with which the financial statements present financial position, results of operations, and changes in financial position in conformity with generally accepted accounting principles as established by the American Institute of Certified Public Accountants and the Financial Accounting Standards Board.

(4) “Batching Cycle” means the grouping for comparative review of Certificate of Need applications submitted for beds or programs having a like Certificate of Need need methodology or licensing category in the same planning horizon and the same applicable District or subdistrict.

(5) “By or on behalf of” means any action taken directly or indirectly by a health care facility which will result in any leasehold or ownership interest for the health care facility.

(6) “Capital project” means a project, whether subject to or not subject to Certificate of Need review, which involves a capital expenditure as defined in Section 408.032(2), F.S., and which the applicant has approved via authorization to execute. For projects subject to Certificate of Need review, a capital project approved by the applicant also means:

(a) A project involving a capital expenditure for which a notice of intent to grant a Certificate of Need has been issued; or

(b) A project involving a capital expenditure for which a notice of intent to deny a Certificate of Need is in litigation, or could still be litigated within any remaining part of the 21-day period provided by Section 408.039(5)(a), F.S.

(7) “Combination” means the combination within one nursing home facility of the beds authorized by two or more Certificates of Need issued in the same planning subdistrict.

(8) “Community nursing home beds” means nursing home beds, other than sheltered nursing home beds, regulated under Rule 59C-1.036, F.A.C.

(9) “Comparative hearing” means a single hearing, conducted pursuant to Section 120.57, F.S., and Rule 59C-1.012, F.A.C., held to review all pending applications in the same batching cycle and comparatively reviewed by the Agency.

(10) “Comparative review” means the process by which Certificate of Need applications, submitted in the same batching cycle for beds or hospice for the same planning area, as defined by applicable rules, are competitively evaluated by the Agency through final Agency action for purposes of awarding a Certificate of Need.

(11) “Conversion from one type of health care facility to another” means the reclassification of one licensed facility type to another licensed facility type, which requires certificate of need approval prior to licensure.

(12) “Conversion of beds” means conversion to or from sheltered beds and community beds for facilities licensed under Chapter 400, Part I, F.S.

(13) “Division” means the division into two or more nursing home facilities of beds or services authorized by one Certificate of Need issued in the same planning subdistrict.

(14) “Existing health care facility” means a licensed health care facility.

(15) “Fixed Need Pool” means the identified numerical need, as published in the Florida Administrative Register, for new beds or programs for the applicable planning horizon established by the Agency in accordance with need methodologies which are in effect by rule at the time of publication of the Fixed Need Pools for the applicable batching cycle.

(16) “Health care provider” means an individual who delivers health services or who is a member of an organization that delivers health services. Health care providers include but are not limited to physicians, medical doctors, osteopaths, dentists, podiatrists, nurses, chiropractors, physician assistants, dental assistants, mental health professionals and other allied health professionals, administrators and employees of health care institutions.

(17) “Health care purchaser” means an individual who is responsible for or an authorized member of an organization or Agency which is responsible for the purchase of health services for a group of 25 or more individuals either directly or through acquisition of health insurance coverage. Health care purchasers as described above include, but are not limited to representatives of individual businesses, employer coalitions, governmental units, labor organizations, consumer groups and health insurers.

(18) “Identifiable portion” means a reduction in the scope of a project proposed that does not involve a change in the type of project.

(19) “Letter of Intent” means a written communication respecting the development of a Certificate of Need proposal, submitted to the Agency in accordance with the provisions in Rule 59C-1.008, F.A.C., and Section 408.039(2), F.S.

(20) “License” means the granting of a privilege, by the Agency, to operate any facility, service or Agency for which the Agency has regulatory responsibility and is evidenced by the document titled “license” issued by the Agency pursuant to its statutory authority.

(21) “Local Health Council” means a public or private nonprofit health planning Agency established consistent with Section 408.033, F.S., which serves the counties of a District of the Agency as defined in Section 408.032(5), F.S.

(22) “Nongovernmental health care consumer” means an individual who is not a health care provider or a health care purchaser as defined in subsections (16) and (17) of this rule. Nongovernmental health care consumers include but are not limited to elected government officials, members of the general public and representatives of consumer organizations.

(23) “Nursing home” means a health care facility licensed under Chapter 400, Part I, F.S.

(24) “Operate” means to have the legal responsibility, pursuant to the appropriate licensure statute where licensure is required, for the proper functioning of all aspects of a health care facility or service.

(25) “Sheltered nursing home beds” means nursing home beds configured into a nursing home facility licensed pursuant to Chapter 400, Part I, F.S., which are located within a continuing care retirement community certified under Chapter 651, F.S., for which a Certificate of Need has been issued as sheltered beds, and which are regulated under Rule 59C-1.037, F.A.C.

(26) “State Agency Action Report” means the single written document prepared by the Agency after reviewing a Certificate of Need application, or applications where more than one Certificate of Need application is accepted by the Agency in the same batching cycle, which sets forth the evaluation of the Agency with respect to the application or applications.

(27) “Subdistricts” mean a subdivision of a district designated by the local health council as established under Rule 59C-2.200, F.A.C.

(28) “Transfer of a Certificate of Need” means the conveyance of a Certificate of Need which has been issued and remains valid from one person to another person.

(29) “Transfer costs” means any expense actually incurred by the transferor. Costs incurred in implementing the Certificate of Need subsequent to its award are project costs, not transfer costs.

History

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.033(1)(a), 408.036(1), (2), 408.037(1), 408.039(1), (2), 651.118 FS. History–New 1-1-77, Joint Administrative Procedures Committee Objection Filed–See F.A.R. Volume 3, No. 10, March 11, 1977, Amended 11-1-77, 9-1-78, 6-5-79, 4-25-80, 2-1-81, 3-31-82, 7-29-82, 12-23-82, Formerly 10-5.02, Amended 11-24-86, 11-17-87, 12-5-90, 1-31-91, 1-1-92, Formerly 10-5.002, Amended 12-14-92, 2-27-94, 6-23-94, 10-18-95, 10-8-97, 12-12-00, Amendment resolved Joint Administrative Procedures Committee objection, 10-27-77, Florida Administrative Register Vol. 35, No. 27, July 10, 2009, Amended 10-17-19, 9-1-26.

Fla. Admin. Code R. 59C-1.0025 Threshold Adjustment Methodology

History

Rulemaking Authority 408.034(5), 408.15(8) FS. Law Implemented 408.032(1), (15) FS. History–New 1-31-91, Formerly 10-5.0025, Amended 11-11-93, 1-31-94, 2-8-95, 2-12-96, 2-27-97, Repealed 10-8-97.

Fla. Admin. Code R. 59C-1.003 Applicability of Projects for Review

History

Rulemaking Authority 408.034(5), 408.15(8) FS. Law Implemented 408.036 FS. History–New 1-1-77, Amended 6-5-79, 2-1-81, Formerly 10-5.03, Amended 11-17-87, 1-31-91, Formerly 10-5.003, Repealed 10-18-95.

Fla. Admin. Code R. 59C-1.004 Projects Subject to Review

(1) Projects Subject to a Comparative Review. Unless subject to expedited review under Section 408.036(2), F.S., and subsection (2) of this rule, or exempted under Section 408.036(3), F.S., and Rule 59C-1.005, F.A.C., the following projects are subject to comparative review and the batching cycle procedures specified in Rule 59C-1.008, F.A.C., and will be reviewed in accordance with procedures set forth in subsection 59C-1.010(3), F.A.C.:

(a) The addition of beds in community nursing homes or intermediate care facilities for the developmentally disabled (ICF/DD) by new construction or alteration.

(b) The new construction or establishment of additional health care facilities, including a replacement health care facility when the proposed project site is not located on the same site or within five miles of the existing health care facility if within the same subdistrict, if the number of beds in each licensed bed category will not increase and unless exempt pursuant to Section 408.036(3)(j), F.S.

(d) The establishment of a Hospice or Hospice inpatient facility.

(2) Projects Subject to Expedited Review. Unless reviewable under Section 408.036(1), F.S., above or exempted under Section 408.036(3), F.S., the following projects are subject to expedited review, and will be reviewed in accordance with procedures set forth in subsection 59C-1.010(4), F.A.C.:

(a) Sheltered nursing home beds.

(b) Transfer of a Certificate of Need.

(c) Replacement of a nursing home, if the proposed project site is within a 30-mile radius of the replaced nursing home. If the proposed project site is outside the subdistrict where the replaced nursing home is located, the prior six-month occupancy rate for licensed community nursing homes in the proposed subdistrict must be at least 85 percent in accordance with the Agency’s most recently published inventory. The nursing home license holder is the only entity that may submit the application to replace the nursing home, pursuant to paragraph 59C-1.008(1)(h), F.A.C.

(d) Replacement of a nursing home within the same district, if the proposed project site is outside a 30-mile radius of the replaced nursing home but within the same subdistrict or a geographically contiguous subdistrict within the district. In the case that a proposed project site is in a geographically contiguous subdistrict within the district, the prior six-month occupancy rate for licensed community nursing homes for that subdistrict must be at least 85 percent in accordance with the Agency’s most recently published inventory.

(e) Relocation of a portion of the nursing home’s licensed beds to a licensed facility or to establish a new facility within the same district, or a geographically contiguous district if the relocation is within a 30-mile radius of the existing facility and the total number of nursing home beds in the state does not increase as a result of this project.

Applications submitted under this paragraph must be submitted by the licensed nursing home proposing to add the beds or by the applicant proposing to establish a new facility. A letter from the facility from which the beds are being relocated must be submitted certifying that beds will be delicensed should the CON be awarded to the applicant.
The relocation of beds under this paragraph shall be limited to a portion of beds such that the occupancy rate of the remaining licensed beds of the facility from which beds are being relocated does not exceed 92 percent.

(f) New construction of a community nursing home in a retirement community pursuant to the provisions in Section 408.036(2)(e), F.S.

History

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.033, 408.035, 408.036(1), (2), 408.037, 408.038, 408.039 FS. History–New 1-1-77, Amended 11-1-77, 9-1-78, 6-5-79, 4-25-80, 2-1-81, Formerly 10-5.04, Amended 11-24-86, 11-17-87, 1-31-91, 1-1-92, Formerly 10-5.004, Amended 9-10-92, 1-9-95, 11-4-97, 12-12-00, 11-12-01, 8-1-05, 3-16-16, 8-8-21, Joint Administrative Procedures Committee Objection Filed–See FAR Vol. 51, No. 53, March 18, 2025, Amended 12-7-25, Amendment resolved Joint Administrative Procedures Committee objection 12-7-25, Florida Administrative Register Vol. 52, No. 21, February 2, 2026, Amended 8-13-26.

Fla. Admin. Code R. 59C-1.005 Certificate of Need Exemption Procedure

(1) Request for Exemption. Certain projects are subject to exemption from batched or expedited Certificate of Need review pursuant to Sections 408.036(3) and (4), F.S., provided the conditions specified in this rule are met. To receive an exemption, the applicant shall file a Certificate of Need exemption request with the Agency and provide documentation to justify the request. A request for exemption may be submitted at any time, and must be submitted to:

Agency for Health Care Administration

Certificate of Need

2727 Mahan Drive, Mail Stop #28

Tallahassee, Florida 32308

(2) General Requirements. In the case of any applicant filing a Certificate of Need exemption request, the request shall include:

(a) The type of exemption requested, with reference to the authorizing paragraph in Section 408.036(3), F.S. Except as provided in paragraph (6)(a) or (b) of this rule, an exemption request must be limited to a single type of exemption.

(b) The name of the health care facility involved, and the name of the licensee. A request for exemption affecting an existing licensed health care facility must be submitted by the current licensee.

(d) The costs of the project.

(e) The gross square footage of the project, if applicable.

(f) The proposed licensed bed capacity of the health care facility, if applicable.

(g) A non-refundable fee of two hundred and fifty dollars ($250) payable to the Agency for Health Care Administration in accordance with Section 408.036(4), F.S. Exemption requests shall not be accepted by the Agency at the time of receipt unless accompanied by the $250 fee. Checks that are returned by the bank for insufficient funds will be processed consistent with the procedures for expedited review applications specified in subparagraph 59C-1.008(3)(c)1., F.A.C.

(h) The applicable project specific information required by subsection (6) of this rule.

(3) Agency Approval Required. No project shall be implemented until the Agency’s approval has been rendered.

(4) Agency Action. The Agency shall determine if a proposed project is exempted from Certificate of Need review within 30 days of receipt of all documentation required by this rule. The Agency shall forward its written decision to the applicant, and shall provide the applicant with specific reasons in the event that the request is denied. The Agency shall publish its notice of exemptions in the Florida Administrative Register within 30 days of the decision date.

(5) Limitation on Validity. An exemption, when granted, is valid only for the project for which it was issued and for the health care facility on whose behalf the exemption was granted and, for projects subject to the monitoring requirements of Section 408.040, F.S., only for the time frame stated in the Agency’s decision letter approving the exemption project.

(6) Project Specific Exemption Requests. In addition to meeting the requirements of subsections (1) and (2) of this rule, requests for exemption of certain projects must meet the additional requirements specified below:

(a) Combination within one nursing home facility of the beds authorized by two or more certificates of need issued in the same planning subdistrict. A request for exemption of a proposed combination of authorized nursing home beds shall specify:

The number of beds authorized by each Certificate of Need that is being combined.
The current holder of each Certificate of Need that is being combined.
The financial impact of combining the certificates of need.
The intended licensee for the beds included in the combined certificates of need.
An exemption granted under this paragraph extends the validity period of the certificates to be combined by the length of the period starting with submission of the exemption request and ending with issuance of the exemption.
The longest validity period among the certificates that are combined will be the validity period for the combined certificates.
An exemption granted under this paragraph does not authorize transfer of the combined Certificates of Need to another entity. Such transfer requires a Certificate of Need consistent with the provisions of Sections 408.036(2)(a) and 408.042, F.S., and Rule 59C-1.0085, F.A.C.

(b) Division into two or more nursing home facilities of the beds authorized by one Certificate of Need issued in the same planning subdistrict. A request for exemption of a proposed division of authorized nursing home beds shall specify:

The number of beds to be included in each component of the divided Certificate of Need.
The financial impact of dividing the Certificate of Need.
The intended licensee for the beds included in each component of a divided Certificate of Need, if known.
An exemption granted under this paragraph extends the validity period of the certificate to be divided by the length of the period starting with submission of the exemption request and ending with issuance of the exemption. The extension is applicable to each component of the divided Certificate of Need.
An exemption granted under this paragraph does not authorize transfer of the component or components of a divided Certificate of Need to another entity. Such transfer requires a Certificate of Need consistent with the provisions of Sections 408.036(2)(c) and 408.042, F.S., and Rule 59C-1.0085, F.A.C.

(c) Addition of nursing home beds in a number not exceeding 10 beds or 10 percent of the licensed capacity of the nursing home being expanded, whichever is greater. A request for exemption of a proposed addition of nursing home beds shall specify:

The licensed bed capacity of the nursing home proposed to be expanded.
The current number of sheltered beds, if any, included within the licensed bed capacity.
The exact number of beds proposed to be added.
The number of sheltered beds, if any, proposed to be included within the total to be added.
The request shall certify that:

a. The facility has not had any Class I or Class II deficiencies within the 30 months preceding the request for an addition.

b. The average occupancy rate for the nursing home beds at the facility, for the 12-month period ending 1 month prior to the exemption request, meets or exceeds 94 percent. For the purpose of calculating average occupancy under this sub-subparagraph, the 12-month total of patient days shall be divided by 365 to determine an average daily census, and the average daily census shall then be divided by the total of licensed and approved beds as of the end of the 12-month period. Approved beds are beds authorized for the facility consistent with the provisions of paragraph 59C-1.008(2)(b), F.A.C.

c. Any beds previously authorized for the facility by an exemption under this paragraph have been licensed and operational for at least 12 months.

An exemption granted under this subparagraph is subject to the project monitoring requirements of Sections 408.040(2)(a)-(c), F.S., and subsections 59C-1.013(2) and (3), F.A.C., including project progress reports, an 18-month validity period for the exemption, and the circumstances for extension of the validity period.
Beds authorized under this paragraph shall be inventoried as approved beds until the beds are licensed.

(d) Addition of nursing home beds to a facility that has been designated as a Gold Seal nursing home under Section 400.235, F.S., in a number not exceeding 20 beds or 10 percent of the licensed capacity of the nursing home being expanded, whichever is greater. A request for exemption of a proposed addition of nursing home beds shall specify:

The licensed bed capacity of the nursing home proposed to be expanded.
The current number of sheltered beds, if any, included within the licensed bed capacity.
The exact number of beds proposed to be added.
The number of sheltered beds, if any, proposed to be included within the total to be added.
The request shall certify that:

a. The facility has not had any Class I or Class II deficiencies within the 30 months preceding the request for an addition.

c. Any beds previously authorized for the facility by an exemption under this paragraph have been licensed and operational for at least 12 months.

An exemption granted under this subparagraph is subject to the project monitoring requirements of Sections 408.040(2)(a)-(c), F.S., and subsections 59C-1.013(2) and (3), F.A.C., including project progress reports, an 18-month validity period for the exemption, and the circumstances for extension of the validity period.
Beds authorized under this subparagraph shall be inventoried as approved beds until the beds are licensed.

(e) Addition of nursing home beds licensed under Chapter 400, F.S., for a replacement nursing home not to exceed 30 total beds or 25 percent of the number of licensed and approved beds in the facility being replaced according to the provisions in Section 408.036(2)(b), (2)(c) or (3)(j), F.S., whichever is less. A request for exemption of a proposed expansion of authorized nursing home beds must specify:

The licensed bed capacity of the nursing home proposed to be expanded.
The exact number of beds proposed to be added.
The subdistrict location of the facility as defined in Rule 59C-2.200, F.A.C.

(f) The consolidation or combination of licensed nursing homes or transfer of beds between licensed nursing homes within the same planning district, by providers that operate multiple nursing homes within that same planning district, if there is no increase in the planning district total number of nursing home beds as a result of this project and the site of the relocation is not more than 30 miles from the original location. A request for exemption under this paragraph shall specify:

For transfer requests:

a. The name and licensed bed capacity of nursing home from which beds will be transferred.

b. The name and licensed beds capacity of the nursing home to which beds will be transferred.

c. The exact number of beds proposed to be added.

d. The total number of licensed beds at each facility should this exemption be granted.

e. The subdistrict location of each facility as defined in Rule 59C-2.200, F.A.C.

f. The physical location of each facility.

For consolidation or combination requests:

a. The name and licensed bed capacity of each nursing home to be consolidated.

b. The name of the resulting consolidated nursing home.

c. The total number of licensed beds at the consolidated facility should this exemption be granted.

Verification that the providers have shared controlled interest in operating the nursing homes from which beds will either be transferred, consolidated, or combined. Certificate of Need exemption requests under this provision shall require verification that providers operate the nursing facilities in question under a common ownership or control. Verification may include copies of nursing home licenses showing common ownership or appropriate documentation that establishes the subject nursing homes are affiliates through a shared common ownership or controlling interest as defined in Section 408.803(7), F.S. If Agency records indicate information inconsistent with that presented by the requesting parties, then Agency records create a rebuttable presumption as to the correctness of those records and the request for exemption will be denied.

(g) The reestablishment of a health care facility or service. A request for exemption under this paragraph shall specify:

Documentation that the exemption applicant was previously licensed within the past 21 days as a health care facility or provider pursuant to Section 408.036(1), F.S.
The request shall certify that the exemption applicant failed to submit a renewal application.
The request shall certify that the exemption applicant does not have a license denial or revocation action pending with the Agency.
The service type, district, service area and site for the reestablished health care facility or service.
If applicable, the number and type of beds for the reestablished health care facility.
If applicable, identify the conditions that were previously imposed on the certificate of need or exemption related to the exemption applicant’s previously licensed health care facility or service.
The request shall certify that the exemption applicant agrees to the conditions that were previously imposed on the certificate of need or exemption related to the exemption applicant’s previously licensed health care facility or service.
An exemption granted under this paragraph will expire on the 22nd day following the Agency’s approval if the exemption applicant does not apply for an initial license as required under Section 408.806, F.S.

(h) The establishment of a hospice program by a entity that shares a controlling interest with a not-for-profit retirement community that offers independent living, assisted living and skilled nursing services provided in facilities on the same premises as the not-for-profit retirement community. A request for exemption under this paragraph shall specify:

Documentation that the skilled nursing home on premise is designated by the Agency as teaching nursing home in accordance with Section 430.80, F.S., and that the facility has been designated as such for at least five years prior to the exemption request.
Verification that the applicant and the not-for-profit retirement community and the licensed skilled nursing facility have shared controlled interest. Requests under this provision shall require verification that the providers operate the facilities under a common ownership or control. Verification may include copies of licenses as well as a copy of the certificate of authority showing common ownership or appropriate documentation that establishes the subject nursing homes are affiliates through a shared common ownership or controlling interest as defined in Section 408.803(7), F.S. If Agency records indicate information inconsistent with that presented by the requesting parties, then Agency records create a rebuttable presumption as to the correctness of those records and the request for exemption will be denied.
The request shall certify that the exemption applicant does not operate another hospice granted under this provision.
The request shall certify that the exemption applicant wil only serve hospice patients residng in communites located within the not-for-profit retirement community, including home and community-based service providers.
A service authorized under this paragraph shall be inventoried as an approved program until the service is licensed.

History

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.036(3), (4) FS. History–New 1-1-77, Amended 6-5-79, 2-1-81, Formerly 10-5.05, Amended 11-17-87, 3-23-88, 1-31-91, Formerly 10-5.005, Amended 7-13-98, 4-2-01, 11-12-01, 8-18-05, 3-16-16, 9-24-18, 8-8-21, 6-11-25.

Fla. Admin. Code R. 59C-1.008 Certificate of Need Application Procedures

(1) Letters of Intent and applications subject to comparative review shall be accepted in two batching cycles annually each for hospice programs and freestanding inpatient hospice facilities and for nursing homes and intermediate care facilities for the developmentally disabled (ICF/DD), as specified in paragraph (g) of this subsection. The category “hospice” includes proposals for new hospice programs and hospice inpatient facilities. The category “nursing homes and ICF/DDs” includes proposals for community nursing home projects unless the project meets criteria in Section 408.036(2) or (3), F.S., and intermediate care facilities for the developmentally disabled.

(a) Letter of Intent. A letter of intent shall state with specificity the type of project proposed with sufficient clarity to notify the public of the intention to file a Certificate of Need application. A separate letter of intent is required for each type of project and for each type of bed, program or facility having a separate need methodology or licensing category. At least 30 days prior to the applicable batching cycle application due date, an applicant shall file a letter of intent respecting the development of a proposal in the following manner:

The letter of intent must be actually received by the Agency by 5:00 p.m. (local time). The original of the letter of intent must be submitted to the Agency at the address in paragraph 59C-1.008(1)(f), F.A.C.
A letter of intent is for a specific project within a specific geographic planning area as defined by rule or statute for an established planning horizon. When no planning area is defined, the District should be specified.
A prospective applicant submitting a letter of intent is solely responsible for its conformity with any and all statutory and rule criteria.
If an application is not filed on or before the earliest subsequent due date for filing applications of the same type as that specified in the letter of intent, the letter of intent will be considered invalid and a new letter of intent must be timely filed in a subsequent batching cycle before an application may be filed.

(b) The contents of the letter of intent shall be consistent with Section 408.039(2)(c), F.S., and must be a written communication with an original signature. The applicant is solely responsible for the content and clarity of the letter of intent. The Agency shall not assume any facts not clearly stated. Applications should be submitted with one bound copy and one unbound print copy.

(c) As to content, the letter of intent shall describe the proposal with specificity by indicating clearly and unequivocally the following information:

Identification of the applicant means the legal name, mailing address, and telephone number of the applicant.

a. If an existing health care facility seeks to undertake a project subject to a comparative review, then the legal name of the license holder must be stated and the license holder must be the applicant except when the applicant has a pending application to become the new licensee of the existing health care facility filed with the applicable licensure unit within the Agency’s Bureau of Health Facility Regulation. In addition, the license number and date of expiration must be stated. It is the responsibility of the person issued a license to keep licensure information current. If Agency records indicate information different from that presented in the letter of intent with respect to the identification of the holder of the license and the licensure status, then the Agency records create a rebuttable presumption as to the correctness of those records and therefore the letter of intent is not valid.

b. If the proposal is for a project which will result in licensure of a new health care facility, the applicant seeking the Certificate of Need must be in existence at the time the letter of intent is submitted. If the applicant is a corporation, Limited Partnership, or otherwise organized, it must have filed an application with the Florida Department of State authorizing the applicant to conduct business in Florida.

The letter of intent must identify the type of project proposed and shall contain only one project type as described in Section 408.036(1), F.S.
The number of beds sought is indicated by the numerical representation of how many beds of a specific type will compose the proposed project.
Location refers to the health planning subdistricts adopted in Chapter 59C-2, F.A.C., for nursing home projects or the service areas adopted in Rule 59C-1.0355, F.A.C., for hospice projects. The applicant must indicate the subdistrict or service area by name or number. Applicants must also give the name of the county where the proposed project will be located.

(d) Letter of Intent Deadline Extension. In order to provide for a mechanism by which applications may be filed to compete with the proposals described in filed letters of intent the following provisions apply:

In cases where a letter of intent for a specific type of project has been received by the Agency 30 calendar days or more prior to the appropriate application filing due date as set forth in paragraph 59C-1.008(1)(g), F.A.C., and been initially accepted by the Agency, a grace period shall be established.
The grace period provides an opportunity for applicants applying for beds, programs or facilities having the same Certificate of Need need methodology or health care facility licensing category proposed in the initially accepted letter of intent in the same applicable subdistrict or district to file a proposed competing letter of intent. Under this grace period, a competing letter of intent must be filed not later than 16 days after the letter of intent deadline promulgated under paragraph 59C-1.008(1)(g), F.A.C.
It shall be the sole responsibility of the Agency to determine if a letter of intent is competing with any other letter of intent.
The application filing due date shall not be extended for any applicant filing a letter of intent under the requirements of this paragraph unless specified under the provisions of subparagraph 59C-1.008(1)(g)1., F.A.C.
The Agency shall publish notices of filing of letters of intent in the Florida Administrative Register in accordance with Section 408.039(2)(d), F.S.

(e) Failure to comply with the applicable provisions of subsection (1) of this rule will result in the Agency’s rejecting the submitted document as a letter of intent. If rejected by the Agency, the submitted document may not be amended or corrected but a new proposed letter of intent may be submitted if time allows. An application will not be accepted for review in a batching cycle for which a letter of intent has not been accepted by the Agency.

(f) Certificate of Need Application Submission.

An application for a Certificate of Need shall be submitted on AHCA Forms 3150-0001, August 2024 Application For A Certificate of Need, which includes a Cover Page, Schedules A, B, C, D, D-1, 1, 2, 3, 4, 5, 6, 6A, 7, 7A, 7B, 8, 8A, 9, 10 and 11, which are incorporated by reference herein http://www.flrules.org/Gateway/reference.asp?No=Ref-17968. An application for a transfer of a Certificate of Need shall be submitted on AHCA Form 3150-0003, August 2024 Transfer Of A Certificate of Need which includes Schedules 1(TRN), 10(TRN), 11(TRN), 12(TRN), B(TRN), D(TRN), D-1(TRN), in addition to a Cover (TRN) Page, which are incorporated by reference herein http://www.flrules.org/Gateway/reference.asp?No=Ref-17969. Paper copies or copies on electronic media of AHCA Form 3150-0001, August 2024 Application For A Certificate of Need, or AHCA Form 3150-0003, August 2024 Transfer of A Certificate of Need, and the Schedules may be obtained from:

Agency for Health Care Administration

Certificate of Need

2727 Mahan Drive, Mail Stop #28

Tallahassee, FL 32308

Electronic versions of AHCA Forms 3150-0001 and 3150-0003 and the Schedules are also available at https://ahca.myflorida.com/con-application.

The application must be actually received by the Agency by 5:00 p.m. (local time) on or before the application due date.
Applications for projects which exceed the proposed number of beds contained in the letter of intent shall not be deemed complete for review by the Agency and shall be withdrawn from further review.
Applications may propose a lesser number of beds than that contained in the letter of intent.

(g) Applications Subject to Comparative Review – Batching Cycles. In order that applications pertaining to similar types of programs or facilities affecting the same service area, district or subdistrict may be considered in relation to each other for purposes of comparative review, letters of intent and applications shall be received by the agency no later than dates prescribed in the following schedule, unless the date is a designated state holiday then it shall be received by the agency the next business day:

Hospice

1st Batching Cycle

Summary Need Projections Published in the F.A.R.

First Friday in February

Letter of Intent Deadline

Fourth Monday in February

Application Deadline

Last Wednesday in March

Completeness Review Deadline

First Wednesday in April

Application Omissions Deadline

Fourth Wednesday in April

Agency Initial Decision Deadline

Third Friday in June

Hospice

2nd Batching Cycle

Summary Need Projections Published in the F.A.R.

First Friday in August

Letter of Intent Deadline

Fourth Monday in August

Application Deadline

Last Wednesday in September

Completeness Review Deadline

First Wednesday in October

Application Omissions Deadline

Fourth Wednesday in October

Agency Initial Decision Deadline

Third Friday in December

Nursing Homes and ICF/DDs

1st Batching Cycle

Summary Need Projections Published in the F.A.R.

First Friday in April

Letter of Intent Deadline

Third Monday in April

Application Deadline

Third Wednesday in May

Completeness Review Deadline

Fourth Wednesday in May

Application Omissions Deadline

Third Wednesday in June

Agency Initial Decision Deadline

Second Friday in August

Nursing Homes and ICF/DDs

2nd Batching Cycle

Summary Need Projections Published in the F.A.R.

First Friday in October

Letter of Intent Deadline

Third Monday in October

Application Deadline

Third Wednesday in November

Completeness Review Deadline

Fourth Wednesday in November

Application Omissions Deadline

Third Wednesday in December

Agency Initial Decision Deadline

Second Friday in February

Section 408.039(2)(a), F.S. prevails in cases of conflict. In months when the application deadline is less than thirty days from the letter of intent deadline, the application deadline, the completeness review deadline, and the application omissions deadline will be extended by one week. The Agency initial decision deadline will remain the same.
Paragraph 59C-1.008(1)(d), F.A.C., prevails in cases of conflict and summary need projections published in the Florida Administrative Register (F.A.R.) shall be published one week earlier than identified above with all other dates in the batching cycle remaining unchanged.
All dates shall be posted by January 1 of each calendar year on the Agency website at http://ahca.myflorida.com/MCHQ/CON_FA/Batching/index.shtml.

(h) An applicant for a project subject to Certificate of Need review which affects an existing licensed health care facility must be the license holder. The legal name of the license holder must be stated. In addition, the license number and date of expiration must be stated. It is the responsibility of the person issued a license to keep licensure information current. If Agency records indicate information different from that presented in the letter of intent with respect to the identification of the holder of the license and the licensure status, then the Agency records create a rebuttable presumption as to the correctness of those records and therefore the application will be rejected.

(i) The applicant for a project shall not change from the time a letter of intent is filed, or from the time an application is filed in the case of an expedited review project, through the time of the actual issuance of a Certificate of Need. Properly executed corporate mergers or changes in the corporate name are not a change in the applicant.

(2) Fixed Need Pools.

(a) Publication of Fixed Need Pools.

The Agency shall publish in the Florida Administrative Register at least 15 days prior to the letter of intent deadline for a particular batching cycle the Fixed Need Pools for the applicable planning horizon specified for each bed or program in applicable Agency rules contained in Rules 59C-1.0355 and 59C-1.036, F.A.C. In cases of conflict with paragraph 59C-1.008(1)(g), F.A.C., subparagraph 59C-1.008(2)(a)1., F.A.C., prevails, and the summary need projections published in the F.A.R. shall be published one week earlier with all other dates in the batching cycle remaining as noticed in paragraph 59C-1.008(1)(g), F.A.C.
Any person who identifies a mathematical or data input error made by the Agency in its calculation of the Fixed Need Pool numbers must advise the Agency of the error within ten (10) days of the date the Fixed Need Pool was published in the Florida Administrative Register. As used in this section, the term “error” does not include inaccuracies in reports which provide the underlying data required to calculated the Fixed Need Pool numbers if such reports were not produced by the Agency. If the Agency concurs in the error, the Fixed Need Pool number will be adjusted and re-published in the first available edition of the Florida Administrative Register. Failure to notify the Agency of the error during this time period will result in no adjustment to the Fixed Need Pool number for that batching cycle.
Except as provided in subparagraph 2. above, the batching cycle specific Fixed Need Pools shall not be changed or adjusted in the future regardless of any future changes in need methodologies, population estimates, bed inventories, or other factors which would lead to different projections of need, if retroactively applied.

(b) Counting Beds and Programs. For the purpose of establishing a Fixed Need Pool, all existing and approved beds at the time the Fixed Need Pool is computed will be included in the beds or program inventory. If a specific substantive rule addresses the date upon which existing and approved beds and programs will be counted, those rules will take precedence over this rule. In all other cases:

Beds and programs will be counted as approved on the date a Certificate of Need is issued or a written decision of intent to award a Certificate of Need is made, whichever occurs first.
Beds or programs initially denied by the Agency and subsequently granted in Administrative Hearing or by stipulated agreement will be counted as approved when the final order granting them is rendered. No beds or programs previously denied will be included in the inventory based on a recommended order.

(c) Deleting Beds or Programs. Beds or programs will be included in the inventory as long as there is a valid intent to grant or a valid Certificate of Need outstanding. Beds or programs will not be deleted from the inventory until an intent to grant is overturned in a final order or judicial review of the final order. Beds or programs will not be deleted from the inventory until a Certificate of Need is rescinded, revoked, modified, voided, or voluntarily surrendered by an applicant. Licensed beds and programs will be deleted when the license is no longer in effect. The effective date for the deletion will be the date the license was voluntarily surrendered by the license holder, the date of final Agency action in the case of a final order or the date of a court order if a final order is appealed.

(d) The Agency will follow these procedures when awarding beds or programs identified in a Fixed Need Pool:

Beds or programs will be awarded based on the availability of a qualified applicant and proposed project which meets statutory review criteria.
In the absence of a qualified applicant and a project which meets statutory review criteria, the Agency may elect not to approve any applications for beds or services.
If a qualified applicant exists but the proposed project exceeds the beds or programs identified in the Fixed Need Pool, the Agency may award beds or programs in excess of the pool when warranted by special circumstances as defined in the applicable section of Chapter 59C-1, F.A.C., for the particular type of bed or program.

(e) Comparative Review. Applications submitted to the Agency in the same batching cycle for the same program or beds having the same Certificate of Need methodology in the same district or subdistrict, as defined in applicable rules, shall be comparatively reviewed through final Agency action against the same Fixed Need Pools in existence at the initial review. The Fixed Need Pools and other relevant planning information shall be used by the Agency to review the application against all applicable statutory review criteria contained in Section 408.035, F.S., and applicable rules, and policies. If an Agency need methodology does not exist for the proposed project:

The Agency will provide to the applicant, if one exists, any policy upon which to determine need for the proposed beds or program. The applicant is not precluded from using other methodologies to compare and contrast with the Agency policy.
If no Agency policy exists, the applicant will be responsible for demonstrating need through a needs assessment methodology which must include, at a minimum, consideration of the following topics, except where they are inconsistent with the applicable statutory or rule criteria:

a. Population demographics and dynamics;

b. Availability, utilization and quality of like services in the district, subdistrict or both;

c. Medical treatment trends; and,

d. Market conditions.

(3) Filing Fees. Certificate of Need applications shall not be accepted by the Agency at the time of filing unless accompanied by the minimum base Certificate of Need application filing fee in accordance with Section 408.038, F.S. The minimum base fee shall be $10,000. In addition to the base fee of $10,000, the fee shall be 0.015 of each dollar of the proposed expenditure, except that no fee shall exceed $50,000.

(a) For the sole purpose of calculating the application fee, the proposed expenditure includes only the items of cost contributing to the capital expenditures of the proposed project. An application filing fee is non-refundable, unless the application is not accepted by the Agency; or unless an accepted application is deemed incomplete and withdrawn by the Agency as a result of the omissions review, and the withdrawal is not challenged by the applicant, in which case all but the $10,000 base fee shall be refunded. No fees shall be refunded for applications deemed complete by the Agency but subsequently voluntarily withdrawn by the applicant, or for applications deemed incomplete as a result of a legal challenge.

(b) The Agency will review the application to determine if the fee is correct.

If the check for an application is insufficient to cover the fee, the Agency staff will notify the applicant in the omissions request letter.
If the correct fee is not received by the Agency staff by the close of business on the promulgated applicant omissions deadline, the application will be deemed incomplete and deemed withdrawn from further review.
If the check was for more than the correct amount, the Agency staff will process a request for a refund to be returned to the applicant with a letter explaining the refunded amount.

For an expedited review application, when a check is returned by the bank for insufficient funds, the Agency or designee will send a letter to the applicant, stating that the application is incomplete due to failure to pay the Certificate of Need filing fee and that, until the appropriate fee is received, the application cannot be further processed. Notification to the applicant will also state that a service charge of $15 or 5% of the face amount of the check, whichever is less, must be added to the amount due pursuant to Section 215.34(2), F.S. The application will be withdrawn from review if the correct fee is not received twenty-one (21) days from the date of the letter informing the applicant of the insufficient fee.
For a batched review application, when a check is returned by the bank for insufficient funds, the Agency or designee will send the applicant a letter advising the applicant that the application is incomplete and is deemed withdrawn from review.

(4) Certificate of Need Application Contents. An application for a Certificate of Need shall contain the following items:

(a) All requirements set forth in Sections 408.037(1) and (2), F.S.

(b) The correct application fee.

(c) An audited financial statement of the applicant or the applicant’s parent corporation if the applicant’s audited financial statements do not exist. The following provisions apply to audited financial statements:

The audited financial statement of the applicant, or the applicant’s parent corporation, must be for the most current fiscal year. If the most recent fiscal year ended within 120 days prior to the application filing deadline and the audited financial statements are not yet available, then the prior fiscal year will be considered the most recent.
Existing health care facilities must provide audited financial statements for the two most recent consecutive fiscal years in accordance with subparagraph 1., above.
Only audited financial statements of the applicant, or the applicant’s parent corporation, will be accepted. Audited financial statements of any part of the applicant or the applicant’s parent corporation, including but not limited to subsidiaries, divisions, specific facilities or cost centers, will not qualify as an audit of the applicant or the applicant’s parent corporation.

(d) To comply with Section 408.037(1)(b)1., F.S., which requires a listing of all capital projects, an applicant shall provide the total approximate amount of anticipated expenditures for capital projects which meet the definition in subsection 59C-1.002(6), F.A.C., at the time of initial application submission, or state that there are none. An itemized list or grouping of capital projects is not required, although an applicant may choose to itemize or group its capital projects. The applicant shall also indicate the actual or proposed financial commitment to those projects, and include an assessment of the impact of those projects on the applicant’s ability to provide the proposed project; and,

(e) Responses to applicable questions contained in the application forms.

(5) Identifiable Portions. If an applicant would like to be considered for an award of an identifiable portion of the project, the application, at the time of submission, must include responses to the applicable questions on the identifiable portion. The Agency may make a partial award only if the applicant included responses to the applicable questions in the application.

History

Rulemaking Authority 408.034(3), (8), 408.15(8) FS. Law Implemented 408.033, 408.034, 408.035, 408.036, 408.037, 408.038, 408.039, 408.040, 408.042 FS. History–New 1-1-77, Amended 11-1-77, 9-1-78, 6-5-79, 2-1-81, 4-1-82, 7-29-82, 9-6-84, Formerly 10-5.08, Amended 11-24-86, 3-2-87, 6-11-87, 11-17-87, 3-23-88, 5-30-90, 12-20-90, 1-31-91, 9-9-91, 5-12-92, 7-1-92, 8-9-92, Formerly 10-5.008, Amended 4-19-93, 6-23-94, 10-12-94, 10-18-95, 2-12-96, 7-18-96, 9-16-96, 11-4-97, 7-21-98, 12-12-00, 4-2-01, 1-10-02, 6-26-03, 12-13-04, 9-28-05, 10-9-07, 4-21-10, 2-13-12, 8-15-13, 10-29-15, 10-17-19, 12-30-20, 8-28-22, 6-5-25.

Fla. Admin. Code R. 59C-1.0085 Project Specific Certificate of Need Application Procedures for Transfer of a Certificate of Need

In addition to the requirements set forth in Rule 59C-1.008, F.A.C., the following requirements apply to the transfer of a Certificate of Need. As provided in Sections 408.037(2) and 408.034(2), F.S., an applicant for a Certificate of Need must certify that it will license and operate the health care facility or service authorized by the Certificate of Need; and the Agency will not issue a license to any health care facility, part of a health care facility, Hospice, or health care service described in Section 408.036(1) or (2), F.S., which fails to receive a required Certificate of Need. This subsection applies to circumstances where the certificate holder will not be the initial licensee or operator of the authorized project. Such circumstances include, for example, a change in the ownership or licensed operator of the certificate holder. Except as provided in this subsection, such changed circumstances require a Certificate of Need that transfers the authorized project to the intended initial licensee or operator.

(1) An application to transfer a Certificate of Need is subject to an expedited review, as specified in Section 408.036(2)(a), F.S.

(2) The proposed transferee is the applicant for the transfer. The transferor is subject to the limitations on transfer costs specified in Section 408.042, F.S., which must be identified in the application for a transfer.

(3) The application fee for transfer of a Certificate of Need is $10,000 provided there is no increase in the project cost approved for the Certificate of Need that is being transferred. The filing fee for a transfer involving an increase in the project cost shall be calculated based on the amount of increase in accordance with Section 408.038, F.S., and paragraph 59C-1.008(3)(a), F.A.C.

(4) A transfer application is required if the intended licensee or operator for approved nursing home beds in a combined Certificate of Need, as authorized by an exemption under Section 408.036(3)(g), F.S., will be an entity other than the holder of any of the uncombined Certificates of Need.

(5) A transfer application is required if the intended licensee or operator for the approved nursing home beds included in a component or components of a divided Certificate of Need, as authorized by an exemption under Section 408.036(3)(h), F.S., will be an entity other than the holder of the undivided Certificate of Need.

(6) A transfer application will be reviewed in accordance with the review criteria in Section 408.035, F.S.

(7) Upon written request from the transferor received at least 15 days prior to the termination date of the Certificate of Need, and receipt of a transfer application, the Agency will extend the validity period of the proposed transferred Certificate of Need for a period of 60 days, consistent with paragraph 59C-1.018(3)(c), F.A.C.

(8) No transfer application is required if a change in the intended initial licensee or operator of an authorized project occurs because of a corporate merger or a change in the corporate name.

History

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.033, 408.034, 408.036(2), 408.037(3), 408.038, 408.039, 408.042 FS. History–New 1-31-91, Formerly 10-5.0085, Amended 10-18-95, 10-8-97, 12-12-00, 7-19-05, 8-8-21, 2-26-26, Technical Change 6-3-26.

Fla. Admin. Code R. 59C-1.010 Certificate of Need Application Review Procedures

(1) The Agency shall review all applications in the context of the review criteria specified in Section 408.035, F.S., and Chapters 59C-1 and 59C-2, F.A.C., and all information relevant to the criteria contained therein.

(2) General Provisions.

(a) Applications subject to comparative or expedited review shall be submitted to the Agency on AHCA Form 3150-0001, August 2020 “Application For A Certificate of Need” or 3150-0003, August 2020 “Transfer of A Certificate of Need” as referenced in paragraph 59C-1.008(1)(f), F.A.C.

(b) Applications for projects involving an existing health care facility shall be filed by the current license holder as listed on the current Agency license in effect at the time of the applicant omission deadline specified in subparagraph (3)(a)3. or (4)(d)3. of this rule, or the application shall be withdrawn from consideration. Applications submitted by corporations required to have filed incorporation papers or foreign corporation papers in order to do business in Florida must be able to do business in Florida prior to notifying the Agency of its intentions in a comparative review cycle or by the time it files an expedited application, if the project is subject to expedited review.

(c) An application shall not be deemed complete by the Agency unless all information required by statute and rule has been submitted by the applicant.

(3) Comparative Review. Applications subject to comparative review shall be reviewed according to the following timetable:

(a) Completeness Review.

Within 15 calendar days after the application submission deadline promulgated under paragraph 59C-1.008(1)(g), F.A.C., the Agency shall determine whether the application is complete.
If the application is deemed incomplete by the Agency, the Agency shall request in writing from the applicant specific information necessary for the application to be deemed complete.
If an applicant does not provide the specific additional information required by statute and rule in writing to the Agency within 21 calendar days of the receipt of the Agency’s request, the application shall be deemed withdrawn from consideration. The applicant’s response must be received by the Agency no later than 5:00 p.m. (local time) on or before the omissions due date promulgated under paragraph 59C-1.008(1)(g), F.A.C.

(b) The Agency shall deem the application complete or withdrawn within 7 calendar days of the receipt of the requested information. Subsequent to an application being deemed complete or withdrawn by the Agency, no further application information or amendment will be accepted by the Agency.

(c) The Agency shall conduct public hearings in accordance with the provisions in Section 408.039(3)(b), F.S. The presiding officer at the hearing will be assigned by the Agency, or the Local Health Council. Unless otherwise ordered by the presiding officer, the applicant and those in support of the proposal will speak followed by those opposing the proposal, and the applicant may then present rebuttal information. The Agency will preserve the proceedings at the hearing.

(d) The Agency shall issue a State Agency Action Report within 60 calendar days from the date the application is deemed complete unless the review period is extended pursuant to subsection (6) of this rule.

(4) Expedited Review. Applications subject to expedited review shall be reviewed according to the following timetable:

(a) Applications shall not be accepted for an expedited review unless they are submitted at least 90 days prior to the implementation of the project. Transfer applications shall be accepted consistent with the provisions of paragraph 59C-1.0085(1)(g), F.A.C.

(b) All such applications shall be exempt from the batching requirements set forth in paragraph 59C-1.008(1)(g), F.A.C.

(c) No letter of intent or letter of intent publication, as prescribed by subsection 59C-1.008(1), F.A.C., shall be required.

(d) Completeness Review.

Within 15 calendar days of receipt of an application by the Agency, the Agency shall determine whether the application is complete.
If the application is deemed incomplete by the Agency, the Agency shall request in writing from the applicant specific information necessary for the application to be deemed complete.
If an applicant does not provide the specific additional information required by statute and rule in writing to the Agency within 21 calendar days of the receipt of the Agency’s request, the application shall be deemed withdrawn from consideration.

(e) The Agency shall deem the application complete or withdrawn within seven calendar days of the receipt of the requested information. Subsequent to an application being deemed complete by the Agency, no further application information or amendment will be accepted by the Agency, unless a statutorily required item was omitted and the Agency failed to clearly request the specific item in its omissions request. In the later case, the application may be supplemented only with the omitted item.

(f) A public hearing shall be held only if the Agency determines there are issues of significant public interest related to the proposed project.

(g) The Agency shall issue a State Agency Action Report within 45 calendar days from the date the application is deemed complete unless the review period is extended pursuant to subsection (6) of this rule.

(5) Issuance of State Agency Action Report.

(a) The Agency shall issue a State Agency Action Report describing the Agency’s findings for each application deemed complete. All applications that were comparatively reviewed shall be described in a single State Agency Action Report. The report shall state the Agency’s intent to grant or deny certificates of need for projects in their entirety or for identifiable portions thereof, and state the conditions required of the Certificate of Need holder, if any. The Agency Secretary or their designee shall sign State Agency Action Reports. The Agency shall publish its notice of intent, as set forth in the State Agency Action Report, in the F.A.R. within 14 calendar days after the State Agency Action Report is issued. A notice of intent and State Agency Action Report shall be mailed to each applicant. The Agency decision embodied in the State Agency Action Report to grant additional beds, services, or programs will be reflected in the Agency’s inventories.

(b) If there is no challenge to all or any part of the Agency decision embodied in the State Agency Action Report within 21 days after the publication of the notice of intent, consistent with Rule 59C-1.012, F.A.C., the State Agency Action Report shall become the final order of the Agency. The Certificate of Need shall be signed by the Secretary of the Agency or their designee and shall become effective on the date when the final order is filed in the Office of the Agency Clerk.

(c) If a request for an Administrative Hearing is filed timely, and a final order is subsequently entered which grants a Certificate of Need in whole or in part, a Certificate of Need shall be signed by the Secretary of the Agency or their designee. The Certificate of Need shall become effective on the date when the final order is filed in the Office of the Agency Clerk. The Agency shall provide a copy of the final order to the local health councils.

(d) The Agency shall issue a Certificate of Need according to the timeframes specified in subsection (3) or (4) of this rule, specifying the scope of the project, any conditions placed on the Certificate of Need, and an approved dollar amount for the project in its entirety or for identifiable portions of the total project; or the Agency shall deny a Certificate of Need for the project in its entirety. The Agency may impose conditions on a Certificate of Need predicated upon statements of intent expressed by an applicant in the Certificate of Need application, which the Agency relied upon in its decision to issue the Certificate of Need, and which relate to the criteria set forth in Section 408.035, F.S., and Chapters 59C-1 and 59C-2, F.A.C.

(6) Review period extension. The Agency shall issue a State Agency Action Report pursuant to the timeframes specified in Section 408.039(4), F.S., and this rule unless an extension is granted by written mutual agreement of all applicants which are subject to comparative review in the applicable batching cycle, or an applicant subject to expedited review, and the Agency.

(7) For purposes of the administration of the Health Facility and Services Development Act, any oral or written communication, regarding the merits of a specific application, between the applicant, any person acting on behalf of the applicant, or any person opposing the application and any person in the Agency who exercises any responsibility respecting the application, subsequent to an application being deemed complete pursuant to paragraph (3)(b) or (4)(e) of this rule, and prior to the time of the Agency’s determination pursuant to paragraph (3)(d) or (4)(g) or this rule, is prohibited.

History

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.033(1), 408.036(2), 408.039(3), (4), (5) FS. History–New 1-1-77, Amended 11-1-77, 9-1-78, 6-5-79, 4-25-80, 2-1-81, 3-31-82, 12-23-82, Formerly 10-5.10, Amended 11-24-86, 11-17-87, 3-23-88, 8-28-88, 1-31-91, 7-1-92, 7-14-92, Formerly 10-5.010, Amended 10-8-97, 12-12-00, 4-2-01, 6-23-05, 4-21-10, 8-8-21, 6-11-25.

Fla. Admin. Code R. 59C-1.0105 Certificate of Need Post Application Review Procedures

(1) Batched Reviews. The following procedure will be utilized in issuance of letters of intent to grant or deny a Certificate of Need in a batched review:

(a) Upon signature of the State Agency Action Report by the Agency Director or designee, a letter of intent to grant or deny will be sent to the applicant.

(b) A notice of the Agency’s Intent to Issue or Deny will be published in the Florida Administrative Register. This notice will report initial Agency action and include: the Certificate of Need number, type of project, District and, if applicable, subdistrict location.

(c) If the initial Agency action is to issue a Certificate of Need and there is no valid request for an Administrative Hearing or timely appeal, a Certificate of Need will be prepared no later than 35 days following the publication in paragraph (1)(b) above. The issuance date of the Certificate of Need will be the 22nd day following the publication in paragraph (1)(b) above.

(d) If the initial Agency action is appealed, the issuance or denial of the Certificate of Need is dependent upon the method of resolution.

(e) If the initial Agency action is to deny a Certificate of Need and no valid request for an Administrative Hearing has been filed, a letter advising the applicant that the initial decision has become the final decision by the operation of law will be prepared no later than 35 days following publication in paragraph (1)(b) above. The effective date of the denial will be the 22nd day following the publication in paragraph (1)(b) above.

(f) If the initial Agency action is to approve an identifiable portion of an application, then this action also contains an initial Agency action to deny the full application. If there is no valid request for an Administrative Hearing, a Certificate of Need will be issued for the identifiable portion, a letter recognizing the operation of law will be prepared no later than 35 days following publication in paragraph (1)(b) above. The effective date of the denial will be the 22nd day following the publication in paragraph (1)(b) above.

(2) Expedited Reviews. The following procedure will be followed regarding letters of transmittal and issuance of a Certificate of Need:

(a) Upon the signing of the State Agency Action Report by the Agency Director or designee, a Certificate of Need or denial letter will be sent to the applicant.

(b) If the decision is to approve the application, then the Certificate of Need will be signed at the same time as the State Agency Action Report. The issuance date of the Certificate of Need will be the same date as the signing of the State Agency Action Report by the Agency Director or the designee.

(c) If the decision is to deny an application, then the transmittal letter denying the project will be signed at the same time as the State Agency Action Report. The denial date will be the same date as the signing of the State Agency Action Report by the Agency Director or the designee.

(d) If the decision is to approve an identifiable portion of the application and deny the remaining portion, then a transmittal letter will be prepared and a Certificate of Need will be issued for the approved identifiable portion. The transmittal letter and the Certificate of Need will reflect the same date as the signing of the State Agency Action Report by the Agency Director or the designee.

(e) Expedited review decisions will be published in the Florida Administrative Register.

(3) Stipulated Agreements. The following procedures will be followed in issuing a Certificate of Need issued as a result of a stipulated agreement:

(a) A Certificate of Need issued pursuant to a stipulated agreement will be prepared and sent to the affected applicant within seven (7) working days of the rendering of a final order.

(b) The issuance date of a Certificate of Need issued pursuant to a stipulated agreement will be the date the final order was rendered.

(4) Final Orders. The following procedures will be used in issuing a Certificate of Need pursuant to a final order:

(a) A Certificate of Need will be prepared and sent, by the Agency, to the affected applicant within seven (7) working days of the rendering of the final order.

(b) The issuance date of a Certificate of Need issued will be the date the order was rendered.

(5) Appeals. The following procedures will be used in issuing a Certificate of Need approved as a result of an appeal to the First District Court of Appeal or the Supreme Court.

(a) Certificate of Need issued pursuant to an appeal will be prepared and sent to the affected applicant within seven (7) working days of receipt of the court’s mandate by the Agency.

(b) The issuance date of a Certificate of Need will be the date the court’s mandate was received by the Agency.

History

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.035, 408.036(2), 408.039(3), (4), (5) FS. History–New 1-31-91, Formerly 10-5.0105.

Fla. Admin. Code R. 59C-1.012 Administrative Hearing Procedures

(1) Administrative Hearings shall be conducted pursuant to the timeframes and conditions specified in Section 408.039(5), F.S. A request for an Administrative Hearing shall be filed with the Agency within 21 days after publication of the Notice of Intent in the F.A.R. by the Agency. The failure of a noticed intended denied applicant to timely file a proper request for Administrative Hearing challenging the denial of its application shall result in the denial becoming final Agency action with respect to such applicant, and the application being severed from the remainder of the batch.

(2) If a valid request for Administrative Hearing is timely filed challenging the noticed intended award of any Certificate of Need application in the batch, that challenged granted applicant shall have ten days from the date the notice of litigation is published in the Florida Administrative Register to file a petition challenging any or all other cobatched applications.

(a) If no valid request for Administrative Hearing is timely filed challenging the noticed intended award of a Certificate of Need to an applicant, there is no pending challenge to the applicable published Fixed Need Pool projection, and there has been no petition filed pursuant to subsection (2), the noticed intended granted application shall be severed from the rest of the batch and become final Agency action with respect to such application. If there are pending challenges to the applicable published Fixed Need Pool projection, no noticed intended granted application can be severed from the batch and become final Agency Action, unless the application is withdrawn.

(b) If all requests for Administrative Hearings challenging a noticed intended award of a CON, and all challenges to the relevant published Fixed Need Pool projection, if any, are subsequently voluntarily dismissed, the unchallenged noticed intended granted application shall be severed from the remainder of the batch and the noticed intended award shall become final Agency action with respect to such applicant. If there remain any pending challenges to the applicable published Fixed Need Pool projection, no noticed intended granted application can be severed from the batch and become final Agency Action, unless the application is withdrawn.

(c) For purposes of comparative hearing on any remaining applications in the batch, the beds or services awarded to unchallenged noticed intended granted applications in the batch which have become final Agency Action shall automatically be subtracted from the unchallenged numeric Fixed Need Pool projection applicable to the batch, even if the projection is zero, and it shall be conclusively presumed that the award of Beds or Services in the batch which have become final Agency action will become operative in the service area in accordance with the representations contained in the Certificate of Need application leading to approval.

History

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.039(5), (6) FS. History–New 1-1-77, Amended 9-1-78, 6-5-79, 10-23-79, 4-25-80, Formerly 10-5.12, Amended 11-24-86, 11-17-87, Formerly 10-5.012, Amended 12-14-92, 4-21-10, 8-8-21, Joint Administrative Procedures Committee Objection Filed–See FAR Vol. 51, No. 53, March 18, 2025, Amended 12-7-25, Amendment resolved Joint Administrative Procedures Committee objection 12-7-25, Florida Administrative Register Vol. 52, No. 21, February 2, 2026.

Fla. Admin. Code R. 59C-1.013 Monitoring Procedures

(1) General Provisions. The Agency, with the assistance of the local health councils, shall monitor the Certificate of Need holder’s progress in meeting the approved timetable for project development. In addition, the Agency shall monitor the holder’s compliance with conditions as specified on the Certificate of Need. A condition is defined as a specific requirement expressed on the face of a Certificate of Need under the heading “conditions”.

(2) Project Status Reports.

(a) The Agency shall require the Certificate of Need holder to provide periodic status reports regarding progress in meeting the timetable. The timetable submitted with the application or otherwise modified by agreement between the Certificate of Need holder and the Agency is binding for the following steps:

Commence construction,
Construction completed,
Survey for certificate of occupancy,
Licensure of project; and,
Facility in use.

Prior to commencing construction, the Certificate of Need holder will submit a revised project timetable, if necessary, which specifies the month, day, and year for completion of each of the five steps identified above.

(b) The status reports shall be submitted on AHCA Form CON-2, Revised July 1997, and incorporated by reference herein. A copy of Form CON-2 may be obtained from:

Agency for Health Care Administration

Certificate of Need

2727 Mahan Drive, Mail Stop #28

Tallahassee, FL 32308

(c) A status report covering the first 15 months from the date of issuance of a Certificate of Need shall be received by the Agency no later than 14 calendar days after the end of the reporting period.

(3) Reporting Requirements Subsequent to Licensure or Commencement of Services. All holders of a Certificate of Need that was issued predicated upon conditions expressed on the face of the Certificate of Need shall provide annual compliance reports to the Agency. The reporting period shall be January 1 through December 31 of each year. The holder of a Certificate of Need who began operation after January 1 will report from the date operation began through December 31. The compliance report shall be submitted no later than April 1 of the subsequent year.

(a) The compliance report will contain information necessary for an assessment of compliance with conditions on the Certificate of Need, utilizing measures, such as a percentage of patient days, that are consistent with the stated condition. The following information shall be provided in the holder’s annual compliance report:

The time period covered by the measures,
The measure for assessing compliance with each of the conditions identified and described on the face of the Certificate of Need,
The way in which the conditions were evaluated by applying the measures,
The data sources used to generate information about the conditions that were measured,
The person and position responsible for supplying the compliance report,
Any other information necessary for the Agency to determine compliance with conditions; and,
If applicable, the reason or reasons, with supporting data, why the Certificate of Need holder was unable to meet the conditions set forth on the face of the Certificate of Need.

(b) A change in the licensee for a facility or service does not affect the obligation for that facility or service to continue to meet conditions imposed on a Certificate of Need and to provide annual condition compliance reports.

(4) Violation of Certificate of Need Conditions. Health care providers found by the Agency to be in noncompliance with conditions set forth in their Certificate of Need shall be fined as defined in Rule 59C-1.021, F.A.C.

History

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.040(1), (2) FS. History–New 1-1-77, Amended 11-1-77, 9-1-78, 6-5-79, 2-1-81, 3-31-82, Formerly 10-5.13, Amended 11-24-86, 7-25-89, Formerly 10-5.013, Amended 10-18-95, 11-4-97, 12-12-00, 4-21-10.

Fla. Admin. Code R. 59C-1.017 Local Health Councils

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.033(1)(a) FS. History–New 7-15-82, Amended 10-1-83, Formerly 10-5.17, Amended 11-24-86, Formerly 10-5.017, Repealed 10-18-95.

Fla. Admin. Code R. 59C-1.018 Termination of Certificate of Need

(1) Validity Period of Certificate of Need. A Certificate of Need shall terminate 18 months from the date of issuance unless the holder meets the applicable conditions for an extension set forth in Section 408.040(2), F.S., and this rule.

(2) Undertaking a Project Authorized by a Certificate of Need. A Certificate of Need will terminate after the 18-month time frame set forth in subsection (1) unless the applicant meets one of the minimum requirements described below:

(a) Certificates of Need for New Construction or Renovation Projects.

A holder of a Certificate of Need with a project for new construction must, by the date of termination of the Certificate of Need, be deemed to have commenced continuous construction as defined in Section 408.032(4), F.S. For purposes of compliance, site preparation must be completed as defined below:

a. Completion of site preparation activities which include clearing of land, removal of soil, placement and compacting of fill dirt, and grading and leveling of the site for that portion of the site which will contain the foundation;

b. Foundation permit;

c. Completion of footprint of the certificated portion of the building, unless the contractor is building a hospital using the fast-track method of construction and the agreement between the contractor and the Certificate of Need holder provides for the use of that method; and,

d. Foundation forming with placement of concrete and steel which will become an integral part of the final facility to be constructed.

A holder of a Certificate of Need for renovation of an existing structure must, by the date of termination of the Certificate of Need, be deemed to have commenced construction. This is established by completing site preparation which is defined as having a demolition permit or building permit, having an executed owner or contractor agreement, and demonstrating proof of the commencement of demolition.
The Agency staff or a designated representative shall make an unannounced visit to each project site on the termination date of the Certificate of Need. The visit shall result in photographs of the site and a written report. The Certificate of Need holder may submit information for evaluation to the staff of the Agency or the designated representative on the day of the site visit. On or before 14 calendar days of receipt of the information, staff designated by the Agency shall evaluate the information and make a determination of whether or not the project has commenced construction.

a. If deemed to have commenced construction, continuous construction must be maintained. For purposes of monitoring compliance, “continuous construction” refers to work performed under the authority of an architect to whom the contractor is responsible and which advances the project towards completion in accordance with the project timetable and standard, acceptable construction procedures. Any return to site preparation as defined in sub-subparagraphs 59C-1.018(2)(a)1.a.-d., F.A.C., without approval, as provided in paragraphs 59C-1.021(2)(a) and (b), F.A.C., of the Agency is strictly prohibited and is deemed not to be continuous construction.

b. If deemed not to have commenced construction, the holder of the Certificate of Need shall be notified, in writing, of the determination and the right to a hearing under Section 120.57, F.S., by the director or his or her designee from the Agency. The Certificate of Need shall terminate by operation of law.

(b) Certificates of Need for Non-construction Projects.

A holder of a Certificate of Need for a non-construction project including Hospice, bed conversions and establishment of new health services, or a substantial change in such services, must provide proof of having made an enforceable capital expenditure greater than 10% percent of the total project cost, or have received appropriate licensure and certification by the date of termination of the Certificate of Need.
A holder of a Certificate of Need who undertook a project authorizing the offering of a new service for which there is neither construction nor enforceable capital expenditure must provide utilization data to the Agency within 30 calendar days after the termination date of the Certificate of Need. The data must demonstrate that the service became operational on or before the termination date of the Certificate of Need.

(3) Extension of Validity Period.

(a) Extensions of up to 60 calendar days per each request may be requested by a Certificate of Need holder who is approaching the end of the 18-month validity period. The holder must submit a written request to the Agency for approval at least 15 calendar days before the Certificate of Need terminates. The filing of a request does not extend the validity period of a Certificate of Need. Failure to timely file is a waiver of the right to request an extension. This request for an extension must demonstrate that good faith commencement of the project is being delayed by litigation or by governmental action or inaction with respect to regulations or permitting which precludes commencement on the project. The request must provide the Agency a detailed explanation of the problem and a plan of action to be undertaken by the holder to resolve the problem within the time frame requested.

Land zoning issues will be considered for extension of the Certificate of Need validity period beyond the 18 months, if the Certificate of Need holder can demonstrate that action has been initiated to obtain proper zoning for the proposed site for the facility, and that such action was timely with respect to the requirements for obtaining proper zoning.
Untimely filing of submission of plans and requests for local and state permits, based on the processing time required by the state and local governments for such plans and permits, will not be considered as justification for an extension beyond the 18-month period.

(b) Where the holder of a valid Certificate of Need is precluded from commencement of the project due to litigation, including appeal, or if the holder’s Certificate of Need is the subject of an appeal of a final order approving the issuance of the Certificate of Need, an extension of the validity period shall be granted for the actual amount of time of the validity period which is equivalent to the period of litigation, including appeal. The holder of a Certificate of Need shall submit a request for an extension to the Agency, in writing, not later than 15 calendar days prior to the termination date.

(c) Upon written request from the holder of a Certificate of Need received at least 15 days prior to the termination date of the Certificate of Need, and upon submission of a transfer application by the proposed transferee, the Agency will extend the validity period of the proposed transferred Certificate of Need for a period of 60 days to ensure that the Certificate of Need remains valid throughout the Agency’s timetable for review of the transfer application. Only one such request for a 60 day extension will be granted under the provisions of this subsection.

History

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.040(2) FS. History–New 11-24-86, Amended 7-25-89, Formerly 10-5.018, Amended 10-8-97, 12-12-00.

Fla. Admin. Code R. 59C-1.019 Modification of Certificate of Need

(1) A modification is defined as an alteration to an issued, valid Certificate of Need, or an alteration to the condition or conditions on the face of a Certificate of Need for a health facility or service that has been licensed, where such an alteration does not result in a project subject to review as specified in either Section 408.036(1) or (2), F.S.

(2) A Certificate of Need holder desiring modification of a Certificate of Need shall submit a written request to the Agency documenting good cause for modification. A request to reduce the number of beds granted in a Certificate of Need prior to licensure of the beds shall show the financial impact of the reduction by revising Schedules 1 and 3 and 7 and 8 or 7a and 8a that were submitted with the application for a Certificate of Need, as found in AHCA Form 3150-0001, August 2020 and incorporated by reference in paragraph 59C-1.008(1)(f), F.A.C.

(3) Good cause includes, for example:

(a) Changes in the adequacy of reimbursement, or

(b) Changes in the overall ability of the health care facility or Hospice for which the Certificate of Need was issued to cover its costs if such changes are of such a degree that the continued viability of the health care facility or Hospice is seriously threatened, or

(4) The Agency shall amend the Certificate of Need if the modification is approved.

History

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.040(1)(c) FS. History–New 11-24-86, Amended 7-25-89, Formerly 10-5.019, Amended 2-5-98, 12-12-00.

Fla. Admin. Code R. 59C-1.020 Effect on Licensure

History

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.034(2) FS. History–New 11-24-86, Amended 7-25-89, 1-31-91, Formerly 10-5.020, Amended 12-12-00, Repealed 8-8-21.

Fla. Admin. Code R. 59C-1.021 Certificate of Need Penalties

(1) General Provisions. The Agency shall initiate administrative proceedings for revocation of a Certificate of Need for violation of Sections 408.040(2)(a) and (b), F.S., or the assessment of administrative fines for failure to comply with conditions placed on a Certificate of Need as specified under Rule 59C-1.013, F.A.C.

(2) Certificate of Need Revocation. The Agency shall issue an administrative complaint seeking revocation of a Certificate of Need if the Agency determines that the Certificate of Need holder has not made a good faith effort to undertake the project as approved or to meet the approved project timetables. A holder shall be deemed to have made a “good faith effort” if the following requirements are met.

(a) Projects which cease continuous construction for a period in excess of 30 calendar days shall perform the following steps:

Within 35 calendar days of work stoppage, notify the Agency in writing of a break in construction and submit for approval, documentation verifying the holder’s inability to control the break in construction.
Within 45 calendar days of work stoppage, submit to the Agency for approval, a plan for recommencement of construction not to exceed 90 calendar days. The revised dates may increase the amount of time elapsed within and among the steps set forth in the original application for completion of the project.
Within 15 calendar days of the projected restart time, the holder shall submit to the Agency a letter from the project’s architect certifying that the project has restarted construction in accordance with the approved plan submitted under this paragraph.

(b) Projects which are more than 30 calendar days behind on any time frame set forth in the approved timetable shall perform the following steps:

Within 5 calendar days of not having met the construction phase identified in the approved timetable, notify the Agency by telephone followed by a letter within 2 calendar days of the telephone call, or by letter of the delay.
Within 10 calendar days of notification, submit to the Agency for approval, documentation of the holder’s inability to control the situation which has caused the slow-down in the specific construction phase.
Within 5 calendar days of approval by the Agency of documents submitted in accordance with paragraphs 59C-1.021(2)(a) and (b), F.A.C., the Certificate of Need holder shall submit a revised timetable for project completion to the Agency for approval. The revised dates may increase the amount of time elapsed within and among the steps set forth in the original application for completion of the project.

(3) Penalties for Failure to Comply with Certificate of Need or Exemption Conditions. The Agency shall review the annual compliance report submitted by the health care providers who are licensed and operate the facilities and other pertinent data to assess compliance with Certificate of Need or exemption conditions. Providers who are not in compliance with Certificate of Need or exemption conditions shall be fined. Failure to report compliance with any condition upon which the issuance of the Certificate of Need or exemption was predicated constitutes noncompliance. The schedule of fines is as follows:

(a) Facilities failing to comply with any conditions or failing to provide the Certificate of Need office with a report on its compliance with conditions set forth on the Certificate of Need or exemption, will be assessed a fine, not to exceed $1,000 per failure per day. In assessing the penalty the Agency shall take into account the degree of noncompliance.

(b) The assessed fine shall be paid to the Agency within 45 calendar days after written notification of assessment by certified mail or within 30 calendar days after final Agency action if an Administrative Hearing has been requested. If a health care provider desires it may remit payment according to a payment schedule accepted by the Agency. The health care provider must submit the schedule of payments to the Agency within 30 calendar days after the date of receipt of the notification of assessment or 21 calendar days after final Agency Action. The final balance will be due no later than 6 months after the health care provider has been notified in writing by the Agency of the amount of the assessed fine or six months after final Agency Action.

(4) The Agency will investigate any person who constructs a facility or operates a service without a Certificate of Need as required under the Health Facility and Services Development Act.

(a) The Agency will notify the person of the allegations in writing. The person may respond in writing to the Agency as to the merits of the alleged violation within 10 calendar days of receipt of the notice of complaint. If an investigation is conducted, a written preliminary report will be prepared by the Agency.

(b) The Agency will prepare a final report and will provide a copy to the person and the complainant, if there is one, within a period not to exceed 90 calendar days of the preliminary report.

(c) Upon substantiation of the complaint, the Agency shall take appropriate action to resolve the complaint. Action may include but is not limited to:

Recourse described in Section 408.044, F.S.,
Referring the complaint to the State Attorney’s office for relief as defined under Section 775.082, 775.083 or 775.084, F.S., or
Seeking revocation of the license as appropriate.

History

Rulemaking Authority 408.040(2)(a), 408.034(8), 408.15(8) FS. Law Implemented 408.034(8), 408.040(1)(b), (d), (2)(a), 408.044, 408.061(6), 408.08(2) FS. History–New 7-25-89, Formerly 10-5.021, Amended 12-13-04, 8-8-21, 6-11-25.

Fla. Admin. Code R. 59C-1.022 Health Care Facilities Fee Assessments and Fee Collection Procedures

(1) Health Care Facilities Subject to Assessment. In accordance with Section 408.033(2), F.S., the following health care facilities and health care service providers, licensed or certified by the Agency for Health Care Administration, shall be assessed an annual fee to be collected prospectively by the Agency within the time frames specified in subsection (4):

(a) Abortion clinics licensed under Chapter 390, F.S.

(b) Assisted living facilities licensed under Chapter 429, Part I, F.S.

(d) Birth centers licensed under Chapter 383, F.S.

(e) Health maintenance organizations certified under Chapter 641, Part I, F.S., and prepaid health clinics certified under Chapter 641, Part II, F.S.

(f) Home health agencies licensed under Chapter 400, Part III, F.S.

(g) Hospices licensed under Chapter 400, Part IV, F.S.

(h) Hospitals licensed under Chapter 395, Part I, F.S.

(i) Intermediate care facilities for developmentally disabled persons licensed under Chapter 400, Part VIII, F.S.

(j) Nursing homes licensed under Chapter 400, Part II, F.S.

(k) Health care clinics licensed under Chapter 400, Part X, F.S.

(2) Health Care Facilities Exempted from Fee Assessments. Facilities operated by the Department of Children and Families, the Department of Health or the Department of Corrections, and any hospital which meets the definition of a rural hospital pursuant to Section 395.602, F.S., are exempted from the health care facility assessment.

(3) Health Care Facility Assessments. The annual fee amount for each health care facility and health care service provider regulated under this rule is as follows:

(a) Hospitals, nursing homes, and assisted living facilities shall be assessed a fee according to the following per bed charges:

Hospitals shall be assessed an annual fee of $2 per bed not to exceed a total of $500 per facility.
Nursing homes shall be assessed an annual fee of $2 per bed not to exceed a total of $500 per facility.
Assisted living facilities shall be assessed an annual fee of $1 per bed not to exceed $150 per facility.

(b) Other health care facilities subject to a health care facility assessment, as specified in paragraphs (1)(a), (c), (d), (e), (f), (g), (h), (j), (l) and (m), shall be assessed an annual fee of $150.

(4) Prospective Collection and Biennial Billing Process. Beginning July 1, 2013, the assessment from all facilities listed in subsection (1) in accordance with the fee schedule specified in subsection (3) shall be collected prospectively for a two year (biennial) period. The biennial period equals two annual assessments (Minimum Annual Assessment x 2) calculated based on the annual fee schedule specified in subsection (3).

(a) For Initial and Change of Ownership applications, the biennial assessment shall be calculated at the time the license is issued. The assessment shall be due within 21 days of issuance of the license.

(b) For Renewal applications, the biennial assessment shall be calculated at the time of the licensure renewal and shall be due at the time of filing of the renewal application.

(c) Transition to biennial billing ‒ Facilities shall be billed a prorated assessment from July 1, 2013 through the license renewal date. The assessments billed under this subsection will be due September 1, 2013. All subsequent assessments shall be due at the time of renewal as described in paragraph (b).

(5) Delinquent Account. The health care facility assessment is considered delinquent when the assessment is not received by the Agency by the due dates specified in subsection (4).

(6) Penalties. In accordance with Section 408.033(2)(e), F.S., the Agency shall impose a fine of $100 per day, not to exceed the total annual amount of the assessment, after the assessment becomes delinquent as specified in subsection (5). Failure to pay the annual assessment or fine shall result in license revocation or denial.

(7) Dishonored Checks. The Agency shall assess a service charge for each returned check of five percent of the face value of the check or $15, whichever is greater.

History

Rulemaking Authority 408.033(2), 408.034(8), 408.15(8) FS. Law Implemented 408.033(2) FS. History–New 12-7-88, Amended 11-29-89, 12-5-90, 8-19-91, Formerly 10-5.022, Amended 6-16-05, 6-20-13, 8-8-21, 6-11-25.

Fla. Admin. Code R. 59C-1.023 Acquisition of Health Care Facilities

History

Rulemaking Authority 408.15(8), 408.034(5), 408.036(1)(i) FS. Law Implemented 408.032, 408.034, 408.036(1)(i) FS. History–New 7-25-89, Amended 5-1-90, Formerly 10-5.023, Repealed 4-2-01.

Fla. Admin. Code R. 59C-1.024 Public Access to Certificate of Need Records

History

Rulemaking Authority 408.034(5), 408.15(8) FS. Law Implemented 119.07 FS. History–New 1-31-91, Amended 8-9-92, Formerly 10-5.024, Repealed 10-18-95.

Fla. Admin. Code R. 59C-1.030 Criteria Used in Evaluation of Applications

In addition to criteria set forth in Section 408.035, F.S., the following health care access criteria are used in the review of an application.

(1) The need that the population served or to be served has for the health or Hospice services proposed to be offered or changed, and the extent to which all residents of the district, and in particular low income persons, racial and ethnic minorities, women, handicapped persons, other underserved groups and the elderly, are likely to have access to those services.

(2) The extent to which that need will be met adequately under a proposed reduction, elimination or relocation of a service, under a proposed substantial change in admissions policies or practices, or by alternative arrangements, and the effect of the proposed change on the ability of members of medically underserved groups which have traditionally experienced difficulties in obtaining equal access to health services to obtain needed health care.

(3) The contribution of the proposed service in meeting the health needs of members of such medically underserved groups, particularly those needs identified in the applicable local health plan and State health plan as deserving of priority.

(4) In determining the extent to which a proposed service will be accessible, the following will be considered:

(a) The extent to which medically underserved individuals currently use the applicant’s services, as a proportion of the medically underserved population in the applicant’s proposed service area, and the extent to which medically underserved individuals are expected to use the proposed services, if approved,

(b) The performance of the applicant in meeting any applicable Federal regulations requiring uncompensated care, community service, or access by minorities and handicapped persons to programs receiving Federal financial assistance, including the existence of any civil rights access complaints against the applicant,

(d) The extent to which the applicant offers a range of means by which a person will have access to its services.

(5) In any case where it is determined that an approved project does not satisfy the criteria specified in subsections (1) through (4), the Agency may, if it approves the application, impose the condition that the applicant must take affirmative steps to meet those criteria.

(6) In evaluating the accessibility of a proposed project, the accessibility of the current facility as a whole must be taken into consideration. If the proposed project is disapproved because it fails to meet the need and access criteria specified herein, the Agency will so state in its written findings.

History

Rulemaking Authority 408.15(8), 408.034(3), (8) FS. Law Implemented 408.035, 408.037 FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(a), (b), 10-5.030, Amended 4-21-10, 8-8-21, Joint Administrative Procedures Committee Objection Filed–See FAR Vol. 51, No. 53, March 18, 2025, Amended 12-7-25, Amendment resolved Joint Administrative Procedures Committee objection 12-7-25, Florida Administrative Register Vol. 52, No. 21, February 2, 2026.

Fla. Admin. Code R. 59C-1.031 Medicare Certified Home Health Agencies

History

Rulemaking Authority 408.15(8), 408.034(5) FS. Law Implemented 408.034(3), 408.036(1)(e) FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 3-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(d), 10-5-031, Amended 8-24-93, 4-14-97, 6-22-99, Repealed 4-2-01.

Fla. Admin. Code R. 59C-1.032 Pediatric Cardiac Catheterization and Angioplasty Institutional Health Services

History

Rulemaking Authority 408.034(3), (8), 408.15(8) FS. Law Implemented 408.032(17), 408.033(3)(b), 408.034(3), 408.035(1), 408.036(1)(f), 408.039(4)(a) FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(e), Amended 11-11-91, 7-6-92, Formerly 10-5.032, Amended 8-24-93, 9-12-94, 6-19-95, 8-23-95, 7-30-17, Repealed 7-8-26.

Fla. Admin. Code R. 59C-1.033 Pediatric Open Heart Surgery Program

History

Rulemaking Authority 408.034(3), (8), 408.15(8) FS. Law Implemented 408.032(17), 408.033(3)(b), 408.034(3), 408.036(1)(f) FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(f), Amended 1-26-92, Formerly 10-5.033, Amended 6-17-93, 8-24-93, 1-24-02, 7-30-17, Repealed 7-8-26.

Fla. Admin. Code R. 59C-1.034 Intermediate Care Facility for the Developmentally Disabled

A Certificate of Need for a proposed Intermediate Care Facility for the Developmentally Disabled (ICF/DD) shall not be issued unless:

(1) The proposal has been determined by the Agency to be justified in context with the applicable review criteria contained in Section 408.035, F.S., and the standards set forth in this rule; Chapter 59A-26, F.A.C.; and current legislative appropriations providing for ICF/DD placements.

(2) The proposal, if for a new facility, provides for not more than 60 beds divided into living units of not more than 15 beds each.

(3) The proposal, if for conversion of an existing facility to ICF/DD utilization, provides for division of such facility into living units of not more than 25 beds each.

History

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.035 FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(i), 10-5.034, Amended 8-24-93.

Fla. Admin. Code R. 59C-1.035 Hospice Programs

History

Rulemaking Authority 408.034(3), (5), 408.15(8) FS. Law Implemented 408.035, 408.036(1)(f) FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(j), 10-5.035, Amended 8-24-93, Repealed 10-30-94.

Fla. Admin. Code R. 59C-1.0355 Hospice Programs

(1) Agency Intent. This rule implements the provisions of Sections 408.034(3), 408.036(1)(d) and 408.043(1), F.S. It is the intent of the Agency to ensure the availability of Hospice programs as defined in this rule to all persons requesting and eligible for Hospice services, regardless of ability to pay. This rule regulates the establishment of new Hospice programs and the construction of freestanding inpatient Hospice facilities as defined in this rule. A separate Certificate of Need application shall be submitted for each service area defined in this rule.

(2) Definitions.

(a) “Agency.” The Agency for Health Care Administration.

(b) “Approved Hospice Program.” A Hospice program for which the Agency has issued an intent to grant a Certificate of Need, or has issued a Certificate of Need, and that is not yet licensed as of 3 weeks prior to publication of the Fixed Need Pool.

(d) “Fixed Need Pool.” The Fixed Need Pool defined in subsection 59C-1.002(16), F.A.C. The Agency shall publish a Fixed Need Pool for Hospice programs twice a year.

(e) “Freestanding Inpatient Hospice Facility.” For purposes of this rule, a facility that houses inpatient beds licensed exclusively to the Hospice program but does not house any inpatient beds licensed to a hospital or nursing home.

(f) “Hospice Program.” A program described in Sections 400.601(3), 400.602(1), 400.609 and 400.6095(1), F.S., that provides a continuum of palliative and supportive care for the terminally ill patient and his family. Hospice services must be available 24 hours a day, 7 days a week, and must be available to all terminally ill persons and their families without regard to age, gender, national origin, sexual orientation, disability, diagnosis, cost of therapy, ability to pay, or life circumstances.

(g) “Inpatient Bed.” Inpatient beds located in a freestanding inpatient Hospice facility, a hospital, or a nursing home and available for Hospice inpatient care.

(h) “Local Health Council.” The council referenced in Section 408.033(1), F.S.

(i) “Planning Horizon.” The date by which a proposed new Hospice program is expected to be licensed. For purposes of this rule, the planning horizon for applications submitted between January 1 and June 30 is July 1 of the year 1 year subsequent to the year the application is submitted; the planning horizon for applications submitted between July 1 and December 31 is January 1 of the year 2 years subsequent to the year the application is submitted.

(j) “Residential Facility.” For purposes of this rule, a facility operated by a licensed Hospice program to provide a residence for Hospice patients, as defined in Section 400.601(5), F.S. A residential facility is not subject to regulation under this rule. Provided, however, that a proposal to convert such a residence to a freestanding inpatient Hospice facility is subject to regulation under this rule.

(k) “Service Area.” The geographic area consisting of a specified county or counties, as follows:

Service Area 1 consists of Escambia, Okaloosa, Santa Rosa, and Walton Counties.
Service Area 2A consists of Bay, Calhoun, Gulf, Holmes, Jackson, and Washington Counties.
Service Area 2B consists of Franklin, Gadsden, Jefferson, Leon, Liberty, Madison, Taylor, and Wakulla Counties.
Service Area 3A consists of Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette, Levy, Putnam, Suwannee, and Union Counties.
Service Area 3B consists of Marion County.
Service Area 3C consists of Citrus County.
Service Area 3D consists of Hernando County.
Service Area 3E consists of Lake and Sumter Counties.
Service Area 4A consists of Baker, Clay, Duval, Nassau, and St. Johns Counties.
Service Area 4B consists of Flagler and Volusia Counties.
Service Area 5A consists of Pasco County.
Service Area 5B consists of Pinellas County.
Service Area 6A consists of Hillsborough County.
Service Area 6B consists of Hardee, Highlands, and Polk Counties.
Service Area 6C consists of Manatee County.
Service Area 7A consists of Brevard County.
Service Area 7B consists of Orange and Osceola Counties.
Service Area 7C consists of Seminole County.
Service Area 8A consists of Charlotte and DeSoto Counties.
Service Area 8B consists of Collier County.
Service Area 8C consists of Glades, Hendry and Lee Counties.
Service Area 8D consists of Sarasota County.
Service Area 9A consists of Indian River County.
Service Area 9B consists of Martin, Okeechobee, and St. Lucie Counties.
Service Area 9C consists of Palm Beach County.
Service Area 10 consists of Broward County.
Service Area 11 consists of Dade and Monroe Counties.

(l) “Terminally Ill.” As defined in Section 400.601(10), F.S., terminally ill refers to a medical prognosis that a patient’s life expectancy is 1 year or less if the illness runs its normal course.

(3) General Provisions.

(a) Quality of Care. Hospice programs shall comply with the standards for program licensure described in Chapter 400, Part IV, F.S. and Chapter 59A-38, F.A.C. Applicants proposing to establish a new Hospice program shall demonstrate how they will meet the standards.

(b) Conformance with Statutory Review Criteria. A Certificate of Need for the establishment of a new Hospice program or construction of a freestanding inpatient Hospice facility shall not be approved unless the applicant meets the applicable review criteria in Sections 408.035 and 408.043(1), F.S., and the standards and need determination criteria set forth in this rule. Applications to establish a new Hospice program shall not be approved in the absence of a numeric need indicated by the formula in paragraph (4)(a) of this rule, unless other criteria in this rule and in Sections 408.035 and 408.043(1), F.S., outweigh the lack of a numeric need.

(4) Criteria for Determination of Need for a New Hospice Program.

(a) Numeric Need for a New Hospice Program. Numeric need for an additional Hospice program is demonstrated if the projected number of unserved patients who would elect a Hospice program is 350 or greater. The net need for a new Hospice program in a service area is calculated as follows:

(HPH) ‒ (HP)  350

where:

(HPH) is the projected number of patients electing a Hospice program in the service area during the 12 month period beginning at the planning horizon. (HPH) is the sum of (U65C × P1) + (65C × P2) + (U65NC × P3) + (65NC × P4)

where:

U65C is the projected number of service area resident cancer deaths under age 65, and P1 is the projected proportion of U65C electing a Hospice program.

65C is the projected number of service area resident cancer deaths age 65 and over, and P2 is the projected proportion of 65C electing a Hospice program.

U65NC is the projected number of service area resident deaths under age 65 from all causes except cancer, and P3 is the projected proportion of U65NC electing a Hospice program.

65NC is the projected number of service area resident deaths age 65 and over from all causes except cancer, and P4 is the projected proportion of 65NC electing a Hospice program.

The projections of U65C, 65C, U65NC, and 65NC for a service area are calculated as follows:

U65C

(u65c/CT)

65C

(65c/CT)

U65NC

(u65nc/CT)

65NC

(65nc/CT)

where:

u65c, 65c, u65nc, and 65nc are the service area’s current number of resident cancer deaths under age 65, cancer deaths age 65 and over, deaths under age 65 from all causes except cancer, and deaths age 65 and over from all causes except cancer.

CT is the service area’s current total of resident deaths, excluding deaths with age unknown, and is the sum of u65c, 65c, u65nc, and 65nc.

PT is the service area’s projected total of resident deaths for the 12-month period beginning at the planning horizon.

“Current” deaths means the number of deaths during the most recent calendar year for which data are available from the Department of Health, Office of Vital Statistics at least 3 months prior to publication of the Fixed Need Pool.

“Projected” deaths means the number derived by first calculating a 3-year average resident death rate, which is the sum of the service area resident deaths for the three most recent calendar years available from the Department of Health, Office of Vital Statistics at least 3 months prior to publication of the Fixed Need Pool, divided by the sum of the July 1 estimates of the service area population for the same 3 years. The resulting average death rate is then multiplied by the projected total population for the service area at the mid-point of the 12-month period which begins with the applicable planning horizon. Population estimates for each year will be the most recent population estimates from the Office of the Governor at least 3 months prior to publication of the Fixed Need Pool.

The projected values of P1, P2, P3, and P4 are equal to current statewide proportions calculated as follows:

(Hu65c/Tu65c)

(H65c/T65c)

(Hu65nc/Tu65nc)

(H65nc/T65nc)

where:

Hu65c, H65c, Hu65nc, and H65nc are the current 12-month statewide total admissions of Hospice cancer patients under age 65, Hospice cancer patients age 65 and over, Hospice patients under age 65 admitted with all other diagnoses, and Hospice patients age 65 and over admitted with all other diagnoses. The current totals are derived from reports submitted under subsection (8) of this rule.

Tu65c, T65c, Tu65nc, and T65nc are the current 12-month statewide total resident deaths for the four categories used above.

(HP) is the number of patients admitted to Hospice programs serving an area during the most recent 12-month period ending on June 30 or December 31. The number is derived from reports submitted under subsection (8) of this rule.

350 is the targeted minimum 12-month total of patients admitted to a Hospice program.

(b) Licensed Hospice Programs. Regardless of numeric need shown under the formula in paragraph (4)(a), the Agency shall not normally approve a new Hospice program for a service area unless each Hospice program serving that area has been licensed and operational for at least 2 years as of 3 weeks prior to publication of the Fixed Need Pool.

(c) Approved Hospice Programs. Regardless of numeric need shown under the formula in paragraph (4)(a), the Agency shall not normally approve another Hospice program for any service area that has an approved Hospice program that is not yet licensed.

(d) Approval Under Special Circumstances. In the absence of numeric need identified in paragraph (4)(a), the applicant must demonstrate that circumstances exist to justify the approval of a new Hospice. Evidence submitted by the applicant must document one or more of the following:

That a specific terminally ill population is not being served.
That a county or counties within the service area of a licensed Hospice program are not being served.

(e) Preferences for a New Hospice Program. The Agency shall give preference to an applicant meeting one or more of the criteria specified in subparagraphs 1. through 5.:

Preference shall be given to an applicant who has a commitment to serve populations with unmet needs.
Preference shall be given to an applicant who proposes to provide the inpatient care component of the Hospice program through contractual arrangements with existing health care facilities, unless the applicant demonstrates a more cost-efficient alternative.
Preference shall be given to an applicant who has a commitment to serve patients who do not have primary caregivers at home; the homeless; and patients with AIDS.
In the case of proposals for a Hospice service area comprised of three or more counties, preference shall be given to an applicant who has a commitment to establish a physical presence in an underserved county or counties.
Preference shall be given to an applicant who proposes to provide services that are not specifically covered by private insurance, Medicaid, or Medicare.

(5) Consistency with Plans. An applicant for a new Hospice program shall provide evidence in the application that the proposal is consistent with the needs of the community and other criteria contained in local health council plans and the State Health Plan. The application for a new Hospice program shall include letters from health organizations, social services organizations, and other entities within the proposed service area that endorse the applicant’s development of a Hospice program.

(6) Required Program Description. An applicant for a new Hospice program shall provide a detailed program description in its Certificate of Need application, including:

(a) Proposed staffing, including use of volunteers.

(b) Expected sources of patient referrals.

(c) Projected number of admissions, by payer type, including Medicare, Medicaid, private insurance, self-pay, and indigent care patients for the first 2 years of operation.

(d) Projected number of admissions, by type of terminal illness, for the first 2 years of operation.

(e) Projected number of admissions by two age groups, under 65 and 65 or older, for the first 2 years of operation.

(f) Identification of the services that will be provided directly by Hospice staff and volunteers and those that will be provided through contractual arrangements.

(g) Proposed arrangements for providing inpatient care (e.g., construction of a freestanding inpatient Hospice facility; contractual arrangements for dedicated or renovated space in hospitals or nursing homes).

(h) Proposed number of inpatient beds that will be located in a freestanding inpatient Hospice facility, in hospitals, and in nursing homes.

(i) Circumstances under which a patient would be admitted to an inpatient bed.

(j) Provisions for serving persons without primary caregivers at home.

(k) Arrangements for the provision of bereavement services.

(l) Proposed community education activities concerning Hospice programs.

(m) Fundraising activities.

(7) Construction of a Freestanding Inpatient Hospice Facility. The Agency will not normally approve a proposal for construction of a freestanding inpatient Hospice facility unless the applicant demonstrates that the freestanding facility will be more cost-efficient than contractual arrangements with existing hospitals or nursing homes in the service area. The application shall include the following:

(a) A description of any advantages that the Hospice program will achieve by constructing and operating its own inpatient beds.

(b) Existing contractual arrangements for inpatient care at hospitals and nursing homes; or, in the case of a proposed new Hospice program, contacts made with hospitals and nursing homes regarding contractual arrangements for inpatient care.

(8) Semi-Annual Utilization Reports. Each Hospice program shall report utilization information to the Agency or its designee on or before July 20 of each year and January 20 of the following year. The July report shall use the Semi-Annual Report of Hospice Utilization (July), AHCA Form 5000-3545 (created June 2013), incorporated by reference within this rule and available on the Agency website at http://ahca.myflorida.com/MCHQ/CON_FA/Forms/index.shtml and https://www.flrules.org/Gateway/reference.asp?No=Ref-03949. The July report shall indicate the number of new patients admitted during the 6-month period composed of the first and second quarters of the current year, the census on the first day of each month included in the report, and the number of patient days of care provided during the reporting period. The January report shall use the Semi-Annual Report of Hospice Utilization (January) AHCA Form 5000-3546 (created June 2013), incorporated by reference within this rule and available on the Agency website at http://ahca.myflorida.com/MCHQ/CON_FA/Forms/index.shtml and https://www.flrules.org/Gateway/reference.asp?No=Ref-03948. The January report shall indicate the number of new patients admitted during the 6-month period composed of the third and fourth quarters of the prior year, the census on the first day of each month included in the report, and the number of patient days of care provided during the reporting period. The following detail shall also be provided.

(a) For the number of new patients admitted:

The 6-month total of admissions under age 65 and age 65 and over by type of diagnosis (e.g., cancer; AIDS).
The number of admissions during each of the 6 months covered by the report, by service area of residence.

(b) For the patient census on January 1 or July 1, as applicable, the number of patients receiving Hospice care in:

A private home.
An assisted living facility.
A Hospice residential unit.
A nursing home.
A hospital.

(9) Grandfathering Provisions. A Hospice program licensed as of the effective date of this rule is authorized to continue to serve all counties in the service area where its principal place of business is located. A Hospice program whose Certificate of Need or current license permits Hospice services in a county or counties in an adjacent service area may continue to serve those adjacent counties. Any expansion to provide service to other counties in an adjacent service area is subject to regulation under this rule.

History

Rulemaking Authority 408.034(3), (8), 408.15(8) FS. Law Implemented 408.035, 408.036(1)(d), 408.043(1) FS. History‒New 4-17-95, Amended 7-30-95, 7-21-09, 5-3-10, 10-14-12, 4-14-14, 9-10-15.

Fla. Admin. Code R. 59C-1.036 Nursing Facility Beds

(1) Agency Intent. This rule implements Section 408.034(3), F.S., which requires the Agency to develop uniform need methodologies for Certificate of Need (CON) review of proposals, and Section 408.036(1)(a), F.S., which requires Certificate of Need review of proposals for the addition of nursing facility beds licensed under Chapter 400, F.S. The rule regulates the construction of new nursing facilities, the addition of new nursing facility beds, and conversion of other health care facility bed types to nursing facility beds, including conversion of licensed sheltered nursing facility beds in continuing care facilities regulated under Section 651.118, F.S. Projects for the addition of sheltered nursing home beds are excluded from this rule and regulated under Rule 59C-1.037, F.A.C. It is the intent of the Agency to ensure the availability of nursing facility services to all persons needing such services, regardless of ability to pay. Nothing in this rule is intended to interpret, modify, limit or expand Florida law regarding standing, or the right of an existing health care provider to initiate or intervene in a formal Administrative Hearing challenging intended Agency action on a Certificate of Need application for nursing facility beds regulated under this rule.

(2) CON Reviews. Proposals for nursing facility beds seeking licensure under Chapter 400, F.S., will be comparatively reviewed to each other. This rule contains a methodology for determining the numeric need for nursing facility beds proposed to be licensed under Chapter 400, F.S. An application for nursing facility beds seeking licensure under Chapter 400, F.S., will not be approved in the absence or insufficiency of a numeric need indicated by the formula in subsection (4) of this rule, unless the absence or insufficiency of numeric need is outweighed by other information presented in a Certificate of Need application showing special circumstances consistent with applicable and relevant criteria in Section 408.035, F.S.

(3) General Provisions.

(a) Planning Horizon. The future need for nursing facility beds shall be determined twice a year and published by the Agency as a Fixed Bed Need Pool for the applicable planning horizon. The planning horizon for applications submitted between January 1 and June 30 is January of the year 3 years subsequent to the year the application is submitted; the planning horizon for applications submitted between July 1 and December 31 is July of the year 3 years subsequent to the year the application is submitted.

(b) Batching Cycles. Proposals for nursing facility beds seeking licensure under Chapter 400, F.S., will be reviewed in the batching cycles for “Other Beds and Programs” described in paragraph 59C-1.008(1)(g), F.A.C.

(c) Population Estimates. The estimates of current and projected population used in this rule shall be the most recent estimates published by the Executive Office of the Governor and available to the Agency at least 3 weeks prior to publication of the Fixed Bed Need Pool. The estimate of projected population is the estimate for the planning horizon. The estimate of current population is the estimate for January of the year the application is submitted when the planning horizon is January; the estimate of current population is the estimate for July of the year the application is submitted when the planning horizon is July.

(d) Subdistrict Need Determination. The Agency will use the subdistrict designation shown in Rule 59C-2.200, F.A.C., for Agency service Districts 1 through 11 respectively in projecting need for nursing facility beds licensed under Chapter 400, F.S.

(e) Geographically Contiguous Subdistricts within a District. If nursing home need is determined by the bed need formula contained in this rule in continguous subdistricts within a District, the applicant may aggregate the subdistrict’s need for a new community nursing home pursuant to Section 408.034(6), F.S.

If need is aggregated from two subdistricts, the proposed nursing home site must be located in the subdistrict with the greatest published need as determined by the bed need formula contained in this rule.
If need is aggregated from more than two subdistricts, the location of the proposed nursing home site must provide reasonable geographic access for residents in the aggregated subdistricts given the relative bed need in each subdistrict.

(f) Geographically Underserved Areas. In a competitive Certificate of Need review within the nursing facility subdistrict as defined in Rule 59C-2.200, F.A.C., the Agency shall award a Certificate of Need if the applicant meets all applicable criteria for a geographically underserved area as specified in Section 408.032(11), F.S., and if the applicant meets applicable statutory Certificate of Need review criteria specified in Section 408.035, F.S., including bed need according to the relevant bed need formula contained in this rule. If an applicant is awarded a Certificate of Need based on the provisions of this paragraph, the applicant shall agree that the nursing facility will be located in a county without a nursing facility, or in the center of an area within the subdistrict with a radius of at least 20 miles which meets the definition of a geographically underserved area. The center of the geographically underserved area shall be the proposed nursing facility location in the application.

(4) Numeric Need for Nursing Facility Beds Seeking Licensure under Chapter 400, F.S.

(a) Projected Need. In addition to the other relevant statutory and rule criteria used in considering the allocation of new or additional nursing facility beds to be licensed under Chapter 400, F.S., the Agency will determine if there is a projected need for new or additional beds at the planning horizon according to the definitions and methodology specified in this subsection.

(b) Summary of Need Formula. The need formula for nursing facility beds seeking licensure under Chapter 400, F.S., links the projected subdistrict need to a projected increase in the district need for beds licensed under Chapter 400, F.S. The District increase is based on the expected increase in the district population age 65 to 74 and age 75 and over, with the age group 75 and over given 6 times more weight in projecting the population increase. The projected district bed need total is then allocated to its subdistricts consistent with the current subdistrict distribution of the total. The result for a given subdistrict is adjusted to reflect the current subdistrict occupancy of beds licensed under Chapter 400, F.S., and a desired standard of 92 percent occupancy. This subdistrict total of allocated beds is then reduced by the current number of Chapter 400, F.S., beds in the subdistrict that are licensed or approved, resulting in the net need for additional nursing facility beds to be licensed under Chapter 400, F.S. The rule also provides that if current occupancy of beds licensed under Chapter 400, F.S., is less than 85 percent, the net need in the subdistrict is zero regardless of whether the formula otherwise would show a net need.

(c) Need Formula. The formula for determining the net need in a subdistrict for nursing facility beds licensed under Chapter 400, F.S., is as follows:

A = (POPA × BA) + (POPB × BB)

where:

A is the projected age-adjusted total number of nursing facility beds to be licensed under chapter 400, F.S., at the planning horizon for the district in which the subdistrict is located.

POPA is the projected population age 65-74 years in the district.

POPB is the projected population age 75 years and older in the district.

BA is the estimated current bed rate for facilities licensed under Chapter 400, F.S., for the population age 65-74 years in the district.

BB is the estimated current bed rate for facilities licensed under Chapter 400, F.S., for the population age 75 years and over in the district.

BA = LB / (POPC + (6 × POPD))

where:

LB is the number of nursing facility beds licensed under Chapter 400, F.S., in the District as of January 1, for fixed bed need pools published between January 1 and June 30, or as of July 1 for fixed bed need pools published between July 1 and December 31.

POPC is the current population age 65-74 years in the district.

POPD is the current population age 75 years and over in the district.

BB = 6 × BA
SA = A × (LBD/LB) × (OR/.92)

where:

SA is the subdistrict allocation of community nursing facility beds to be licensed under Chapter 400, F.S., at the planning horizon.

LBD is the number of nursing facility beds licensed under Chapter 400, F.S., in the subdistrict as of January 1, for fixed bed need pools published between January 1 and June 30, or as of July 1 for fixed bed need pools published between July 1 and December 31.

Or is the average 6 month occupancy rate for nursing facility beds licensed in the subdistrict under Chapter 400, F.S. For fixed bed need pools published between January 1 and June 30, occupancy rates shall be based upon patient days in nursing facilities licensed under Chapter 400, F.S., for the 6 month period from July 1 through December 31 of the previous year; for fixed bed need pools published between July 1 and December 31, occupancy rates shall be based upon patient days in nursing facilities licensed under Chapter 400, F.S., for the 6 month period from January 1 through June 30 of the year the fixed bed need pool is published.

.92 equals the desired average 6 month occupancy rate for nursing facility beds licensed under Chapter 400, F.S., in the subdistrict.

The net bed need allocation for a subdistrict at the planning horizon is determined by subtracting the total number of licensed and approved beds for facilities licensed under Chapter 400, F.S., in the subdistrict from the bed allocation determined under subparagraphs (c)1. through (c)4. unless, as defined in subparagraph (c)4. is less than 85% percent, in which case the net bed need allocation is zero. The number of licensed beds that is subtracted from the bed need allocation shall be the number licensed under Chapter 400, F.S., as of the most recent published deadline for Agency initial decisions prior to publication of the Fixed Bed Need Pool. The number of approved beds that is subtracted shall be the number for which the Agency has issued a Certificate of Need, a letter stating the Agency’s intent to issue a Certificate of Need, a signed stipulated agreement, or a final order granting a Certificate of Need, as of the most recent published deadline for Agency initial decisions prior to publication of the Fixed Bed Need Pool.

(d) Proposed Services. Applicants proposing the establishment of Medicare-certified nursing facility beds to be licensed under Chapter 400, F.S., shall provide a detailed description of the services to be provided, staffing pattern, patient characteristics, expected average length of stay, ancillary services, patient assessment tools, admission policies, and discharge policies.

(e) Quality of Care. In assessing the applicant’s ability to provide quality of care pursuant to Section 408.035(3), F.S., the Agency shall evaluate the following facts and circumstances:

Whether the applicant has had a Chapter 400, F.S., nursing facility license denied, revoked, or suspended within the 36 months prior to the application.
Whether the applicant has had a nursing facility placed into receivership at any time during the period of ownership, management, or leasing of a nursing facility in the 36 months prior to the current application.
The extent to which the conditions identified within subparagraphs 1. and 2. threatened or resulted in direct, significant harm to the health, safety or welfare of the nursing facility residents.
The extent to which the conditions identified within subparagraph 3. were corrected within the time frames allowed by the appropriate state Agency in each respective state and in a manner satisfactory to the Agency.

(f) Harmful Conditions. The Agency shall question the ability of the applicant to provide quality of care within any nursing facility when the conditions identified in subparagraphs (e)1. and (e)2. resulted in direct, significant harm to the health, safety or welfare of a nursing facility resident, and were not corrected within the time frames allowed by the appropriate state Agency in each respective state and in a manner satisfactory to the Agency.

(g) Other Factors to be Considered in the Review of Certificate of Need Applications for nursing facility beds. An applicant who agrees to voluntarily relinquish licensed community nursing home beds in one or more subdistricts where there is no calculated need, may be recognized as a postitive application factor when applying for nursing facility beds in a subdistrict with published need. The applicant must demonstrate that it operates or has a controlled interest as defined in subparagraph 59C-1.005(6)(f)3., F.A.C., or has an agreement with another licensed community nursing home to ensure that beds are voluntarily relinquished if the application is approved. The nursing home from which the beds are being relinquished must submit a letter certifying that the identified number of beds at its facility will be delicensed no later than initial licensure of the proposed facility should the CON be awarded to the applicant. The relocation of beds under this paragraph must be limited to a portion of beds such that the occupancy rate of the remaining licensed beds of the facility from which the beds are being relinquished does not exceed 92 percent.

(5) Utilization Reports. Within 45 days after the end of each calendar quarter, facilities with nursing facility beds licensed under Chapter 400 or 395, F.S., shall report to the Agency, or its designee, the total number of patient days which occurred in each month of the quarter and the number of such days which were Medicaid patient days.

History

Rulemaking Authority 408.034(3), (5), (8), 408.15(8) FS. Law Implemented 408.034(3), (5), (6), (7), 408.036(1)(a), (b), (c) FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(k), Amended 8-9-92, Formerly 10-5.036, Amended 10-6-92, 8-24-93, 6-11-98, 4-7-02, 8-1-05, 3-16-16.

Fla. Admin. Code R. 59C-1.0365 Hospital-Based Skilled Nursing Units

History

Rulemaking Authority 408.15(8), 408.034(5) FS. Law Implemented 408.036(1)(g) FS. History–New 4-7-02, Repealed 7-19-05.

Fla. Admin. Code R. 59C-1.037 Sheltered Nursing Home Beds

(1) Definitions.

(a) Sheltered Nursing Home Beds. A sheltered nursing home bed is a nursing home bed within a continuing care facility as defined under Section 651.118, F.S.

(b) Use of Sheltered Nursing Home Beds. Under Section 651.118(7), F.S., sheltered nursing home beds may be used for persons who are not residents of the continuing care facility, and who are not a party to a continuing care contract, for a period of up to five years from the date of issuance of the initial nursing home license for sheltered beds constructed in conjunction with the non-nursing home portion of the continuing care facility. Applicants applying at a later time for additional sheltered nursing home beds without increasing the number of residential units shall restrict the use of the additional sheltered beds to continuing care residents. Applicants who are adding additional residential units shall be allowed to apply for additional sheltered nursing home beds not exceeding a ratio of one nursing home bed per four residential units. Nursing home beds approved under this condition may be used for community residents for a period of up to five years from the date of issuance of the initial license of these beds.

(c) Nursing home beds in continuing care facilities, which are permitted to be used for persons who are not residents of the facility, and who are not a party to a continuing care contract, pursuant to Section 651.118(7), F.S., and paragraph (1)(b) of this rule, shall not be counted in the inventory of community nursing home beds under subsection 59C-1.036(2), F.A.C.

(2) Criteria and Standards. In addition to meeting the applicable review criteria in Section 408.035, F.S., and the provisions in this rule, applicants for certificates of need for sheltered nursing home beds shall comply with the criteria and standards outlined under Section 651.118, F.S.

(3) Data Collection and Reporting Procedures. Within 45 days after the end of each calendar quarter, facilities with nursing facility beds licensed under Chapter 400, F.S., shall report to the Agency, or its designee, the total number of patient days which occurred in each month of the quarter and the number of such days which were Medicaid patient days. Continuing care providers shall submit bed utilization reports for the purpose of determining community and sheltered nursing home bed utilization based on historical use by residents and non-residents of the continuing care facility. Monthly bed utilization data shall include:

(a) Total number of resident admissions during the month.

(b) Total number of non-resident admissions during the month.

(d) Total resident patient days for the month.

(e) Total non-resident patient days for the month.

(f) Total patient days for the month.

(g) Total Medicaid patient days for the month.

History

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.034(4), 408.035 FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(l), 10-5.037, Amended 8-24-93, 6-25-17.

Fla. Admin. Code R. 59C-1.038 Acute Care Bed Need

History

Rulemaking Authority 408.15(8), 408.034(3), (5), 408.039(4)(a) FS. Law Implemented 408.034(3), 408.035, 408.036(1)(a), (b), (e), (h), 408.039(4)(a) FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5-11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(m), 10-5-038, Amended 8-24-93, 7-1-96, Repealed 4-21-05.

Fla. Admin. Code R. 59C-1.039 Comprehensive Medical Rehabilitation Inpatient Services

(1) Agency Intent. It is the intent of the Agency to ensure the availability of Comprehensive Medical Rehabilitation Inpatient Services for persons in need of these services, including Medicaid and charity care patients. This rule regulates the establishment of new Comprehensive Medical Rehabilitation Inpatient Services, the construction or addition of new Comprehensive Medical Rehabilitation Inpatient Beds, and the conversion of licensed hospital acute care beds to Comprehensive Medical Rehabilitation Inpatient Beds.

(2) Definitions.

(a) “Agency.” The Agency for Health Care Administration.

(b) “Approved Comprehensive Medical Rehabilitation Inpatient Bed.” A proposed Comprehensive Medical Rehabilitation Inpatient Bed for which a Certificate of Need, a letter of intent to grant a Certificate of Need, a signed stipulated agreement, or a final order granting a Certificate of Need was issued, consistent with the provisions of paragraph 59C-1.008(2)(b), F.A.C., as of the most recent published deadline for Agency initial decisions prior to publication of the Fixed Need Pool, as specified in paragraph 59C-1.008(1)(g), F.A.C.

(d) “Comprehensive Medical Rehabilitation Inpatient Services.” An organized program of integrated intensive care services provided by a coordinated multidisciplinary team to patients with severe physical disabilities, such as stroke; spinal cord injury; congenital deformity; amputation; major multiple trauma; fracture of femur (hip fracture); brain injury; polyarthritis, including rheumatoid arthritis; neurological disorders, including multiple sclerosis, motor neuron diseases, polyneuropathy, muscular dystrophy, and Parkinson’s disease; and burns.

(e) “District.” A district of the Agency defined in Section 408.032(5), F.S.

(f) “Fixed Bed Need Pool.” The numerical Comprehensive Medical Rehabilitation Inpatient Bed need for the applicable planning horizon, as established by the Agency in accordance with this rule and subsection 59C-1.008(2), F.A.C.

(g) “General Hospital.” Any facility which meets the provisions of Section 395.002(12), F.S.

(h) “Local Health Council.” The council referenced in Section 408.033, F.S.

(i) “Planning Horizon.” The projected date by which a proposed comprehensive medical rehabilitation inpatient service would be initiated. For purposes of this rule, the planning horizon for applications submitted between January 1 and June 30 is July of the year 5 years subsequent to the year the application is submitted; the planning horizon for applications submitted between July 1 and December 31 is January of the year 5 years subsequent to the year which follows the year the application is submitted. For example, an application submitted in March 2016 would have a planning horizon of July 2021; an application submitted in September 2016 would have a planning horizon of January 2022.

(j) “Separately Organized Unit.” A specific section, ward, wing, or floor with a separate nursing station designated exclusively for the care of comprehensive medical rehabilitation patients.

(k) “Specialty Bed.” A category of hospital inpatient beds for which the Agency has promulgated a separate rule specifying need determination criteria, including hospital inpatient general psychiatric beds, hospital inpatient substance abuse beds, Level II and Level III Neonatal Intensive Care Unit Beds; and the Comprehensive Medical Rehabilitation Inpatient Beds regulated under this rule.

(l) “Specialty Hospital.” As defined in Section 395.002(28), F.S., a specialty hospital is any facility which meets the provisions of Section 395.002(12) F.S., and which regularly makes available either:

The range of medical services offered by general hospitals, but restricted to a defined age or gender group of the population, or
A restricted range of services appropriate to the diagnosis, care and treatment of patients with specific categories of medical or psychiatric illnesses or disorders, or
Intensive residential treatment programs for children and adolescents as defined in Section 395.002(15), F.S.

(3) General Provisions.

(a) Service Location. The Comprehensive Medical Rehabilitation Inpatient Services regulated under this rule may be provided in a hospital licensed as a general hospital or licensed as a specialty hospital.

(b) Separately Organized Units. Comprehensive Medical Rehabilitation Inpatient Services shall be provided in one or more separately organized units within a general hospital or specialty hospital.

(c) Minimum Number of Beds. A general hospital providing Comprehensive Medical Rehabilitation Inpatient Services should normally have a minimum of 20 Comprehensive Medical Rehabilitation Inpatient Beds. A specialty hospital providing Comprehensive Medical Rehabilitation Inpatient Services shall have a minimum of 60 Comprehensive Medical Rehabilitation Inpatient Beds. Hospitals with licensed or approved Comprehensive Medical Rehabilitation Inpatient Beds as of the effective date of this rule are exempt from meeting the requirements for a minimum number of beds.

(d) Conformance with the Criteria for Approval. A Certificate of Need for the establishment of new Comprehensive Medical Rehabilitation Inpatient Services, the construction or addition of new Comprehensive Medical Rehabilitation Inpatient Beds, or the conversion of licensed hospital acute care beds to Comprehensive Medical Rehabilitation Inpatient Beds shall not normally be approved unless the applicant meets the applicable review criteria in Section 408.035, F.S., and the standards and need determination criteria set forth in this rule.

(e) Medicare and Medicaid Participation. An applicant proposing to increase the number of licensed Comprehensive Medical Rehabilitation Inpatient Beds at its facility shall participate in the Medicare and Medicaid programs. Applicants proposing to establish a new comprehensive medical rehabilitation inpatient service shall state in their application that they will participate in the Medicare and Medicaid programs.

(f) Comparative Review. A Certificate of Need application submitted for review under this rule will be subject to a comparative review with all other Certificate of Need applications subject to review under this rule that propose to serve the same district and which were submitted during the same review cycle.

(g) Excluded Hospitals. Hospitals operated by the State of Florida are not regulated under this rule pursuant to Sections 408.036(3)(d), (r) and (s), F.S.

(4) Required Staffing and Services.

(a) Director of Rehabilitation. Comprehensive Medical Rehabilitation Inpatient Services must be provided under a medical director of rehabilitation who is a Board certified or Board eligible physiatrist and has had at least 2 years of experience in the medical management of inpatients requiring rehabilitation services.

(b) Other Required Services. In addition to the physician services in paragraph (4)(a), Comprehensive Medical Rehabilitation Inpatient Services shall include at least the following services provided by qualified personnel:

Rehabilitation nursing,
Physical therapy,
Occupational therapy,
Speech pathology and audiology,
Social services,
Psychological services, or
Orthotic and prosthetic services.

(5) Criteria for Determination of Need.

(a) Bed Need. A favorable need determination for proposed new or expanded Comprehensive Medical Rehabilitation Inpatient Services shall not normally be made unless a bed need exists according to the numeric need methodology in paragraph (5)(c) of this rule.

(b) Fixed Bed Need Pool. The future need for Comprehensive Medical Rehabilitation Inpatient Services shall be determined twice a year and published by the Agency as a Fixed Bed Need Pool for the applicable planning horizon.

(c) Need Formula for Comprehensive Medical Rehabilitation Inpatient Beds. The net bed need for Comprehensive Medical Rehabilitation Inpatient Beds in each District shall be calculated in accordance with the following formula:

NN = ((PD/P) × PP / (365 × .85))

– LB – AB

where:

NN equals the net need for Comprehensive Medical Rehabilitation Inpatient Beds in a District.
PD equals the number of inpatient days in Comprehensive Medical Rehabilitation Inpatient Beds in a district for the 12-month period ending 6 months prior to the beginning date of the quarter of the publication of the Fixed Bed Need Pool.
P equals the estimated population in the district. For applications submitted between January 1 and June 30, P is the population estimate for January of the preceding year; for applications submitted between July 1 and December 31, P is the population estimate for July of the preceding year. The population estimate shall be the most recent estimate published by the Office of the Governor and available to the Department at least 4 weeks prior to publication of the Fixed Bed Need Pool.
PP equals the estimated population in the district for the applicable planning horizon. The population estimate shall be the most recent estimate published by the Office of the Governor and available to the Department at least 4 weeks prior to publication of the Fixed Bed Need Pool.
.85 equals the desired average annual occupancy rate for Comprehensive Medical Rehabilitation Inpatient Beds in the district.
LB equals the district’s number of licensed Comprehensive Medical Rehabilitation Inpatient Beds as of the most recent published deadline for Agency initial decisions prior to publication of the Fixed Bed Need Pool.
AB equals the district’s number of approved Comprehensive Medical Rehabilitation Inpatient Beds, as determined consistent with the provisions of paragraph (2)(a) of this rule.

(d) Most Recent Average Annual District Occupancy Rate. Regardless of whether bed need is shown under the need formula in paragraph (5)(c), no additional Comprehensive Medical Rehabilitation Inpatient Beds shall normally be approved for a district unless the average annual occupancy rate of the licensed Comprehensive Medical Rehabilitation Inpatient Beds in the district was at least 80% percent for the 12 month period ending 6 months prior to the beginning date of the quarter of the publication of the Fixed Bed Need Pool.

(e) Special Circumstances for Approval of Expanded Capacity at Hospitals with Licensed Comprehensive Medical Rehabilitation Inpatient Services should the applicant not meet the exemption criteria in Section 408.036(3)(j), F.S.

Subject to the provisions of paragraph (7)(b) of this rule, and subparagraph 2. of this paragraph, need for additional Comprehensive Medical Rehabilitation Inpatient Beds is demonstrated at a hospital with licensed Comprehensive Medical Rehabilitation Inpatient Services in the absence of need shown under the formula in paragraph (5)(c), and regardless of the most recent average annual district occupancy rate determined under paragraph (5)(d), if the applicant demonstrates need through a need assessment methodology which must include, at a minimum, consideration of the following topics:

a. Population demographics and dynamics,

b. Availability, utilization, and quality of like services in the district,

c. Medical treatment trends; and,

d. Market conditions.

The existence of unmet need will not be based solely on the absence of Comprehensive Medical Rehabilitation services or beds in the district.

(f) Priority Considerations for Comprehensive Medical Rehabilitation Inpatient Services Applicants. In weighing and balancing statutory and rule review criteria, the Agency will give priority consideration to:

An applicant that is a disproportionate share hospital as determined consistent with the provisions of Section 409.911, F.S.
An applicant proposing to serve Medicaid-eligible persons.
An applicant that is a designated trauma center, as defined in Rule 64J-2.011, F.A.C.

(6) Access Standard. Comprehensive Medical Rehabilitation Inpatient Services should be available within a maximum ground travel time of 2 hours under average travel conditions for at least 90 percent of the district’s total population.

(7) Quality of Care.

(a) Compliance with Agency Standards. Comprehensive Medical Rehabilitation Inpatient Services shall comply with the Agency standards for program licensure described in Chapter 59A-3, F.A.C. Applicants who submit an application that is consistent with the Agency licensure standards are deemed to be in compliance with this provision.

(b) Licensure Provisions. Applicants proposing a new Comprehensive Medical Rehabilitation Inpatient Service shall state how they will comply with the provisions of hospital licensure as defined in Rule 59A-3.066, F.A.C.

(8) Services Description. An applicant for Comprehensive Medical Rehabilitation Inpatient Services shall provide a detailed program description in its Certificate of Need application including:

(a) Age groups to be served.

(b) Specialty inpatient rehabilitation services to be provided, if any (e.g. spinal cord injury; brain injury).

(c) Proposed staffing, including qualifications of the medical director, a description of staffing appropriate for any specialty program, and a discussion of the training and experience requirements for all staff who will provide Comprehensive Medical Rehabilitation Inpatient Services.

(d) A plan for recruiting staff, showing expected sources of staff.

(e) Expected sources of patient referrals.

(f) Projected number of Comprehensive Medical Rehabilitation Inpatient Services patient days by payer type, including Medicare, Medicaid, private insurance, self-pay and charity care patient days for the first 2 years of operation after completion of the proposed project.

(g) Admission policies of the facility with regard to charity care patients.

(9) Applications from Licensed Providers of Comprehensive Medical Rehabilitation Inpatient Services. A facility providing licensed Comprehensive Medical Rehabilitation Inpatient Services seeking Certificate of Need approval for additional Comprehensive Medical Rehabilitation Inpatient Beds shall provide the following information in its Certificate of Need application in addition to the information required by subsection (8):

(a) Number of Comprehensive Medical Rehabilitation Inpatient Services admissions and patient days for the 12-month period ending 6 months prior to the beginning date of the quarter of the publication of the Fixed Bed Need Pool.

(b) Number of Comprehensive Medical Rehabilitation Inpatient Services patient days by payer type, including Medicare, Medicaid, private insurance, self-pay and charity care patient days, for the 12-month period ending 6 months prior to the beginning date of the quarter of the publication of the Fixed Bed Need Pool.

(c) Gross revenues by payer source for the 12-month period ending 6 months prior to the beginning date of the quarter of the publication of the Fixed Bed Need Pool.

(d) Current staffing.

(e) Current specialty inpatient rehabilitation services, if any (e.g. spinal cord injury; brain injury).

(10) Utilization Reports. Facilities providing licensed Comprehensive Medical Rehabilitation Inpatient Services shall provide utilization reports to the Agency or its designee within 45 days after the end of each calendar quarter, facilities shall provide a report of the number of Comprehensive Medical Rehabilitation Inpatient Services discharges and patient days which occurred during the quarter.

History

Rulemaking Authority 408.034(3), (8), 408.15(8) FS. Law Implemented 408.034(3), 408.035, 408.036(1)(b), (c), (f), 408.039(4)(a) FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(n), Amended 4-30-92, Formerly 10-5.039, Amended 8-24-93, 2-22-95, 7-2-17.

Fla. Admin. Code R. 59C-1.040 New Hospital Inpatient Psychiatric Services

(1) Agency Intent. It is the intent of the Agency to ensure the availability of hospital inpatient psychiatric services as defined in this rule for children, adolescents and adults in need of these services regardless of their ability to pay. This rule regulates the establishment of new inpatient psychiatric hospitals and new inpatient intensive residential treatment facilities for children and adolescents, and specifies which services can be provided by licensed or approved providers of hospital inpatient psychiatric services.

(2) Definitions.

(a) “Adolescent.” A person age 14 through 17.

(b) “Adult.” A person age 18 and over.

(d) “Approved Hospital Inpatient Psychiatric Bed.” A proposed hospital inpatient psychiatric bed for which an exemption pursuant to paragraph 59C-1.005(6)(i), F.A.C., or notification pursuant to paragraph 59C-1.0085(2)(b), F.A.C., a letter of intent to grant a certificate of need, a signed stipulated agreement, or a final order granting a certificate of need was issued, consistent with the provisions of paragraph 59C-1.008(2)(b), F.A.C., as of the most recent published deadline for Agency initial decisions prior to publication of the fixed need pool, as specified in paragraph 59C-1.008(1)(g), F.A.C.

(e) “Charity Care.” Is defined the same as in Section 409.911(1), F.S.

(f) “Child.” A person under the age of 14 years.

(g) “District.” A District of the Agency defined in Section 408.032(5), F.S.

(h) “Fixed Bed Need Pool.” The numerical hospital inpatient psychiatric bed need for adults, or for children and adolescents, for the applicable planning horizon, as established by the Agency in accordance with this rule and subsection 59C-1.008(2), F.A.C.

(i) “Gross Bed Need.” The number of hospital inpatient psychiatric beds projected for a District for the applicable planning horizon under paragraph (4)(c) or (4)(f) of this rule, except that the number of licensed beds and approved beds is not subtracted from the projected total.

(j) “Hospital Inpatient Psychiatric Bed.” A bed designated for the exclusive use of patients receiving hospital inpatient psychiatric services as defined by this rule.

(k) “Hospital Inpatient Psychiatric Services.” Services provided under the direction of a psychiatrist or clinical psychologist to persons whose sole diagnosis, or in the event of more than one diagnosis, the principal diagnosis is a psychiatric disorder defined in subsection (2) of this rule.

(l) “Intensive Residential Treatment Program for Children and Adolescents.” An inpatient program which provides intensive residential treatment services for children and adolescents, as described in Section 395.002(15), F.S. The net need for intensive residential treatment program beds for children and adolescents in facilities seeking to have the beds licensed as specialty hospital beds is included in the net need for hospital inpatient psychiatric beds for children and adolescents calculated under paragraph (4)(f) of this rule.

(m) “Planning Horizon.” The projected date by which a proposed hospital inpatient psychiatric service would be initiated. For purposes of this rule, the planning horizon for applications submitted between January 1 and June 30 is July of the year 5 years subsequent to the year the application is submitted; the planning horizon for applications submitted between July 1 and December 31 is January of the year 5 years subsequent to the year which follows the year the application is submitted.

(n) “Psychiatric Disorder.” For purposes of this rule, a psychiatric disorder is a mental illness as defined in Section 394.455(18), F.S., which requires inpatient hospitalization.

(o) “Separately Organized Unit.” A specific section, ward, wing, or floor with a separate nursing station designated exclusively for the care of hospital inpatient psychiatric services patients.

(p) “Specialty Beds.” Specialty beds include hospital inpatient substance abuse beds, hospital inpatient psychiatric beds and beds in intensive residential treatment programs for children and adolescents licensed as specialty hospital beds.

(q) “Specialty Hospital.” A specialty hospital as defined by Section 395.002(28), F.S.

(r) “Substance Abuse.” The misuse or abuse of, or dependence on alcohol, illicit drugs, or prescription medications which requires inpatient hospitalization.

(3) General Provisions.

(a) Admissions to Hospital Inpatient Psychiatric Services. Admission to facilities with a certificate of need for hospital inpatient psychiatric services is limited to persons whose sole diagnosis, or in the event of more than one diagnosis, the principal diagnosis, is a psychiatric disorder as defined in subsection (2). Psychiatric patients in need of medical/surgical care may be treated in acute care medical/surgical beds for their medical/surgical care needs or in a psychiatric services unit if the unit is properly staffed and equipped to care for the medical/surgical problem.

(b) Service Location. This rule applies to the establishment of new psychiatric inpatient specialty hospitals, including a facility with an intensive residential treatment program for children and adolescents which is licensed as a specialty hospital.

(c) Separate Regulation of Age Categories. The Agency regulates two types of hospital inpatient psychiatric services, those services which are used for psychiatric treatment of adults, and those services used for psychiatric treatment of children and adolescents. Certificate of need applications for the establishment of hospital inpatient psychiatric services for adults shall be reviewed separately from certificate of need applications for hospital inpatient psychiatric services for children and adolescents. A separate certificate of need shall be issued for each service.

(d) Separately Organized Units. Hospital inpatient psychiatric services for adults shall be provided in one or more separately organized units within a specialty hospital. Hospital inpatient psychiatric services for children and adolescents shall be provided in one or more separately organized units within a specialty hospital.

(e) Minimum Size of Specialty Hospitals. A specialty hospital providing hospital inpatient psychiatric services, or an intensive residential treatment program for children and adolescents licensed as a specialty hospital, shall have a minimum capacity of 40 beds. The minimum capacity of a specialty hospital providing hospital inpatient psychiatric services may include beds used for hospital inpatient substance abuse services regulated under Rule 59C-1.041, F.A.C. The separately organized units for hospital inpatient psychiatric services for adults or for children and adolescents in specialty hospitals shall meet the minimum size requirements stated in subsection (5) of this rule. Hospitals inventoried consistent with the provisions of subsection (11) of this rule are exempt from meeting the minimum capacity and minimum unit size requirements of this paragraph unless or until they submit a proposal which would modify the number of beds listed in the inventory.

(f) Conformance with the Criteria for Approval. A certificate of need for the establishment of new inpatient psychiatric specialty hospital services shall not normally be approved unless the applicant meets the applicable review criteria in Section 408.035, F.S., and the standards and need determination criteria set forth in this rule.

(g) Required Services. Hospital inpatient psychiatric services whether provided directly by the hospital or under contract shall include, at a minimum, emergency screening services, pharmacology, individual therapy, family therapy, activities therapy, discharge planning, and referral services.

(h) Excluded Hospitals. Hospitals operated by the State of Florida are not regulated under this rule pursuant to Sections 408.036(3)(d), (r) and (s), F.S.

(4) Criteria for Determination of Need.

(a) Bed Need. A favorable need determination for proposed new inpatient psychiatric hospital services shall not normally be made unless a bed need exists according to the numeric need methodology specified in paragraph (4)(c) or (4)(f) of this rule.

(b) Fixed Bed Need Pool. The future need for hospital inpatient psychiatric services for adults shall be determined twice a year and published by the Agency as a fixed bed need pool for the applicable planning horizon. The future need for hospital inpatient psychiatric services for children and adolescents shall be determined twice a year and published by the Agency as a fixed bed need pool for the applicable planning horizon.

(c) Need Formula for Hospital Inpatient Psychiatric Beds for Adults. The net bed need for hospital inpatient psychiatric beds for adults in each District shall be calculated in accordance with the following formula:

NNA = ((PDA/PA × PPA) / (365 × .75)) - LBA - ABA

where:

NNA equals the net need for hospital inpatient psychiatric beds for adults in a district.
PDA equals the number of inpatient days in hospital inpatient psychiatric beds for adults in a district for the 12-month period ending 6 months prior to the beginning date of the quarter of the publication of the fixed bed need pool.
PA equals the estimated population age 18 and over in the District. For applications submitted between January 1 and June 30, PA is the population estimate for January of the preceding year; for applications submitted between July 1 and December 31, PA is the population estimate for July of the preceding year. The population estimate shall be the most recent estimate published by the Office of the Governor and available to the Agency at least 6 weeks prior to publication of the fixed bed need pool.
PPA equals the estimated population age 18 and over in the District for the applicable planning horizon. The population estimate shall be the most recent estimate published by the Office of the Governor and available to the Agency at least 6 weeks prior to publication of the fixed bed need pool.
.75 equals the desired average annual occupancy rate for hospital inpatient psychiatric beds for adults in the district.
LBA equals the District’s number of licensed hospital inpatient psychiatric beds for adults as of the most recent published deadline for Agency initial decisions prior to publication of the fixed bed need pool.
ABA equals the District’s number of approved hospital inpatient psychiatric beds for adults, as determined consistent with the provisions of subsection (2) of this rule.

(d) Need formula for hospital inpatient psychiatric beds for children and adolescents. The net bed need for hospital inpatient psychiatric beds for children and adolescents in each district, including beds in intensive residential treatment programs for children and adolescents seeking to have the program beds licensed as specialty hospital beds, shall be calculated in accordance with the following formula:

NNCA = ((PDCA/PCA × PPCA) / (365 × .75)) - LBCA - ABCA

where:

NNCA equals the net need for hospital inpatient psychiatric beds for children and adolescents in a district, including beds in intensive residential treatment programs for children and adolescents seeking to have the program beds licensed as specialty hospital beds.
PDCA equals the number of inpatient days in hospital inpatient psychiatric beds for children and adolescents in a district, including days in intensive residential treatment program beds for children and adolescents which are licensed as specialty hospital beds, for the 12-month period ending 6 months prior to the beginning date of the quarter of the publication of the fixed bed need pool.
PCA equals the estimated population under age 18 in the district. For applications submitted between January 1 and June 30 of each year, PCA is the population estimate for January of the preceding year; for applications submitted between July 1 and December 31 of each year, PCA is the population estimate for July of the preceding year. The population estimate shall be the most recent estimate published by the Office of the Governor and available to the agency at least 6 weeks prior to publication of the fixed bed need pool.
PPCA equals the estimated population under age 18 in the district for the applicable planning horizon. The population estimate shall be the most recent estimate published by the Office of the Governor and available to the Agency at least 6 weeks prior to publication of the fixed bed need pool.
.75 equals the desired average annual occupancy rate for hospital inpatient psychiatric beds for children and adolescents in the district, including beds in intensive residential treatment programs for children and adolescents which are licensed as specialty hospital beds.
LBCA equals the district’s number of licensed hospital inpatient psychiatric beds for children and adolescents as of the most recent published deadline for agency initial decisions prior to publication of the fixed bed need pool, including beds in intensive residential treatment programs for children and adolescents which are licensed as specialty hospital beds.
ABCA equals the district’s number of approved hospital inpatient psychiatric beds for children and adolescents, as determined consistent with the provisions of subsection (2) of this rule, including beds in intensive residential treatment programs for children and adolescents which are seeking to have the program beds licensed as specialty hospital beds.

(e) Other factors to be considered in the review of certificate of need applications for hospital inpatient psychiatric services for children and adolescents.

The applicant for an intensive residential treatment program for children and adolescents seeking to have the program beds licensed as specialty hospital beds shall provide documentation that the district’s licensed non-hospital residential treatment programs for children and adolescents with psychiatric disorders do not meet the need for the proposed service. This documentation shall include the number of residential facilities and beds in the district, the type of clients served, and the type of program provided. In addition, the applicant shall provide letters of support from other mental health professionals in the district for the proposed facility.

(f) Preferences Among Competing Applicants for Hospital Inpatient Psychiatric Services. In weighing and balancing statutory and rule review criteria, preference will be given to applicants who:

Provide Medicaid and charity care days as a percentage of their total patient days equal to or greater than the average percentage of Medicaid and charity care patient days of total patient days provided by other hospitals in the district, as determined by the Florida Center for Health Information and Policy Analysis hospital discharge data for the 12-month period ending 6 months prior to the beginning date of the quarter of the publication of the fixed bed need pool.
Propose to serve the most seriously mentally ill patients (e.g. suicidal patients; patients with acute schizophrenia; patients with severe depression) to the extent that these patients can benefit from a hospital-based organized inpatient treatment program.
Propose to serve Medicaid-eligible persons.
Propose to serve individuals without regard to their ability to pay.
Agree to be a designated public or private receiving facility.
Provide a continuum of psychiatric services for children and adolescents, including services following discharge.

(5) Unit Size. A separately organized unit for hospital inpatient psychiatric services for adults shall have a minimum of 15 beds. A separately organized unit for hospital inpatient psychiatric services for children and adolescents shall have a minimum of 10 beds.

(6) Access Standard. Hospital inpatient psychiatric services should be available within a maximum ground travel time of 45 minutes under average travel conditions for at least 90% percent of the district’s total population.

(7) Quality of Care.

(a) Compliance with Agency Standards. Hospital inpatient psychiatric services for adults or for children and adolescents shall comply with the Agency standards for program licensure described in Chapter 59A-3, F.A.C. Intensive residential treatment programs for children and adolescents with beds licensed as specialty hospital beds shall comply with the Agency standards for program licensure described in Chapter 59A-3, F.A.C. Applicants who include a statement in their certificate of need application that they will meet applicable Agency licensure standards are deemed to be in compliance with this provision.

(b) Hospital Inpatient Psychiatric Services for Children. As required by Section 394.4785(2), F.S., facilities providing hospital inpatient psychiatric services to children must have beds and common areas designated for children which cannot be used by adults. Adolescents may be treated in the units designated for children. Adolescents may only be treated in units designated for adult hospital inpatient psychiatric services if the admitting physician indicates that such placement is medically indicated, or for reasons of safety.

(c) Applicants proposing a new hospital inpatient general psychiatric service shall state how they will comply with the provisions of hospital licensure as defined in Rule 59A-3.066, F.A.C., applicable to the establishment of a new inpatient psychiatric hospital.

(d) Continuity. Providers of hospital inpatient psychiatric services shall also provide outpatient services, either directly or through written agreements with community outpatient mental health programs, such as local psychiatrists, local psychologists, community mental health programs, or other local mental health outpatient programs.

(e) Screening Program. All facilities providing hospital inpatient psychiatric services shall have a screening program to assess the most appropriate treatment for the patient. Patients with a dual diagnosis of a psychiatric disorder, as defined in subsection (2) and substance abuse, as defined in subsection (2), shall be evaluated to determine the types of treatment needed, the appropriate treatment setting, and, if necessary, the appropriate sequence of treatment for the psychiatric and substance abuse disorders.

(8) Services Description. An applicant for new inpatient psychiatric hospital services shall provide a detailed program description in its certificate of need application including:

(a) Age groups to be served.

(b) Specialty programs to be provided (e.g., programs for eating disorders, stress management programs).

(c) Proposed staffing, including the qualifications of the clinical director and a description of staffing appropriate for any specialty program.

(d) Patient groups that will be excluded from treatment.

(e) Therapeutic approaches to be used.

(f) Expected sources of patient referrals.

(g) Expected average length of stay for the hospital inpatient psychiatric services discharges by age group.

(h) Projected number of hospital inpatient psychiatric services patient days by payer type, including Medicare, Medicaid, Baker Act, private insurance, self-pay and charity care patient days for the first 2 years of operation after completion of the proposed project.

(i) Admission policies of the facility with regard to charity care patients.

(9) Quarterly Reports. Facilities providing licensed hospital inpatient psychiatric services, including facilities with intensive residential treatment program beds for children and adolescents licensed as specialty hospital beds, shall report to the Agency or its designee, within 45 days after the end of each calendar quarter, the number of hospital inpatient psychiatric services admissions and patient days by age groups (patients under age 18 years and adults).

(10) Intensive Residential Treatment Programs for Children and Adolescents. An intensive residential treatment program for children and adolescents which is licensed as a specialty hospital consistent with the requirements of Chapter 59A-3, F.A.C., or a provider who has received certificate of need approval for an intensive residential treatment program for children and adolescents which is not yet licensed, may apply to the Agency for licensure of the program as a psychiatric hospital with services restricted to children and adolescents if it complies with the requirements specified in Chapter 59A-3, F.A.C., which are applicable to licensure of a psychiatric hospital.

History

Rulemaking Authority 408.034(3), (8), 408.15(8) FS. Law Implemented 408.035, 408.036(1)(b), (c), 408.039(4)(a) FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(o), 10-5.040, Amended 8-24-93, 2-22-95, 6-23-16.

Fla. Admin. Code R. 59C-1.041 New Hospital Inpatient Substance Abuse Services

(1) Agency Intent. It is the intent of the Agency to ensure the availability of hospital inpatient substance abuse services for children, adolescents and adults in need of these services regardless of their ability to pay. This rule regulates the establishment of new inpatient substance abuse hospitals, and specifies which services can be provided by licensed or approved providers of hospital inpatient substance abuse services.

(2) Definitions.

(a) “Adolescent.” A person age 14 through 17.

(b) “Adult.” A person age 18 and over.

(d) “Approved Hospital Inpatient Substance Abuse Bed.” A proposed hospital inpatient substance abuse bed for which an exemption, notification, a certificate of need, a letter of intent to grant a certificate of need, a signed stipulated agreement, or a final order granting a certificate of need was issued, consistent with the provisions of paragraph 59C-1.008(2)(b), F.A.C., as of the most recent published deadline for Agency initial decisions prior to publication of the fixed need pool, as specified in paragraph 59C-1.008(1)(g), F.A.C.

(e) “Charity Care.” Is defined the same as in Section 409.911(1), F.S.

(f) “Child.” A person under the age of 14 years.

(g) “District.” A District of the Agency defined in Section 408.032(5), F.S.

(h) “Fixed Bed Need Pool.” The numerical hospital inpatient substance abuse bed need for adults for the applicable planning horizon, as established by the Agency in accordance with this rule and subsection 59C-1.008(2), F.A.C.

(i) “General Hospital.” Means any facility which meets the provisions of Section 395.002(12), F.S.

(j) “Hospital Inpatient Substance Abuse Bed.” A bed designated for the exclusive use of patients receiving hospital inpatient substance abuse services as defined by this rule.

(k) “Hospital Inpatient Substance Abuse Services.” Services provided under the direction of a professional trained and experienced in substance abuse services, including a psychiatrist, a physician certified by the American Society of Addiction Medicine, a physician subspecialty certified in Addiction Medicine by the American Osteopathic Association, a Certified Addictions Professional, a clinical psychologist, a clinical social worker (as defined in Section 491.003(2), F.S.) or a certified master social worker (as defined in Section 491.0145, F.S.) to persons whose sole diagnosis, or in the event of more than one diagnosis, the principal diagnosis is a substance abuse disorder defined in paragraph (2)(s) of this rule.

(l) “Planning Horizon.” The projected date by which a proposed hospital inpatient substance abuse service would be initiated. For purposes of this rule, the planning horizon for applications submitted between January 1 and June 30 is July of the year 5 years subsequent to the year the application is submitted; the planning horizon for applications submitted between July 1 and December 31 is January of the year 5 years subsequent to the year which follows the year the application is submitted.

(m) “Psychiatric Disorder.” For purposes of this rule, a psychiatric disorder is a mental illness as defined in Section 394.455(18), F.S., which requires inpatient hospitalization.

(n) “Separately Organized Unit.” A specific section, ward, wing, or floor with a separate nursing station designated exclusively for the care of hospital inpatient substance abuse services patients.

(o) “Specialty Hospital.” A specialty hospital is as defined by Section 395.002(28), F.S.

(p) “Substance Abuse.” The misuse or abuse of, or a dependence on alchohol, illicit drugs or prescription medications which requires inpatient hospitalization. A disorder coded in any sub-classification of categories 291, 292, 303, 304 or 305 in Axis I or Axis II consistent with the diagnostic categories defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-III-R), incorporated herein by reference; or equivalent codes in the following sub-classifications in the International Classification of Disease (ICD 9), incorporated herein by reference: category 291, 292, 303, 304 or 305.

(3) General Provisions.

(a) Admissions to Hospital Inpatient Substance Abuse Services. Admission to facilities with a certificate of need for hospital inpatient substance abuse services is limited to persons whose sole diagnosis, or in the event of more than one diagnosis, the principal diagnosis is a substance abuse disorder as defined in subsection (2).

(b) Service Location. The hospital inpatient substance abuse services regulated under this rule may be provided in a hospital licensed as a general hospital or licensed as a specialty hospital.

(c) Separate Regulation of Age Categories. The Agency regulates two types of hospital inpatient substance abuse services, those services which are used for substance abuse treatment of adults, and those services used for substance abuse treatment of children and adolescents. Certificate of need applications for the establishment of hospital inpatient substance abuse services for adults shall be reviewed separately from certificate of need applications for hospital inpatient substance abuse services for children and adolescents. A separate certificate of need shall be issued for each service.

(d) Separately Organized Units. Hospital inpatient substance abuse services for adults shall be provided in one or more separately organized units within a general hospital or specialty hospital. Hospital inpatient substance abuse services for children and adolescents shall be provided in one or more separately organized units within a general hospital or specialty hospital.

(e) Minimum Size of Specialty Hospitals. A specialty hospital providing hospital inpatient substance abuse services shall have a minimum total capacity of 40 beds, which may include beds used for hospital inpatient psychiatric services regulated under Rule 59C-1.040, F.A.C. The separately organized units for hospital inpatient substance abuse services for adults or for children and adolescents in specialty hospitals shall meet the minimum size requirements stated in subsection (5) of this rule.

(f) Conformance with the Criteria for Approval. A certificate of need for the establishment of new inpatient substance abuse hospitals shall not normally be approved unless the applicant meets the applicable review criteria in Section 408.035, F.S., and the standards and need determination criteria set forth in this rule.

(g) Required Services. Hospital inpatient substance abuse services whether provided directly by the hospital or under contract shall include, at a minimum, emergency screening services; treatment planning services; pharmacology, if appropriate; individual therapy; family therapy; discharge planning; referral services, including written referral agreements for educational and vocational services; and occupational and recreational therapies.

(h) Excluded Hospitals. Hospitals operated by the State of Florida are not regulated under this rule pursuant to Sections 408.036(3)(d), (r) and (s), F.S.

(4) Criteria for Determination of Need.

(a) Bed Need. A favorable need determination for proposed inpatient substance abuse hospitals for adults shall not normally be made unless a bed need exists according to the numeric need methodology in paragraph (4)(c) of this rule.

(b) Fixed Bed Need Pool. The future need for hospital inpatient substance abuse services for adults shall be determined twice a year and published by the Agency as a fixed bed need pool for the applicable planning horizon.

(c) Need Formula for Hospital Inpatient Substance Abuse Beds for Adults. The net bed need for hospital inpatient substance abuse beds for adults in each District shall be calculated in accordance with the following formula:

NNA = ((PDA/PA × PPA) / (365 × .75)) – LBA – ABA

where:

NNA equals the net need for hospital inpatient substance abuse beds for adults in a district.
PDA equals the number of inpatient days in hospital inpatient substance abuse beds for adults in a district for the 12-month period ending 6 months prior to the beginning date of the quarter of the publication of the fixed bed need pool.
PA equals the estimated population age 18 or over in the district. For applications submitted between January 1 and June 30, PA is the population estimate for January of the preceding year; for applications submitted between July 1 and December 31, PA is the population estimate for July of the preceding year. The population estimate shall be the most recent estimate published by the Office of the Governor and available to the Agency at least 6 weeks prior to publication of the fixed bed need pool.
PPA equals the estimated population age 18 or over in the district for the applicable planning horizon. The population estimate shall be the most recent estimate published by the Office of the Governor and available to the Agency at least 6 weeks prior to publication of the fixed bed need pool.
.75 equals the desired average annual occupancy rate for hospital inpatient substance abuse beds for adults in the district.
LBA equals the district’s number of licensed hospital inpatient substance abuse beds for adults as of the most recent published deadline for Agency initial decisions prior to publication of the fixed bed need pool.
ABA equals the district’s number of approved hospital inpatient substance abuse beds for adults, as determined consistent with the provisions of subsection (2) of this rule.

(d) Need for Hospital Inpatient Substance Abuse Services for Children and Adolescents. The need for proposed hospital inpatient substance abuse services for children and adolescents shall be determined consistent with the following:

The Agency shall consider the need for hospital inpatient substance abuse services for children and adolescents within the context of licensed or approved hospital inpatient substance abuse services for children and adolescents and licensed non-hospital residential treatment programs for children and adolescents with substance abuse disorders. The applicant for hospital inpatient substance abuse services for children and adolescents shall provide documentation that the district’s licensed non-hospital residential treatment programs for children and adolescents with substance abuse disorders do not meet the need for the proposed service.
No additional hospital inpatient substance abuse beds for children and adolescents shall normally be approved in a district having one or more facilities with hospital inpatient substance abuse services for children and adolescents unless the average annual occupancy rate of all licensed hospital inpatient substance abuse beds for children and adolescents in the district equaled or exceeded 75 percent during the 12 month period ending 6 months prior to the application submission deadline.

(e) Preferences among competing applicants for hospital inpatient substance abuse services. In weighing and balancing statutory and rule review criteria, preference will be given to applicants who:

Provide Medicaid and charity care days as a percentage of their total patient days equal to or greater than the average percentage of Medicaid and charity care patient days of total patient days provided by other hospitals in the district, as determined by the Florida Center for Health Information and Policy Analysis hospital discharge data for the 12-month period ending six months prior to the beginning date of the quarter of the publication of the fixed bed need pool.
Propose to serve Medicaid-eligible persons.
Propose to serve substance-abusing pregnant and post-partum women regardless of their ability to pay.
Propose to serve individuals without regard to their ability to pay.

(f) Non-Competitive Applicants. The factors contained in paragraph (4)(e), shall also be considered in the review of a single non-competitive certificate of need application within the district.

(5) Unit Size. A separately organized unit for hospital inpatient substance abuse services for adults shall have a minimum of 10 beds. A separately organized unit for hospital inpatient substance abuse services for children and adolescents shall have a minimum of five beds.

(6) Access Standard. Hospital inpatient substance abuse services should be available within a maximum ground travel time of 45 minutes under average travel conditions for at least 90% percent of the district’s total population.

(7) Quality of Care.

(a) Compliance with Agency Standards. Hospital Inpatient Substance Abuse Services for Adults or for Children and Adolescents shall comply with the Agency standards for program licensure described in Chapter 59A-3, F.A.C. Applicants who include a statement in their certificate of need application that they will meet applicable Agency licensure standards are deemed to be in compliance with this provision.

(b) Hospital Inpatient Substance Abuse Services for Children. Facilities providing Hospital Inpatient Substance Abuse Services to children must have beds and common areas designated for children which cannot be used by adults. Adolescents may be treated in the units designated for children. Adolescents may only be treated in units designated for adult hospital inpatient substance abuse services if the admitting physician indicates that such placement is medically indicated, or for reasons of safety.

(c) Applicants proposing a new hospital inpatient substance abuse service shall state how they will comply with the provisions of hospital licensure as defined in Rule 59A-3.066, F.A.C.

(d) Continuity. Providers of hospital inpatient substance abuse services shall also provide outpatient or referral services, either directly or through written agreements with community outpatient substance abuse programs, such as local psychiatrists, other physicians trained in the treatment of psychiatric or substance abuse disorders, local psychologists, community mental health programs, or other local substance abuse outpatient programs.

(e) Screening Program. All facilities providing hospital inpatient substance abuse services shall have a screening program to assess the most appropriate treatment for the patient. Patients with a dual diagnosis of substance abuse, as defined in subsection (2), and a psychiatric disorder, as defined in subsection (2), shall be evaluated to determine the types of treatment needed, the appropriate treatment setting, and, if necessary, the appropriate sequence of treatment for the substance abuse and psychiatric disorders.

(8) Services Description. An applicant for an inpatient substance abuse hospital shall provide a detailed program description in its certificate of need application including:

(a) Age groups to be served.

(b) Specialty programs to be provided (e.g. alcoholism treatment programs, drug abuse treatment programs).

(c) Proposed staffing, including qualifications of the clinical director, a description of staffing appropriate for any specialty program, and a discussion of the training and experience requirements for all staff who will provide substance abuse services.

(d) Therapeutic approaches to be used.

(e) Expected sources of patient referrals.

(f) Expected average length of stay for the hospital inpatient substance abuse services discharges by age group.

(g) Projected number of hospital inpatient substance abuse services patient days by payer type, including Medicare, Medicaid, private insurance, self-pay and charity care patient days for the first 2 years of operation after completion of the proposed project.

(h) Admission policies of the facility with regard to charity care patients.

(9) Quarterly Reports. Facilities providing licensed hospital inpatient substance abuse services shall report to the Agency or its designee, within 45 days after the end of each calendar quarter, the number of hospital inpatient substance abuse services admissions and patient days by age groups (patients under age 18 years and adults).

History

Rulemaking Authority 408.034(3), (8), 408.15(8) FS. Law Implemented 408.035, 408.036(1)(b), (c), 408.039(4)(a) FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(q), 10-5.041, Amended 8-24-93, 2-22-95, 6-23-16.

Fla. Admin. Code R. 59C-1.042 Neonatal Intensive Care Services

History

Rulemaking Authority 408.034(3), (8), 408.15(8) FS. Law Implemented 408.032(17), 408.034(3), 408.035, 408.036(1)(f), 408.039(4)(a) FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(v), 10-5.042, Amended 1-4-93, 8-24-93, 2-22-95, 4-10-96, 3-15-17, Repealed 12-20-22.

Fla. Admin. Code R. 59C-1.043 Burn Units

History

Rulemaking Authority 408.034(3), (5), 408.039(4)(a), 408.15(8) FS. Law Implemented 408.034(3), 408.035, 408.036(1)(a), (e), (h), (m), 408.039(4)(a) FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(w), 10-5.043, Amended 8-24-93, Repealed 5-7-12.

Fla. Admin. Code R. 59C-1.044 Organ Transplantation

(1) Agency Intent. This rule implements the provision of Section 408.036(1)(f), F.S., which requires the Agency to review the establishment of organ transplantation programs under the Certificate of Need program which shall include heart, kidney, liver, bone marrow, lung, lung and heart, pancreas and islet cells, and intestines. Applications for organ transplantation programs shall be reviewed against the applicable review criteria in Section 408.035, F.S., and the standards and need determination criteria set forth in this rule. This rule defines the minimum requirements for personnel, equipment, and support services for organ transplantation programs. In addition, the rule includes a need methodology for the establishment of organ transplantation programs by type. An applicant shall apply for each type of organ transplantation program. A separate Certificate of Need is required for pediatric organ transplant programs by type. Applicants for each type of transplantation program shall meet the requirements specified in subsections (3), (4) and (5). Additional requirements for heart transplantation programs are specified in subsection (6); for liver transplantation programs in subsection (7); for kidney transplantation programs in subsection (8); for allogeneic and autologous bone marrow transplantation programs in subsection (9); and for lung, heart and lung, pancreas and islet cells, and intestines transplants, in subsection (10). The following organ transplantation programs shall be restricted to teaching or research hospitals: liver, adult allogeneic bone marrow, pediatric allogeneic and autologous bone marrow, lung, heart and lung, pancreas and islet cells, and intestines.

(2) Definitions.

(a) Bone Marrow Transplantation. Human blood precursor cells, stem cells, administered to a patient to restore normal hematological and immunological functions following ablative or nonablative therapy with curative or life-prolonging intent. Human blood precursor cells may be obtained from the patient in an autologous transplant or from a medically acceptable related or unrelated donor, and may be derived from bone marrow, circulating blood, or a combination of bone marrow and circulating blood. If chemotherapy is an integral part of the treatment involving bone marrow transplantation, the term “bone marrow transplantation” includes both the transplantation and the chemotherapy. (Section 627.4236(1), F.S.).

(b) Organs. Organs as used in this rule include heart, kidney, liver, bone marrow, lung, heart and lung, pancreas and islet cells, and intestines.

(d) Research Hospital. A hospital which devotes clearly defined space, staff, equipment, and other resources for research purposes, and has documented teaching affiliations with an accredited school of medicine in Florida or another state.

(e) Research Program. An organized program that conducts clinical trial research, collects treatment data, assesses outcome data, and publishes statistical reports showing research activity and findings.

(f) Service Planning Area. Planning for organ transplantation programs shall be done on a regionalized basis. Certificate of Need applications shall be competitively reviewed within each of the four service planning areas delineated below:

Service planning area one includes District 1, District 2, District 3 excluding Lake County, and District 4 excluding Volusia County;
Service planning area two includes District 5, District 6, and District 8 excluding Collier County;
Service planning area three includes District 7, District 9 excluding Palm Beach County, and includes Lake and Volusia Counties; and,
Service planning area four includes District 10, District 11, and Collier and Palm Beach Counties.

(g) Teaching Hospital. Any hospital which meets the conditions specified in Section 408.07(45), F.S.

(h) Transplantation Program. The offering of surgical services by a hospital through which one or more types of organ transplants are provided to one or more patients; and the offering of some or all phases of bone marrow transplantation.

(3) Coordination of Services. Applicants for transplantation programs, regardless of the type of transplantation program, shall have:

(a) Staff and other resources necessary to care for the patient’s chronic illness prior to transplantation, during transplantation, and in the post-operative period. Services and facilities for inpatient and outpatient care shall be available on a 24-hour basis.

(b) If cadaveric transplantation will be part of the transplantation program, a written agreement with an organ acquisition center for organ procurement is required. A system by which 24-hour call can be maintained for assessment, management and retrieval of all referred donors, cadaver donors or organs shared by other transplant or organ procurement agencies is mandatory. Applicants for a bone marrow transplantation program are exempt from this requirement.

(c) An age-appropriate (adult or pediatric) intensive care unit which includes facilities for prolonged reverse isolation when required.

(d) A clinical review committee for evaluation and decision-making regarding the suitability of a transplant candidate.

(e) Written protocols for patient care for each type of organ transplantation program including, at a minimum, patient selection criteria for patient management and evaluation during the pre-hospital, in-hospital, and immediate post-discharge phases of the program.

(f) Detailed therapeutic and evaluative procedures for the acute and long term management of each transplant program patient, including the management of commonly encountered complications.

(g) Equipment for cooling, flushing, and transporting organs. If cadaveric transplants are performed, equipment for organ preservation through mechanical perfusion is necessary. Applicants for a bone marrow transplantation program are exempt from this requirement. This requirement may be met through an agreement with an organ procurement Agency.

(h) An onsite tissue-typing laboratory or a contractual arrangement with an outside laboratory within the State of Florida, which meets the requirements of the American Society of Histocompatibility.

(i) Pathology services with the capability of studying and promptly reporting the patient’s response to the organ transplantation surgery, and analyzing appropriate biopsy material.

(j) Blood banking facilities.

(k) A program for the education and training of staff regarding the special care of transplantation patients.

(l) Education programs for patients, their families and the patient’s primary care physician regarding after-care for transplantation patients.

(4) Staffing Requirements. Applicants for transplantation programs, regardless of the type of transplantation program, shall meet the following staffing requirements:

(a) A staff of physicians with expertise in caring for patients with end-stage disease requiring transplantation. The staff shall have medical specialties or sub-specialties appropriate for the type of transplantation program to be established. The program shall employ a transplant physician, and a transplant surgeon, if applicable, as defined by the United Network for Organ Sharing (UNOS) June 1994. The UNOS definitions are incorporated herein by reference. A physician with one year experience in the management of infectious diseases in the transplant patient shall be a member of the transplant team;

(b) A program director who shall have a minimum of 1 year of formal training and 1 year of experience at a transplantation program for the same type of organ transplantation program proposed. Provided, however, that an applicant for a bone marrow transplantation program shall meet the requirements in subsection (9);

(d) A staff of nurses, and nurse practitioners with experience in the care of chronically ill patients and their families;

(e) Contractual agreements with consultants who have expertise in blood banking and are capable of meeting the unique needs of transplant patients on a long term basis;

(f) Nutritionists with expertise in the nutritional needs of transplant patients;

(g) Respiratory therapists with expertise in the needs of transplant patients; and,

(h) Social workers, psychologists, psychiatrists, and other individuals skilled in performing comprehensive psychological assessments, counselling patients, and families of patients, providing assistance with financial arrangements, and making arrangements for use of community resources.

(5) Data Reporting Requirements. Facilities with organ transplantation programs shall submit data regarding each transplantation program to the Agency or its designee, within 45 days after the end of each calendar quarter, facilities with organ transplantation programs, shall report to the Agency, or its designee, the total number of transplants by organ type which occurred in each month of the quarter.

(6) Heart Transplantation Programs. In addition to meeting the requirements specified in subsections (3), (4) and (5), applications for a heart transplantation program shall not normally be approved in a service planning area unless the following additional criteria are met.

(a) Staffing Requirements. An applicant for a heart transplantation program shall have the following program personnel and services:

A board-certified or board eligible adult cardiologist; or, in the case of a pediatric heart transplantation program, a board-certified or board eligible pediatric cardiologist;
An anesthesiologist experienced in both open heart surgery and heart transplantation; and,
A one bed isolation room in an age-appropriate intensive care unit.

(b) Need Determination. An application for a Certificate of Need to establish a heart transplantation program shall not normally be approved in a service area unless:

Each existing heart transplantation provider in the applicable service area performed a minimum of 24 heart transplants in the most recent calendar year preceding the application deadline for new programs, and no other heart transplantation program has been approved for the same service planning area;
The application contains documentation that a minimum of 12 heart transplants per year will be performed within 2 years of Certificate of Need approval. Such documentation shall include, at a minimum, the number of hearts procured by Florida hospitals during the most recent calendar year, and an estimate of the number of patients in the service planning area who would meet commonly-accepted criteria identifying potential heart transplant recipients;
The application includes documentation that the annual duplicated cardiac catheterization patient caseload was at or exceeded 500 for the calendar year preceding the Certificate of Need application deadline; and that the duplicated patient caseload for open heart surgery was at or exceeded 150 for the calendar year preceding the Certificate of Need application deadline; and,
An application for a pediatric heart transplantation program shall include documentation that the annual duplicated cardiac catheterization patient caseload was at or exceeded 200 for the calendar year preceding the Certificate of Need application deadline; and that the duplicated cardiac open heart surgery caseload was at or exceeded 125 for the calendar year preceding the Certificate of Need application deadline.

(7) Liver Transplantation Programs. In addition to meeting the requirements specified in subsections (3), (4) and (5), applications for a liver transplantation program shall not normally be approved unless the following additional criteria are met:

(a) An applicant for a Certificate of Need to establish a liver transplantation program must be a teaching hospital or research hospital with training programs relevant to liver transplantation.

(b) Coordination of Services. The following services shall be available in the hospital, or through contractual arrangements:

A department of gastroenterology, including clinics, and adequately equipped procedure rooms;
Radiology services to provide complex biliary procedures, including transhepathic cholangiography, protal venography and arteriography;
A laboratory with the capability of performing and promptly reporting the results of liver function tests as well as required chemistry, hematology, and virology tests; and,
A patient convalescent unit for further monitoring of patient progress for approximately one month post-hospital discharge following liver transplantation.

(c) Staffing Requirements. In addition to the general staffing requirements for all transplantation programs, program staff for liver transplantation programs shall be trained in the care of patients with hepatic diseases, and liver transplantation.

(d) Need Determination.

The application includes documentation that a minimum of five liver transplants will be performed within 2 years of Certificate of Need approval. Such evidence shall include, at a minimum, the number of livers procured in the state during the most recent calendar year, and an estimate of the number of patients in the service delivery area who would meet commonly-accepted criteria identifying potential liver transplant recipients. The caseload estimate shall be based on the number of persons with end-stage hepatic diseases in the service planning area, for which death due to the disease is likely to occur within 1 year without the transplantation.
The application includes documentation that the new liver transplantation program improves patient access.

(8) Kidney Transplantation Programs. In addition to meeting the requirements specified in subsections (3), (4) and (5), a Certificate of Need for a new kidney transplantation program shall not normally be approved unless the following additional criteria are met:

(a) Coordination of Services.

Inpatient services shall be available which shall include renal dialysis, and pre- and post operative care. There shall be 24-hour availability of onsite dialysis under the supervision of a board-certified or board eligible nephrologist. If pediatric patients are served, a separate pediatric dialysis unit shall be established.
Outpatient services shall be available which shall include renal dialysis services and ambulatory renal clinic services.
Ancillary services shall include pre-dialysis, dialysis, and post transplantation nutritional services; bacteriologic, biochemical, and pathological services; radiologic services; and nursing services with the capability of monitoring and support during dialysis and assisting in home care including vascular access, and home dialysis management, when applicable.

(b) Staffing Requirements for Adult Kidney Transplantation Programs.

The kidney transplantation program shall be under the direction of a physician with experience in physiology, immunology and immuno-suppressive therapy relevant to kidney transplantation.
The transplant surgeon shall be board-certified in surgery or a surgical subspecialty, and shall have a minimum of 18 months training in a transplant center.
The transplant team performing kidney transplantation shall include physicians who are board-certified or board-eligible in the areas of Anesthesiology, Nephrology, Psychiatry, Vascular Surgery, and Urology.
Additional support personnel which shall be available include a nephrology nurse with experience in nursing care of patients with permanent kidney failure, and a renal dietician.
A laboratory with the capability of performing and promptly reporting bacteriologic, biochemical and pathologic analysis.
An anesthesiologist experienced in kidney transplantation.

(c) Staffing Requirements for Pediatric Kidney Transplantation Programs. Applicants for a kidney transplantation program which will serve pediatric patients shall have the following staffing:

A medical director who is sub-board-certified or sub-board-eligible in pediatric nephrology.
A dialysis unit head nurse with special training and expertise in pediatric dialysis.
Nurse staffing at a nurse to patient ratio of 1 to 1 in the pediatric dialysis unit.
A registered dietician with expertise in nutritional needs of children with chronic renal disease.
A surgeon with experience in pediatric renal transplantation.
A radiology service with specialized equipment for obtaining x-rays on pediatric patients.
Education services to include home and hospital programs to ensure minimal interruption in school education.

(d) Need Determination. Applications for the establishment of new kidney transplantation programs shall not normally be approved unless the following need criteria are met:

Each existing kidney transplantation provider in the applicable service area performed a minimum of 30 kidney transplants in the most recent calendar year preceding the application deadline, and no additional program has been approved for the same service planning area;
If pediatric kidney transplants will be performed, each existing pediatric kidney transplant program performed a minimum of 10 pediatric kidney transplants during the calendar year preceding the application deadline, and no additional program has been approved for the same service planning area;
The application shall include documentation that a minimum of fifteen kidney transplants per year will be performed within 2 years of program operation. Such documentation shall include, at a minimum, the number of kidneys procured in the state during the most recent calendar year, and an estimate of the number of patients who would meet commonly-accepted criteria identifying potential kidney transplant recipients. This estimate shall be based on the number of patients on dialysis within the same service planning area; and,
If pediatric kidney transplants will be performed, the application shall include documentation that a minimum of 5 pediatric kidney transplants per year will be performed within two years of Certificate of Need approval.

(9) Allogeneic and Autologous Bone Marrow Transplantation Programs. In addition to meeting the requirements specified in subsections (3), (4) and (5), applications for new bone marrow programs shall not normally be approved unless the following additional requirements and criteria are met.

(a) Pediatric Allogeneic and Autologous Bone Marrow Transplantation Programs. Pediatric allogeneic and autologous bone marrow transplantation programs shall be limited to teaching and research hospitals with training programs relevant to pediatric bone marrow transplantation. All applicants shall meet the requirements specified in subparagraph 1., below. Applicants for allogeneic programs shall meet the additional requirements specified in subparagraph 2., below:

Requirements for Pediatric Allogeneic and Autologous Transplantation Programs;

a. Applicants shall be able to project that at least 10 pediatric transplants will be performed each year. If both allogeneic and autologous pediatric transplants are performed, at least 10 of each shall be projected. New units shall be able to project the minimum volume for the third year of operation;

b. A program director who is a board certified hematologist or oncologist with experience in the treatment and management of pediatric acute oncological cases involving high dose chemotherapy or high dose radiation therapy. The program director must have formal training in pediatric bone marrow transplantation;

c. Clinical nurses with experience in the care of critically ill immuno-suppressed patients. Nursing staff shall be dedicated full time to the program;

d. An interdisciplinary transplantation team with expertise in hematology, oncology, immunologic diseases, neoplastic diseases, including hematopoietic and lymphopoietic malignancies, and non-neoplastic disorders. The team shall direct permanent follow-up care of the bone marrow transplantation patients, including the maintenance of immunosuppressive therapy and treatment of complications;

e. Age appropriate inpatient transplantation units for post-transplant hospitalization. Post-transplantation care must be provided in a laminar air flow room; or in a private room with positive pressure, reverse isolation procedures, and terminal high efficiency particulate aerosol filtration on air blowers. The designated transplant unit shall have a minimum of 2 beds. This unit can be part of a facility that also manages patients with leukemia or similar disorders;

f. A radiation therapy division onsite which is capable of sub-lethal x-irradiation, bone marrow ablation, and total lymphoid irradiation. The division shall be under the direction of a board certified radiation oncologist;

g. An ongoing research program that is integrated either within the hospital or by written agreement with a bone marrow transplantation center operated by a teaching hospital. The program must include outcome monitoring and long-term patient follow-up; and;

h. An established research-oriented oncology program.

Additional Requirements for Pediatric Allogeneic Transplantation Programs:

a. A laboratory equipped to handle studies including the use of monoclonal antibodies, if this procedure is employed by the hospital, or T-cell depletion, separation of lymphocyte and hematological cell subpopulations and their removal for prevention of graft versus host disease. This requirement may be met through contractual arrangements;

b. An onsite laboratory equipped for the evaluation and cryopreservation of bone marrow;

c. An age appropriate patient convalescent facility to provide a temporary residence setting for transplant patients during the prolonged convalescence; and,

d. An age appropriate outpatient unit for close supervision of discharged patients.

(b) Adult Allogeneic Bone Marrow Transplantation Programs. Adult allogeneic bone marrow transplantation programs shall be limited to teaching and research hospitals. Applicants shall meet the following requirements:

Applicants shall be able to project that at least 10 adult allogeneic transplants will be performed each year. New units shall be able to project the minimum volume for the third year of operation;
A program director who is a board certified hematologist or oncologist with experience in the treatment and management of adult acute oncological cases involving high dose chemotherapy or high dose radiation therapy. The program director must have formal training in bone marrow transplantation;
Clinical nurses with experience in the care of critically ill immuno-suppressed patients. Nursing staff shall be dedicated full time to the program;
An interdisciplinary transplantation team with expertise in hematology, oncology, immunologic diseases, neoplastic diseases, including hematopoietic and lymphopoietic malignancies, and non-neoplastic disorders. The team shall direct permanent follow-up care of the bone marrow transplantation patients, including the maintenance of immunosuppressive therapy and treatment of complications;
Inpatient transplantation units for post-transplant hospitalization. Post-transplantation care must be provided in a laminar air flow room; or in a private room with positive pressure, reverse isolation procedures, and terminal high efficiency particulate aerosol filtration on air blowers. The designated transplant unit shall have a minimum of 2 beds. This unit can be part of a facility that also manages patients with leukemia or similar disorders;
A radiation therapy division onsite which is capable of sub-lethal x-irradiation, bone marrow ablation, and total lymphoid irradiation. The division shall be under the direction of a board certified radiation oncologist;
A laboratory equipped to handle studies including the use of monoclonal antibodies, if this procedure is employed by the hospital, or T-cell depletion, separation of lymphocyte and hematological cell subpopulations and their removal for prevention of graft versus host disease. This requirement may be met through contractual arrangements;
An onsite laboratory equipped for the evaluation and cryopreservation of bone marrow;
An ongoing research program that is integrated either within the hospital or by written agreement with a bone marrow transplantation center operated by a teaching hospital. The program must include outcome monitoring and long-term patient follow-up;
An established research-oriented oncology program;
A patient convalescent facility to provide a temporary residence setting for transplant patients during the prolonged convalescence; and,
An outpatient unit for close supervision of discharged patients.

(c) Adult Autologous Bone Marrow Transplantation Programs. Adult autologous bone marrow transplantation programs can be established at teaching hospitals or research hospitals; or at community hospitals having a research program, or who are affiliated with a research program, as defined in this rule. Applicants shall meet the following requirements:

Applicants shall be able to project that at least 10 adult autologous transplants will be performed each year. New units shall be able to project the minimum volume for the third year of operation;
A program director who is a board certified or board eligible hematologist or oncologist with experience in the treatment and management of adult acute oncological cases involving high dose chemotherapy or high dose radiation therapy. The program director must have formal training in bone marrow transplantation, or have at least 1 year of documented experience in performing autologous bone marrow transplantation;
Clinical nurses with experience in the care of critically ill immuno-suppressed patients. Nursing staff shall be dedicated full time to the program;
An interdisciplinary transplantation team with expertise in hematology, oncology, immunologic diseases, neoplastic diseases, including hematopoietic and lymphopoietic malignancies, and non-neoplastic disorders. The team shall direct permanent follow-up care of the bone marrow transplantation patients;
Inpatient transplantation units for post-transplant hospitalization. Post-transplantation care must be provided in a laminar air flow room; or in a private room with positive pressure, reverse isolation procedures, and terminal high efficiency particulate aerosol filtration on air blowers. The designated transplant unit shall have a minimum of 2 beds. This unit can be part of a facility that also manages patients with leukemia or similar disorders;
A radiation therapy division onsite which is capable of sub-lethal x-irradiation and total lymphoid irradiation. The division shall be under the direction of a board certified radiation oncologist;
An ongoing research program that is integrated either within the hospital or by written agreement with a bone marrow transplantation center operated by a teaching hospital; or the applicant may enter into an agreement with an outpatient provider having a research program, as defined in this rule. Under the agreement, the outpatient research program may perform specified outpatient phases of adult autologous bone marrow transplantation, including blood screening tests, mobilization of stem cells, stem cell rescue, chemotherapy, and reinfusion of stem cells; and,
An established research-oriented oncology program.

(d) Grandfathering Provisions for Hospitals Without Certificate of Need Approval. Hospitals that prior to March 1, 1993, operated a bone marrow transplantation program, as defined in this rule, without Certificate of Need approval, shall provide written documentation to the Agency that they meet the applicable requirements of subsections (3), (4) and (9) of this rule. Hospitals that meet the requirements shall be authorized to continue to provide the service.

(10) Transplantation Programs for Lung, Heart and Lung, Pancreas and Islet Cells, and Intestines. In addition to meeting the requirements specified in subsections (3), (4) and (5), Certificate of Need applications for the establishment of new transplantation programs involving lung, heart and lung, pancreas and islet cells or intestines shall not normally be approved unless the following additional criteria are met:

(a) The applicant is a teaching or research hospital with training programs relevant to the type of organ transplantation program proposed to be established; and,

(b) Applicants have established interactive programs of basic and applied research in organ failure, transplantation, immunoregulatory responses, and related biology.

(11) Pediatric transplant programs with a valid CON at a Medicaid designated transplant center may perform transplants for patients under the age of 21. In case of conflict between provisions in this rule, the provisions of this subsection shall prevail.

History

Rulemaking Authority 408.034(3), (8), 408.15(8) FS. Law Implemented 408.034(3), 408.035, 408.036(1)(f), 408.032(17), 408.033(1)(b)4., 11. FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(x), 10-5.044, Amended 8-24-93, 12-13-94, 7-6-09, 4-18-18.

Fla. Admin. Code R. 59C-1.050 Consideration of Approved Projects

History

Rulemaking Authority 408.034(3), (5), 408.039(4)(a), 408.15(8) FS. Law Implemented 408.034(3) FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5-11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(2), 10-5-050, Repealed 10-18-95.

Chapter 59C-2 LOCAL HEALTH PLAN ELEMENTS AGAINST WHICH APPLICATIONS FOR CERTIFICATES OF NEED SHALL BE EVALUATED

Fla. Admin. Code R. 59C-2.100 Acute Care Subdistricts

History

Rulemaking Authority 408.15(8), 408.034(8) FS. Law Implemented 408.033(1)(b), FS. History–New 2-12-96, Amended 10-31-96, Repealed 11-6-19.

Fla. Admin. Code R. 59C-2.200 Nursing Home Subdistricts

(1) General Provisions. Nursing home subdistricts are proposed by Local Health Councils and utilized by the agency in conjunction with the methodology for determining need for community nursing home beds. A full description of the need methodology appears in Rule 59C-1.036, F.A.C.

(2) Definitions.

(a) “Agency.” The Agency for Health Care Administration.

(b) “District.” A health service planning district of the agency defined in subsection 408.032(5), F.S.

(d) “Subdistrict.” A group of counties, a county, or a portion of a county which forms a subdivision of a district. For purposes of this rule, ten of the eleven districts of the agency are divided into subdistricts; District 10 is not divided.

(3) Nursing Home Subdistricts. The nursing home subdistricts are defined and numbered as follows:

(a) Subdistricts for District 1.

Subdistrict 1-1 consists of Escambia and Santa Rosa Counties.
Subdistrict 1-2 consists of Okaloosa County.
Subdistrict 1-3 consists of Walton County.

(b) Subdistricts for District 2.

Subdistrict 2-1 consists of Gadsden, Holmes, Jackson, and Washington Counties.
Subdistrict 2-2 consists of Bay County.
Subdistrict 2-3 consists of Calhoun, Franklin, Gulf, Liberty, and Wakulla Counties.
Subdistrict 2-4 consists of Leon County.
Subdistrict 2-5 consists of Jefferson, Madison, and Taylor Counties.

Subdistrict 3-1 consists of Columbia, Hamilton and Suwannee Counties.
Subdistrict 3-2 consists of Alachua, Bradford, Dixie, Gilchrist, Lafayette, Levy and Union Counties.
Subdistrict 3-3 consists of Putnam County.
Subdistrict 3-4 consists of Marion County.
Subdistrict 3-5 consists of Citrus County.
Subdistrict 3-6 consists of Hernando County.
Subdistrict 3-7 consists of Lake and Sumter Counties.

(d) Subdistricts for District 4.

Subdistrict 4-1 consists of Nassau County, and the northern portion of Duval County lying within ZIP codes 32202, 32206, 32208, 32209, 32218, 32219, 32220, 32226 and 32254.
Subdistrict 4-2 consists of Baker County, Clay County, and the southwestern portion of Duval County lying within ZIP Codes 32204, 32205, 32210, 32212, 32215, 32221, 32222, 32234 and 32244.
Subdistrict 4-3 consists of St. John’s County, and the southeastern portion of Duval County lying within ZIP Codes 32207, 32211, 32216, 32217, 32223, 32224, 32225, 32228, 32233, 32246, 32250, 32256, 32257, 32258, 32266 and 32277.
Subdistrict 4-4 consists of Flagler and Volusia Counties.

(e) Subdistricts in District 5.

Subdistrict 5-1 consists of Pasco County.
Subdistrict 5-2 consists of Pinellas County.

(f) Subdistricts for District 6.

Subdistrict 6-1 consists of Hillsborough County.
Subdistrict 6-2 consists of Manatee County.
Subdistrict 6-3 consists of Hardee County.
Subdistrict 6-4 consists of Highlands County.
Subdistrict 6-5 consists of Polk County.

(g) Subdistricts for District 7.

Subdistrict 7-1 consists of Brevard County.
Subdistrict 7-2 consists of Orange County.
Subdistrict 7-3 consists of Osceola County.
Subdistrict 7-4 consists of Seminole County.

(h) Subdistricts for District 8.

Subdistrict 8-1 consists of Charlotte County.
Subdistrict 8-2 consists of Collier County.
Subdistrict 8-3 consists of DeSoto County.
Subdistrict 8-4 consists of Glades and Hendry Counties.
Subdistrict 8-5 consists of Lee County.
Subdistrict 8-6 consists of Sarasota County.

(i) Subdistricts for District 9.

Subdistrict 9-1 consists of Indian River County.
Subdistrict 9-2 consists of Martin County.
Subdistrict 9-3 consists of Okeechobee County.
Subdistrict 9-4 consists of Palm Beach County.
Subdistrict 9-5 consists of St. Lucie County.

(j) Subdistricts for District 10.

Subdistrict 10-1 consists of all of District 10. For purposes of need determination under Rule 59C-1.036, F.A.C., District 10 is treated in the same manner as a subdistrict.

(k) Subdistricts for District 11.

Subdistrict 11-1 consists of Dade County.
Subdistrict 11-2 consists of Monroe County.

History

Rulemaking Authority 408.15(8), 408.034(8) FS. Law Implemented 408.033(1)(b) FS. History–New 2-12-96, Amended 10-31-96, 7-16-03.

Division 59B Cost Management and Control

Chapter 59B-6 REPORTS REQUIRED OF HOSPITALS AND OTHER FACILITIES

Fla. Admin. Code R. 59B-6.008 Health Care Entities Required to Report and Pay Assessment

History

Rulemaking Authority 395.7015(5), 408.15(8), 408 FS. Law Implemented 395.7015 FS. History–New 5-7-92, Formerly 10N-6.008, Amended 2-10-93, Repealed 5-10-12.

Fla. Admin. Code R. 59B-6.009 Definitions

History

Rulemaking Authority 395.7015(5), 408.15(8), 408 FS. Law Implemented 395.7015 FS. History–New 5-7-92, Formerly 10N-6.009, Amended 2-10-93, Repealed 5-10-12.

Fla. Admin. Code R. 59B-6.010 Adoption and Establishment of AHCA AMBFAC Report Forms

History

Rulemaking Authority 395.7015(5), 408.15(8), 408 FS. Law Implemented 395.7015 FS. History–New 5-7-92, Formerly 10N-6.010, Amended 2-10-93, 12-11-95, Repealed 5-10-12.

Fla. Admin. Code R. 59B-6.011 Manner for Submitting Reports

History

Rulemaking Authority 395.7015(5), 408.15(8), 408 FS. Law Implemented 395.7015 FS. History–New 5-7-92, Formerly 10N-6.011, Amended 2-10-93, 12-11-95, Repealed 5-10-12.

Fla. Admin. Code R. 59B-6.012 Physician Professional Fees

History

Rulemaking Authority 395.7015(5), 408.15(8), 408 FS. Law Implemented 395.7015 FS. History–New 5-7-92, Formerly 10N-6.012, Amended 2-10-93, Repealed 5-10-12.

Fla. Admin. Code R. 59B-6.013 Unrelated Revenue

History

Rulemaking Authority 395.7015(5), 408.15(8), 408 FS. Law Implemented 395.7015 FS. History–New 5-7-92, Formerly 10N-6.013, Amended 2-10-93, Repealed 5-10-12.

Fla. Admin. Code R. 59B-6.014 Change of Fiscal Year

History

Rulemaking Authority 395.7015(5), 408.15(8), 408 FS. Law Implemented 395.7015 FS. History–New 5-7-92, Formerly 10N-6.014, Amended 2-10-93, Repealed 5-10-12.

Fla. Admin. Code R. 59B-6.015 Change of Ownership or New Health Care Entity

History

Rulemaking Authority 395.7015(5), 408.15(8), 408 FS. Law Implemented 395.7015 FS. History–New 5-7-92, Formerly 10N-6.015, Amended 2-10-93, Repealed 5-10-12.

Fla. Admin. Code R. 59B-6.016 Change of Health Care Entity Address

History

Rulemaking Authority 395.7015(5), 408.15(8), 408 FS. Law Implemented 395.7015 FS. History–New 5-7-92, Formerly 10N-6.016, Amended 2-10-93, Repealed 5-10-12.

Fla. Admin. Code R. 59B-6.017 Extensions

History

Rulemaking Authority 395.7015(5), 408.15(8), 408 FS. Law Implemented 395.7015 FS. History–New 5-7-92, Formerly 10N-6.017, Amended 2-10-93, Repealed 5-10-12.

Fla. Admin. Code R. 59B-6.018 Information Letters

History

Rulemaking Authority 395.7015(5), 408.15(8), 408 FS. Law Implemented 395.7015 FS. History–New 5-7-92, Formerly 10N-6.018, Amended 2-10-93, Repealed 5-10-12.

Fla. Admin. Code R. 59B-6.019 Notice of Reporting Deficiencies and Response

History

Rulemaking Authority 395.7015(5), 408.15(8), 408 FS. Law Implemented 395.7015 FS. History–New 5-7-92, Formerly 10N-6.019, Amended 2-10-93, Repealed 5-10-12.

Fla. Admin. Code R. 59B-6.020 Audits of Health Care Entities

History

Rulemaking Authority 395.7015(5), 408.15(8), 408, 408.08(1) FS. Law Implemented 395.7015 FS. History–New 5-7-92, Formerly 10N-6.020, Amended 2-10-93, Repealed 5-10-12.

Fla. Admin. Code R. 59B-6.021 Certification of PMATF Assessment

History

Rulemaking Authority 395.7015(5), 408.15(8), 408 FS. Law Implemented 395.7015 FS. History–New 5-7-92, Formerly 10N-6.021, Amended 2-10-93, Repealed 5-10-12.

Fla. Admin. Code R. 59B-6.022 Calculation and Payment of Assessment

History

Rulemaking Authority 395.7015(5), 408.15(8), 408 FS. Law Implemented 395.7015 FS. History–New 5-7-92, Formerly 10N-6.022, Amended 2-10-93, 12-11-95, Repealed 5-10-12.

Fla. Admin. Code R. 59B-6.023 Penalties for Reporting Deficiencies

History

Rulemaking Authority 395.7015(5), 408.15(8), 408 FS. Law Implemented 395.7015, 408.08 FS. History–New 5-7-92, Formerly 10N-6.023, Amended 2-10-93, 12-11-95, Repealed 5-10-12.

Fla. Admin. Code R. 59B-6.024 Penalties for Assessment Payment Deficiencies

History

Rulemaking Authority 395.7015(5), 408.15(8), 408 FS. Law Implemented 395.7015(5), 408.08 FS. History–New 5-7-92, Formerly 10N-6.024, Amended 2-10-93, 12-11-95, Repealed 5-10-12.

Chapter 59B-9 PATIENT DATA COLLECTION, AMBULATORY SURGERY AND EMERGENCY DEPARTMENT

Fla. Admin. Code R. 59B-9.010 Purpose of Ambulatory Patient Data Reporting

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063 FS. History–New 9-6-93, Formerly 59B-7.010, Amended 6-29-95, Amended 12-28-98, 2-25-02, 4-18-04, Repealed 1-1-10.

Fla. Admin. Code R. 59B-9.011 Submission of Ambulatory Patient Data

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063, 408.07, 408.08 FS. History–New 9-6-93, Formerly 59B-7.011, Amended 6-29-95, 12-28-98, 7-11-01, 2-25-02, Repealed 1-1-10.

Fla. Admin. Code R. 59B-9.012 Exemptions

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.006(5), 408.061 FS. History–New 9-6-93, Formerly 59B-7.012, Repealed 6-29-95.

Fla. Admin. Code R. 59B-9.013 Definitions

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063 FS. History–New 9-6-93, Formerly 59B-7.013, Amended 6-29-95, 12-28-98, 7-11-01, 2-25-02, 4-18-04, Repealed 1-1-10.

Fla. Admin. Code R. 59B-9.014 Schedule for Submission of Ambulatory Patient Data and Extensions

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.15(11) FS. History–New 9-6-93, Formerly 59B-7.014, Amended 6-29-95, 4-18-04, Repealed 1-1-10.

Fla. Admin. Code R. 59B-9.015 Reporting Instructions

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063 FS. History–New 9-6-93, Formerly 59B-7.015, Amended 6-29-95, 12-28-98, 1-4-00, 7-11-01, 2-25-02, 4-18-04, Repealed 1-1-10.

Fla. Admin. Code R. 59B-9.016 Notice of Reporting Deficiencies and Response

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.006(5), 408.061 FS. History–New 9-6-93, Formerly 59B-7.016, Amended 6-29-95, 7-11-01, Repealed 1-1-10.

Fla. Admin. Code R. 59B-9.017 Certification and Audit Procedures

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.08(1), 408.08(5), 408.15(11) FS. History–New 9-6-93, Formerly 59B-7.017, Amended 6-29-95, 7-11-01, Repealed 1-1-10.

Fla. Admin. Code R. 59B-9.018 Ambulatory Patient Data Format - Data Elements, Codes and Standards

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063 FS. History–New 9-6-93, Formerly 59B-7.018, Amended 6-29-95, 12-28-98, 7-11-01, 2-25-02, 4-18-04, Repealed 1-1-10.

Fla. Admin. Code R. 59B-9.019 Ambulatory Patient Data Format – Record Layout

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063 FS. History–New 9-6-93, Formerly 59B-7.019, Amended 6-29-95, 12-28-98, 7-11-01, 2-25-02, Repealed 4-18-04.

Fla. Admin. Code R. 59B-9.020 Data Standards

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063 FS. History–New 9-6-93, Formerly 59B-7.020, Amended 6-29-95, 12-28-98, 7-11-01, 2-25-02, Repealed 4-18-04.

Fla. Admin. Code R. 59B-9.021 Manual Submission of Data

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061 FS. History–New 9-6-93, Formerly 59B-7.021, Amended 6-29-95, 1-4-00, Repealed 7-11-01.

Fla. Admin. Code R. 59B-9.022 Penalties for Ambulatory Patient Data Reporting Deficiencies

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061 FS. History–New 9-6-93, Formerly 59B-7.022, Amended 6-29-95, Repealed 1-1-10.

Fla. Admin. Code R. 59B-9.023 Ambulatory Patient Data Release

History

Rulemaking Authority 408.15(8) FS. Law Implemented 119.07, 120.53(2)(a), 408.061 FS. History–New 9-6-93, Formerly 59B-7.023, Amended 6-29-95, Repealed 1-1-10.

Fla. Admin. Code R. 59B-9.030 Purpose of Ambulatory and Emergency Department Patient Data Reporting

The reporting of ambulatory patient data will provide a statewide integrated database that includes hospital based and free standing ambulatory surgery centers, and hospital emergency department services for the assessment of variations in utilization, disease surveillance, access to care and cost trends.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063 FS. History–New 1-1-10, Formerly 59B-9.010, Amended 1-1-18.

Fla. Admin. Code R. 59B-9.031 Definitions

(1) “Ambulatory Center.” For the purposes of this rule, “ambulatory center” means a freestanding ambulatory surgical center, short-term acute care hospital, emergency department, or freestanding cardiac catheterization laboratory.

(2) “Ambulatory Surgical Center” means a facility licensed as an ambulatory surgical center under Chapter 395, F.S.

(3) “CPT” means Current Procedural Terminology and refers to a coding system established by the American Medical Association to describe physician services which is published annually in Physicians’ Current Procedural Terminology manual which is incorporated by reference.

(4) “ECMORB” means a Supplementary Classification of External Causes of Morbidity and Poisoning ICD-10-CM, where environmental events, circumstances, and conditions are the cause of injury, poisoning and other adverse effects as specified in the ICD-10-CM manual and the conventions of coding.

(5) “Emergency Department” means any department of any general hospital when a request is made for emergency services and care for any emergency medical condition which is within the service capability of the hospital as specified in Section 395.1041, F.S.

(6) “Executive Officer” means a reporting facility’s chief executive officer, chief financial officer, chief operating officer, president, or vice president of the facility in charge of a principal business unit, division or function (administration or finance).

(7) “HCPCS” means Health Care Common Procedure Coding System which is published annually by the United States Department of Health and Human Services and is required by the Federal Government for Medicare reporting purposes.

(8) “Inpatient” means a patient who has an admission order given by a licensed physician or other individual who has been granted admitting privileges by the hospital.

(9) “NPI” means National Provider Identification. An NPI is a unique identification number assigned to a provider by the Centers for Medicare & Medicaid Services.

(10) “Short-Term Acute Care Hospital” means a hospital as defined in Section 395.002(12), F.S.

(11) “Visit” means a face to face encounter between a health care provider and a patient who is not formally admitted as an inpatient in an acute care hospital setting at the time of the encounter or who is not admitted to the same facility’s acute care hospital setting immediately following the encounter as described in subsection 59B-9.034(3), F.A.C. Visits which require the patient to appear in an ambulatory setting prior to the actual procedure (even if this occurs one or more days before the procedure) shall be counted as one visit. The admit date in these instances should be the day of the procedure.

(12) ISO 3166 – International Standard for Organization is a standardized list of country names and codes first published in 1974 and updated 2008. ISO 3166 is available at: http://www.iso.org/iso/english_country_names_and_code_elements.

(13) “Cardiac catheterization laboratory” as defined in Section 408.07, F.S.

(14) “FDDC” means Florida Discharge Data Collection system. An online portal for all data collection applications including, but not limited to, quarterly data submissions, facility contact information, exemption requests, resubmission requests and certification.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063 FS. History–New 1-1-10, Amended 12-5-10 Formerly 59B-9.013, Amended 10-1-15, 2-16-23.

Fla. Admin. Code R. 59B-9.032 Ambulatory and Emergency Department Data Reporting and Audit Procedures

(1) The following entities shall submit patient data to the Agency for Health Care Administration (AHCA or Agency):

(a) All licensed short-term acute care hospitals licensed under Chapter 395, F.S.;

(b) All licensed ambulatory surgical centers as defined in Section 395.002(3), F.S.;

(d) All cardiac catheterization laboratories defined in Section 408.07, F.S.

(2) Each facility in subsection (1) above shall submit a separate report for each location per Section 408.061(3), F.S.

(3) All ambulatory centers performing the services set forth in Rules 59B-9.030 through 59B-9.039, F.A.C., shall submit ambulatory patient data as set forth in Rules 59B-9.037 and 59B-9.038, F.A.C., unless the reporting entity meets the criteria listed in subsection 59B-9.032(5), F.A.C., below.

(4) Any Ambulatory Surgical Center (ASC) or cardiac catheterization laboratory receiving 200 or more patient visits during any reporting quarter periods outlined in Rule 59B-9.033, F.A.C., is required to report data as specified in Rules 59B-9.037 and 59B-9.038, F.A.C.

(5) Any Ambulatory Surgical Centers (ASC) or cardiac catheterization laboratory receiving fewer than 200 patient visits during any reporting quarter outlined in Rule 59B-9.033, F.A.C., may request an exemption from that quarter’s reporting requirement. A facility must request an exemption in FDDC and electronically certify that it is accurate, complete, and verifiable. Exemption requests may be submitted for each quarter with fewer than 200 visits.

(6) Upon notification by the Agency staff, all facilities shall provide access to all required information from the medical records and billing documents underlying and documenting the ambulatory patient data submitted, as well as other patient related documentation deemed necessary by the Agency to conduct complete ambulatory patient data audits subject to the limitations as set forth in Section 408.061(1)(d), F.S. No patient records that support patient data are exempt from disclosure to AHCA for audit purposes.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063, 408.07, 408.08, 408.15(11) FS. History–New 1-1-10, Amended 7-1-11, 10-5-11, Formerly 59B-9.011, Amended 2-16-23.

Fla. Admin. Code R. 59B-9.033 Schedule for Submission of Ambulatory and Emergency Department Patient Data

(1) Ambulatory centers and emergency departments shall report patient data according to the provisions in Rules 59B-9.030 through 59B-9.039, F.A.C.

(a) Each data file covering patient visits ending between January 1 and March 31 inclusive, may be submitted no later than May 10 of the calendar year in which the visit occurred. This is considered to be the first quarter, regardless of the facility’s fiscal year. First quarter data must be certified by August 31 of the same calendar year.

(b) Each data file covering patient visits ending between April 1 and June 30 inclusive, may be submitted no later than August 10 of the calendar year in which the visit occurred. This is considered to be the second quarter, regardless of the facility’s fiscal year. Second quarter data must be certified by November 30 of the same calendar year.

(c) Each data file covering patient visits ending between July 1 and September 30 inclusive, may be submitted no later than November 10 of the calendar year in which the visit occurred. This is considered to be the third quarter, regardless of the facility’s fiscal year. Third quarter data must be certified by February 28 of the following calendar year.

(d) Each data file covering patient visits ending between October 1 and December 31 inclusive, may be submitted no later than February 10 of the calendar year following the year in which the visit occurred. This is considered to be the fourth quarter, regardless of the facility’s fiscal year. Fourth quarter data must be certified by May 31 of the next calendar year.

(2) Failure to certify the data on or before the certification due date as specified in paragraphs 59B-9.033(1)(a)-(d), F.A.C., or failure to correct a data file that has been submitted but contains errors or deficiencies, by the certification deadline is punishable by fine pursuant to Rule 59B-9.036, F.A.C. FDDC will send notification to the facility of pending errors or deficiencies. Rejected data files must be corrected, resubmitted and certified by the certification due date.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.08(1), (2), 408.15(11) FS. History–New 1-1-10, Formerly 59B-9.014, Amended 1-1-18, 2-16-23.

Fla. Admin. Code R. 59B-9.034 Reporting Instructions

(1) An ambulatory center shall report data for all surgical procedures or services performed in the operating room, or for ambulatory surgical care, cardiology (cardiac catheterization and percutaneous transluminal coronary angioplasty (PTCA)), gastro intestinal, extra-corporeal shock wave treatment (lithotripsy) surgery, or endoscopy corresponding to the following Current Procedural Terminology (CPT) and corresponding HCPCS Codes. A hospital facility reporting type of service “1”, ambulatory surgical procedures, shall only include visits where the CPT codes are in the reportable range defined in paragraphs 59B-9.034(1)(a), and (b), F.A.C., and have revenue charges for 36XX, 48XX, 49XX, 75XX or 79XX as used in the UB-04. Visits without these revenue charges should not be reported even if the CPT codes are in the reportable range. Type of service “2”, Emergency Room, visits are not restricted to a CPT-HCPCS reportable range and should report all procedure codes.

(a) 10001 through 69999. Including surgery, cardiac catheterization, endoscopy procedures, and lithotripsy revenue associated procedure codes.

(b) 92920 through 92998 and 93451 through 93533. Includes percutaneous transluminal coronary angioplasty (PTCA) and Cardiac Catheterization.

(d) Report one record for each visit, except pre-operation visits may be combined with the record of the associated ambulatory surgery visit. See subsection 59B-9.031(11), F.A.C.

(2) Emergency departments (ED) shall report data for:

(a) Emergency department visits in which emergency department registration occurs for the purpose of seeking emergency care services, including observation, and the patient is not admitted for inpatient care at the reporting entity.

(b) The CPT-HCPCS codes representing the services provided as part of the emergency department visit. CPT-HCPCS codes are reported in the ‘OTHER CPT-HCPCS’ fields (1-30) and are not restricted to the CPT-HCPCS reportable range defined in paragraph 59B-9.034(1)(a), F.A.C., for an ambulatory center.

(c) An Emergency Department Evaluation and Management Procedure code representing the patient’s acuity as part of the emergency department visit.

(d) An ED visit occurs even if the only service provided to a registered patient is triage or screening. If a registered patient leaves prior to being seen by a physician, report the discharge status as “07” “AMA/discontinued care” and charges if incurred. Report zero if charges are not incurred.

(e) Do not include visits for registrations that occur in the Emergency Department when the hospital central registration department is closed unless emergency services are provided.

(3) Hospitals shall exclude records of any patient visit in which the outpatient and inpatient billing record is combined because the patient was admitted to inpatient care within a facility at the same location per Section 408.061(3), F.S.

(4) For each patient visit, ambulatory centers shall report all services provided using procedural codes specified in Rules 59B-9.037 and 59B-9.038, F.A.C.

(5) A facility must register through the FDDC portal to submit its data file according to the specifications in paragraphs (a) and (b), below.

(a) Internet Transmission. The Internet address for submitting ambulatory patient data files is https://apps.ahca.myflorida.com/Fddc/.

(b) Beginning with the fourth quarter 2022 data reporting period as defined in paragraph 59B-9.033(1)(d), F.A.C., ambulatory patient data files must be submitted using Ambulatory Patient Data XML Schema AS10-5, available at: http://ahca.myflorida.com/xmlschemas/AS10-5.xsd, The Ambulatory patient Data XML AS10-5 Schema (effective January 2023) is incorporated by reference at https://www.flrules.org/Gateway/reference.asp?No=Ref-15078. The data in the XML file shall contain the data elements, codes and standards required in Rules 59B-9.037 and 59B-9.038, F.A.C.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063 FS. History–New 1-1-10, Formerly 59B-9.015, Amended 12-5-10, 10-1-15, 1-1-18, 2-16-23.

Fla. Admin. Code R. 59B-9.035 Certification, Audits, and Resubmission Procedures

(1) Submission of data files for all ambulatory centers must be in compliance with Rules 59B-9.030 through 59B-9.039, F.A.C. The executive officer, administrator, or authorized designee shall certify the data quarterly as accurate, complete and verifiable by completing the electronic certification in FDDC. The electronic certification attests the ambulatory patient data file has been examined and, to the best of the submitter’s knowledge and belief, the information contained in this data file is true, accurate, and complete, and has been prepared from the books and records of this ambulatory center. The data is considered “certified” for the reporting quarter upon completion of the facility’s electronic certification.

(2) A facility whose data file is not certified within five (5) calendar months following the last day of the reporting quarter shall be subject to penalties pursuant to Rule 59B-9.036, F.A.C. A facility will not be penalized for delays caused by the Agency that are documented by the reporting facility to include online reporting system downtime.

(3) Changes or corrections to certified data may be accepted from a facility for a period of twelve (12) months following the first date of the affected quarter. The Agency may grant approval if it determines that resubmission will significantly impact data quality. The facility must submit an electronic resubmission request in FDDC. The electronic request must explain the cause contributing to the inaccurate reporting, and include the reason for the corrections or changes, the total number of records affected by quarters and years, the data type, and the date that the replacement file will be submitted to the Agency. Any changes to a facility’s data after this twelve (12) month period shall be subject to penalties pursuant to Rule 59B-9.036, F.A.C. Resubmission of previously certified data must be certified within thirty (30) days following receipt of the data file from the facility.

(4) A facility must electronically update its facility contact information in FDDC when a change of the facility contact responsible for handling the data file submission, or the facility CEO or Administrator occurs. Information must include full name, title, applicable phone and fax numbers, and email address.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.08, 408.15(11) FS. History–New 1-1-10, Formerly 59B-9.017, Amended 1-1-18, 2-16-23.

Fla. Admin. Code R. 59B-9.036 Penalties for Ambulatory Patient Data Reporting and Deficiencies

(1) For purposes of this rule chapter, a report or other information is “incomplete” when it does not contain all data required by the Agency in this rule, and in forms incorporated by reference, or when it contains inaccurate data. The Agency shall to the extent practical, apply the same audit standards and use the same audit procedures for all facilities or audit a random sample of facilities. The Agency will notify each facility of any possible errors discovered by audit and request that the facility either correct the data or verify that the data is complete and correct. A report or other information is “false” if done or made with the knowledge of the preparer or an administrator that it contains information or data which is not true or accurate.

(2) An ambulatory center which refuses to file, fails to timely file or files false or incomplete reports or other information required to be filed under the provisions of Section 408.08(2), F.S., other Florida Law, or a rule adopted there under, shall be subject to administrative fines pursuant to Section 408.813, F.S. Failure to comply with reporting requirements will also result in the referral of a facility to the Agency’s Bureau of Health Facility Regulation.

(3) Notifications will be sent to reporting facilities who do not submit their data file by the initial due date as specified in Rule 59B-9.033, F.A.C.

(4) The penalty period will begin on the first calendar day following the certification due date for purposes of penalty assessments.

(5) Any ambulatory center which is delinquent for a reporting deficiency other than submission of a false report shall be subject to a fine of $100.00 per day of violation for the first violation, $350.00 per day of violation for the second violation, and $1,000.00 per day of violation for the third or subsequent violations. Following four consecutive non-delinquent quarters, the fine violation matrix will reset to the first violation rate. Violations will be considered those activities which necessitate the issuance of an administrative complaint by the Agency unless the administrative complaint is withdrawn or final order dismissing the administrative complaint is entered. All fines are to be fixed, imposed and collected by the Agency. Any ambulatory center which files a false report with the Agency or provides false information to the Agency shall be subject to a fine not exceeding $1,000.00 per day per violation, in addition to any other fine imposed hereunder, pursuant to Section 408.813, F.S.

History

Rulemaking Authority 408.15(8), 408.813 FS. Law Implemented 408.08, 408.061,408.813 FS. History–New 1-1-10, Formerly 59B-9.022, 59B-9.016, Amended 1-1-18.

Fla. Admin. Code R. 59B-9.037 Header Record

The first record in the data file shall be a header record containing the information described below.

(1) Report Year. Enter the year of the data in the format YYYY.

(2) Report Quarter. Enter the quarter of the data, 1, 2, 3 or 4, where 1 corresponds to the first quarter of the calendar year, 2 corresponds to the second quarter of the calendar year, 3 corresponds to the third quarter of the calendar year, and 4 corresponds to the fourth quarter of the calendar year.

(3) Data Type. Enter AS10-5 for ambulatory data and emergency department aata. A required entry.

(4) Submission Type. Enter I or R where I indicates an initial submission of a data file or resubmission of a data file prior to certification and R indicates a replacement submission of previously certified patient data where resubmission has been requested or authorized by the Agency. A required entry.

(5) Processing Date. Enter the date that the data file was created in the format YYYY-MM-DD where MM represents numbered months of the year from 1 to 12, DD represents numbered days of the month from 1 to 31, and YYYY represents the year in four digits.

(6) AHCA Facility Number. Enter the identification number of the ambulatory center as assigned by the Agency for reporting purposes. A valid identification number must be between one (1) digit and eight (8) digits. A required entry.

(7) Medicare Number. Enter the Medicare number of the facility as assigned by Centers for Medicare & Medicaid Services (CMS). A valid identification number must contain seven (7) numeric digits. A required entry.

(8) Organization Name. Enter the name of the ambulatory center that performed the ambulatory services represented by the data, and which is responsible for reporting the data. All questions regarding data accuracy and integrity will be referred to this entity. Up to a forty (40) character field.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063 FS. History–New 1-1-10, Formerly 59B-9.018, Amended 10-1-15, 1-1-18, 2-16-23.

Fla. Admin. Code R. 59B-9.038 Ambulatory Data Elements, Codes and Standards

All data elements and data element codes listed below shall be reported. All facilities submitting data in compliance with Rules 59B-9.030 through 59B-9.039, F.A.C., shall report the following required data elements as stipulated by the Agency.

(1) AHCA Facility Number. An identification number assigned by the Agency for reporting purposes. The number must match the facility number recorded on the header record. A valid identification number must be between one (1) digit and eight (8) digits. A required entry.

(2) Patient Control Number. An alpha-numeric code containing standard letters or numbers assigned by the facility as a unique identifier for each record submitted in the reporting period to facilitate retrieval of individual’s account of services (accounts receivable) containing the financial billing records and any postings of payment. The ‘Patient Control Number’ is defined as ‘Record id’ in the schema. Up to twenty four (24) characters. Duplicate patient control numbers are not permitted. The facility must maintain a key list to locate actual records upon request by the Agency. A required field.

(3) Medical or Health Record Number. An alpha-numeric code assigned to the patient’s medical or health record by the facility. The medical/health record number references a file that contains the history of treatment. It should not be substituted for the Patient Control Number which is the financial record associated with a visit. Up to twenty four (24) characters. A required field.

(4) Patient Social Security Number. The social security number (SSN) of the patient. A nine digit field to facilitate retrieval of individual case records, to be used to track multiple patient visits, and for medical research. Reporting 777777777 is acceptable for those patients where efforts to obtain the SSN have been unsuccessful or the patient is under two (2) years of age and does not have a SSN or for patients who are non-U.S. citizens who have not been issued SSNs. If only the last four digits of a patients SSN are known, report 77777XXXX where XXXX represent the last known four digits of the patient SSN. The last four digit SSN format must be used only when the full SSN is unknown and not as a substitute for all nine digit SSN’s. A required entry.

(5) Patient Ethnicity. Self-designated by the patient, patient’s parent or guardian. Use “Unknown” where efforts to obtain the information from the patient or from the patient’s parent or guardian have been unsuccessful. The patient’s ethnic background shall be reported as one choice from the following list of alternatives. A required entry. Must be a two (2) digit code as follows:

(a) E1 = Hispanic or Latino. A person of Mexican, Puerto Rican, Cuban, Central or South American or other Spanish culture or origin, regardless of race.

(b) E2 = Non-Hispanic or Latino. A person not of any Spanish culture or origin.

(6) Patient Race. Self-designated by the patient, patient’s parent or guardian. Use “Unknown” where efforts to obtain the information from the patient or from the patient’s parent or guardian have been unsuccessful. The patient’s racial background shall be reported as one choice from the following list of alternatives. A required entry. Must be a one (1) digit code as follows:

(a) 1 – American Indian or Alaskan Native. A person having origins in any of the original peoples of North and South America (including Central America) America, and who maintains cultural identification through tribal affiliation or community recognition.

(b) 2 – Asian. A person having origins in any of the original peoples of the Far East, Southeast Asia or the Indian subcontinent. This area includes, for example, Cambodia, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand and Vietnam.

(d) 4 – Native Hawaiian or other Pacific Islander. A person having origins in any of the original peoples of Hawaii, Guam, Samoa or other Pacific Islands.

(e) 5 – White. A person having origins in any of the original peoples of Europe, North Africa, or the Middle East.

(f) 6 – Other. Any other possible options not covered in the above categories, including a patient who has more than one race.

(g) 7 – Unknown. Use if the patient refuses or fails to disclose.

(7) Patient Birth Date. The date of birth of the patient. A ten character field in the format YYYY-MM-DD where MM represents the numbered months of the year from 1 to 12, DD represents numbered days of the month from 1 to 31, and YYYY represents the year in four digits. Unknown birthdates should use the default of 1880-01-01 where efforts to obtain the patient’s birth date have been unsuccessful. A birth date after the patient visit ending date is not permitted. A required entry.

(8) Patient Sex – The patient sex at the time of admission. A required entry. Alpha characters must be in upper case. Must be a one (1) digit code as follows:

(a) M – Male.

(b) F – Female.

(c) U – Unknown. Use where efforts to obtain the information have been unsuccessful or where the patient’s sex cannot be determined due to a medical condition.

(9) Patient Zip Code. The five digit United States Postal Service ZIP Code of the patient’s address. Use 00009 for foreign residences. Use 00007 for homeless patients. Use 00000 where efforts to obtain the information have been unsuccessful. A required entry.

(10) Patient Country Code. The country code of residence. A two (2) digit upper case alpha code from the Code for Representation of Names of Countries, ISO 3166 or latest release. Use 99 where the country of residence is unknown, or where efforts to obtain the information have been unsuccessful. A required entry for type of service “2”.

(11) Type of Service Code. A code designating the type of service, either ambulatory surgery or emergency department visit. A required entry. Must be a one (1) digit code as follows:

(a) 1 – Ambulatory surgery, as described in subsection 59B-9.034(1) , F.A.C.

(b) 2 – Emergency department visit, as described in subsection 59B-9.034(2), F.A.C.

(12) Source or Point of Origin of Admission. Must be a one (1) character alpha code or two (2) digit numeric code indicating the direct source or point of patient origin for this visit. A required entry if type of service is “2”. Zero fill if type of service is “1”. Alpha characters must use upper case.

(a) 01 – Non-health care facility point of origin – The patient presented to this facility for outpatient services. Includes patients coming from home or workplace.

(b) 02 – Clinic or Physician’s Office. The patient presented to this facility for outpatient services from a clinic or physician’s office.

(c) 04 – Transfer from a hospital. The patient was transferred to this facility as an outpatient from an acute care facility. Transfer must be from a different hospital.

(d) 05 – Transfer from a Skilled Nursing Facility (SNF) or Intermediate Care Facility (ICF). The patient was referred to this facility as a transfer from a SNF or ICF where the patient was a resident.

(e) 06 – Transfer from another health care facility. The patient was referred to this facility for services by another health care facility not defined elsewhere in this code list where he or she was an inpatient or outpatient.

(f) 08 – Court/Law Enforcement. The patient was referenced to this facility upon the direction of a court of law, or upon the request of a law enforcement agency representative for outpatient or referenced diagnostic services. Includes transfers from incarceration facilities.

(g) 09 – Information Not Available. The means by which the patient was referred to this hospital’s outpatient department is not known.

(h) D – Transfer from one distinct unit of the hospital to another distinct unit of the same hospital resulting in a separate claim. The patient received outpatient services in this facility as a transfer from within this hospital resulting in a separate claim to the payer.

(i) E – Transfer from Ambulatory Surgery Center. The patient was referred to this facility for outpatient or referenced diagnostic services from an ambulatory surgery center.

(j) F – Transfer from hospice and under a hospice plan of care or enrolled in a hospice program. The patient was referred to this facility for outpatient or referenced diagnostic services from a hospice.

(13) Principal Payer Code. Describes the primary source of expected reimbursement for services rendered based on the patient’s status at the time of reporting. A required entry. Must be a one (1) character alpha field using upper case as follows:

(a) A – Medicare. Patients covered by Medicare where Centers for Medicare & Medicaid Services is the direct payer.

(b) B – Medicare Managed Care. Patients covered by Medicare Advantage plans, Medicare HMO, Medicare PPO, Medicare Private Fee for Service or any other type of Medicare plan where Centers for Medicare & Medicaid Services is not the direct payer.

(c) C – Medicaid. Patients covered by state administered, non-managed Florida Medicaid. This would include those Medicaid recipients enrolled in MediPass.

(d) D – Medicaid Managed Care. Patients covered by Medicaid HMOs, Medicaid provider sponsored networks (PSNs) or other Medicaid funded plans that are licensed in the state of Florida. This would include any type of program where the patient qualifies for Medicaid but payment is not directly from the State of Florida Medicaid program regardless of whether the hospital has a contract with that plan.

(e) E – Commercial Health Insurance. Patients covered by any type of private coverage, including HMO, PPO or self-insured plans.

(f) H – Workers Compensation. Patients covered by any type of workers compensation plan, including self insured plans, managed care plans or the State of Florida sponsored workers compensation plan.

(g) I – TriCare or Other Federal Government. Patients covered by any federal government program for active and retired military and their families; Black Lung, Section 1011; the Federal Prison System; or any other federal program.

(h) J – VA. Patients covered by the Veteran’s Administration (VA).

(i) K – Other State/Local Government. Patients covered by a state program or local government that does not fall into any of the payer categories listed. This would include those covered by the Florida Department of Corrections or any county or local corrections department, patients covered by county or local government indigent care programs if the reimbursement is at the patient level; any out-of-state Medicaid programs and county health departments or clinics.

(j) L – Self Pay. Patients with no insurance coverage.

(k) M – Other. This would include patients covered by any other type of payer not meeting the descriptions in paragraphs (a)-(j), above, or paragraphs (l)-(o), below.

(l) N – Non-Payment. Includes charity, professional courtesy, no charge, research/clinical trial, refusal to pay/bad debt, Hill Burton free care, research/donor that is known at the time of reporting.

(m) O – KidCare. Includes Healthy Kids, MediKids and Children’s Medical Services.

(n) P – Unknown. Unknown shall be reported if principal payer information is not available and type of service is “2” and patient status is “07”.

(o) Q – Commercial Liability Coverage. Patients whose health care is covered under a liability policy, such as automobile, homeowners or general business.

(14) Principal Diagnosis Code. The code representing the diagnosis chiefly responsible for the services performed during the visit. Must contain a valid ICD-10-CM diagnosis code if type of service is “1” indicating ambulatory surgery. Must contain a valid ICD-10-CM diagnosis code if type of service is “2” indicating an emergency department visit unless patient status is “07” indicating that the patient left against medical advice or discontinued care. A blank field is permitted if type of service is “2” and patient status is “07.” If not space filled, must contain a valid ICD-10-CM diagnosis code for the reporting period. A diagnosis code cannot be used more than once as a principal or other diagnosis for each visit reported. The code must be entered with a decimal point that is included in the valid code. Alpha characters must be in upper case.

(15) Other Diagnosis Code (1), Other Diagnosis (2), Other Diagnosis (3), Other Diagnosis (4), Other Diagnosis (5), Other Diagnosis (6), Other Diagnosis (7), Other Diagnosis (8), Other Diagnosis (9). A code representing a diagnosis related to the services provided during the visit. If no principal diagnosis code is reported, another diagnosis code must not be reported unless the patient discharge status is “07” indicating that the patient left against medical advice or discontinued care. No more than nine other diagnosis codes may be reported. Less than nine entries is permitted. If not space filled, must contain a valid ICD-10-CM code for the reporting period. A diagnosis code cannot be used more than once as a principal or other diagnosis for each visit reported. The code must be entered with use of a decimal point that is included in the valid code. Alpha characters must be in upper case.

(16) Evaluation and Management Code (1), Evaluation and Management Code (2), Evaluation and Management Code (3), Evaluation and Management Code (4), Evaluation and Management Code (5). A code representative of the patient acuity level for the services provided. If type of service is “2,” must contain a valid Evaluation and Management (EM) Code range 99281-99285; 99288; 99291-99292; and G0380-G0384, even if the only service provided to a registered patient is triage or screening. If patient discharge status is “07” meaning the patient left against medical advice or discontinued care, or where a visit occurs resulting in zero charges, enter default code 99999 to indicate that the patient was not evaluated by a physician. No more than five EM codes may be reported. Less than five entries is permitted. Ambulatory surgical centers, type of service “1,” should not report Evaulation and Management codes. A required field.

(17) Other CPT or HCPCS Procedure Code (1), Other CPT or HCPCS Procedure Code (2), Other CPT or HCPCS Procedure Code (3), Other CPT or HCPCS Procedure Code (4), Other CPT or HCPCS Procedure Code (5), Other CPT or HCPCS Procedure Code (6), Other CPT or HCPCS Procedure Code (7), Other CPT or HCPCS Procedure Code (8), Other CPT or HCPCS Procedure Code (9), Other CPT or HCPCS Procedure Code (10), Other CPT or HCPCS Procedure Code (11), Other CPT or HCPCS Procedure Code (12), Other CPT or HCPCS Procedure Code (13), Other CPT or HCPCS Procedure Code (14), Other CPT or HCPCS Procedure Code (15), Other CPT or HCPCS Procedure Code (16), Other CPT or HCPCS Procedure Code (17), Other CPT or HCPCS Procedure Code (18), Other CPT or HCPCS Procedure Code (19), Other CPT or HCPCS Procedure Code (20), Other CPT or HCPCS Procedure Code (21), Other CPT or HCPCS Procedure Code (22), Other CPT or HCPCS Procedure Code (23), Other CPT or HCPCS Procedure Code (24), Other CPT or HCPCS Procedure Code (25), Other CPT or HCPCS Procedure Code (26), Other CPT or HCPCS Procedure Code (27), Other CPT or HCPCS Procedure Code (28), Other CPT or HCPCS Procedure Code (29), Other CPT or HCPCS Procedure Code (30). A code representing a procedure or service provided during the patient visit. If not space filled, must be a valid CPT or HCPCS code for the reporting period. Alpha characters must be in upper case. No more than thirty (30) other CPT or HCPCS procedure codes may be reported. Less than thirty (30) entries or no entry is permitted.

(18) Attending Practitioner Identification Number. The Florida license number of the medical doctor, osteopathic physician, dentist, podiatrist, chiropractor or advanced practice registered nurse who had primary responsibility for the patient’s care during the visit. An alpha-numeric field of up to fifteen (15) characters, alpha characters must be in upper case. For military physicians not licensed in Florida, use US999999999. Use NA if the patient was not treated by a medical doctor, osteopathic physician, dentist, podiatrist, chiropractor, or advanced practice registered nurse. A required entry.

(19) Attending Practitioner National Provider Identification (NPI). A unique ten (10) character identification number assigned to a provider. A required entry for providers in the US or its territories and providers not in the U.S. or its territories upon mandated HIPAA NPI implementation date. For military physicians, medical residents, or individuals not required to obtain a NPI number, use 9999999999.

(20) Operating or Performing Practitioner Identification Number. The Florida license number of the medical doctor, osteopathic physician, dentist, podiatrist, chiropractor or advanced practice registered nurse who had primary responsibility for the principal procedure performed. The operating or performing practitioner may be the attending practitioner. An alpha-numeric field of up to fifteen (15) characters, alpha characters must be in upper case. For military physicians not licensed in Florida, use US999999999. A required entry. A blank or no entry is permitted if a principal procedure is not reported.

(21) Operating or Performing Practitioner National Provider Identification (NPI). A unique ten (10) character identification number assigned to a provider. A required entry for providers in the U.S. or its territories and providers not in US or its territories upon mandated HIPAA NPI implementation date. For military physicians, medical residents, or individuals not required to obtain a NPI number, use 9999999999.

(22) Other Operating or Performing Practitioner Identification Number. The Florida license number of a different operating or performing practitioner. Report a medical doctor, osteopathic physician, dentist, podiatrist, chiropractor or advanced practice registered nurse who rendered care to the patient other than the person reported in paragraph (18) or (20), above. An alpha-numeric field of up to fifteen (15) characters, alpha characters must be in upper case. For military physicians not licensed in Florida, use US999999999. A blank or no entry is permitted.

(23) Other Operating or Performing Practitioner National Provider Identification (NPI). A unique ten (10) character identification number assigned to a provider. A required entry for providers in the US or its territories and providers not in US or its territories upon mandated HIPAA NPI implementation date. For military physicians, medical residents, or individuals not required to obtain a NPI number, use 9999999999.

(24) Pharmacy Charges. Charges for medication. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report 0 (zero) if there are no pharmacy charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(25) Medical and Surgical Supply Charges. Charges for supply items required for patient care. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report 0 (zero) if there are no medical and surgical supply charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(26) Laboratory Charges. Charges for the performance of diagnostic and routine clinical laboratory tests. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report 0 (zero) if there are no laboratory charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(27) Radiology and Other Imaging Charges. Charges for the performance of diagnostic and therapeutic radiology services including computed tomography, mammography, magnetic resonance imaging, nuclear medicine, and chemotherapy administration of radioactive substances. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report 0 (zero) if there are no radiology or computed tomography charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(28) Cardiology Charges (Cardiac Cath). Charges for cardiac procedures rendered such as heart catheterization. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report 0 (zero) if there are no cardiology charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(29) Operating Room Charges. Charges for the use of the operating room. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report 0 (zero) if there are no operating room charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(30) Anesthesia Charges. Charges for anesthesia services by the facility. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report 0 (zero) if there are no anesthesia charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(31) Recovery Room Charges. Charges for the use of the recovery room. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report 0 (zero) if there are no recovery room charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(32) Emergency Room Charges. Charges for medical examinations and emergency treatment. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report 0 (zero) if there are no emergency room charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(33) Trauma Response Charges. Charges for a trauma team activation at a State of Florida licensed Trauma Center. Report charges for revenue code 68X used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no trauma response charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(34) Treatment or Observation Room Charges. Charges for use of a treatment room or for the room charge associated with observation services. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report 0 (zero) if there are no treatment or observation room charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(35) Gastro-Intestinal (GI) services. Charges for gastro-intestinal procedures rendered such as colonoscopy and endoscopy services. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report 0 (zero) if there are no GI charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(36) Extra-Corporeal Shock Wave Therapy (Lithotripsy). Charges for Extra-Corporeal Shock Wave Therapy (Lithotripsy) procedures. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report 0 (zero) if there are no Lithotripsy charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(37) Other Charges. Other facility charges not included in paragraphs (24) to (36), above. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report 0 (zero) if there are no other charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(38) Total Gross Charges. The total of undiscounted charges for services rendered by the reporting entity. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Include charges for services rendered by the ambulatory center excluding professional fees. Negative amounts are not permitted unless verified separately by the reporting entity. The sum of pharmacy charges, medical and surgical supply charges, laboratory charges, radiology and other imaging charges, cardiology charges, operating room charges, anesthesia charges, recovery room charges, emergency room charges, treatment or observation room charges, Gastro-Intestinal (GI) services, Extra-Corporeal Shock Wave Therapy (Lithotripsy), and other charges must equal total charges, plus or minus 13. A required entry.

(39) Patient Visit Beginning Date. The date at the beginning of the patient’s visit for ambulatory surgery or the date at the time of registration in the emergency department. A ten (10) character field in the format YYYY-MM-DD where MM represents the numbered months of the year from 1 to 12, DD represents numbered days of the month from 1 to 31, and YYYY represents the year in four digits. Patient visit beginning date must equal or precede the patient visit ending date. A required entry.

(40) Patient Visit Ending Date. The date at the end of the patient’s visit. A ten (10) character field in the format YYYY-MM-DD where MM represents the numbered months of the year from 1 to 12, DD represents numbered days of the month from 1 to 31, and YYYY represents the year in four digits. Patient visit ending date must equal or follow the patient visit beginning date. Patient visit ending date must occur within the calendar quarter included in the data report.

(41) Hour of Arrival. The hour on a 24-hour clock during which the patient’s visit for ambulatory surgery began or during which registration in the emergency department occurred. A required entry. Use 99 where efforts to obtain the information have been unsuccessful. Must be two digits as follows:

A.M. HOURS

(a) 00 – 12:00 midnight to 12:59:59

(b) 01 – 01:00 to 01:59:59

(d) 03 – 03:00 to 03:59:59

(e) 04 – 04:00 to 04:59:59

(f) 05 – 05:00 to 05:59:59

(g) 06 – 06:00 to 06:59:59

(h) 07 – 07:00 to 07:59:59

(i) 08 – 08:00 to 08:59:59

(j) 09 – 09:00 to 09:59:59

(k) 10 – 10:00 to 10:59:59

(l) 11 – 11:00 to 11:59:59

P.M. HOURS

(m) 12 – 12:00 noon to 12:59:59

(n) 13 – 01:00 to 01:59:59

(o) 14 – 02:00 to 02:59:59

(p) 15 – 03:00 to 03:59:59

(q) 16 – 04:00 to 04:59:59

(r) 17 – 05:00 to 05:59:59

(s) 18 – 06:00 to 06:59:59

(t) 19 – 07:00 to 07:59:59

(u) 20 – 08:00 to 08:59:59

(v) 21 – 09:00 to 09:59:59

(w) 22 – 10:00 to 10:59:59

(x) 23 – 11:00 to 11:59:59

(y) 99 – Unknown.

(42) Emergency Department (ED) Hour of Discharge. The hour on a 24-hour clock during which the patient left the emergency department. A required entry. Use 99 where efforts to obtain the information have been unsuccessful or type of service is “1.” Must be two digits as follows:

A.M. HOURS

(a) 00 – 12:00 midnight to 12:59:59

(b) 01 – 01:00 to 01:59:59

(d) 03 – 03:00 to 03:59:59

(e) 04 – 04:00 to 04:59:59

(f) 05 – 05:00 to 05:59:59

(g) 06 – 06:00 to 06:59:59

(h) 07 – 07:00 to 07:59:59

(i) 08 – 08:00 to 08:59:59

(j) 09 – 09:00 to 09:59:59

(k) 10 – 10:00 to 10:59:59

(l) 11 – 11:00 to 11:59:59

P.M. HOURS

(m) 12 – 12:00 noon to 12:59:59

(n) 13 – 01:00 to 01:59:59

(o) 14 – 02:00 to 02:59:59

(p) 15 – 03:00 to 03:59:59

(q) 16 – 04:00 to 04:59:59

(r) 17 – 05:00 to 05:59:59

(s) 18 – 06:00 to 06:59:59

(t) 19 – 07:00 to 07:59:59

(u) 20 – 08:00 to 08:59:59

(v) 21 – 09:00 to 09:59:59

(w) 22 – 10:00 to 10:59:59

(x) 23 – 11:00 to 11:59:59

(y) 99 – Unknown.

(43) Patient’s Reason for Visit ICD-10-CM Code (Admitting Diagnosis). The code representing the patient’s chief complaint or stated reason for seeking care in the Emergency Department. Must contain a valid ICD-10-CM code for the reporting period if type of service is “2” indicating an emergency department visit. If not space filled, must contain a valid ICD-10-CM diagnosis code. The code must be entered with use of a decimal point that is included in the valid code. Space fill if type of service is “1” indicating ambulatory surgery. Alpha characters must be in upper case.

(44) External Cause of Morbidity Code (1), External Cause of Morbidity Code (2) and External Cause of Morbidity Code (3). A code representing circumstances or conditions as the cause of the injury, poisoning or other adverse effects recorded as a diagnosis. No more than three (3) external cause of morbidity codes may be reported. Less than three (3) or no entry is permitted. If not space filled, must be a valid ICD-10-CM cause of morbidity code for the reporting period. An external cause of morbidity code cannot be used more than once for each encounter reported. The code must be entered with use of a decimal point that is included in the valid code. Alpha characters must be in upper case.

(45) Service Location. A code designating services performed at an offsite emergency department location at facilities whose license includes a “offsite” emergency department. For type of service “2,” enter an upper case “A through Z” for services performed at each offsite emergency department location. Facilities with a single off-site location will use service location code “A.” The Agency will assign an alpha service code to identify each location if a facility has more than one location. The Agency’s Data Layout will reference the assigned offsite identifiers for each facility having more than one location. Remove element tag if type of service is “1” or for hospitals without an offsite emergency department location.

(46) Patient Status. Patient disposition at end of visit. A required entry. Must be a two (2) digit code as follows:

(a) 01 – Discharged to home or self care (routine discharge).

(b) 02 – Transferred to a short-term general hospital for inpatient care.

(d) 04 – Transferred to an intermediate care facility.

(e) 05 – Transferred to a designated cancer center or Children’s Hospital.

(f) 06 – Discharged to home under care of home health care organization service in anticipation of covered skilled care.

(g) 07 – Left against medical advice or discontinued care.

(h) 20 – Expired.

(i) 21 – Discharged or transferred to court/law enforcement.

(j) 50 – Discharged to hospice – home.

(k) 51 –. Transferred to hospice. Hospice medical facility (certified) providing hospice level of care.

(l) 62 – Transferred to an Inpatient Rehabilitation Facility (IRF) including rehabilitation distinct part units of a hospital.

(m) 63 – Discharged or transferred to a Medicare certified long term care hospital.

(n) 64 – Discharged or transferred to a Nursing Facility certified under Medicaid but not certified under Medicare.

(o) 65 – Discharged or transferred to a psychiatric hospital including psychiatric distinct part units of a hospital.

(p) 66 – Discharged or transferred to a Critical Access hospital.

(q) 70 – Discharged or transferred to another type of health care institution not defined elsewhere in this code list.

(47) Trailer Record: The last record in the data file shall be a trailer record and must accompany each data set. Report only the total number of patient data records contained in the file, excluding header and trailer records. The number entered must equal the number of records processed. Do not include leading zeros.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063 FS. History–New 1-1-10, Amended 12-5-10, Formerly 59B-9.018, Amended 10-1-15, 1-1-18, 2-16-23.

Fla. Admin. Code R. 59B-9.039 Patient Data Release

(1) Agency records, public records under Chapter 119, F.S., (Florida’s Public Records Law), are available for public inspection during normal business hours. Copies of such records may be obtained upon request and upon payment of the cost of copying.

(2) Patient-specific records collected by the Agency pursuant to Rules 59B-9.030 through 59B-9.039. F.A.C., are exempt from disclosure pursuant to Section 408.061(7), F.S., and shall not be released unless modified to protect patient confidentiality as described in paragraph (2)(a), below, and released in the manner described in paragraphs (2)(c) and (2)(d).

(a) The patient-specific record shall be modified to protect patient confidentiality as follows:

Patient Control Number

Delete

Patient Social Security Number

Delete

Patient Birth Date

Substitute Age in years and an indicator of Age <29 Days except for persons 100 and older, substitute Age > 100 years

Visit Date

Substitute Quarter Indicator (1-4) (visit month cannot be substituted)

Medical or Health Record Number

Delete

(b) A record linkage number shall be assigned which does not identify an individual patient and cannot reasonably be used to identify individual patients through use of data available through the Agency, but which can be used for confidential data output for bonafide research purposes.

(c) The modified data records described in paragraph (2)(a), shall be released as a set of all records occurring in one calendar quarterly period based on date of visit.

(d) The modified data described in paragraph (2)(a), shall be released in accordance with the Limited Data Set requirements of the federal Health Insurance Portability and Accountability Act and shall be made available on or after quarterly data has been certified as accurate by the facility as required by Section 408.061(1)(a), F.S.

(3) Aggregate reports derived from patient-specific records collected pursuant to Rules 59B-9.030 through 59B-9.038, F.A.C., are public records and shall be released as described in subsection (1), of this rule, provided the aggregate reports do not include patient control number, patient birth date, visit date, patient social security number, medical or health record number or provided the aggregate reports contain the combination of five or more records for any data disclosed.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061 FS. History–New 1-1-10, Formerly 59B-9.023, Amended 1-1-18.

Chapter 59B-12 BONE MARROW TRANSPLANTATION

Fla. Admin. Code R. 59B-12.001 Bone Marrow Transplantation

As used in this rule, the term “appropriate oncological specialty” means that where a particular kind of tumor or disease is usually treated by a subspecialty group within the general discipline of oncology, those who practice within that subspecialty have had specific input into the decision making process. Cellular therapies include cellular immunotherapies, chimeric antigen receptor (CAR) T cells, cancer vaccines, and other types of both autologous and allogeneic cells for certain therapeutic indications. Human gene therapy refers to products that introduce genetic material into a person’s DNA to replace faulty or missing genetic material, thus treating a disease or abnormal medical condition.

(1) Upon the recommendation of the Bone Marrow Transplant Panel, each of the following procedures meets a minimum level of evidence based on high quality systematic reviews of case control or cohort studies, high quality case-control or cohort studies with a very low risk of confounding bias, or chance, and a high probability that the relationship is causal, and is considered accepted within the appropriate oncological specialty and not experimental for the purposes of Section 627.4236, F.S.

(a) Allogeneic bone marrow transplant for the following:

Acute myelogenous leukemia and myeloid sarcoma;
Acute lymphoblastic leukemia;
Chronic myelogenous leukemia;
Myelodysplastic syndromes;
Chronic myelomonocytic leukemia;
Myelofibrosis;
Non-Hodgkin lymphoma;
Hodgkin lymphoma after autologous stem cell collection failure or relapsed after autologous transplant but not progressing on salvage chemotherapy;
Chronic lymphocytic leukemia;
Severe or very severe aplastic anemia from HLA compatible siblings and any type of bone marrow transplant for acquired severe aplastic anemia unresponsive to immunosuppression or bone marrow failure syndromes;
Severe aplastic anemia and other bone marrow failure syndromes;
Thalassemia;
Inborn errors of immune system including severe combined immune deficiencies, primary immune deficiencies, and primary immune regulatory disorders;
Sickle cell disease.

(b) Autologous bone marrow transplant for the following:

Multiple myeloma (including double bone marrow transplant), Waldenstrom macroglobulinemia and primary amyloidosis;
Non-Hodgkin lymphoma;
Hodgkin lymphoma;
Acute myelogenous leukemia (stem cells collected in remission);
Neuroblastoma;
Germ cell tumor, after failure of first therapy but not progressing on salvage therapy;
Primitive neuroectodermal tumor (PNET), (including medulloblastoma and pinealoblastoma), chemotherapy sensitive after first relapse;
Medulloblastoma and other PNET tumors, metastatic, at diagnosis;
Ewing sarcoma, chemotherapy sensitive after first relapse.

1.Tisagenlecleucel, a CD19-directed, genetically modified autologous T cell immunotherapy is medically necessary for the treatment of:

a. Adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including:

b. Diffuse large B-cell lymphoma not otherwise specified.

c. High grade B-cell lymphoma and diffuse large B-cell lymphoma arising from follicular lymphoma.

d. Pediatric patients up to 25 years old with B-cell precursor acute lymphoblastic leukemia that is relapsed or refractory.

Axicabtagene ciloleucel, a CD19-directed, genetically modified autologous T cell immunotherapy is medically necessary for adult patients with:

a. Adult patients with diffuse large B-cell lymphoma that is refractory to first line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

b. Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including:

(I) Diffuse large B-cell lymphoma not otherwise specified,

(II) Primary mediastinal large B-cell lymphoma,

(III) High grade B-cell lymphoma, and

(IV) Diffuse large B-cell lymphoma arising from follicular lymphoma.

c. Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

d. Axicabtagene ciloleucel is not indicated for the treatment of patients with primary central nervous system lymphoma.

Brexucabtagene autoleucel, a CD19-directed, genetically modified autologous T cell immunotherapy, is medically necessary for the treatment of adult patients with:

a. Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

b. Relapsed or refractory Mantle cell lymphoma.

Lisocabtagene maraleucel, a CD19-directed, genetically modified autologous T cell immunotherapy, is medically necessary for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including:

a. Diffuse large B-cell lymphoma not otherwise specified;

b. High-grade B-cell lymphoma;

c. Primary mediastinal large B-cell lymphoma;

d. Diffuse large B-cell lymphoma arising from indolent lymphoma; and

e. Follicular lymphoma grade 3B.

Idecabtagene vicleucel, a genetically modified autologous T cell immunotherapy directed against the B-cell maturation antigen called BCMA, is medically necessary for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Ciltacabtagene autoleucel, a genetically modified autologous T cell immunotherapy directed against the B-cell maturation antigen BCMA, is medically necessary for adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Betibeglogene autotemcel, patient’s own bone marrow stem cells that are genetically modified to produce functional beta-globin, is medically necessary for adult and pediatric patients with ß-thalassemia who require regular red blood cell transfusions.
Elivaldogene autotemcel, patient’s own bone marrow stem cells that are genetically modified, is medically necessary to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy.
Allogeneic processed thymus tissue–agdc is medically necessary for immune reconstitution in pediatric patients with congenital athymia.
Sipuleucel-T, an autologous T cell immunotherapy, is medically necessary for patients with asymptomatic or minimally symptomatic metastatic castrate resistant, hormone refractory, prostate cancer.

(d) Cellular therapies that are Food and Drug Administration (FDA)-approved for a specific indication and are medically necessary, accepted within the appropriate oncological specialty and not experimental for the purposes of section 627.4236, F.S. are covered. In cases where treatment for any of the above conditions includes a clinical trial that conforms to subsection (6), routine care costs associated with the bone marrow transplant will be covered.

(2) Each of the following procedures is considered accepted within the appropriate oncological specialty and not experimental for the purposes of Section 627.4236, F.S., provided that the bone marrow transplantation procedure is performed in the context of a well-designed clinical treatment trial as described in subsection (6).

Routine care costs associated with the bone marrow transplant will be covered for the following procedures:

(a) Allogeniec bone marrow transplant for multiple myeloma and other plasma cell dyscrasias; (e.g., Waldenstrom, amyloid).

(b) Autologous bone marrow transplant for:

Chronic lymphocytic leukemia;
Germ cell tumor, high risk, at diagnosis;
Ewing sarcoma, after relapse;
Wilms tumor, at relapse;
Soft tissue sarcoma, pediatric, after failure of first therapy;
Multiple autologous bone marrow transplants for pediatric solid tumors;
Autoimmune disorders.

(3) The following rare diseases, where there are no existing clinical trials available, are covered for bone marrow transplant when deemed medically necessary:

(a) Prolymphocytic leukemia;

(b) Blastic plasmacytoid dendritic cell neoplasm;

(d) POEMS syndrome;

(e) Atypical chronic myeloid leukemia;

(f) Chronic neutrophilic leukemia;

(g) Juvenile myelomonocytic leukaemia;

(h) Paroxysmal nocturnal hemoglobinuria (PNH); and,

(i) Cerebral form of adrenoleukodystoryphy and metachromatic leukodystrophy;

(j) Mucopolysaccharidoses.

(k) Treatment of other rare conditions for which there is no definitive data documenting the indication for BMT and cannot realistically be expected to generate such data, can be covered. There must be reasonable evidence of benefit from reputable sources and prior practice must have demonstrated a benefit.

(4) Transplants from living related donors incompatible for HLA-A, -B, and -DRB1 loci are covered for bone marrow transplant at BMT CTN core or non-core medical facilities.

(5) Any bone marrow transplant performed outside of a clinical trial will be covered when all the following criteria are met:

(a) The plan of care follows a clinical trial protocol that meets the requirements of subsection (6);

(b) Patient cannot be enrolled in the proposed clinical trial;

(d) Patient is an appropriate candidate for bone marrow transplant; and,

(e) Treatment center is part of the BMT CTN at a core or non-core center.

(6) A well-designed and conducted clinical treatment trial is one which includes an IRB-approved written protocol. At a minimum, such protocol shall have specific criteria for evaluating the effect of treatment with defined endpoints that are precise, meaningful, and reliable and which allow valid conclusions to be drawn about therapeutic efficacy and safety. Protocols should include an adequate statistical section describing the method of randomization and stratification, if any, expected outcome parameters relating to response rates, time to progression, survival times and other relevant information. Such clinical treatment trials shall be consistent with protocols reviewed and approved by the National Cancer Institute for scientific merit.

(7) Phases of the BMT Episode:

(a) Evaluation: The evaluation phase includes services required to assess and evaluate whether a patient and, in the case of allogeneic BMT, the donor, are suitable for the transplantation procedure. It may also include evaluations to assess whether a transplantation is an appropriate treatment option for the patient.

(b) Pretransplantation Care: The pretransplantation care phase involves care provided from the time a patient is identified as a candidate for BMT and includes all related care until the initiation of conditioning regimen.

(c) Transplantation Event: The transplantation event phase usually starts from the day of starting conditioning regimen and it can last from 30 to 120 days after transplantation. This phase covers the hematopoietic stem cell infusion and the transplantation hospitalization, and it also typically includes graft procurement, stem cell mobilization, and processing. In some situations, this phase can extend for a longer period of time (eg, tandem transplantation for germ cell tumors). This phase also includes any clinic visits associated with providing care to patients receiving an outpatient transplantation.

(d) Follow-Up Care: The follow-up care phase of the BMT episode of care starts on completion of the transplantation event phase that may extend up to one year. However, transplant physicians will continue caring for patients life long, to deal with late effects of therapy including chronic GVHD from allogeneic transplant. Therefore, patients are never truly discharged from transplantation center follow-up.

History

Rulemaking Authority 627.4236 FS. Law Implemented 627.4236 FS. History–New 11-9-95, Formerly 10D-127.001, Amended 9-26-00, 8-10-05, 7-7-13, 7-12-15, 2-4-19, 9-28-23.

Chapter 59B-13 HEALTH PLAN QUALITY INDICATORS

Fla. Admin. Code R. 59B-13.001 Health Plan Quality Indicators

(1) Reporting Instructions.

(a) Any health maintenance organization authorized to transact business in the state under chapter 641, F.S., as of January 1 of the report year shall report access and quality indicator data for Florida members to the Agency as identified in this rule and specified in the Healthcare Effectiveness Data and Information Set (HEDIS) Volume 2: Technical Specifications for Health Plans developed by the National Committee for Quality Assurance (NCQA), 1100 13th St. NW, Third Floor, Washington , DC 20005.

(b) Beginning with calendar year 2018 data, each health maintenance organization shall submit indicator data for each calendar year period no later than October 1 of the following year.

(c) Extensions to the indicator data due date will be granted by the Agency for a maximum of 30 days from the due date in response to a written request signed by the chief executive officer of the health maintenance organization or his/her designee. The request must be received prior to the due date and the delay must be due to unforeseen and unforeseeable factors beyond the control of the reporting health maintenance organization. Extensions shall not be granted verbally.

(d) Each health maintenance organization must submit the HEDIS measures from the NCQA Interactive Data Submission System (IDSS) file as an Excel file.

(e) Each health maintenance organization shall send indicator data by electronic mail to HMOguide@ahca.myflorida.com and shall include in the electronic mailing the following information:

“HMO Indicator Data”;
Health maintenance organization identification number assigned by the Agency;
Health maintenance organization name; and
File name in the format HMOyyyy.xls where yyyy is the year of the indicator data.

(2) Definitions – “HEDIS” means the Healthcare Effectiveness Data and Information Set 2019 Volume 2: Technical Specifications for Health Plans developed and published by the National Committee for Quality Assurance, 1100 13th St. NW, Third Floor, Washington, DC 20005. HEDIS Volume 2: Technical Specifications for Health Plans includes technical specifications for the calculation of indicators of access and quality of care.

(3) Measures Required to be Reported.

Each health maintenance organization shall submit Florida member aggregate data for each HEDIS measure listed in paragraphs (a) through (k) for each line of business included for that measure. For each measure, the applicable guideline is HEDIS 2019 Volume 2: Technical Specifications for Health Plans which is hereby incorporated by reference and effective at adoption. The copyrighted material can be viewed at the Agency 2727 Mahan Drive, Tallahassee, FL 32308 and the Department of State, R.A. Gray building 500 South Bronough Street, Tallahassee, FL 32399. A copy may also be obtained from the National Committee for Quality Assurance (NCQA), 1100 13th St. NW, Third Floor, Washington, DC 20005.

(a) Adult BMI Assessment (ABA) Medicaid;

(b) Childhood Immunization Status (CIS) Medicaid;

(d) Breast Cancer Screening (BCS) Medicaid, Commercial, Medicare;

(e) Cervical Cancer Screening (CCS) Medicaid, Commercial;

(f) Chlamydia Screening in Women (CHL) Medicaid, Commercial;

(g) Controlling High Blood Pressure (CBP) Medicaid, Commercial, Medicare;

(h) Comprehensive Diabetes Care (CDC) Medicaid, Commercial, Medicare;

(i) Prenatal and Postpartum Care (PPC) Medicaid, Commercial;

(j) Well-Child Visits in the First 15 Months of Life (W15) Medicaid, Commercial;

(k) Well-Child Visits in the Third, Fourth, Fifth and Sixth Years of Life (W34) Medicaid, Commercial.

(4) Certification.

A copy of the statement of certification from the HEDIS auditor that includes report designations for each performance measure must accompany the plan’s report submission.

(5) Penalties for Report Deficiencies.

(a) For purposes of this rule, a report, certification, or other information is incomplete when it does not contain all data required by the Agency in this rule or when it contains inaccurate data. A report or certification is “false” if done or made with the knowledge of the preparer or a superior of the preparer that it contains information or data which is not true or accurate.

(b) A health maintenance organization that refuses to file, fails to timely file, or files a false or incomplete report, certification or other information required to be filed under the provisions of Section 408.061, F.S., other Florida law, or rules adopted thereunder, shall be subject to administrative penalties pursuant to Section 408.08(5), F.S.

(d) The penalty for filing a false report or refusal to file a report is $1,000 per day for each day until the report is corrected. The penalty for filing an incomplete report is $50 per day for each day until the complete report is filed. The penalty for failing to file timely is $50 per day until the report is filed.

(6) Uniform Publication Format.

(a) The Agency shall publish the following indicator data for each indicator no less frequently than every two years:

Health maintenance organization name;
Calendar year of data;
Type of product line;
Rate; and,
Notation that the health plan is new or small (not measurable) if applicable.

(b) In each publication of indicator data, the Agency shall include a title and a summary description of the indicator.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.063(2), 408.08(5), 641.51(9) FS. History–New 6-27-00, Amended 10-22-02, 7-25-19.

Fla. Admin. Code R. 59B-13.002 Definitions

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.063(2), 408.08(5), 408.15(11), 641.51(9) FS. History–New 6-27-00, Repealed 12-4-19.

Fla. Admin. Code R. 59B-13.003 Uniform Data Specifications

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.063(2), 408.08(5), 408.15(11), 641.51(9) FS. History–New 6-27-00, Amended 10-22-02, Repealed 12-4-19.

Fla. Admin. Code R. 59B-13.004 Certification

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.063(2), 408.08(5), 408.15(11), 641.51(8) FS. History–New 6-27-00, Repealed 12-4-19.

Fla. Admin. Code R. 59B-13.005 Penalties for Report Deficiencies

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.063(2), 408.08(5), 408.15(11), 641.51(8) FS. History–New 6-27-00, Repealed 12-4-19.

Fla. Admin. Code R. 59B-13.006 Uniform Publication Format

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.063(2), 408.08(5), 408.15(11), 641.51(9) FS. History–New 6-27-00, Amended 10-22-02, Repealed 12-4-19.

Chapter 59B-14 HEALTH PLAN CONSUMER REPORT

Fla. Admin. Code R. 59B-14.001 Purpose

(1) The rules in this chapter describe the requirements for reporting satisfaction survey data to the Agency for Health Care Administration (agency) for the purpose of providing consumers with comparative information about consumers’ experience with their health plan or their health care if that experience is directly related to the services provided by all types of health plans subject to these requirements.

(2) The rules in this chapter describe the requirements for reporting information about the health insurer’s health plans to the agency for the purpose of providing descriptive information about health plans to consumers.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061(1)(c), (e) FS. History–New 12-25-05.

Fla. Admin. Code R. 59B-14.002 Definitions

(1) “Health plan” means a health benefit plan as defined in Section 627.6699(3)(k), F.S., that is, any hospital or medical policy or certificate, hospital or medical service plan contract, or health maintenance organization subscriber contract. The term does not include accident-only, specified disease, individual hospital indemnity, credit, dental-only, vision-only, Medicare supplement, long-term care, or disability income insurance; similar supplemental plans provided under a separate policy, certificate, or contract of insurance, which cannot duplicate coverage under an underlying health plan and are specifically designed to fill gaps in the underlying health plan, coinsurance, or deductibles; coverage issued as a supplement to liability insurance; workers’ compensation or similar insurance; or automobile medical-payment insurance. The term does not include Medicare health plans, Medicaid health plans, or Florida Healthy Kids health plans described in Section 624.91, F.S. The term does not include limited or short term hospital, medical or surgical benefit policies.

(2) “Measurement year” means the year prior to the year in which the report is due to be submitted to the Agency for Health Care Administration (agency).

(3) “Insured” means a person who has health care coverage under a health plan of the health insurer.

(4) “Covered lives” means the sum of primary insureds (the total number of resident individual policyholders or resident group employee or member certificateholders) and covered dependents (the total number of individuals who are covered by the primary insured’s plan and who receive coverage due to his or her dependent relationship to the primary insured).

(5) “Cost sharing” means any co-insurance, co-payment, deductible or similar arrangement the member agrees to pay upon receipt of covered health care services.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061(1)(c), (e) FS. History–New 12-25-05.

Fla. Admin. Code R. 59B-14.003 Exclusions

Health insurers who meet the criteria in subsections (1), (2) or (3) of this section are exempt from the data collection and reporting requirements of Rules 59B-14.001 through 59B-14.008, F.A.C.

(1) Health insurers with less than $1,000,000 in direct premiums earned for new and renewal business specific to covered Florida residents from all health plans as described in subsection 59B-14.002(1), F.A.C., in the year prior to the measurement year.

(2) Health insurers with less than 5,000 covered lives in the state of Florida for all health plans excluding self-insured plans at any time during the measurement year.

(3) New health insurers starting operations after January 1 of the measurement year excluding health insurers formed by the merger of one or more health insurers that had more than $1,000,000 in direct premiums earned for new and renewal business specific to covered Florida residents from all health plans as described in subsection 59B-14.002(1), F.A.C., in the year prior to the measurement year.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061(1)(c), (e) FS. History–New 12-25-05.

Fla. Admin. Code R. 59B-14.004 Satisfaction Survey Reporting Requirements

(1) Beginning July 1, 2006, health insurers shall report annual survey data using the Consumer Assessment of Health Plans (CAHPS) questionnaire of the National Committee for Quality Assurance (NCQA) and supplemental questions described in paragraphs (a), (b) and (c) below to the Agency for Health Care Administration (agency) performed for a random sample of Florida insureds fielded during the first half of the year following the measurement year except that health insurers defined under Chapter 627, F.S., shall report selected CAHPS data to include health plan customer service, health plan claims processing, obtaining information about the health plan, overall satisfaction with the health plan, age of insured, gender of insured, health status of insured, race of insured, level of education of insured, ethnic group of insured and the supplemental questions described in paragraphs (a), (b) and (c) of this subsection. The data shall be submitted with an acceptable audit report as provided in subsection (6) below.

(a) Would you recommend your health plan to your family or friends?

Definitely yes;
Probably yes;
Probably not;
Definitely not.

(b) How would you rate the number of doctors you had to choose from?

Excellent;
Very good;
Good;
Fair;
Poor;
No experience.

Definitely yes;
Probably yes;
Uncertain;
Probably not;
Definitely not.

(2) Health insurers shall use the most current version of the NCQA CAHPS questionnaire available on the effective date of this rule to perform the member satisfaction survey. The NCQA CAHPS questionnaire may be obtained by contacting the National Committee for Quality Assurance at: www.ncqa.org.

(3) The survey shall be performed for adults 18 years and older.

(4) Health insurers shall perform a separate member satisfaction survey for the following plan types (a) and (b) if the number of covered lives exceeds 5,000 for all plans within each type:

(a) Health plans of health maintenance organizations as defined under Chapter 641, F.S.; and,

(b) Health plans of health insurers defined under Chapter 627, F.S.

(5) Health insurers shall administer the survey in a manner that meets or exceeds the survey protocol standards of the National Committee for Quality Assurance (NCQA) as set forth in the most current version of the Specifications for Survey Measures available on the effective date of this rule. The Specifications for Survey Measures may be obtained by contacting NCQA at: www.ncqa.org. The required final sample size submitted to the agency must equal or exceed 411 surveys except that a health insurer with less than 20,000 covered lives in Florida will not be penalized if the health insurer can document that the survey was administered according to the NCQA survey protocol.

(6) Health insurers shall report the name of the survey vendor and the auditor, if any, as specified in Rule 59B-14.006, F.A.C.

(7) The survey data shall be submitted to the agency in a text file in the order of survey questions in the adjunct file described in subsection (8), using a tab between each data element and starting a new line for each respondent.

(8) Health insurers shall report a separate adjunct text file to the agency containing contact information and survey questions for each plan type reported. Report the survey questions in the adjunct file in the order administered, starting a new line for each question. Include the health plan contact information required in Rule 59B-14.006, F.A.C., at the beginning of the adjunct file followed by the survey questions. Report health plan contact information in the order specified in Rule 59B-14.006, F.A.C., using four lines of text starting a new line beginning with contact name, survey vendor name and auditor name.

(9) Health insurers shall submit the CAHPS survey data annually to the National CAHPS Benchmarking Database (NCBD) according to the specifications provided on the NCDB website: http://ncbd.cahps.org/Home/Index.asp. Each health insurer will permit the NCBD to release the data to the agency provided that the data is released in a manner that does not or could not be used to identify specific health insurers. Health insurers will retain ownership of the data submitted to and maintained by the NCBD.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061(1)(c), (e) FS. History–New 12-25-05.

Fla. Admin. Code R. 59B-14.005 Health Plan Reporting Requirements

(1) Health insurers shall report health plan data to the Agency for Health Care Administration (agency) on July 1 of each year for each of the insureds included in the satisfaction survey results to be reported on July 1 of the same year as specified in Rule 59B-14.004, F.A.C. The reported health plan data must be current as of the date the sampling frame is prepared.

(2) Health plan data shall be reported for each insured sampled as described in paragraphs (a) through (f) below. All data elements (a) through (f) are required except that data elements (e) and (f) may be reported as UNKNOWN if the information is missing or unavailable. The percentage of unknown responses for any data element must not exceed 2 percent of total records, except that for measurement year 2005, the percentage of unknown responses for any data element must not exceed 5 percent of total records.

(a) Report the Florida company code assigned by the Florida Office of Insurance Regulation.

(b) Report the NAIC company code as assigned by the National Association of Insurance Commissioners.

(d) Designate the plan type as:

Health plan of health maintenance organization as defined under Chapter 641, F.S.; or
Health plan of health insurer defined under Chapter 627, F.S.

(e) Report the county of record for the insured in text, capitalizing the first letter, without using abbreviations or the word “County.” Report the insured’s county of residence except for employer groups, report the county where the employer is located. Report Dade County as Miami-Dade.

(f) Designate covered benefits as:

Network; or
No network.

If the health plan conditions payment of covered benefits on the use of providers with whom the health insurer has entered into written agreements to provide such benefits by altering cost sharing or in any manner altering covered benefits, report subparagraph 1. network. If the health plan does not condition payment of covered benefits on the use of providers who have entered into written agreements with the health insurer to provide such benefits by altering cost sharing or in any manner altering covered benefits, report subparagraph 2. no network. Report responses as a single digit, 1 or 2.

(3) The health plan data shall be reported in a text file in the order described in subsection (2) using a tab between each data element. Report each plan type in a separate file, appending data (a) through (f) for each insured to the corresponding survey data for the insured required in Rule 59B-14.004, F.A.C., starting a new line for each respondent as described in subsection 59B-14.004(7), F.A.C.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061(1)(c), (e) FS. History–New 12-25-05.

Fla. Admin. Code R. 59B-14.006 Health Plan Contact Information

(1) Each health insurer shall include the following company and contact information when submitting a report required in this section to the Agency for Health Care Administration:

(a) Name of company;

(b) Florida company code assigned by the Florida Office of Insurance Regulation;

(d) Measurement year;

(e) Covered lives in Florida on December 31 of the measurement year;

(f) Year beginning continuous license in Florida;

(g) Company website;

(h) Company telephone number;

(i) Contact name;

(j) Contact title;

(k) Contact address;

(l) Contact direct telephone number;

(m) Contact e-mail address;

(n) Contact FAX number;

(o) Survey vendor name;

(p) Survey vendor organization;

(q) Survey vendor telephone number;

(r) Auditor name;

(s) Auditor organization;

(t) Auditor telephone number; and,

(u) Designate plan type as:

Health plans of health maintenance organizations as defined under Chapter 641, F.S.; or
Health plans of health insurers defined under Chapter 627, F.S.

(2) The health insurer company contact information shall be reported in a text file as described in subsection 59B-14.004(8), F.A.C., using a tab between each data element.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061(1)(c), (e) FS. History–New 12-25-05.

Fla. Admin. Code R. 59B-14.007 Certification

(1) Each health insurer shall provide certification that the survey in Rule 59B-14.004, F.A.C., was performed according to NCQA specifications and that the information submitted is true and accurate as provided in Section 408.061(1)(c), F.S.

(2) The certification shall be submitted to the Agency for Health Care Administration (agency) by July 1 of each year using the Certification of Health Plan Consumer Report form (HPCR-1) incorporated by reference. The HPCR-1 will be available from the agency website at: http://ahca.myflorida.com/. The signed Certification of Health Plan Consumer Report may be submitted electronically using a pdf file with a scanned signature.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061(1)(c), (e) FS. History–New 12-25-05.

Fla. Admin. Code R. 59B-14.008 Administrative Penalties

(1) Failure to report as required in this section in whole or in part is subject to administrative fines as provided in Section 408.08(5), F.S., unless the health insurer has been granted an extension of up to 30 days by the Agency for Health Care Administration for reasons of extraordinary or hardship circumstances such as a natural disaster or emergency event impacting the health insurer or the collection of data required in this section. Health insurers must request the extension, in writing, prior to the due dates specified in Rules 59B-14.004 and 59B-14.005, F.A.C.

(2) The Agency for Health Care Administration shall notify the Office of Insurance Regulation if a health insurer fails to report in whole or in part as provided in Section 408.08(4), F.S.

History

Rulemaking Authority 408.08(4), 408.08(5), 408.15(8), 408.15(11) FS. Law Implemented 408.061(1)(c), (e) FS. History–New 12-25-05.

Chapter 59B-15 SURGICAL INFECTION PREVENTION DATA COLLECTION

Fla. Admin. Code R. 59B-15.001 Purpose

History

Specific Authority 408.061(1)(a), 408.061(1)(e) FS. Law Implemented 408.05(3)(l)1. FS. History–New 11-27-05, Repealed 6-8-08.

Fla. Admin. Code R. 59B-15.002 Definitions

History

Specific Authority 408.061(1)(a), 408.061(1)(e) FS. Law Implemented 408.05(3)(l)1. FS. History–New 11-27-05, Repealed 6-8-08.

Fla. Admin. Code R. 59B-15.003 Exclusions

History

Specific Authority 408.061(1)(a), 408.061(1)(e) FS. Law Implemented 408.05(3)(l)1. FS. History–New 11-27-05, Repealed 6-8-08.

Fla. Admin. Code R. 59B-15.004 Reporting Requirements

History

Specific Authority 408.061(1)(a), 408.061(1)(e) FS. Law Implemented 408.05(3)(l)l. FS. History–New 11-27-05, Repealed 6-8-08.

Fla. Admin. Code R. 59B-15.005 Hospital Contact Information

History

Specific Authority 408.061(1)(a), 408.061(1)(e) FS. Law Implemented 408.05(3)(l)1. FS. History–New 11-27-05, Repealed 6-8-08.

Fla. Admin. Code R. 59B-15.006 Certification

History

Specific Authority 408.061(1)(a), 408.061(1)(e) FS. Law Implemented 408.05(3)(l)1. FS. History–New 11-27-05, Repealed 6-8-08.

Fla. Admin. Code R. 59B-15.007 Administrative Penalties

History

Specific Authority 408.061(1)(a), 408.061(1)(e), 408.08(2), 408.08(5), 408.15(11) FS. Law Implemented 408.05(3)(l)1. FS. History–New 11-27-05, Repealed 6-8-08.

Chapter 59B-16 ELECTRONIC HEALTH RECORDS

Fla. Admin. Code R. 59B-16.001 Definitions

As used in Rules 59B-16.001 through 59B-16.002, F.A.C.:

(1) “Health care provider” means any person or organization that furnishes, bills, or is paid for health care services in the normal course of business.

(2) “Electronic format” means an electronic copy of the forms provided in Rule 59B-16.002, F.A.C., in a Portable Document Format (PDF).

History

Rulemaking Authority 408.051(4)(b), 408.15(8) FS. Law Implemented 408.051(4) FS. History–New 7-28-10, Amended 5-14-12.

Fla. Admin. Code R. 59B-16.002 Universal Patient Authorization Forms

(1) The Universal Patient Authorization Form for Full Disclosure of Health Information for Treatment and Quality of Care including instructions for completing the form is posted at: www.FHIN.net. The form may be printed, completed, signed and scanned into an electronic format as provided in subsection 59B-16.001(2), F.A.C. The Universal Patient Authorization Form for Full Disclosure of Health Information for Treatment and Quality of Care, Form Florida AHCA FC4200-004 7.1.2011 is incorporated by reference and the Spanish language version, Formulario de Autoización Universal para Dar a Conocer Información Médica Completa para Tratamiento & Calidad de Cuidado, Form Florida AHCA FC4200-006 7.1.2011, https://www.flrules.org/gateway/reference.asp?NO=Ref-01202, is incorporated by reference.

(2) The Universal Patient Authorization Form for Limited Disclosure of Health Information including instructions for completing the form is posted at: www.FHIN.net. The form may be printed, completed, signed and scanned into an electronic format as provided in subsection 59B-16.001(2), F.A.C. The Universal Patient Authorization Form for Limited Disclosure of Health Information, Form Florida AHCA FC4200-005 7.1.2011 is incorporated by reference and the Spanish language version, Formulario de Autoización Universal para Dar a Conocer Información Médica Completa para Tratamiento & Calidad de Cuidado, Form Florida AHCA FC4200-006 7.1.2011, https://www.flrules.org/gateway/reference.asp?NO=Ref-01202.

History

Rulemaking Authority 408.051(4)(b), 408.15(8) FS. Law Implemented 408.051(4) FS. History–New 7-28-10, Amended 5-14-12.

Chapter 59B-17 DIABETES OUPATIENT SELF-MANAGEMENT

Fla. Admin. Code R. 59B-17.001 Diabetes Outpatient Self-Management Training and Educational Services Standards

All health insurance policies, group health insurance policies and health maintenance contracts subject to the requirements of Sections 627.6408, 627.65745 and 641.31, F.S., shall provide, if the patient’s treating provider or a provider who specializes in the treatment of diabetes certifies that such services are necessary:

Diabetes outpatient self-management training and education services based on the current standards endorsed by the American Diabetes Association as outlined in the “National Standards for Diabetes Self-Management Education and Support” published in Diabetes Care, September 20, 2012, which is incorporated by reference. Copies of these standards are available from the Agency for Health Care Administration, Bureau of Managed Health Care, 2727 Mahan Drive, Mail Stop #26, Tallahassee, FL 32308, or the American Diabetes Association at 1701 North Beauregard Street, Alexandria, VA 22311.

History

Rulemaking Authority 627.6408(3), 627.65745(3), 641.31(26) FS. Law Implemented 627.6408, 627.65745, 641.31 FS. History‒New 6-25-13.

Division 59 Departmental

Chapter 59-1 ADMINISTRATION

Fla. Admin. Code R. 59-1.018 Uniform Rules of Procedure

History

Rulemaking Authority 408.15(8) FS. Law Implemented 120.54(5) FS. History–New 6-3-93, Amended 2-6-96, 7-21-96, 4-12-98, Repealed 11-22-07.

Fla. Admin. Code R. 59-1.024 Judicial Review

History

Rulemaking Authority 408.15(8) FS. Law Implemented 59.081, 120.52(7), 120.54(5), 120.68 FS. History–New 6-3-93, Amended 4-12-98, Repealed 11-22-07.

Fla. Admin. Code R. 59-1.025 Dismissal of Administrative Complaint

History

Rulemaking Authority 408.15(8) FS. Law Implemented 120.53(1), 120.57 FS. History–New 6-3-93, Repealed 11-22-07.

Fla. Admin. Code R. 59-1.031 Default Orders

History

Rulemaking Authority 408.15(8) FS. Law Implemented 120.53(1) FS. History–New 6-3-93, Repealed 11-22-07.

Fla. Admin. Code R. 59-1.038 Authority

History

Rulemaking Authority 120.53(1)(c)5. FS. Law Implemented 120.53 FS. History–New 6-3-93, Repealed 8-8-11.

Fla. Admin. Code R. 59-1.039 Official Reporter

History

Rulemaking Authority 120.53(2)(a) FS. Law Implemented 120.53(2)(a)-(d) FS. History–New 6-3-93, Repealed 2-13-14.

Fla. Admin. Code R. 59-1.044 Access to Final Orders

History

Rulemaking Authority 120.53(1)(c)5. FS. Law Implemented 120.53(1)(a)-(h) FS. History–New 6-3-93, Repealed 2-13-14.

Fla. Admin. Code R. 59-1.045 Final Orders Required to Be Indexed

History

Rulemaking Authority 120.53(1)(c)5. FS. Law Implemented 120.53(1)(a)-(e) FS. History–New 6-3-93, Amended 12-23-99, Repealed 2-13-14.

Fla. Admin. Code R. 59-1.046 Listing of Final Orders

History

Rulemaking Authority 120.53(1)(c)5. FS. Law Implemented 120.53(1)(f) FS. History–New 6-3-93, Repealed 2-13-14.

Fla. Admin. Code R. 59-1.047 Numbering of Final Orders

History

Rulemaking Authority 120.53(1)(c)5. FS. Law Implemented 120.53(1)(h) FS. History–New 6-3-93, Amended 12-23-99, Repealed 2-13-14.

Fla. Admin. Code R. 59-1.052 Maintenance of Records

History

Rulemaking Authority 120.53(1)(c)5. FS. Law Implemented 119.021(3), 120.53(3) FS. History–New 6-3-93, Repealed 8-8-11.

Fla. Admin. Code R. 59-1.062 Procurement for Minority Business Enterprises

History

Rulemaking Authority 287.0947(2) FS. Law Implemented 287.042 FS. History–New 8-17-93, Repealed 11-22-07.

Division 59H Health Care Responsibility Program

Chapter 59H-1 FLORIDA HEALTH CARE INDIGENCY ELIGIBILITY CERTIFICATION STANDARDS

Fla. Admin. Code R. 59H-1.001 Title

History

Rulemaking Authority 154.308 FS. Law Implemented 154.308 FS. History–New 12-29-77, Formerly 10C-26.01, 10C-26.001, Repealed 3-16-16.

Fla. Admin. Code R. 59H-1.0035 Definitions

The following words and phrases shall have the following meanings for the purpose of this rule chapter.

(1) Act: The Florida Health Care Responsibility Act (HCRA or Program).

(2) Adequate Third Party Insurance: Coverage of the hospitalization by a third party insurer that would be equal to or greater than either: 80 percent of the amount the hospital would receive if reimbursed at the hospital’s outpatient or inpatient reimbursement rate allowed for Florida Medicaid or the reimbursement rate negotiated by the county with the affected hospitals, if that negotiated rate is greater than 80 percent of the hospital’s outpatient or inpatient reimbursement rate allowed for Florida Medicaid.

(3) Agency: As defined in Section 154.304(1), F.S., (AHCA).

(4) Applicant: Any person who applies, through written application, for medical assistance under the Act.

(5) Application: The Health Care Assistance Application, AHCA Form 5220-0001, used to apply for coverage for hospital services under the Act. The application must include at least the individual’s name, date of birth, living address, mailing address, citizenship and signature to initiate the process. Only one hospital visit per applicant shall be submitted on a single application. Interested parties may obtain copies of the application from the HCRA Handbook.

(6) Assets: Those items defined as assets in 20 CFR 416 for determining eligibility for Supplemental Security Income (SSI), except as otherwise provided in Rule 59H-1.008, F.A.C., shall be used in determining eligibility under the Act.

(7) Asset Limits: The overall amount of countable assets an applicant may retain and still remain eligible. This amount shall be the same as used in the Medicaid medically needy program as defined in Rule 65A-1.716, F.A.C.

(8) Certified Resident: A United States citizen or lawfully admitted alien who has been certified by a Florida county or the Agency as being a resident of that county at the time hospital care was rendered.

(9) Certifying Agency: The person or office designated by the county of residence responsible for determining patient eligibility and certifying the county of residency under the Act. The Agency will make this determination on behalf of the county of residence only if it is unable to do so for circumstances beyond its control. Such determinations made by the Agency may not be disputed by the county of residence.

(10) Charity Care Obligation: As defined in Section 154.304(4), F.S.

(11) Claim: The universal hospital billing form, UB 04/CMS-1450. Only one original claim form may be used for each eligible individual. All information must be in black type with no written modifications. The claim shall be completed pursuant to subsection 59H-1.0065(1) F.A.C. A copy of the form is provided in the HCRA Handbook.

(12) County fiscal year: October 1 of a given year through September 30 of the subsequent calendar year.

(13) County of Residence:

(a) A specific county within the State of Florida where an individual establishes or maintains a living arrangement, outside of a medical facility, and which the individual, or someone responsible for the individual, considers to be the individual home with the intent to remain a resident of that county. A visit to another county for any purpose does not make a person a resident of that county, nor does a temporary living arrangement prior to admission in a medical facility. The length of time a person physically resides in a county is not a factor in determining residency. If the applicant or a member of the applicant’s family unit maintains a primary residence in another county with the intent to return to that county, then the county of residence is the county in which the primary residence is located.

(b) A student attending school away from home is considered a resident of the county in which the student’s parents reside if the student is claimed as a dependent for Federal Income Tax purposes. In those situations where one parent resides in-state and one parent resides out-of-state, the county where a parent resides in-state is the county of residence, even if the in-state parent is not claiming the student as a dependent for tax purposes.

(14) Designated Representative: An individual who has personal knowledge of the applicant’s circumstances and is authorized to act responsibly on behalf of an applicant by providing information, verification and documentation required by the certifying agency to determine eligibility.

(15) Eligible Individual: An applicant who is a certified resident of a Florida county, has met the Act’s criteria in regards to income, assets, and other eligibility requirements, who has received covered hospital services from a participating hospital, and who is either a qualified indigent patient or a spend-down provision eligible patient.

(16) Emergency Medical Condition: As defined in Section 409.901(10), F.S.

(17) Emergency Services and Care: As defined in Section 409.901(11), F.S.

(18) Family Unit: One or more persons residing together in the same household whose needs, income and assets are included in the household budget, excluding roomers and boarders. Members may include the applicant, legal spouse, partner, dependent children, stepchildren, adopted children and blood relatives under 21 years of age, unrelated minor children for whom the applicant, the applicant’s spouse, or partner has legal guardianship or custody, legal guardian or parents of minor children, minor siblings, and partner’s children under the age of 21.

(a) A boarder is a person for whom payment is made for room and meals and who is not the spouse or partner of the landlord.

(b) A roomer is a person for whom a payment is made for a room and who is not the spouse or partner of the landlord.

(c) An applicant who is a roomer or boarder must verify the applicant’s status as a roomer or boarder by providing a written statement from the landlord stating that the applicant is a roomer or boarder, the amount of the cash payment, that the cash payment is for a room or a room and meals, and that the applicant is not the spouse or partner of the landlord.

(d) An applicant who wishes to exclude a person from the applicant’s family unit based on the fact that the person is a roomer or boarder must verify that person’s status as a roomer or boarder by providing a written statement from the person stating that the applicant is a roomer or boarder, the amount of the cash payment, that the cash payment is for a room or a room and meals, and that the person is not the spouse or partner of the landlord.

(19) Gross Family Income: The sum of gross income a family unit receives or is entitled to receive at the time of eligibility determination, as defined under Section 154.308(4), F.S. Income shall include the following:

(a) Wages and salary;

(b) Child support;

(d) Unemployment compensation;

(e) Worker’s compensation;

(f) Veteran’s pension;

(g) Social security;

(h) Pensions or annuities;

(i) Dividends;

(j) Interest on savings or bonds;

(k) Income from estates or trusts;

(l) Net rental income or royalties;

(m) Net income from self-employment; and,

(n) Contributions from any source, including any amount contributed toward the support of any individuals and not otherwise excluded under the HCRA guidelines.

(20) HCRA Handbook: The Florida Health Care Responsibility Act (Act, HCRA, or Program), Handbook, February 2016, and herein incorporated by reference, for the purpose of providing detailed and uniform policies and procedures to the hospitals, counties and others in complying with the applicable statutes and administrative rules. Copies of the HCRA Handbook may be obtained at https://www.flrules.org/Gateway/reference.asp?No=Ref-07331 and from the Agency’s HCRA website at http://www.ahca.myflorida.com/MCHQ/Central_Services/Financial_Ana_Unit/HCRA/index.shtml. The following forms are included in the HCRA Handbook and are incorporated by reference: Health Care Assistance Application, AHCA Form 5220-0001, February 2016; Monthly Caseload and Appeals Report, AHCA Form 3160-0017, February 2016; Notification of Eligibility, AHCA Form 5220-0002, February 2016; and Quarterly Financial Report, AHCA Form 3160-0018, February 2016; and the UB 04/CMS-1450 Claim.

(21) Homestead: House, trailer, boat or motor vehicle in which the family unit resides and which is owned by the applicant or a member of the applicant’s family unit. Only one homestead shall be excluded as an asset. The composition and value of real property shall be determined by the county property appraiser. If the family unit leaves the homestead and establishes residence elsewhere, the homestead becomes an asset regardless of how it is considered for tax purposes. If a member of the family unit continues to reside in the homestead, it will not be considered an asset. If, in the case of a single person family unit, the individual is absent because of a physical or mental illness, and the individual intends to return, the homestead will not be considered as an asset.

(22) Hospital: As defined in Section 154.304(7), F.S.

(23) Inpatient: A patient of a hospital who: (1) receives professional services in the hospital for a 24-hour period or longer; or (2) is expected by the hospital to receive professional services in the hospital for a 24-hour period or longer even though it later develops that the patient dies, is discharged or is transferred to another facility and does not actually stay in the hospital for 24 hours.

(24) Maximum County Financial Responsibility: That amount obtained by multiplying total county population, as defined in Section 154.306(3), F.S., by $4 per capita using the most recent official state population estimate for the total county population published by the Florida Legislature’s Office of Economic and Demographic Research.

(25) Medicaid Program: As defined in Section 409.901(16), F.S.

(26) Monthly Caseload and Appeals Report: The form, Monthly Caseload and Appeals Report, AHCA Form 3160-0017, used by the counties on a monthly basis and submitted by the 15th of the month following the end of the reported month to the Agency to document and report each county’s caseload activity on applications and appeals. Copies of the report form may be obtained from the HCRA Handbook.

(27) Notification of Eligibility: The form, Notification of Eligibility, AHCA Form 5220-0002, used by the Certifying Agency to notify hospitals of the eligibility determination of an application. Copies of the notification form may be obtained from the HCRA Handbook.

(28) Outpatient: A patient of a hospital who receives professional services for less than a 24-hour period regardless of the hour of admission, whether or not a bed is used, or whether or not the patient remains in the hospital past midnight, meaning that a hospital stay may occur over the course of two calendar days and still be less than a 24-hour period. Only one day’s services are billable on one outpatient claim.

(29) Participating Hospital: As defined in Section 154.304(8), F.S.

(30) Poverty Guidelines: The federal poverty measure published annually in the Federal Register by the U.S. Department of Health & Human Services (formally known as the Federal Poverty Level, or FPL).

(31) Public Institution: Institution over which a governmental unit exercises administrative control, such as a correctional institution or holding facility for individuals who are prisoners, have been arrested or detained pending dispositions of charges, or are held under court order as material witnesses or juveniles.

(32) Qualified Indigent Patient: As defined in Section 154.304(9), F.S.

(33) Quarterly Financial Report: The form, Quarterly Financial Report, AHCA Form 3160-0018, used by the counties on a quarterly basis and submitted within 30 calendar days following the end of the reported quarter to the Agency to document and report each county’s expenditures and claim activity. Copies of the report form may be obtained from the HCRA Handbook.

(34) Regional Referral Hospital: As defined in Section 154.304(10), F.S.

(35) Share of Cost: The difference between the spend-down provision applicant’s monthly gross family income and the amount of income equal to 100 percent of the poverty guidelines specified for the size of the applicant’s family unit.

(36) Spend-down Provision: The provision through which an applicant who meets the following criteria becomes eligible by meeting a share of cost requirement. Such an applicant must:

(a) Be a resident of a spend-down provision eligible county as defined in subsection 59H-1.0035(37), F.A.C.;

(b) Meet the definition of a qualified indigent patient as defined in subsection 59H-1.0035(32), F.A.C., excluding the income requirement;

(c) Have a gross family unit income, for the 12 months preceding the determination, between 100 percent and 150 percent of the poverty guidelines; and,

(d) Have incurred hospital bills which would have otherwise qualified for payment under this section and which exceed the applicant’s share of cost.

(37) Spend-down Provision Eligible County: A Florida county which was not at its 10 mill cap on ad valorem taxes as of October 1, 1991, as determined by the Florida Department of Revenue.

(38) State Fiscal Year: July 1 of a given year through June 30 of the subsequent calendar year.

(39) Teaching Hospital: As defined in Section 408.07(45), F.S.

(40) Uncompensated Charity Care: Defined in the Florida Hospital Uniform Reporting System (FHURS) as charity/uncompensated care – other and charity/uncompensated care – Hill-Burton as reported on work sheet C-3a of the hospitals’ prior year report.

(41) Verification: Confirmation of the accuracy of the information on an application used by the Certifying Agency to determine the applicant’s eligibility through sources other than the self-declaratory statement of the individual originally supplying the information. Verification can be secured by telephone, in written form, or by face-to-face contact. Verification does not require a written document to confirm an applicant’s statement. In the event an employer will not verify the wages paid, the self-declaratory statement provided by the applicant must be accepted as accurate, except in those circumstances where there is substantial evidence to indicate that actual wages are in excess of those stated in the application.

History

Rulemaking Authority 154.3105 FS. Law Implemented 154.304, 154.306, 154.308, 154.309 FS. History–New 3-29-89, Amended 12-24-90, 2-24-92, Formerly 10C-26.0035, Amended 6-7-00, 12-17-01, 8-25-16.

Fla. Admin. Code R. 59H-1.0045 County Financial Responsibility

(1) The maximum amount of HCRA funds that a county can allocate for in-county reimbursement is up to 1/2 of its total HCRA funds. No county shall have the authority to use out-of-county designated funds to supplement its in-county reimbursement amount above the aforementioned one half. Should a county exceed its designated in-county reimbursement limit, the additional funds must be provided through other funding sources from the county’s budget and the amount exceeded shall not reduce the out-of-county obligation.

(2) A county’s financial responsibility for each of its qualified indigent patients or spend-down provision eligible patients who received treatment in a participating hospital shall not exceed 45 days of inpatient services per county fiscal year, per applicant. If a qualified indigent patient has at least one day of coverage remaining within his/her 45-day benefit limit at the time of admission, then the eligible days shall be equal to the full length of stay.

(3) Reimbursement for treatment in a hospital emergency room for emergency medical conditions shall be at the Medicaid outpatient reimbursement rate and shall be limited to the annual Medicaid reimbursement limits as defined in Rule 59G-4.160, F.A.C.

(4) No county shall be required to pay more than the equivalent of $4 per capita as the maximum county financial responsibility in that county’s fiscal year. As detailed in Section 154.306(1), F.S., the Agency shall calculate and certify to each county and hospital by March 1 of each year the maximum county financial responsibility the county shall be required to pay during the subsequent county fiscal year.

(5) For counties that are spend-down provision eligible, the rate of reimbursement to participating hospitals shall not be less than 100 percent of the reimbursement rate in effect for the hospital under the Medicaid Program, unless the county and the hospital sign a formal agreement to treat such county’s indigent patients at a lower or higher negotiated rate. The county shall provide written notification to the Agency of the rate negotiated for each hospital and the effective date within 30 calendar days of the date the agreement is signed. If the due date falls on a weekend or holiday, the deadline is the next business day.

(6) For counties that are not spend-down provision eligible, the rate of reimbursement to participating hospitals shall not be less than 80 percent of the reimbursement rate in effect for the hospital under the Medicaid Program unless the county and the hospital sign a formal agreement to treat such county’s indigent patients at a lower or higher negotiated rate. The county shall provide written notification to the Agency of the rate negotiated for each hospital and the effective date within 30 calendar days of the date the agreement is signed. If the due date falls on a weekend or holiday, the deadline is the next business day.

(7) The Agency will provide annually a list of Medicaid hospital outpatient and inpatient reimbursement rates which would be effective July 1, or the beginning of the state fiscal year. If a hospital does not have a Medicaid reimbursement rate provided, the Agency shall take an average of other hospitals within the same county to determine the reimbursement rate. Hospitals are responsible for notifying the county of any interim adjustments to its reimbursement rate under the Medicaid Program. The reimbursement rate utilized at the time of claim adjudication is considered the final rate for that claim. No retroactive rate adjustment is allowed.

(8) Each county shall certify to the agency, within 60 days of the end of the county’s fiscal year, the amount of reimbursement it paid to all out-of-county hospitals. Additionally, should a county reach its maximum county financial responsibility before the end of the fiscal year, the county has 60 days from the date the responsibility has been met to provide the certification to the agency that the responsibility has been met. If the due date falls on a weekend or holiday, the deadline is the next business day.

(9) If there is adequate third party insurance or coverage, the county shall make payment only if such third party insurance or coverage is less than 80 percent of the reimbursement amount allowed through HCRA. Joint payment may be made on a claim by both HCRA and such third party insurance or coverage provided the combined total payment does not exceed 100 percent of the reimbursement amount allowed through HCRA.

(10) At the end of each month, each county must complete a Monthly Caseload and Appeals Report, AHCA Form 3160-0017, documenting caseload activity for the specified month and submit this report to the Agency by the 15th of the month following the end of the reported month, to the address provided on the form. If a county has no caseload activity for any month, the county must file the Caseload and Appeals Report indicating no activity. Timely filing of the report is required. Copies of the form may be located as provided in subsection 59H-1.0035(26), F.A.C.

(11) At the end of each quarter, each county must complete a Quarterly Financial Report, AHCA Form 3160-0018, for expenditures and claim activity during a specified quarter and submit this report to the Agency within 30 calendar days following the end of the reported quarter to the address provided on the report form. If the due date falls on a weekend or holiday, the deadline is the next business day. Quarters are based on the county’s fiscal year. If a county has no expenditures or activity for any quarter, the county must file the Quarterly Financial Report indicating no activity. Timely filing is required to insure accurate financial information is available to determine if and when the maximum financial responsibility has been met. Copies of the form may be located as provided in subsection 59H-1.0035(33), F.A.C.

(12) When the maximum county financial responsibility has been met, the county shall notify the Agency, those hospitals with which they have agreements and those hospitals which serve county residents that the maximum county financial responsibility has been met.

(13) In order to be reimbursed, a participating hospital must have met its charity care obligation based on the most recent audited actual experience as reported and certified by the Agency’s Financial Analysis Unit. As defined in Section 154.306, F.S., and subsection 59H-1.0055(5), F.A.C., the Agency will provide, to the hospitals and the counties, annually and more frequently when revised, a list of hospitals meeting their charity care obligation.

(14) Payment made to a hospital by the county under this chapter for covered services provided to an eligible individual shall be considered as payment in full and the eligible individual shall not be billed, except for the applicant’s share of cost and the cost of any non-covered services.

History

Rulemaking Authority 154.3105 FS. Law Implemented 154.306 FS. History–New 3-29-89, Amended 12-24-90, 2-24-92, Formerly 10C-26.0045, Amended 6-7-00, 8-25-16.

Fla. Admin. Code R. 59H-1.0055 Hospital Participation

(1) The Agency’s Financial Analysis Unit shall determine and certify by August 31 of each year, those hospitals that meet the charity care obligation as defined in subsection 59H-1.0035(10), F.A.C., based on audited actual experience for the hospital’s fiscal year ending within the preceding calendar year. Hospital eligibility is determined annually for the coming county fiscal year.

(2) Those hospitals that meet the charity care obligation may elect to become participating hospitals as defined in subsection 59H-1.0035(29), F.A.C., if the hospitals:

(a) Have a signed formal agreement with a county or counties to treat indigent patients, or

(b) Have at least 2.5 percent of its uncompensated charity care generated by out-of-county patients, as attested by the hospital. For purposes of this section, out-of-county patients shall include non-Florida residents.

(3) Those hospitals that meet the charity care obligation but are not eligible under paragraph 59H-1.0055(2)(a), F.A.C., must provide annually to the Agency’s Financial Analysis Unit by July 31 the following information in the format prescribed by the Agency in order for the Agency to determine the amount of out-of-county uncompensated charity care:

(a) Patients by identification number;

(b) City and county of residence for each patient;

(d) Amount written off as charity care;

(e) Date written off as charity care; and,

(f) Criteria accepted by the hospital for verification of residency as provided by a statement signed by the patient or the patient’s legal guardian or designated representative attesting to the patient’s county of residence.

This information shall be for the same period as the period of the hospital’s last fiscal year ending within the preceding calendar year. The Agency’s Financial Analysis Unit shall certify by August 31 of each year, those hospitals that meet out-of-county requirements as specified in paragraph 59H-1.0055(2)(b), F.A.C.

(4) Teaching hospitals that meet the charity care obligation are eligible for participation as regional referral hospitals.

(5) Subsequent to the initial determination of hospital participation, the Agency’s Financial Analysis Unit shall determine the hospital’s eligibility annually following submission of the hospital’s audited actual experience. The Agency shall annually distribute by September 15, update and annotate a list of participating hospitals and regional referral (or teaching) hospitals to all counties. If, after a hospital has been determined eligible pursuant to subsection 59H-1.0055(3), F.A.C., the Agency’s Financial Analysis Unit finds that the hospital incorrectly reported information used to verify having met its charity care obligations and that based on accurate data the hospital was not eligible to participate, then the hospital’s eligibility shall be rescinded pursuant to the Administrative Procedures Act, Chapter 120, F.S. The hospital shall also repay to the county any amounts paid to the hospital based upon the erroneous certification of eligibility.

(6) The county shall not be liable for payment of treatment of a certified resident who is a qualified indigent patient or spend-down provision eligible patient, until the Agency’s Financial Analysis Unit has determined that the hospital has met its charity care obligations.

(7) The county shall not be liable for payment of treatment of a certified resident who is a qualified indigent patient or spend-down provision eligible patient, until such time as that hospital has documented to the Agency that the hospital has met its obligation to be able to provide the necessary information to the counties required to calculate the rate of reimbursement.

(8) Timely reimbursement to the counties is required, as applicable, pursuant to subsection 59H-1.010(4), F.A.C.

(9) The county shall notify the Agency of any hospital which has met the charity care obligation and with which the county has a formal signed agreement, within 30 calendar days of the effective date of the agreement. If the due date falls on a weekend or holiday, the deadline is the next business day.

(10) The name, title, address, and phone number of the person(s) which shall determine eligibility and process claims on behalf of the hospital shall be provided to the Agency on an annual basis each fiscal year, and when modified. The hospital is responsible for informing the Agency of any changes in this information within 30 calendar days of such change. The Agency shall provide such information to the counties on an annual and modified basis. In the event the hospitals that meet the charity care obligation do not so designate, the Agency shall assume that it is their election to not participate in the HCRA program.

History

Rulemaking Authority 154.3105 FS. Law Implemented 154.31 FS. History–New 3-29-89, Amended 12-24-90, 2-24-92, Formerly 10C-26.005, Amended 6-7-00, 8-25-16.

Fla. Admin. Code R. 59H-1.0065 Covered Services

(1) Covered services are limited to hospital services as defined in Rules 59G-4.160 and 59G-4.150, F.A.C., and the Florida Medicaid – Outpatient Hospital Services Coverage Policy, incorporated by reference in Rule 59G-4.160, F.A.C., unless otherwise specified in this rule. Copies of the policy may be obtained at https://www.flrules.org/Gateway/reference.asp?No=Ref-06979.

(2) The county of residence shall be liable for the cost of emergency services and care or treatment for emergency medical conditions in a hospital emergency room, as defined in the Florida Medicaid – Outpatient Hospital Services Coverage Policy, unless otherwise specified in this rule.

(3) Elective or non-emergency services or admissions require written pre-authorization and pre-approval if the county of residence has established written procedures to authorize and approve admissions to an out-of-county hospital for such services and admissions. The procedures shall include requirements for hospitals to request and obtain written authorization and approval for elective and non-emergency admissions or services.

(4) Elective or non-emergency admissions or services are not covered when a county provides funding for such services and the services are available at a local hospital within the county where the individual resides.

History

Rulemaking Authority 154.3105 FS. Law Implemented 154.306, 154.31 FS. History–New 3-29-89, Amended 12-24-90, Formerly 10C-26.0065, Amended 6-7-00, 12-9-03, 8-25-16.

Fla. Admin. Code R. 59H-1.007 Individual Eligibility Requirements

(1) For a hospital to receive reimbursement for hospital services under the act, an individual must meet the following conditions:

(a) Be a certified resident of a county in the state of Florida;

(b) Be a qualified indigent patient or spend-down provision eligible patient; and,

(c) Receive treatment for a covered service as defined in Rule 59H-1.0065, F.A.C., at a participating hospital or a regional referral hospital not located in the county of residence, unless the county has established a procedure to reimburse a qualified in-county hospital as allowed in Section 154.306(1), F.S.

(2) The county may establish income or asset standards for eligibility, or both, which are less restrictive than those found in subsection 59H-1.0035(30), F.A.C. A county shall not establish income or asset standards which are more restrictive than those found in subsection 59H-1.0035(30), F.A.C.

(3) The county shall notify the agency of any income or asset standards that are less restrictive than those found in subsection 59H-1.0035(30), F.A.C., within 30 days of adopting such standards and within 30 days of any subsequent changes.

History

Rulemaking Authority 154.3105 FS. Law Implemented 154.304(9), 154.306 FS. History–New 3-29-89, Amended 12-24-90, 2-24-92, Formerly 10C-26.007, Amended 6-7-00.

Fla. Admin. Code R. 59H-1.008 Determination of a Qualified Indigent Patient

(1) The county of residence has the primary responsibility for determining eligibility for individuals applying for coverage, using the eligibility determination procedures described in this section. The Agency shall conduct eligibility determinations only when the county demonstrates to the Agency that staff are not available. The county shall notify the Agency of its intent to determine eligibility. The participating hospital may elect to provide some of the eligibility documentation to the certifying agency.

(2) The governing board of the county shall designate a person or county agency to be responsible for the administration of the Act. The name, title, address, and phone number of the person or county agency, which shall determine eligibility and certify county of residence under the Act shall be provided to the Agency on an annual basis, and when modified. The county is reponsible for informing the Agency of any changes in this information within 30 calendar days of such change. The Agency shall provide such information to the participating hospitals and regional referral hospitals on an annual and modified basis.

(3) Hospitals shall screen applicants to determine the availability and adequacy of third party insurance and potential eligibility for Medicaid or other State or Federal governmental programs. Participating hospitals are responsible for initiating the eligibility determination procedures and assisting the applicant in completing the application. The hospital has 30 calendar days from the date of admission or emergency treatment to notify the certifying agency by certified mail of an individual who may qualify or the hospital forfeits its right to reimbursement. The postage date shall be used to determine such deadline.

(4) Notification shall consist of an application signed by the applicant or the applicant’s designated representative.

(5) In those situations where the applicant is comatose or is physically incapacitated to the extent that an application cannot be completed, and there is no designated representative to complete the application, the hospital may serve as designated representative.

(6) The hospital shall include with the application any documentation available that would assist the certifying agency in determining eligibility or residency, and shall include hospital bills applicable to the applicant’s meeting the applicant’s share of cost. Lack of documentation will not preclude submission of the application nor constitute a reason to delay the submission of the application within proscribed time limits.

(7) The certifying agency has 60 days following receipt of an application from the hospital to determine eligibility. When the applicant provides all required information or verification, the certifying agency determines eligibility for the HCRA program. If for any reason eligibility cannot be determined within 60 days, the hospital shall be notified, in writing, of the reason for the delay. If the due date falls on a weekend or holiday, the deadline is the next business day.

(8) If the certifying agency determines at any time during the application process, including interviews, that the applicant must provide additional information or verification, the certifying agency must give the applicant written notice to provide the requested information, allowing at least 10 calendar days from request or the interview, whichever is later. If the due date falls on a weekend or holiday, the deadline is the next business day.

(9) The certifying agency shall use gross family income to determine if the family unit’s income is less than or equal to 100 percent of the poverty guidelines or less than or equal to 150 percent of the poverty guidelines for residents of spend-down provision eligible counties. Verification of earnings shall be requested for the 4-week period prior to the date of determination pursuant to Section 154.308(4), F.S. The certifying agency shall require additional income verification for the preceding 12-month period if the income received for the 4-weeks prior to determination is not representative of the family unit’s gross income.

(10) If the family unit’s monthly gross income is more than 100 percent of the poverty guidelines and the applicant is a resident of a spend-down provision eligible county, the certifying agency shall use monthly gross family income to determine if the family unit’s income is between 100 percent and 150 percent of the poverty guidelines. Verification of earnings shall be for the one month period prior to the applicant’s date of determination. The certifying agency shall require additional income verification for the preceding 12-month period if the income received for the month prior to the date of determination is not representative of the family unit’s annual gross income.

(11) Verification of income, except as provided in subsection 59H-1.0035(41), F.A.C., may be a written or oral statement that certifies the applicant’s income includes:

(a) A statement from a state or federal agency which attests to the patient’s financial status;

(b) A statement from the employer;

(d) A statement from the source providing unearned income to the applicant or family unit.

(12) The certifying agency shall determine if the applicant’s assets exceed the standards of the asset limits specified in subsection 59H-1.0035(7), F.A.C. The certifying agency shall verify assets but such verification must be completed within 30 days of receipt of the application. If verification is not requested and received within 30 days of receipt of the application, the assets will be accepted as stated in the application unless the certifying agency documents by independent means that assets exceed the limit.

(13) The following shall not be included as assets in the eligibility determination:

(a) One homestead;

(b) Household furnishings;

(d) Clothing;

(e) Tools used in employment;

(f) Cemetery plots, crypts, vaults, mausoleums, and urns;

(g) Produce and animals raised for home consumption; and,

(h) The income and assets of roomers and boarders. The applicant must verify the person’s status as a roomer or boarder by providing a written statement from the person stating that the applicant is a roomer or boarder, the amount of payment and that the payment is for a room or a room and meals and that the person is not the spouse or partner of the landlord.

(14) The certifying agency may conduct phone or face-to-face interviews with applicants to complete the eligibility review process. The certifying agency may determine eligibility based on documentation submitted by the hospital or applicant without a phone or face-to-face interview, if adequate information is provided to verify income, assets and spend-down provision eligibility.

(15) If the applicant is a resident of a spend-down provision eligible county and the applicant’s gross family income is between 100 percent and 150 percent of the poverty guidelines, the certifying agency shall determine the applicant’s share of cost for the spend-down provision as defined in subsection 59H-1.0035(37), F.A.C. The applicant’s share of cost is the difference between the applicant’s monthly gross family income and 100 percent of the poverty guidelines.

(16) For out-of-county hospital reimbursement, the applicant must have out-of-county hospital bills that exceed the applicant’s share of cost, as defined in subsection 59H-1.0035(35), F.A.C., to be eligible. Allowable out-of-county hospital bills are the out-of-county hospital bill for the date(s) of service indicated on the application and all other hospital bills for related services, which would have otherwise qualified for payment under this part, that had been provided during the four weeks prior to the date(s) of service indicated on the application. Follow-up care which occurs within 4-weeks from the date of discharge of a related reimbursed incident shall not require an additional share of cost.

(17) For in-county hospital reimbursement, the applicant must live in a county that uses up to 1/2 of its designated HCRA funds for in-county hospital reimbursement and have in-county hospital bills that exceed the applicant’s share of cost, as defined in subsection 59H-1.0035(35), F.A.C., to be eligible. Allowable in-county hospital bills are the in-county hospital bill for the date(s) of service indicated on the application and all other hospital bills for related services, which would have otherwise qualified for payment under this part, that had been provided during the four weeks prior to the date(s) of service indicated on the application. Follow-up care which occurs within 4 weeks from the date of discharge of a related reimbursed incident shall not require an additional share of cost.

(18) To determine if the applicant has met the applicant’s share of cost, the certifying agency shall first determine the amount of reimbursement for which the hospital would have been eligible if no share of cost was involved. To determine the amount of reimbursement for inpatient hospital care, the certifying agency shall multiply the number of approved days by 100 percent of the Medicaid per diem rate or other negotiated rate. The certifying agency shall determine the amount of reimbursement for any outpatient services provided, for which the hospital would have been eligible if no share of cost was involved, based on the Medicaid rate, or other negotiated rate, for each covered service. If the applicant’s share of cost is less than the determined amount of reimbursement, then the applicant has met his share of cost and is eligible for reimbursement through the spend-down provision, within the limitations specified in Rule 59H-1.0045, F.A.C.

(19) The certifying agency shall notify the applicant and the hospital of the disposition of the application using the Notification of Eligibility within 10 calendar days of the disposition. If the eligibility criteria are met, the applicant is approved for benefits through the HCRA program. A copy of the Notification of Eligibility shall be included with the request for payment submitted by the hospital.

(20) Eligibility shall be retroactive to the date of admission or treatment, as indicated on the application.

(21) The eligibility determination may be done prior to admission for applicants who expect to be hospitalized for non-emergency or elective services.

(22) The certifying agency shall establish a case record for each individual applying for assistance under the Act. The case record shall contain the application, any documentation or evidence used in the determination of eligibility and a copy of any notices issued to the applicant or hospital making the referral.

(23) The certifying agency shall retain all case records for a period of 3 years from the date of the last action taken.

History

Rulemaking Authority 154.3105 FS. Law Implemented 154.306, 154.308, 154.316 FS. History–New 3-29-89, Amended 12-24-90, 2-24-92, Formerly 10C-26.008, Amended 6-7-00, 8-25-16.

Fla. Admin. Code R. 59H-1.009 Certification of County of Residence

(1) The hospital shall send the application to the certifying agency for the county indicated on the application as the county of residence for the determination of eligibility and certification of the county of residence of the applicant.

(2) The county has 60 days from the date of receipt of the application to determine the applicant’s county of residence. This time limit shall run concurrent with the time limit for determining eligibility. If the county fails to make or is unable to make a determination within 60 days, for reasons other than awaiting eligibility for other state of federal hospital reimbursement programs, the hospital shall notify the agency, providing a copy of the application and all supporting documentation. The agency shall determine residency within 45 days of receipt of notification from the hospital that the county was unable to determine residency. The agency shall notify the hospital and the county of the residency determination.

(3) County of Residence Verification: The applicant must provide or make available one of the following as corroborating evidence of current residency within the county:

(a) Current active driver’s license or State of Florida Identification Card;

(b) Mortgage, lease or rental receipt or letter from the landlord;

(d) Water, electric, or other public utility bill in the name of the applicant or family unit member to a residential address within the county;

(e) A state, county or federal document mailed to the applicant to a residential address within the county;

(f) Vehicle registration in the name of the applicant or family unit member to a residential address within the county;

(g) Voter registration;

(h) Proof of children enrolled in public schools within the county;

(i) Recent historical record of residence documented through a county department’s case record;

(j) Other documents of equal weight as those above that verify an applicant’s residency; and,

(k) In the absence of any of the above documentation, a declaration of domicile shall be accepted.

(4) The certifying agency may determine eligibility based on documentation submitted by the hospital or applicant without a face-to-face interview, if adequate information and documentation are provided to verify the county of residence.

(5) The agency’s determination of county of residence is binding on the county of residence and that county shall be liable to reimburse the treating hospital for a qualified indigent patient or spend-down provision eligible patient to the extent provided in the rule. The agency must provide the county with the basis for the determination.

(6) If for any reason the county or agency is unable to determine an applicant’s county of residence, the county or agency shall notify the hospital in writing of such reason.

(7) The agency’s residency determination shall be based solely on the application and supporting documentation submitted by the hospital and the county. The agency shall not verify residency information or seek additional information to establish residency.

History

Rulemaking Authority 154.3105 FS. Law Implemented 154.309, 154.316 FS. History–New 3-29-89, Amended 12-24-90, 2-24-92, Formerly 10C-26.009, Amended 6-7-00.

Fla. Admin. Code R. 59H-1.010 Reimbursement Procedures

(1) The hospital shall use the universal hospital claim form, UB 04/CMS-1450, to submit claims to the county for eligible individuals who received covered hospital care.

(2) Each county shall designate an office or agency that will pay claims. The name, title, address, and phone number of the person or county agency, which shall process claims under the act shall be provided to the Agency on an annual basis, and when modified. The county is responsible for informing the Agency of any changes to this information within 30 calendar days of such change. The Agency shall provide such information to the participating hospitals and regional referral hospitals on an annual and modified basis.

(3) The hospital shall submit the completed claim and a copy of the notification of eligibility to the resident county office designated to pay claims within 6 months of the date of the notice of eligibility. Failure to receive a claim within 6 months may result in rejection of the claim at the option of the county.

(4) The county shall reimburse the hospital within 90 calendar days of receipt of a claim, unless the claim is disputed under the provisions of Chapter 120, F.S. In cases where the patient becomes eligible for third party payment, disability benefits or other state or federal benefits, the hospital shall reimburse the county for any overpayment by the county within 60 calendar days of receipt of such payment from any other source. In cases where the hospital has received overpayment on a claim(s), the hospital shall reimburse the county for any overpayment within 60 calendar days of receipt of such notification. If the due date falls on a weekend or holiday, the reimbursement deadline is the next business day. Overpayment is an adjustment of charges, including credit balance resulting from a payment made by an insurance carrier or another responsible party, duplicate payment, reimbursement calculation error (as examined by one or more individuals with either the county, hospital or Agency and determined to have been paid in error based on the review of documentation supporting the claim), or misapplied charges or credits.

(5) In cases where payment is made to a hospital for a spend-down provision eligible applicant and no third party payor or other government program is involved, the total payment to the hospital shall not exceed the Medicaid reimbursement rate, or other negotiated rate, minus the applicant’s share of cost.

(6) The county shall provide the agency, if requested, a copy of the claim for which payment is made or denied, indicating disposition and date.

History

Rulemaking Authority 154.3105 FS. Law Implemented 154.306, 154.314 FS. History–New 3-29-89, Amended 2-24-92, Formerly 10C-26.010, Amended 6-7-00, 8-25-16.

Fla. Admin. Code R. 59H-1.011 Coordination of Third Party Payments

(1) The hospital shall pursue all third party payors prior to submitting a claim to a county. This requirement shall not preclude submission of the application within time frames established in Rule 59H-1.008, F.A.C. The county, through the HCRA, shall serve as payor of last resort in regard to third party insurance, federally funded and state-funded hospital programs which may be available to the applicant.

(2) If a third party payment is less than 80 percent of the Medicaid per diem rate or less than a negotiated rate, total payment to the hospital by a third party payor, other government program and the county shall not exceed the Medicaid reimbursement rate or the negotiated rate.

(3) In cases where a hospital is reimbursed by a third party payor or other government program, after the county has paid the hospital under this program, the hospital shall reimburse the county up to the amount paid by the county, with in 30 days of receipt of such payment.

(4) In cases where a hospital is reimbursed by a third party payor or other government program and a share of cost is involved for a spend-down provision eligible applicant, total payment to the hospital by a third party payor or other government program, combined with the applicant’s share of cost, shall not exceed the Medicaid reimbursement rate or other negotiated rate.

(5) In cases where patients are dually eligible for the Shared County and State Health Care Program and the Health Care Responsibility Act, the county may choose from which program to reimburse the hospital. The choice exercised by the county shall not reduce the amount of payment to the hospital. Reimbursement shall not exceed 45 days of service per county fiscal year through the act and the Shared County and State Health Care Program (SCS).

History

Rulemaking Authority 154.3105 FS. Law Implemented 154.304(9) FS. History–New 3-29-89, Amended 12-24-90, 2-24-92, Formerly 10C-26.011, Amended 6-7-00.

Fla. Admin. Code R. 59H-1.012 State Comptroller Responsibilities

(1) If a hospital has not received payment from the responsible county for an eligible individual within 90 days of receipt of a claim, or if the claim is disputed and payment is not received from the county determined to be responsible within 60 days after all legal and administrative remedies under Chapter 120, F.S., have been exhausted, the hospital shall certify to the Comptroller the amount owed by the responsible county. The certification shall include the name of the patient, patient ID number, the amount of the claim and the documented date the claim was received by the county. A copy of the invoice as submitted to the county, a copy of the final order for disputed claims pursuant to Chapter 120, F.S., and such other documentation as the Comptroller might require that would support payment of the claim shall be filed with the certification submitted by the hospital.

(2) Section 154.314, F.S., requires the Comptroller to forward the amount delinquent to the hospital from any funds due the county under any tax-sharing or revenue-sharing fund established by the state, except as otherwise provided by the state constitution, within 45 days of the date of receiving the hospital’s certified notice.

(3) Section 154.314, F.S., requires the Comptroller to provide reports quarterly to the Governor, appropriations and finance and tax committees in the House of Representatives and the Senate and to the agency the amount certified by the hospitals as owed by counties and the amounts paid to hospitals out of any revenue or tax sharing funds due to the county.

(4) Hospitals shall be reimbursed not less than 100 percent of the Medicaid per diem rate unless the hospital or county provides the Comptroller:

(a) Evidence that the county is not a spend-down provision eligible county,

(b) Evidence of a different rate negotiated pursuant to subsection 59H-1.0045(4), F.A.C., or

(5) The Comptroller shall reimburse hospitals for counties that are not eligible for the spend-down provision at a rate not less than 80% percent of the Medicaid per diem rate, minus the applicant’s share of cost, unless the hospital or county provides the Comptroller:

(a) Evidence of a different rate negotiated pursuant to subsection 59H-1.0045(5), F.A.C., or

(b) The order of a hearing officer providing for a different rate of reimbursement.

History

Rulemaking Authority 154.3105 FS. Law Implemented 154.314 FS. History–New 3-29-89, Amended 12-24-90, 2-24-92, Formerly 10C-26.012, Amended 6-7-00.

Fla. Admin. Code R. 59H-1.013 Procedures for Handling Disputes

All disputes among counties, the agency, a participating hospital or a regional referral hospital shall be resolved by order as provided in Chapter 120, F.S. Hearings shall be conducted as provided in Section 120.57, F.S., except that the hearing officer’s order shall be the final agency action.

History

Rulemaking Authority 154.3105 FS. Law Implemented 154.312 FS. History–New 3-29-89, Formerly 10C-26.013, Amended 6-7-00.

Fla. Admin. Code R. 59H-1.014 Utilization Review

(1) Hospitals shall follow utilization review procedures established under the approved hospital utilization review plan for Medicaid.

(2) Disputes between counties and hospitals over the appropriateness of an admission, length of stay, and medical necessity of the services provided may be resolved pursuant to Chapter 120, F.S., or in lieu of an appeal under Chapter 120, F.S., appealed to the federally designated Utilization and Quality Control Peer Review Organization (PRO) for resolution. Both parties must agree voluntarily to take an appeal to the PRO; that the decision of the PRO is binding on the county and hospital; and that no appeal shall be taken pursuant to Chapter 120, F.S.

(3) The county and the hospital shall share equally in the costs incurred by the PRO in resolving such disputes.

History

Rulemaking Authority 154.3105 FS. Law Implemented 154.306 FS. History–New 3-29-89, Formerly 10C-26.014.

Fla. Admin. Code R. 59H-1.015 Administrative Hearings, Applicant’s Rights and Responsibilities

(1) The hospital may appeal any decision made by the certifying agency concerning an applicant’s eligibility under the Act. A fair hearing shall be conducted in accordance with Chapter 120, F.S.

(2) Applicants or designated representatives are responsible for keeping appointments as required by the certifying agency, assuming the responsibility to assist in the determination of eligibility and providing the certifying agency with sources of information, documentation and verification concerning the individual’s affairs related to the eligibility determination. Failure to do so shall result in a rejection of the application.

(3) An applicant or designated representative of the applicant assumes the responsibility for providing accurate information on which to determine eligibility. If the applicant or designated representative does not provide required verifications or information by the deadline date specified in Rule 59H-1.008, F.A.C, the application will be denied.

(4) The applicant is responsible to repay any amount paid on the applicant’s behalf if it is later determined that fraud was committed or intentionally incorrect information was provided by the applicant or designated representative that resulted in an inappropriate eligibility determination.

History

Rulemaking Authority 154.3105 FS. Law Implemented 154.312 FS. History–New 3-29-89, Formerly 10C-26.015, Amended 8-25-16.

Chapter 59H-2 SHARED COUNTY AND STATE HEALTH CARE PROGRAM

Fla. Admin. Code R. 59H-2.003 Definitions

History

Rulemaking Authority Chapter 88-294, Section 27, Laws of Florida. Law Implemented 409.2673 FS. History–New 3-29-89, Amended 12-24-90, Formerly 10C-34.003, Amended 6-7-00, Repealed 12-22-09.

Fla. Admin. Code R. 59H-2.004 County Financial Participation and Lead Agency Responsibilities

History

Rulemaking Authority Chapter 88-294, Section 27, Laws of Florida. Law Implemented 409.2673(4), (7), (9) FS. History–New 3-29-89, Amended 12-24-90, Formerly 10C-34.004, Amended 6-7-00, Repealed 12-22-09.

Fla. Admin. Code R. 59H-2.005 Hospital Participation

History

Rulemaking Authority Chapter 88-294, Section 27, Laws of Florida. Law Implemented 409.2673(9) FS. History–New 3-29-89, Amended 12-24-90, Formerly 10C-34.005, Amended 6-7-00, Repealed 12-22-09.

Fla. Admin. Code R. 59H-2.006 Covered Services

History

Rulemaking Authority Chapter 88-294, Section 27, Laws of Florida. Law Implemented 409.2673(2) FS. History–New 3-29-89, Amended 12-24-90, Formerly 10C-34.006, Amended 6-7-00, Repealed 12-22-09.

Fla. Admin. Code R. 59H-2.007 Determination of Eligibility

History

Rulemaking Authority Chapter 88-294, Section 27, Laws of Florida. Law Implemented 409.2673(2), (8), (9) FS. History–New 3-29-89, Amended 12-24-90, Formerly 10C-34.008, Amended 6-7-00, Repealed 12-22-09.

Fla. Admin. Code R. 59H-2.009 Reimbursement Procedures

History

Rulemaking Authority Chapter 88-294, Section 27, Laws of Florida. Law Implemented 409.2673(2), (9), (10) FS. History–New 3-29-89, Amended 12-24-90, Formerly 10C-34.009, Amended 6-7-00, Repealed 12-22-09.

Fla. Admin. Code R. 59H-2.010 Administrative Hearing; Applicant’s Rights and Responsibilities

History

Rulemaking Authority Chapter 88-294, Section 27, Laws of Florida. Law Implemented 409.2673(2) FS. History–New 3-29-89, Amended 12-24-90, Formerly 10C-34.010, Amended 6-7-00, Repealed 12-22-09.

Fla. Admin. Code R. 59H-2.011 Utilization Review

History

Rulemaking Authority Chapter 88-294, Section 27, Laws of Florida. Law Implemented 409.2673(2) FS. History–New 3-29-89, Formerly 10C-34.011, Repealed 12-22-09.

Division 59A Health Facility and Agency Licensing

Chapter 59A-1 CERTIFICATION OF ORGAN PROCUREMENT ORGANIZATIONS, TISSUE BANKS, AND EYE BANKS (IN MEMORY OF CHARLES ARLEIGH LINCOLN, PH.D.)

Fla. Admin. Code R. 59A-1.001 Title

History

Rulemaking Authority 381.6021(1), (2), 381.6022 FS. Law Implemented 381.6021, 381.6022 FS. History–New 11-26-92, Repealed 8-20-96.

Fla. Admin. Code R. 59A-1.002 Purpose

History

Rulemaking Authority 381.6021(1), (2), 381.6022 FS. Law Implemented 381.6021, 381.6022 FS. History–New 11-26-92, Repealed 8-20-96.

Fla. Admin. Code R. 59A-1.003 Definitions

For the purpose of this section the word, phrase, or term:

(1) “Adverse reaction” means the patient’s unfavorable physical response to the transplantation of an organ or tissue with regard to the transmission of infections of other diseases of potential danger.

(2) “Allograft” means the transplantation of tissue or organ taken from one individual of the same species as the recipient but with different hereditary factors.

(3) “Brain death” means the determination of death in accordance with Section 382.009, F.S., where there is the irreversible cessation of the functioning of the entire brain, including the brain stem.

(4) “Certificate” means a license to operate as an organ procurement organization, tissue bank, or eye bank which is issued by the Agency for Health Care Administration.

(5) “Clean, non-sterile” means the use of methods and techniques that reduce gross contamination.

(6) “Consent” means authorization or permission to procure organ(s) or tissue(s) from a non-living donor which is obtained only under circumstances that provide the prospective donor or donor’s next of kin sufficient opportunity to consider whether or not to agree to such donation and that minimize the possibility of coercion or undue influence.

(7) “Container (final container)” means the immediate unit, bottle, vial, ampule, tube, or other receptacle containing grafts as distributed.

(8) “Coordinators” means registered nurses, physicians’ assistants, or other medically trained personnel who assist in the medical management of organ donors or in the surgical retrieval of organs.

(9) “Designee” means one who has been assigned a duty or duties, and who has the necessary training and educational qualifications to act on behalf of an agency director or medical director of an agency.

(10) “Distribution” means the shipment and delivery of final container grafts for recipient use.

(11) “Donation” means the free and voluntary gift of one or more organs or tissues for the purpose of transplant surgery.

(12) “Donor” means a medically acceptable person where appropriate permissions have been obtained to procure organ(s) and tissue(s) according to the provisions of Chapter 765, F.S., or if applicable, Chapter 406, F.S.

(13) “Facilities” means any area used for retrieval, processing, testing, storage, or distribution of organs, tissues, and tissue components.

(14) “Graft” means a piece of skin, bone, or other tissue to be transplanted to another place on the human body.

(15) “Gross autopsy” means the anatomical examination of a body without microscopic examination.

(16) “Indirect supervision” means the direction that is provided to coordinators and other staff under protocols expressly approved by the licensed physician medical director. The medical director or his physician designee shall always be available, in person or by telephone, to provide medical direction and consultation.

(17) “Label” means written, printed, or graphic matter on the container or package or any such matter clearly visible through the immediate carton, receptacle, or wrapper.

(18) “Next of kin” means the person or persons most closely related to a deceased individual as designated by Section 765.512, F.S.

(19) “Organ” means a body part such as a heart, kidneys, pancreas, liver, lungs, that requires vascular reanastomosis.

(20) “Organ Procurement and Transplantation Network (OPTN)” means the corporation under the Public Health Service Act that approves transplant programs to ensure that all organ donors meet minimum standards and requirements.

(21) “Package” means the immediate carton, receptacle, or wrapper, including all labeling matter therein and thereon, and the contents of the one or more enclosed containers.

(22) “Preservation” means the proper combination of conditions that serve to protect organs from decay during established periods.

(23) “Procedure” means a series of activities followed in a regular and definite order.

(24) “Processing” means the procedure employed after organ or tissue retrieval and before storage of the final container material; includes identification of the organ or tissue, organ or tissue treatment, preparation of components from such organ or tissue, testing, labeling, and associated record-keeping.

(25) “Procure” means the removal of transplantable organs or tissues for the benefit of one or more patients.

(26) “Procurement” as it applies to an OPO and eye bank means the retrieval, processing or distribution of organs and eye tissues; procurement as it applies to a tissue bank means the retrieval, processing, storage or distribution of tissues.

(27) “Quality assurance” means the monitoring procedures that ensure and document that the entire agency (e.g., facilities, personnel, methods, practices, and records) conforms with these standards.

(28) “Quality control” means laboratory tests and procedures for measuring or monitoring properties of organs and tissues essential to the evaluation of their safety or usefulness.

(29) “Retrieval” means the excision of organs or tissues from a donor’s body.

(30) “Storage” means the proper combination of conditions that serve to protect tissues from decay during established periods.

(31) “Tissue” means any non-visceral collection of human cells and their associated intercellular substances.

(32) “Tissue bank” means a public or private entity which is involved in at least one of the following activities: a) retrieving, processing, storing, or distributing viable or nonviable human tissues to clinicians who are not involved in the procurement process; b) retrieving, processing, and storing human tissues in one institution and making these tissues available to clinicians in other institutions; or c) retrieving, processing, and storing human tissues for individual depositors and releasing these tissues to clinicians at the depositor’s request. Establishments such as transplantation centers and other hospitals which store tissue only for a short term pending scheduled surgery within the same facility but do not otherwise participate in the retrieving, processing, or distribution of tissue would not be regulated under these provisions.

(33) “Transplant safety” means the assurance of relative freedom from harmful effect to persons affected, directly or indirectly, by a transplant when administered, taking into consideration the character of the transplant in relation to the condition of the recipient at the time.

(34) “Transplant physician” means a licensed practitioner who performs surgical repair or replacement using organs or tissues donated by a living or non-living donor.

History

Rulemaking Authority 765.541(2) FS. Law Implemented 765.541, 765.542 FS. History–New 11-26-92, Amended 8-20-96, 3-21-18.

Fla. Admin. Code R. 59A-1.004 Certification Procedure

(1) No person shall engage in the procurement of cadaveric organs, eyes or tissues within this state without first being certified to operate by the AHCA.

(2) A dentist or physician using tissue processed by a tissue bank, but who is not involved in the retrieval, processing and distribution of tissue, is not required to be certified pursuant to these rules.

(3) All persons seeking to apply for initial or renewal certification shall submit to the AHCA a completed application, Health Care Licensing Application, Organ Procurement, Tissue Bank, Eye Bank, AHCA Form 3140-2001, July 2014, which is incorporated by reference. This form is available at: http://www.flrules.org/Gateway/reference.asp?No=Ref-05305, or http://ahca.myflorida.com/HQAlicensureforms and from the Agency for Health Care Administration, 2727 Mahan Drive, MS #32, Tallahassee, Florida 32308. An application for initial certification, including change of ownership, shall be accompanied with a check or money order in the amount of $1,000 for an OPO or tissue bank and $500 for an eye bank. Application fees shall be made payable to the AHCA and are non-refundable.

(4) Upon receipt of a completed initial application, the AHCA shall conduct an inspection or review the inspection report from an approved accreditation organization as specified in subsection 59A-1.009(2), F.A.C., to determine the applicant’s compliance with the standards.

(5) A limited certificate may be issued to a tissue bank or eye bank certifying only those components of procurement which the bank has chosen to perform in Florida.

(6) A certified OPO, tissue bank or eye bank that proposes an addition in procurement services (i.e., retrieval, processing, storage or distribution) shall notify the AHCA 60 days prior to such addition. This notification shall include an explanation in the change of any aspect of the procurement process and how this change affects the agency’s operations. Prior to the addition of services, the AHCA shall conduct an inspection or review the inspection report from an approved accreditation organization as specified in subsection 59A-1.009(2), F.A.C., to determine if the standards of this rule are met.

(7) A certificate holder shall notify the AHCA of impending closure 90 days prior to such closure and shall be responsible for advising the AHCA as to the placement of inventory and disposition of records.

History

Rulemaking Authority 408.819, 765.541(2) FS. Law Implemented 408.805, 408.806, 408.809, 408.810, 408.811, 765.541, 765.542, 765.544 FS. History–New 11-26-92, Amended 8-20-96, 6-19-08, 5-18-15.

Fla. Admin. Code R. 59A-1.005 Standards for OPOs, Tissue Banks and Eye Banks

(1) Organizational Requirements.

(a) Institutional Identity.

The purpose of the OPO, eye bank, or tissue bank shall be clearly established and documented.
Documentation of institutional identity shall include whether the OPO, eye bank, or tissue bank is independent or part of another institution.

3.The OPO, eye bank, or tissue bank shall have a functional identity with a professional staff and a commitment to maintain and preserve records and operating procedures for future reference and historical continuity.

Policies and procedures shall be maintained for personnel and other activities.

(b) Each OPO, eye bank, or tissue bank shall have a board of directors, an advisory board, or a designated individual to provide consultation and direction on all policy-making decisions.

(c) OPO, Eye Bank, or Tissue Bank Director. Each OPO, eye bank, or tissue bank shall have a director qualified by training and experience for the scope of activities being pursued.

The director shall be responsible for:

a. Development, implementation and maintenance of all procedures and policies,

b. All administrative operations including compliance with these standards,

c. The daily operation of the OPO, eye bank, or tissue bank,

d. Specifying technically acceptable means for retrieving, processing, quality control, storage, and distribution, as applies to the scope of activities being pursued,

e. Providing all staff members with adequate information to perform their duties safely and competently,

f. Appointing technical staff with capabilities and training appropriate to their function and ensuring that competency is maintained by participation in training courses and technical meetings or other educational programs. Such training shall be recorded in the employee’s personnel file,

g. Establishing quality control and quality assurance programs. These programs shall include ongoing monitoring and evaluation of activities, identification of problems, and development of plans for corrective action. These procedures and records shall be reviewed at least annually; and,

h. Maintaining a working relationship with medical examiner offices in the OPO, eye bank, or tissue bank’s service area.

If the director appointed does not have medical licensure, the OPO, eye bank, or tissue bank shall have at least one physician, employed or under contract, to ensure compliance with all medical aspects and with all requirements for specialist knowledge of the particular organs and tissues processed.
The director is authorized to delegate his or her responsibilities to trained and competent staff. If responsibilities are delegated, the director remains responsible for ensuring that all duties are properly performed.

(d) Personnel Policies and Procedures. Job descriptions, including scope of activities, specific responsibilities, and reporting relationships, for all personnel shall be established by written personnel policies and procedures.

(e) Policies and Procedures. Each OPO, eye bank or tissue bank shall maintain detailed and unambiguous policies and procedures which detail all aspects of retrieval, processing, testing, storage, and distribution practices; as applicable.

Each of these procedures shall be reviewed and affirmed in writing annually by the director or designee.
Modifications of standard procedures and development of new procedures shall be approved by the director or designee prior to implementation.
Obsolete revised procedures shall be retained separately to maintain a historical sequence.
Copies of policies and procedures shall be available to the staff at all times. Technical staff shall be required to state in writing that they have read and understand the policies and procedures applicable to his or her specific responsibilities.
Copies of policies and procedures shall be available to surveyors for inspection upon request.

(f) Clinical Laboratory Testing. Any clinical laboratory tests performed within an OPO, tissue bank or eye bank must comply with chapter 483, F.S., and the Clinical Laboratories Improvement Act of 1988 (CLIA-88), as applicable.

(g) Records.

Donor and recipient records shall be accurate, complete, and confidential as required by Section 456.057, F.S. Donor record confidentiality shall not preclude access by surveyors for the Agency when conducting an inspection or investigation pursuant to paragraphs 59A-1.009(1)(a), (b), (c), F.A.C., and the medical examiner for cases which fall within the medical examiner’s jurisdiction, as established under section 406.05, F.S. Donor medical records and final results of all laboratory tests shall be reviewed and affirmed by the medical director, designees, or medical contractee to ensure suitability of the donated organ(s) or tissue(s) for the intended application.
Documentation shall be concurrent with the performance of each activity in the retrieval, preparation, testing, storage, and distribution of organs and tissues in such a manner that all activities can be clearly traced. All records shall be legible and indelible and shall identify the person performing the procedures/tasks. The record shall include dates of entries and test results. The expiration period assigned to specific categories of processed tissues is to be recorded in the policies and procedures.
Records shall be as detailed as necessary for a clear understanding of each activity and shall be available for inspection by surveyors when conducting an inspection or investigation pursuant to paragraphs 59A-1.009(1)(a), (b), (c), F.A.C., upon request and within the bounds of medical-legal confidentiality, pursuant to Section 456.057, F.S.
Each organ donor, tissue and any components derived from tissue shall be assigned, in addition to generic designation, a unique identification number to identify the material from retrieval through distribution and utilization.
Records shall identify the donor, document the pathological and microbiological evaluation of the donor, verify the conditions under which the organ or tissue is retrieved, processed and stored, if applicable, and indicate disposition of the transplanted organ or tissue. Maintenance of these records shall be the responsibility of the director or designee. All records concerning donor history and processing information shall be made available to the transplant surgeon upon request, except those infringing upon donor confidentiality.
All records and communication between the OPO, eye bank or tissue bank and its donors, persons identified by section 765.512(3), F.S., and patient recipients shall be regarded as confidential and privileged. Surveyors shall have access to records and communication at the time of the inspection as specified in Rule 59A-1.009, F.A.C.
Maintenance and certification records, if applicable, on facilities, instruments, and equipment, including their monitors, shall be maintained. These records shall indicate dates of inspection, name of facility, and performance evaluations. Each OPO, eye bank or tissue bank shall include in its procedures manual, the monitoring, inspection and cleaning procedures and schedules for each piece of equipment. Documented cleaning schedules for laboratory equipment shall be maintained. Records of function checks requiring interpretation of findings must include the interpretation. Records must include:

a. Temperature of incubators when in use,

b. Spore lot number and expiration date used for autoclave function check; and,

c. Control and test results.

Each OPO, eye bank, or tissue bank shall document all aspects of its quality assurance program.
An adverse reactions file shall be maintained pursuant to Rule 59A-1.011, F.A.C.
All of these records shall be retained for seven years for OPOs and ten years for tissue banks and eye banks and be available for Agency inspection.

(2) Safety and environmental control. Written procedures for the operation shall be established and approved by the director. Instructions for action in case of emergency or exposure to communicable disease, chemical and biological hazard precautions shall be included.

(a) Human waste items shall be disposed so as to minimize any hazard to personnel or the environment in accordance with the following rules and statutes administered by the Department of Environmental Protection and the Department of Health: Section 381.0098, F.S., Chapter 403, Part IV, F.S., and Chapter 64E-16, F.A.C.

(b) Dignified and proper disposal procedures shall be used to obviate recognizable human remains.

(c) All organs or tissues found positive for human immunodeficiency virus shall be rendered noncommunicable or shall be destroyed, unless specifically labeled to identify the human immunodeficiency virus and:

Is used for research purposes, or
Is used to save the life of another and is transferred with the recipient’s informed consent.

(d) Each OPO, eye bank or tissue bank shall comply with Occupational Safety and Health Administration (OSHA) rules 29 Code of Federal Regulations (CFR) Part 1910.1030, effective April 3, 2012, which are incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-09015. These rules establish requirements for minimizing exposure to hepatitis, HIV, and other blood-borne pathogens.

(3) Facilities and equipment.

(a) Each OPO, eye bank or tissue bank shall have established procedures regarding maintenance and acceptability guidelines.

(b) Facilities shall be designated for the specialized purposes for which they are to be used and shall be maintained in a clean and orderly manner. All instruments and equipment shall be subject to regularly scheduled maintenance and calibration. All temperature measuring devices must be calibrated against National Institute of Standards and Technology (NIST) certified thermometers. Refrigerators and freezers used for the storage of tissues shall have monitors. Each OPO, eye bank or tissue bank shall have established procedures to follow in the event of electrical failure.

(c) Facility access shall be limited to employees of the OPO, eye bank or tissue bank, contractual employees of the OPO, eye bank or tissue bank, surveyors for an approved accreditation organization, and governmental surveyors as permitted by applicable laws. A security system or physical configuration shall be established to prevent entry of unauthorized persons. There shall be policies and procedures to define limited facility access. Such policies and procedures shall be made available for review by surveyors as specified in Rule 59A-1.009, F.A.C.

(4) Ethical Standards.

(a) Each OPO, tissue bank, and eye bank shall have policies to avoid conflicts of interest. The policy shall ensure that no employee of the OPO, tissue bank or eye bank shall incur any obligation of any nature which is in substantial conflict with the full and competent performance of duties.

(b) In the event that services are provided to the procuring OPO, eye bank or tissue bank arrangements may be made to pay expenses incurred for services rendered. Reimbursement to the individual shall not be in conflict with the personnel policies of the primary employer.

(5) Each OPO, eye bank or tissue bank shall provide to the Agency, upon request, a copy of any audit, review, or study performed by any federal or accreditation organization.

(6) Acquisition of Organs and Tissues.

(a) General.

OPO, eye bank, or tissue bank personnel shall have written procedures to ensure that consent for donation is obtained in compliance with Chapter 765, F.S.
OPO, eye bank, or tissue bank personnel shall be trained regarding obtaining and documenting consent for donation.
Consent shall be obtained from the donor, next of kin, or other designated legal entity in order of priority and availability according to Section 765.512, F.S.
A copy of the signed consent form shall remain a part of the patient’s hospital medical record if signed at the hospital.
The original signed consent form or record of telephone consent shall be retained in the OPO, eye bank, or tissue bank’s donor record.

(b) Informed Consent.

Permission to procure organs and tissues from donors which is obtained by informed consent shall be as defined in Rule 59A-1.003, F.A.C., and shall be documented in writing. The consent form shall include the organs and tissues for which permission is granted (e.g., bone from the upper or lower extremities or bone from below the waist). Information provided shall be written or spoken in language understandable to the donor or the donor’s next of kin.
Permission to retrieve organs and tissues from non-living donors shall be sought from next of kin in order of legal precedence as required by Section 765.512, F.S.
In any cases falling under the provisions of Chapters 406 and 765, F.S., the permission of the medical examiner or appropriate designee shall be obtained prior to the procurement of any organ(s) and tissue(s). The donor records shall indicate the name of the contact person in the medical examiner’s office, date and time of contact, and limitations, if any, imposed by those giving permission (e.g., DO NOT TOUCH CHEST).

(7) Premortem donations under the Anatomical Gift Statute. Consent expressed by a living person to donate organs and tissues under provisions of the Anatomical Gift Statute, Chapter 765, Part V, F.S., are legally valid and permits organ procurement organizations, tissue banks, and eye banks to procure organs and tissues without further authorization from next of kin.

(8) Compensation for Donors. Monetary compensation other than reimbursement of donation-related expenses is prohibited.

(9) Autopsy. A gross external and internal examination of any area of the donor altered by the excision of organs or tissues shall be performed and dictated or otherwise recorded by the procuring person(s) at the time of the of the surgical removal. A written report of these findings shall be immediately prepared and delivered to the person(s) responsible for the autopsy of the donor. The report shall contain itemized notation of normal conditions as well as an itemization of all abnormal findings identified during the gross examination of the donor. Whenever a full medical autopsy will not be subsequently performed by a medical examiner, the medical director or designees may elect to obtain one by other means when deemed necessary. If performed, the medical director or designees shall justify and document the need for the full autopsy in the donor’s medical record and shall affix a copy of the report to the donor’s record.

(10) Donor Selection. Each OPO,tissue bank or eye bank engaged in the retrieval or recovery of organs or tisssues, shall have written procedures regarding donor selection.

(a) The medical director or designee shall be responsible for the donor selection.

(b) Suitability of an individual for donation shall be based upon the medical history and clinical status of the donor and the need for particular organs and tissues.

(c) Criteria for evaluating a potential donor shall include presence of infectious disease, malignant disease (with specific exceptions), neurological degenerative disease, and diseases of unknown etiology or any other diseases or conditions which may be transferred to the recipient.

(d) Evaluation of the donor record shall be performed by a licensed physician or a professional familiar with the conditions for which the procured organs or tissues will be used so that organs or tissues procured shall not be the source of any toxic or harmful effects per se when transplanted to another individual.

(e) Age of the donor shall be a consideration in the effective transplantation of certain organs or tissues but does not preclude an individual from donation.

(f) The medical director, designee, or medical contractee shall have the responsibility to document that the donor is acceptable according to the criteria established in this rule and by the procedure established by the OPO, eye bank or tissue bank.

(11) Reconstruction. Each OPO, eye bank or tissue bank who is engaged in the retrieval or recovery of organs or tisssues shall have a policy for the reconstruction of the body which is integral to maintaining the dignity of the donor.

(12) Quality Assurance. The quality assurance program shall include a method for the transplanting surgeon to report adverse reactions from the transplantation of organ(s) and tissue(s) to the source OPO, tissue bank or eye bank, which in turn shall forward the adverse reaction information to the Agency as described in Rule 59A-1.011, F.A.C.

(13) Recall Procedures. A written procedure shall exist for recall of organs or tissues or notification of recipient agencies of the possibility of contamination, defects in processing, preparation or distribution, or other factors affecting suitability of the organs or tissues for their intended application. Procedures for documenting the steps in recall or notification shall be included in the policies and procedures.

(14) Look Back Procedures. Each OPO, tissue bank, and eye bank shall have procedures for notifying the transplanting facility or physician that they may have received infected organs or tissues. Documentation of look back procedures shall be included in the policies and procedures.

(15) HIV Notification Requirements. Notification of HIV test results shall be given in accordance with the following statutes and rules administered by the Department of Health: Section 381.0041, F.S., and Rule 64D-2.005, F.A.C.

(16) Data Collection. Each OPO, tissue bank, and eye bank shall collect, maintain, and report the following data annually to the Agency:

(a) Number of donors by age and race;

(b) Type of donation;

(d) Donor source (hospital, medical examiner, or funeral home);

(e) Number of organs retrieved and number of tissue allografts and eyes processed;

(f) Disposition of processed organs, tissues, and eyes with respect to in-state, national, or international distribution; and,

(g) Revenues derived from retrieving, processing, or distributing organs and eye tissue, and revenues derived from retrieving, processing, storing or distributing tissues;

(h) Expenses associated with retrieving, processing, or distributing organs and eye tissue, and expenses associated with retrieving, processing, storing or distributing tissues.

(17) Fair and Equitable System. Each OPO, eye bank, or tissue bank shall establish and document a system of distribution that is just, equitable, and fair to all patients served. Documentation of distribution (date of requests for, offer of, and delivery of organs and tissues) shall be available for examination by authorized individuals, including surveyors for the Agency. Access to organs and tissues shall be provided without regard to recipient sex, age, religion, race, creed, color or national origin.

(18) Each OPO shall comply with 42 CFR Parts 413, 441, 486, and 498, effective May 31, 2006, incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-09014. Records relating to the federal standards must be made available upon request.

(19) Each OPO shall be a member in good standing of the Organ Procurement Transplantation Network (OPTN) created by 42 CFR Part 121.

(20) Each OPO shall employ or have under contract a physician medical director who:

(a) Is licensed to practice medicine in the state of Florida;

(b) Is board certified in a specialty recognized by the American Board of Medical Specialties (ABMS); and,

(c) Has a minimum of two (2) years affiliation with an OPO, transplant program or tertiary care hospital associated with a transplant program.

(21) The Medical Director of an OPO shall provide direction and supervision to coordinators and all other staff who assist in the procurement of organs for transplantation. With the exception of organ recovery surgery, this may be indirect supervision.

(22) Financial Policies and Procedures.

(a) The OPO shall have accounting and other fiscal procedures necessary to ensure the fiscal stability of the organization, including procedures to obtain payment for kidneys and non-renal organs provided to transplant centers.

There shall be an annual budget approved by the board of directors or advisory board.
Unless otherwise provided by law, there shall be an annual audit conducted by an independent public accountant. In the case of hospital OPOs, the hospital must undergo an annual financial audit.
There shall be adequately trained staff or qualified contractors to ensure the establishment and maintenance of internal controls and general accounting functions. The general accounting functions shall include management of accounts receivable, management of accounts payable and other disbursements, and the handling of cash. An OPO shall maintain the ability to generate periodic statements of the status of the assets, liabilities and fund balance, and statements of its periodic revenues and expenses. Hospital OPOs shall be exempt from this requirement to the extent that these functions are performed by hospital staff.

(b) The OPO shall have policies and procedures established for the documentation of all direct and indirect costs. These costs shall be used as the basis for the establishment of organ and tissue procurement charges.

(c) An OPO shall establish accounting policies and procedures to permit allocation of all its direct and indirect costs to the organ and tissue cost centers maintained. Hospital OPOs shall adhere to an appropriate hospital authority for established accounting policies and procedures.

(d) The accounting records of the OPO shall include documentation of allocations made to organ and tissue cost centers, as applicable, for each direct expense incurred by the OPO. Allocations shall be made insofar as they are related to the procurement of the particular organ. For example, records documenting the payment of a donor hospital bill shall identify the procured organs of the particular case and shall document the equal allocation of the costs to each organ type. The same procedure shall apply to other direct expenses related to the procurement, such as tissue typing or transportation. When these expenses are for the purpose of procurement of a particular organ(s), the cost shall be allocated only to that organ(s).

(e) The accounting records of the OPO shall permit the expensing of indirect costs, (e.g., office rent, utilities, administrative salaries and salary related costs) so that they may be allocated in compliance with Medicare rules and guidelines.

The OPO’s costs shall be charged as expenses and allocated in accordance with the appropriate guidance provided by the Medicare program or by the appropriate hospital authority for hospital OPOs and by established agreements with other agencies, companies, providers or vendors.
The costs paid by the OPO for services used in the procurement of organs (for example, surgeon’s fees, donor evaluation fees, laboratory, transportation, etc.) shall be based on reasonable and customary fees within the service area as determined by the OPO. The OPO may refer to limitations on the reimbursement of such costs as specified by the Medicare program.

(f) The OPO shall maintain the ability to develop and utilize average procurement costs as a basis for establishment of its organ and tissue acquisition charges. The acquisition charges are to be established in accordance with the OPO’s board of directors or advisory board and with reference to prevailing Medicare program rules and regulations. These charges shall be reviewed at least semi-annually and appropriate adjustments made unless otherwise proscribed.

(23) Verification of Death. The OPO shall ensure that death has been determined in accordance with traditional cardiopulmonary criteria or as required by Section 382.009, F.S., and documented in the organ donor’s medical record.

(24) An OPO’s policies and procedures for the evaluation and management of a potential organ donor shall be in writing. Evaluation and management of donors is mandatory for organs which may be allocated to and received by the Organ Procurement and Transplantation Network (OPTN)-approved transplant programs to ensure that all organ donors meet the minimum standards and the requirements established by the OPTN policies, effective April 6, 2017, incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-09009.

(a) The OPO’s organ donor evaluation and management procedures shall be approved by the OPO’s medical director.

(b) Once the patient has been declared dead or death is imminent and consent for donation has been obtained from the next of kin and from the medical examiner, if the death meets the requirements for referral to the medical examiner as specified in chapter 406, F.S., the OPO shall implement the guidelines for the evaluation and management of the potential organ donor.

An attempt to acquire a social history which may be obtained from individuals not limited to the person giving consent;
A physical examination of the donor;
Documentation of the donor’s ABO group, donor’s weight and height;
A review of the donor’s current inpatient medical record; and,
Documentation of significant events in the donor’s clinical course.

(d) In the brain dead donor, the OPO shall ensure that adequate respiratory, hemodynamic and electrolyte management of the donor is provided.

(e) The OPO shall ensure that the donor receives appropriate antibiotic coverage, if a need is indicated.

(f) The OPO shall evaluate the infectious disease status of the potential donor. All serological testing shall be noted to be either pre- or post-transfusion. Such evaluation shall include:

Hepatitis testing according to OPTN policies and procedures;
Appropriate FDA-licensed HIV-1/HIV-2 screens;
Serologic test for syphilis (STS);
Blood and urine cultures;
Cytomegalovirus (CMV); and,
Complete blood count (CBC).

(25) Allocation of Donated Organs.

(a) Each OPO shall have a policy to ensure that donated organs are allocated according to OPTN policies, effective April 6, 2017.

(b) The OPO shall document that the OPTN computer was accessed and reason for selection of a donor/recipient match and the placement allocation of the donor organ.

(d) Documentation of actual allocation of each organ procured shall be filed in accordance with OPTN policies, effective April 6, 2017.

(26) Procurement Procedures. The OPO shall have written policies and procedures to facilitate and coordinate the recovery of donated organs by trained and qualified personnel.

(a) A certified HHS OPO shall ensure that any surgeons (i.e., surgeons whose fees are paid by the OPO) working as consultants to the OPO for the surgical recovery of donated organs meet qualifications and standards as set by the OPO’s medical director.

(b) The medical director of the OPO shall be responsible for the surgical standards.

(c) The OPO is responsible for coordinating anesthesia support for the organ procurement process. The OPO shall provide protocols to the anesthesia support service for the intra-operative procedure which address:

Maintaining an adequate blood pressure, fluid volume, organ perfusion and function;
Adequate oxygenation and oxygen transport to the organs being procured;
Replacement of excessive volume loss; and,
Administration of required and desirable medications to facilitate organ procurement and function.

(d) If the anesthesia records are not included in the donor’s chart, records reflecting documentation of anesthesia protocol used by the OPO shall be available for inspection.

(e) In all organ donors, the OPO is responsible for packaging and labeling organs, tissue typing material and blood, according to OPTN policies, effective April 6, 2017.

(f) In all organ donors, the OPO is responsible for distributing the following documentation to each transplant center receiving an organ from an individual donor:

Verification of donor ABO type;
Copy of death determination from the donor’s medical record;
Copy of consent for organ procurement from the donor’s medical record; and,
Copy of the following OPO donor information:

a. The OPO shall be responsible for documentation of demographic information relative to the donor so that pertinent information is available for centers considering organs for transplant. The OPO shall document information that will enable follow-up with the next of kin and donor hospital personnel.

b. The OPO shall have a standardized method of recording the following information on each donor:

(I) Name;

(II) Age, sex, race;

(III) Cause of death;

(IV) Time and date of hospital admission;

(V) Time and date of pronouncement of death;

(VI) United Network for Organ Sharing (UNOS) identification number; and,

(VII) OPO identification number.

c. The OPO shall document the following information for purposes of follow-up:

(I) Name and address of the legal next of kin;

(II) Record of the organs donated;

(III) Name of attending and consulting doctor;

(IV) Medical examiner or coroner, as applicable;

(V) Copy of signed consent form; and,

(VI) Copy of declaration of death note.

d. Documentation of donor history. The OPO shall obtain a medical and social history of each potential donor in an attempt to determine whether the potential donor is at increased risk as described in “PHS Guideline for Reducing Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Transmission Through Organ Transplantation”, as published in Public Health Reports/July-August 2013/Volume 128, incorporated herein by reference and available online at: http://www.flrules.org/Gateway/reference.asp?No=Ref-09010. That history shall be communicated to the physician responsible for the care of the recipient.

e. The documented past medical history shall, when available, include significant episodes of the following:

(I) Any previous hospitalization;

(II) Any prior surgery;

(III) History of a chronic illness, e.g., diabetes, hypertension, cardiovascular disease, etc.;

(IV) History of communicable disease, e.g., hepatitis; and,

(V) History of disease specific to transplantable organs and treatment of same.

f. The current hospital history is the most vital and shall include:

(I) Description of injuries and treatments (e.g., surgeries);

(II) Account of significant febrile episodes – duration, treatment, and response;

(III) Account of cardiac and pulmonary arrests – type, duration, and all treatment required to restore function (particularly closed chest massage); and,

(IV) Record of blood transfusions – type and amount.

g. Documentation of donor hemodynamics.

h. Documentation of blood pressures shall include:

(I) Average pressure;

(II) Any hypotensive periods – noting lowest pressure and duration;

(III) Use of vasopressors – type, amount, duration, and response;

(IV) Any periods of prolonged hypertension – highest pressure, duration, and treatment instituted;

(V) Any abnormal heart rhythm and treatment; and,

(VI) Swan Ganz and central venous pressure readings and which shall be correlated with blood pressure, when available.

i. Transfused donor. All potential donors are to be tested for HIV-1/HIV-2 antibodies in accordance with the following rule administered by the Department of Health: Rule 64D-2.005, F.A.C. If the donor’s pre-transfusion test is antibody negative and subsequent transfusions are pre-tested, retesting for HIV-1/HIV-2 antibodies is not necessary. If no pre-transfusion blood sample is available, the donor institution must provide, along with the screening test results, a complete history of all transfusions received by the donor during the ten (10) day period immediately prior to removal of the organs. Except as provided in paragraph 59A-1.005(2)(c), F.A.C., organs from donors with repeatedly reactive screening tests for HIV-1/HIV-2 antibodies are not suitable for transplantation unless subsequent confirmation testing unequivocally indicates that the original test result was unconfirmed. If additional tests related to HIV-1/HIV-2 antibodies are performed, the results of all tests must be communicated immediately to the recipient’s institution.

(27) Documentation of Organ-Specific Test Results. Requirements for organ specific testing shall be in writing. The OPO shall provide the transplanting physician with certain test results for the evaluation of organ function. These results shall be documented in a standardized manner.

(a) The OPO shall, at minimum, document the following available lab results for ALL donors:

CBC;
Electrolytes;
ABO typing;
Blood and urine cultures;
Serological testing in accordance with OPTN policies, effective April 6, 2017;
Appropriate FDA-licensed HIV-1/HIV-2 screens. If blood products have been given, a pre-transfused sample shall be obtained. If unavailable, explanation shall be documented in the donor’s medical record;
Cultures, including blood, and urine, which allow for interpretation of laboratory results. Each OPO must define procedures for the type, source and indication for obtaining these cultures;
CMV antibody.

(b) Kidney evaluation:

Urinalysis;
Creatinine; and,
Blood urea nitrogen (BUN).

Liver enzymes;
Total bilirubin;
Direct bilirubin; and,
Prothrombin time/partial thromboplastin time (PT/PTT).

(d) Heart evaluation:

12 lead EKG;
Cardiology consult;
Chest X-ray;
Blood gases;
Echocardiogram or cardiac cath (optional); and,
Creatine phosphokinase including MB fraction.

(e) Pancreas evaluation:

Serum amylase;
Serum lipase; and,
Glucose.

(f) Lung evaluation:

Blood gases;
Chest X-ray; and,
Sputum gram stain and culture.

(g) The OPO shall utilize an internal standard format or form to document all of the above-mentioned information.

(28) The OPO shall document detailed information on volume intake and urine output in order to assess and maintain donor stability.

(a) The OPO shall document volume intake type (crystalloid vs. colloid) and amount for a minimum of 8 hours prior to organ procurement and for the duration of the operative procedure. The use of any blood or blood products shall be noted.

(b) The OPO shall document urine output for a minimum of 8 hours prior, if possible, to organ retrieval and for the duration of the operative procedure. Any periods of oliguria, anuria, or the occurrence of diabetes insipidus and its treatment shall be documented.

(29) Documentation of Organ Retrieval Procedure.

(a) The OPO is responsible for proper documentation of intraoperative information and all information related to the surgical recovery of all organs for transplantation.

(b) Documentation shall include:

Blood pressures, urine output, and fluids administered;
Medications administered;
Blood products administered;
Type and amount of perfusion solution and flush characteristics;
Type of storage solution;
Type of procurement procedure (i.e., enbloc, in-situ perfusion);
Aortic cross-clamp time and date;
Description of typing material available;
Warm ischemia time;
Anatomical description:

a. Kidneys – include number of vessels and approximate length and diameter of each;

b. Extra renal – include description and any injuries or abnormalities; and,

Organs recovered and not utilized. If the organs are not used for transplantation or research, a written note regarding disposition shall be documented in the OPO’s donor records.

(30) Documentation of Organ Recipient Information.

(a) The OPO shall document specific information on the recipients of recovered organs.

(b) The following information shall be documented on each recipient:

Name;
A recipient identification number;
Recipient center; and,
Age, sex, and race.

(31) Each tissue bank shall comply with 21 CFR Part 1270, 2010 Edition, which is incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-09011 and 21 C.F.R. Part 1271, 2012 Edition which is incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-09012 and make the records demonstrating compliance with the federal standards available to surveyors for the Agency.

(32) Each tissue bank shall be registered as a tissue establishment with the U.S. Food and Drug Administration (FDA) as required by 21 C.F.R. Part 1271.21.

(33) Tissue Bank Organizational Staff Requirements.

(a) Each tissue bank shall employ or have under contract a physician medical director who maintains a valid state license from any state within the United States.

(b) Medical directors are required to assure that no actual or potential conflict of interest occurs when acting as Medical Director for multiple tissue banks.

(c) Qualifications of technical personnel vary by nature of responsibility. Qualifications may be demonstrated by certification by examination administered by the American Association of Tissue Banks.

(d) All supervisory or senior technical personnel responsible for performing retrieval or processing activities shall be certified in tissue banking by the American Association of Tissue Banks within 18 months of employment with a licensed tissue bank.

(34) Tissue Donor Selection.

(a) The eligibility of each donor must be determined by a licensed Medical Director using all available relevant information. Such determination shall be documented.

(b) A medical history shall be examined, if available. If scant medical history is available, as in the case of a sudden death, a documented attempt shall be made to acquire information beyond what is available before these tissues can be released. In the event that additional information or records cannot be found, the medical director shall determine if these tissues are suitable for release for transplantation and document the release in the donor’s medical record.

(c) HIV infections. HIV testing shall be performed in accordance with the following rule administered by the Department of Health: Rule 64D-2.005, F.A.C.

(d) Tissues with evidence of infectious diseases are conditions which shall preclude distribution for transplantation. The following is a list of examples of commonly encountered conditions which preclude donation of tissues:

Infectious diseases such as:

a. Septicemia (demonstrable) at time of death;

b. Systemic mycoses;

c. Meningitis or encephalitis;

d. Active systemic viral disease or past history of chronic viral disease;

e. Active tuberculosis;

f. Active or chronic hepatitis of viral or unknown etiology; and,

g. Active syphilis or anatomically demonstrable syphilitic lesions.

Bacterial infections such as:

a. Pyelonephritis associated with sepsis or systemic infection;

b. Gross Peritonitis or abdominal abcess (not only microscopic inflammation);

c. Pneumonia associated with sepsis or systemic infection;

d. Bacterial endocarditis;

e. Osteomyelitis; and,

f. Other potentially transmittable bacterial diseases.

Malignancies. Individuals with malignancies arising anywhere in the body shall be excluded from the donor pool. Any exceptions shall be approved by the medical director.
Collagen and immune complex diseases determined by the Medical Director to impact the specific tissues to be distributed such as:

a. Rheumatoid arthritis;

b. Systemic lupus erythematosus;

c. Polyarteritis nodsa;

d. Sarcoidosis;

e. Myasthenia gravis; and,

f. Acute rheumatic fever.

Transfused Donor. Tissues from a donor who has been transfused shall comply with the FDA Guidance for Industry “Eligibility Determination for Donors of Human Cells, Tissues and Cellular and Tissue-based Products (HCT/Ps),” August 2007, incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-09016.
Recipients of organ transplants. Recipients of organ transplants shall not be automatically eliminated because of the transplant.
Other. Toxic exposure sufficient to affect tissue procured and an unknown but suspicious medical history shall constitute a reason for rejecting a donor.

(35) Required studies of the tissue donor in addition to FDA requirements specified in Rule 59A-1.005, F.A.C.

(a) Serologies:

HBcAb;
FDA-licensed HTLV test for viable, leukocyte rich cells or tissues only;
Serologic test for syphilis (STS) – confirmed. Tissues from donors with positive (confirmed) tests shall not be used for transplantation; and,
Rh determination shall be provided cautioning about the possibility of sensitization.

(b) Evaluation of the donor. Prior to transplantation, the medical director, designees, or medical contractee shall state in writing that the current medical history, postmortem examination and laboratory test results, together with the available previous medical history, are sufficient to indicate that the donor is acceptable for tissue donation.

(36) Microbiological Examination. Each tissue bank shall have written microbiological laboratory policies and procedures which, at minimum, ensure allograft safety. Documentation of adherence to these policies and procedures is required.

(37) Tissue Bank Records.

(a) Responses from transplant centers which identify adverse reactions attributable to allografts shall be maintained. The records of the tissue bank shall be open to inspection by the Agency at a mutually convenient time.

(b) Records shall show the expiration date assigned to specific processed tissues as defined in the policies and procedures.

(c) To ensure suitability of donated tissues for transplantation, records shall be made concurrently with the performance of each step of processing of tissue allografts. Distribution records shall be available but these may be collected and stored separately. All records shall be legible and indelible, shall identify the person or persons performing the procedures, and shall include the dates of written entry. All records shall be made available to that surgeon on request. The only exception is information infringing upon donor confidentiality. All records shall be maintained for a minimum of ten years.

(d) A tissue bank, when sending tissue to a hospital or surgeon, must request in writing that the transplanting surgeon report allograft-related complications to the tissue bank’s medical director. Records of adverse reactions and all related follow-up documentation shall be maintained for a period of ten years.

(e) Inventory. A record of all unprocessed, processed, and distributed tissues shall be maintained.

(38) Documentation of Tissue Donor Information. The records shall include all information on the donor including laboratory reports, autopsy reports, a clinical history, a tissue procurement record, donor eligibility and related material. The records of the consent to procure the tissue are kept at least ten (10) years after the date of its administration, or if the date of its administration is not known, at least ten (10) years after the date of distribution, disposition, or expiration, whichever is later.

(39) Timely Procurement. The tissue bank shall have written procedures that specify the time limits for the recovery of tissue consistent with tissue-specific standards, where applicable.

(40) Tissue Bank Facilities and Equipment. Environmental monitoring procedures shall be established in writing as part of the quality assurance program, when applicable. Monitoring procedures for processing tissue, at minimum, shall include equipment and personnel monitoring where tissue contact occurs, work-surface cultures, and, where appropriate, static and dynamic air particulate air sampling.

(41) Tissue Retrieval and Processing Procedures.

(a) Tissues shall be retrieved using either aseptic or clean, nonsterile techniques. If tissues are retrieved using aseptic techniques, methods shall be consistent with standard operating room practice. Aseptic technique does not necessarily preclude the need for subsequent tissue sterilization. Allografts procured using aseptic or clean, nonsterile techniques are suitable for transplantation if adequate precautions are taken to identify and eliminate microorganisms.

(b) Tissue banks employing ethylene oxide (ETO) for sterilization of tissues, chambers of freeze-dryers, instruments or equipment must monitor occupational exposure to ethylene oxide. Semi-annual reports of ETO monitoring must be kept for 30 years. Specifically the following requirements must be met and documented:

Air change rate – minimum rate for rooms where ethylene oxide is used is 10 air changes per hour.
Review of gas circuits. The following must be checked for leaks:

a. Gas tank valves;

b. Gas tank manifolds including filter cartridges;

c. Sterilizer and other equipment door seals;

d. Pressure relief valves;

e. Gas-steam mixing chambers;

f. All elbows, compression fittings, gauges, valves, etc. along the gas circuit;

g. Gas inlet into chamber; and,

h. Chamber air intake filter.

ETO alarm must be installed near equipment where ETO spill may be possible.
Automatic aeration after sterilization without having to open sterilizer door must be provided.
Periodic personnel exposure monitoring must be conducted.
A canister type respirator (NIOSH approved and rated for 5,000 ppm ETO) and gloves must be kept in the gas sterilization area in case of an emergency.
Safety data sheets must be kept in the tissue bank and the location of these sheets and content must be known to the employee.
An emergency evacuation plan must be posted for all employees to see.
Personnel must be trained regarding the safe use of ETO and records retained in the file.
All exhaust systems must be non-circulating.

(c) Tissues shall be processed into specimens appropriate for clinical use. The specific methods employed may vary with each type of tissue and with the manner in which it has been procured. Each type of tissue shall be processed according to written tissue bank procedures.

(d) Bone and tissue allografts shall be packaged in an environment specified in written procedures.

(42) Tissue Labeling.

(a) Container label. Containers shall be labeled so as to identify the following:

Name of the product;
Name and address of the tissue bank;
Tissue identification number; and,
Expiration date, if applicable.

(b) Shipping label. Packages shall be labeled so as to identify the following:

Identification of human tissue;
Name and address of tissue bank;
Name of facility to which tissue is being shipped;
Recommended storage temperature; and,
Special instructions indicated by the particular product, e.g., DO NOT FREEZE.

(43) Tissue Shipping.

(a) Each tissue bank shall have written procedures for shipping.

(b) Packaging shall be designed to ensure tissue quality and prevent contamination of the contents of the final container(s).

(c) All tissues shall be accompanied by a package insert which contains instructions for proper storage and reconstituting when appropriate. Specific instructions shall be enclosed with tissues requiring special handling. Such instructions shall include:

Presence of known sensitizing substances;
Type of antibiotics present, if applicable;
A statement that it has undergone infectious disease testing;
Sterilization procedure, if utilized; and,
Concentration of preservative(s) and/or cryoprotectant(s) in final package solution, if applicable.

(44) Tissue Tracking.

(a) Each tissue bank shall have written procedures for tissue tracking.

(b) Each tissue and any components derived therefrom shall be assigned, in addition to generic designation, one unique tissue identification number which shall identify the material during all steps from retrieval through distribution and utilization.

(45) Each eye bank shall comply with 21 C.F.R. Part 1270, 2010 Edition, and 21 C.F.R. Part 1271, 2012 Edition.

(46) Each eye bank shall be registered as a tissue establishment with the U.S. Food and Drug Administration (FDA) as required by 21 C.F.R. Part 1271.21.

(47) Eye Bank Organization Staff Requirements.

(a) The medical director shall have served a corneal fellowship, and shall be certified by the American Board of Ophthalmology.

(b) Eye Bank technical personnel.

A supervisory eye bank technician shall be the individual responsible for the daily operation of the eye bank laboratory. The supervisory eye bank technician shall ensure compliance with these standards for the eye bank laboratory. Each eye bank processing laboratory must have at least one certified technician in a supervisory role.
An eye bank technician shall be trained in acquisition, evaluation, processing, storage and distribution of eye tissue for transplantation.
A procurement technician shall be proficient in screening and retrieval of the eye tissue.

(48) Training, Certification, and Continuing Education.

(a) An eye bank shall provide an orientation program for each new technician and the employee’s participation shall be documented.

(b) An eye bank shall provide educational opportunities such as in-service training programs, attendance at meetings, seminars, and workshops for all technical personnel, including laboratory supervisors, at a frequency that is defined and reasonable for the size and needs of the technical staff.

(c) To function as the supervisory technician in the eye bank processing laboratory, the technician must pass the Eye Bank Association of America’s (EBAA) Technician Certification examination or an approved examination administered by a medical school’s Department of Ophthalmology approved for residency training in ophthalmology.

(49) Performance Standards.

(a) Each eye bank shall demonstrate proficiency in all aspects of eye banking by annually retrieving, processing, or distributing at least 100 corneas for penetrating keratoplasty and provide the Agency with documentation of its performance upon request.

(b) Each eye bank shall have a consistent policy for the physical inspection of the donor and examination and documentation of the prospective donor’s available medical record or death investigation.

(c) Review of all available records on each eye donor shall be performed by an individual who is qualified by profession, education and training to do so, and who is familiar with the intended use of the tissue.

(50) Eye Donor Selection.

(a) Eye tissue from donors with the following shall not be used for penetrating keratoplasty, lamellar keratoplasty, patch grafts, epikeratoplasty or any other type of surgery:

Death of unknown cause;
Death from central nervous system diseases of unknown etiology;
Creutzfeldt-Jakob disease;
Subacute sclerosing panencephalitis;
Progressive multifocal leukoencephalopathy;
Congenital rubella;
Reye’s syndrome;
Active viral encephalitis of unknown origin;
Active septicemia (bacteremia, fungemia, viremia);
Active bacterial or fungal endocarditis;
Active viral hepatitis;
Rabies;
Intrinsic eye disease:

a. Retinoblastoma;

b. Malignant tumors of the anterior ocular segment;

c. Active ocular or intraocular inflammation: conjunctivitis, scleritis, iritis, uveitis, vitreitis, choroiditis, retinitis;

d. Congenital or acquired disorders of the eye which would preclude a successful outcome for the intended use, e.g., a central donor corneal scar for an intended penetrating keratoplasty, keratoconus, and keratoglobus; and,

e. Pterygia or other superficial disorders of the conjunctiva or corneal surface involving the central optical area of the corneal button.

f. Exceptions are that tissue with local eye disease affecting the corneal endothelium may be used for epikeratoplasty, patch grafts, and scleral transplant surgery, and tissue with local eye disease affecting the corneal endothelium or previous ocular surgery that does not compromise the corneal stroma may be used for lamellar keratoplasty or patch grafts.

Prior intraocular or anterior segment surgery:

a. Refractive corneal procedures, e.g., radial keratotomy, lamellar inserts, etc.;

b. Laser photoablation surgery;

c. If corneas are used from donors who have had prior anterior segment surgery (e.g., cataract, intraocular lens, glaucoma filtration), the corneas shall be screened by specular microscopy and meet the eye bank’s endothelial standards as determined by the medical director; and,

d. Laser surgical procedures such as argon laser trabeculoplasty, retinal and panretinal photocoagulation do not necessarily preclude use for penetrating keratoplasty but shall be cleared by the medical director.

Active leukemia;
Active disseminated lymphomas;
Hepatitis B surface antigen positive donors;
Recipients of human pituitary-derived growth hormone (pit-hGH) during the years from 1963-1985;
HIV seropositive donors;
Acquired immunodeficiency syndrome (AIDS);
Children (under 13 years old) and infants of mothers with AIDS or at high risk of HIV infection;
High risk for HIV infection based on the FDA Guidance Concerning Application of Testing and High Risk Criteria for HIV and Hepatitis for Banked Human Tissue, incorporated herein by reference.
HTLV infection except in the case of viable, leukocyte cell or tissue donors;
Active syphilis; and,
Hepatitis C seropositive donors.

(b) Tissue from donors meeting the criteria in paragraph 59A-1.005(50)(a), F.A.C., above shall not be used for epikeratoplasty or other surgery with the exception that tissue with local eye disease affecting the corneal endothelium (e.g., aphakia, iritis) is acceptable for use. Interval of time from donor’s death to preservation of eye tissue may be extended.

(51) Eye Donor Testing.

(a) Microbiologic Culturing. Culturing of eye bank donor eyes is recommended. However, the responsibility for determining the need for culturing shall reside with the transplanting surgeon.

Presurgical Cultures. Eye banks may elect to perform corneal-scleral rim cultures at the time of corneal preservation in tissue culture medium. Positive culture reports shall be reported to the receiving surgeon or recipient eye bank.
Surgical Culturing. Each eye bank shall recommend culturing of the corneal-scleral rim for corneal transplantation, or a piece of sclera for scleral implantation at the time of surgery. Positive culture results in cases of postoperative infection shall be reported to the eye bank that processed the tissue.

(b) HIV Screening.

Each eye bank shall have an HIV screening program using FDA-approved tests, pursuant to Rule 64D-2.005, F.A.C., for all donors of surgically designated tissue. A negative screening test shall be documented prior to release of tissue for transplantation.
Eye tissue from a donor who has been transfused shall comply with the FDA Guidance for Industry “Eligibility Determination for Donors of Human Cells, Tissues and Cellular and Tissue-based Products (HCT/Ps)”, August 2007.

(c) Hepatitis B Screening. Each eye bank shall have a hepatitis B screening program using an FDA-approved test for hepatitis B surface antigen for all donors of surgically designated tissue. A negative screening test or neutralization or confirmatory test must be documented prior to release of tissue for transplantation.

(d) Hepatitis C Screening. Each eye bank shall have a hepatitis C screening program using an FDA-approved test for hepatitis C surface antigen for all donors of surgically designated tissue. A negative screening test or neutralization or confirmatory test must be documented prior to release of tissue for transplantation.

(e) HTLV Screening. HTLV screening is required of viable, leukocyte rich cells or tissues only. If donor screening for HTLV has been performed, a negative screening test shall be obtained and documented prior to release of tissue for transplantation.

(f) Syphilis Screening. If the screening test is performed and is positive, a negative confirmatory test shall be obtained and documented prior to release of tissue for transplantation.

(52) Documentation of Eye Donor Information.

(a) Donor screening forms and copies of medical charts, medical examiner, or coroner review forms and gross autopsy results, if performed, shall be completed and retained on all donated eye tissue as part of the donor record. Until the final written autopsy report becomes available, documentation of verbal reports of autopsy findings are acceptable.

(b) Donor information forms shall contain information regarding the circumstances surrounding the death of the donor and medical history so that the suitability of the tissue for transplantation may be evaluated.

(c) Minimum information to be retained. A report form for retaining donor and recipient information shall be established for permanent record and shall be readily accessible for inspection by authorized individuals, including surveyors for the Agency. The record shall include the following minimum information:

Eye bank identification number unique to each tissue graft;
Name of eye bank;
Location of eye bank;
Phone number;
Type of preservation;
Age of donor;
Cause of death;
Death date and time;
Enucleation or in-situ retrieval date and time;
Preservation date and time;
Slit lamp report;
Specular microscopy, if performed;
Name of enucleator/evaluator/technician;
Name of surgeon receiving tissue;
Recipient identification;
Utilization of non-transplantable tissue;
All serological or microbiological tests performed; and,
Adverse reactions, when reported.

(d) Length of storage. All records shall be maintained for a minimum of ten years from the date of transplantation/implantation.

(53) Eye Bank Facilities and Equipment.

(a) Each eye bank shall have sufficient space, equipment and supplies to perform the volume of laboratory services with optimal accuracy, efficiency, sterility, timeliness and safety.

(b) Each eye bank shall have an adequate stable electrical source and a sufficient number of grounded electrical outlets for operating laboratory equipment. Laminar flow hoods or similar piece of equipment shall be available for sterile processing.

(c) Each eye bank shall have a refrigerator with a device for recording temperature variations. Temperature variations shall be recorded daily and remain within the range of 2 degrees to 6 degrees C. These records shall be kept for a minimum of ten years. The refrigerator shall be maintained for the exclusive use of donor related material and shall contain clearly defined and labeled areas for all tissue stored, i.e., quarantined tissue, surgical tissue awaiting distribution, and research tissue.

(d) In the event of a power failure, there shall be established policies and procedures for action to be taken, which may include an emergency power supply to maintain essential refrigeration.

(e) No sterilized instruments, supplies, and reagents, such as corneal preservation medium for surgical tissues, shall be used beyond the expiration date for surgical tissues.

(54) Satellite Eye Banks. Satellite eye banks that retrieve, process, and distribute tissue shall have a technician and be supervised by and have access to a qualified medical director or designee. Such satellite eye bank shall be inspected by surveyors for the Agency as part of the certification process for the parent eye bank.

(55) Eye Bank Retrieval and Processing Procedures.

(a) Enucleation procedure. Ultimate responsibility for personnel who perform enucleation rests with the director and the medical director.

(b) In-situ and facility-based removal of the corneal-scleral rim. Removal of the corneal-scleral rim shall be performed using sterile technique by individuals specifically trained in in-situ retrieval and facility-based removal of the corneal-scleral segment.

(c) Use of preservation medium. Eye banks shall use a corneal storage medium which has been used and stored according to the manufacturer’s recommendations. The manufacturer’s recommendations must be retained and made available for inspection by surveyors for the Agency.

(d) Long-term preservation. Eye banks employing long-term preservation of corneal tissue, such as organ culturing, shall carefully document the procedure in their procedures manual, and adhere to strict aseptic technique.

(e) Whole globe preservation. Eye banks that store whole eyes for lamellar or refractive keratoplasty shall employ aseptic practices using one of the preservation methods given in the eye bank’s procedures manual. The selected preservation method shall be documented in the eye bank’s own procedure manual.

(f) Scleral Preservation.

If the eye bank preserves scleral tissue, the selected preservation method shall be documented in the eye bank’s own procedures manual.
An expiration date for use of tissue shall be indicated based on the container capability and factors documented or recommended by the eye bank.

(g) Interval between death, enucleation, procurement, and preservation. Acceptable time intervals from death, enucleation, or procurement to preservation of eye tissue may vary according to the circumstances of death and interim means of storage of the body. Corneal preservation shall occur as soon as possible after death and within the time frame determined by the medical director as defined by the policies and procedures. All time intervals (i.e., time of death to the time of enucleation and preservation) shall be recorded for each donor.

(h) Eye maintenance prior to enucleation. The prospective donor’s corneal integrity shall be maintained. Procedures for eye maintenance shall be described in the eye bank’s policies and procedures. Each individual eye bank’s procedure is left to the discretion of the medical director and shall be clearly documented and adhered to.

(i) Review of donor medical history. Prior to distribution of tissue for transplantation, the medical director or designee shall review and document the medical and laboratory information in accordance with criteria established in this rule.

(j) Non-surgical donor tissue. If donor tissue is provided for purposes other than surgery, e.g., research, practice surgery, etc., and if that donor tissue is not screened for HIV, hepatitis, or syphilis, a label stating that screening for HIV-antibody, hepatitis B, hepatitis C, or syphilis has not been carried out or stating “Potentially Hazardous Biological Material” shall be attached to the container used for the donor tissue storage and transport.

(56) Eye Tissue Evaluation. The transplanting surgeon has ultimate responsibility for determining the suitability of the tissue for transplantation.

(a) Gross examination. The corneal-scleral segment shall be initially examined grossly for clarity, epithelial defects, foreign objects, contamination, and scleral color (e.g., jaundice).

(b) Slit lamp examination. The cornea shall be examined for epithelial and stromal pathology and in particular endothelial disease. Enucleated whole globes shall be examined in the laboratory prior to distribution and corneal retrieval. After corneal retrieval, the corneal-scleral rim shall be evaluated by slit lamp biomicroscopy, even if the donor eye has been examined with the slit lamp prior to retrieval of the corneal-scleral rim, to ensure that damage to the corneal endothelium or surgical detachment of Descemet’s membrane did not occur.

(57) Eye Tissue Storage.

(a) All surgical tissue shall be stored in quarantine until negative serology results have been documented, in accordance with the following rule administered by the Department of Health: Rule 64D-2.005, F.A.C.

(b) All tissue shall be stored at a temperature appropriate to the method of preservation used.

(58) Corneal or Scleral Tissue Labeling.

(a) Visual inspection. A sufficient area of the container shall remain unobstructed to permit inspection of the contents.

(b) Each corneal or scleral tissue shall be clearly and indelibly labeled to include, at least, the following:

Name of source eye bank;
Tissue identification number;
Type of tissue;
Date and time of donor’s death;
Date and time of corneal-scleral preservation;
Expiration date for scleral tissue; and,
A statement shall accompany the tissue stating that:

a. The tissue is intended for single patient application only and that it is not to be considered sterile and that the FDA therefore recommends culturing or reculturing; and,

b. The tissue has undergone infectious disease testing.

(59) Eye Tissue Packaging.

(a) Each tissue shall be individually packaged and sealed with a shrink wrap.

(b) The tissue shall be packed in a water proof container with wet ice, so as to maintain the temperature of the tissue at an acceptable level. Packing shall be done so that the package insert and tissue label do not become wet. Special instructions shall be included on the package insert.

(c) Package insert. A package insert form shall accompany the tissue for transplantation. This form shall include the following:

Recommended storage temperature with specific emphasis on Do Not Freeze;
That the surgeon shall check for integrity of the seal and immediately report to the eye bank any evidence of possible tampering;
That color change per the manufacturer’s guidelines may indicate a change in pH, in which case the tissue shall not be used and a report made immediately to the eye bank;
Whether pre-surgical microbiological cultures were performed by the eye bank, including the advisement that culture of the donor rim and sclera shall be performed at the time of surgery; and,
The form shall also advise the receiving surgeon that the tissues are delivered with no warranty as to merchantability or fitness for a particular purpose, and that the receiving surgeon is ultimately responsible for judging if the tissue is suitable for use.

History

Rulemaking Authority 765.541(2) FS. Law Implemented, 765.541, 765.542, 765.543, 765.545 FS. History–New 11-26-92, Amended 8-20-96, 1-17-18.

Fla. Admin. Code R. 59A-1.006 Organ Procurement Organization Standards

History

Rulemaking Authority 381.6021(2) FS. Law Implemented 381.0041, 381.6021, 381.6022, 381.6023, 381.6025, 382.009, 406.11, 455.241483.035, 732.912 FS. History–New 11-26-92, Repealed 8-20-96.

Fla. Admin. Code R. 59A-1.007 Tissue Bank Standards

History

Rulemaking Authority 381.6021(1), (2), 381.6022, 381.6023(3)(e) FS. Law Implemented 381.6021, 381.6022, 381.6023 FS. History–New 11-26-92, Repealed 8-20-96.

Fla. Admin. Code R. 59A-1.008 Eye Bank Standards

History

Rulemaking Authority 381.6021(1), (2), 381.6022, 381.6023(3)(e) FS. Law Implemented 381.6021, 381.6022, 381.6023 FS. History–New 11-26-92, Repealed 8-20-96.

Fla. Admin. Code R. 59A-1.009 Inspections; Acceptance of Accreditation Inspection Reports; Annual Reporting Requirements

(1) The AHCA may inspect each organ procurement organization, tissue bank and eye bank on no less than a biennial period. The AHCA is permitted at its sole discretion to inspect any organ procurement organization, eye bank or tissue bank by on-site inspection, off-site inspection or acceptance of documentation from an accreditation inspection that includes the approved accreditation organization inspector’s report of findings, the organization’s responses and the final determination. The purpose of these inspections is to:

(a) Ensure compliance with the standards of rule Chapter 59A-1, F.A.C.;

(b) Evaluate the accreditation organization’s process; or

(2) Acceptance of Accreditation Organization Inspection Reports.

(a) For certifying organ procurement activities, each accredited organ procurement organization shall submit the results of each Association of Organ Procurement Organization (AOPO) inspection report and proof of accreditation or reaccreditation to the Agency within 30 days of receipt of such reports and accreditation or reaccreditation.

(b) For certifying tissue banking activities, each accredited tissue bank organization shall submit the results of each American Association of Tissue Banks (AATB) inspection report and proof of accreditation or reaccreditation to the Agency within 30 days of receipt of such reports and accreditation or reaccreditation.

(c) For certifying eye bank activities, each accredited eye bank shall submit the results of each Eye Bank Association of America (EBAA) inspection report and proof of accreditation or reaccreditation to the Agency within 30 days of receipt of such reports and accreditation or reaccreditation.

(d) If the certified organization voluntarily forfeits its accreditation by AOPO, AATB or EBAA, if the accreditation is suspended or terminated, or if the certified organization is denied accreditation or re-accreditation by any of these accrediting organizations, the certified organization must provide written notification to the AHCA within 30 days of the forfeiture or denial.

(e) Failure to submit the required accreditation inspection report and final determination or written notification of forfeiture, suspension, termination or denial of accreditation shall be considered a failure to submit to an inspection and will result in administrative action as provided in Chapter 408, Part II, F.S. and these rules.

(f) The AHCA shall conduct a biennial certification inspection of all agencies to ensure compliance with the standards in Rule 59A-1.005, F.A.C. All deficiencies to the standards will be submitted in writing to the agency by the AHCA. The AHCA shall conduct additional inspections to determine agency compliance with the standards. If an agency fails to correct the deficiencies the AHCA shall take administrative action as specified in Rule 59A-1.012, F.A.C.

(3) If, as the result of an inspection in response to a complaint, the AHCA determines that an agency is out of compliance with the standards in Rule 59A-1.005, F.A.C., or other sections of this rule, the AHCA shall take administrative action as specified in subsection 59A-1.012(1), F.A.C. If the agency remains out of compliance with the standards and rules of this chapter upon subsequent inspection by the AHCA, further administrative action as specified in subsection 59A-1.012(1), F.A.C., shall be taken.

(4) Each certified agency shall submit to the AHCA its most recently completed annual audit within 30 days after the anniversary date of certification.

(5) Each certified OPO shall submit to the AHCA the Annual Report for Organ Procurement, Distribution, Revenues and Expenses, AHCA Form 3140-2002-APR 2008, incorporated herein by reference and available at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Laboratory_Licensure/organ.shtml, within 30 days after the anniversary date of certification.

(6) Each certified tissue bank shall submit to the AHCA the Annual Report for Tissue Procurement, Distribution, Revenues and Expenses, AHCA Form 3140-2004-DEC 2008, incorporated herein by reference and available at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Laboratory_Licensure/organ.shtml, within 30 days after the anniversary date of certification.

(7) Each certified eye bank shall submit to the AHCA the Annual Report for Eye Procurement, Distribution, Revenues and Expenses, AHCA FORM 3140-2005-DEC 2008, incorporated herein by reference and available at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Laboratory_Licensure/organ.shtml, within 30 days after the anniversary date of certification.

(8) These forms shall be available on the Agency website at: www.licensing_cert.shtml, or from the Agency for Health Care Administration, Division of Health Quality Assurance, Laboratory Licensure Unit, 2727 Mahan Drive, MS #32, Tallahassee, Florida 32308. The data to be submitted to the AHCA are described in subsection 59A-1.005(17), F.A.C. All reported donor information shall be based on the previous calendar year. All revenue and expense information shall be based on the most recently completed fiscal or operational year.

History

Rulemaking Authority 765.541(2) FS. Law Implemented 765.541, 765.543 FS. History–New 11-26-92, Amended 8-20-96, 6-19-08.

Fla. Admin. Code R. 59A-1.010 Annual Reporting Requirements

History

Rulemaking Authority 381.6021(2), 381.6023(3)(b), (d) FS. Law Implemented 381.6021, 381.6023 FS. History–New 11-26-92, Repealed 8-20-96.

Fla. Admin. Code R. 59A-1.011 Adverse Reactions

(1) General. Each agency shall inform physicians and hospital personnel involved in the transplantation of organs, tissues, and eyes of policies and procedures regarding the reporting of adverse reactions to agencies. It is the responsibility of each physician and organization that utilizes organs and tissues for transplantation to notify the providing organ procurement organization, tissue bank, or eye bank in writing of any and all adverse reactions with regard to transmission of infections or other diseases. The providing organization shall notify the medical examiner if the adverse reaction involves donation from a medical examiner’s case. Every reasonable effort shall be made by each providing agency to inform each receiving agency or physician of this fact and to provide a mechanism for follow-up (e.g., pre-addressed follow-up cards, a toll free number, etc.) to report such instance.

(2) Notification of adverse reaction.

(a) In accordance with subsection 59A-1.005(14), F.A.C., each agency shall, upon notification of an adverse reaction by a transplanting physician or hospital:

Immediately notify the Agency for Health Care Administration, Division of Health Quality Assurance, by telephone of a potential adverse reaction;
Immediately suspend distribution of grafts coming from that donor;
Initiate an investigation to determine whether or not the adverse reaction was due to the donor organs and tissues; and
Submit to the Agency for Health Care Administration, Division of Health Quality Assurance, within two working days, Part I of the AHCA’s Organ and Tissue Adverse Reaction Reporting Form, AHCA Form 3140-2003-OCT 95. This entire form is incorporated herein by reference and available from the Agency for Health Care Administration, Division of Health Quality Assurance, Ft. Knox Office Building, 2727 Mahan Drive, Tallahassee, Florida 32308.

(3) Follow-up procedures.

(a) Where it is determined that the adverse reaction was due to the donor organs and tissues, each agency shall institute recall procedures in accordance with subsection 59A-1.005(15), F.A.C., and look back procedures in accordance subsection 59A-1.005(16) F.A.C.

(b) Once a final determination of the cause of an adverse reaction is made, each agency shall submit Part II of the AHCA’s Organ and Tissue Adverse Reaction Reporting Form, AHCA Form 3140-2003-OCT 95, to the Division of Health Quality Assurance.

History

Rulemaking Authority 765.541(2) FS. Law Implemented 765.541 FS. History–New 11-26-92, Amended 8-20-96.

Fla. Admin. Code R. 59A-1.012 Denial, Revocation, or Suspension of Certificate; Imposition of Administrative Fine; Grounds; Moratorium on Agency Activities

(1) Depending upon the seriousness of the violation, the AHCA shall deny, revoke, or suspend a certificate or impose an administrative fine not to exceed $500 per day per violation for any of the following actions:

(a) Making false statements on an application or on any document associated with certification;

(b) Advertising false services or credentials;

(d) Failing to comply with the provisions of Chapter 59A-1, F.A.C.;

(e) Failing to correct deficiencies within the time required by the AHCA;

(f) Failing to submit an annual income statement and annual data on organ and tissue procurement, revenues and expenses specified in subsection 59A-1.005(17), F.A.C.;

(g) Failing to inform the AHCA of an adverse reaction or failing to comply with all provisions of Rule 59A-1.011, F.A.C.;

(h) Violating or aiding and abetting in the violation of any other provision of these regulations or the rules promulgated thereunder; or

(j) Violating an agency moratorium as described in Rule 59A-1.012, F.A.C.

(2) In addition to the reasons in subsection (1), above, the AHCA shall deny certification to an applicant who owns or operates an agency which, during the 24 months prior to the application for certification, has had certification revoked pursuant to subsection (1), above, had a moratorium imposed on agency activities, had injunction proceedings initiated against it, or had a receiver appointed.

(3) In determining if an administrative penalty, including a fine and the amount of the fine, is to be imposed, and in determining the terms of the administrative action, the AHCA shall consider the following factors:

(a) The gravity of the violation, including the probability that death or serious physical harm will result or has resulted; the severity of the potential harm; and the extent to which the provisions of the applicable statutes, rules, or standards were violated;

(b) Actions taken by the owner or agency director to correct violations;

(d) The financial benefit to the facility of committing or continuing the violation.

(4) When administrative action is taken against an agency, the AHCA shall immediately serve the agency with written notice of the administrative action by personal service or registered or certified mail, return receipt requested. All administrative actions shall be in accordance with Chapter 120, F.S., and shall state the following:

(a) The reasons for the administrative action;

(b) The terms of the administrative action, including the daily amount of any administrative fine; and,

(5) Each agency receiving a written notice of administrative action has the right to appeal. Procedures for appeal and administrative hearing shall be in accordance with Chapter 120, F.S.

(6) If, as the result of a hearing, an administrative action taken by the AHCA is upheld, the administrative action shall be immediately imposed and, in the case of a fine, the violator shall pay the fine for each day beyond the date set by the AHCA for payment of the fine.

(7) Following denial or revocation of certification, an agency shall be permitted to reapply for certification in accordance with the provisions of Rule 59A-1.004, F.A.C.

(8) The AHCA shall impose a moratorium on all or selected agency activities which the AHCA determines to be a potential threat to the health, safety, or welfare of the public.

History

Rulemaking Authority 765.541(2), 765.544 FS. Law Implemented 75.541, 765.542, 765.544 FS. History–New 11-26-92, Amended 8-20-96.

Fla. Admin. Code R. 59A-1.013 Moratorium on Agency Activities

History

Rulemaking Authority 381.6024(2) FS. Law Implemented 381.6024 FS. History–New 11-26-92, Repealed 8-20-96.

Fla. Admin. Code R. 59A-1.014 Establishment of Trust Fund; Agency Assessments; Administrative Fines

(1) Annual agency fee assessments shall be determined in accordance with section 765.544(1), F.S., and shall be based on the annual report as described in subsections 59A-1.009(5), (6) or (7), F.A.C., received by the AHCA 30 days after the anniversary date of certification.

(2) The AHCA shall issue annual agency fee assessments to each agency within 60 days after the anniversary date of certification for each agency of each year. Each agency must pay its annual assessment by the close of business 90 days after the anniversary date of certification.

(3) Annual agency fee assessments and administrative fines, collected in accordance with subsection 59A-1.012(1), F.A.C., shall be deposited in the Florida Organ and Tissue Donor Education and Procurement Trust Fund.

History

Rulemaking Authority 765.541, 765.544 FS. Law Implemented 765.544 FS. History–New 11-26-92, Amended 8-20-96.

Chapter 59A-3 HOSPITAL LICENSURE

Fla. Admin. Code R. 59A-3.045 Scope

History

Rulemaking Authority 395.0205 FS. Law Implemented 395.0205 FS. History–New 5-28-85, Formerly 10D-28.45, 10D-28.045, Repealed 12-12-96.

Fla. Admin. Code R. 59A-3.046 Definitions

History

Rulemaking Authority 395.0205 FS. Law Implemented 395.002, 395.0205, 415.503, 415.5055 FS. History–New 5-28-85, Formerly 10D-28.46, 10D-28.046, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.0465 Child Abuse and Neglect

History

Rulemaking Authority 395.1055, 415.103 FS. Law Implemented 395.002, 395.1023, 395.1055, 415.103, 415.111, 415.503, 415.5055 FS. History–New 4-17-97, Transferred to 59A-3.280.

Fla. Admin. Code R. 59A-3.047 Reporting of Child Abuse

History

Rulemaking Authority 395.1055, 395.103 FS. Law Implemented 395.1023, 395.1055, 415.103 FS. History–New 5-28-85, Formerly 10D-28.47, 10D-28.047, Amended 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.048 Physician Liaison

History

Rulemaking Authority 395.1023, 395.1055 FS. Law Implemented 395.1023, 395.1055 FS. History–New 5-28-85, Formerly 10D-28.48, 10D-28.048, Amended 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.049 Child Abuse and Neglect Policy Reporting

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1023, 395.1055 FS. History–New 5-28-85, Formerly 10D-28.49, 10D-28.049, Amended 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.050 Remedies

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1023, 395.1055, 415.111 FS. History–New 5-28-85, Formerly 10D-28.50, 10D-28.050, Amended 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.065 Definitions

In addition to definitions contained in Chapters 395 and 408, Part II, F.S., the following definitions shall apply specifically to hospitals, as used in Rules 59A-3.065-.310, F.A.C.:

(1) “Advanced Practice Registered Nurse” or “APRN” means a person licensed in the State of Florida under the provisions of Chapter 464, F.S. to practice professional nursing and certified in advanced or specialized nursing practice.

(2) “Agency” means the Agency for Health Care Administration (AHCA).

(3) “Ambulatory care” means the delivery of care pertaining to non-emergency, adult, adolescent, and pediatric outpatient encounters, whether performed through the clinical departments of the hospital or an organized ambulatory program which is included as a component of the licensed hospital, regardless of the physical location of such services.

(4) “At or near the Time of Death” means that point in time in the care of the patient at which the procedures have begun for the determination and certification of brain death as defined under the provisions of Section 382.009, F.S., or cardiorespiratory (cardiac) death as defined under the provisions of Rule 59A-3.065, F.A.C.

(5) “Brain Death” means the determination of death under provisions of Section 382.009, F.S., where there is irreversible cessation of the functioning of the entire brain, including the brain stem.

(6) “Cardiorespiratory Death” means the cessation of life which is manifested by the loss or absence of spontaneous heart beat and breathing.

(7) “Child abuse or neglect” means harm, pursuant to Section 39.01(32), F.S., or threatened harm to a child’s physical or mental health or welfare by the acts or omissions of a parent, adult household member, or other person responsible for the child’s welfare, or, for purposes of reporting requirements, by any person.

(8) “Continuous” means available at all times without cessation, breaks or interruption.

(9) “Dentist” means a doctor of dentistry legally authorized to practice under Chapter 466, F.S.

(10) “Designee or Requester” means a person or organization identified, designated, and delegated by the hospital administrator to carry out the provisions of this chapter and the responsibilities mandated by Section 765.522, F.S., and to make the request to the patient or next of kin for the donation of organs, tissues and eyes.

(11) “Diagnostic imaging” means those ionizing and non-ionizing radiological procedures, including but not limited to x-rays, and computerized tomographic scanning, requiring the supervision and expertise of a physician with appropriate training or experience.

(12) “District Medical Examiner” means a physician who fills a position defined according to the provisions of Section 406.06, F.S.

(13) “Donation” means the free and voluntary gift of one or more organs, tissues or eyes for the purpose of medical research or transplant surgery.

(14) “Donor” means a person from whom organs, tissues or eyes have been surgically removed for the purpose of transplantation.

(15) “Emergency Medical Technician (EMT)” means any person who is certified as an EMT pursuant to Chapter 401, F.S.

(16) “Eye bank” means a public or private entity which is involved in the retrieval, processing or distribution of human eye tissue for transplantation and certified pursuant to Section 765.541, F.S. Funeral homes or direct disposers engaged solely in the retrieval of eye tissue are not considered an eye bank for these purposes.

(17) “Facilities” means those objects, including physical plant, equipment and supplies, necessary for providing required services.

(18) “General hospital” as defined in Section 395.002(10), F.S., means any facility which meets the provisions of subsection (29) and which regularly makes its facilities and services available to the general population.

(19) “Governing board” means the individual, agency, group or corporation appointed, elected, or otherwise designated, in which the ultimate responsibility and authority for the conduct of the hospital is vested.

(20) “Health professional” means a person specifically licensed to practice a health profession, or a person specifically trained to practice one or more aspects of a health profession by a school or program officially recognized by this State or accredited by a national accrediting organization.

(21) “Inpatient beds” means accommodations with supporting services for patients who are admitted by physician order with the expectation that the patient would stay in excess of 24 hours and occupy a bed.

(22) “Intensive residential treatment programs for children and adolescents” or “intensive residential treatment facilities” or “IRTF” means a specialty hospital restricted to providing intensive residential treatment programs for children and adolescents as defined in Section 395.002(16), F.S.

(23) “Licensed practical nurse” means one who is currently licensed in the state of Florida to practice practical nursing as defined in Chapter 464, F.S.

(24) “Long term care hospital” means a general hospital which:

(a) Meets the provisions of Section 395.002(12), F.S.;

(b) Has an average length of inpatient stay greater than 25 days for all hospital beds; and,

(25) “Medical Examiner’s Case” means any death occurring in the State and which is defined according to the provisions of Section 406.11, F.S.

(26) “Nursing services” means those services pertaining to the curative, restorative, and preventive aspects of nursing care that are performed or supervised by a registered professional nurse under the direction of a physician.

(27) “On duty” means personnel within the hospital, appropriately dressed, continuously alert and responsive to patient needs.

(28) “Operating room suite” means a room, or set of physically contiguous rooms located on the same floor, used primarily for the purpose of performing operations and other physically invasive procedures on patients, as well as rooms for surgical supply and disinfecting.

(29) “Organ” means a body part such as a heart, kidney, pancreas, liver, or lung that requires vascular reanastomosis.

(30) “Organ Procurement Organization” means a public or private entity designated as an OPO by the Secretary of the U.S. Department of Health and Human Services (HHS) which is engaged in the process of recovering organs for the purposes of transplantation and certified pursuant to Section 765.541, F.S.

(31) “Organized medical staff” means a formal organization of physicians and other health professionals approved by the governing board with the delegated responsibility to provide for the quality of all medical care, and other health care as appropriate, provided to patients, for planning for the improvement of that care, and for the ethical conduct and professional practices of its members. Nothing herein shall be construed to preclude a governing board from restricting membership on the organized medical staff to only those disciplines required to be included by Florida law.

(32) “Paramedic” means any person who is certified as a paramedic pursuant to Chapter 401, F.S.

(33) “Pharmacist” means one who is licensed under Chapter 465, F.S., and engages in the practice of the profession of pharmacy.

(34) “Physician” means a doctor of medicine or osteopathy legally authorized to practice under the provisions of Chapter 458 or 459, F.S.

(35) “Physician Assistant” or “PA” means a person who is licensed to perform medical services delegated by the supervising physician pursuant to Chapter 458 or 459, F.S.

(36) “Podiatrist” means a person legally authorized to practice podiatry under Chapter 461, F.S.

(37) “Potential Donor” means any person approaching death or who has died in a Florida hospital and is deemed medically acceptable according to the medical standards of the affiliated OPO, tissue bank or eye bank for organ, tissue, or eye donation.

(38) “Premises” means those buildings, beds, and facilities located at the main address of the licensee and all other buildings, beds, and facilities for the provision of hospital care located in such reasonable proximity to the main address of the licensee as to appear to the public to be under the dominion and control of the licensee.

(39) “Provisional accreditation” means a determination by a hospital accrediting organization that substantial standards compliance deficiencies exist in a hospital.

(40) “Provisional license” means a restricted license issued to a hospital which does not meet requirements for a standard license, but is in compliance with the pertinent statutes and rules.

(41) “Psychiatric hospital” means a Class III specialty hospital primarily restricted to treating persons whose sole diagnosis, or in the event of more than one diagnosis, the principal diagnosis, as defined in the Diagnostic and Statistical Manual of Mental Disorders is a psychiatric disorder, as defined in Rule 59C-1.040, F.A.C.

(42) “Qualified medical person” means for the purposes of Section 395.1041, F.S., the licensed individual responsible for the operation of the emergency services area during the time of a transfer.

(43) “Quality improvement program” means a program of ongoing activities designed to objectively and systematically evaluate the quality of patient care and services, pursue opportunities to improve patient care and services, and resolve identified problems which applies standards of patient care to evaluate the quality of the hospital’s performance.

(44) “Registered dietitian” means one who meets the standards and qualifications established by the Commission on Dietetic Registration of the Academy of Nutrition and Dietetics and is currently registered with the Academy of Nutrition and Dietetics.

(45) “Registered professional nurse” means one who is currently licensed in the State of Florida to practice professional nursing as defined in Chapter 464, F.S.

(46) “Rehabilitation hospital” means a Class III specialty hospital in which an organized program of integrated intensive care services is provided by a coordinated multidisciplinary team to patients with severe physical disabilities, as defined under paragraph 59C-1.039(2)(c), F.A.C.

(47) “Routine Inquiry Form” means a reporting document developed by the hospital that is used to indicate that a request for donation of organs, tissues, or eyes was made.

(48) “Rural hospital” means a general hospital which meets the definition of Section 395.602(2)(e), F.S.

(49) “Selected Infectious Diseases” means Acquired Immunodeficiency Syndrome; anthrax; syphilis in an infectious stage; diphtheria; disseminated vaccinia; Hansen’s disease; hepatitis A; hepatitis B; hepatitis non-A, non-B; Legionnaire’s disease; malaria; measles; meningococcal meningitis; plague; poliomyelitis; psittacosis; pulmonary tuberculosis; Q fever; rabies; rubella; typhoid fever.

(50) “Special care unit” means a unit designated to provide acute care services, with a concentration of qualified professional staffing and supportive resources, to patients requiring extraordinary care on a concentrated and continuous 24-hour basis. Special care units include, but are not limited to burn, cardiac, cardiovascular surgery, neonatal, respiratory, renal care provided in the hospital, but not including ambulatory units, spinal injury units, trauma and multipurpose special care units, operating room suite, including medical-surgical intensive care or any combination of the above.

(51) “Substance abuse hospital” means a Class III specialty hospital primarily restricted to treating persons whose sole diagnosis, or in the event of more than one diagnosis, the principal diagnosis, as defined in the Diagnostic and Statistical Manual of Mental Disorders is a substance abuse disorder defined under paragraph 59C-1.041(2)(u), F.A.C.

(52) “Tissue” means any non-visceral or non-vascularized collection of similar cells and their associated intercellular substances. There are four generally accepted basic body tissues:

(a) Epithelium (including corneal tissue);

(b) Connective tissues including blood, bone and cartilage;

(d) Nerve tissue.

(53) “Tissue Bank” means a public or private entity certified pursuant to Section 765.541, F.S., which is involved in at least one of the following activities:

(a) Procuring, processing, storing or distributing viable or nonviable human tissues to clinicians who are not involved in the procurement process;

(b) Procuring, processing, and storing human tissues in one institution and making these tissues available to clinicians in other institutions; or

(c) Procuring, processing, and storing human tissues for individual depositors and releasing these tissues to clinicians at the depositor’s request.

(54) “Transplantation” means the surgical grafting or implanting in its entirety or in part one or more tissues or organs taken from another person.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1023, 395.1055 FS. History–New 9-4-95, Formerly 59A-3.201, Amended 10-16-14.

Fla. Admin. Code R. 59A-3.066 Licensure Procedure

(1) No person or entity shall establish, conduct, or maintain a hospital in this state without first obtaining a license.

(2) All applicants or licensees requesting licensure for the operation of a hospital under the provisions of Chapter 395, F.S., must make application to the Agency as required by Rule 59A-35.040 and 59A-35.060, F.A.C.

(a) The following documents must be available for review by the Agency at the licensure inspection:

Governing authority bylaws, rules and regulations, or other written organization plan;
Organized professional staff bylaws, rules and regulations;
The hospital’s fire and Comprehensive Emergency Management Plans;
Roster of organized medical staff members;
Nursing procedure manual;
Roster of registered nurses, licensed practical nurses, emergency medical technicians and paramedics with current registration number; and
A copy of the child abuse and neglect policy as specified in Rule 59A-3.280, F.A.C.

(b) An application for initial licensure will not be accepted unless plans and specifications as required by Section 395.0163, F.S., have been received by the Agency’s Office of Plans and Construction.

(c) An application for a change of ownership will not be approved until the Agency receives written confirmation signed by the buyer and the seller that the ownership transfer is complete and specifying the effective date.

(d) An application for change during licensure period is required to amend the classification, addresses, emergency services, licensed programs, bed capacity and type, administrative personnel, board members, and less than 51% change of controlling interests.

(e) All permanent changes to the street address, hospital-based off-campus emergency departments and outpatient surgical center addresses, and the constructed bed capacity or bed type must be:

Approved by the Agency’s Office of Plans and Construction, pursuant to Section 395.0163, F.S., and Rule 59A-3.080, F.A.C.;
In compliance with life safety codes pursuant to Sections 408.811 and 395.0161, F.S., except the life safety code inspection for a change in bed type in which life safety requirements are identical may be postponed until the next scheduled inspection; and,
Amended on the license prior to occupancy.

(f) Evidence of medical malpractice insurance as provided for under Section 395.1061, F.S., must be submitted annually to the Agency.

(g) Upon receipt of a completed initial application the Agency will conduct an inspection of the facility to determine compliance with Chapter 395, Part I, F.S., and Rules 69A-3.012 and 59A-3.065-.310, F.A.C.

(h) When the applicant and hospital are in compliance with Chapter 395, Part I, F.S., and Rules 69A-3.012 and 59A-3.065 through 59A-3.310, F.A.C., and have received all approvals required by law, the Agency will issue a license.

(i) A single license number will be issued to a licensee for facilities located on separate premises, upon request of the applicant in accordance with Section 395.003(2), F.S. Each license certificate issued under a single license number will include the information listed in subsection (3) and shall have a common mailing address. There shall be one chief executive officer and one medical staff for the facilities issued a single license number.

(3) Each license will specifically state the name of the licensed operator of the hospital, the class of hospital, the emergency services, if applicable, licensed programs, bed capacity, and the name and location of the hospital.

(4) No licensed facility shall continuously operate a number of hospital beds greater than the number indicated by the Agency on the face of the license.

(5) Hospitals shall not lease a portion of their licensed beds to another entity or facility, except for hospices licensed pursuant to Chapter 400, Part IV, F.S.

(6) The collocation of any residential program on the premises of a licensed hospital requires prior approval from the agency, based on the following criteria:

(a) Health, safety, and welfare cannot be jeopardized for any individual;

(b) The essential needs of patients must be met; and,

(7) All hospitals must make available on their Internet websites a description of and link to the Agency’s webpage which contains the hospital patient charge and performance outcome data that is collected pursuant to Section 408.061(1), F.S. and, if requested, hospitals must provide a hard copy of the description and the link.

(8) Each hospital must designate a mailing address and a street address. All additional addresses under the administrative control of the hospital and operated as a department of the hospital must be identified as hospital-based off-campus emergency departments, outpatient surgery centers, urgent care centers, or off-site outpatient locations.

(9) Each hospital must be designated by a distinctive name, and the name may not be changed without first notifying the Agency’s licensing unit and receiving approval in writing. Duplication of an existing hospital name is prohibited in new hospitals. Fictitious names must be registered with the Florida Department of State Division of Corporations, as required by the Department of State.

(10) A hospital may be designated as a statutory teaching hospital, behavioral health teaching hospital, or family practice teaching hospital upon documentation of the qualifications to the satisfaction of the Agency.

(a) Statutory Teaching Hospital (STH). A hospital meeting the definition of teaching hospital per s. 408.07, F.S. may petition the Secretary of the Agency for STH designation. The petition must contain evidence of:

A contract or other document confirming an affiliation with an accredited Florida medical school;
At least seven accredited graduate medical education programs verifying the number of approved resident slots, number of currently filled resident slots, training locations, and length of training at each location for the program year(s) for each program; and
Presence of 100 or more full-time equivalent (FTE) residents verifying the name and license number of each resident by program, program year, and allocated FTE value.

(b) Behavioral Health Teaching Hospital (BHTH). To be designated as BHTH, a hospital currently designated as STH must submit a change during licensure period application with documentaion verifying that the requirements of (b) through (e) of Section 395.902(2), F.S. are met.

(c) Family Practice Teaching Hospital (FPTH). To be designated as FPTH, a hospital must submit a change during licensure period application with documentaion of all graduate medical education programs offered at the hospital, verifying the number of approved resident slots and number of filled resident slots for each program. To maintain the designation, the hospital must document meeting the requirements of Section 395.806(1)(c) and (2), F.S

(11) A hospital meeting the qualifications per Section 395.607, F.S. may apply to convert its current classification to Class V rural emergency hospital by submitting a change during licensure period application. The application will not be approved unless the hospital:

(a) Removes inpatient beds from its licensed bed inventory, except for skilled nursing beds;

(b) Has a current transfer agreement with a Level I or Level II trauma center;

(c) Submits a plan outlining the hospital’s actions for conversion to and operation as a rural emergency hospital, including;

A transition plan identifying the hospital services retained, modified, added, and discontinued;
A service plan identifying staffing provisions and number and type of qualified staff to provide emergency services, observation care, outpatient services, and other medical and health services provided by the hospital;
A financial plan detailing how the hospital intends to use the additional Medicare facility payment to support such services as operation and maintenance of the facility and the provision of outpatient and support services; and

(d) Submits an attestation of compliance for rural emergency hospital enrollment and conversion, stating the hospital is currently enrolled in the Medicare program as a rural hospital with not more than 50 beds, or a critical access hospital, and is in compliance with the Conditions of Participatieon in 42 C.F.R., Part 485, Subpart E.

(12) Effective July 1, 2025, each hospital offering emergency services and care shall submit a nonemergent care access plan (NCAP) as part of the hospital’s initial, renewal, or change of ownership application.

(a) The NCAP must meet the criteria specified in Section 395.1055(1)(j), F.S.

(b) For each subsequent renewal, the hospital shall provide its NCAP, updated as needed, with a narrative demonstrating the implentation and results of the plan. The narrative must:

Include the number of patients presenting to the emergency department indicating a lack of regular access to primary care;
Must reflect activities during at least 18 months of the current license biennium.

History

Rulemaking Authority 395.003, 395.004, 395.1055, 395.902, 408.033, 408.819 FS. Law Implemented 395.003, 395.004, 395.0161, 395.1055, 395.607, 395.806, 395.902, 408.033, 408.805, 408.806, 408.809, 408.811 FS. History–New 9-4-95, Amended 6-18-96, Formerly 59A-3.203, Amended 10-16-14, 1-16-23, 6-1-25.

Fla. Admin. Code R. 59A-3.077 Fire Protection

(1) Each hospital shall provide fire protection through the elimination of fire hazards. All portions of the existing facility shall comply with the requirements of the Existing Health Care Occupancies chapter of the NFPA 101 Life Safety Code. The edition shall be as described in the fire codes in Rule 69A-3.012, F.A.C.; as adopted by the State Fire Marshal.

(2) All fires or explosions shall be reported to the Agency’s Office of Plans and Construction by telephone at (850)412-4477 or by fax at (850)922-6483 by the next working day after the occurrence. The facility shall complete and submit a Fire Incident Report, AHCA form 3500-0031, July 2014, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06023, to the Office of Plans and Construction and a copy to the appropriate Agency Field Office within 15 calendar days of the incident. All reports shall be complete and thorough and shall record the cause of the fire or explosion, the date and time of day it occurred, the location within the facility, how it was extinguished, any injuries which may have occurred and a description of the local fire department participation. The Fire Incident Report is available from the Agency for Health Care Administration, Office of Plans and Construction, 2727 Mahan Drive, Mail Stop 24, Tallahassee, Florida 32308 or at the web address: http://ahca.myflorida.com/plansandconstruction.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 1-1-77, Formerly 10D-28.77, 10D-28.077, Amended 1-16-87, 9-3-92, 5-12-16.

Fla. Admin. Code R. 59A-3.078 Comprehensive Emergency Management Plan

(1) Each hospital shall develop and adopt a written comprehensive emergency management plan for emergency care during an internal or external disaster or an emergency, which is reviewed and updated annually.

(2) The emergency management plan shall be developed in conjunction with other agencies and providers of health care services within the local community pursuant to Section 395.1055(1)(c), F.S., and in accordance with the “Emergency Management Planning Criteria for Hospitals,” AHCA Form 3130-8005-September 94, which is incorporated by reference. The form is available from the Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop #31, Tallahassee, Florida 32308. The plan shall include:

(a) Provisions for internal and external disasters and emergencies;

(b) A description of the hospital’s role in community wide emergency management plans;

(c) Information about how the hospital plans to implement specific procedures outlined in the hospital’s emergency management plan;

(d) Precautionary measures, including voluntary cessation of hospital admissions, to be taken by the hospital in preparation and response to warnings of inclement weather, or other potential emergency conditions;

(e) Provisions for the management of patients, including the discharge of all patients that meet discharge requirements, in the event of an evacuation order, at the direction of the hospital administrator, or when a determination is made by the Agency that the condition of the facility or its support services is sufficient to render it a hazard to the health and safety of patients and staff, pursuant to Chapter 59A-3, F.A.C. Such provisions shall address moving patients within the hospital and relocating patients outside the hospital, including the roles and responsibilities of the physician and the hospital in the decision to move or relocate patients whose life or health is threatened;

(f) Education and training of personnel in carrying out their responsibilities in accordance with the adopted plan;

(g) A provision for coordinating with other hospitals that would receive relocated patients;

(h) Provisions for the management of staff, including the distribution and assignment of responsibilities and functions, and the assignment of staff to accompany those patients located at off-site locations;

(i) Provisions for the individual identification of patients, including the transfer of patient records;

(j) Provisions to ensure that a verification check will be made to ensure relocated patients arrive at designated hospitals;

(k) Provisions to ensure that medication needs will be reviewed and advance medication for relocated patients will be forwarded to respective hospitals, when permitted by existing supplies, and state and federal law;

(l) Provisions for essential care and services for patients who may be relocated to the facility during a disaster or an emergency, including staffing, supplies and identification of patients;

(m) Provisions for contacting relatives and necessary persons advising them of patient location changes. A procedure must also be established for responding to inquiries from patient families and the press;

(n) Provisions for the management of supplies, communications, power, emergency equipment, security, and the transfer of records;

(o) Provisions for coordination with designated agencies including the Red Cross and the county emergency management office; and,

(p) Plans for the recovery phase of the operation, to be carried out as soon as possible.

(3) The plan, including the “Emergency Management Planning Criteria for Hospitals,” shall be submitted annually to the county emergency management agency for review and approval. A fee may be charged for the review of the plan as authorized by Sections 252.35(2)(m) and 252.38(1)(e), F.S.

(a) The county office of emergency management has 60 days in which to review and approve the plan, or advise the facility of necessary revisions. If the county emergency management agency advises the facility of necessary revisions to the plan, those revisions shall be made and the plan resubmitted to the county office of emergency management within 30 days of notification by the county emergency management agency.

(b) The county office of emergency management shall be the final administrative authority for emergency plans developed by hospitals.

(4) The hospital shall test the implementation of the emergency management plan semiannually, either in response to a disaster or an emergency or in a planned drill, and shall evaluate and document the hospital’s performance to the hospital’s safety committee. As an alternative, the hospital may test its plan with the frequency specified by an accrediting organization.

(5) The emergency management plan shall be located for immediate access by hospital staff.

(6) In the event a disaster or emergency conditions have been declared by the local emergency management authority, and the hospital does not evacuate the premises, a facility may provide emergency accommodations above the licensed capacity for patients. However, the following conditions must be met:

(a) The facility must report being over capacity and the conditions causing it to the Agency area office within 48 hours or as soon as practical. As an alternative, the facility may report to the Agency central office, Hospital and Outpatient Services Unit, at (850)412-4549;

(b) Life safety cannot be jeopardized for any individual;

(d) The facility must be staffed to meet the essential needs of patients.

(7) If the hospital will be over capacity after the declared disaster or emergency situation ends, the agency shall approve the over capacity situation on a case-by-case basis using the following criteria:

(a) Life safety cannot be jeopardized for any individual;

(b) The essential needs of patients must be met; and,

(8) If a facility evacuates during or after a disaster or an emergency situation, the facility shall not be reoccupied until a determination is made by the hospital administrator that the facility can meet the needs of the patients.

(9) A facility with significant structural damage shall relocate patients until approval is received from the Agency’s Office of Plans and Construction that the facility can be safely reoccupied, in accordance with Rule 59A-3.080, F.A.C.

(10) A facility that must evacuate the premises due to a disaster or emergency conditions shall report the evacuation to the Agency area office within 48 hours or as soon as practical. The administrator or designee is responsible for knowing the location of all patients until the patient has been discharged from the facility. The names and location of patients relocated shall be provided to the local emergency management authority or it’s designee having responsibility for tracking the population at large. The licensee shall inform the Agency area office of a contact person who will be available 24 hours a day, seven days a week, until the facility is reoccupied.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055(1)(c) FS. History–New 1-1-77, Formerly 10D-28.78, 10D-28.078, Amended 9-3-92, 12-28-94, 10-16-14.

Fla. Admin. Code R. 59A-3.079 Physical Plant Codes and Standards Hospitals

(1) The Agency provides technical assistance to the Florida Building Commission and the State Fire Marshal in developing and maintaining standards for the design and construction of hospitals. These standards are included in the following:

(a) The building codes in Rule 61G20-1.001, F.A.C.; as adopted by the Florida Building Commission.

(b) The fire codes in Rule 69A-3.012, F.A.C.; as adopted by the State Fire Marshal.

(c) The handicap accessibility standards in Chapter 553, Part V, F.S., and Rule 61G20-4.002, F.A.C; as adopted by the Florida Building Commission.

(2) No building shall be converted to a licensed hospital unless it complies with the standards and codes in effect when the building is converted.

(3) Where modernization or replacement construction is done within an existing facility, all new work and additions shall comply with applicable sections of the codes for new facilities.

(4) In renovation projects and those projects that are making additions to existing facilities, only that portion of the total facility affected by the project requires compliance with applicable sections of the codes for new construction identified in subsection (1) of this rule.

(5) Existing portions of the facility that are not included in the additions, modifications, alterations, refurbishing, renovations or reconstruction, shall be in compliance with the requirements of Chapter 19, Existing Health Care Occupancy, of the National Fire Protection Association (NFPA) Life Safety Code 101, as adopted by the State Fire Marshall and described in Rule 69A-3.012, F.A.C.

(6) When a building is converted from another type of occupancy to a hospital, it shall be in compliance with the requirements for an Institutional Group I-2 Occupancy and the hospital occupancy chapter, of the Florida Building Code (FBC) as adopted by the Florida Building Commission and the National Fire Protection Association (NFPA) Life Safety Code 101, Chapter 18, New Health Care Occupancy, as adopted by the State Fire Marshal and described in Rule 69A-3.012, F.A.C. A change of ownership shall not constitute a change of occupancy.

(7) Nothing in these standards shall be construed as restrictive to a facility that chooses to do work or alterations as part of a long-range, phased safety improvement plan. All hazards to life and safety and all areas of noncompliance with applicable codes and regulations are to be corrected in accordance with a plan of correction approved in advance by the Office of Plans and Construction.

(8) An ambulatory surgical center or a birth center shall not be constructed, located or operated within the same physical plant of, nor shall it be physically attached with any interior openings to a hospital facility. Other facilities not owned or operated by the licensee of a hospital may be fully integrated with the hospital’s physical plant only when it has been successfully demonstrated to the agency that the following conditions have been met:

(a) The Agency is granted the authority to enter and inspect any part of the physical plant of the facility to determine full compliance with all applicable federal and state codes and standards.

(b) All areas of the physical plant of the facility are maintained in a manner that will ensure continued licensure compliance of the hospital.

(c) The Agency is granted the authority to review for approval all contemplated additions, conversions, renovations or alterations to the physical plant of the facility before such additions, conversions, renovations or alterations are commenced.

(d) The unlicensed or separately licensed facility shall provide and maintain clear, visible and readable signs denoting its separateness from the licensed hospital.

(9) In addition to meeting the standards contained in subsection 59A-3.079(9), F.A.C., a separately licensed hospital facility to be located within the physical plant or on the premises of another facility must also meet the following:

(a) Have a separate pharmacy and basic radiographic equipment located within the boundaries of the physical plant of the newly licensed hospital;

(b) Be in compliance with all codes and standards as required for a new hospital facility as described in subsection 59A-3.079(6), F.A.C. above; or

(c) Be in compliance with all codes and standards as required for an existing hospital as described in subsection 59A-3.079(5), F.A.C. above, if the new facility is to be located in a currently licensed Class I hospital utilizing currently licensed hospital beds and spaces or utilizing previously licensed hospital beds and spaces that have not been altered in a manner that reduced code compliance.

(10) In addition to the codes and standards of this section, a new physically detached emergency department of a hospital facility must be in compliance with the requirements of the hospital occupany chapter and with the requirements for an Institutional Group I-2 Occupancy, of the Florida Building Code (FBC), as adopted by the Florida Building Commission and described in Rule 61G20-1.001, F.A.C., and with the National Fire Protection Association (NFPA) Life Safety Code 101, Chapter 18, New Health Care Occupancy, as adopted by the State Fire Marshal and described in Rule 69A-3.012, F.A.C.

(11) Projects that have not received a Stage II Preliminary Plan approval or Stage III Construction Document approval from the Office of Plans and Construction on the effective date of this rule shall conform to the requirements as set forth in these rules.

History

Rulemaking Authority 395.0163 FS. Law Implemented 395.0163 FS. History–New 1-1-77, Formerly 10D-28.79, Amended 1-16-87, 11-23-88, Formerly 10D-28.079, Amended 9-3-92, 5-12-16.

Fla. Admin. Code R. 59A-3.080 Plans Submission and Fee Requirements

(1) No construction work, including demolition, shall be started until prior written approval has been given by the Agency’s Office of Plans and Construction. This includes all construction of new facilities and any and all additions, modifications, renovations, or refurbishment of the site, building, equipment or systems of all existing facilities. Approval to start construction will be granted by the Agency when the design complies with all applicable codes and standards, as evidenced by a thorough examination of the documents submitted to the Agency, as required for Stage III construction documents.

(2) Approval to start construction limited to demolition, site work, foundation, and building structural frame may be obtained prior to the approval of Stage III construction documents when the following is submitted for review and approval:

(a) A Preliminary Stage II approval letter from the Office of Plans and Construction granted by the Agency when the design complies with applicable life safety code requirements, flood requirements and the layout will accommodate all required functional spaces as evidenced by a thorough examination of the documents submitted to the Agency as required in this rule for Stage II preliminary plans.

(b) Construction documents, specifications and construction details for all work to be undertaken.

(c) A letter from the facility holding the Agency harmless for any changes that may occur to the project as a result of the final construction document review.

(d) An infection control risk assessment (ICRA) and a life safety plan indicating temporary egress and detailed phasing plans indicating how the area(s) to be demolished or constructed are to be separated from all occupied areas shall be submitted for review and approval when demolition or construction in and around occupied buildings is to be undertaken. Submissions that fail to provide an ICRA or depict the safety measures prescribed by the ICRA will not be approved.

(3) Projects which have not received approval to begin construction will be considered abandoned following 12 months of inactivity and the project will be terminated. Construction must commence within 12 months of receiving approval from the Agency’s Office of Plans and Construction to begin construction. Once construction begins construction activities should be continuous until the completion of the project. Failure to commence construction within 12 months of plan approval or periods of construction inactivity exceeding 12 months following commencement of construction will result in termination of the project. Restarting a terminated project will require resubmission of the construction documents accompanied by a new plan review application and will be subject to all fees prescribed by Section 395.0163, F.S. Projects requiring a Certificate of Need (CON) must also comply with the conditions of the CON relating to the commencement, completion and continuity of construction.

(4) When construction is planned, either for new buildings or additions, alterations or renovations to existing buildings, the plans and specifications shall be prepared and submitted to the Office of Plans and Construction for approval by the appropriate Florida-registered design professionals as required by the Florida Building Code, Chapter 471, F.S., and Chapter 481, F.S. All architecture or engineering firms not practicing as a sole proprietor shall also be registered as an architecture or engineering firm with the Florida Department of Business and Professional Regulation or Board of Professional Engineers, as applicable.

(5) The initial submission of plans to the Agency’s Office of Plans and Construction for any new project shall include a completed Application for Plan Review, AHCA Form 3500-0011, June 2014, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-05456, and a valid Certificate of Need if required by the Agency. This information shall accompany the initial submission, and approval will not be granted for any project without a certificate of need if required by the Agency. Applications for Plan Review are available from the Agency for Health Care Administration, Office of Plans and Construction, 2727 Mahan Drive, Mail Stop #24, Tallahassee, Florida 32308, or at the web address at: http://ahca.myflorida.com/MCHQ/HQALicensureForms/index.shtml.

(6) Projects submitted for review shall be subject to the fees authorized by Section 395.0163, F.S. All fees shall be payable to the Agency for Health Care Administration and shall annotate the Office of Plans and Construction and the facility log number. The initial review fee is due with the first submission of plans. Fees are not refundable. The Agency will conduct onsite construction inspections as needed to verify compliance with applicable codes and standards.

(7) Plans and specifications may be submitted for review at any of the three stages of development described in this rule. Only the submission of Stage III documents is mandatory.

(a) Stage I, schematic plans.

(b) Stage II, preliminary plans or design development drawings.

(8) For each stage of submission, a program or scope of work shall be submitted. It shall consist of a detailed written description of all contemplated work and any required phasing and shall identify the types of medical services to be provided.

(9) For projects involving only equipment changes or system renovations, only Stage III, construction documents may be submitted. These documents shall include the following:

(a) Life safety plans showing the fire/smoke compartments in the area of renovation.

(b) Detailed phasing plans indicating how the new work will be separated from all occupied areas.

(10) Stage I, Schematic Plans.

(a) The following shall be incorporated into the schematic plans:

Single-line drawings of each floor that indicates the relationship of the various activities or services to each other and the room arrangement in each.
The function of each room or space shall be noted in or near the room or space.
The proposed roads and walkways, service and entrance courts, parking, and orientation shown on either a small plot plan or on the first floor plan.
A simple cross-section diagram showing the anticipated construction.
A schematic life safety plan showing smoke and fire compartments, exits, exit passageways and gross areas of required smoke and fire compartments.
Indication of which areas are sprinklered, both new and existing.

(b) If the proposed construction is an addition or is otherwise related to existing buildings on the site, the schematic plans shall show the facilities and general arrangement of those buildings.

(c) If the project involves increasing, decreasing, relocating or transferring licensed beds, a schedule showing the total number of beds, types of bedrooms and types of ancillary spaces must be provided.

(11) Stage II, Preliminary Plans. The following shall be incorporated into the preliminary plans.

(a) A Vicinity Map. For new facility construction, provide a vicinity map showing the major local highway intersections.

(b) Site Development Plans.

(d) Building location dimensions.

(e) Evidence of compliance with the hospital disaster preparedness site standards of the Florida Building Code, must be provided for projects that involve a new facility, an addition to an existing facility, or substantial improvements to an existing facility.

(f) Location of the fire protection services water source to the building.

(g) Architectural Plans.

Floor plans, 1/8-inch scale minimum, showing door swings, windows, case work and mill work, fixed equipment and plumbing fixtures. Indicate the function of each space.
A large-scale plan of typical new bedrooms with a tabulation of gross and net square footage of each bedroom. Tabulate the size of the bedroom window glass.
Typical large-scale interior and exterior wall sections to include typical rated fire and fire/smoke barriers and a typical corridor partition.
All exterior building elevations.

(h) Equipment which is not included in the construction contract that requires mechanical or electrical service connections or construction modifications shall be identified to assure coordination with the architectural, mechanical and electrical phases of construction.

(i) If the project is located in an occupied facility, preliminary phasing plans indicating how the project is to be separated from all occupied areas.

(j) Life Safety Plans.

Life safety plans must include the following:

a. Single-sheet floor plans depicting required fire and smoke compartmentation, all means of egress and all exit signs. If smoke compartmentation is required, depict and provide the dimension for the longest path of travel in each smoke compartment to the door(s) accessing the nearest adjoining smoke compartment, calculate the total area of the smoke compartment in square feet, and tabulate exit inches.

b. All sprinklered areas.

c. All fire extinguishers.

d. All fire alarm devices and pull station locations.

If the project is an addition, or conversion of an existing building, fully developed life safety plans must be submitted.
If the project is a renovation in an existing building, life safety plans of the floor being renovated and the required exit egress floor(s) must be submitted.
When demolition or construction in and around occupied buildings will be undertaken, a life safety plan indicating temporary egress, and detailed phasing plans indicating how the area(s) to be demolished or constructed will be separated from all occupied areas must be submitted.

(k) Mechanical Engineering Plans.

Single-sheet floor plans with a one-line diagram of the ventilating system with relative pressures of each space. Provide a written description and drawings of the anticipated smoke control system, passive or active, and a sequence of operation correlated with the life safety plans.
The general location of all fire and smoke dampers, all duct smoke detectors and fire stats.
If the building is equipped with fire sprinklers, indicate the location of the sprinkler system risers and the point of connection for the fire sprinkler system. State the method of design for the existing and new fire sprinkler systems.
The locations of all plumbing fixtures and other items of equipment requiring plumbing services and/or gas services.
The locations of any fume, radiological or chemical hoods.
The locations of all medical gas outlets, piping distribution risers, terminals, alarm panel(s), low pressure emergency oxygen connection, isolation/zone valve(s), and gas source location(s).
The locations and relative size of major items of mechanical equipment such as chillers, air handling units, fire pumps, medical gas storage, boilers, vacuum pumps, air compressors and fuel storage vessels.
The locations of hazardous areas and the volume of products to be contained therein.
The location of fire pump, stand pipes, and sprinkler riser(s).

(l) Electrical Engineering Drawings.

A one-line diagram of normal and essential electrical power systems showing service transformers and entrances, switchboards, transfer switches, distribution feeders and over-current devices, panel boards and step-down transformers. The diagram shall include a preliminary listing and description of new and existing, normal and emergency loads, preliminary estimates of available short-circuit current and all new equipment and existing equipment serving any new equipment, short-circuit and withstand ratings of existing equipment serving new loads and any new or revised grounding requirements.
Show fire alarm zones and correlate with the life safety plan.

(m) Outline Specifications. Outline specifications must include a general description of the construction, including construction classification and ratings of components, interior finishes, general types and locations of acoustical material, floor coverings, ventilating equipment, plumbing fixtures, fire protection equipment, medical gas equipment and electrical equipment.

(n) Whenever an existing building is to be converted to a health care facility, the general layout of spaces of the existing structure shall be submitted with the preliminary plans for the proposed facility.

(o) Whenever an addition, alteration, renovation or remodeling to an existing facility is proposed, the general layout of spaces of the existing facility shall be submitted with the preliminary plans.

(12) Stage III, Construction Documents.

The Stage III, construction documents shall be an extension of the Stage II, preliminary plan submission and shall provide a complete description of the contemplated construction. Construction documents shall be signed, sealed, dated, and submitted for written approval to the Office of Plans and Construction by a Florida-registered architect and/or Florida-registered professional engineer. These documents shall consist of work related to civil, structural, mechanical, and electrical engineering, fire protection, lightning protection, landscape architecture and all architectural work. In addition to the requirements for Stage II submission, the following shall be incorporated into the construction documents:

(a) Site and civil engineering plans indicating building and site elevations, site utilities, paving plans, grading and drainage plans and details, locations of the two fire hydrants utilized to perform the water supply flow test, and landscaping plans.

(b) Life safety plans for the entire project. Projects located on floors above or below the exit discharge level must also include life safety plans for the exit discharge serving the project area.

Typical large-scale details of all typical interior and exterior walls and smoke walls, horizontal exits and exit passageways.
Comprehensive ceiling plans that show all utilities, lighting fixtures, smoke detectors, ventilation devices, sprinkler head locations and fire-rated ceiling suspension member locations where applicable.
Floor/ceiling and roof/ceiling assembly descriptions for all conditions.
Details and other instructions to the contractor on the construction documents describing the techniques to be used to seal floor construction penetrations necessary to prevent smoke migration from floor to floor during a fire.

(d) Structural engineering plans, schedules and details.

(e) Mechanical engineering plans including fire and smoke control plans. Show all items of owner furnished equipment requiring mechanical services. Provide a clear and concise narrative control sequence of operations for each item of mechanical equipment including, but not limited to, air conditioning, heating, ventilation, medical gas, plumbing, fire protection and any interconnection of the equipment of the systems. Mechanical engineering drawings shall depict completely the systems to be utilized, whether new or existing, from the point of system origination to termination. Provide a tabular schedule giving the required air flow (as computed from the information contained on the ventilation rate table) in cubic feet per minute (cfm) for supply, return, exhaust, outdoor, and ventilation air for each space, as applicable, shown on the architectural documents. The schedule shall also contain the HVAC system design air flow rates and the resulting space relative pressures. The schedule or portion of the schedule as applicable shall be placed on each floor plan drawing sheet containing the spaces depicted on the drawing.

(f) Fire protection system layout documents as defined by the Department of Business and Professional Regulation in Rule 61G15-32.002, F.A.C., where applicable, that shall include the existing system as necessary to define the new work. These documents shall be signed and sealed by a Florida-registered professional engineer.

(g) Electrical engineering plans describing complete power, lighting, alarm, communications and lightning protection systems and power system study.

(h) A power study that shall include a fault study complete with calculations to demonstrate that over-current devices, transfer switches, switchboards, panel boards, motor controls, transformers and feeders are adequately sized to safely withstand available phase-to-phase and phase-to-ground faults. The study shall also include an analysis of generator performance under fault conditions and a coordination study resulting in the tabulation of settings for all over-current device adjustable trips, time delays, relays and ground fault coordination. This must be provided for all new equipment and existing equipment serving any new equipment. Power studies for renovations of existing distribution systems shall include only new equipment and existing equipment upstream to the normal and emergency sources of the new equipment. Renovations involving only branch circuit panel boards without modifications to the feeder do not require a full power study; instead, the power study shall be limited to the calculation of new and existing loads of the branch circuit panel.

(13) A complete set of specifications for all work to be undertaken.

(a) All project required contractor supplied testing and/or certification reports shall be submitted in writing reviewed and accepted by the Engineer of Record prior to presenting to the agency for review.

(b) The specifications shall require a performance verification test and balance air quantity values report with the specified air filters installed for each air handling unit system operating in the minimum pressure drop condition (clean filter state) and at the maximum pressure drop condition (dirty filter state).

(14) All construction documents shall be coordinated to provide consistency of design intent throughout the documents and phasing plans shall be clear and provide continuity of required services. It is specifically required that in the case of additions to existing institutions, the mechanical and electrical, especially existing essential electrical systems and all other pertinent conditions shall be a part of this submission.

(a) All subsequent addenda, change orders, field orders and other documents altering the above shall also be signed, sealed, dated, and submitted in advance to the Agency’s Office of Plans and Construction for review. The Agency will either approve or disapprove the submission based on compliance with all applicable codes and standards and shall provide a listing of deficiencies in writing.

(b) All submissions will be acted upon by the Agency within 60 days of the receipt of properly executed construction documents and the initial payment of the plan review fee. The Agency will either approve or disapprove the submission and shall provide a listing of deficiencies in writing. All deficiencies noted by the Agency must be satisfactorily corrected before final approval will be provided from the Agency.

(15) Additions or revisions that increase the scope of the project work greater than fifty percent or change the original scope of the project more than fifty percent will be required to be submitted as a new project.

(16) Record Drawings. Within 60 days after final approval of the project has been obtained from the Agency, the Office of Plans and Construction shall be provided with a complete set of legible record drawings showing all of the construction, fixed equipment and the mechanical and electrical systems as installed. These drawings shall include the life safety plans. Record drawings may be submitted electronically in Portable Document Format (PDF).

History

Rulemaking Authority 395.0163, 395.1055 FS. Law Implemented 395.0163, 395.1055 FS. History–New 1-1-77, Amended 4-26-78, Formerly 10D-28.80, Amended 1-16-87, 11-23-88, Formerly 10D-28.080, Amended 9-3-92, 6-29-97, 5-12-16.

Fla. Admin. Code R. 59A-3.081 Physical Plant Requirements for Mobile Surgical Facilities

History

Rulemaking Authority 395.0163, 395.1055 FS. Law Implemented 395.0163, 395.1055 FS. History–New 1-1-77, Formerly 10D-28.81, Amended 1-16-87, 11-23-88, Formerly 10D-28.081, Amended 9-3-92, 6-29-97, 3-18-98, 11-29-99, 12-20-99, 5-25-00, 5-12-16, Repealed 7-1-18.

Fla. Admin. Code R. 59A-3.0815 Rehabilitation Hospitals

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 1-16-87, Formerly 10D-28.0815, Amended 9-3-92, Repealed 6-29-97.

Fla. Admin. Code R. 59A-3.0816 Psychiatric Hospitals

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 1-16-87, Amended 9-3-92, Repealed 6-29-97.

Fla. Admin. Code R. 59A-3.082 Details and Finishes

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 1-1-77, Formerly 10D-28.82, Amended 1-16-87, Formerly 10D-28.082, Amended 9-3-92, Repealed 6-29-97.

Fla. Admin. Code R. 59A-3.083 Elevators Where Required

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 1-1-77, Formerly 10D-28.83, Amended 1-16-87, Formerly 10D-28.083, Amended 9-3-92, Repealed 6-29-97.

Fla. Admin. Code R. 59A-3.084 Water Supply and Sewage Disposal

History

Rulemaking Authority 395.007 FS. Law Implemented 381.031(1)(g)3., 395.002, 395.007 FS. History–New 1-1-77, Formerly 10D-28.84, 10D-28.084, Amended 9-3-92, Repealed 6-29-97.

Fla. Admin. Code R. 59A-3.085 Incinerators

History

Rulemaking Authority 395.007 FS. Law Implemented 395.002, 395.007 FS. History–New 1-1-77, Formerly 10D-28.85, 10D-28.085, Repealed 9-3-92.

Fla. Admin. Code R. 59A-3.086 Heating, Ventilating and Air Conditioning Systems

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 1-1-77, Formerly 10D-28.86, Amended 1-16-87, Formerly 10D-28.086, Amended 9-3-92, Repealed 6-29-97.

Fla. Admin. Code R. 59A-3.087 Plumbing

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 1-1-77, Formerly 10D-28.87, Amended 1-16-87, Formerly 10D-28.087, Amended 9-3-92, Repealed 6-29-97.

Fla. Admin. Code R. 59A-3.088 Fire Pump

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 1-1-77, Formerly 10D-28.88, Amended 1-16-87, Formerly 10D-28.088, Amended 9-3-92, Repealed 6-29-97.

Fla. Admin. Code R. 59A-3.089 Electrical Requirements

History

Rulemaking Authority 395.007 FS. Law Implemented 395.002, 395.007 FS. History–New 1-1-77, Formerly 10D-28.89, Amended 1-16-87, Formerly 10D-28.089, Amended 9-3-92, Repealed 6-29-97.

Fla. Admin. Code R. 59A-3.0895 Fire Alarm Systems

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 1-16-87, Formerly 10D-28.0895, Amended 9-3-92, Repealed 6-29-97.

Fla. Admin. Code R. 59A-3.090 Nurse Call System

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 1-1-77, Formerly 10D-28.90, Amended 1-16-87, Formerly 10D-28.090, Amended 9-3-92, Repealed 6-29-97.

Fla. Admin. Code R. 59A-3.091 Emergency Electric Service

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 1-1-77, Formerly 10D-28.91, Amended 1-16-87, 1-23-88, Formerly 10D-28.091, Amended 9-3-92, Repealed 6-29-97.

Fla. Admin. Code R. 59A-3.093 Lightning Protection

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 1-16-87, Formerly 10D-28.093, Amended 9-3-92, Repealed 6-29-97.

Fla. Admin. Code R. 59A-3.100 Scope

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.003, 395.1055 FS. History–New 2-15-82, Amended 8-14-86, Formerly 10D-28.100, Amended 9-4-95, Repealed 12-12-96.

Fla. Admin. Code R. 59A-3.101 Licensure Procedure

History

Rulemaking Authority 395.003, 395.004, 395.0161, 395.1055 FS. Law Implemented 395.001, 395.002, 395.003, 395.004, 395.0161, 395.0191, 395.1055 FS. History–New 2-15-82, Amended 8-14-86, Formerly 10D-28.101, Amended 9-4-95, 4-17-97, Transferred to 59A-3.309.

Fla. Admin. Code R. 59A-3.102 Surveys, Evaluations and Consultations

History

Rulemaking Authority 395.003, 395.0161, 395.1055 FS. Law Implemented 395.003, 395.0161, 395.1055 FS. History–New 2-15-82, Amended 8-14-86, Formerly 10D-28.102, Amended 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.103 Governing Authority

History

Rulemaking Authority 395.003, 395.1055 FS. Law Implemented 395.001, 395.003, 395.1091, 395.1055, 395.301 FS. History–New 2-15-82, Amended 8-14-86, Formerly 10D-28.103, Amended 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.104 Finances

History

Rulemaking Authority 395.003, 395.1055 FS. Law Implemented 395.002, 395.003, 395.1055 FS. History–New 2-15-82, Amended 8-14-86, Formerly 10D-28.103, Amended 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.105 Goads, Policies and Procedures

History

Rulemaking Authority 395.003, 395.005 FS. Law Implemented 395.002, 395.003, 395.005 FS. History–New 2-15-82, Formerly 10D-28.105, Transferred to 59A-3.301.

Fla. Admin. Code R. 59A-3.106 Personnel

History

Rulemaking Authority 395.003, 395.1055 FS. Law Implemented 395.002, 395.003, 395.1055 FS. History–New 2-15-82, Formerly 10D-28.106, Transferred to 59A-3.302.

Fla. Admin. Code R. 59A-3.107 Volunteer Program

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.002, 395.003, 395.1055 FS. History–New 2-15-82, Formerly 10D-28.107, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.108 Facilities and Physical Plant Safety

History

Rulemaking Authority 395.1055 FS. Law Implemented 252.35(2)(f), 252.38(1)(e), 395.1055 FS. History–New 2-15-82, Formerly 10D-28.108, Amended 9-4-95, Transferred to 59A-3.303.

Fla. Admin. Code R. 59A-3.110 Intensive Residential Treatment Facility Services

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 1-1-77, Formerly 10D-28.92, 10D-28.110, Amended 9-4-95, 10-16-14, Tranferred to 59A-3.310.

Fla. Admin. Code R. 59A-3.111 Exceptions

History

Rulemaking Authority 395.003, 395.0163, 395.1055 FS. Law Implemented 395.002, 395.1055 FS. History–New 2-15-82, Formerly 10D-28.111, Transferred to 59A-3.312.

Fla. Admin. Code R. 59A-3.129 Scope

History

Rulemaking Authority 381.231, 395.0147 FS. Law Implemented 381.231, 395.0147 FS. History–New 3-11-86, Formerly 10D-28.129, Repealed 12-12-96.

Fla. Admin. Code R. 59A-3.130 Definitions

History

Rulemaking Authority 381.231, 395.0147 FS. Law Implemented 381.231, 395.0147 FS. History–New 3-11-86, Formerly 10D-28.130, Repealed 12-12-96.

Fla. Admin. Code R. 59A-3.131 Hospital Reporting of Exposure to Selected Infectious Diseases

History

Rulemaking Authority 381.231, 395.1025, 395.1055 FS. Law Implemented 381.0031, 395.1025 FS. History–New 3-11-86, Formerly 10D-28.131, Amended 4-17-97, Transferred to 59A-3.251.

Fla. Admin. Code R. 59A-3.151 Purpose

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.003, 395.005 FS. History–New 8-14-86, Formerly 10D-28.151, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.152 Definitions

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.002, 395.005 FS. History–New 8-14-86, Formerly 10D-28.152, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.153 Licensure Procedure

History

Rulemaking Authority 395.004(2)(a) FS. Law Implemented 395.001, 395.003, 395.004, 395.005 FS. History–New 8-14-86, Amended 8-7-89, 10-7-91, Formerly 10D-28.153, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.154 Investigations and License, Life Safety and Validation Inspections

History

Rulemaking Authority 395.005, 395.006 FS. Law Implemented 395.001, 395.003, 395.005, 395.006 FS. History–New 8-14-86, Amended 8-7-89, Formerly 10D-28.154, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.155 Classifications of Hospitals

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.002, 395.005 FS. History–New 8-14-86, Formerly 10D-28.155, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.156 Governing Body

History

Rulemaking Authority 395.005 FS. Law Implemented 395.005, 395.011, 395.0115, 395.014 FS. History–New 8-14-86, Formerly 10D-28.156, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.157 Organized Medical Staff

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005, 395.011, 395.015 FS. History–New 8-14-86, Formerly 10D-28.157, Repealed 9-4-95

Fla. Admin. Code R. 59A-3.158 Medical Records Department

History

Rulemaking Authority 395.005, 395.016 FS. Law Implemented 395.001, 395.005, 395.016, 395.017 FS. History–New 8-14-86, Formerly 10D-28.158, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.159 Itemized Patient Bill

History

Rulemaking Authority 395.005, 395.015 FS. Law Implemented 395.001, 395.005, 395.015 FS. History–New 8-14-86, Formerly 10D-28.159, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.160 Radiology Department

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 8-14-86, Formerly 10D-28.160, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.161 Laboratories

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005, 395.009 FS. History–New 8-14-86, Formerly 10D-28.161, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.162 Pharmacy

History

Rulemaking Authority 395.005 FS. Law Implemented 395.005 FS. History–New 8-14-86, Formerly 10D-28.162, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.163 Dietetic Department

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 8-14-86, Formerly 10D-28.163, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.164 Obstetrical Department

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 8-14-86, Formerly 10D-28.164, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.165 Surgical Department

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 8-14-86, Formerly 10D-28.165, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.166 Anesthesia Department

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 8-14-86, Formerly 10D-28.166, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.167 Respiratory Therapy

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 8-14-86, Formerly 10D-28.167, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.168 Rehabilitation and Psychiatric Programs

History

Rulemaking Authority 395.003, 395.005 FS. Law Implemented 395.001, 395.003, 395.005 FS. History–New 8-14-86, Formerly 10D-28.168, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.169 Nursing Service

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 8-14-86, Formerly 10D-28.169, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.170 Emergency Care

History

Rulemaking Authority 395.005 FS. Law Implemented 395.005, 395.0011, 395.0143, 395.0145 FS. History–New 8-14-86, Formerly 10D-28.170, Repealed 7-18-93.

Fla. Admin. Code R. 59A-3.1701 Purpose

History

Rulemaking Authority 395.1041 FS. Law Implemented 395.1041 FS. History–New 7-18-93, Repealed 9-4-93.

Fla. Admin. Code R. 59A-3.1702 Scope

History

Rulemaking Authority 395.1041 FS. Law Implemented 395.1041 FS. History–New 7-18-93, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.1703 Definitions

History

Rulemaking Authority 395.1041 FS. Law Implemented 395.1041 FS. History–New 7-18-93, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.1704 Signage Requirements

History

Rulemaking Authority 395.1041 FS. Law Implemented 395.1041 FS. History–New 7-18-93, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.1705 Transfer Procedures

History

Rulemaking Authority 395.1041 FS. Law Implemented 395.1041 FS. History–New 7-18-93, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.1706 Inventory Reporting

History

Rulemaking Authority 395.1041 FS. Law Implemented 395.1041 FS. History–New 7-18-93, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.1707 Exemptions

History

Rulemaking Authority 395.1041 FS. Law Implemented 395.1041 FS. History–New 7-18-93, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.1708 Agency Review Process

History

Rulemaking Authority 395.1041 FS. Law Implemented 395.1041 FS. History–New 7-18-93, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.1709 Complaint Reporting Requirements

History

Rulemaking Authority 395.1041 FS. Law Implemented 395.1041 FS. History–New 7-18-93, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.171 Special Care Units

History

Rulemaking Authority 395.005, 395.031 FS. Law Implemented 395.001, 395.005, 395.031 FS. History–New 8-14-86, Formerly 10D-28.171, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.172 Infection Control

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005, 395.0101 FS. History–New 8-14-86, Formerly 10D-28.172, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.173 Maintenance

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 8-14-86, Formerly 10D-28.173, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.174 Functional Safety

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 8-14-86, Formerly 10D-28.174, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.175 Housekeeping Services

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 8-14-86, Formerly 10D-28.175, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.176 Qualify Control and Utilization Review

History

Rulemaking Authority 395.005 FS. Law Implemented 395.001, 395.005 FS. History–New 8-14-86, Formerly 10D-28.176, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.180 Hospital Routine Inquiry for Organ Donation

History

Rulemaking Authority 732.922, 873.01(3)(a) FS. Law Implemented 732.922(2)(f), 873.01(3)(a) FS. History–New 8-17-87, Formerly 10D-28.180, Repealed 9-4-95.

Fla. Admin. Code R. 59A-3.190 Advance Directives

History

Rulemaking Authority 765.110 FS. Law Implemented 765.110 FS. History–New 1-11-93, Repealed 4-20-97.

Fla. Admin. Code R. 59A-3.200 Scope

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 9-4-95, Repealed 12-12-96.

Fla. Admin. Code R. 59A-3.201 Definitions

History

Rulemaking Authority 381.231, 395.1023, 395.1025, 395.1055 FS. Law Implemented 381.006, 381.0098, 381.231, 395.001, 395.002, 395.1023, 395.1025, 395.1055, 408.035, 408.036, 415.503, 415.5055 FS. History–New 9-4-95, Transferred to 59A-3.065.

Fla. Admin. Code R. 59A-3.202 Classification of Hospitals

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.002, 395.1055, 408.035, 408.036 FS. History–New 9-4-95, Transferred to 59A-3.252.

Fla. Admin. Code R. 59A-3.203 Licensure Procedure

History

Rulemaking Authority 395.003, 395.004, 455.239 FS. Law Implemented 395.001, 395.003, 395.004, 395.1055, 395.035, 408.036, 455.239 FS. History–New 9-4-95, Amended 6-18-96, Transferred to 59A-3.066.

Fla. Admin. Code R. 59A-3.204 Investigations and License, Life Safety and Validation Inspections

History

Rulemaking Authority 395.0161, 395.1055 FS. Law Implemented 395.001, 395.003, 395.0161, 395.1055, 395.035, 408.036 FS. History–New 9-4-95, Transferred to 59A-3.253.

Fla. Admin. Code R. 59A-3.205 Patient Rights

History

Rulemaking Authority 395.1055, 765.101 FS. Law Implemented 381.026, 394.459, 395.001, 395.1055, 395.3025, 395.310, 765.02, 765.101 FS. History–New 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.2055 Patient Rights and Care

History

Rulemaking Authority 395.003, 395.004, 455.1055, 455.239 FS. Law Implemented 395.003, 395.004, 395.1023, 395.1055, 408.035, 408.036 FS. History–New 4-17-97, Transferred to 59A-3.254.

Fla. Admin. Code R. 59A-3.206 Patient Assessment

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1023, 395.1055 FS. History–New 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.207 Emergency Care

History

Rulemaking Authority 395.1031, 395.1041, 395.1055, 401.024 FS. Law Implemented 395.1031, 395.1041, 395.1055 FS. History–New 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.208 Nutritional Care

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055 FS. History–New 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.2085 Department and Services

History

Rulemaking Authority 395.1055, 395.3038, 395.401, 408.036, 408.0361(2) FS. Law Implemented 395.001, 395.1055, 395.1065, 395.3038, 395.401, 408.036, 408.0361, 957.05 FS. History–New 4-17-97, Amended 3-29-98, 8-23-99, 3-23-06, 1-8-09, 11-3-09, 1-11-11, Repealed 11-21-18.

Fla. Admin. Code R. 59A-3.209 Pharmacy

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.210 Surgical Department

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055 FS. History–New 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.211 Anesthesia Department

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055 FS. History–New 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.212 Patient and Family Education

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.213 Coordination of Care

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.214 Health Information Management

History

Rulemaking Authority 395.1055, 395.3015 FS. Law Implemented 395.001, 395.1055, 395.3015, 395.3025 FS. History–New 9-4-95, Transferred to 59A-3.270.

Fla. Admin. Code R. 59A-3.215 Surveillance, Prevention, and Control of Infection

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1011, 395.1055 FS. History–New 9-4-95, Transferred to 59A-3.250.

Fla. Admin. Code R. 59A-3.216 Quality Improvement

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055 FS. History–New 9-4-95, Transferred to 59A-3.271.

Fla. Admin. Code R. 59A-3.217 Governing Body

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.0191, 395.0193, 395.0195, 395.1055 FS. History–New 9-4-95, Transferred to 59A-3.272.

Fla. Admin. Code R. 59A-3.218 Management and Administration

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.0197, 395.1055 FS. History–New 9-4-95, Transferred to 59A-3.273.

Fla. Admin. Code R. 59A-3.219 Anatomical Gifts, Routine Inquiry

History

Rulemaking Authority 20.42(2)(a)1., 732.922, 893.01(3)(a) FS. Law Implemented 732.922, 873.01(3)(a) FS. History–New 9-4-95, Transferred to 59A-3.274.

Fla. Admin. Code R. 59A-3.220 Organized Medical Staff

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.0191, 395.1055, 395.301 FS. History–New 9-4-95, Transferred to 59A-3.275.

Fla. Admin. Code R. 59A-3.221 Nursing Service

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055 FS. History–New 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.222 Maintenance

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055 FS. History–New 9-4-95, Transferred to 59A-3.276.

Fla. Admin. Code R. 59A-3.223 Functional Safety

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055 FS. History–New 9-4-95, Transferred to 59A-3.277.

Fla. Admin. Code R. 59A-3.224 Housekeeping Services

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055 FS. History–New 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.225 Ambulatory Care Services

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1021, 395.1023, 395.1055, 395.3015 FS. History–New 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.226 Obstetrical Department

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055 FS. History–New 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.227 Laboratories and Pathology Services

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.009, 395.1055 FS. History–New 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.228 Radiology Services

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055 FS. History–New 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.229 Rehabilitation, Psychiatric and Substance Abuse Programs

History

Rulemaking Authority 395.003, 395.1055 FS. Law Implemented 395.001, 395.003, 395.1055, 408.031, 408.036 FS. History–New 9-4-95, Transferred to 59A-3.278.

Fla. Admin. Code R. 59A-3.230 Respiratory Therapy

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055 FS. History–New 9-4-95, Repealed 4-17-97.

Fla. Admin. Code R. 59A-3.232 Itemized Patient Bill

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055, 395.301 FS. History–New 9-4-95, Transferred to 59A-3.279.

Fla. Admin. Code R. 59A-3.240 Nutritional Services

All licensed hospitals shall have a dietetic department, service or other similarly titled unit which shall be organized, directed and staffed, and integrated with other units and departments of the hospitals in a manner designed to assure the provision of appropriate nutritional care and quality food service.

(1) The dietetic department shall be directed on a full-time basis by a registered dietitian or other individual with education or specialized training and experience in food service management, who shall be responsible to the chief executive officer or his designee for the operations of the dietetic department.

(2) If the director of the dietetic department is not a registered dietitian, the hospital shall employ a registered dietitian at a minimum on a part-time or consulting basis to supervise the nutritional aspects of patient care and assure the provision of quality nutritional care to patients. The consulting dietitian shall regularly submit reports to the chief executive officer concerning the extent of services provided.

(3) Whether employed full-time, part-time or on a consulting basis, a registered dietitian shall provide the following services to the hospital on the premises on a regularly scheduled basis:

(a) Liaison with administration, medical and nursing staffs;

(b) Patient and family counseling as needed;

(d) Required nutritional assessments;

(e) Participation in development of policies, procedures and continuing education programs; and

(f) Evaluation of dietetic services.

(4) Annually, a registered dietitian shall conduct a review and evaluation of the dietetic department to include:

(a) A review of menus for nutritional adequacy;

(b) A review of tray identification methods, patients who are not receiving oral intake, and the elapsed time between the evening meal and the next substantial meal;

(d) A review of committee activities concerning nutritional care; and

(e) A review of the appearance, palatability, serving temperature, patient acceptability and choice, and retention of nutrient value of food served by the dietetic department.

(5) Nothing in this section shall prevent a hospital from employing an outside food management company for the provision of dietetic services, provided the requirements of this section are met, and the contract specifies this compliance.

(6) The dietetic department, service or other similarly titled unit shall employ sufficient qualified personnel under competent supervision to meet the dietary needs of patients.

(7) Personnel in the dietetic department shall receive, as appropriate to their level of responsibility, instruction in:

(a) Personal hygiene and infection control;

(b) Food handling, preparation, serving and storage; cleaning and safe operation of equipment;

(d) Portion control;

(e) Diet instruction; and

(f) The writing of modified diets and the recording of pertinent dietetic information in the patient’s medical record.

(8) Personnel in the dietetic department shall receive quarterly in-service training of which a record shall be kept by the dietetic department.

(9) The dietetic department, service or other similarly titled unit shall be guided by written policies and procedures that cover food procurement, preparation and service. Dietetic department policies and procedures shall be developed by the director of the dietetic department with nutritional care policies and procedures developed by a registered dietitian, shall be subject to annual review, revised as necessary, dated to indicate the time of last review, and enforced. Written dietetic policies shall include the following:

(a) A description of food purchasing, storage, inventory, preparation, service, and disposal policies and procedures.

(b) A requirement that diet orders be recorded in the patient’s medical record by an authorized individual before the diet is served to the patient.

(c) A requirement that the proper use and adherence to standards for nutritional care, including dietary reference intakes are specified by the provider’s diet manual.

(d) A requirement for patients who are on oral intake and do not have specific dietary requirements, that a minimum of three meals or their equivalent be provided daily, with not more than a 15 hour span between the evening meal and breakfast.

(e) A requirement that temperatures for holding and serving cold foods be below 45° degrees F, and for hot foods be above 140° degrees F.

(f) A requirement that a supply of non-perishable foods sufficient to serve a hospital’s patients for a minimum of a one week period be available.

(g) A requirement that written reports of sanitary inspections be kept on file, with a record of actions undertaken to comply with recommendations.

(h) A description of the role of the dietetic department in the hospital's internal and external disaster plans.

(i) Menus.

(j) The role of the dietetic department in the preparation, storage, distribution and administration of enteric feeding, tube feeding and total parenteral nutrition programs.

(k) Alterations in diets or diet schedules, including the provision of food service to patients who do not receive regular meal service.

(l) Ancillary dietetic services, as appropriate, including food storage and kitchens on patient care units, formula supply, cafeterias, vending operations and ice making.

(m) Personal hygiene and health of dietetic personnel.

(n) A description of dietetic department policies and procedures designed to provide for infection control including a monitoring system to assure that dietetic personnel are free from communicable infections and open skin lesions.

(o) A description of the identification system used for patient trays and other methods for assuring that each patient receives the appropriate diet as ordered,

(p) Safety practices, including the control of electrical, flammable, mechanical, and as appropriate, radiation hazards.

(10) The dietetic department shall be designed and equipped to facilitate the safe, sanitary, and timely provision of food service to meet the nutritional needs of patients.

(11) The dietetic department shall have adequate equipment and facilities to prepare and distribute food, protect food from contamination and spoilage, to store foods under sanitary and secure conditions, and to provide adequate lighting, ventilation and humidity control.

(12) The dietetic department shall thoroughly cleanse and sanitize food contact surfaces, utensils, dishes and equipment between periods of use, shall ensure that toilet, hand-washing and hand-drying facilities are conveniently available, and provide for dishwashing and utensil washing equipment that prevent recontamination and are apart from food preparation areas.

(13) The dietetic department shall ensure that all walk-in refrigerators and freezers can be opened from inside and that all food and nonfood supplies are clearly labeled. Where stored in the same refrigerator, all nonfood supplies and specimens shall be stored on separate shelves from food supplies.

(14) The dietetic department shall implement methods to prevent contamination in the making, storage, and dispensing of ice.

(15) The dietetic department shall ensure that disposable containers and utensils are discarded after one use, and that worn or damaged dishes and glassware are discarded.

(16) The dietetic department shall hold, transfer, and dispose of garbage in a manner which does not create a nuisance or breeding place for pests or otherwise permit the transmission of disease.

(17) Information on specifications, operation and maintenance of all major and fixed dietetic department equipment shall be maintained. A preventive and corrective maintenance program on such equipment shall be conducted and recorded.

(18) Dietetic services shall be provided in accordance with written orders by the health professional responsible for the patient and appropriate information shall be recorded in the patient’s medical record. Such information shall include:

(a) A summary of the dietary history and a nutritional assessment when the past dietary pattern is known to have a bearing on the patient’s condition;

(b) Timely and periodic assessments of the patient’s nutrient intake and tolerance to the prescribed diet modification, including the effect of the patient’s appetite and food habits on food intake and any substitutions made; and

(19) Within 24 hours of admission and within 24 hours of any subsequent orders for diet modification, the diet order shall be confirmed by the practitioner responsible for the patient receiving oral alimentation.

(20) Each hospital shall establish appropriate quality control mechanisms to assure that:

(a) All menus are evaluated for nutritional adequacy.

(b) There is a means for identifying those patients who are not receiving oral intake.

(d) The nutritional intake of patients is assessed and recorded as appropriate.

(e) Effort is made to assure appetizing appearance, palatability, proper serving temperature, and retention of nutritional value of food.

(f) Whenever possible, patient food preferences are respected and appropriate dietary substitutions are made available.

(g) Surveys of patient acceptance of food are conducted, particularly for long-stay patients.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 8-15-18.

Fla. Admin. Code R. 59A-3.241 Pharmacy Services

Each Class I and Class II hospital shall have on the premises, and each Class III hospital shall have on the premises or by contract, a pharmacy, pharmaceutical department or service, or similarly titled unit, and, when applicable, shall present evidence that it holds a current institutional or community pharmacy permit under the provisions of the Florida Pharmacy Act, Chapter 465, F.S. The pharmacy department shall have a licensed pharmacist serve as pharmacy director on a full time or consulting basis. The director shall develop and monitor procedures to ensure the proper use of medications. Such procedures shall address prescription and ordering, preparation and dispensing, administration, and patient monitoring for medication effects.

(1) The director shall ensure a hospital formulary or drug list is developed, maintained, and regularly updated by authorized hospital staff. The formulary shall include the availability of non-legend medications, but does not preclude the use of unlisted drugs. Where unlisted drugs are used, there shall be a written policy and procedure for their prescription and procurement. Selection of medications for inclusion on the formulary shall be based on need, effectiveness, risks, and costs.

(2) The director shall ensure that individuals who prescribe or order medications are legally authorized through the granting of clinical privileges.

(3) All drugs shall be prepared and stored under proper conditions of sanitation, temperature, light, moisture, ventilation, security and segregation to promote patient safety and proper utilization and efficacy.

(4) All medications shall be appropriately labeled as to applicable accessory or cautionary statements and their expiration date, shall be dispensed in as ready-to-administer forms as possible, and in quantities consistent with the patient’s needs which are designed to ensure minimization of errors and diversion.

(5) A pharmacist shall review each order before dispensing the medication, with the exception of situations in which a licensed independent practitioner with appropriate clinical privileges controls prescription ordering, preparation and administration of medicine. The pharmacist shall verify the order with the prescriber when there is a question.

(6) All medications shall be prepared and dispensed consistent with applicable law and rules governing professional licensure and pharmacy operation and in accordance with professional standards of pharmacy practice.

(7) A medication profile shall be developed and maintained by the pharmacy department for each patient and shall be available to staff responsible for the patient’s care. The medication profile shall include the name, birth date, sex, pertinent health problems and diagnoses, current medication therapy, medication allergies or sensitivities, and potential drug or food interactions.

(8) The director shall develop and implement a process for providing medications when the pharmacy is closed that ensures control, accountability, and the appropriate use of medications.

(9) The director shall ensure there is an adequate and proper supply of emergency drugs within the pharmacy and in designated areas of the hospital.

(10) Receipt, distribution and administration of controlled drugs are documented by the pharmacy, nursing service and other personnel, to ensure control and accountability in accordance with state and federal law.

(11) The director shall ensure that the administration of drugs shall take place in accordance with written policies, approved by the professional staff and designed to ensure that all medications are administered safely and efficiently.

(12) The director may supervise satellite pharmacies. The director of the hospital pharmacy, or other licensed pharmacists who are properly designated, shall be available to the hospital at all times, whether on duty or on call.

(13) Administration of drugs shall be undertaken only upon the orders of authorized members of the professional staff, where the orders are verified before administration, the patient is identified, and the dosage and medication is noted in the patient’s chart or medical record.

(14) Investigational medications shall be used only in accordance with specific hospital policy which addresses:

(a) Review and approval of hospital participation in investigational studies by the appropriate hospital committee;

(b) Requirements for informed consent by the patient;

(d) Administration by personnel approved by the principal investigator after they have received information and demonstrated an understanding of the basic pharmacologic information about the medications; and

(e) Documentation of doses dispensed, administered and destroyed.

(15) Each hospital shall have a system for the ongoing monitoring of each patient for medication effectiveness and actual or potential adverse effects or toxicity which includes:

(a) A collaborative assessment of the effect of the medication on the patient based on observation and information gathered and maintained in the patient’s medical record and medication profile;

(b) A process for the definition, identification, and review of significant medication errors and adverse drug reactions are reported in a timely manner in accordance with written procedures. Significant adverse drug reactions shall be reported promptly to the Food and Drug Administration;

(d) Conclusions and findings of the medication monitoring are communicated to the appropriate health care personnel involved in the patient’s care.

(16) Each hospital shall have written policies and procedures governing the selection, procurement, distribution, administration, and record-keeping of all drugs, including provision for maintaining patient confidentiality. The policies and procedures shall be reviewed at least annually, dated to indicate time of last review, revised as necessary, and enforced.

(17) Parenteral nutrition services, when provided, shall be designed, implemented, and maintained to address assessment and reassessment of the patient, initial ordering and ongoing maintenance of medication orders, preparation and dispensing, administration, and assessing the effects on the patient.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 8-15-18.

Fla. Admin. Code R. 59A-3.242 Laboratory, Radiology, and Respiratory Services

(1) Clinical and Pathology Laboratory Services. Each hospital must provide on the premises, or by contract, clinical and pathology laboratory services commensurate with the hospital’s needs. The hospital laboratory, and any contracted laboratory providing services for hospital patients, must be certified by the Centers for Medicare and Medicaid Services under the federal Clinical Laboratory Improvement Amendments (CLIA) and the federal rules adopted thereunder in all specialties or subspecialties in which testing is performed. Hospitals may operate more than one CLIA certified laboratory. Each hospital laboratory shall have a qualified laboratory director. Qualifications for laboratory director, supervisor, technologist, and technician are found in Chapter 483, Part II, F.S., and the rules adopted thereunder.

(a) The laboratory director is responsible for the supervision of the laboratory, including alternate-site testing locations, and shall maintain and enforce policies and procedures for the provision of clinical and pathology laboratory examinations.

(b) Provision shall be made for assuring the availability of emergency laboratory services. Such services shall be available 24 hours a day, seven days a week, including holidays.

(d) All specimens removed in operations shall be examined by a pathologist, except when another suitable means of verification of removal is routinely employed, when there is an authenticated report to document the removal, and when quality of care will not be compromised by the exception. Hospitals may establish a policy for excepting certain categories of specimens from examination when it determines quality of care will not be compromised or examination will yield no useful information. Signed reports on all specimens removed in an operation, whether documented by a pathologist or through an alternative means, shall be filed with the patient’s medical record.

(e) All hospitals utilizing blood and blood products, shall:

Maintain facilities for procurement, safekeeping and transfusion of blood and blood products, or have them readily available.
Maintain a temperature alarm system for blood storage facilities, where applicable, which is tested and inspected quarterly and is otherwise safe.
The alarm system must be audible, and must monitor proper blood and blood product storage temperature over a 24-hour period.
Tests of the alarm system must be documented.
If blood is stored or maintained for transfusion outside of a monitored refrigerator, the hospital must ensure and document that storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product.
Promptly dispose of blood which has exceeded its expiration date.
Records shall be kept on file indicating the receipt and disposition of all blood provided to patients in the facility.

(f) Hospitals not utilizing blood and blood products need not maintain blood storage facilities.

(g) Alternate-site testing locations (alternate-sites) are hospital units or departments on the hospital premises that are located outside of the physical or administrative confines of the hospital’s central laboratory (hospital laboratory), but still under the administrative control of the hospital and under the supervision of the laboratory director. Each hospital laboratory may operate more than one alternate-site.

Hospitals must register their alternate-sites at license renewal by submitting a hospital licensure application as specified in subsection 59A-3.066(2), F.A.C. and attaching AHCA Form 3130-8013, July 2018, License Application Alternate-Site Testing, herein incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-10652.
Testing at alternate-sites shall not exceed test categorization of moderate complexity as described in Title 42 CFR Part 493.17 and administered by the Centers for Medicare and Medicaid Services and shall be limited to those tests:

a. Within the specialties and subspecialties for which the laboratory is CLIA certified and the laboratory director or supervising delegate is qualified;

b. Approved by the laboratory director and documented in the internal needs assessment;

c. Utilizing instrumentation in which instrument calibration is performed automatically without access by the operator to modify or adjust calibration limits, and if the instrumentation has a requirement to establish quality control ranges, the ranges must be established by licensed clinical laboratory personnel under the supervision of the laboratory director; and

d. Requiring a specimen to be directly introduced into the instrumentation without manual specimen or reagent manipulation, treatment, extraction, centrifugation, separation or other processing of any kind by the operator, except for bodily fluids such as amniotic fluid, requiring minimal preparation as approved by the laboratory director and documented in the internal needs assessment and procedure manual.

The laboratory director in consultation with the appropriate medical staff shall prepare an internal needs assessment for each alternate-site. Each assessment shall include an evaluation of patient benefits and criteria for such testing, location of alternate-site, population to be served, and an evaluation of proposed instruments or testing methodologies.

a. The selection of alternate-site test methods shall assure that performance and operational characteristics meet the clinical requirements for the intended location. Alternate-site testing shall only be conducted at sites where the laboratory director has established and documented in the internal needs assessment that such testing is necessary for the proper care and treatment of patients.

b. The internal needs assessment must include an evaluation of proposed methodologies for tests to be performed at the alternate-sites composed of evaluation of accuracy, precision, reportable range and reference interval studies, comparison of test results with the hospital laboratory, instrument performance, maintenance requirements, storage and availability of supplies such as reagents, controls and proficiency samples for the testing site and a written validation procedure.

c. The internal needs assessment must be reviewed and approved by the laboratory director prior to initiation of testing at any alternate-site and biennially thereafter. All records related to the internal needs assessment for the purpose of alternate-site testing must be readily available for inspection by the Agency and any other surveying agency including accrediting organizations, if the laboratory is accredited, for a minimum of two years after testing is discontinued.

A written protocol shall be established by the laboratory director and implemented according to the service(s) being performed at the alternate-site applicable to tests performed.

a. There shall be a procedure manual at each alternate-site which shall specifically address the tests performed at that location. The procedure manual shall be reviewed and signed by the laboratory director biennially.

b. There shall be a quality assurance program that is appropriate for the test methods used at the alternate-site. Criteria for repeating a result or obtaining a sample for assay in the hospital laboratory must be outlined by the director and included in the quality assurance program. The hospital laboratory must maintain the capability of verifying the validity of test results obtained at alternate-sites.

Records of alternate-site tests, locations, quality control, evaluation of accuracy, precision, correlation studies, instrument performance, and instrument maintenance must be maintained for a minimum of two years after testing is discontinued and available to any surveying agency including an accrediting organization if accredited.
All records of personnel authorized to perform testing at an alternate-site must be readily available for inspection by the Agency and any other surveying agency including accrediting organizations, if accredited. The records must be maintained during the tenure of all testing personnel and for a minimum of two years thereafter. The records shall include the name of each person performing testing, copies of professional licensure or certification, initial and ongoing competency evaluations, in-service training, and any corrective actions.

a. Successful completion of a training program approved by the Board of Clinical Laboratory Personnel provided under Section 483.811, F.S., shall meet the minimum training requirements specified in this rule.

b. Personnel authorized to perform testing at an alternate-site, as authorized under this subsection, are not required to be licensed under Chapter 483, Part II, F.S., as clinical laboratory personnel.

c. Individuals who meet the CLIA requirements for performing tests categorized as waived, but do not meet any of the testing personnel requirements of this rule are restricted to performing tests categorized as waived.

d. Testing personnel shall have a high school diploma, or its equivalent, and have met the HIV/AIDS educational requirements pursuant to Section 381.0035, F.S. In addition, all testing personnel in the alternate-site shall meet one of the following requirements:

(I) Is licensed as an emergency medical technician or paramedic pursuant to Chapter 401, F.S.;

(II) Is licensed as a physician assistant or anesthesiologist assistant pursuant to Chapter 458 or 459, F.S.;

(III) Is licensed as an advanced practice registered nurse, a registered nurse or licensed practical nurse pursuant to Chapter 464, F.S.;

(IV) Is licensed as a radiologic technologist pursuant to Chapter 468, Part IV, F.S.;

(V) Is licensed as a respiratory care practitioner certified in critical care services or a respiratory therapist pursuant to Chapter 468, Part V, F.S.;

(VI) Is licensed as a director, supervisor, technologist or technician pursuant to Chapter 483, Part II, F.S., or exempt from such licensure as provided in that chapter;

(VII) Is a phlebotomist certified by the American Society of Clinical Pathologists (ASCP), National Certification Agency for Medical Laboratory Personnel (NCA), American Society of Phlebotomy Technicians (ASPT) or American Medical Technologists (AMT);

(VIII) Is a clinical laboratory assistant certified by the AMT or American Society for Clinical Laboratory Science, or is a medical laboratory assistant certified by the ASCP;

(IX) Is a perfusionist certified or determined eligible for certification by the American Board of Cardiovascular Perfusion, or has two years of clinical experience in cardiovascular perfusion with 100 clinical perfusions conducted as of January 1, 1981; or

(X) Is a cardiovascular technician certified by the Cardiovascular Credentialing International (CCI).

e. The laboratory director will determine if the above listed personnel are suitable to perform testing at the alternate-site. The laboratory director shall:

(I) Ensure that testing personnel are limited to those who meet the requirements of this rule; and

(II) Establish methods for the evaluation of competency to verify that alternate-site testing personnel perform procedures and report tests results promptly and accurately. Evaluation of competency shall include:

(A) Specimen collection, handling and storage;

(B) Skills required to perform the test method;

(C) Skills required to perform preventive maintenance, troubleshooting, and calibration procedures applicable to the testing methodologies;

(D) Demonstration of knowledge of reagent stability and storage applicable to the test system in use;

(E) Skills required to implement quality control policies and procedures and evaluate quality control results;

(F) An awareness of factors that influence test results;

(G) Skills required to assess and verify the validity of patient test results through the assessment of quality control testing outcomes;

(H) Demonstration of knowledge of patient preparation for each test performed;

(I) Demonstration of knowledge of standard precautions; and

(J) Demonstration of knowledge of reporting procedures for life threatening results.

f. The laboratory director shall ensure validation of personnel competency, which shall include review of test results, quality control records, proficiency testing results and preventive maintenance records; direct observation of test performance and instrument maintenance; and assessment of performance through testing previously analyzed specimens, internal blind samples, or proficiency testing samples.

g. Evaluation of competency for alternate-site testing personnel must be performed prior to initiation of patient testing and annually thereafter.

Data output must be directly reportable in the final units of measurement needed for patient care without need for data conversion or other manipulation, with the exception of heparin concentration, heparin assay, heparin dose response and thrombelastograph tests, which shall be interpreted by the attending physician.
When patient results exceed the reportable operating range of the test method and when calibration is not acceptable, such results shall not be used for the diagnosis, treatment, management or monitoring of patients and shall be validated through the hospital laboratory.

(2) Radiology Services. Each Class I and Class II hospital shall provide on the premises, and each Class III hospital shall provide on the premises or by contract, diagnostic imaging facilities commensurate with the hospital’s needs. The radiology department or similarly titled unit shall have a radiologist to serve as medical director on a full time or part time consulting basis to discharge professional radiology services.

(a) The radiology department or other similarly titled part shall be maintained free of hazards for patients and personnel.

(b) Each hospital shall have certified radiologic technologists or basic x-ray machine operators in hospitals of 150 beds or less, and shall be on duty or on call at all times.

(c) The use of all diagnostic imaging apparatus shall be limited to Florida licensed or certified individuals working within their scope of practice, as determined by their regulatory board.

(d) The credentials of each person providing diagnostic and therapeutic radiation, imaging and nuclear medicine services, including formal training, on-the-job experience, and certification or licensure where applicable, shall be maintained on file at all times.

(e) The medical director shall maintain and enforce policies and procedures for the provision of all diagnostic and therapeutic radiation, imaging, and nuclear medicine services. Such policies and procedures shall be written, reviewed annually, and revised as necessary, and shall be dated as to time of last review.

(f) The medical director shall require that all radiology, imaging or nuclear medicine services be performed only upon written order of a licensed physician or by another licensed health professional if that health professional is acting within their scope of practice as defined by applicable laws and rules of the licensing board. Nothing herein shall be construed to expand or restrict such laws and rules pertaining to the practice of various health professions. The request and all results must be recorded in the patient’s medical record;

(g) The medical director shall document all misadministration of radioactive materials, as those terms are defined by Chapter 64E-5, F.A.C.

(h) The medical director shall maintain and document in writing a quality control program designed to minimize the unnecessary duplication of radiographic studies, to minimize exposure time of patients and personnel, and to maximize the quality of diagnostic information and therapy provided.

(3) Respiratory Therapy. Each hospital shall have written policies and procedures describing the scope of respiratory services provided to patients of the hospital. This document shall contain written guidelines for the transfer or referral of patients requiring respiratory care services not provided at the hospital.

(a) When respiratory care services are provided outside the hospital, the hospital shall ensure by contract or other enforceable mechanism that such services meet all safety requirements and quality control measures required by the hospital.

(b) Respiratory care services provided within a hospital shall have medical direction provided by a physician member of the organized medical staff with special interest and knowledge in the management of acute and chronic respiratory problems. The physician director shall be responsible for the overall direction of respiratory services, for conducting a review of the quality, safety and appropriateness of respiratory care services quarterly, and shall be available for any required respiratory care consultation.

(c) Respiratory care services in a hospital may be supervised by a technical director who is registered or certified by the National Board of Respiratory Care Inc., or has the documented equivalent education, training and experience. Other respiratory care personnel shall provide respiratory care commensurate with their documented training, experience, and competence.

(d) The formal training of respiratory therapy students shall be carried out only in programs accredited by appropriate professional educational organizations. Individuals in student status shall be directly supervised when engaged in patient care activities.

(e) The education, training and experience of personnel who provide respiratory care services shall be documented, and shall be related to each individual’s level of participation in the provision of respiratory care services.

(f) Nonphysician respiratory care personnel shall not perform patient procedures associated with a potential hazard, including arterial puncture for obtaining blood samples, unless authorized in writing by the physician director of the respiratory care service acting in accordance with professional staff policy.

(g) The physician director shall be responsible for ensuring all personnel providing respiratory care services participate in education programs designed to augment the personnel’s knowledge of pertinent new developments in respiratory care services and maintain current competency. Such participation shall occur annually, and shall include instruction in safety, infection control, and cardiopulmonary resuscitation.

(h) There shall be written policies and procedures specifying the scope and conduct of patient care rendered in the provision of respiratory care services. All policies and procedures must be approved by the physician director, reviewed annually, revised as necessary, dated to indicate the time of last review, and enforced. Respiratory care policies shall include the following:

Specification as to who may perform specific procedures and provide instruction, under what circumstances, and under what degree of supervision.
Assembly and sequential operation of equipment and accessories to implement therapeutic regimens.
Steps to be taken in the event of adverse reactions, and other emergencies.
Procurement, handling, storage and dispensing of therapeutic gases.
Infection control measures, including specifics as to changing and cleansing of equipment.
Administration of medications in accordance with the physician’s order.

(i) The respiratory care service shall have equipment and facilities to assure the safe, effective and timely provision of respiratory care service to patients.

All equipment shall be calibrated and operated according to manufacturer’s specifications, and shall be periodically inspected and maintained.
Where piped-in gas is used, an evaluation shall be made prior to use to assure identification of the gas and its delivery within an established safe pressure range.
Ventilators used for continuous assistance or controlled breathing shall have operative alarm systems at all times.

(j) Prescriptions for respiratory care shall specify the type, frequency and duration of treatment and, as appropriate, the type and dose of medication, the type of dilutent, and the oxygen concentration, and shall be incorporated into the patient’s medical record.

History

Rulemaking Authority 395.0091, 395.1055 FS. Law Implemented 395.0091, 395.1055 FS. History–New 8-15-18, Amended 10-10-19.

Fla. Admin. Code R. 59A-3.243 Nursing Services

Each hospital shall have a nursing department organized and staffed to provide quality nursing care to each patient. The relationship of the nursing department to other units of the hospital shall be documented by an organizational chart.

(1) The nursing department shall have a written organizational plan that delineates lines of authority, accountability and communication, and shall assure that the following nursing management functions are fulfilled:

(a) Review and approval of policies and procedures that relate to qualifications and employment of nurses.

(b) Establishment of standards for nursing care and mechanisms for evaluating such care.

(d) Assuring that a written evaluation is made of the performance of registered nurses and ancillary nursing personnel at the end of any probationary period and at a defined interval thereafter.

(2) The nursing department shall have written standards of nursing practice and related policies and procedures to define and describe the scope and conduct of patient care provided by the nursing staff. These policies and procedures shall be reviewed annually, revised as necessary, dated to indicate the time of the last review, signed by the responsible reviewing authority, and enforced.

(3) The nursing department shall maintain a list of licensed personnel, including private duty and per diem nurses, with each individual’s current license number, and documentation of the nurses’ hours of employment, and unit of employment within the hospital.

(4) Each hospital shall employ a registered nurse on a full time basis who shall have the authority and responsibility for managing nursing services and taking all reasonable steps to assure that a uniformly optimal level of nursing care is provided throughout the hospital.

(a) The registered nurse shall be responsible for ensuring that a review and evaluation of the quality and appropriateness of nursing care is accomplished. The review and evaluation shall be based on written criteria, shall be performed quarterly, and shall examine the provision of nursing care and its effect on patients.

(b) The registered nurse shall ensure that education and training programs for nursing personnel are available and are designed to augment nurses’ knowledge of pertinent new developments in patient care and maintain current competence. Cardiopulmonary resuscitation training shall be conducted as often as necessary, but not less than annually, for all nursing staff members who cannot otherwise document their competence.

(c) The registered nurse shall be responsible for determining the number of qualified registered nurses to be on duty at all times. The number of qualified nurses shall be sufficient to ensure immediate availability of a registered nurse for bedside care of any patient when needed, to assure prompt recognition of an untoward change in a patient’s condition, and to facilitate appropriate intervention by nursing, medical or other hospital staff members.

(5) The nursing process of assessment, planning, intervention and evaluation shall be documented for each hospitalized patient from admission through discharge.

(a) Each patient’s nursing needs shall be assessed by a registered nurse at the time of admission or within the period established by each hospital’s policy.

(b) Nursing goals shall be consistent with the therapy prescribed by the responsible member of the organized medical staff.

(c) Nursing intervention and patient response, and patient status on discharge from the hospital, must be noted on the medical record.

(6) Each Class I and Class II hospital shall have a minimum of one licensed registered nurse on duty at all times on each nursing unit or similarly titled part of the hospital for rendering patient care services.

(7) A hospital authorized by the Centers for Medicare and Medicaid Services to provide acute hospital care at home via waiver request as provided at https://qualitynet.cms.gov/acute-hospital-care-at-home shall be exempt from subsections (4)(c) and (6) of this rule for patients receiving acute hospital care at home services.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 8-15-18, Amended 8-6-25.

Fla. Admin. Code R. 59A-3.244 Ambulatory, Obstetrical, and Special Care Units

(1) Ambulatory Care Services. Each hospital offering ambulatory care services under its hospital license shall establish policies and procedures to ensure that quality care based on the needs of the patient will be delivered at all times.

(a) Ambulatory care services shall be under the direction of a licensed physician(s) responsible for the clinical direction of patient care and treatment services, and whose qualifications, authority, and responsibilities are defined in writing as approved by the governing board.

(b) Ambulatory care services shall be staffed with appropriately trained and qualified individuals to provide the scope of services anticipated to meet the needs of the patients.

(c) Each patient’s general medical condition shall be managed by a member of the organized medical staff with appropriate clinical privileges, as determined by medical staff bylaws.

(d) When any ambulatory care services are provided by non-hospital employees, the provider shall meet all safety requirements, abide by all pertinent rules and regulations of the hospital and medical staff, and document the quality improvement measures to be implemented.

(e) The provisions of ambulatory nursing care shall be supervised by a registered nurse who is qualified by relevant training and experience in ambulatory care.

(f) Sufficient personnel shall be on duty to provide efficient and effective patient care services.

(g) The scope of services offered, and the relationship of the ambulatory services program to other hospital units, as well as all supervisory relationships within the program, shall be defined in writing, and must be provided in accordance with the standards set by the governing board’s bylaws and the rules and regulations of the medical staff.

(h) Written policies and procedures to guide the operation of the ambulatory services program shall be developed, reviewed, and revised as necessary, dated to indicate the time of last revision, and enforced.

(i) A medical record must be maintained on every patient who receives ambulatory care services. Medical records shall be managed and maintained in accordance with acceptable professional standards and practices. Confidentiality and disclosure of patient information contained in the medical record must be maintained in accordance with hospital policy and state and federal law. Each patient’s medical record must include the following information, and be updated as necessary:

Patient identification;
Relevant history of the illness or injury and of physical findings;
Diagnostic and therapeutic orders;
Clinical observations, including the results of treatment;
Reports of procedures and tests, and their results;
Diagnosis or impression;
Allergies;
Referrals to practitioners or providers of services internal or external to the hospital;
Communications to and from practitioners or providers of service external to the hospital;
Growth charts for children and adolescents as needed when the service is the source of primary care; and
Immunization status of children and adolescents and others as determined by law and/or hospital policy.

(j) To facilitate the ongoing provision of care, a problem list of known significant diagnoses, conditions, procedures, drug allergies and medications shall be maintained for each patient who receives ambulatory services. The problem list shall be initiated no later than the third visit and include items based on any initial medical history and physical examination, and updated on subsequent visits with additional information as necessary. The problem list shall include the following items:

Known significant medical diagnoses and conditions;
Known significant surgical and invasive procedures;
Known adverse and allergic reactions to drugs; and
Medications known to be prescribed for and/or used by the patient.

(2) Obstetrical Department. If provided, obstetrical services shall include labor, delivery, and nursery facilities, and be formally organized and operated to provide complete and effective care for each patient.

(a) Except in hospitals licensed for 75 beds or less, the obstetrical service shall be separated from other patient care rooms and shall have separate nursing staff. When obstetrical services are provided in hospitals of 75 beds or less, there shall be:

A written and enforced policy concerning the placement of obstetrical patients in a manner most conducive to meet their special needs, and
Nursing staff who possess specialized skills in obstetrics and neonatal care, whether by training or experience, and can provide service to obstetrical patients and their infants on a 24 hour basis, whether on duty, on call, or on a consultative basis.

(b) In those hospitals with a formally organized obstetrical department, clean gynecological and surgical patients may be admitted to the unit under specific written controls approved by the medical staff and governing board when there is a written demonstrated need in each case.

(c) Every infant born in a hospital shall be properly identified immediately at the time of birth. Identification of the infant shall be done in the delivery room, birthing room, or other place of birth within the hospital, before either the mother or the infant is transferred to another part of the facility.

(3) Special Care Units. The hospital shall ensure that a special care unit is a physically and functionally distinct entity within the hospital, has controlled access, and has an effective means of isolation for patients suffering from communicable or infectious disease or acute mental disorder.

(a) Special care units shall provide:

Direct or indirect visual observation by unit staff of all patients from one or more vantage points;
A direct intercommunication or alarm system between the nurse’s station and the bedside; and
Beds that are adjustable to positions required by the patient, that are easily movable, and that have a locking or stabilizing mechanism to attain a secure, stationary position. Headboards, when present, shall be removable or adjustable to permit ready access to the patient’s head.

(b) Each special care unit shall be advised by a physician who is a member of the organized medical staff.

(c) Each special care unit shall have its relationship to other departments and units of the hospital specified in writing (organizational chart).

(d) All staff shall participate in annual in-service education programs concerning cardiopulmonary resuscitation and safety and infection control requirements.

(e) Written policies and procedures shall be developed concerning the scope and provision of care in each special care unit. Such policies and procedures shall be reviewed annually, revised as necessary, dated to indicate the time of last review, enforced, and include the following:

Specific criteria for the admission and discharge of patients;
A system for informing the responsible member of the organized medical staff of changes in the patient's condition;
Methods for procurement of equipment and drugs at all times;
Specific procedures relating to infection and traffic control;
Specification as to who may perform special procedures, under what circumstances, and under what degree of supervision; and specific policies as to the use of standing orders; and
A protocol for handling emergency conditions related to the breakdown of essential equipment.

(f) No hospital shall hold itself out as a Trauma Center unless it has been verified as a Trauma Center by the Department of Health. Any violation of the Trauma Center provisions shall subject any violator to appropriate remedies provided by Section 395.1065, F.S.

History

Rulemaking Authority 395.1055, 408.036 FS. Law Implemented 395.1055 FS. History–New 8-15-18.

Fla. Admin. Code R. 59A-3.245 Surgical and Anesthesia Departments

(1) Surgical Department. Each Class I and Class II hospital, and each Class III hospital providing operative and other invasive procedures, shall have a functionally and physically distinct surgical department within the hospital, organized under written policies and procedures regarding surgical privileges, maintenance of the operating rooms, and evaluation and recording of treatment of the patient. The surgical department shall have a physician member of the organized medical staff serve as medical advisor to the surgical department and a registered nurse to direct nursing services within the operating rooms of a surgical department. All surgical department policies and procedures shall be available to the Agency, shall be reviewed annually, dated to indicate time of last review, revised as necessary, and enforced.

(a) The determination of the appropriateness of the procedure for a patient shall be based on:

The patient’s medical, anesthetic, and drug history;
The patient’s physical status;
Diagnostic data;
The risks and benefits of the procedure; and,
The need to administer blood or blood components.

(b) The risks and benefits of the procedure shall be discussed with the patient prior to documenting informed consent and include:

Other treatment options, if they exist;
The need and risk of blood transfusions and available alternatives; and
Anesthesia options and risks.

(c) A preanesthesia evaluation of the patient shall be performed prior to surgery, except in the case of extreme emergency.

(d) Plans of care for the patient shall be formulated and documented in the medical record prior to the performance of surgery and shall include a plan for anesthesia, nursing care, the operative or invasive procedure, and the level of post-procedure care.

(e) The measurement of the patient’s physiological status shall be assessed during the administration of anesthesia and the surgical procedure.

(f) The post-procedure status of the patient shall be assessed on admission to the recovery area and prior to discharge from the recovery area.

(g) The patient shall be discharged from the recovery area by a member of the organized medical staff.

(h) The operating room and accessory services shall be located in a manner to prevent through traffic, control traffic in and out, and maximize infection control.

(i) All infections of clean surgical cases shall be recorded and reported to the appropriate infections control authority, and a procedure shall exist for the investigation of such cases.

(j) The registered nurse shall document that all surgical nursing staff have received annual continuing education in safety, infection control and cardiopulmonary resuscitation.

(k) A roster of members of the organized medical staff specifying the surgical privileges of each, shall be maintained, reviewed annually and revised as necessary.

(l) A roster of “on-call” surgeons shall be promptly available at the operating room nursing stations. An on-call surgeon must be available to the hospital when a call for services has been placed.

(m) A record shall be maintained on a current basis that contains the following information:

Patient’s name;
Hospital number;
Preoperative diagnosis;
Post-operative diagnosis;
Procedure;
Names of surgeon, first assistant, and anesthetist;
Type of anesthetic; and,
Complications, if any.

(n) Regardless of whether surgery is classified as major or minor, the surgical department shall ensure, prior to any surgery being performed, except in emergency situations:

That there is a complete history and physical workup in the chart of every patient or, if such has been transcribed, but not yet recorded in the patient’s chart, that there is a statement to that effect in the chart; and,
That there is evidence of informed consent for the operation in the patient’s chart.

(o) The surgical department shall ensure that immediately following each surgery, there is an operative report describing techniques and findings that is written or dictated and signed by the surgeon.

(p) The following equipment shall be in each operating room suite:

Call-in system;
Oxygen, and means of administration;
Mechanical ventilatory assistance equipment, including airways, manual breathing bag, and ventilator and respirator;
Cardiac defibrillator with synchronization capability;
Respiratory and cardiac monitoring equipment;
Thoracentesis and closed thoracostomy sets;
Tracheostomy set, tourniquets, vascular cutdown sets, infusion pumps, laryngoscopes and endotracheal tubes;
Tracheobronchial and gastric suction equipment; and
A portable x-ray which shall be available, but need not be physically present in the operating suite.

(2) Anesthesia Department. Each Class I and Class II hospital, and each Class III hospital providing surgical or obstetrical services, shall have an anesthesia department, service or similarly titled unit directed by a physician member of the organized professional staff.

(a) The anesthesia department of each hospital shall have written policies and procedures that are approved by the organized medical staff, are reviewed annually, dated at time of last review, revised, and enforced as necessary. Such written policies and procedures shall include the following requirements:

A preanesthesia evaluation of the patient by the physician, or qualified oral surgeon in the case of patients without medical problems admitted for dental procedures, or certified registered nurse anesthetist where authorized by established protocol approved by the medical staff, except in the case of emergencies.
A review of the patient’s condition immediately prior to induction of anesthesia.
A mechanism for release of patients from postanesthesia care.
A recording of all pertinent events taking place during the induction of, maintenance of, and emergence from anesthesia.
Guidelines for the safe use of all general anesthetic agents used in the hospital.

(b) The responsibilities and qualifications of all anesthesia personnel, including physician, nurse and dentist anesthetists and all trainees, must be defined in a policy statement, job description, or other appropriate document.

(c) Anesthetic safety regulations shall be developed, posted, and enforced. Such regulations shall include the following:

A requirement that all operating room electrical and anesthesia equipment be inspected on an annual basis and at intervals not exceeding the manufacturer’s recommendations. A written record of the inspection results and corrective action shall be maintained by the hospital.
A requirement that flammable anesthetic agents be employed only in areas in which a conductive pathway can be maintained between the patient and a conductive floor.
A requirement that each anesthetic gas machine have a pin-index or equivalent safety system.
A requirement that all reusable anesthesia equipment coming in direct contact with the patient be cleaned or sterilized in the manner prescribed by current medical standards.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 8-15-18.

Fla. Admin. Code R. 59A-3.246 Licensed Programs

(1) Adult Diagnostic Cardiac Catheterization Program. All licensed hospitals that establish adult diagnostic cardiac catheterization laboratory services under Section 395.1055, F.S., shall operate in compliance with the most recent guidelines of the American College of Cardiology and American Heart Association, including collaborating organizations, regarding the operation of diagnostic cardiac catheterization laboratories. Hospitals are considered to be in compliance with American College of Cardiology and American Heart Association guidelines when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The applicable guideline is Rao, S, O’Donoghue, M, Ruel, M. et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025;151:e771–e862. doi: 10.1161/CIR.0000000000001309 (Guidelines) which is hereby incorporated by reference and effective at adoption. The copyrighted material is available for public inspection at the Agency for Health Care Administration, Hospital and Outpatient Services Unit, 2727 Mahan Drive, Tallahassee, FL 32308 and the Department of State, R.A. Gray Building, 500 South Bronough Street, Tallahassee, FL 32399. The document is available on the World Wide Web site of the American Heart Association at www.ahajournals.org/journal/circ. Aspects of the guideline related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. All such licensed hospitals shall have a department, service or other similarly titled unit which shall be organized, directed and staffed, and integrated with other units and departments of the hospitals in a manner designed to assure the provision of quality patient care.

(a) Licensure.

A hospital may apply for licensure to provide adult diagnostic cardiac catheterization laboratory services by submitting a hospital licensure application as specified in subsection 59A-3.066(2), F.A.C., indicating the addition of an adult diagnostic cardiac catheterization laboratory services program available at: https://ahca.myflorida.com/health-quality-assurance/hqa-applications-for-licensure. The license application form must be signed by the hospital’s Chief Executive Officer or the authorized representative, confirming the hospital’s intent and ability to comply with Section 395.1055, F.S.
An authorized representative of a hospital providing adult diagnostic cardiac catheterization services must renew this licensed program at the time of the hospital licensure renewal by completing the subsection entitled Adult Cardiovascular Services on the hospital licensure application specified in subsection 59A-3.066(2), F.A.C. Failure to renew the hospital’s license or failure to complete the subsection entitled Adult Cardiovascular Services, thereby not attesting to meeting the requirements, shall cause the licensed program to expire.
Hospitals licensed to provide adult diagnostic cardiac catheterization services, and not Level I or Level II adult cardiovascular services may provide the services to patients 15 to 17 years of age provided the physician in charge of the procedure is a pediatric cardiologist or an adult cardiologist with specialized training in adult congenital heart disease.

(b) Therapeutic Cardiac Catheterization Procedures. An adult diagnostic cardiac catheterization program established pursuant to Section 395.1055, F.S., shall not provide therapeutic services, such as percutaneous coronary intervention or stent insertion, intended to treat an identified condition or the administering of intra-coronary drugs, such as thrombolytic agents.

(c) Diagnostic Cardiac Catheterization Procedures. Procedures performed in the adult diagnostic cardiac catheterization laboratory shall include the following:

Left heart catheterization with coronary angiography and left ventriculography;
Right heart catheterization;
Hemodynamic monitoring line insertion;
Aortogram;
Emergency temporary pacemaker insertion;
Myocardial biopsy;
Intra-coronary ultrasound (CVIS);
Fluoroscopy; and
Hemodynamic stress testing.

(d) Support Equipment. A crash cart containing the necessary medication and equipment for ventilatory support shall be located in each cardiac catheterization procedure room. A listing of all crash cart contents shall be readily available. At the beginning of each shift, the crash cart shall be checked for intact lock; the defibrillator and corresponding equipment shall be checked for function and operational capacity. A log shall be maintained indicating review.

(e) Radiographic Cardiac Imaging Systems. A quality improvement program for radiographic imaging systems shall include patient and operator safety, measures of image quality, dynamic range, and modulation transfer function. Documentation indicating the manner in which this requirement will be met shall be available for the Agency’s review.

(f) Physical Plant Requirements. The Florida Building Code contains the physical plant requirements for cardiac catheterization facilities.

(g) Personnel Requirements. There shall be trained personnel available to meet the needs of the patient. At a minimum, a team involved in cardiac catheterization shall consist of a physician, one registered nurse, and one technician.

(h) Quality Improvement Program. A quality improvement program for the adult diagnostic cardiac catheterization program laboratory shall include an assessment of proficiency in diagnostic coronary procedures and integrated in the hospital wide program described in Rule 59A-3.271, F.A.C. Essential data elements for the quality improvement program include the individual physician procedural volume and major complication rate; the institutional procedural complication rate; patient clinical and demographic information; verification of data accuracy; and procedures for patient, physician and staff confidentiality. Documentation indicating the manner in which this requirement will be met shall be available for the Agency’s review.

(i) Emergency Services.

All hospitals providing adult diagnostic cardiac catheterization services, except hospitals licensed as a Level II adult cardiovascular services provider, shall have written transfer agreements developed specifically for diagnostic cardiac catheterization patients with one or more hospitals licensed as a Level II adult cardiovascular services provider. Written agreements must be in place with a ground ambulance service capable of advanced life support and Intra-Aortic Balloon Pump (IABP) transfer. Agreements may include air ambulance service, but must have ground ambulance backup. A transport vehicle must be onsite to begin transport within 30 minutes of a request and have a transfer time within 60 minutes. Transfer time is defined as the number of minutes between the recognition of an emergency as noted in the hospital’s internal log and the patient’s arrival at the receiving hospital. Transfer and transport agreements must be reviewed and tested once every 6 months, with appropriate documentation maintained, including the hospital’s internal log or emergency medical services data.
Patients at high risk for diagnostic catheterization complications shall be referred for diagnostic catheterization services to hospitals licensed as a Level II adult cardiovascular services provider. Hospitals not licensed as a Level II adult cardiovascular services provider must have documented patient selection and exclusion criteria and provision for identification of emergency situations requiring transfer to a hospital with a Level II adult cardiovascular services program. Documentation indicating the manner in which this requirement will be met shall be available for the Agency’s review.

(j) Policy and Procedure Manual for Medicaid and Charity Care.

Each provider of adult diagnostic cardiac catheterization services shall maintain a policy and procedure manual, available for review by the Agency, which documents a plan to provide services to Medicaid and charity care patients.
The policy and procedure manual shall document specific outreach programs directed at Medicaid and charity care patients for adult diagnostic cardiac catheterization services.

(k) In case of conflict between the provisions of this rule and the 2025 Guidelines, the provisions of this part shall prevail.

(2) Level I Adult Cardiovascular Services.

(a) Licensure.

A hospital may apply for licensure to provide Level I adult cardiovascular services by submitting a hospital licensure application as specified in subsection 59A-3.066(2), F.A.C., indicating the addition of a Level I adult cardiovascular services program. This form is available at: https://ahca.myflorida.com/health-quality-assurance/hqa-applications-for-licensure. The hospital licensure application must be signed by the hospital’s Chief Executive Officer or the authorized representative, confirming that for the most recent 12-month period, the hospital has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred a minimum of 300 patients with the principal diagnosis of ischemic heart disease (defined by ICD-10-CM codes I20-I25).

a. Reportable cardiac catheterizations are defined as single sessions with a patient in the hospital’s cardiac catheterization procedure room(s), irrespective of the number of specific procedures performed during the session.

b. Reportable cardiac catheterizations shall be limited to those provided and billed for by the Level I licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant.

The request shall confirm the hospital’s intent and ability to comply with the following publications, herein incorporated by reference and effective at adoption. The publications are applicable to this section and will be referred to as the Guidelines:

a. Grines CL, BoxLC, Mamas MA, et al. SCAI Expert Consensus Statement on Percutaneous Coronary Intervention Without On-Site Surgical Backup. J Soc Cardiovasc Angiogr Interv. 2023 Jan 30;2(2):100560. The copyrighted material is available for public inspection at the Agency for Health Care Administration, Hospital and Outpatient Services Unit, 2727 Mahan Drive, Tallahassee, FL 32308 and the Department of State, R.A. Gray Building, 500 South Bronough Street, Tallahassee, FL 32399. This document is available on the World Wide Web site of the Journal of the Society for Cardiovascular Angiography and Interventions at https://www.jscai,.org.

b. Rao, S, O’Donoghue, M, Ruel, M. et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025;151:e771–e862. doi: 10.1161/CIR.0000000000001309. The copyrighted material is available for public inspection at the Agency for Health Care Administration, Hospital and Outpatient Services Unit, 2727 Mahan Drive, Tallahassee, FL 32308 and the Department of State, R.A. Gray Building, 500 South Bronough Street, Tallahassee, FL 32399. The document is available on the World Wide Web site of the American Heart Association at www.ahajournals.org/journal/circ.

c. Lawton JS, Tamis-Holland JE, Bangalore S, et al. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022;145:e18–e114. doi: 10.1161/CIR.0000000000001038. The copyrighted material is available for public inspection at the Agency for Health Care Administration, Hospital and Outpatient Services Unit, 2727 Mahan Drive, Tallahassee, FL 32308 and the Department of State, R.A. Gray Building, 500 South Bronough Street, Tallahassee, FL 32399. The document is available on the World Wide Web site of the American Heart Association at www.ahajournals.org/journal/circ.

The request shall confirm the hospital’s intent and ability to comply with the Guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety.
The request shall confirm the hospital’s intent and ability to comply with physical plant requirements regarding cardiac catheterization laboratories and operating rooms found in the Florida Building Code.
The request shall confirm the hospital has one or more written transfer agreements with hospitals that operate a Level II adult cardiovascular services program, as specified in paragraph (2)(c), below.
All providers of Level I adult cardiovascular services shall operate in compliance with subsection 59A-3.246(1), F.A.C. and the Guidelines regarding the operation of adult diagnostic cardiac catheterization laboratories and the provision of percutaneous coronary intervention. Level I adult cardiovascular services may be provided to adult patients. Level I adult cardiovascular services may be provided to patients 15 to 17 years of age provided the physician in charge of the procedure is a pediatric cardiologist or an adult cardiologist with specialized training in adult congenital heart disease.
Aspects of the Guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule. Aspects of the Guidelines related to the provision of elective percutaneous coronary intervention only in hospitals authorized to provide cardiovascular surgery are not applicable to this rule.
Hospitals are considered to be in compliance with the Guidelines when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must document an ongoing quality improvement plan designed to analyze data, correct errors, identify system improvements and ongoing improvement in patient care and delivery of services. Hospitals must participate in submission of data to the American College of Cardiology’s National Cardiovascular Data Registry or the American Heart Association’s Get with the Guidelines–Coronary Artery Disease registry to ensure that the Level I program meet or exceed national quality and outcome benchmarks in which the hospital participates. Hospitals providing Level I adult cardiovascular services must have available upon request of the Agency the number of diagnostic and therapeutic adult cardiac catheterizations performed during the most recent 12-month period.
Notwithstanding guidelines to the contrary in the Guidelines all providers of Level I adult cardiovascular services may provide emergency and elective percutaneous coronary intervention procedures.
Hospitals with Level I adult cardiovascular services programs are prohibited from providing any lead extraction for a pacemaker, biventricular pacer or implanted cardioverter defibrillator.
An authorized representative of hospitals with Level I adult cardiovascular services must renew this licensed program at the time of the hospital licensure renewal by completing the subsection entitled Adult Cardiovascular Services on the hospital licensure application specified in subsection 59A-3.066(2), F.A.C. Failure to renew the hospital’s license or failure to complete the subsection entitled Adult Cardiovascular Services, thereby attesting to meeting at least the minimum requirements, shall cause the licensed program to expire.

(b) Staffing. All staff participating as members of the catheterization team, including physicians, nurses, and technical cathererization laboratory staff shall maintain Advanced Cardiac Life Support certification, and must participate in a 24-hour-per-day, 365 day-per-year call schedule.

At initial licensure, each cardiologist shall be an experienced physician who has performed a minimum of 50 interventional cardiology procedures, including at least 11 primary cardiology interventional procedures, exclusive of fellowship training, and within the previous 12 months from the date of the Level I adult cardiovascular licensure application.
At licensure renewal, interventional cardiologists shall perform a minimum of 50 interventional cardiology procedures per year averaged over a 2-year period or be confirmed by the review process described in subparagraph 59A-3.246(3)(b)3., F.A.C.
The providers of Level I adult cardiovascular services shall develop internal review processes to assess interventional cardiologists performing less than the required annual volume. Low volume operators must be evaluated and confirmed by an independent institutional committee consisting of physicians and other healthcare personnel as selected by the hospital, or an external review organization. Factors that shall be considered in assessing operator competence include operator volume, lifetime experience, institutional volume, individual operator’s other cardiovascular interventions and quality assessment of the operator’s ongoing performance.
Technical catheterization laboratory staff shall be credentialed as Registered Cardiovascular Invasive Specialists or shall complete a hospital-based education and training program at a hospital providing Level I or Level II adult cardiovascular services. This training program shall include a minimum of 500 hours proctored clinical experience and didactic education components of hemodynamics, pharmacology, arrhythmia recognition, radiation safety, and interventional equipment.
Nursing staff within the adult coronary care unit must be trained and experienced with invasive hemodynamic monitoring, operation of temporary pacemaker, management of Intra-Aortic Balloon Pump (IABP), management of in-dwelling arterial/venous sheaths and identifying potential complications such as abrupt closure, recurrent ischemia and access site complications.

(c) Emergency Services. All providers of Level I adult cardiovascular services shall have written transfer agreements developed specifically for emergency transfer of interventional cardiology patients with one or more hospitals licensed as a Level II adult cardiovascular services provider. Written agreements must be in place with a ground ambulance service capable of advanced life support and IABP transfer. Agreements may include air ambulance service, but must have ground ambulance backup. A transport vehicle must be onsite to begin transport within 30 minutes of a request and have a transfer time within 60 minutes. Transfer time is defined as the number of minutes between the recognition of an emergency as noted in the hospital’s internal log and the patient’s arrival at the receiving hospital. Transfer and transport agreements must be reviewed and tested once every 6 months, with appropriate documentation maintained, including the hospital’s internal log or emergency medical services data.

(d) Policy and Procedure Manual for Medicaid and Charity Care.

Each provider of Level I adult cardiovascular services shall maintain a policy and procedure manual, available for review by the Agency, which documents a plan to provide services to Medicaid and charity care patients.
The policy and procedure manual shall document specific outreach programs directed at Medicaid and charity care patients for Level I adult cardiovascular services.

(e) Physical Plant Requirements. Each provider of Level I adult cardiovascular services must comply with the Florida Building Code regarding the physical plant requirements for cardiac catheterization laboratories operated by a licensed hospital.

(f) In case of conflict between the provisions of this rule and the Guidelines, the provisions of this part shall prevail.

(3) Level II Adult Cardiovascular Services.

(a) Licensure.

A hospital may apply for licensure to provide Level II adult cardiovascular services by submitting a hospital licensure application as specified in subsection 59A-3.066(2), F.A.C., indicating the addition of a Level II adult cardiovascular services program. This form is available at: https://ahca.myflorida.com/health-quality-assurance/hqa-applications-for-licensure. The hospital licensure application must be signed by the hospital’s Chief Executive Officer or the authorized representative, confirming that for the most recent 12-month period, the hospital has provided a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease (defined by ICD-10-CM codes I20-I25). Reportable cardiac catheterizations shall be limited to those provided and billed for by the Level II licensure applicant and shall not include procedures performed at the hospital by physicians who have entered into block leases or joint venture agreements with the applicant.
The request shall confirm the hospital’s intent and ability to comply with the Guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety.
The request shall confirm to the hospital’s intent and ability to comply with physical plant requirements regarding cardiac catheterization laboratories and operating rooms found in the Florida Building Code.
All providers of Level II adult cardiovascular services shall operate in compliance with subsections (1) and (2) of this rule and the Guidelines regarding the operation of diagnostic cardiac catheterization laboratories, the provision of percutaneous coronary intervention and the provision of coronary artery bypass graft surgery. Level II adult cardiovascular services may be provided to adult patients. Level II adult cardiovascular services may be provided to patients 15 to 17 years of age provided the physician in charge of the procedure is a pediatric cardiologist or an adult cardiologist with specialized training in adult congenital heart disease. Aspects of the Guidelines related to pediatric services or outpatient cardiac catheterization in freestanding non-hospital settings are not applicable to this rule.
Hospitals are considered to be in compliance with the Guidelines when they adhere to standards regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. Hospitals must document an ongoing quality improvement plan designed to analyze data, correct errors, identify system improvements and ongoing improvement in patient care and delivery of services. Hospitals must participate in submission of data to the American College of Cardiology’s National Cardiovascular Data Registry or the American Heart Association’s Get with the Guidelines–Coronary Artery Disease registry and participate in the clinical outcome reporting systems operated by the Society of Thoracic Surgeons to ensure that the Level II program and the cardiac surgical program meet or exceed national quality and outcome benchmarks in which the hospital participates. Hospitals providing Level II adult cardiovascular services must have available upon request of the Agency the number of diagnostic and therapeutic adult cardiac catheterizations performed during the most recent 12-month period.
An authorized representative of hospitals with Level II adult cardiovascular services must renew this licensed program at the time of the hospital licensure renewal by completing the subsection entitled Adult Cardiovascular Services on the hospital licensure application specified in subsection 59A-3.066(2), F.A.C. Failure to renew the hospital’s license or failure to complete the subsection entitled Adult Cardiovacular Services, thereby attesting to meeting at least the minimum requirements, shall cause the licensed program to expire.

(b) Staffing. All staff participating as members of the catheterization team, including physicians, nurses, and technical catheterization laboratory staff shall maintain Advanced Cardiac Life Support certification, and must participate in a 24-hour-per-day, 365 day-per-year call schedule.

Each cardiac surgeon shall be Board certified.

a. New surgeons shall be Board certified within 4 years after completion of their fellowship.

b. Experienced surgeons with greater than 10 years experience shall document that their training and experience preceded the availability of Board certification.

All interventional cardiologists shall perform a minimum of 50 coronary interventional procedures per year averaged over a 2-year period which includes at least 11 primary cardiology interventional procedures per year or be confirmed by an internal review process described in this subsection.
The providers of Level II adult cardiovascular services shall develop internal review processes to assess interventional cardiologists performing less than the required annual volume. Low volume operators must be evaluated and confirmed by an independent institutional committee consisting of physicians and other healthcare personnel as selected by the hospital, or an external review organization. Factors that shall be considered in assessing operator competence include operator volume, lifetime experience, institutional volume, individual operator’s other cardiovascular interventions and quality assessment of the operator’s ongoing performance.
Technical catheterization laboratory staff shall be credentialed as Registered Cardiovascular Invasive Specialists or shall complete a hospital-based education and training program at a hospital providing Level I or Level II adult cardiovascular services. This training program shall include a minimum of 500 hours proctored clinical experience and didactic education components of hemodynamics, pharmacology, arrhythmia recognition, radiation safety, and interventional equipment.
Coronary care unit nursing staff must be trained and experienced with invasive hemodynamic monitoring, operation of temporary pacemaker, management of IABP, management of in-dwelling arterial/venous sheaths and identifying potential complications such as abrupt closure, recurrent ischemia and access site complications.

Each provider of Level II adult cardiovascular services shall maintain a policy and procedure manual, available for review by the Agency, which documents a plan to provide services to Medicaid and charity care patients.
The policy and procedure manual shall document specific outreach programs directed at Medicaid and charity care patients for Level II adult cardiovascular services.

(d) Physical Plant Requirements. Each provider of Level II adult cardiovascular services must comply with the Florida Building Code regarding the physical plant requirements for cardiac catheterization laboratories and operating rooms for cardiac surgery operated by a licensed hospital.

(e) In case of conflict between the provisions of this rule and the Guidelines, the provisions of this part shall prevail.

(4) Stroke centers. Hospitals providing acute stroke ready center, primary stroke center, thrombectomy-capable stroke center, or comprehensive stroke center services shall have the services available 24 hours per day, 7 days per week.

(a) Licensure. A hospital may apply for designation as an acute stroke ready center, primary stroke center, thrombectomy-capable stroke center, or comprehensive stroke center by submitting a hospital licensure application as specified in subsection 59A-3.066(2), F.A.C., and attaching documentation verifying stroke center certification through:

Center for Improvement in Healthcare Quality;
DNV GL Healthcare;
Health Facilities Accreditation Program; or
The Joint Commission.

(b) Documentation must include a copy of a certificate identifying the level of stroke services provided and the effective and expiration dates of the certification.

(5) Burn Units.

(a) All licensed hospitals that operate burn units under Section 395.1055, F.S., shall comply with the verification criteria published by the American Burn Association. Hospitals are considered to comply with the American Burn Association verification criteria when they adhere to criteria regarding staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria to ensure patient quality and safety. The applicable criteria, herein incorporated by reference and effective at adoption, are currently listed in the Pre-Review Questionnaire PRQ 2026 and is available at https://flrules.org/Gateway/reference.asp?No=Ref-19224 or online at https://www.ameriburn.org/quality-care/verification#get-verified. The determination of compliance with the guidelines is based on the burn unit providing evidence of verification from the American Burn Association.

(b) A hospital may apply for the initial licensure of a burn unit by submitting a hospital licensure application as specified in subsection 59A-3.066(2), F.A.C. This form is available at: https://ahca.myflorida.com/health-quality-assurance/hqa-applications-for-licensure. Applicants documenting an application to the American Burn Association for verification as a burn center but have not received initial verification as a burn center from the American Burn Association shall be licensed as a provisional burn unit. Applicants that have received verification as a burn center from the American Burn Association shall be licensed as a burn unit.

(c) At the time of licensure renewal, burn unit operators shall submit current burn center verification documentation from the American Burn Association.

(d) Each provider of burn unit services shall maintain a policy and procedure manual, available for review by the Agency, which documents a plan to provide services to Medicaid and charity care patients.

(e) Enforcement of these rules shall follow procedures established in Rule 59A-3.253, F.A.C., Chapter 408, Part II and 395, Part I, F.S., including suspension or revocation of the burn unit license.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055, 395.1065, 395.3038 FS. History–New 8-15-18, Amended 4-22-26.

Fla. Admin. Code R. 59A-3.247 Housekeeping Services

Each hospital shall have an organized housekeeping department with a qualified person designated as responsible for all housekeeping functions. The designated supervisor of housekeeping shall be responsible for developing written policies and procedures for coordinating housekeeping services with other departments, developing a work plan and assignments for housekeeping staff, and developing a plan for obtaining relief housekeeping personnel.

(1) A sufficient number of housekeeping personnel shall be employed to fulfill the responsibilities of the housekeeping department seven days a week.

(2) When housekeeping services are provided by a third party, the hospital shall have a formal written agreement with the third party provider on file.

(3) The designated supervisor of housekeeping shall develop, implement, and maintain an effective housekeeping plan to ensure that the facility is maintained in compliance with the following:

(a) The facility and its contents shall be kept free from dust, dirt, debris, and noxious odors;

(b) All rooms and corridors shall be maintained in a clean, safe, and orderly condition, and shall be properly ventilated to prevent condensation, mold growth, and noxious odors;

(d) All mattresses, pillows, and other bedding; window coverings, including curtains, blinds, and shades, cubicle curtains and privacy screens; and furniture shall be kept clean;

(e) Floors shall be kept clean and free from spillage, and non-skid wax shall be used on all waxed floors;

(f) Articles in storage shall be elevated from the floor;

(g) Aisles in storage areas shall be kept unobstructed;

(h) All garbage and refuse from patient areas shall be collected daily and stored in a manner to make it inaccessible to insects and rodents;

(i) Garbage or refuse storage rooms, if used, shall be kept clean, shall be vermin-proof, and shall be large enough to store the garbage and refuse containers that accumulate. Outside garbage or refuse storage areas or enclosures shall be large enough to store the garbage and refuse containers that accumulate, and shall be kept clean. Outside storage of unprotected plastic bags, wet strength paper bags, or baled units containing garbage or refuse is prohibited. Garbage and refuse containers, dumpsters, and compactor systems located outside shall be stored on or above a smooth surface of non-absorbent material, such as concrete or machine-laid asphalt, that is kept clean and maintained in good repair; and

(j) Garbage and refuse shall be removed from both interior and outside storage areas as often as necessary to prevent sanitary nuisance conditions. If garbage and refuse are disposed of on the facility premises, the method of disposal shall not create a sanitary nuisance.

(4) The designated supervisor of housekeeping shall ensure that:

(a) There is a sufficient quantity of linen, including at least sheets, pillow cases, drawsheets or their alternative, blankets, towels and washcloths to provide comfortable, clean and sanitary conditions for each patient at all times;

(b) Written policies and procedures for linen and laundry services, including methods of collection, storage, and transportation are developed, implemented, and maintained in conjunction with the policies and procedures developed by the infection control committee;

(d) Separate containers are used for transporting clean linen and laundry, and soiled linen and laundry;

(e) Soiled linen and laundry are stored in a ventilated area separate from any other supplies, and are not stored, sorted, rinsed, or laundered in patient rooms, bathrooms, areas of food preparation or storage, or areas in which clean material and equipment are stored; and

(f) When linen and laundry services are provided by a third party, the third party provider shall be required to maintain the standards contained herein, and shall ensure that clean linen is packaged and protected from contamination until received by the facility.

(5) Effective control methods shall be employed to protect against the entrance into the facility and the breeding or presence on the premises of flies, roaches, rodents, and other vermin.

(6) The designated supervisor of housekeeping shall develop and implement, in coordination with the infection control committee, written procedures for the cleaning of the physical plant, equipment, and reusable supplies. Such procedures shall include:

(a) Special written procedures for cleaning all infectious disease areas;

(b) Special written procedures for cleaning all operating room suites, delivery suites, nurseries, intensive and other critical care units, the emergency suite, and other areas performing similar functions; and

(c) Special written procedures for the separate handling and storage of both clean and dirty linen, with special attention being given to identification, separation and handling of linens from isolation or infectious disease areas.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 8-15-18.

Fla. Admin. Code R. 59A-3.248 Pediatric Cardiac Programs

(1) Licensure. No hospital may provide pediatric cardiac services without first obtaining a license pursuant to this rule, and Chapters 395, Part I, and 408, Part II, F.S.

(a) A hospital authorized to provide pediatric cardiac catheterization and angioplasty, and pediatric open heart surgery prior to July 1, 2019, shall be licensed to provide pediatric cardiac services as of the effective date of this rule and must comply with the provisions of this rule within one year from the effective date.

(b) Initial. A hospital seeking to provide pediatric cardiac services must submit a hospital licensure application for Agency approval as specified in subsection 59A-3.066(2), F.A.C., which includes:

Approval from the Agency’s Office of Plans and Construction pursuant to Rule 59A-3.080, F.A.C., of the hospital’s operating rooms and cardiac catheterization laboratories to be used for pediatric cardiac services; and
Affirmation that the hospital meets the requirements of this rule.

(c) Renewal. The hospital’s chief executive officer or designee must attest as part of the biennial licensure renewal application as specified in subsection 59A-3.066(2), F.A.C., that the requirements of this rule continue to be met.

(2) Quality of Care.

(a) A hospital providing pediatric cardiac services must:

Ensure all staff participating as members of a catheterization team or cardiovascular surgery team, including physicians, nurses, and technical staff, participate in a 24-hours per day, 7 days per week call schedule capable of rapid mobilization of the team(s) such that all on-call team members are present in the facility and ready to provide services and care within 30 minutes for emergency catheterization procedures or cardiovascular surgery;
Develop a quality assurance and improvement program, including a risk adjustment surgical procedure protocol following the guidelines established by the Society of Thoracic Surgeons, to monitor processes and outcomes, analyze data, and identify system improvements for each component of pediatric cardiac services, and integrate the program into the hospital-wide quality improvement program as required by Rule 59A-3.271, F.A.C.;
Have a dedicated intensive care unit or component within a unit for pediatric acquired or congenital heart disease patients with personnel specially trained as provided in subsection (3) of this rule;
Have a Level III or Level IV neonatal intensive care unit;
Have written policies and procedures for the transition of care from pediatric to adult congenital services, including providing information on recommendations on endocarditis prophylaxis, anticoagulation therapy, diet, weight control, contraception, pregnancy risk with referral to maternal-fetal medicine physicians as appropriate, employment, education, and exercise limitations;
Provide adult congenital heart disease patients contraception, pre-pregnancy and genetic counseling, and fetal echocardiography studies, as appropriate; and
Participate in national registries as specified in subsection (7) of this rule.

(b) Each hospital must have the capability to provide:

Immediate endocardiac catheter pacemaking in cases of cardiac arrest;
Pressure recording for monitoring and evaluation of all cardiovascular parameters;
Repair or replacement of heart valves;
Repair of congenital heart defects;
Emergency cardiac catheterization for interventions, including septostomy;
Repair or reconstruction of intrathoracic vessels, and
Treatment of penetrating and blunt force cardiac injury.

Meet the requirements for ambulatory care services as described in subsection 59A-3.244(1), F.A.C.;
Have an exercise physiology laboratory providing arrhythmia (holter) monitoring, implanted electronic device monitoring, exercise and metabolic stress testing, imaging, and pulmonary function testing to meet the needs of pediatric and adult congenital heart disease patients;
Have a board certified pediatric cardiologist immediately available whenever a stress test is being performed;
Have a licensed APRN or PA to coordinate care for adult congenital heart disease patients;
Conduct stress testing with at least one staff who is Pediatric Advanced Life Support or Advanced Cardiac Life Support certified in the room at all times with the patient during the test; and
Have at least one Basic Life Support certified cardiology technologist or respiratory care practitioner immediately available whenever a stress test is being performed.

(d) Hospitals providing birthing services must have a neonatal screening program using pulse oximetry to detect critical congenital heart disease.

(e) Each hospital must have policies and procedures for accommodating a parent, relative or guardian of a pediatric patient to reside overnight with the patient.

(3) Personnel.

(a) Medical Director. Pediatric cardiac services must be under the direction of one or more physician members of the hospital’s organized medical staff.

The pediatric cardiac catheterization laboratory and ambulatory care cardiac clinic must be under the direction of a physician board certified or eligible by the Sub-Board of Pediatric Cardiology of the American Board of Pediatrics.
Electrophysiology services must be under the direction of a pediatric electrophysiologist board certified by the Sub-Board of Pediatric Cardiology of the American Board of Pediatrics and by the International Board of Heart Rhythm Examiners.
Adult congenital cardiac services must be under the direction of a physician board certified in Adult Congenital Heart Disease, American Board of Internal Medicine.
The pediatric intensive care unit must be under the direction of a board certified pediatric intensivist or a board certified pediatric cardiologist with demonstrated expertise in critical cardiac congenital care.
Notwithstanding any provision to the contrary, the requirements of subparagraphs (3)(a)1. through (3)(a)4. may be satisfied by a physician who is not board certified, or who is not eligible to be board certified due to foreign training or similar circumstances, upon documentation of education, training, or equivalent alternative certification acceptable to the hospital’s governing board or designated credentialing committee.

(b) Medical Staff. The medical director(s) must ensure trained and qualified physician members of the organized medical staff are available at all times to meet the needs of patients.

The physician-in-charge of a cardiac catheterization procedure must be board certified or eligible by the Sub-Board of Pediatric Cardiology of the American Board of Pediatrics.
The physician-in-charge of an electrophysiology procedure must be a pediatric electrophysiologist board certified by the Sub-Board of Pediatric Cardiology of the American Board of Pediatrics.
At least one pediatric cardiovascular surgeon member of the organized medical staff must be board certified or eligible by the American Board of Thoracic Surgery, specialty certification in congenital cardiac surgery.
Board eligible physicians must be board certified within 5 years of becoming eligible.
A physician who is not board certified, or who is not eligible due to foreign training or similar circumstances may provide pediatric cardiac services, including as physician-in-charge of a cardiac catheterization procedure, physician-in-charge of electrophysiology procedures, or pediatric cardiovascular surgeon upon documentation of education, training, or equivalent alternative certification acceptable to the medical director and hospital’s governing board or designated credentialing committee.
A cardiovascular surgery team, including an anesthesiologist and thoracic surgeon must be immediately available during interventional and electrophysiology cardiac catheterizations.
The organized medical staff membership must contain a complement of physicians with training and experience with pediatric cardiac patients to be available for consultation including:

a. Pediatric cardiologists;

b. Pediatric sub-specialists with expertise in hematology, nephrology, neurology, infectious disease, critical care, genetics, gastroenterology and pulmonology;

c. Pediatric radiologists;

d. Pediatric anesthesiologists;

e. Pediatric intensivists; and

f. Pathologists with skills and training in cardiovascular pathology.

All physicians caring for adult congenital heart disease patients must be Advanced Cardiac Life Support certified.

(c) Nursing Staff. Each hospital unit in which pediatric cardiac services are provided must have registered nurses on duty at all times sufficient to ensure immediate availability to any patient when needed.

The cardiac catheterization, electrophysiology and cardiovascular surgical services must have registered nurses with special training in cardiovascular techniques in the care of pediatric and adult congenital heart disease patients and have skills in the pre- and post-procedure evaluations and provision of instruction to the patient and their family members, including intensive care and convalescent care.
Registered nurses providing care in the cardiac catheterization and electrophysiology laboratories must be trained in cardiovascular implantable electronic device management and be certified in Basic Life Support and Pediatric Advanced Life Support.
Registered nurses providing care in the cardiac intensive care unit must have training with validated competencies in caring for congenital heart patients.

(d) Additional Staff. Each hospital providing pediatric cardiac services must have perfusionists, cardiovascular technologists, respiratory therapists, radiologic technicians, clinical laboratory personnel, and social workers available at all times sufficient to meet the needs of any patient.

Cardiovascular technologists must be credentialed as a Registered Cardiovascular Invasive Specialist or Registered Cardiac Electrophysiology Specialist or must complete a hospital-based education and training program acceptable to the medical director.
Cardiovascular technologists serving as the cardiovascular recorder must have no other duties during a procedure.

(4) Physical Plant Requirements.

The Florida Building Code contains the physical plant requirements for cardiac catheterization laboratories and operating suites for cardiac surgery operated by a licensed hospital. The addition or renovation of cardiac catheterization laboratories and operating suites are subject to the Florida Building Code applicable at the time of construction or renovation, and are reviewed by the Agency as required by section 395.0163, F.S.

(5) Equipment.

(a) Each hospital must have policies and procedures for the selection, procurement, use, and maintenance of age- and size-appropriate equipment used for pediatric cardiac services, and must document preventive and daily maintenance activities following manufacturer’s directions.

(b) Each hospital unit in which pediatric cardiac services are provided must have:

A protocol for handling emergency conditions related to the breakdown of essential equipment, including the immediate availability of personnel trained in equipment repair and maintenance.
A crash cart containing the necessary medication and age- and size-appropriate equipment for ventilatory support. A listing of all crash cart contents must be readily available. At the beginning of each shift, the crash cart must be checked for an intact lock; the defibrillator and corresponding equipment must be checked for function and operational capacity. A log must be maintained indicating the review.
A quality improvement program for radiographic imaging systems must include measures of image quality, dynamic range and modulation transfer function.

(c) Each hospital must have age- and size-appropriate equipment available for patients receiving pediatric cardiac services, including:

Multi-dimensional imaging equipment for magnetic resonance imaging/magnetic resonance angiography (MRI/MRA), computed tomography, echocardiography, and scintigraphy;
A special procedure x-ray room with diagnostic x-ray examination table;
X-ray equipment with the capability in cineangiocardiography, or equipment with similar capabilities;
An automatic injector;
An electrocardiograph;
A multi-channel electrophysiology recording system;
A cardiopulmonary monitoring system;
Emergency equipment, including temporary pacemaker units with catheters, ventilatory assistance devices, and a DC defibrillator;
Biplane angiography, with framing rates of 30-60 fps and injection rates of up to 40 mL/s;
Extracorporeal Membrane Oxygenation machine;
Treadmill or cycle ergometer;
Blood pressure cuffs; and
Oxygen saturation monitors.

(d) Cardiac MRI scanners must:

Be accredited by a national accrediting organization that is approved by the Centers for Medicare and Medicaid Services for magnetic resonance imaging and advanced diagnostic imaging services;
Have field strength of not less than 1.5 Tesla and equipped with localized multichannel radiofrequency surface coil and ECG gating capable of prospective triggering, retrospective gating, and triggered retrogating;
Have an MRI-compatible power injector for performing myocardial perfusion MR imaging or any MR angiographic methods;
Be capable of fast 3-D gradient-echo imaging, steady-state imaging with free precession, phase- contrast flow quantification, fast multi-slice myocardial perfusion imaging, and late contrast-enhanced myocardial imaging. Parallel imaging and half-Fourier capabilities are desirable to permit shortened breath-hold requirements.

(e) Each hospital must have a pediatric echocardiography laboratory accredited by the Intersocietal Accreditation Commission for pediatric echocardiography in order to perform Transthoracic Echoes, Transesophageal Echoes, and Fetal Echoes.

(f) In addition to the requirements in Rule 59A-3.270, F.A.C., each hospital must maintain a complete database of patients with devices to include all device models and ID numbers, and Lead models and ID numbers.

(6) Emergency Transportation.

Each hospital must have policies and procedures to effectuate the rapid transport of pediatric and adult congenital heart disease patients. The polices and procedures must consider factors affecting inter- and intra- facility transport, including:

(a) Providing emergency transportation directly or by contract;

(b) Age and size of the patient;

(d) Weather conditions; and

(e) Distance.

(7) Data Reporting.

(a) Each hospital must submit data to the Society of Thoracic Surgeons Congenital Heart Surgery Database (National Database), including the Anesthesia Model in the manner set forth herein. Each hospital must be deemed to have certified that the data submitted for each time period is accurate, complete and verifiable. Data must be submitted in accordance with the timetables and procedures established by the Society of Thoracic Surgeons National Database, and:

All data must be reported using the specific data elements, definitions and transmission format as set forth by the Society of Thoracic Surgeons;
Maintain participation in the Society of Thoracic Surgeons National Database;
Release the data reported by the Society of Thoracic Surgeons National Database to the Agency upon request;
Except for programs with less than the requisite number of years of data for publication, publish cardiac surgical outcomes to the public on the Society of Thoracic Surgeons website https://publicreporting.sts.org and maintain an overall risk-adjusted observed to expected operative mortality ratio whose lower limit of the 95% confidence interval is less than or equal to 1;
Use the Society of Thoracic Surgeons National Database and use software approved by the Society of Thoracic Surgeons for data reporting;
Ensure that software formats are established and maintained in a manner that meets Society of Thoracic Surgeons transmission specifications and encryption requirements. If necessary, each hospital must contract with a vendor approved by the Society of Thoracic Surgeons National Database for software and hardware required for data collection and reporting;
Implement procedures to transmit data via a secure website or other means necessary to protect patient privacy as required by the Society of Thoracic Surgeons National Database;
Ensure that all appropriate data is submitted on every patient who receives medical care and is eligible for inclusion in the Society of Thoracic Surgeons National Database;
Maintain an updated and current institutional profile with the Society of Thoracic Surgeons National Database;
Ensure that data collection and reporting will only be performed by trained, competent staff and that such staff must adhere to Society of Thoracic Surgeons National Database standards;
Submit corrections to any data submitted to the Society of Thoracic Surgeons National Database as discovered by the hospital or by the Society of Thoracic Surgeons National Database. Such corrections must be submitted within thirty days of discovery of the need for a correction or within such other time frame as set forth by the Society of Thoracic Surgeons National Database;
Designate a Society of Thoracic Surgeons National Database site manager that will serve as the primary contact between the hospital and the Society of Thoracic Surgeons National Database with regard to data reporting; and
Compile quality assurance data annually from their Society of Thoracic Surgeons Congenital Heart Surgery Database Report and provide for Agency review upon request which includes:

a. Number of patients/operations submitted and an analysis of operative mortality, and complexity information, by year;

b. Number of patient/operations in analysis, operative mortality, and complexity information, by age group;

c. Primary Procedure Operative Mortality;

d. Society of Thoracic Surgeons - European Association of Cardio-Thoracic Surgery Mortality Category Operative Mortality, by year; and

e. Society of Thoracic Surgeons - European Association of Cardio-Thoracic Surgery Mortality Category Operative Mortality, by age group.

(b) Report to an established, nationally recognized, multicenter pediatric and congenital interventional cardiology data registry, and:

Submit reports using the specific data elements, definitions, timetables, transmission format, required software, and procedures established and in accordance with the registry criteria;
Ensure that software formats are established and maintained in a manner that meets transmission specifications and encryption requirements necessary to protect patient privacy;
Maintain an updated and current institutional profile with the registry; and
Maintain participation in the registry.

(c) Each hospital must register with the Adult Congenital Heart Association and submit data as required by the Adult Congenital Heart Association in order to maintain a current registration.

(8) Enforcement. Enforcement of these rules shall follow procedures established in Rule 59A-3.253, and Rule 59A-35.120, F.A.C., and Chapters 395, Part I, 408, Part II, F.S., including suspension, revocation or denial of the pediatric cardiac program license.

(a) The Agency may conduct or cause to be conducted an inspection to determine compliance with the requirements of this rule.

(b) The Agency shall notify the facility of the findings and provide a timeframe in which to provide a plan of correction related to any identified deficient practice.

(c) A program that fails to maintain an overall risk-adjusted observed to expected operative mortality ratio whose lower limit of the 95% confidence interval is less than or equal to 1 shall provide an assessment to the Agency of the quality assurance data described in paragraph (7)(a) every month until the requirement is met.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 4-19-26.

Fla. Admin. Code R. 59A-3.249 Neonatal Intensive Care Units (NICU)

Each hospital with an obstetrical department as described in subsection 59A-3.244(2), F.A.C. must have a neonatal nursery to provide Level I neonatal services. Level I neonatal services means well-baby care services including sub-ventilation care, intravenous feedings, intravenous medications, and gavage to neonates, as needed. Services in a Level I neonatal nursery are restricted to neonates born at 35 weeks gestation or later and who are considered low risk and physiologically stable. Ventilation assistance must not be provided except for resuscitation and stabilization. Upon beginning ventilation, the hospital must implement a patient treatment plan which includes the transfer of the neonate to a hospital providing Level II, III, or IV NICU services at such time that it becomes apparent that ventilation assistance will be required beyond the neonate’s resuscitation and stabilization. A hospital only providing Level I neonatal services must establish a triage procedure to assess the need for transfer of obstetrical patients to hospitals providing Level II, III, or IV NICU services prior to their delivery when there is an obstetrical indication that resuscitation will be required for their neonates.

(1) Definitions. As used in this section:

(a) “Telemedicine” means on call and readily available for remote consultation, diagnosis, and treatment by means of audiovisual telecommunications technology.

(b) “Onsite” means on call and readily available for consultation and continuous patient management.

(2) Licensure.

(a) A hospital may not provide neonatal intensive care services prior to obtaining licensure of NICU beds as evidenced by the bed type appearing on the face of the hospital’s license. A hospital authorized to provide neonatal intensive care services as of the effective date of this rule shall be licensed to provide the same level of care for neonatal intensive care services and must meet all of the requirements of this rule within one year from the effective date. This does not preclude a hospital from qualifying for a higher level during the transition year.

(b) A hospital establishing neonatal intensive care services must apply for licensure of Level II, III, or IV NICU services and NICU beds by submitting a hospital licensure application as specified in subsection 59A-3.066(2), F.A.C.

(c) A hospital may utilize any licensed NICU bed at the level of neonatal intensive care services required to meet the patient’s needs if the licensure, staffing, equipment, and supplies requirements established by this rule for the necessary level of service is met.

(3) Emergency Transportation. A hospital providing Level II, III, or IV neonatal intensive care services must have, directly or by contract, an emergency 24-hour neonatal transportation system in accordance with Rule 64J-1.006, F.A.C. administered by the Department of Health. Hospitals providing Level II neonatal intensive care services must have a written transfer agreement with a hospital providing Level III or Level IV neonatal intensive care services, and hospitals providing Level III neonatal intensive care services must have a written transfer agreement with a hospital providing Level IV neonatal intensive care services. A hospital providing Level IV neonatal intensive care services that does not provide pediatric cardiovascular surgery and pediatric cardiothoracic surgery onsite must have a written transfer agreement with a hospital providing Level IV neonatal intensive care services including onsite pediatric cardiovascular surgery and pediatric cardiothoracic surgery as specified in paragraph (7)(h).

(4) Transfer agreements. A hospital providing Level II, III, or IV neonatal intensive care services must have transfer agreements for all neonatal intensive care services that are not provided by the hospital with another hospital that provides such services. A transfer agreement must specifically address the services included in the transfer agreement. The hospital must maintain a policy requiring that such transfer agreements be made with other hospitals in reasonable geographic proximity, taking into account the services in question, the location of the hospital, and other factors relevant to the care of the patient. Medically necessary transfers shall be made in accordance with Section 395.1041(3)(e), F.S.

(5) Level II Neonatal Intensive Care Services.

(a) Hospitals that are licensed for Level II NICU services may only provide care for infants at greater than or equal to 30 weeks’ gestation and/or have reached a weight of greater than or equal to 1,250 grams.

(b) Hospitals that are licensed for Level II NICU services, but not Level III or Level IV NICU services, may perform only Level II NICU services.

(c) Each Level II NICU must be capable of providing invasive ventilation up to 72 hours, or continuous positive airway pressure as needed.

(d) An infant in a Level II NICU must be transferred to a higher level NICU if the infant requires more than 72 hours of invasive ventilation.

(e) Director. Each Level II NICU must be directed by a board certified pediatrician with experience in the care of newborn infants including intubation and invasive ventilation, or a board certified neonatologist.

(f) Personnel. Each Level II NICU must have physically present in the facility at all times, a board certified or board eligible neonatologist or other neonatal provider with demonstrated competence in the management of severely ill infants as evidenced by completion of the Neonatal Resuscitation Program and continuing education requirements specific to the care of infants. Other neonatal providers, for the purposes of this subsection, must be either pediatric hospitalists, neonatal physician assistants, or neonatal advanced practice registered nurses. If the personnel present at the facility at any time pursuant to this paragraph is not a board certified or board eligible neonatologist, at all such times a neonatologist must be available for consultation and must be available to arrive onsite within 30 minutes of an urgent request. If the neonatologist designated to be either at the facility or available for consultation and arrival upon an urgent request is covering more than one facility, the facility must ensure that a back-up neonatologist be available, documented in an on-call schedule and readily available to facility staff, for consultation or to arrive within 30 minutes upon an urgent request.

(g) Pediatric Medical Subspecialties. Each Level II NICU must have the following pediatric medical subspecialties available onsite or via telemedicine:

Cardiology;
Maternal-fetal medicine, including a board certified obstetrician who is qualified by training, experience, or special competent certification in maternal-fetal medicine, if the hospital provides delivery services;
Neurology; and
Ophthalmologist or retinal specialist with expertise in retinopathy of prematurity.

(h) Onsite Pediatric Services. Each Level II NICU must have the following pediatric services available onsite:

Echocardiogram;
Electroencephalogram;
Laboratory services;
Lactation;
Nutrition;
Pastoral care;
Pharmacy;
Physician-led multidisciplinary NICU follow up clinic or affiliation with a clinic and referral system;
Radiology, including magnetic resonance imaging, computed tomography, and ultrasound;
Rehabilitation therapy;
Retinopathy of prematurity screening (screening may be reviewed via telemedicine);
Respiratory therapy; and
Social work.

(i) Neonatal Nursing.

Supervision. The nursing staff must be under the supervision of a registered professional nurse with experience and training in neonatal intensive care nursing.
Training and Qualifications. Nurses must be trained to administer cardio-respiratory monitoring, assist in ventilation, administer intravenous fluids, provide pre-operative and post-operative care of patients requiring surgery, manage patients being transported, and provide emergency treatment of conditions such as apnea, seizures, and respiratory distress. All nurses must maintain current certification in the Neonatal Resuscitation Program.
Staffing.

a. There must be at least one nurse for every four patients receiving Level II neonatal intensive care services.

b. At least one-half of the nursing personnel assigned to each work shift in Level II NICUs must be registered professional nurses.

(j) Respiratory Therapist. There must be at least one certified respiratory therapist with current certification in the Neonatal Resuscitation Program and expertise in the care of neonates continuously available in the hospital at all times. There must be at least one respiratory therapy technician for every four patients receiving assisted ventilation.

(k) Level II NICU Bed Equipment. Each bed must have:

One cardiopulmonary monitor and pulse oximeter;
At least one resuscitation bag and mask; and
At least one infusion pump.

(l) Level II NICU Equipment. Each unit must have available on demand:

At least one oxygen analyzer for every three occupied beds;
At least one non-invasive blood pressure monitoring device for every three occupied beds;
At least one ventilator for every three occupied beds;
An EKG machine with printout capability;
Continuous blood pressure measurement equipment;
A portable digital x-ray capable of directly displaying radiography and digital images in the NICU;
An incubator or radiant warmer for each occupied bed;
One heated humidifier and humidified oxygen delivery systems for each occupied bed; and
At least one neonatal fixed or portable suction device for each occupied bed.

(6) Level III Neonatal Intensive Care Services.

(a) Hospitals providing Level III NICU services must meet the staffing and personnel, equipment, and service standards required of hospitals providing Level II NICU services, in addition to the standards set forth within this subsection. Hospitals providing Level III NICU services may perform Level II and Level III NICU services.

(b) Director. Each Level III NICU must be directed by a full-time, board certified neonatologist.

(c) Onsite Medical Subspecialties. Each Level III NICU must provide an anesthesiologist onsite with sufficient expertise in pediatric anesthesiology and with the ability to consult with a pediatric anesthesiologist through a prearranged and documented consultative agreement.

(d) Other Pediatric Medical Subspecialties. Each Level III NICU must provide the pediatric medical subspecialties required of Level II NICUs. In addition, each Level III NICU must provide the following pediatric medical subspecialties onsite or via telemedicine:

Endocrinology;
Gastroenterology;
Genetics;
Hematology-oncology;
Infectious disease;
Nephrology;
Otolaryngology;
Pulmonary;
Radiology; and
Urology.

(e) Onsite Surgical Subspecialties. Each Level III NICU must provide pediatric general surgery onsite or provide onsite a general surgeon with sufficient expertise in pediatric general surgery with the ability to consult with a pediatric general surgeon through a prearranged and documented consultative agreement.

(f) Pediatric Services. Each Level III NICU must provide the pediatric services required of a Level II NICU. In addition, a Level III NICU must provide therapeutic hypothermia services onsite and may provide inhaled nitric oxide services.

(g) Neonatal Nursing.

Each Level III NICU must meet the supervision, training, and qualifications standards for neonatal nurses for Level II NICUs.
There must be at least one nurse for every two patients receiving Level III neonatal intensive care services. Patients requiring neonatal surgery or multi-system support must have at least one nurse for every patient during the immediate preoperative, intraoperative, and immediate postoperative periods.

(h) Level III NICU Equipment. A Level III NICU must be capable of life support as needed. Level III NICUs must have the equipment and services required of a Level II NICU.

(7) Level IV Neonatal Intensive Care Services.

(a) Hospitals providing Level IV NICU services must meet the staffing and personnel, equipment, and service standards required of Level III NICUs in addition to the standards set forth within this subsection.

(b) Hospitals providing Level IV NICU services may perform Level II, Level III and Level IV NICU services.

(d) Personnel. Each Level IV NICU must have a board certified or board eligible neonatologist available at all times at the facility.

(e) Onsite Pediatric Medical Subspecialties. Each Level IV NICU must provide the following pediatric medical subspecialties onsite:

Anesthesiology;
Cardiology;
Endocrinology;
Gastroenterology;
Hematology-oncology;
Infectious Disease;
Maternal-fetal medicine, including a board certified obstetrician who is qualified by training, experience, or special competent certification in maternal-fetal medicine, if the hospital provides delivery services;
Nephrology;
Neurology;
Ophthalmologist or retinal specialist with expertise in retinopathy of prematurity;
Orthopedics;
Otolaryngology;
Palliative care;
Pulmonology;
Radiology; and
Urology.

(f) Other Pediatric Medical Subspecialties. Each Level IV NICU must provide genetics services onsite or via telemedicine.

(g) Onsite Pediatric Surgical Subspecialties. Each Level IV NICU must provide the following pediatric surgical subspecialties onsite:

Craniofacial surgery;
General surgery; and
Neurosurgery.

(h) If a hospital providing Level IV NICU services does not provide pediatric cardiovascular surgery and pediatric cardiothoracic surgery onsite, it must have a transfer agreement for such surgeries.

(i) Onsite Pediatric Services. Each Level IV NICU must provide the following pediatric services onsite:

Echocardiogram;
Electroencephalogram;
Extracorporeal membrane oxygenation;
Inhaled nitric oxide;
Laboratory services;
Lactation;
Nutrition;
Pastoral care;
Pharmacy;
Physician-led multidisciplinary NICU follow up clinic
Radiology, including magnetic resonance imaging, computed tomography, and ultrasound;
Rehabilitation therapy;
Respiratory therapy;
Retinopathy prematurity screening;
Social work; and
Therapeutic hypothermia.

(j) Other Pediatric Services. A Level IV may provide pediatric dialysis onsite or, if it does not provide pediatric dialysis onsite, must have a transfer agreement for pediatric dialysis.

(k) General hospitals providing Level IV NICU services must provide obstetric services for women with high risk pregnancies onsite, on a 24-hour basis. Specialty children’s hospitals are excluded from this requirement.

(l) Hospitals providing Level IV NICU services must:

Maintain continuous availability of neonatal surgery;
Assure age and size appropriate transport to and from other facilities;
Coordinate continuing education programs for staff; and
Provide outreach education for other hospitals in their service area.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055, 408.0455 FS. History–New 5-19-22.

Fla. Admin. Code R. 59A-3.250 Surveillance, Prevention, and Control of Infection

(1) Each hospital shall establish an infection control program involving members of the organized medical staff, the nursing staff, other professional staff as appropriate, and administration. The program shall comply with the requirements in Sections 381.0098 and 395.1011, F.S. and shall provide for:

(a) The surveillance, prevention, and control of infections among patients and personnel;

(b) The establishment of a system for identifying, reporting, evaluating and maintaining records of infections;

(d) Development and coordination of training programs in infection control for all hospital personnel.

(2) Each hospital shall have written policies and procedures reflecting the scope of the infection control program outlined in subsection (1). The written policies and procedures shall be reviewed at least every two years by the infection control program members, dated at the time of each review, revised as necessary, and enforced.

(3) The policies and procedures devised by the infection control program shall be approved by the governing board, and shall contain the following:

(a) Specific policies for the shelf life of all stored sterile items.

(b) Specific policies and procedures related to occupational exposure to blood and body fluids.

(c) Specific policies and procedures related to admixture and drug reconstitution, and to the manufacture of intravenous and irrigating fluids.

(d) Specific policies related to the handling and disposal of biomedical waste as required by Chapter 64E-16, F.A.C., OSHA 29 CFR Part 1910.1030, Bloodborne Pathogens.

(e) Specific policies related to the selection, storage, handling, use and disposition of disposable items.

(f) Specific policies related to decontamination and sterilization activities performed in central services and throughout the hospital, including a requirement that steam gas (ETO) and hot air sterilizers be tested with live bacterial spores at least weekly.

(g) Specific policies regarding the indications for universal precautions, body substance isolation, CDC isolation guidelines, or equivalent and the types of isolation to be used for the prevention of the transmission of infectious diseases.

(h) A requirement that soiled linen is collected in such a manner as to minimize microbial dissemination into the environment.

(i) A requirement that all cases of communicable diseases as set forth in Chapter 64D-3, F.A.C., be promptly and properly reported as required by the provisions of that rule.

(4) The individuals involved in the infection control program shall meet at least quarterly, shall maintain written minutes of all meetings, and shall make a report at least annually to the assigned professional staff and the governing board.

(5) Each hospital shall establish an employee health policy to minimize the likelihood of transmission of communicable disease by both employees and patients. Such policies shall include work restrictions for an employee whenever it is likely that communicable disease may be transmitted until such time as a medical practitioner certifies that the employee may return to work.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1011, 395.1055 FS. History–New 9-4-95, Formerly 59A-3.215, Amended 10-16-14.

Fla. Admin. Code R. 59A-3.251 Hospital Reporting of Exposure to Selected Infectious Diseases

The licensed facility shall establish a written policy and procedure for notifying EMTs, paramedics or their emergency medical transportation service employer, or other persons known to have been exposed to a patient with a selected infectious disease while transporting or treating an ill or injured patient to that licensed facility. Selected infectious diseases are defined as Acquired Immunodeficiency Syndrome; anthrax; syphilis in an infectious stage; diphtheria; disseminated vaccinia; Hansen’s disease; hepatitis A; hepatitis B; hepatitis non A, non B, Legionnaire’s disease; malaria; measles; meningococcal meningitis; plague; poliomyelitis, psittacosis; pulmonary tuberculosis; Q fever; rabies; rubella; typhoid fever. Each licensed facility shall designate a person or persons to notify the EMT’s, paramedics or their emergency medical transportation service employer or other persons known to have been exposed to a patient with a selected infectious disease. These procedures shall include at a minimum the following:

(1) Notification of exposure to a selected infectious disease, either verbal or written, must take place within 48 hours of a confirmed diagnosis.

(2) Verbal notification of such exposure to a selected infectious disease must be followed by written notification within 48 hours of a confirmed diagnosis.

(3) Identification of EMT, paramedic, or other known persons to have been in contact with the patient during treatment or transport, if notification is made to the EMS provider.

(4) Both written and verbal notification shall contain at a minimum:

(a) Name of disease;

(b) Signs and symptoms of clinical disease;

(d) Incubation period of disease;

(e) Mode of spread of the disease; and,

(f) Advisement of appropriate diagnosis, prophylaxis, and treatment, if any.

(5) Confidentiality of patient information must be maintained. The name of the patient shall not be disclosed.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1025 FS. History–New 3-11-86, Formerly 10D-28.131, Amended 4-17-97, Formerly 59A-3.131.

Fla. Admin. Code R. 59A-3.252 Classification of Hospitals

(1) The Agency will license five classes of facilities.

(a) Class I or general hospitals which includes:

General acute care hospitals with an average length of stay of 25 days or less for all beds;
Long term care hospitals, which meet the provisions of subsection 59A-3.065(24), F.A.C.; and,
Rural hospitals designated under Chapter 395, Part III, F.S.

(b) Class II specialty hospitals offering the range of medical services offered by general hospitals, but restricted to a defined age or gender group of the population which includes:

Specialty hospitals for children; and,
Specialty hospitals for women.

(c) Class III specialty hospitals offering a restricted range of services appropriate to the diagnosis, care, and treatment of patients with specific categories of medical or psychiatric illnesses or disorders which include:

Specialty medical hospitals;
Specialty rehabilitation hospitals;
Specialty psychiatric hospitals, which may include beds licensed to offer Intensive Residential Treatment programs; and,
Specialty substance abuse hospitals, which may include beds licensed to offer Intensive Residential Treatment programs.

(d) Class IV specialty hospitals restricted to offering Intensive Residential Treatment Facility Services for Children and Adolescents, pursuant to Section 395.002(15), F.S., and subsection 59A-3.065(22), F.A.C.

(e) Class V specialty hospitals restricted to offering Rural Emergency Hospital services as defined in Section 395.607, F.S. and described in 42 USC Chapter 7, Subchapter XVIII, Part E, (kkk).

(2) In addition to other requirements specified in these rules, all licensed hospitals shall have at least the following:

(a) Inpatient beds, except Class V hospitals may only have skilled nursing unit inpatient beds;

(b) A governing authority legally responsible for the conduct of the hospital;

(c) A chief executive officer or other similarly titled official to whom the governing authority delegates the full-time authority for the operation of the hospital in accordance with the established policy of the governing authority;

(d) An organized medical staff to which the governing authority delegates responsibility for maintaining proper standards for medical and other health care;

(e) A current and complete medical record for each patient receiving health care services from the hospital;

(f) A policy requiring that all patients be admitted or receive health care services on the authority of and under the care of a member of the organized medical staff;

(g) Facilities and professional staff available to provide food to patients to meet their nutritional needs;

(h) A procedure for providing care in emergency cases;

(i) A method and policy for infection control; and,

(j) An on-going organized program to enhance the quality of patient care and review the appropriateness of utilization of services.

(3) In addition to the requirements of subsection (2) and other requirements of these rules, Class I, and Class II hospitals shall have at least the following:

(a) One licensed registered nurse on duty at all times on each floor or similarly titled part of the hospital for rendering patient care services;

(b) A pharmacy supervised by a licensed pharmacist either in the facility or by contract sufficient to meet patient needs;

(d) Clinical laboratory services either in the facility or by contract sufficient to meet patient needs;

(e) Operating room services; and,

(f) Anesthesia service.

(4) In addition to the requirements of subsection (2) and other requirements of these rules, all Class II, Class III, Class IV, and Class V hospitals shall provide the treatment services, equipment, supplies and staff appropriate to the particular category of patients treated at the facility.

(5) All Class III hospitals, in addition to meeting the requirements of subsection (2) and other requirements of these rules, must provide:

(a) For at least one qualified staff person at all times on each floor or similarly titled part of the hospital for rendering patient care services;

(b) A pharmacy supervised by a licensed pharmacist either in the facility or by contract sufficient to meet patient needs;

(d) Clinical laboratory services, either in the facility or by contract sufficient to meet patient needs; and,

(e) Any other services, when provided by a Class III or Class IV hospital, shall meet the standards pertinent to that particular service as promulgated in Rules 59A-3.065 through 59A-3.303, F.A.C., as applicable.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 9-4-95, Formerly 59A-3.202, Amended 10-16-14, 6-1-25.

Fla. Admin. Code R. 59A-3.253 Investigations and License, Life Safety and Validation Inspections

(1) Inspections. The Agency shall conduct periodic inspections of hospitals in order to ensure compliance with all licensure requirements in accordance with Section 395.0161, F.S.

(2) Non-accredited hospitals. Hospitals which are not accredited by an accrediting organization shall be subject to a licensure inspection.

(3) Accredited hospitals. The Agency shall accept the report of an accrediting organization in lieu of a licensure inspection for accredited hospitals and for hospitals seeking accreditation, provided that the standards included in the report demonstrate that the hospital is in compliance with state licensure requirements found in Chapters 395 and 408, F.S., and Chapters 59A-3 and 59A-35, F.A.C., and the hospital does not meet the criteria specified under subparagraphs (c)1. and 2.

(a) Upon receipt of the accrediting organization’s report, the Agency will review the findings to determine if the hospital is in compliance with state licensure requirements.

(b) The Agency shall notify the hospital within 60 days of the receipt of the accrediting organization’s survey report regarding the Agency’s determination of the hospital’s compliance or non-compliance with state licensure requirements.

The hospital has been denied accreditation or has received a provisional or conditional accreditation from an accrediting organization on its most recent accreditation report, and has not submitted an acceptable plan of correction to the accrediting organization;
The hospital has received full accreditation but has not authorized the release of the report to the Agency, or has not ensured that the Agency received the accrediting organization’s report prior to the Agency scheduling a licensure inspection.

(4) Licensure inspection fees. With the exception of state-operated licensed facilities, the licensure inspection fee shall be $12.00 per hospital bed, provided that no licensed facility shall be assessed less than $400.00 per inspection for licensure, and further provided that a separate fee for the licensure inspection shall be charged for each hospital located on a separate premises, regardless of its inclusion on a single license.

(5) Life safety inspection fees. With the exception of state-operated licensed facilities, the fee for a life safety inspection shall be $1.50 per hospital bed, provided that no licensed facility shall be assessed less than $40 for a life safety inspection, and further provided that a separate fee for the life safety inspection shall be charged for each hospital located on a separate premises, regardless of its inclusion on a single license. A separate fee for a life safety inspection will not be assessed when conducted as part of a licensure or a Centers for Medicare and Medicaid Services certification inspection.

(6) Validation inspections. Each year, the Agency shall conduct validation inspections on a minimum of five percent of those hospitals that have undergone a full accreditation inspection from an accrediting organization to determine ongoing compliance with licensure requirements.

(a) If the Agency determines, based on the results of validation inspection findings, that a fully accredited hospital is not in compliance with licensure requirements, the Agency shall report its findings to the accrediting organization and shall conduct a full licensure inspection on that hospital during the following year.

(b) The fee for conducting a licensure validation inspection shall be the same as that specified for licensure inspections under subsection (4). A separate fee for a validation inspection will not be assessed when conducted in conjunction with a Centers for Medicare and Medicaid Services certification inspection.

(7) Complaint inspections. The Agency shall conduct investigations of complaints regarding violations of licensure and life safety standards in accordance with Sections 395.0161 and 408.811, F.S. Complaint investigations will be unannounced. An entrance conference must be conducted upon arrival, by Agency personnel investigating the complaint, to inform the hospital’s administrator about the nature of the complaint investigation and to answer questions from hospital staff. An exit conference must be provided at the conclusion of the onsite investigation to inform the hospital of the scope of the investigation and to receive any additional information that the hospital wishes to furnish.

(a) Upon receipt of a complaint, the Agency shall review the complaint for allegations of non-compliance with licensure requirements, and shall take the following action:

Complaints involving accredited hospitals shall be reported to the appropriate accrediting organization;
Complaints involving Medicare certified hospitals shall be referred to the Centers for Medicare and Medicaid Services for a determination as to the need for an investigation under certification standards.
Complaints involving diagnostic radiology equipment or personnel, or biomedical, waste disposal shall be referred to the Department of Health for investigation.

(b) Upon a determination that investigation of a complaint is warranted, the Agency shall conduct an investigation.

(8) Conformance with accreditation standards. In all hospitals where the Agency does not conduct a licensure inspection, by reason of the hospital’s accreditation status, the hospital shall continue to conform to the standards of accreditation throughout the term of accreditation, or shall notify the Agency of the areas of non-conformance. Where the Agency is notified of non-conformance, it shall take appropriate action as specified under subsection (3).

(9) Sanctions. The Agency shall impose sanctions, in accordance with Section 395.1065, F.S., on those hospitals which fail to submit an acceptable plan of correction or implement actions to correct deficiencies identified by the Agency or an appropriate accrediting organization which are specified in an approved plan of correction or as identified as a result of a complaint investigation.

History

Rulemaking Authority 395.1055, 408.819 FS. Law Implemented 395.0161, 395.1055, 395.1065, 408.811 FS. History–New 9-4-95, Formerly 59A-3.204 Amended 5-16-06, 10-16-14, 3-19-17.

Fla. Admin. Code R. 59A-3.254 Patient Rights and Care

(1) Patient Assessment. Each hospital shall develop and adopt policies and procedures to ensure an initial assessment of the patient’s physical, psychological and social status, appropriate to the patient’s developmental age, is completed to determine the need and type of care or treatment required, and the need for further assessment. The scope and intensity of the initial assessment shall be determined by the patient’s diagnosis, the treatment setting, the patient’s desire for treatment, and response to previous treatment.

(a) Such policies shall:

Specify the time period preceding or following admission within which the initial assessment shall be conducted;
Require that the initial assessment be documented in writing in the patient’s medical record;

(b) The initial assessment shall determine the need for an assessment of the patient’s nutritional and functional status, as well as discharge planning needs, when appropriate;

(c) The hospital shall have policies and procedures to ensure that periodic reassessments of the patient are conducted based on changes in either the patient’s condition, diagnosis, or response to treatment;

(d) The hospital shall ensure that care and treatment decisions are based on the patient’s identified needs and treatment priorities;

(e) An individualized treatment plan shall be developed for each patient based upon the initial assessment and other diagnostic information as appropriate.

(2) Coordination of Care. Each hospital shall develop and implement policies and procedures on discharge planning which address:

(a) Identification of patients requiring discharge planning;

(b) Initiation of discharge planning on a timely basis;

(c) Evaluation of prescription medications, ensuring the continued availability of medications for at least three days after discharge;

(d) The role of the physician, other health care givers, the patient, and the patient’s family in the discharge planning process; and

(e) Documentation of the discharge plan in the patient’s medical record including an assessment of the availability of appropriate services to meet identified needs following hospitalization.

(3) Patient and Family Education.

(a) General Provisions. Each hospital shall develop a systematic approach to educating the patient and family to improve patient outcomes by promoting recovery, speedy return to function, promoting healthy behaviors, and involving patients in their care and care decisions.

(b) Each hospital shall provide the patient and family with education specific to the patient’s assessed needs, capabilities, and readiness. Such education shall include when indicated:

An assessment when indicated, of the educational needs, capabilities, and readiness to learn based on cultural and religious practices, emotional barriers, desire and motivation to learn, physical and cognitive limitations, and language barriers;
Instruction in the specific knowledge or skills needed by the patient or family to meet the patient’s ongoing health care needs including:

a. The use of medications.

b. The use of medical equipment.

c. Potential drug or food interactions, and nutritional intervention or modified diets.

d. Rehabilitation techniques.

e. Available community resources.

f. When and how to obtain further treatment; and

g. The patient’s and family’s responsibilities in the treatment process.

Information about any discharge instructions given to the patient or family shall be provided to the organization or individual responsible for providing continuing care.
Each hospital shall plan and support the provision and coordination of patient and family education activities by ensuring that:

a. Educational resources required are identified and made available; and

b. The educational process is interdisciplinary, as appropriate to the plan of care.

(4) Patient Rights. Each hospital shall develop and adopt policies and procedures to ensure the following rights of the patient:

(a) The right to refuse treatment and life-prolonging procedures as specified under Section 765.302, F.S.;

(b) The right to formulate advance directives and designate a surrogate to make health care decisions on behalf of the patient as specified under Chapter 765, F.S. The policies shall not condition treatment or admission upon whether or not the individual has executed or waived an advance directive. In the event of conflict between the facility’s policies and procedures and the individual’s advance directive, provision should be made in accordance with Section 765.302, F.S. Policies shall include:

Provide each adult individual, at the time of the admission as an inpatient, with a copy of “Health Care Advance Directives – The Patient’s Right to Decide,” revised 2006, which is hereby incorporated by reference, and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-04606 and from the Agency for Health Care Administration at: https://floridahealthfinderstore.blob.core.windows.net/documents/reports-guides/documents/English-Health%20Care%20Advance%20Dir%202006.pdf or with a copy of some other substantially similar document which is a written description of Chapter 765, F.S., regarding advance directives;
Providing each adult individual, at the time of admission as an inpatient, with written information concerning the health care facility’s policies respecting advance directives; and
The requirement that documentation of the existence of an advance directive be contained in the medical record. A health care facility which is provided with the individual’s advance directive shall make the advance directive or a copy thereof a part of the individual’s medical record.

(c) The right to information about patient rights as set forth in Section 381.026, F.S., and procedures for initiating, reviewing and resolving patient complaints;

(d) The right to participate in the consideration of ethical issues that arise in the care of the patient;

(e) The right to personal privacy and confidentiality of information including access to information contained in the patient’s medical records as specified under Section 395.3025, F.S.;

(f) The right of the patient’s next of kin or designated representative to exercise rights on behalf of the patient;

(g) The right to an itemized patient bill upon request as specified under Section 395.301, F.S.;

(h) The right to be free of restraints consistent with the rights of mentally ill persons or patients as provided in Section 394.459, F.S.

(5) In addition to the provisions of this section, hospitals must comply with Section 381.026, F.S.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.003, 395.1055 FS. History–New 4-17-97, Formerly 59A-3.2055, Amended 10-16-14.

Fla. Admin. Code R. 59A-3.255 Emergency Care

(1) Signage Requirements.

(a) Each hospital offering emergency services and care shall post, in a conspicuous place in the emergency service area, a sign clearly stating a patient’s right to emergency services and care as set forth in Section 395.1041, F.S. The sign shall be posted in both English and in Spanish.

(b) Each hospital offering emergency services and care shall post a sign identifying the service capability of the hospital. The categories of services listed on the sign may be general in nature if the sign refers patients to another location within that facility where a list of the subspecialties is available. The sign identifying the service capability of the hospital and the additional listing of subspecialties, if a separate subspecialty list is maintained, shall be in both English and in Spanish.

(c) The signs required by this rule section shall be posted in a location where individuals not yet admitted to the hospital would reasonably be expected to present themselves for emergency services and care.

(2) Transfer Procedures. Each hospital providing emergency services and care shall establish policies and procedures which incorporate the requirements of Chapter 395, F.S., relating to emergency services. The policies and procedures shall incorporate:

(a) Decision protocols identifying the emergency services personnel within the hospital responsible for the arrangement of outgoing and incoming transfers;

(b) Decision protocols stating the conditions that must be met prior to the transfer of a patient to another hospital. These conditions are:

If a patient, or a person who is legally responsible for the patient and acting on the patient’s behalf, after being informed of the hospital’s obligation under Chapter 395, F.S., and of the risk of transfer, requests that the transfer be effected; or
If a physician has signed a certification that, based upon the reasonable risks and benefits to the patient, and based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another hospital outweigh the increased risks to the individual’s medical condition from effecting the transfer; or
If a physician is not physically present in the emergency services area at the time an individual is transferred, a qualified medical person may sign a certification that a physician with staff privileges at the transferring hospital, in consultation with such personnel, has determined that the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual’s medical condition from effecting the transfer. The certification shall summarize the basis for such determination. The consulting physician must sign the certification within 72 hours of the transfer.

(c) A provision providing that all medically necessary transfers shall be made to the geographically closest hospital with the service capability, unless another prior arrangement is in place or the geographically closest hospital is at service capacity as stated in Section 395.1041(3)(e), F.S.

(d) Protocols for maintaining records of patient transfers made or received for a period of five years. Patient transfer information shall be incorporated separately in transfer logs and into the patient’s permanent medical record as stated in Section 395.1041(4)(a)1., F.S.

(e) Documentation of all current transfer arrangements that have been made with other hospitals and physicians.

(f) A copy of Section 395.1041, F.S., Access to Emergency Services and Care, and a copy of this rule.

(g) Provisions for informing hospital emergency services personnel and medical staff of the hospital’s emergency service policies and procedures, having at a minimum, the requirement to provide emergency services and care pursuant to Section 395.1041, F.S.

(3) Inventory Reporting.

(a) Pursuant to Section 395.1041, F.S., the Agency is responsible for compiling an inventory of hospitals with emergency services. This inventory shall list all services within the service capability of the hospital. A copy of this inventory is available on the Agency’s website at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/hospital.shtml.

(b) Every hospital offering emergency services and care shall report to the Agency for inclusion in the inventory those services which are within the service capability of the hospital. The following services, when performed on an infrequent and short time limited basis, are not considered to be within the service capability of the hospital:

Services performed for investigative purposes under the auspices of a federally approved institutional review board; or
Services performed for educational purposes; or
Emergencies performed by physicians who are not on the active medical staff of the reporting hospital.

(c) Any addition of service shall be reported to the Agency prior to the initiation of the service. The Agency will act accordingly to include the service in the next publication of the inventory and to add the service on the face of the hospital license.

(d) If the Agency has reason to believe that a hospital offers a service and the service was not reported on the inventory, the Agency will notify the hospital and provide the hospital with an opportunity to respond. The Agency shall arrange for an on-site visit prior to the Agency’s determination of capability, with advance notice of the onsite visit. If, after investigation, the Agency determines that a service is offered by the hospital as evidenced by the patient medical records or itemized bills, the Agency shall amend the inventory and the face of the hospital license.

(4) Exemptions.

(a) Every hospital providing emergency services shall ensure the provision of services within the service capability of the hospital, 24 hours per day, 7 days per week either directly or indirectly through:

An agreement with another hospital made prior to receipt of a patient in need of the service; or
An agreement with one or more physicians made prior to receipt of a patient in need of the service; or
Any other arrangement made prior to receipt of a patient in need of the service.

(b) If a hospital has determined that it is unable to provide a service on a 24 hour per day, 7 day per week basis, either directly or indirectly through arrangement with another hospital or physician(s), the hospital must file an application with the Agency to request a service exemption. The application must identify the service for which the hospital is requesting an exemption. This information shall be submitted to the Agency on the Emergency Services Exemption Request, AHCA Form 3000-1, November 2013, which is incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-04607 and available from the Agency at http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/hospital.shtml. The Agency will make a determination of exemption status pursuant to the procedures in subsection (5) of this rule and notify the hospital of the determination within 45 days of receipt of the request.

(c) Upon receipt of a hospital exemption request, the Agency must act to approve or deny the exemption request within 45 days, during which time deemed exemption status does not exist. If the Agency fails to notify the hospital of the status of the exemption request within the 45 day time frame, the hospital is deemed to be exempt from offering the service until such time that the Agency acts to deny the request.

(d) When a hospital has been providing 24 hour per day, 7 day per week coverage either directly or indirectly through an agreement with another hospital or physician(s) for a specialty service as evidenced by the inventory and hospital license, and the circumstances significantly change such that the hospital can no longer provide the service on a 24 hour per day, 7 day per week basis, the hospital must apply for an exemption from the Agency. The Agency will make a determination of exemption status pursuant to subsection (5) of this rule and notify the hospital of the determination within 45 days of receipt of the request.

(e) When a hospital has been granted an exemption from providing a specialty service 24 hours per day, 7 days per week, either directly or indirectly through an agreement with another hospital or physician(s), and the Agency has information to indicate that the circumstances forwarded by the hospital, and accepted by the Agency, as the basis for the granting of the exemption have changed, the Agency will notify the hospital of this information and shall provide the hospital with an opportunity to respond. If the change in circumstances is confirmed and the hospital failed to report the change, the Agency will amend the inventory accordingly and add the service capability to the face of the hospital license accordingly. Revocation of exemption status shall be effective upon the expiration of 21 days following the hospital’s receipt of the Agency decision or the entry of a final order if appealed.

(f) Each hospital shall immediately report any change in the conditions which led to the granting of an exemption.

(5) Agency Review Process. The review process for exemption requests shall be as follows:

(a) Upon receipt of application, the Agency shall schedule an onsite visit at the hospital when deemed necessary to verify the facts as set forth in the application. The hospital will be notified of the date of the visit in advance. The Agency shall have access to all records necessary for the confirmation and substantiation of the information submitted in the application and to any other records deemed necessary by the Agency to make a determination.

(b) Upon receipt of an application, the Agency shall publish, in the next available Florida Administrative Register, notice of receipt of the application, identifying the applicant and the service(s) for which exemption is requested. Comments submitted within 15 days of the date of publication will be considered by the Agency prior to making a determination of exemption status.

(c) Within 45 days of receipt of application, the Agency shall determine if the hospital has demonstrated that it meets the requirements for service exemption set forth in Section 395.1041, F.S. The Agency shall notify the applicant in writing of its decision, and shall provide the applicant with specific reasons in the event that the request is denied.

(d) If the Agency fails to notify the hospital of the status of the exemption request within the required 45 day time frame, pursuant to Section 395.1041(3)(d)4., F.S., the hospital is deemed to be exempt from offering the service until such time that the Agency acts to deny the request.

(6) Service Delivery Requirements.

(a) Every hospital offering emergency services and care shall provide emergency care available 24 hours a day within the hospital to patients presenting to the hospital. At a minimum:

Emergency services personnel shall be available to ensure that emergency services and care are provided in accordance with Section 395.002(10), F.S.
At least one physician shall be available within 30 minutes through a medical staff call roster; initial consultation through two-way voice communication is acceptable for physician presence.
Specialty consultation shall be available by request of the attending physician or by transfer to a designated hospital where definitive care can be provided.

(b) When a patient is transferred from one hospital to another, all pertinent medical information shall accompany the patient being transferred.

(c) Every hospital offering emergency services and care shall maintain a transfer manual, which shall include in addition to the requirements in subsection (2) of this rule:

Decision protocols for when to transfer a patient;
A list of receiving hospitals with special care capabilities, including the telephone number of a contact person;
A list of all “on-call” critical care physicians available to the hospital, including their telephone numbers; and
Protocols for receiving a call from a transferring hospital, including:

a. Requirements for specific information regarding the patient’s problem;

b. Estimated time of patient arrival;

c. Specific medical requirements;

d. A request to transfer the patient’s medical record with the patient; and

e. The name of the transporting service.

(d) Both transferring and receiving hospitals shall assign a specific person on each shift who shall have responsibility for being knowledgeable of the transfer manual and maintaining it.

(e) Each hospital offering emergency services and care shall maintain written policies and procedures specifying the scope and conduct of emergency services to be rendered to patients. Such policies and procedures must be approved by the organized medical staff, reviewed at least annually, revised as necessary, dated to indicate the time of last review, and enforced. Such policies shall include requirements for the following:

Direction of the emergency department by a designated physician who is a member of the organized medical staff.
A defined method of providing for a physician on call at all times.
Supervision of the care provided by all nursing service personnel with the emergency department by a designated registered nurse who is qualified by relevant training and experience in emergency care.
A written description of the duties and responsibilities of all other health personnel providing care within the emergency department.
A planned formal training program on emergency access laws, and participation, by all health personnel working in the emergency department.
A control register adequately identifying all persons seeking emergency care be established, and that a medical record be maintained on every patient seeking emergency care that is incorporated into the patient’s permanent medical record and that a copy of the Patient Care Record, in accordance with Rules 64J-1.001 and 64J-1.014, F.A.C., be included in the medical record, if the patient was delivered by ambulance. The control register must be continuously maintained and shall include at least the following for every individual seeking care:

a. Identification to include patient name, age and sex;

b. Date, time and means of arrival;

c. Nature of complaint;

d. Disposition; and

e. Time of departure.

(f) Every hospital offering emergency services and care shall have a method for assuring that a review of emergency patient care is performed and documented at least monthly, using the medical record and preestablished criteria.

(g) Every hospital offering emergency services and care shall insure the following:

That clinical laboratory services with the capability of performing all routine studies and standard analyses of blood, urine, and other body fluids are readily available at all times to the emergency department.
That an adequate supply of blood is available at all times, either in-hospital or from an outside source approved by the organized medical staff, and that blood typing and cross-matching capability and blood storage facilities are readily available to the emergency department.
That diagnostic radiology services within the service capability of the hospital are readily available at all times to the emergency department.
That the following are available for immediate use to the emergency department at all times:

a. Oxygen and means of administration;

b. Mechanical ventilatory assistance equipment, including airways, manual breathing bag, and ventilator;

c. Cardiac defibrillator with synchronization capability;

d. Respiratory and cardiac monitoring equipment;

e. Thoracentises and closed thoracostomy sets;

f. Tracheostomy or cricothyrotomy set;

g. Tourniquets;

h. Vascular cutdown sets;

i. Laryngoscopes and endotracheal tubes;

j. Urinary catheters with closed volume urinary systems;

k. Pleural and pericardial drainage set;

l. Minor surgical instruments;

m. Splinting devices;

n. Emergency obstetrical pack;

o. Standard drugs as determined by the facility, common poison antidotes, syringes and needles, parenteral fluids and infusion sets, and surgical supplies;

p. Refrigerated storage for biologicals and other supplies requiring refrigeration, within the emergency department; and

q. Stable examination tables.

(h) Hospital personnel and physicians shall report any apparent violations of emergency access requirements under Section 395.1041, F.S., to the Agency. Reports shall be made within 30 days following the occurrence. Violations include failure to report when on-call or intentionally misrepresenting the patient’s condition in cases of medically necessary transfers or in determining the presence or absence of an emergency medical condition or rendering appropriate emergency services and care, or failure or refusal to sign a certificate of transfer as required by this section.

(7) Each hospital offering emergency services and care shall have the capability to communicate via two-way radio with licensed EMS providers, as required by Section 395.1031, F.S.

History

Rulemaking Authority 395.1041, 395.1055 FS. Law Implemented 395.1031, 395.1041, 395.1055 FS. History–New 9-4-95, Formerly 59A-3.207, Amended 10-16-14.

Fla. Admin. Code R. 59A-3.256 Price Transparency and Patient Billing

(1) Website. Each hospital shall make available to patients and prospective patients price transparency and patient billing information on its website regarding the availability of estimates of costs that may be incurred by the patient, financial assistance, billing practices, and a hyperlink to the Agency’s service bundle pricing website. The content on the hospital’s website shall be reviewed at least every 90 days and updated as needed to maintain timely and accurate information. For the purpose of this rule, service bundles means the reasonably expected hospital services and care provided to a patient for a specific treatment, procedure, or diagnosis as posted on the Agency’s website. In accordance with Section 395.301, F.S., the hospital’s website must include:

(a) A hyperlink to the Agency’s pricing website upon implementation of the same that provides information on payments made to the facilities for defined service bundles and procedures. The Agency’s pricing website is located at: http://pricing.floridahealthfinder.gov;

(b) A statement informing patients and prospective patients that the service bundle information is a non-personalized estimate of costs that may be incurred by the patient for anticipated services and that actual costs will be based on services actually provided to the patient;

(c) A statement informing patients and prospective patients of their right to request a personalized estimate from the hospital;

(d) A statement informing patients of the hospital’s financial assistance policy, charity care policy, and collection procedure;

(e) A list of names and web addresses of health insurers and health maintenance organizations (HMO) contracted with the hospital as a network provider or participating provider;

(f) A list of names and contact information of health care practitioners and medical practice groups contracted to provide services within the hospital, grouped by specialty or service; and,

(g) A statement informing patients to contact the health care practitioners anticipated to provide services to the patient while in the hospital regarding a personalized estimate, billing practices, and participation with the patient’s insurance provider or HMO as the practitioners may not participate with the same health insurers or HMO as the hospital.

(2) Estimate. The hospital shall provide an estimate upon request of the patient, prospective patient, or legal guardian for nonemergency medical services.

(a) An estimate or an update to a previous estimate shall be provided within 7 business days from receipt of the request. Unless the patient requests a more personalized estimate, the estimate may be based upon the average payment received for the anticipated service bundle. Every estimate shall include:

A statement informing the requestor to contact their health insurer or HMO for anticipated cost sharing responsibilities,
A statement advising the requestor that the actual cost may exceed the estimate,
The web address of the hospital’s financial assistance policies, charity care policy, and collection procedures,
A description and purpose of any facility fees, if applicable,
A statement that services may be provided by other health care providers who may bill separately,
A statement, including a web address if different from above, that contact information for health care practitioners and medical practice groups that are expected to bill separately is available on the hospital’s website; and,
A statement advising the requestor that the patient may pay less for the procedure or service at another facility or in another health care setting.

(b) If the hospital provides a non-personalized estimate, the estimate shall include a statement that a personalized estimate is available upon request.

(3) Itemized statement or bill. The hospital shall provide an itemized statement or bill upon request of the patient or the patient’s survivor or legal guardian. The itemized statement or bill shall be provided within 7 business days after the patient’s discharge or release, or 7 business days after the request, whichever is later. The itemized statement or bill must include:

(a) A description of the individual charges from each department or service area by date, as prescribed in Section 395.301(1)(d), F.S.;

(b) Contact information for health care practitioners or medical practice groups that are expected to bill separately based on services provided; and,

History

Rulemaking Authority 395.301 FS. Law Implemented 395.301 FS. History–New 2-19-18.

Fla. Admin. Code R. 59A-3.270 Health Information Management

(1) Each hospital must establish processes to obtain, manage, and utilize information to enhance and improve individual and organizational performance in patient care, governance, management, and support processes. Such processes must:

(a) Be planned and designed to meet the hospital’s internal and external information needs;

(b) Provide for confidentiality, security and integrity;

(c) Provide uniform data definitions and methods for capturing and storing data, including electronic mediums and optical imaging;

(d) Provide education and training in information management principles to decision-makers and other hospital personnel who generate, collect, and analyze information;

(e) Transmit information in a timely and accurate manner; and

(f) Provide for the manipulation, communication and linkage of information.

(2) All hospitals involved in the transplantation of organs or tissues must maintain a centralized tracking system to record the receipt and disposition of all organs and tissues transplanted within the hospital.

(a) The tracking system must be kept separate from patients’ medical records, and must include:

The organ or tissue type;
The donor identification number;
The name and license number of the procurement or distribution center supplying the organ or tissue;
Recipient information, including, at a minimum the patient’s name and identification number;
The name of the physician who performed the transplant;
The date the organ or tissue was received by the hospital; and
The date the organ or tissue was transplanted.

(b) This information must be provided, on a quarterly basis, to the organ procurement organization or tissue bank that originally provided the organ or tissue.

(3) Each hospital must maintain a current and complete medical record for every patient seeking care or service. The medical record must contain information required for completion of birth, death and stillbirth certificates, and must, contain the following information:

(a) Identification data;

(b) Chief complaint or reason for seeking care;

(d) Personal medical history;

(e) Family medical history;

(f) Physical examination report;

(g) Provisional and pre-operative diagnosis;

(h) Clinical laboratory reports;

(i) Radiology, diagnostic imaging, and ancillary testing reports;

(j) Consultation reports;

(k) Medical and surgical treatment notes and reports;

(l) Evidence of appropriate informed consent;

(m) Evidence of medication and dosage administered;

(n) A copy of the Patient Care Record, in accordance with subsection 64J-1.001(18), F.A.C., if the patient was delivered to the hospital by ambulance;

(o) Tissue reports;

(p) Physician, APRN, PA and nurse progress notes;

(q) Principal diagnosis, secondary diagnoses and procedures when applicable;

(r) Discharge summary;

(s) Appropriate social work services reports, if provided;

(t) Autopsy findings when performed;

(u) Individualized treatment plan;

(v) Clinical assessment of the patients needs;

(w) Certifications of transfer of the patient between hospitals as specified by Rule 59A-3.255, F.A.C.; and,

(x) Routine Inquiry Form regarding request for organ donation in the event of the death of the patient.

(y) A copy of the Hospital Outpatient Observation Notice or Medicare Outpatient Observation Notice as required by Section 395.301(3), F.S., if the patient was placed on observation status.

(4) For patients undergoing operative or other invasive procedures the medical record policies must also require:

(a) The recording of preoperative diagnoses prior to surgery;

(b) That operative reports be recorded in the health record immediately following surgery or that an operative progress note is entered in the patient record to provide pertinent information; and,

(c) Postoperative information must include vital signs, level of consciousness, medications, blood components, complications and management of those events, identification of direct providers of care, discharge information from the post-anesthesia care area.

(5) Medical records for ambulatory care patients must consist of the information specified in paragraph 59A-3.244(1)(i), F.A.C.

(6) Each hospital must have a patient information system, medical records department or similarly titled unit with administrative responsibility for medical records. The medical records department must:

(a) Maintain a system of identification and filing to ensure the prompt location of a patient’s medical record. Patient records may be stored on electronic medium such as optical imaging, computer, or microfilm;

(b) Centralize all appropriate clinical information relating to a patient’s hospital stay in the patient’s medical record;

(7) Patient records must have a privileged and confidential status and must not be disclosed without the consent of the person to whom they pertain unless disclosed in accordance with Section 395.3025(4), F.S.

(8) Any licensed facility must, upon request, and only after discharge of the patient, furnish to any patient admitted or treated in the facility, or to any patient’s guardian, curator, or personal representative, or to anyone designated by the patient in writing, a true and correct copy of all of the patient’s records, including X-rays, which are in the possession of the licensed facility, provided the person requesting such records agrees to pay a reasonable charge for copying the records, pursuant to Section 395.3025, F.S. The per page fee is applicable to each page generated during copying of the medical record by the facility or from a copy service providing these services on behalf of the facility. Progress notes and consultation reports of a psychiatric or substance abuse nature concerning the care and treatment performed by the licensed facility are exempted from this requirement. The licensed facility shall further allow any such person to examine the original records in its possession, or microfilms or other suitable reproductions of the records stored on electronic mediums, upon such reasonable terms imposed to assure that the records will not be damaged, destroyed, or altered.

(a) The provisions of this section do not apply to any licensed facility whose primary function is to provide psychiatric care or substance abuse treatment to its patients.

(b) Disclosure of the medical records of inmates of any institution, facility or program of the Department of Corrections must be made in conformance with Section 945.10, F.S., and applicable rules adopted thereunder.

(9) Each hospital operated by the Department of Corrections must use a problem oriented medical record for each patient, which must be initiated at the time of intake or admission and which must contain all pertinent information required by this section.

(10) Each problem oriented medical record maintained by hospitals operated by the Department of Corrections must be standardized within each hospital and must be capable of providing easy comparison of basic information on medical records at all such hospitals. Each problem oriented medical record maintained by these hospitals must contain at least the following information:

(a) A patient data base which compiles all known facts about the patient which have relevance to his health care, and which in addition to the other requirements of this section contains:

Comments and complaints as spoken by the patient or other persons significant in the patient’s life, including relatives, friends and caretakers;
A patient profile, including health related habits, social, nutritional and educational information, and a review of physical systems;
Relevant legal documents, including but not limited to status forms, forensic forms, consent forms, authority permits, and Baker Act forms; and
A medical diagnosis listed according to the International Classification of Diseases and a mental illness diagnosis listed according to the Diagnosis and Statistical Manual of Mental Disorders, as relevant to the patient’s condition.

(b) A problem list, which is a table of contents to the patient’s record, which identifies by number, date and description of the patients problems.

(c) A plan of care which must specify the specific course of action to be taken to address the problem(s) described, including diagnosis, diagnostic and therapeutic orders, treatment, examination, patient education, referral, and other necessary activities.

(d) Progress notes which must document the activity and follow-up undertaken for each problem in a structured format which is dated, titled and numbered according to the problem to which it relates.

(11) The discharge summary of each problem oriented medical record in hospitals operated by the Department of Corrections must be completed, signed and dated within 15 days following the patient’s discharge. The summary must include:

(a) The reason for admission;

(b) A recapitulation of the patient’s hospitalization;

(d) The facility or person, including the patient themself when relevant, assuming responsibility for the patient after discharge; and,

(e) Recommendations, when necessary, for after care, follow-up, referral or other action necessary to help the patient deal with problems.

(12) Each hospital must immediately notify a non-Medicare patient or the patient’s representative when the patient is placed on observation status. Notification must utilize the Hospital Outpatient Observation Notice, AHCA Form 3190-2000, April 2021, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-13012. The form is available online at http://www.ahca.myflorida.com/HQAlicensureforms.

(a) A hospital may provide AHCA Form 3190-2000 in electronic format, including electronic signature, unless the patient requests a paper version.

(b) The signed version must be incorporated into the patient’s medical record and provided to the patient, patient’s survivor, or legal guardian through discharge papers.

(13) Information provided pursuant to Section 395.1012(3)(a), F.S., must be provided on Quality Measures and Patient Safety Information, AHCA Form 3190-2001OL, April 2021, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-13013. The form is available online at https://www.floridahealthfinder.gov/index.html.

(14) The Agency will review this rule five years from the effective date and repromulgate, amend or repeal the rule as appropriate, in accordance with Section 120.54, F.S., and Chapter 1-1, F.A.C.

History

Rulemaking Authority 395.1012, 395.1055, 395.301, 395.3015 FS. Law Implemented 395.1055, 395.301, 395.1012, 395.3015, 395.3025 FS. History–New 9-4-95, Formerly 59A-3.214, Amended 10-16-14, 5-17-21.

Fla. Admin. Code R. 59A-3.271 Quality Improvement

(1) General Provisions. Each hospital shall have a planned, systematic, hospital wide approach to the assessment, and improvement of its performance to enhance and improve the quality of health care provided to the public.

(a) Such a system shall be based on the mission and plans of the organization, the needs and expectations of the patients and staff, up-to-date sources of information, and the performance of the processes and their outcomes.

(b) Each system for quality improvement, which shall include utilization review, must be defined in writing, approved by the governing board, and enforced, and shall include:

A written delineation of responsibilities for key staff;
A policy for all privileged staff, whereby staff members do not initially review their own cases for quality improvement program purposes;
A confidentiality policy;
Written, measurable criteria and norms;
A description of the methods used for identifying problems;
A description of the methods used for assessing problems, determining priorities for investigation, and resolving problems;
A description of the methods for monitoring activities to assure that desired results are achieved and sustained; and,
Documentation of the activities and results of the program.

(2) Each hospital shall have in place a systematic process to collect data on process outcomes, priority issues chosen for improvement, and the satisfaction of the patients. Processes measured shall include:

(a) Appropriate surgical and other invasive procedures;

(b) Preparation of the patient for the procedure;

(d) Provision of post-procedure care;

(e) Use of medications including prescription, preparation and dispensing, administration, and monitoring of effects;

(f) Results of autopsies;

(g) Risk management activities;

(h) Quality improvement activities including at least clinical laboratory services, diagnostic imaging services, dietetic services, nuclear medicine services, and radiation oncology services.

(3) Each hospital shall have a process to assess data collected to determine:

(a) The level and performance of existing activities and procedures,

(b) Priorities for improvement, and,

(4) Each hospital shall have a process to incorporate quality improvement activities in existing hospital processes and procedures.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 9-4-95, Formerly 59A-3.216.

Fla. Admin. Code R. 59A-3.272 Governing Board

(1) The licensee shall have a governing board responsible for the conduct of the hospital as a functioning institution.

(2) The governing board shall be organized under written bylaws, rules and regulations which it reviews at least every two years, dates to indicate time of last review, revises as necessary, and enforces. Governing board by-laws shall:

(a) State the role and purpose of the hospital, including an organizational chart defining the lines of authority. The description of the structure of the hospital shall include full disclosure in writing of the names and addresses of all owners and persons controlling 5 percent or more interest in the hospital. In the case of corporations, holding companies, partnerships, and similar organizations, the names and addresses of officers, directors, and stockholders, both beneficial and of record, when holding 5 percent or more interest, shall be disclosed.

(b) State the qualifications for governing board membership, and the method of selecting members as well as the terms of appointment or election of members, officers and chairmen of committees.

(c) Provide for the designation of officers, their duties, and for the organization of the governing board into essential committees with the number and type consistent with the size and scope of the hospital’s activities.

(d) Coordinate through an executive committee or the governing board as a whole, the policies and activities of the facility and special committees established by the governing board.

(e) Specify the frequency of meetings, at regularly stated intervals, the number or percentage of members constituting a quorum, and require that minutes be recorded and made available to all members of the governing board.

(3) The governing board shall establish the position of chief executive officer or other similarly titled position, and define in writing the responsibility, authority and accountability of the chief executive officer for operation and maintenance of the hospital.

(4) The governing board shall approve the by-laws, rules and regulations of the organized medical staff, provide for the appointment, reappointment, or dismissal of members of the organized medical staff, and provide a procedure for hearings and appeals on all actions concerning appointment, reappointment or dismissal. No action on appointment, reappointment, or dismissal of a member of the organized medical staff shall be taken without prior referral to the organized medical staff for their recommendation, except in emergency cases.

(a) The governing board shall provide that no qualified applicant is denied organized medical staff privileges or clinical privileges solely because the applicant is licensed as a physician, dentist or podiatrist, psychologist, advanced practice registered nurse, or physician assistant.

(b) The governing board shall set standards and procedures to be applied by the hospital and the organized medical staff in considering and acting upon applications for staff membership or professional privileges, including delineation of privileges. Such standards or procedures shall be available for public inspection, and shall not operate to deny staff privileges or clinical privileges in an arbitrary, unreasonable or capricious manner, or on the basis of sex, race, creed, or national origin.

(c) When the standards and procedures established by the governing board require, as a precondition to obtaining staff membership or professional clinical privileges, the completion of or eligibility in, a program established by the American Medical Association or the Liaison Committee on Graduate Medical Education, the governing board shall also make available staff membership or privileges to physicians who have obtained the completion of or eligibility in, any program which is in the same area of medical specialization established by the American Osteopathic Association.

(d) The governing board shall require a delineation of privileges for each member of the organized medical staff. The delineation of privileges shall not be stated simply as a specialty designation, such as “general surgery” or “general medicine” unless such terms are specifically defined elsewhere.

(e) The governing board shall require that eligibility for privileges, delineation of privileges, and reappointments, be based on the applicant’s background, experience, health, training, demonstrated current competence, adherence to applicable professional ethics, reputation, ability to work with others, ability of the hospital to provide adequate facilities and supportive services for the applicant and his patients, and such other elements as the governing board determines that are not inconsistent with this part.

(f) The governing board shall establish a procedure, within a time-limited period, for approving, approving in part, or denying an applicant’s request for privileges.

(g) The governing board shall establish a procedure for an applicant for privileges to appeal an adverse decision, and shall establish a time-limited period for rendering a final decision after the appeal.

(h) The governing board shall set standards and procedures which provide for reasonable access by licensed chiropractors to the reports of diagnostic x-rays and laboratory tests of the institutions licensed facilities, subject to the same standards and procedures as other licensed physicians. However, nothing contained in the provisions of this section shall require a licensed facility to grant staff privileges to a chiropractor.

(5) Within 30 days of receipt of a written request, either by an applicant for staff privileges, or by a member of the organized medical staff whose privileges have been suspended, denied, revoked or curtailed, whether in whole or in part, the licensed facility shall supply the reasons for such action in writing to the requesting applicant or staff member. A denial of staff membership or professional clinical privileges to any applicant shall be submitted, in writing, to the applicant’s respective licensing board.

(6) Nothing herein shall prohibit the licensee of the facility from acting as the governing board, provided that the articles of incorporation or other written organizational plan describe the manner in which the licensee executes the governing board’s responsibility.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.0191, 395.0193, 395.0195, 395.1055 FS. History–New 9-4-95, Formerly 59A-3.217, Amended 11-21-18.

Fla. Admin. Code R. 59A-3.273 Management and Administration

(1) Each hospital shall be under the direction of a chief executive officer appointed by the governing board, who is responsible for the operation of the hospital in a manner commensurate with the authority conferred by the governing board.

(2) The chief executive officer shall take all reasonable steps to provide for:

(a) Compliance with applicable laws and regulations; and,

(b) The review of and prompt action on reports and recommendations of authorized planning, regulatory, and inspecting agencies.

(3) The chief executive officer shall provide for the following:

(a) Establishment and implementation of organized management and administrative functions, including:

Clear lines of responsibility and accountability within and between department heads and administrative staff;
Effective communication mechanisms among departments, medical staff, the administration and the governing board;
Internal controls;
Coordination of services with the identified needs of the patient population;
A policy on patient rights and responsibilities;
A mechanism for receiving and responding to complaints concerning patient care;
A policy on withholding resuscitative services;
Policies and procedures on identification and referral of organ and tissue donors including notification of organ and tissue procurement agencies when organs and tissues become available as specified under Rule 59A-3.274, F.A.C.;
Policies and procedures for meeting the communication needs of multicultural populations and persons with impaired hearing or speaking skills;
Policies and procedures on discharge planning;
A policy to assist in accessing educational services for children or adolescents when treatment requires a significant absence from school;
Policies and procedures to assure that the treatment, education and developmental needs of neonates, children and adolescents transferred from one setting to another are assessed;
Dissemination and enforcement of a policy prohibiting the use of smoking materials in hospital buildings and procedures for exceptions authorized for patients by a PA, APRN or physician’s written authorization;
A policy regarding the use of restraints and seclusion; and,
A comprehensive emergency management plan which meets the requirements of Section 395.1055(1)(c), F.S., and Rule 59A-3.078, F.A.C.

(b) Personnel policies and practices which address:

Non-discriminatory employment practices;
Verification of credentials including current licensure and certification;
Periodic performance evaluations; and,
Provision of employee health services.

(d) An internal risk management program which meets the requirements of Section 395.0197, F.S., and Chapter 59A-10, F.A.C.;

(e) Assurance of compliance with educational requirements on human immunodeficiency virus and acquired immune deficiency syndrome pursuant to Sections 381.0034 and 381.0035, F.S., and Chapter 64D-2, F.A.C., and;

(f) Policies and procedures to ensure medical student training prioritization pursuant to section 395.1055, F.S. Documentation of compliance such as clinical placement agreements shall be made available for Agency review upon request.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.0197, 395.1055 FS. History–New 9-4-95, Formerly 59A-3.218, Amended 10-16-14, 6-1-25.

Fla. Admin. Code R. 59A-3.274 Anatomical Gifts, Routine Inquiry

(1) Each Class I and Class II hospital shall establish a mechanism whereby the next of kin of all patients who are deemed medically acceptable and who die in Florida hospitals are given the opportunity to consider the donation of organs, tissues and eyes for transplantation and research.

(2) Education and Training of Designee. The hospital administrator or designee making the request of the next of kin for organ, tissue and eye donations shall be trained in the request procedures used in organ and tissue donation. The Organ Procurement Organization (OPO), tissue bank and eye bank shall, in conjunction with their affiliated hospitals, develop a requester training curriculum that will meet the individual needs of each affiliated hospital. The Agency shall assist, if requested, in the implementation of the requester training curriculum in conjunction with an OPO, tissue bank and eye bank where the OPO, tissue bank and eye bank do not have adequate resources for the implementation of the requester training curriculum within their affiliated hospitals. This training shall include the following minimum basic curriculum:

(a) The criteria used by the affiliated OPO, tissue bank, and eye bank for determining the acceptability of patients as organ, tissue, or eye donors;

(b) The requirements of Florida law to be met in order for a donation to be allowed to proceed including:

Explanatory information regarding the family’s rights to allow or refuse a donation, to donate specific organs, tissues or eyes and to designate the organs, tissues or eyes for the purpose of transplantation, medical research or instruction, and,
The criteria for determining whether a particular death falls within the scope of Section 406.11, F.S., necessitating close communication with the Medical Examiner’s office, and permission from the Medical Examiner when required;

(c) Necessary basic information regarding the process and procedures related to organ, tissue, and eye donation and transplantation including the following:

The procedures and techniques used in the recovery and preservation of organs, tissues and eyes;
The success rates of currently accepted transplant procedures;
The numbers of patients presently awaiting these procedures; and,
The financial procedures and arrangements applicable to the donation of organs, tissues and eyes.

(d) The various approaches which can be used in dealing with a family in a grief situation and offering them the opportunity of organ, tissue, or eye donation. These approaches shall be based on the criteria of the affiliated OPO, tissue bank, and eye bank, which shall not be inconsistent with these guidelines;

(e) Notification of the affiliated OPO, tissue bank and eye bank; and,

(f) Training regarding the administrative rules and guidelines promulgated by the Agency for the purpose of implementing the Routine Inquiry provisions of the Anatomical Gift Act, in accordance with Section 765.522, F.S.

(3) Each Class I and Class II hospital or its designee shall, using the criteria of the affiliated OPO, tissue bank, and eye bank, implement the following procedures:

(a) Establish and publish a formal written policy and procedure for the identification and referral of organ, tissue, and eye donors. This policy shall include the procedure to be followed for the determination of brain death.

(b) Identify and designate the personnel or organization which will make the request for organ, tissue, or eye donation. These personnel shall be trained as required in subsection (2), above, and shall be available on a 24-hour “on call” basis to make the initial evaluations of donor suitability, request, and referrals.

(c) The Hospital Administrator or designee shall ensure that the District Medical Examiner is contacted in all medical examiners’ cases regarding the wishes of the family as to organ, tissue, and eye donation and to determine whether or not the medical examiner has released such organs, tissues or eyes for transplantation, medical research or instruction. This contact shall be recorded on the Routine Inquiry Form and placed in the patient’s medical record. When completion of the Routine Inquiry Form is designated by the hospital administrator and accepted by the affiliated procurement agency, the contact shall be noted in the records of the affiliated procurement agency. This notation shall indicate that request for donation of organs, tissue or eyes was made.

(d) The hospital administrator or designee shall ensure that all identified potential organ, tissue, or eye donors meeting the criteria of brain death as defined in section 382.009, F.S., or cardiorespiratory death as defined in subsection 59A-3.065(9), F.A.C., shall be referred to the affiliated OPO, tissue bank, or eye bank for evaluation and recovery of the organs, tissues, or eyes to be donated according to the medical standards of the affiliated OPO, tissue bank and eye bank. This referral shall be recorded on the Routine Inquiry Form and placed in the patient’s medical record. When completion of the Routine Inquiry Form is designated by the hospital administrator and accepted by the affiliated procurement agency, the referral shall be noted in the records of the affiliated procurement agency.

(e) The hospital shall work with the affiliated OPO, tissue bank, and eye bank to evaluate the patient as a potential organ, tissue, or eye donor in accordance with Section 765.522, F.S. The medical acceptability of such organs, tissues, and eyes shall be determined according to the medical standards of the affiliated procurement agency. The hospital administrator may designate personnel of the affiliated OPO, tissue bank, or eye bank who shall make the request for donation. Where non-hospital personnel are designated to make the request for organ, tissue or eye donation, the affiliated OPO, tissue bank, or eye bank shall be given the opportunity to approach the next of kin about donation and shall utilize the following procedure when approaching the next of kin:

The affiliated OPO shall be given the opportunity to approach the next of kin about donation of organs in all suitable vascular organ donor cases when the potential donor meets the medical standards of the affiliated OPO. Where the suitable vascular organ donor also meets the medical standards of the affiliated tissue bank or eye bank, and in the absence of a contrary agreement between the affiliated OPO, tissue bank, and eye bank, the affiliated OPO may represent the affiliated tissue bank and eye bank and approach the next of kin about donation in all suitable tissue and eye donor cases.
The affiliated tissue bank shall be given the opportunity to approach the next of kin about donation in all suitable tissue donor cases where the potential donor meets the medical standards of the affiliated tissue bank and where the affiliated OPO has not already approached the next of kin for donation of tissues and eyes in all non-suitable vascular organ donor cases. Where the suitable tissue donor also meets the medical standards of the affiliated eye bank, and in the absence of a contrary agreement between the affiliated tissue bank and eye bank, the affiliated tissue bank may represent the affiliated eye bank and approach the next of kin about donation in all suitable eye donor cases.
The affiliated eye bank shall be given the opportunity to approach the next of kin about donation in all suitable eye donor cases where the potential donor meets the medical standards of the affiliated eye bank, and where the affiliated OPO or tissue bank has not already approached the next of kin for donation of eyes. Where the suitable eye donor also meets the medical standards of the affiliated tissue bank, and in the absence of a contrary agreement between the affiliated eye bank and tissue bank, the affiliated eye bank may represent the affiliated tissue bank and approach the next of kin about donation in all suitable tissue donor cases.

(f) The request for organ, tissue, or eye donation shall be made at or near the time of death, and in a manner which is conducive to the discussion of organ, tissue, and eye donation with the grieving next of kin according to the priority specified in Section 765.512, F.S.

(g) A Routine Inquiry Form shall be completed upon every patient death occurring within the hospital and shall become a part of each patient’s medical record.

The form shall document whether the patient was deemed medically suitable for donation of organs, tissues and eyes, and if the patient is not medically suitable for donation, the form shall document the specific reason according to the criteria of the affiliated procurement agency.
If the patient is deemed medically acceptable for donation, the form shall document that the patient’s appropriate next of kin was approached, as well as the outcome of the patient’s expressed wishes, if known, regarding the donation of organs, tissues, and eyes. If the family allows donation, a specific consent form shall be signed or completed by means of telegraphic, recorded telephonic, or other recorded message by the appropriate next of kin as specified in Section 765.512, F.S.
If a request for donation is deemed to be exempted according to subsection (4) of this section, or the medical standards of the affiliated OPO, tissue bank, and eye bank, the form shall document the specific reason for the lack of a request.

(h) The lack of request and a complete written explanation shall be noted on the Routine Inquiry Form and made a part of the patient’s medical record or if designated by the hospital administrator, and accepted by the affiliated procurement agency, in the affiliated procurement agency’s records. If the affiliated procurement agency has been designated, the patient’s medical record shall document the referral of the potential donor to the affiliated procurement agency. All Routine Inquiry Forms maintained by the affiliated procurement agency shall be complete and include the patient’s name and medical record number. These records shall be made available to the hospital during normal working hours. The referral of the affiliated procurement agency shall be documented in the patient’s medical record. This documentation shall include the name of the procurement agency and time and date of the referral. This referral shall be documented in the patient’s death record.

(4) Request Exemptions.

(a) The appropriate next of kin as defined by Section 765.512, F.S., of patients deemed medically acceptable by the medical standards of the affiliated OPO, tissue bank and eye bank, and dying in the hospital shall be asked about organ, tissue, and eye donation except as follows:

There is on record notification of prior objection by the individual, or the appropriate next of kin as defined by Section 765.512, F.S., or
The appropriate next of kin cannot be found after a reasonable search; or
No positive identification of the potential donor has been found; or
The medical examiner has denied permission; or
The hospital or designee, in accordance with a request for the affiliated procurement agency, has agreed to delay the request until the family has left the hospital.

History

Rulemaking Authority 765.522, 873.01(3)(a) FS. Law Implemented 765.522 FS. History–New 9-4-95, Formerly 59A-3.219, Amended 10-16-14.

Fla. Admin. Code R. 59A-3.275 Organized Medical Staff

(1) Each hospital shall have an organized medical staff organized under written by-laws approved by the governing board and responsible to the governing board of the hospital for the quality of all health care provided to patients in the facility and for the ethical and professional practices of its members.

(2) Each hospital’s organized medical staff shall determine its appropriate committee structure and shall provide that the following required committee functions are carried out with sufficient periodicity to assure their objectives being achieved by separate committee, combined committees, or committee of the whole:

(a) Coordination of the activities and general policies of the various departments.

(b) Interim decision making for the organized medical staff between staff meetings, under such limitations as shall be set by the organized medical staff.

(d) Review of all applications for appointment and reappointment to all categories of staff, and recommendations on each to the governing board, including delineation of privileges to be granted in each case, and right of hearing and appearance. Except in emergency cases, recommendations to the governing board for withdrawal of any privileges of a member of the organized medical staff or dismissal from the organized medical staff will be made only after a thorough investigation by the organized medical staff or a committee thereof, with the subject member being given the right of hearing before the organized medical staff or a committee thereof, if requested within a reasonable time as specified in the hospital’s by-laws.

(e) Medical records currently maintained describing the condition, treatment, and progress of patient in sufficient completeness to assure transferable comprehension of the case at any time.

(f) Clinical evaluation of the quality of medical care provided to all categories of patients on the basis of documented evidence.

(g) Review of hospital admissions with respect to need for admission, length of stay, discharge practices and evaluation of the services ordered and provided.

(h) Surveillance of hospital infection potentials and cases and the promotion of a preventive and corrective program designed to minimize these hazards.

(i) Surveillance of pharmacy and therapeutic policies and practices within the institution.

(j) Hospital tests may be ordered only by the attending physician, or by another licensed health professional if that licensed health professional is acting within his scope of practice as defined by applicable laws and rules of the agency. Nothing herein shall be construed to expand or restrict such laws and rules pertaining to the practice of the various health professions.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.0191, 395.1055 FS. History–New 9-4-95, Formerly 59A-3.220.

Fla. Admin. Code R. 59A-3.276 Maintenance

(1) Each hospital shall develop, implement, and maintain a written preventive maintenance plan, in conjunction with the policies and procedures developed by the infection control committee, to ensure that the facility is maintained in accordance with the following:

(a) The interior and exterior of buildings shall be in good repair, free of hazards, and painted as needed.

(b) All patient care equipment shall be maintained in a clean, properly calibrated, and safe operating condition;

(c) All plumbing fixtures shall be maintained in good repair to assure proper functioning, and provided with back flow prevention devices, when required, to prevent contamination from entering the water supply;

(d) All mechanical and electrical equipment shall be maintained in working order, and shall be accessible for cleaning and inspection;

(e) Loose, cracked, or peeling wallpaper or paint shall be promptly replaced or repaired to provide a satisfactory finish;

(f) All furniture and furnishings, including mattresses, pillows, and other bedding; window coverings; including curtains, blinds, shades, and screens; and cubicle curtains or privacy screens, shall be maintained in good repair; and,

(g) The grounds and buildings shall be maintained in a safe and sanitary condition and kept free from refuse, litter, and vermin breeding or harborage areas.

(2) Each hospital shall employ or otherwise arrange for sufficient personnel to implement and maintain its preventive maintenance program.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 9-4-95, Formerly 59A-3.222.

Fla. Admin. Code R. 59A-3.277 Functional Safety

(1) Each hospital shall have a hospital safety committee to adopt, implement and monitor a comprehensive, hospital wide safety program. The committee’s functions and responsibilities may be assumed by another hospital committee. The committee shall adopt written policies and procedures to enhance the safety of the hospital, its personnel and patients. Such policies shall include but not be limited to the following:

(a) A method of coordination of the safety policies of the various hospital units, departments and committees;

(b) An incident reporting system;

(d) Conduct of a hazardous surveillance program at specifically defined intervals.

(2) In addition to other requirements, each hospital shall provide a complete system for patient identification within the hospital, including a system for all emergency room cases, including DOA, and disasters.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 9-4-95, Formerly 59A-3.223.

Fla. Admin. Code R. 59A-3.278 Rehabilitation, Psychiatric and Substance Abuse Programs

(1) All rehabilitation, psychiatric, and substance abuse programs provided by hospitals shall provide to the patient:

(a) An evaluation upon referral;

(b) Establishment of goals;

(c) Development of a plan of treatment, including discharge planning, in coordination with the referring individual and rehabilitation staff, and after discussion with the patient and family;

(d) Regular and frequent assessment, performed on an interdisciplinary basis, of the patient’s condition and progress, and of the results of treatment;

(e) Maintenance of treatment and progress records; and,

(f) At least a quarterly assessment of the quality and appropriateness of the care provided.

(2) When any rehabilitation activity, psychiatric or substance abuse treatment is provided from outside the hospital, the source shall be available whenever needed for patient care, meet all safety requirements, abide by all pertinent rules and regulations of the hospital and medical staff, and document the quality assurance measures to be implemented.

(3) The scope of services offered, and the relationship of the rehabilitation, psychiatric or substance abuse program to other hospital units, as well as all supervisory relationships within the program, shall be defined in writing. Responsibility for the performance of clinical services also shall be clearly defined. Delegation of authority within the program shall be specified in job descriptions and in organizational plans. Written policies and procedures to guide the operation of the rehabilitation program shall be developed and reviewed at least annually, revised as necessary, dated to indicate the time of last revision, and enforced.

(4) There shall be a current written plan of care for each patient receiving rehabilitative, psychiatric or substance abuse services. The plan shall state the diagnosis, and problem list when appropriate, pertinent to the rehabilitation or treatment process; precautions necessitated by the patient’s general medical condition or other factors; the short-term and long-term goals of the treatment program; and require monthly or more frequent review of the patient’s progress. The medical record and the written plan shall evidence a team approach, with participation of the professional and administrative staffs, the patient, and, as appropriate, the patient’s family. The medical record shall document the written instructions given to the patient and the family concerning appropriate care after discharge from the hospital.

(5) The rehabilitation, psychiatric or substance abuse program must have notes and log records that are separately identified from the other admission and discharge records in the hospital in which it is located, and are separately retrievable.

(6) The beds assigned to the program must be physically separate from and not commingled with beds not included in the unit. Rehabilitation, psychiatric or substance abuse programs and beds may be located on the same floor as other programs or beds.

(7) In addition to meeting the requirements of subsections (1) through (6) of this section, rehabilitation programs provided by hospitals must place responsibility for the medical direction of the rehabilitation program on a physician member of the organized medical staff who, on the basis of training, experience and interest, is knowledgeable in the rehabilitation services offered. Unless otherwise permitted by law, rehabilitation services shall be initiated by a physician. The written request for services shall include reference to the diagnosis or problems for which treatment is planned.

(8) In addition to meeting the requirements of subsections (1)-(6) of this section, psychiatric, or substance abuse rehabilitation programs provided by hospitals shall meet at least the following additional standards:

(a) The program, unit, service or similarly titled part shall treat only those patients whose primary reason for admission was a diagnosis contained in the third edition of the American Psychiatric Association Diagnostic and Statistical Manual.

(b) The program, unit, service or similarly titled part shall have medical direction by an appropriately qualified practitioner, including a physician who is certified by the American Board of Psychiatry and Neurology or is eligible for examination by the Board or similar specialty board recognized by the American Osteopathic Association, a clinical psychologist, or a licensed physician with postgraduate training and experience in the diagnosis and treatment of nervous and mental disorders.

(c) The program, unit, service or similarly titled part shall furnish, through qualified personnel, psychological services, social work services, psychiatric nursing, occupational therapy, and recreational therapy, as appropriate to the needs of the patient.

(d) The program, unit, service or similarly titled part shall have a charge nurse who is a registered professional nurse qualified in psychiatric or mental health nursing.

(9) In addition to the medical direction required in subsection (7), overall supervision and administration of the following specialty rehabilitation programs may be provided by staff with the following credentials:

(a) Physical Therapy – A qualified physical therapist who shall be a graduate of a physical therapy program approved by a nationally recognized accrediting body or have documented equivalent training or experience, shall meet any current requirements for licensure or registration, and shall be currently competent in the field.

(b) Occupational Therapy – A qualified occupational therapist who shall be a graduate of an occupational therapy program approved by a nationally recognized accrediting body; or shall currently hold certification by the American Occupational Therapy Association as an Occupational Therapist, Registered; or shall have documented equivalent training or experience; and shall meet all current requirements for licensure under Chapter 468, part IV, F.S.

(c) Speech Pathology and Audiology – A qualified speech-language pathologist or audiologist who shall hold the Certificate of Clinical Competence or a Statement of Equivalence in either speech pathology or audiology issued by the American Speech-Language-Hearing Association, or have documented equivalent training or experience; and shall meet all current requirements for licensure under Chapter 468, Part II, F.S.

(d) Rehabilitation Nursing – A professionally qualified licensed registered nurse who shall have documented training in rehabilitation nursing and at least one year of rehabilitation nursing experience.

(e) Vocational or Educational Rehabilitation – A qualified individual who shall be a graduate of vocational rehabilitation program at the graduate level, or have documented equivalent training or experience.

(f) Comprehensive Medical Rehabilitation – A qualified physician who shall be a member of the organized professional staff and who is certified, or eligible for examination, either by the American Board of Physical Medicine and Rehabilitation or by a specialty related to rehabilitation.

(10) Nothing in this section shall be construed to prevent a hospital from providing rehabilitation, psychiatric or substance abuse programs to its patients. However, no hospital shall have rehabilitation, psychiatric, intensive residential treatment program, or substance abuse beds unless it has obtained a valid certificate of need as required by Section 408.031 through 408.045, F.S., and meets the requirements of this section.

History

Rulemaking Authority 395.003, 395.1055, 408.036 FS. Law Implemented 395.1055, 408.036 FS. History–New 9-4-95, Formerly 59A-3.229.

Fla. Admin. Code R. 59A-3.279 Itemized Patient Bill

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055, 395.301 FS. History–New 9-4-95, Formerly 59A-3.232, Repealed 7-15-14.

Fla. Admin. Code R. 59A-3.280 Child Abuse and Neglect

(1) Every licensed hospital admitting or treating shall adopt and incorporate a policy that requires every staff member to report any case of actual or suspected child abuse or neglect pursuant to Chapter 39, F.S.

(a) Each report of actual or suspected child abuse or neglect shall be made immediately to the Department of Children and Family Services’ Florida Abuse Hotline, statewide toll free number 1(800)962-2873 or to the local office of the Department of Children and Family Services responsible for investigating such reports.

(b) Any person required to report suspected child abuse or neglect, who has reasonable cause to suspect that a child died as a result of abuse or neglect, shall report his suspicion to the local medical examiner.

(2) Each hospital admitting or treating children shall designate, at the request of the Department of Children and Family Services, a staff physician, APRN or PA to act as a liaison between the hospital, the child protective investigator and the child protection team.

(3) Child Abuse and Neglect Policy Reporting. Each hospital admitting or treating children shall formulate a child abuse and neglect policy and shall submit a copy of this policy to the Department of Children and Family Services, Office of Family Safety, 1317 Winewood Boulevard – Building 1, Tallahassee, Florida 32399-0700.

(4) Remedies. Failure to comply with these rules will result in a fine being imposed in accordance with the provisions of Sections 395.1023 and 39.205, F.S.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1023, 395.1055 FS. History–New 4-17-97, Formerly 59A-3.0465, Amended 10-16-14.

Fla. Admin. Code R. 59A-3.281 Spontaneous Fetal Demise

When a spontaneous fetal demise occurs after a gestation of less than 20 completed weeks, the health care facility identified in Section 383.33625(4), F.S., shall follow the provisions of that section and shall provide AHCA Form 3100-0006, January 2005, Notification of Disposition of Fetal Demise, to the mother for her completion. AHCA Form 3100-0006, January 2005 is incorporated in this rule by reference and available at http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/hospital.shtml, or from the Hospital and Outpatient Services Unit at 2727 Mahan Drive, MS #31, Tallahassee, FL 32308. A copy of the signed and completed form shall by retained in the mother’s medical record and shall be available for review by the Agency or Department of Health.

History

Rulemaking Authority 383.33625(6), 395.1055 FS. Law Implemented 383.33625, 395.1055(1)(b) FS. History–New 4-27-06, Amended 10-16-14.

Fla. Admin. Code R. 59A-3.282 Medical Records Procedures for Treatment of Premature Rupture of Membranes and Other Life Threatening Conditions

Each hospital shall maintain written policies and procedures governing the maintenance of medical records for the treatment of preterm premature rupture of membranes, premature rupture of membranes, ectopic pregnancies, trophoblastic tumors, and other life-threatening conditions. The policies and procedures shall be reviewed at least annually, dated to indicate time of last review, and revised as necessary. At a minimum, the policies and procedures shall address the following:

(1) When a patient receives a diagnosis of preterm premature rupture of membranes or premature rupture of membranes, the patient shall be admitted for observation unless the treating physician determines that another course of action is more medically appropriate under the circumstances to ensure the health of the mother and the unborn baby. When the treating physician determines that another course of action is more medically appropriate, the physician shall document the reasons why the alternate course of action is more appropriate.

(2) When a physician attempts to induce the live birth of an unborn baby, regardless of gestational age, to treat the preterm premature rupture of membranes or premature rupture of membranes, and the unborn baby does not survive, the incident does not constitute an abortion and shall not be reported pursuant to Rule 59A-9.034, F.A.C. The treating physician shall document the treatment in the patient’s medical record.

(3) The treatment of an ectopic pregnancy is not an abortion and shall not be reported pursuant to Rule 59A-9.034, F.A.C. The treating physician shall document the treatment in the patient’s medical record.

(4) The treatment of a trophoblastic tumor is not an abortion and shall not be reported pursuant to Rule 59A-9.034, F.A.C. The treating physician shall document the treatment in the patient’s medical record.

History

Rulemaking Authority 395.1055 FS. Law Implemented 390.0112, 395.3015 FS. History–New 11-19-24.

Fla. Admin. Code R. 59A-3.300 Licensure Procedure for Intensive Residential Treatment Facilities

Facilities desiring licensure under this rule shall follow the procedure as described in Rule 59A-3.066, F.A.C., and shall comply with the provisions of Rules 59A-3.300 through 59A-3.310, F.A.C., which establishes the minimum standards for licensure as a Class IV specialty hospital. These rules emphasize the programmatic requirements designed to meet the needs of the patient in a safe therapeutic environment and are intended to be used in licensing intensive residential treatment facilities for children and adolescents as specialty hospitals pursuant to Section 395.002(15), F.S. Unless otherwise specified, Rules 59A-3.300 through 59A-3.310, F.A.C., supersede the requirements of Rules 59A-3.240-.243, 59A-3.247, 59A-3.254, 59A-3.255 and 59A-3.278, F.A.C., for the purpose of licensing intensive treatment facilities for children and adolescents as specialty hospitals.

History

Rulemaking Authority 395.003, 395.004, 395.0161, 395.1055, 408.819 FS. Law Implemented 395.003, 395.0191, 395.1055 FS. History–New 2-15-82, Amended 8-14-86, Formerly 10D-28.101, Amended 9-4-95, 4-17-97, Formerly 59A-3.101, Amended 10-16-14.

Fla. Admin. Code R. 59A-3.301 Goals, Policies and Procedures

History

Rulemaking Authority 395.003, 395.1055 FS. Law Implemented 395.002, 395.003, 395.1055 FS. History–New 2-15-82, Formerly 10D-28.105, 59A-3.105, Repealed 3-16-16.

Fla. Admin. Code R. 59A-3.302 Personnel for Intensive Residential Treatment Facilities

(1) Composition. The composition of the staff shall be determined by the needs of the patients being served and the goals of the facility, and shall have available a sufficient number of mental health professionals, health care workers, program staff and administrative personnel to meet these goals.

(a) The administrator of the facility shall have a master’s degree in administration or be of a professional discipline related to child and adolescent mental health and have at least three (3) years administrative experience. A person with a baccalaureate degree may also qualify for administrator with seven (7) years experience of child and adolescent mental health care with no less than three (3) years administrative experience.

(b) The clinical director shall be at least board eligible in psychiatry with the American Board of Psychiatry with experience in child and adolescent mental health.

(c) If the clinical director is not full-time, then there shall be a full-time service coordinator who is a mental health professional with at least a master’s degree who is experienced in child and adolescent mental health and is responsible for the coordination of treatment aspects of the program.

(d) Mental health professionals shall include psychiatrists, psychologists, and social workers. These persons, if not on a full-time basis, must be on a continuing consulting basis. The authority and participation of such mental health professionals shall be such that they are able to assume responsibility for supervising and reviewing the needs of the patients and the services being provided. Such individuals shall participate in specific functions, e.g., assessment, treatment planning, treatment plan and individual case reviews, and program planning and policy and procedure development and review.

(e) Other professional and paraprofessional staff shall include physicians, registered nurses, educators and 24-hour a day mental assistants. Also included on a regular staff basis, or as consultants on a continuing basis, shall be activity staff and vocational counselors; and,

(f) Consultation shall be available as needed from dieticians, speech, hearing and language specialists, or other specialists.

(2) Organization. The program shall have an organizational plan which clearly explains the responsibilities of the staff. This plan shall also include:

(a) Lines of authority, accountability and communication;

(b) Committee structure and reporting or dissemination of material; and,

(c) Established requirements regarding the frequency of attendance at general and departmental/service or team/unit meetings.

(3) Policies and Records. Personnel policies and practices shall be designed, established and maintained to promote the objectives of the program and to insure that there are personnel to support a high quality of patient care.

(a) Each program shall have a written personnel practice plan covering the following areas: job classification; pay plan; personnel selection; probation or work-test period; tenure of office; dismissal; salary increases; procedure for health evaluations; holidays; leave policies; training programs; work evaluation procedures; additional employment benefits; and personnel records. Each new employee shall be given a copy of personnel practices when hired and documentation of receipt shall be maintained in the employee’s personnel file. A procedure shall be established for notifying employees of changes in established policies.

(b) There shall be clear job descriptions for all personnel. Each description shall contain the position title, immediate supervisor, responsibilities and authority. These shall also be used as a basis for periodic evaluations by the supervisor.

(c) Accurate and complete personnel records shall be maintained on each employee. Content shall be established to include the following:

Current background information, including the application, references and any accompanying documentation sufficient to justify the initial and continued employment of the individual and the position for which he was employed. Applicants for the positions requiring a licensed person shall be employed only after the facility has obtained verification of their licenses. Where accreditation is a requirement, this shall also be verified. Evidence of renewal of license as required by the licensing agent shall be maintained in the employee’s personnel record;
Current information relative to work performance evaluation;
Records of pre-employment health examinations and subsequent health services rendered to employees, as are necessary to ensure that all facility employees are physically and emotionally able to perform their duties;
Medical reports that verify the absence of active communicable disease in facility employees; and,
Record of any continuing education or staff development programs completed.

(4) Staff Development. The program must provide opportunities and motivation for continuing education or training to enable each member to add to his knowledge and skills and thus improve the quality of services offered. This must be documented in the employee personnel file.

Programs shall be facility-based with a designated person or committee who is responsible, on a continuing basis, for planning and insuring that Plans are implemented. The facility shall also make use of educational programs outside the facility such as workshops, and seminars.

History

Rulemaking Authority 395.003, 395.1055 FS. Law Implemented 395.003, 395.1055 FS. History–New 2-15-82, Formerly 10D-28.106, 59A-3.106, Amended 10-16-14.

Fla. Admin. Code R. 59A-3.303 Facilities and Physical Plant Safety

(1) General Requirements. The facility shall plan and provide an environment that is therapeutic to, and supportive of, all the patients in regard to their disturbances, their healthy development and their changing needs. The therapeutic environment shall take into consideration the architecture of the facility, indoor and outdoor activity areas, furnishings, equipment, decorations and all other factors that involve the interpersonal and physical environment.

(2) Facilities shall:

(a) Be designed to meet the needs of the age group of the patients and the objectives of the program;

(b) Provide adequate and appropriate space and equipment for all of the programs of the facility and the various functions within the facility;

(c) Provide sufficient space and equipment to ensure housekeeping and maintenance programs capable of keeping the building and equipment clean and in good repair; and,

(d) Provide buildings and grounds of the special hospital that shall be maintained, repaired and cleaned so that they are not hazardous to the health and safety of the patients and staff.

Floors, walls, ceilings, windows, doors and all appurtenances of the structures shall be of sound construction, properly maintained, easily cleanable and shall be kept clean.
All areas of the facility other than closets or cabinets shall be well lighted. Dormitories, toilets and dayrooms shall have light sources capable of providing adequate illumination to permit observation, cleaning, maintenance and reading. Light fixtures shall be kept clean and maintained.
All housing facilities shall be kept free of offensive odors with adequate ventilation.

a. If natural ventilation is utilized, the opened window area for ventilation purposes shall be equal to one-tenth of the floor space in the residential area.

b. When mechanical ventilation or cooling systems are employed, the system shall be kept clean and properly maintained. Intake air ducts shall be designed and installed so that dust or filters can be readily removed. In residence areas and isolation rooms without natural ventilation, mechanical ventilation systems shall provide a minimum of 10 cubic feet of fresh or filtered recirculated air per minute for each patient occupying the area.

c. All toilet rooms shall be provided with direct openings to the outside or provided with mechanical ventilation to the outside.

d. Facilities which utilize permanent heating units shall maintain a minimum temperature of 65° degrees F at a point 20 inches above the floor in sleeping areas. Facilities, such as outdoor programs, which cannot provide permanent heating units, shall ensure that patients are provided with items which will provide adequate warmth during sleep. These shall include items such as portable catalytic heaters and sleeping bags, extra blankets and clothing designed to ensure comfortable sleep in cold weather.

(e) Provide both indoor and outdoor areas where patients can gather for appropriate activities. The grounds on which the facility is located shall provide adequate space to carry out the stated goals of the program; for outdoor activity areas that are appropriate for the ages and clinical needs of children; and provide an appropriate transitional area between the facility and the surrounding neighborhood which is consistent with the goals of the facility, and compatible with existing zoning ordinances.

(f) Provide sleeping areas that shall promote comfort and dignity and provide space and privacy for residents.

There shall be no more than eight patients in a sleeping room unless written justification on the basis of the program requirements has been submitted to and approved by the licensing agency.
Beddings, Clothing and Personal Items. Beds and beddings shall be kept in good repair and cleaned regularly. Used mattress and pillow covers shall be laundered before being issued. Sheets and personal clothing shall be washed at least weekly and blankets washed or dry cleaned at least quarterly. Sheets and blankets shall be stored in a clean, dry place between laundering and issue.
Each patient shall have his own bed consisting of a level bedstead and a clean mattress in good condition.
All mattresses shall have fire retardant mattress covers or protectors. Water repellent mattress covers shall be available if needed.

(g) Provide individual and separate accessible storage areas for each resident’s clothing and personal possessions.

(h) Provide laundry and/or dry cleaning facilities. Where laundry facilities are provided, they shall be adequate to ensure an ample quantity of clean clothing, bed linens and towels. Laundry facilities shall be of sound construction and shall be kept clean and in good repair. Laundry rooms shall be well lighted and properly ventilated. Clothes dryers and dry cleaning machines shall be vented to the exterior. If laundry facilities are not available, sheets and blankets shall be sent to commercial laundries.

(i) Provide privacy for personal hygiene.

All toilets shall have secured seats and be kept clean and in good working order, and all toilets shall be partitioned for privacy.
Bathrooms shall be cleaned thoroughly each day.
Bathrooms shall be conveniently located to the sleeping areas.

(j) Provide for the personal hygiene for all patients.

A written policy shall be maintained on file at the facility.
Toothbrushes, toothpaste, soap, and other items of personal hygiene shall be provided by the facility if not provided by the patients.
Shatterproof mirrors shall be furnished in each bathroom.

(k) Maintain food service facilities in accordance with the regulations described in Chapter 64E-11, F.A.C.

(3) The facility shall be constructed and maintained in a manner that protects the lives and insures the physical safety of patients, staff and visitors. The center will comply with all relevant federal, state and local building codes, fire, health, safety laws and ordinances and regulations as specified below. Current inspection reports shall be retained in the facility’s files for Agency review.

(a) It is the responsibility of the program to arrange for the necessary inspections and to comply within the time frame with any resulting recommendations noted in the inspection reports.

(b) The grounds and all buildings on the grounds shall be maintained in a safe and sanitary condition, as required in Chapter 386, F.S. (Particular Conditions Affecting Public Health).

(c) Water Supply. Water supplies shall be adequate to serve the demands of the facility and shall be constructed, operated and maintained in accordance with requirements of Chapter 64E-8, F.A.C.

Drinking water shall be accessible to all clients. When drinking fountains are available, the jet of the fountain shall issue from a nozzle of non-oxidizing impervious material set at an angle from the vertical. The nozzle and every other opening in the water pipe or conductor leading to the nozzle shall be above the edge of the bowl so that such nozzle or opening will not be flooded in case a drain from the bowl of the fountain becomes clogged. The end of the nozzle shall be protected by non-oxidizing guards to prevent persons using the fountain from coming into contact with the nozzle. Vertical or bubbler drinking fountains shall be replaced with approved type water fountains or be disconnected. When no approved drinking fountains are available, clients shall be provided with single service cups which shall be stored and dispensed in a manner to prevent contamination. Common drinking cups are prohibited.
Hot and cold running water under pressure and at safe temperatures (not to exceed 120° degrees F for washing and bathing to prevent scalding) shall be provided at regular washing and bathing areas.

(d) Sanitary System, Facilities and Fixtures.

All sewage and liquid waste shall be disposed of in accordance with Chapter 64E-6, F.A.C.
All plumbing shall be in compliance with the requirements of the Florida Building Code, Plumbing as adopted by the Florida Building Commission and described in rule Chapter 61G20-1, F.A.C., or the plumbing code legally applicable to the area where the facility is located.
For facilities with nine or more patients, curbed areas with floor drains shall be available in convenient locations throughout the facility for the proper disposal of cleaning water and to facilitate cleaning.

(e) Garbage and Rubbish. All garbage, trash and rubbish from residential areas shall be collected daily and taken to storage facilities. Garbage shall be removed from storage facilities at least twice per week. Wet garbage shall be collected and stored in impervious, leak proof, fly tight containers pending disposal. All containers, storage areas and surrounding premises shall be kept clean and free of vermin. If public or contract garbage collection service is available, the facility shall subscribe to these services unless the volume makes onsite disposal feasible. If garbage and trash are disposed on premises, the method of disposal shall not create sanitary nuisance conditions and shall comply with provisions of Rule 64E-12.010, F.A.C.

(f) Outdoor Areas. Outdoor areas shall be kept free of litter and trash and be well drained. If swimming pools are available in facilities with nine or more clients, such pools shall comply with requirements of Chapter 64E-9, F.A.C., and shall be supervised at all times when they are in use. Indoor and outdoor recreational areas shall be provided with safeguards designed for the needs of the residents.

(g) Insect and Rodent Control. Facilities shall be kept free of all insects and rodents. All outside openings shall be effectively sealed or screened to prevent entry of insects or rodents. All pesticides used to control insects or rodents shall be applied in accordance with instructions on the registered product label. Persons applying restricted use pesticides shall be certified by the Department of Agriculture. Facilities not having certified pest control operators shall utilize commercial licensed pest control companies.

(4) All facilities shall be required to meet the uniform fire safety standards for special hospitals as established by the State Fire Marshal pursuant to Section 633.206, F.S.

(a) All staff shall be instructed in the use of fire extinguishers.

(b) All fire extinguishers shall be inspected as regulated by local requirements and shall be serviced as required.

(d) Fire safety systems shall be inspected regularly as regulated by local requirements, and records of such inspections shall be kept on file.

(5) The special hospital shall provide for safety inspections by a facility personnel committee.

(a) Personnel responsible for safety evaluation shall receive appropriate training.

(b) Safety inspections shall be done on a monthly basis, shall be made into a written report, and shall be maintained on file at the facility.

(c) Special safety measures shall be provided for areas of the facility that may present an unusual hazard to patients, staff or visitors. Poisonous or toxic compounds are to be stored apart from food and other areas that would constitute a hazard to the residents.

(6) Disaster Planning. Programs licensed under Rules 59A-3.300 through 59A-3.312 shall comply with Rule 59A-3.078, F.A.C., in regard to a comprehensive emergency management plan.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 2-15-82, Formerly 10D-28.108, Amended 9-4-95, Formerly 59A-3.108, Amended 5-12-16.

Fla. Admin. Code R. 59A-3.310 Intensive Residential Treatment Facility Services

Services shall be designed to meet the needs of the emotionally disturbed patient and must conform to stated purposes and objectives of the program.

(1) Intake and Admission. Every IRTF shall develop written policies and procedures governing the facilities intake and admissions process.

(a) Acceptance of a child or adolescent for inpatient treatment shall be based on the assessment, arrived at by the multidisciplinary clinical staff involved and clearly explained to the patient and the family. Whether the family voluntarily requests services or the patient is referred by the court, the special hospital shall involve the family’s participation to the fullest extent possible. Discharge planning shall begin at the time of intake and admission.

(b) Acceptance of the child or adolescent for treatment shall be based on the determination that the child or adolescent requires treatment of a comprehensive and intensive nature and is likely to benefit by the programs that the facility has to offer.

(c) Admission shall be in keeping with stated policies of the special hospital and shall be limited to those patients for whom the special hospital is qualified by staff, program and equipment to give adequate care.

(d) Staff members who will be working with the patient, but who did not participate in the initial assessment shall be oriented regarding the patient and the patient’s anticipated admission prior to meeting the patient. When the patient is to be assigned to a group, the other patients in the group shall be prepared for the arrival of the new member. There shall be a specific staff member assigned to the new patient to observe him and help with the unit orientation period.

(e) The admission procedure shall include documentation concerning:

Responsibility for and amount of financial support;
Responsibility for medical and dental care, including consent for medical and surgical care and treatment;
Arrangements for appropriate family participation in the program, phone calls and visits when indicated;
Arrangements for clothing, allowances and gifts; and
Arrangements regarding the patient’s leaving the facility with or without medical consent.

(f) Decisions for admission shall be based on the initial assessment of the patient made by the appropriate multidisciplinary clinical staff. This assessment must be documented on the record of treatment on admission.

(g) The admission order must be written by a staff or consultant physician.

(2) Assessment and Treatment Planning Including Discharge. Every IRTF shall develop written policies and procedures to ensure an initial assessment of the patient’s physical, psychological and social status, appropriate to the patient’s developmental age, is completed to determine the need and type of care or treatment required, and the need for further assessment. These policies and procedures shall include the assessment process as well as treatment planning including discharge planning, and include methods for involving family members or significant others (i.e., guardians, counselors, friends) in assessment, treatment, discharge, and follow-up care plans.

(a) Assessment. The facility is responsible for a complete assessment of the patient, some of which may be required just prior to admission, by professionals acceptable to the facility’s staff. The complete assessment shall include:

Physical. Subparagraphs a., b. and c. must be completed by a physician, APRN or PA on the staff of the facility prior to admission or within 24 hours after admission.

a. Complete medical history, including history of medications;

b. General physical examinations;

c. Neurological assessment;

d. Motor development and functioning;

e. Dental assessment;

f. Speech, hearing and language assessment;

g. Vision assessment;

h. Review of immunization status;

i. Laboratory workup including routine blood work and analysis;

j. Chest x-ray and/or tuberculin test;

k. Serology; and,

l. Urinalysis.

m. If any of the physical health assessments indicate the need for further testing or definitive treatment, arrangements shall be made to carry out or obtain the necessary evaluations or treatment by clinicians, physicians, APRNs or PAs trained as applicable, and plans for these treatments shall be coordinated with the patient’s overall treatment plan.

Psychiatric/Psychological.

a. The assessment includes direct psychiatric evaluation and behavioral appraisal, evaluation of sensory, motor functioning, a mental status examination appropriate to the age of the patient and a psychodynamic appraisal. A psychiatric history, including history of any previous treatment for mental, emotional or behavioral disturbances shall be obtained, including the nature, duration and results of the treatment, and the reason for termination.

b. The psychological assessment includes appropriate testing.

Developmental/Social.

a. The developmental history of the patient includes the prenatal period and from birth until present, the rate of progress, developmental milestones, developmental problems, and past experiences that may have affected the development. The assessment shall include an evaluation of the patient’s strengths as well as problems. Consideration shall be given to the healthy developmental aspects of the patient, as well as to the pathological aspects, and the effects that each has on the other shall be assessed. There shall be an assessment of the patient’s current age, appropriate developmental needs, which shall include a detailed appraisal of his peer and group relationships and activities.

b. The social assessment includes evaluation of the patient’s relationships within the structure of the family and with the community at large, and evaluation of the characteristics of the social, peer group, and institutional settings from which the patient comes. Consideration shall be given to the patient’s family circumstances, including the constellation of the family group, their current living situation, and all social, religious, ethnic, cultural, financial, emotional and health factors. Other factors that shall be considered are past events and current problems that have affected the patient and family; potential of the family’s members meeting the patient’s needs; and their accessibility to help in the treatment and rehabilitation of the patient. The expectations of the family regarding the patient’s treatment, the degree to which they expect to be involved, and their expectations as to the length of time and type of treatment required shall be assessed.

Nursing. The nursing assessment shall be performed by a person, who at a minimum, is duly licensed in the State of Florida to practice as a registered nurse and shall include the evaluation of:

a. Self-care capabilities including bathing, sleeping, eating;

b. Hygienic practices such as routine dental and physical care and establishment of healthy toilet habits;

c. Dietary habits including a balanced diet and appropriate fluid and calorie intake;

d. Response to physical diseases (e.g., acceptance by the patient of a chronic illness as manifested by his compliance with prescribed treatment);

e. Responses to physical handicaps (e.g., the use of prostheses for coping patterns used by the visually handicapped); and,

f. Responses to medications (e.g., allergies or dependence).

Educational/Vocational. The patient’s current educational/vocational needs in functioning, including deficits and strengths, shall be assessed. Potential educational impairment and current and future educational vocational potential shall be evaluated using, as indicated, specific educational testing and special educators or others.
Recreational. The patient’s work and play experiences, activities, interests and skills shall be evaluated in relation to planning appropriate recreational activities.

(b) Treatment Planning. An initial treatment plan shall be formulated, written and interpreted to the staff and patient within 72 hours of admission. The comprehensive treatment plan shall be developed for each child by a multidisciplinary staff, within 14 days of admission. This plan must be reviewed at least monthly, or more frequently if the objectives of the program indicate. Review shall be noted in the record. A psychiatrist as well as multidisciplinary professional staff must participate in the preparation of the plan and any major revisions.

The treatment plan shall be based on the assessment and shall include clinical consideration of the physical, developmental, psychological, chronological age, family, education, social and recreational needs. The reason for admission shall be specified as shall specific treatment goals, stated in measurable terms, including a projected time frame, treatment modalities to be used, staff who are responsible for coordinating and carrying out the treatment, and expected length of stay and designation of the person or agency to whom the child will be discharged.
The degree of the family’s involvement (parent or parent surrogates) shall be defined in the treatment planning program.
Collaboration with resources and significant others shall be included in treatment planning, when the treatment team determines it will not interfere with the child’s treatment.
Procedures that place the patient at physical risk or pain shall require special justification. The rationale for their use shall be clearly set forth in the treatment plan and shall reflect the prior involvement and specific review of the treatment plan by a child psychiatrist. When potentially hazardous procedures or modalities are contemplated for treatment, there shall be additional program specific policies governing their use to protect the rights and safety of the patient. The facility shall have specific written policies and procedures governing the use of electroconvulsive therapy or other forms of convulsive therapy. If such procedures are to be used they shall be carried out in a setting with emergency equipment available and shall be administered only by medical personnel who have been trained in the use of such equipment. Policies and procedures shall insure that:

a. Electroconvulsive therapy or other forms of convulsive therapy shall not be administered to any patient unless, prior to the initiation of treatment, two child psychiatrists with training or experience in the treatment of adolescents, who are not affiliated with the treating facility, have examined the patient, consulted with the responsible child psychiatrist and have written and signed reports which show concurrence with the administration of such treatment. Such reviews shall be carried out only by American Board of Psychiatry certified or American Board of Psychiatry eligible child psychiatrists;

b. All signed consultation reports, either recommending or opposing the administration of such treatment, shall be made a part of the patient’s clinical record;

c. Written informed consent of members of the family authorized to give consent, and where appropriate the patient’s consent shall be obtained and made a part of the patient’s clinical records. The person who is giving such consent may withdraw consent at any time;

d. Lobotomies or other surgical procedures for intervention or alterations of a mental, emotional or behavioral disorder shall not be performed on patients.

(c) Discharge. Discharge planning begins at the time of admission. A discharge date shall be projected in the treatment plan. Discharges shall be signed by a staff physician of the facility. A discharge summary shall be included in the records. Discharge planning shall include input from the multidisciplinary staff and will include family participation.

Discharge planning shall include a period of time for transition into the community (e.g., home visits gradually lengthened) for those patients who have been in the program for six months or longer. There must be a written plan for follow-up services, either by the facility or by another agency.

(3) Staff Coverage. Every IRTF shall develop written policies and procedures to ensure the program is staffed with appropriately trained and qualified individuals to meet the needs of the patients. There shall be a master clinical staffing pattern which provides for adequate clinical staff coverage at all times.

(a) There shall be at least one registered nurse on duty at all times. Services of a registered nurse shall be available for all patients at all times.

(b) A physician shall be on call twenty-four (24) hours a day and accessible to the facility within forty-five (45) minutes.

(c) Special attention shall be given to times which probably indicate the need for increased direct care (e.g., weekends, evenings, during meals, transition contained herein, and substantiated by the results between activities, and waking hours).

(d) Staff interaction shall insure that there is adequate communication of information regarding patients (e.g., between working shifts or change of personnel) with consulting professional staff for routine planning and patient review meetings. These interactions shall be documented in writing.

(4) Program Activities. Every IRTF must develop an organizational chart with a description of each unit or department and its services, goals, policies and procedures, its relationship to other services and departments and how these are to contribute to the priorities and goals of the program, and ways in which the program carries out any community education consultation programs. Program goals of the facility shall include those activities designed to promote the physical and emotional growth and development of the patients, regardless of pathology or age level. There should be positive relationships with general community resources, and the facility staff shall enlist the support of these resources to provide opportunities for patients to participate in normal community activities as they are able. All labeling of vehicles used for transportation of patients shall be such that it does not call unnecessary attention to the patients.

(a) Group Size. The size and composition of each living group shall be therapeutically planned and depend on the age, developmental level, sex and clinical conditions. It shall allow for staff-patient interaction, security, close observation and support.

(b) Routine Activities. Basic routine shall be delineated in a written plan which shall be available to all personnel. The daily program 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 the individual patient or the living group change. Basic daily routine shall be coordinated with special requirements of the patient’s treatment plan.

(c) Social and Recreation Activities. Program of recreational and social activities shall be provided for all patients for daytime, evenings and weekends, to meet the needs of the patients and goals of the program. There shall be documentation of these activities as well as schedules maintained of any planned activities.

(d) Religious Activities. Opportunity shall be provided for all patients to participate in religious services and other religious activities within the framework of their individual and family interests and clinical status. The option to celebrate holidays in the patient’s traditional manner shall be provided and encouraged.

(e) Education. The facility shall arrange for or provide an educational program for all patients receiving services in that facility.

The particular educational needs of each patient shall be considered in both placement and programming.
Children or adolescents placed in the special hospital by a public agency or at the expense of a public agency shall receive education consistent with the requirements of Chapter 6A-6, F.A.C., as applicable.

(f) Vocational Programs. The facility shall arrange for, or provide, vocational or prevocational training for patients in the facility for whom it is indicated.

If there are plans for work experience developed as part of the patient’s overall treatment plan, the work shall be in the patient’s interest with payment where appropriate, as determined by the treatment facility and the vocational program, and never solely in the interest of the facility’s goals or needs.
Patients shall not be solely responsible for any major phase or institutional operation or maintenance, such as cooking, laundering, housekeeping, farming or repairing. Patients shall not be considered as substitutes for employed staff.

(g) Nutrition and Standards. There shall be a provision of planning and preparation of special diets as needed (e.g., diabetic, bland, high calorie). Menus shall be evaluated by a consultant dietitian relative to nutritional adequacy at least monthly, with observation of food intake and changes seen in the patient.

(5) Physical Care. The facility shall have available, either within its own organizational structure or by written agreements or contracts with outside health care clinicians or facilities, a full range of services for the treatment of illnesses and the maintenance of general physical health.

(a) The facility shall develop a written plan for medical services which delineates the ways the facility obtains or provides all general and specialized medical, surgical, nursing, pharmaceutical and dental services.

Insofar as Rules 59A-3.300 through 59A-3.310, F.A.C., are intended to establish minimum requirements for intensive residential treatment facilities for children and adolescents that have a primary purpose of treating emotional and mental disorders, such facilities are not required to establish and maintain medical buildings and equipment required of general or specialty hospitals as specified in Rules 59A-3.080 through 59A-3.281, F.A.C. Services which require such specialized buildings and equipment may be obtained from outside health care providers by written agreement or contract. This shall not preclude the facility from maintaining a medical services area or building which does not meet the requirements of Rules 59A-3.065 through 59A-3.281, F.A.C., for the purpose of isolating patients with contagious diseases, conducting physical examinations, providing preventive medical care services, or providing first aid services.
If the facility chooses to establish and operate a specialty or general hospital for the purposes of offering medical care more intensive than those specified in subsection 59A-3.065(32), F.A.C., the plans for construction shall be submitted for review in accordance with Rule 59A-3.080, F.A.C., and such facilities shall be required to be licensed, built and operated in accordance with Rules 59A-3.065 through 59A-3.281, F.A.C.

(b) Patients who are physically ill may be cared for on the grounds of the facility if medically feasible as determined by a physician, ARNP or PA. If medical isolation is necessary, there shall be sufficient and qualified staff available to provide care and attention.

(c) Provisions shall be made in writing for patients from the facility to receive care from outside health care providers and hospital facilities, in the event of serious illness which the facility cannot properly handle. Such determinations shall be made by a licensed physician.

(d) Every patient shall have a complete physical examination annually and more frequently if indicated. This examination shall be as inclusive as the initial examination. Efforts shall be made by the institution to have physical defects of the patients corrected through proper medical care. Immunization shall be kept current (DT, polio, measles, mumps, M-M-R).

(e) Each member of the program staff shall be trained to recognize common symptoms of the illnesses of patients, and to note any marked dysfunctions of patients.

(f) Staff shall have knowledge of basic health needs and health problems of patients, such as mental health, physical health and nutritional health. Staff shall teach attitudes and habits conducive to good health through daily routines, examples and discussion, and shall help the patients to understand the principles of health.

(g) Each program shall have a planned program of dental care and dental health which shall be consistently followed. Each patient shall receive a dental examination by a qualified dentist and prophylaxis at least once a year. Reports of all examinations and treatment shall be included in the patient’s clinical record.

(6) Emergency Services. All clinical staff shall have training in matters related to handling emergency situations.

(a) Policies and procedures shall be written regarding handling and reporting of emergencies and these shall be reviewed at least yearly thereafter by all staff.

(b) There shall be a physician on call twenty-four (24) hours a day; his/her name and where he/she can be reached shall be clearly posted in accessible places for program staff.

(d) An emergency medication kit shall be made available and shall be constituted to meet the needs of the facility. The emergency medication kit shall contain items selected by the staff or consultant medical doctor and staff or consultant pharmacist which shall be maintained and safeguarded in accordance with federal and state laws and regulations pertaining to the specific drug items included.

(e) There shall be an adequate number of first aid kits available to program staff at all times. Contents of the first aid kits shall be selected by the staff or consultant medical personnel and shall include items designed to meet the needs of the facility.

(f) The program shall have written policies and procedures of obtaining emergency diagnosis and treatment of dental problems. The program shall have written agreement with a licensed dentist(s) who is a consultant or a member of the staff for emergency dental care.

(g) The facility shall have a written plan to facilitate emergency hospitalization in a licensed medical facility. The facility shall make available a written agreement from a licensed hospital verifying that routine and emergency hospitalization will be provided.

(h) The special hospital shall have a written plan for providing emergency medical and psychiatric care.

There shall be a written posted plan which shall clearly specify who is available and authorized to provide necessary emergency psychiatric or medical care, or to arrange for referral or transfer to another facility to include ambulance arrangements, when necessary.
There shall be a written plan regarding emergency notification to the parents or legal guardian. This plan and arrangements shall be discussed with all families or guardians of patients upon admission.

(7) Pharmaceutical Services. Pharmaceutical services, if provided, shall be maintained and delivered as described in the applicable sections of Chapters 465 and 893, F.S.

(8) Laboratory and Pathology Services.

(a) The facility shall provide clinical and pathology services within the institution, or by contractual arrangement with a laboratory commensurate with the facility’s needs and which is registered under the provisions of Chapter 483, F.S.

Provision shall be made for the availability of emergency laboratory services 24 hours a day, 7 days a week, including holidays.
All laboratory tests shall be ordered by a licensed practitioner in accordance with Section 483.041(7), F.S.
All laboratory reports shall be filed in the patient’s medical record.
The facility shall have written policies and procedures governing the collection, preservation and transportation of specimens to assure adequate stability of specimens.

(b) Where the facility 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 medical staff, administrator and the governing board.

(9) Patients’ Rights. Every effort shall be made to safeguard the legal and civil rights of patients and to make certain that they are kept informed of their rights, including the right to legal counsel and all other requirements of due process.

(a) Individual dignity and human rights are guaranteed to all clients of mental health facilities in Florida by the Florida Mental Health Act, known as the “Baker Act,” Chapter 394, F.S.

(b) Each facility shall be administered in a manner that protects the client’s rights, his life, and his physical safety while under treatment.

The special hospital’s space and furnishings should be designed and planned to enable the staff to respect the patient’s right to privacy and, at the same time, provide adequate supervision according to the development and clinical needs of the patients. Provisions for an individual patient’s rights regarding privacy shall be made explicit to the patient and family. A written policy concerning patient’s rights shall be provided to the patient of authentic research or studies, or innovations of client’s record.
The special hospital center’s policies shall allow patient visitation and communication with all members of the family and other visitors as clinically indicated and when such visits are consistent with the facility’s program. When therapeutic considerations recommended by the responsible licensed psychologist or physician necessitate restriction of communication or visits, as set forth in the programs policies and procedures, these restrictions shall be evaluated at least weekly by the clinical staff for their continuing effectiveness. These restrictions shall be documented and signed by the responsible psychologist or physician and be placed in the patient’s record. The special hospital shall make known to the patient, the family and referring agency its policies regarding visiting privileges on and off the premises, correspondence and telephone calls. These policies shall be stated in writing and shall be provided to the patient and family and updated when change in policy occurs. When limitations on such visits, calls or other communications are indicated by practical reason, e.g., the expense of travel or telephone calls, such limitations shall be determined with participation of the patient’s family or guardian.
Patients shall be allowed to request an attorney through their parents or guardians. This shall be established as written policy, and the policy shall be provided to families and patients.
Patient’s opinions and recommendations shall be considered in the development and continued evaluation of the therapeutic program. The special hospital shall have written policies to carry out appropriate procedures for receiving and responding to patient communications concerning the total program.
The special hospital shall have written policies regarding methods used for control of patients’ behavior. Such written policies shall be provided to the appropriate staff and to the patient and his family. Only staff members responsible for the care and treatment of patients shall be allowed to handle discipline. Patients shall not be subject to cruel, severe, unusual or unnecessary punishment. Patients shall not be subjected to remarks which ridicule them or their families, or others.
Protective restraint consists of any apparatus or condition which interferes with the free movement of the patient. Only in an emergency shall physical holding be employed unless there are physician’s orders for a mechanical restraint. Physical holding or mechanical restraints, such as canvas jackets or cuffs, shall be used only when necessary to protect the patient from injury to himself or others. Use of mechanical restraints reflect a psychiatric emergency and must be ordered by the responsible staff/consultant physician, be administered by trained staff and be documented in the patient’s clinical records. The need for the type of restraint used and the length of time it was employed and condition of the patient shall be recorded in the patient’s record. An order for a mechanical restraint shall designate the type of restraint to be used, the circumstance under which it is to be used and the duration of its use. A patient in a mechanical restraint shall have access to a staff member at all times during the period of restraint.
The facility shall have written policies and procedures which govern the use of seclusion. The use of seclusion shall require clinical justification and shall be employed only to prevent a patient from injuring himself or others, or to prevent serious disruption of the therapeutic environment. Seclusion shall not be employed as punishment or for the convenience of staff. A written order from a physician shall be required for the use of seclusion for longer than one hour. Written orders for seclusion shall be limited to twenty-four (24) hours. The written approval of the medical director or the director of psychiatrist services shall be required when seclusion is utilized for more than twenty-four (24) hours. Staff who implement written orders for seclusion shall have documented training in the proper use of the procedures. Appropriate staff shall observe and visually monitor the patient in seclusion every fifteen (15) minutes, documenting the patient’s condition and identifying the time of observation. A log shall be maintained which will record on a quarter- hour basis the observation of the patient in seclusion, and will also indicate when the patient was taken to the bathroom, when and where meals were served, when other professional staff visited, etc., and shall be signed by the observer. The need or reason for seclusion shall be made clear to the patient and shall be recorded in the patient’s clinical record. The length of time in seclusion shall also be recorded in the clinical record, as well as the condition of the patient. A continuing log shall be maintained by the facility that will indicate by name the patients placed in seclusion, date, time, specified reason for seclusion and length of time in seclusion. In an emergency, orders may be given by a physician over the telephone to a registered professional nurse. Telephone orders must be reviewed within twenty-four (24) hours by the director of psychiatric services.
The special hospital shall not exploit a patient or require a patient to make public statements to acknowledge his gratitude to the treatment center.
Patients shall not be required to perform at public gatherings.
The special hospital shall not use identifiable patients’ pictures without written consent. The signed consent form shall be on file at the facility before any such pictures are used. A signed consent form must indicate how pictures shall be used and a copy shall be placed in the patient’s clinical record.

(10) Records. The form and detail of the clinical records may vary but shall minimally conform to the following standards:

(a) Content. All clinical records shall contain all pertinent clinical information and each record shall include:

Identification data and consent forms; when these are not obtainable, reason shall be noted;
Source of referral;
Reason for referral, example, chief complaint, presenting problem;
Record of the complete assessment;
Initial formulation and diagnosis based upon the assessment;
Written treatment plan;
Medication history and record of all medications prescribed;
Record of all medication administered by facility staff, including type of medication, dosages, frequency of administration, persons who administered each dose, and route of administration;
Documentation of course of treatment and all evaluations and examinations, including those from other facilities, for example, emergency rooms or general hospitals;
Periodic treatment summaries; updated at least every 90 days;
All consultation reports;
All other appropriate information obtained from outside sources pertaining to the patient;
Discharge or termination summary report; and,
Plans for follow-up and documentation of its implementation.

(b) Identification data and consent form shall include the patient’s name, address, home telephone number, date of birth, sex, next of kin, school and what grade, date of initial contact or admission to the program, legal status and legal document, and other identifying data as indicated.

(c) Progress Notes. Progress notes shall include regular notations at least weekly by staff members, consultation reports and signed entries by authorized identified staff. Progress notes by the clinical staff shall:

Document a chronological picture of the patient’s clinical course;
Document all treatment rendered to the patient;
Document the implementation of the treatment plan;
Describe each change in each of the patient’s conditions;
Describe responses to and outcome of treatment; and,
Describe the responses of the patient and the family or significant others to significant inter-current events.

(d) Discharge Summary. The discharge summary shall include the initial formulation and diagnosis, clinical resume, 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 patient’s condition during appraisal of the fundamental needs of the patients. Records of discharged patients shall be completed following discharge within a reasonable length of time, and not to exceed 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 resume. 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 staff or consultant physician.

(e) Recording. Entries in the clinical records shall be made by staff having pertinent information regarding the patient, consistent with the facility policies, and authors shall fully sign and date each entry. When mental health trainees are involved in patient care, documented evidence shall be in the clinical records to substantiate the active participation of supervisory clinical staff. Symbols and abbreviations shall be used only when they have been approved by the clinical staff and when there is an explanatory notation. Final diagnosis, both psychiatric and physical, shall be recorded in full, and without the use of either symbols or abbreviations.

(f) Policies and Procedures. The facility shall have written policies and procedures regarding clinical records which shall provide that:

Clinical records shall be confidential, current and accurate;
The clinical record is the property of the facility and is maintained for the benefit of the patient, the staff and the facility;
The facility is responsible for safeguarding the information in the record against loss, defacement, tampering or use by unauthorized persons;
The facility shall protect the confidentiality of clinical information and communication between staff members and patients;
Except as required by law, the written consent of the patient, family, or other legally responsible parties, is required for the release of clinical record information;
Records may be removed from the facility’s jurisdiction and safekeeping only according to the policies of the facility or as required by law; and,
That all staff shall receive training, as part of new staff orientation and with periodic update, regarding the effective maintenance of confidentiality of the clinical record. It shall be emphasized that confidentiality refers as well to discussions regarding patients inside and outside the facility. Verbal confidentiality shall be discussed as part of all employee training.

(g) Maintenance of Records. Each facility shall provide for a master filing system which shall include a comprehensive record on each patient’s involvement in every program aspect.

Appropriate records shall be kept on the unit where the patient is being treated or be directly and readily accessible to the clinical staff caring for the patient;
The facility shall maintain a system of identification and coding to facilitate the prompt location of the patient’s clinical records;
There shall be policies regarding the permanent storage, disposal or destruction of the clinical records of disclosure of confidential information later in life;
The clinical record services required by the facilities shall be directed, staffed and equipped to facilitate the accurate processing, checking, indexing, filing, retrieval and review of all clinical records. The clinical records service shall be the responsibility of an individual who has demonstrated competence and training or experience in clinical record administrative work. Other personnel shall be employed as needed, in order to effect the functions assigned to the clinical record services;
There shall be adequate space, equipment and supplies, compatible with the needs of the clinical record service, to enable the personnel to function effectively and to maintain clinical records so that they are readily accessible.

(11) Program and Patient Evaluation. The staff shall work towards enhancing the quality of patient care through specified, documented, implemented and ongoing the designing professions having as their purpose processes of clinical care evaluation studies and utilization review mechanisms.

(a) Individual Case Review.

There shall be regular staff meetings or unit meetings to review and monitor the progress of the individual child or adolescent patient. Each patient’s case shall be reviewed within a month after admission and at least monthly during residential treatment. This shall be documented. This meeting may also be used for review and revision of treatment plans.
The facility shall provide for a follow-up review on each discharged patient to determine effectiveness of treatment and disposition.

(b) Program Evaluation.

Clinical Care Evaluation Studies. There shall be evidence of ongoing studies to define standards of care consistent with the goals of the program effectiveness of the program, and to identify gaps and inefficiencies in service. Evaluation shall include follow-up studies. Studies shall consist of the following elements:

a. Selection of an appropriate design;

b. Specification of information to be included;

c. Collection of data;

d. An analysis of data with conclusions and recommendations;

e. Transmissions of findings; and,

f. Follow-up on recommendations.

Utilization Review. Each facility shall have a plan for and carry out utilization review. The review shall cover the appropriateness of admission to services, the provision of certain patterns of services, and duration of services. There shall be documentation of utilization review meetings either in minutes or in individual clinical records. The improvement of patient care, shall receive special consideration following a request and documentation of the proposed project by the individual sponsor.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 1-1-77, Formerly 10D-28.92, 10D-28.110, Amended 9-4-95, 10-16-14, Formerly 59A-3.110.

Fla. Admin. Code R. 59A-3.312 Exceptions

History

Rulemaking Authority 395.003, 395.0163, 395.1055 FS. Law Implemented 395.002, 395.1055 FS. History–New 2-15-82, Formerly 10D-28.111, 59A-3.111, Repealed 5-14-12.

Chapter 59A-4 MINIMUM STANDARDS FOR NURSING HOMES

Fla. Admin. Code R. 59A-4.071 Purpose

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented Chapter 77-401, Sections 1, 2, 3, 4, 6, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.71, 10D-29.071, Transferred to 59A-4.150.

Fla. Admin. Code R. 59A-4.072 Definitions

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented Chapter 77-401, Sections 1, 2, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.72, 10D-29.072, Transferred to 59A-4.151.

Fla. Admin. Code R. 59A-4.073 Application

History

Rulemaking Authority 381.031(1)(g)7., 11., 381.493-.497, 400.141(3), 400.23(2) FS. Law Implemented Chapter 77-401, Sections 1, 2, 3, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Amended 8-28-78, Formerly 10D-29.73, 10D-29.073, Transferred to 59A-4.152.

Fla. Admin. Code R. 59A-4.074 Treatment Rooms and Access Areas

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented Chapter 77-401, Sections 1, 2, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.74, 10D-29.074, Transferred to 59A-4.153.

Fla. Admin. Code R. 59A-4.075 Administration

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented Chapter 77-401, Sections 1, 2, 3, 5, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.75, 10D-29.075, Transferred to 59A-4.154.

Fla. Admin. Code R. 59A-4.076 Fiscal Management

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented Chapter 77-401, Sections 1, 2, 3, 4, 5, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.76, 10D-29.076, Transferred to 59A-4.155.

Fla. Admin. Code R. 59A-4.077 Personnel Policies

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented Chapter 77-401, Sections 1, 2, 3, 5, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.77, 10D-29.077, Transferred to 59A-4.156.

Fla. Admin. Code R. 59A-4.078 Personnel Functions and Responsibilities

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented Chapter 77-401, Sections 1, 2, 3, 5, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.78, 10D-29.078, Transferred to 59A-4.157.

Fla. Admin. Code R. 59A-4.079 Patient Eligibility Criteria

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented Chapter 77-401, Sections 1, 2, 5, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.79, 10D-29.079, Transferred to 59A-4.158.

Fla. Admin. Code R. 59A-4.080 Patient Rights

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented Chapter 77-401, Sections 1, 2, 5, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.80, 10D-29.080, Transferred to 59A-4.159.

Fla. Admin. Code R. 59A-4.081 Scope of Services

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented Chapter 77-401, Sections 1, 3, 5, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.81, 10D-29.081, Transferred to 59A-4.160.

Fla. Admin. Code R. 59A-4.082 Clinical Records

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented Chapter 77-401, Sections 1, 3, 5, Laws of Florida, 400.23(2), 405.01-.03 FS. History–New 4-27-78, Formerly 10D-29.82, 10D-29.082, Transferred to 59A-4.161.

Fla. Admin. Code R. 59A-4.083 Medications

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented Chapter 77-401, Sections 1, 3, 5, Laws of Florida, 400.23(2), 464.012 FS. History–New 4-27-78, Formerly 10D-29.83, 10D-29.083, Amended 10-5-92, Transferred to 59A-4.162.

Fla. Admin. Code R. 59A-4.084 Right of Inspection

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented Chapter 77-401, Sections 1, 3, 5, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.84, 10D-29.084, Transferred to 59A-4.163.

Fla. Admin. Code R. 59A-4.085 Evaluation and Report

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented Chapter 77-401, Sections 1, 5, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.85, 10D-29.085, Repealed 4-18-94.

Fla. Admin. Code R. 59A-4.086 Patient Protection Trust Fund

History

Rulemaking Authority 400.063 FS. Law Implemented 400.063, 400.162, 400.23 FS. History–New 4-6-80, Formerly 10D-29.86, 10D-29.086, Transferred to 59A-4.164.

Fla. Admin. Code R. 59A-4.100 Purpose

History

Rulemaking Authority 400.23 FS. Law Implemented 400.011, 400.022, 400.102, 400.23 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.100, Amended 4-18-94, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.101 Definitions

History

Rulemaking Authority 381.031(1)(g)7., 400.23 FS. Law Implemented 381.031, 400.011, 400.021, 400.22, 400.102, 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.101, Repealed 4-18-94.

Fla. Admin. Code R. 59A-4.102 License Required

History

Rulemaking Authority 400.23 FS. Law Implemented 381.493-.499, 400.051, 400.062, 400.071, 400.102, 400.111, 400.141, 400.23 FS. History–New 4-1-82, Amended 9-5-82, 4-1-84, Formerly 10D-29.102, Repealed 4-18-94.

Fla. Admin. Code R. 59A-4.103 Licensure, Administration and Fiscal Management

(1) The licensee or applicant shall make application for an initial, renewal or change of ownership license to operate a nursing home facility and shall provide:

(a) All of the information required by this rule, Chapter 400, Part II, F.S., and Chapter 408, Part II, on the Health Care Licensing Application Nursing Homes, AHCA Form 3110-6001, July 2014, which is incorporated by reference. These forms may be obtained at http://www.flrules.org/Gateway/reference.asp?No=Ref-06014 and are available from the Agency for Health Care Administration, Long-Term Care Unit, 2727 Mahan Drive, Mail Stop #33, Tallahassee, FL 32308 or at the web address: http://ahca.myflorida.com/HQAlicensureforms; and,

(b) Proof of Financial Ability to Operate, AHCA Form 3100-0009, July 2009, which is incorporated by reference in subsection 59A-35.062(1), F.A.C., available from the Agency for Health Care Administration, Long Term Care Unit, 2727 Mahan Drive, Mail Stop #33, Tallahassee, Florida 32308 or online at http://ahca.myflorida.com/HQAlicensureforms.

(2) The licensure fees must be included with the application. The licensure fees are: a biennial fee of $100.00 per bed and a resident protection fee of $.50 per bed as required by Section 400.062(3), F.S., and the Data Collection and Analysis Assessment of $12.00 per bed as required by Section 408.20(1)(b), F.S. The assessment required by Section 408.20(1)(b), F.S. is waived for facilities having a certificate of authority under Chapter 651, F.S.

(3) A nursing home licensee may request an inactive license for part of a facility to use an occupied contiguous portion of the facility for an alternative use as authorized by Section 400.0712, F.S. Prior to providing alternative services, the facility must submit a written request to the Agency. A request may be submitted at any time during the licensure period and must provide: the intended use of the inactive portion, a floor plan of the building identifying the inactive area, the total number of inactive beds and the prospective date the beds will become inactive.

(a) Upon receipt of written approval by the Agency, as required in Section 408.808, F.S., to continue with the plan for the partial inactive license, the licensee must submit a completed Health Care Licensing Application, Nursing Homes, AHCA Form 3110-6001, July 2014, to the Agency within 60 days of the approval and a bed change request form for beds certified through the Centers for Medicare and Medicaid Services. The appropriate facility licensure application for the alternative use must accompany this application, unless the space will be utilized for services authorized under the existing nursing home licensure.

(b) If the alternative service license is approved, a partial inactive license will be issued concurrently with the issuance of the license for the alternative use. The expiration date of the partial inactive license will be the same date that the licensee’s nursing home must file for renewal of their nursing home license. The licensee must indicate the intent to continue the partial inactive license at each nursing home licensure renewal. Licensure fees will remain at the standard rate for nursing home beds, whether active or inactive, at the time of renewal and will not be assessed for another Agency license for the alternative use of the inactive beds.

(c) Notification to reactivate the inactive portion of the building and the appropriate change request form for beds certified through the Centers for Medicare and Medicaid Services, must be submitted to the Agency at least 30 days prior to the planned date to admit residents to the previously inactive beds. The inactive portion of the license will be reactivated upon Agency approval.

(4) Administration.

(a) The licensee of each nursing home must have full legal authority and responsibility for the operation of the facility.

(b) The licensee of each facility must designate one person, who is licensed by the Florida Department of Health, Board of Nursing Home Administrators under Chapter 468, Part II, F.S., as the Administrator who oversees the day to day administration and operation of the facility.

(5) Fiscal Management.

(a) The licensee, for each nursing home it operates, must maintain fiscal records in accordance with the requirements of Chapter 400, Part II, F.S., and this rule.

(b) An accrual or cash system of accounting must be used to reflect transactions of the business. Records and accounts of transactions, such as, general ledgers and disbursement journals, must be brought current no less than quarterly and shall be available for review by authorized representatives of appropriate state and federal agencies.

(c) A licensee must obtain a surety bond as required by Section 400.162, F.S.; it must be based on twice the average monthly balance in the resident trust fund during the prior fiscal year or $5,000, whichever is greater. A licensee who owns more than one nursing home may purchase a single surety bond to cover the residents’ funds held in nursing homes located within the state. A surety bond must contain substantially the same language as is found in the Nursing Home Patient Trust Surety Bond, AHCA Form 3110-6002, May 2008, which is incorporated by reference, and may be obtained at http://www.flrules.org/Gateway/reference.asp?No=Ref-06016 and from the Agency online at http://ahca.myflorida.com. The surety bond must be filed with the Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop #33, Tallahassee, Florida 32308.

(d) A self-insurance pool, which may be an interest bearing account, may be established for non-certified facilities only to provide compensation to any resident suffering financial loss in accordance with the provisions of Section 400.162(5)(c), F.S., as the result of one or more of the member licensees violating any of the provisions of Section 400.162, F.S.

Such self-insurance pool must be administered under the direction of an elected board of trustees. The membership of the board of trustees must be composed of one representative from each participating licensee.
An application for establishing a self-insurance pool must be made by the trustees to the Agency. Such application shall contain the following information: the names, complete addresses, and affiliation of the trustees; the name and complete address of each licensee participating in the pool; the total dollar amount of the pool; and the name and complete address of the bank in which the account is maintained and the account number. The application must be accompanied by:

a. An individual application from each licensee applying for membership in the self-insurance pool. Such application must contain the following information: the name, telephone number, and complete address of the facility and the licensee, the name of the facility’s administrator, manager or supervisor, his or her license and renewal number; the names of all employees involved in the administration of the resident trust fund account; the average monthly balance in the resident trust fund account during the prior year; the total dollar amount the licensee has deposited in the self-insurance pool; and the name and complete address of the bank in which the account is maintained and the account number.

b. Prima facie evidence showing that each individual member of the pool has deposited an amount equal to twice the average monthly balance of the trust fund account or $5,000.00 dollars, whichever is greater, in a separate account maintained by the board of trustees in the name of the self-insurance pool in a bank authorized under Chapter 658, F.S., in the State of Florida that is a member of the Federal Reserve System to secure performance of payment of all lawful awards made against any member or members of the self-insurance pool as required by Section 400.162(5), F.S., and this rule.

After the inception date of the pool, prospective new members of the pool must submit an application for membership to the board of trustees. Such application must contain the information specified in subparagraph (5)(d)2. of this rule. The trustees may approve the application for membership in accordance with these rules. If so approved, the application for membership in accordance with these rules must be filed with the Agency at the Agency for Health Care Administration, Long-Term Care Unit, 2727 Mahan Drive, Mail Stop #33, Tallahassee, FL 32308.
The amount deposited in such an account must be maintained at all times.

(e) If, at any time during the period for which a license is issued, a licensee who has not purchased a surety bond or entered into a self-insurance agreement is requested to hold funds in trust as provided in Section 400.162(5), F.S., the licensee must notify the Agency, in writing, of the request at the Agency for Health Care Administration, Long-Term Care Unit, 2727 Mahan Drive, Mail Stop #33, Tallahassee, FL 32308, and make application for a surety bond or for participation in a self-insurance agreement within seven business days of the request. Copies of the application, along with written documentation of related correspondence with an insurance agency or group, must be maintained and must be available for review. All notices required by this rule provision must be sent to the Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop #33, Tallahassee, Florida 32308.

History

Rulemaking Authority 400.062, 400.0712(3), 400.162(5)(c), 400.23, 408.034, 408.810(8), 408.819 FS. Law Implemented 400.062, 400.071, 400.0712, 400.102, 400.111, 400.141, 400.162, 400.20, 408.805, 408.806, 408.808, 408.810 FS. History–New 4-1-82, Amended 4-1-84, 8-1-85, 1-1-86, 11-12-89, 12-25-90, 10-6-91, Formerly 10D-29.103, Amended 4-18-94, 2-6-97, 5-5-02, 12-21-15.

Fla. Admin. Code R. 59A-4.104 Administration

History

Rulemaking Authority 400.23 FS. Law Implemented 400.022, 400.121, 400.141, 400.151, 400.18 FS. History–New 4-1-82, Amended 9-5-82, 4-1-84, 8-1-85, 4-29-86, 7-10-91, Formerly 10D-29.104, Amended 4-18-94, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.1045 Fiscal Management

History

Rulemaking Authority 400.23 FS. Law Implemented 400.022, 400.121, 400.141, 400.151, 400.162, 400.18 FS. History–New 4-18-94, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.105 Admission, Retention, Transfer, and Discharge Policies

History

Rulemaking Authority 400.23 FS. Law Implemented 400.022, 400.102, 400.151, 400.23 FS. History–New 4-1-82, Amended 4-1-84, 11-19-84, 12-25-90, Formerly 10D-29.105, Amended 4-18-94, 1-10-95, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.106 Facility Policies

(1) Admission, retention, transfer, and discharge policies:

(a) Each resident must receive the following at the time of admission and as changes are being made and upon request, in a language the resident or his representative understands:

A copy of the residents’ bill of rights as required by Section 400.022, F.S.;
A copy of the facility’s admission and discharge policies; and,
Information regarding advance directives.

(b) Each resident admitted to the facility must have a contract as required by Section 400.151, F.S., which includes the following:

A list of services and supplies, complete with a list of standard charges for those services and supplies, available to the resident, but not covered by the facility’s per diem or by Title XVIII and Title XIX of the Social Security Act and a copy of the bed reservation and refund policies of the facility.
When a resident is in a facility offering continuing care, and is transferred from independent living or assisted living to the nursing home section, a new contract need not be executed; an addendum must be attached to describe any additional services, supplies or costs not included in the most recent contract that is in effect.

(c) No resident who is suffering from a communicable disease shall be admitted or retained unless the medical director or attending physician certifies that adequate or appropriate isolation measures are available to control transmission of the disease.

(d) Residents may not be retained in the facility who require services beyond those for which the facility is licensed or has the functional ability to provide as determined by the Medical Director and the Director of Nursing in consultation with the facility administrator.

(e) Residents must be assigned to a bedroom area and must not be assigned bedroom space in common areas except in an emergency. Emergencies must be documented and must be for a limited, specified period of time.

(f) All resident transfers and discharges must be in accordance with the facility’s policies and procedures, provisions of Sections 400.022 and 400.0255, F.S., this rule, and Title 42 Code of Federal Regulations section 483.12(a), revision date October 1, 2014, herein incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-12.xml and http://www.flrules.org/Gateway/reference.asp?No=Ref-06375, and will include notices provided to residents by using Nursing Home Transfer and Discharge Notice, AHCA Form 3120-0002, April 2014, herein incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06017, “the Fair Hearing Request for Transfer or Discharge From a Nursing Home, AHCA Form 3120-0003, April 2014, herein incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06018, the Long-Term Care Ombudsman Council Request for Review of Nursing Home Discharge and Transfer, AHCA Form 3120-0004, April 2014, herein incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06019 or the Spanish language version, Solicitud de Revisión de Long-Term Care Ombudsman de la Dada de Alta o El Traslado de un Hogar de Ancianos, AHCA Form 3120-0004A, April 2014, herein incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06020. These forms may also be obtained from the Agency for Health Care Administration, Long Term Care Unit, 2727 Mahan Drive, Mail Stop #33, Tallahassee, FL 32308 or at the web address http://ahca.myflorida.com/.

(2) Each nursing home licensee must adopt, implement, and maintain written policies and procedures governing all services provided in the facility.

(3) All policies and procedures must be reviewed at least annually and revised as needed with input from the facility Administrator, Medical Director, and Director of Nursing.

(4) Each facility shall maintain policies and procedures in the following areas:

(a) Activities;

(b) Advance directives;

(d) Death of residents in the facility;

(e) Dental services;

(f) Staff education, including HIV/AIDS Training as required by Section 381.0035, F.S.;

(g) Diagnostic services;

(h) Dietary services;

(i) Disaster preparedness;

(j) Fire prevention and control;

(k) Housekeeping;

(l) Infection control;

(m) Laundry service;

(n) Loss of power, water, air conditioning or heating;

(o) Medical director/consultant services;

(p) Medical records;

(q) Mental health;

(r) Nursing services;

(s) Pastoral services;

(t) Pharmacy services;

(u) Podiatry services;

(v) Resident care planning;

(w) Resident identification;

(x) Resident’s rights;

(y) Safety awareness;

(z) Social services;

(aa) Specialized rehabilitative and restorative services;

(bb) Therapeutic spa services, if offered;

(cc) Volunteer services; and,

(dd) The reporting of accidents or unusual incidents involving any resident, staff member, volunteer or visitor. This policy shall include reporting within the facility and to the Agency as required by Section 400.147, F.S.

(5) Staff Education.

(a) Each nursing home licensee must develop, implement, and maintain a written staff education plan which ensures a coordinated program for staff education for all facility employees. The staff education plan must be reviewed at least annually by the risk management and quality assurance committee and revised as needed.

(b) The staff education plan must include both pre-service and in-service programs.

(c) The staff education plan must ensure that education is conducted annually for all facility employees, at a minimum, in the following areas:

Prevention and control of infection;
Fire prevention, life safety, and disaster preparedness;
Accident prevention and safety awareness program;
Resident’s rights’;
Federal law, 42 CFR 483, Requirements for State and Long Term Care Facilities, October 1, 2014, which is incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-part483.xml and http://www.flrules.org/Gateway/reference.asp?No=Ref-06385, Chapter 400, Part II, F.S., and subsection 59A-4.106(5), F.A.C.;

(d) The staff education plan must ensure that all employees of the nursing home complete an initial educational course on HIV/AIDS as required by Section 381.0035, F.S. If the employee does not have a certificate of completion at the time they are hired, they must complete the course within six months of employment or before the employee provides care for an HIV/AIDS diagnosed resident.

(6) Advance directives.

(a) Each nursing home licensee must have written policies and procedures, which delineate the nursing home’s position with respect to the state law and rules relative to advance directives. The policies must not condition treatment or admission upon whether or not the individual has executed or waived an advance directive. In the event of conflict between the facility’s policies and procedures and the individual’s advance directive, provision should be made in accordance with Section 765.1105, F.S.

(b) The facility’s policy must include:

Providing each adult individual, at the time of the admission as a resident, with a copy of “Health Care Advance Directives – The Patient’s Right to Decide,” revised April 2006, which is hereby incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06021, and from the Agency for Health Care Administration at http://www.floridahealthfinder.gov/reports-guides/advance-directives.aspx or with a copy of some other substantially similar document which is a written description of Florida’s state law regarding advance directives;
Providing each adult individual, at the time of the admission as a resident, with written information concerning the nursing home’s policies respecting advance directives; and,
Providing documentation of the existence of an advance directive be contained in the medical record. A nursing home licensee that is provided with the individual’s advance directive must make the advance directive or a copy thereof a part of the individual’s medical record.

History

Rulemaking Authority 400.0255(16), 400.142(3), 400.23, 765.110 FS. Law Implemented 400.022, 400.0255, 400.142(3), 400.151, 400.23, 765.110 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.106, Amended 4-18-94, 1-10-95, 2-6-97, 5-5-02, 12-21-15.

Fla. Admin. Code R. 59A-4.107 Physician Services

(1) Each nursing home facility licensee must retain, pursuant to a written agreement, a physician licensed under Chapter 458 or 459, F.S., to serve as Medical Director. In facilities with a licensed capacity of 60 beds or less, pursuant to written agreement, a physician licensed under Chapter 458 or 459, F.S., may serve as medical consultant in lieu of a Medical Director. Medical Directors and medical consultants must be certified as set forth in Rule 59A-4.1075, F.A.C.

(2) Each resident or legal representative, must be allowed to select his or her own private physician.

(3) Verbal orders, including telephone orders, must be immediately recorded, dated, and signed by the person receiving the order. All verbal treatment orders must be countersigned by the physician or other health care professional on the next visit to the facility.

(4) Physician orders may be transmitted by facsimile machine, email or electronic medical record as required Section 501.171, F.S. and 45 Code of Federal Regulation, Section 164, effective October 1, 2014, which is incorporated by reference and is available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title45-vol1/xml/CFR-2014-title45-vol1-part164.xml and http://www.flrules.org/Gateway/reference.asp?No=Ref-06388 and http://www.flrules.org/Gateway/reference.asp?No=Ref-06389. It is not necessary for a physician to re-sign a facsimile order when he or she visits a facility.

(5) All physician orders must be followed as prescribed, and if not followed, the reason must be recorded on the resident’s medical record during that shift.

(6) Each resident must be seen by a physician or another licensed health professional acting within their scope of practice at least once every 30 days for the first 90 days after admission, and at least once every 60 days thereafter. A physician visit is considered timely if it occurs not later than 10 days after the date the visit was required. If a physician documents that a resident does not need to be seen on this schedule and there is no other requirement for physician’s services that must be met due to Title XVIII or XIX of the Social Security Act, the resident’s physician may document an alternate visitation schedule.

(7) If the physician chooses to designate another health care professional to fulfill the physician’s component of resident care, they may do so after the required visit. All responsibilities of a physician, except for the position of medical director, may be carried out by other health care professionals acting within their scope of practice.

(8) Each nursing home licensee must have a list of physicians designated to provide emergency services to residents when the resident’s attending physician, or designated alternate is not available.

History

Rulemaking Authority 400.23 FS. Law Implemented 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.107, Amended 10-5-92, 4-18-94, 1-10-95, 12-21-15, 5-5-26.

Fla. Admin. Code R. 59A-4.1075 Medical Director

(1) Each nursing home licensee must have only one physician who is appointed as Medical Director.

(2)(a) The Medical Director must be a physician licensed under Chapter 458 or 459, F.S., and beginning on January 1, 2026, must hold an active certification as a medical director or be in the process of seeking such certification. Recognized certifying or credentialing organizations include the American Medical Directors Association now known as the Post-Acute and Long-Term Care Medical Association (PALTmed).

(b) For the purpose of this rule, “in the process of seeking such certification” means the medical director is actively engaged in obtaining certification as evidenced by his or her enrollment and participation in the PALTmed “Core Curriculum on Medical Direction in Post-Acute and Long-Term Care” program or other required certification program education in clinical or management topics for post-acute and long-term care.

For a medical director appointed before January 1, 2026, the individual must complete certfication or recertification, if applicable, by December 31, 2028.
For a medical director appointed on or after January 1, 2026 who is not certified, the individual must complete certification within three years from the date of appointment as the medical director of a nursing home facility.

(c) A physician must have his or her principal office within 60 miles of all facilities for which he or she serves as Medical Director. The principal office is the office maintained by a physician as required by Section 458.348 or 459.025(3), F.S., and where the physician delivers the majority of medical services. The physician must specify the address of his or her principal office at the time of becoming Medical Director. The agency may approve a request to waive this requirement for rural facilities that exceed this distance requirement as outlined in Section 120.542(2), F.S. A rural facility is a facility located in a county with a population density of no greater than 100 persons per square mile, which is at least 30 minutes of travel time, on normally traveled roads under normal traffic conditions, from any other nursing home facility within the same county.

(d) The Medical Director must visit the facility at least once a month. The Medical Director must review all new policies and procedures; review all new incident and new accident reports from the facility to identify clinical risk and safety hazards. The Medical Director must review the most recent grievance logs for any complaints or concerns related to clinical issues. Each visit must be documented in writing by the Medical Director.

(3) A physician may be Medical Director of a maximum of 10 nursing homes at any one time. The Medical Director, in an emergency where the health of a resident is in jeopardy and the attending physician or covering physician cannot be located, may assume temporary responsibility of the care of the resident and provide the care deemed necessary.

(4) The Medical Director must meet at least quarterly with the risk management and quality assessment and assurance committee of the facility.

(5) The Medical Director must participate in the development of the comprehensive care plan for the resident when he or she is also the attending physician of the resident.

(6) Each nursing home facility must provide information on the facility’s appointed medical director to the Agency including proof of certification or progress towards certification for the medical director. This information must be reported to the Agency as part of the nursing home’s licensure application for initial, renewal, change of ownership, or as the medical director changes.

History

Rulemaking Authority 400.141, 400.23 FS. Law Implemented 400.141(1)(b), 400.23 FS. History–New 8-2-01, Amended 12-21-15, 5-5-26.

Fla. Admin. Code R. 59A-4.108 Nursing Services

(1) The Administrator of each nursing home must designate one registered nurse as a Director of Nursing (DON) who shall be responsible and accountable for the supervision and administration of the total nursing services program. When a Director of Nursing is delegated institutional responsibilities, a full time qualified registered nurse (RN), as defined in Chapter 464, F.S., must be designated to serve as Assistant Director of Nursing. In a facility with a census of 121 or more residents, an RN must be designated as an Assistant Director of Nursing.

(2) Persons designated as Director of Nursing or Assistant Director of Nursing must serve only one nursing home facility in this capacity, and shall not serve as the administrator of the nursing home facility.

(3) The Director of Nursing must designate one licensed nurse on each shift to be responsible for the delivery of nursing services during that shift.

(4) In accordance with the requirements outlined in Section 400.23(3)(a), F.S., the nursing home licensee must have sufficient nursing staff, on a 24-hour basis to provide nursing and related services to residents in order to maintain the highest practicable physical, mental, and psychosocial well-being of each resident, as determined by resident assessments and individual plans of care.

(5) In multi-story, multi-wing, or multi-station nursing home facilities, there must be a minimum of one nursing services staff person who is capable of providing direct care on duty at all times on each floor, wing, or station.

(6) No nursing services staff person shall be scheduled for more than 16 hours within a 24 hour period, for three consecutive days, except in an emergency. Emergencies shall be documented and must be for a limited, specified period of time.

(7) Upon approval by the Agency, a nursing home licensee may allow a licensed nurse that performs both licensed nursing and certified nursing assistant duties during the same shift to divide the hours of patient care provided between the licensed nurse and certified nursing assistant staffing ratio requirements consistent with services provided, as referenced in Section 400.23(3)(a)4., F.S. Approval to utilize licensed nurses to perform certified nursing assistant duties must be requested in writing. This request may be submitted upon license renewal on the Health Care Licensing Application, Nursing Homes, AHCA Form 3110-6001, July 2014, incorporated by reference in paragraph 59A-4.103(1)(a), F.A.C. or by letter from the facility administrator. The Agency’s approval depends upon review of the last three years’ inspections from the date of the request to determine if there were deficiencies cited related to staffing. The licensee must document daily the time the licensed nurse performed personal care services to comply with minimum staffing requirements. The hours of a licensed nurse with dual job responsibilities may not be counted twice.

History

Rulemaking Authority 400.23 FS. Law Implemented 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, 8-1-85, 7-1-88, 7-10-91, Formerly 10D-29.108, Amended 4-18-94, 12-21-15.

Fla. Admin. Code R. 59A-4.1081 Personal Care Attendant Training Program Requirements

(1) This program permits a nursing home licensed pursuant to Chapter 400 Part II, Florida Statutes (F.S.) to employ a trained Personal Care Attendant.

(2) Purpose – This Personal Care Attendant Training Program will enable the Personal Care Attendant to further obtain skills and training from their employer toward the goal of successfully passing the Certified Nursing Assistant (CNA) exam.

(3) Definitions.

(a) “Personal Care Attendant” or “PCA” means a person who meets the training requirement in this rule and Section 400.141(1)(w), F.S., and provides care to and assists residents with tasks related to the activities of daily living.

(b) “Training Program” means the Personal Care Attendant Training Program as specified in Section 400.141(1)(w), F.S.

(4) Scope – The Training Program must consist of a minimum of sixteen (16) hours of education. The 16 hours of required education and eight (8) hours of simulation must be completed before the PCA has any direct contact with a resident.

(5) Program Requirements.

(a) A candidate for the Training Program must be at least eighteen (18) years of age.

(b) The candidate must be able to read, write and complete written materials pertinent to their job duties.

(6) Training Standards.

(a) Completion of all training and documentation requirements for PCA candidates is the ultimate responsibility of the hiring facility.

(b) Training must consist of a minimum of sixteen (16) hours of classroom teaching and eight (8) hours of supervised simulation in which the PCA candidate is required to demonstrate competency in all areas of training.

(c) Upon completion of classroom instruction, PCA candidates must simulate and demonstrate competency in all required areas of instructions and competency in accordance with section (7) of this rule.

(d) The PCA Training Program must be taught by a registered nurse. For the purposes of this training program, the instructor must be a licensed professional registered nurse.

(e) Under observation by the instructor, PCA candidates will first simulate procedures while working together in pairs or teams. Next, the instructor must observe each candidate’s simulation of required skills and document the candidate’s competency.

(f) Upon completion of the Training Program, the facility must maintain a record of all PCA candidates who complete training and demonstrate the required competencies. The facility shall post daily the names of the PCAs on duty. When requested by the Agency, the facility will provide the names of all PCAs working in the facility at the time of the request.

(g) PCAs must be supervised by a licensed nurse and shall report to the facility’s nursing management or supervisor.

(h) The facility must notify its certified and licensed staff members that PCAs have a limited scope of permissible work, and detail duties they may not be delegated to perform as PCAs. If the facility learns that any PCA is performing duties outside the limited scope of permissible work, the facility must immediately intervene, stop the PCA, and reassign those duties to authorized personnel.

(i) Upon completion of the 16 hour education requirement and eight (8) hour simulation requirement, the PCA will work under the supervision of the licensed nursing staff and in collaboration with the Certified Nursing Assistants.

(7) Required areas of classroom instruction (16 hours).

(a) Residents’ rights (2 hours).

Immediate reporting of abuse and neglect to nurse/manager on duty.
Sample scenarios of situations involving resident rights, abuse, and neglect.
Review of immediate protection of resident until assistance arrives if abuse is in process.
Review of duty to immediately report abuse or neglect to nurse/manager on duty.
Department of Children and Families (DCF) reporting requirements for mandated reporters.
Maintaining resident privacy and honoring resident preferences.

(b) Confidentiality of residents’ personal information and medical records (1.5 hours).

How to maintain confidentiality of resident information.
Response to a witnessed (or reported) breach.

How infection is spread (chain of infection/modes of transmission) and how to prevent infection.
Hand hygiene: handwashing, alcohol-based hand rub (ABHR), cough etiquette.
Standard precautions/personal protective equipment.
Handling of clean and soiled linens.
Disinfection of common use articles/equipment/high touch objects/areas.
Personal protective equipment (PPE) use and disposal.
The PCA will not be assigned or provide care or services to a resident on isolation precautions.

(d) Emergency response measures (2 hours of classroom education and 1.5 hours of simulation).

Fall prevention.
What to do when a resident is found on the floor.
Choking: abdominal thrusts.
Fire safety.
Weather safety.

(e) Assistance with activities of daily living (4 hours of classroom education and 2 hours of simulation).

Initial steps/responding to a call light.
Obtaining a temperature (all routes other than rectal), reporting/documentation.
Making an unoccupied bed/handling of linens.
Turning and repositioning the resident while in bed.
Transfer from bed to chair/wheelchair/use of Gait belt – one person standby/transfer.
For anything beyond a one-person transfer, the PCA may only assist and must be directed by a certified/licensed staff member.
Assistance with dressing/undressing.
Incontinence/perineal care.
Assist to toilet/use of urinal (only for a resident requiring one person/standby assistance).
Oral care – conscious residents only.
Devices/use/storage.

a. Hearing aids.

b. Eyeglasses.

c. Dentures.

PCA may not apply or don orthotics and prosthetics devices or braces.
Final steps/observations to report to the nurse.
Assistance with bathing/showering.

(f) Measuring vital signs (1 hour of classroom education and 1.5 hours of simulation).

(g) Skin care and pressure sores prevention (30 minutes of classroom education and 1 hour of simulation).

Basic care/interventions/devices.
Offloading/floating heels.
Observations to report to the nursing management or supervisor on duty.

a. Open area or skin condition observed to be lacking a dressing ‒ emphasis on no dressing applied by the PCA.

b. Observed bruises, abrasions, or skin tears.

(h) Portable oxygen use and safety (30 minutes of classroom education and 30 minutes of simulation).

Nasal cannula/tubing/storage/observing liter flow.
Potential hazards safety.

(i) Nutrition and hydration (30 minutes).

Mechanically altered diets/thickened liquids/adherence to diet.
Passing trays/retrieving trays (set up/opening packages for residents who can consume meals independently).
Passing ice water.
Food storage/safety.
PCAs cannot feed a resident prior to completing the training for paid feeding assistants required in Section 400.141, F.S.

(j) Dementia care (1 hour).

Stages of dementia/overview.
Tips on communicating with cognitively impaired residents.
Recognition of when to seek additional staff assistance.

(k) Mental health/challenging behaviors (1 hour).

Responding to a challenging behavior.
Recognition of when to seek additional staff assistance.
Reporting a challenging behavior to nurse/manager on duty.
Trauma informed care.

(8) Required areas of hands on simulation (8 hours).

(a) Hand hygiene: handwashing, alcohol-based hand rub (ABHR), cough etiquette.

(b) Handling of clean and soiled linens.

(d) Personal protective equipment (PPE) use and disposal.

(e) What to do when a resident is found on the floor.

(f) Choking: abdominal thrusts.

(g) Fire safety.

(h) Initial steps/responding to a call light.

(i) Obtaining a temperature (all routes other than rectal), reporting/documentation.

(j) Making an unoccupied bed/handling of linens.

(k) Turning and repositioning the resident while in bed.

(l) Transfer from bed to chair/wheelchair/use of gait belt – one person standby/transfer.

(m) Assistance with dressing/undressing.

(n) Incontinence/perineal care.

(o) Assist to toilet/use of urinal (only for a resident requiring one person/standby assistance).

(p) Assistance with bathing/showering.

(q) Oral care – conscious residents only.

(r) Measuring Vital Signs.

(s) Basic care/interventions/devices.

(t) Offloading/floating heels.

(u) Nasal cannula/tubing/storage/observing liter flow.

History

Rulemaking Authority 400.141, 400.23 FS. Law Implemented 400.141, 400.211(2)(d), 400.23 FS. History–New 5-4-22, Amended 2-26-26.

Fla. Admin. Code R. 59A-4.109 Resident Assessment and Care Plan

(1) Each resident admitted to the nursing home facility must have a plan of care. The plan of care must consist of:

(a) Physician’s orders, diagnosis, medical history, physical exam and rehabilitative or restorative potential.

(b) A preliminary nursing evaluation with physician’s orders for immediate care, completed upon admission.

(c) A complete, comprehensive, accurate and reproducible assessment of each resident’s functional capacity which is standardized in the facility, and is completed within 14 days of the resident’s admission to the facility and every twelve months, thereafter. The assessment must be:

Reviewed no less than once every 3 months;
Reviewed promptly after a significant change, which is a need to stop a form of treatment because of adverse consequences (e.g., an adverse drug reaction), or commence a new form of treatment to deal with a problem, in the resident’s physical or mental condition; and,
Revised as appropriate to assure the continued accuracy of the assessment.

(2) The nursing home licensee develop a comprehensive care plan for each resident that includes measurable objectives and timetables to meet a resident’s medical, nursing, mental and psychosocial needs that are identified in the comprehensive assessment. The care plan must describe the services that are to be furnished to attain or maintain the resident’s highest practicable physical, mental and social well-being. The care plan must be completed within 7 days after completion of the resident assessment.

(3) At the resident’s option, every effort must be made to include the resident and family or responsible party, including private duty nurse or nursing assistant, in the development, implementation, maintenance and evaluation of the resident’s plan of care.

(4) All staff personnel who provide care, and at the resident’s option, private duty nurses or personnel who are not employees of the facility, must be knowledgeable of, and have access to, the resident’s plan of care.

(5) A summary of the resident’s plan of care and a copy of any advanced directives must accompany each resident discharged or transferred to another health care facility, licensed under Chapter 395 or 400, F.S., or must be forwarded to the receiving facility as soon as possible consistent with good medical practice.

History

Rulemaking Authority 400.23 FS. Law Implemented 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.109, Amended 4-18-94, 1-10-95, 12-21-15.

Fla. Admin. Code R. 59A-4.110 Food and Nutrition Services

(1) The Administrator must designate one full-time person as a Director of Food and Nutrition Services.

(2) The Director of Food and Nutrition Services must be a qualified dietitian licensed in the state of Florida under Chapter 468, Part X, F.S., or a person who meets the requirements in Title 42 Code of Federal Regulations (CFR) Section 483.60(a)(1) or (2), hereby adopted in this rule and available at: https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-483/subpart-B/section-483.60. If the Director of Food and Nutrition Services is not a qualified dietitian, the facility shall obtain consultation from a qualified dietitian. The qualified dietitian functions at a minimum include:

(a) Assessing the nutritional needs of residents;

(b) Developing and evaluating regular and therapeutic diets, including texture of foods and liquids, to meet the specilized needs of residents;

(c) Developing and implementing person-centered education programs involving food and nutrition services for all facility staff;

(d) Overseeing the budget and purchashing of food and supplies, and food preparation, service and storage; and

(e) Participating in the quality assurance program, when food and nutrition services are involved.

History

Rulemaking Authority 400.141, 400.23 FS. Law Implemented 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, 7-1-88, 7-10-91, Formerly 10D-29.110, Amended 4-18-94, 2-6-97, 12-21-15, 3-22-23.

Fla. Admin. Code R. 59A-4.111 Specialized Rehabilitative and Restorative Services

History

Rulemaking Authority 381.031(1)(g)7., 400.23 FS. Law Implemented 381.031, 400.022, 400.102, 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.111, Repealed 4-18-94.

Fla. Admin. Code R. 59A-4.112 Pharmacy Services

(1) The nursing home licensee must adopt procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals, to meet the needs of each resident.

(2) As required by the Department of Health, the facility shall employ, or obtain, the services of a state licensed consultant pharmacist. A consultant pharmacist is a pharmacist who is licensed by the Department of Health, Board of Pharmacy and registered as a consultant pharmacist by the Board of Pharmacy in accordance with Rules 64B16-26.300 and 64B16-28.501, F.A.C., and who provides consultation on all aspects of the provision of pharmacy services in the facility.

(3) The consultant pharmacist must establish a system to accurately record the receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation.

(4) The consultant pharmacist must determine that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled.

(5) Prescription drugs and biologicals used in the facility shall be labeled in accordance with currently accepted professional principles, Chapter 499, F.S., and Rules 64B16-28.108 and 64B16-28.502, F.A.C., as required by the Department of Health.

(6) Prescription drugs and non-prescription medications requiring refrigeration must be stored in a refrigerator. The refrigerator must be locked or located within a locked medication room and accessible only to licensed staff.

(7) All controlled substances must be disposed of as required by the Department of Health, Rule 64B16-28.303, F.A.C. All non-controlled substances may be destroyed in accordance with the facility’s policies and procedures. Records of the disposition of all substances shall be maintained in sufficient detail to enable an accurate reconciliation and a copy of the disposition must be filed in the resident’s record or maintained electronically in a readily accessible format.

(8) Non-controlled substances, in unit dose containers, may be returned to the dispensing pharmacy.

(9) If ordered by the resident’s physician, the resident or his or her representative may, upon discharge, take all current prescription drugs with him or her. An inventory list of the drugs released must be completed, shall be dated, and signed by both the person releasing the drugs and the person receiving the drugs, and must be placed in the resident’s record.

(10) The facility shall maintain an Emergency Medication Kit. The kit must contain a limited supply of medications in the facility for use during emergency or after-hours situations. The contents must be determined by the residents’ needs in consultation with the Medical Director, Director of Nursing and Pharmacist and it must be in accordance with facility policies and procedures. The kit must be readily available and kept sealed. All items in the kit must be properly labeled. The licensee must maintain an accurate log of receipt and disposition of each item in the Emergency Medication Kit. An inventory of the contents of the Emergency Medication Kit must be attached to the outside of the kit, which must include the earliest expiration date of the kit drugs. If the seal is broken, the kit must be restocked and resealed the next business day after use.

History

Rulemaking Authority 400.23, 400.142 FS. Law Implemented 400.141, 400.142, 400.23 FS. History–New 4-1-82, Amended 4-1-84, 7-10-91, Formerly 10D-29.112, Amended 4-18-94, 12-21-15.

Fla. Admin. Code R. 59A-4.113 Laboratory and Radiological Services

History

Rulemaking Authority 381.031(1)(g)7., 400.23, 400.0625 FS. Law Implemented 381.031, 400.022, 400.102, 400.141, 400.23, 290, 483 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.113, Repealed 4-18-94.

Fla. Admin. Code R. 59A-4.114 Dental Services

History

Rulemaking Authority 381.031(1)(g)7., 400.23 FS. Law Implemented 381.031, 400.022, 400.102, 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.114, Repealed 4-18-94.

Fla. Admin. Code R. 59A-4.115 Social Services

History

Rulemaking Authority 381.031(1)(g)7., 400.23 FS. Law Implemented 381.031, 400.022, 400.102, 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.115, Repealed 4-18-94.

Fla. Admin. Code R. 59A-4.116 Resident Activities

History

Rulemaking Authority 381.031(1)(g)7., 400.23 FS. Law Implemented 381.031, 400.022, 400.102, 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.116, Repealed 4-18-94.

Fla. Admin. Code R. 59A-4.117 Mental Health Services

History

Rulemaking Authority 381.031(1)(g)7., 400.23 FS. Law Implemented 381.031, 400.102, 400.23 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.117, Repealed 4-18-94.

Fla. Admin. Code R. 59A-4.118 Medical Records

(1) The licensee must designate a full-time employee as being responsible and accountable for the facility’s medical records.

(2) Each medical record must contain sufficient information to clearly identify the resident, his or her diagnosis and treatment, and results.

(3) Medical records must be retained for a period of five years from the date of discharge. In the case of a minor, the record must be retained for 3 years after a resident reaches legal age under state law.

History

Rulemaking Authority 400.23 FS. Law Implemented 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, 3-2-88, Formerly 10D-29.118, Amended 4-18-94, 12-21-15.

Fla. Admin. Code R. 59A-4.119 Fire Prevention, Fire Protection, and Life Safety

History

Rulemaking Authority 381.031(1)(g)7., 400.191(2), 400.23 FS. Law Implemented 381.031, 400.102, 400.141, 400.23, 633.05(8), 633.051 FS. History–New 4-1-82, Amended 4-1-84, 8-1-85, Formerly 10D-29.119, Transferred to 59A-4.130.

Fla. Admin. Code R. 59A-4.120 Plans Submission and Review

History

Rulemaking Authority 381.031(1)(g)7., 400.23 FS. Law Implemented 381.031, 400.102, 400.23 FS. History–New 4-1-82, Amended 4-1-84, 4-29-92, Formerly 10D-29.120, Transferred to 59A-4.133.

Fla. Admin. Code R. 59A-4.121 Coonstruction Standards

History

Rulemaking Authority 381.031(1)(g)7., 400.23 FS. Law Implemented 381.031, 400.011, 400.021, 400.022, 400.102, 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, 8-1-85, 7-21-87, Formerly 10D-29.121, Transferred to 59A-4.132.

Fla. Admin. Code R. 59A-4.122 Physical Environment and Physical Maintenance

(1) The licensee must provide a safe, clean, comfortable, and homelike environment, which allows the resident to use his or her personal belongings to the extent possible.

(2) The licensee must provide:

(a) Housekeeping and maintenance services necessary to maintain a sanitary, orderly, and comfortable interior;

(b) Clean bed and bath linens that are in good condition;

(d) Adequate and comfortable lighting levels in all areas;

(e) Comfortable and safe room temperature levels in accordance with 42 CFR, Section 483.15(h)(6), which is effective October 1, 2014, and is incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-15.xml and http://www.flrules.org/Gateway/reference.asp?No=Ref-06376; and,

(f) The maintenance of comfortable sound levels. Individual radios, TVs and other such transmitters belonging to the residentwill be tuned to stations of the resident’s choice.

(3) Each nursing home licensee must establish written policies designed to maintain the physical plant and overall nursing home environment to assure the safety and well-being of residents.

(4) The building and mechanical maintenance programs must be supervised by a person who is knowledgeable in the areas of building and mechanical maintenance as determined by the facility.

(5) All mechanical and electrical equipment must be maintained in working order and must be accessible for cleaning and inspection.

(6) All heating, ventilation and air conditioning (HVAC) systems must be maintained in accordance with the manufacturer’s recommendation to ensure they are operating within specified parameters to meet manufacturers’ specifications. Operation manuals and as-built drawings must be maintained for equipment installed after June 1, 2015.

History

Rulemaking Authority 400.23 FS. Law Implemented 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.122, Amended 4-18-94, 12-21-15.

Fla. Admin. Code R. 59A-4.123 Risk Management and Quality Assurance

(1) The facility shall maintain a risk management and quality assurance committee as required in Section 400.147, F.S.

(2) The facility shall use AHCA Form 3110-0009, Revised, January, 2002, October, 2001, “Confidential Nursing Home Initial Adverse Incident Report – 1 Day,” and AHCA Form 3110-0010, 3110-0010A, and 3110-0010B, Revised, January, 2002, “Confidential Nursing Home Complete Adverse Incident Report – 15 Day,” which are incorporated by reference when reporting events as stated in Section 400.147, F.S. These forms may be obtained from the Agency for Health Care Administration, Long Term Care Unit, 2727 Mahan Drive, MS #33, Tallahassee, FL 32308.

(3) Each facility shall use AHCA Form 3110-0008, Revised, October 2008, “Nursing Home Monthly Liability Claim Information”, which are incorporated by reference when reporting liability claims filed against it as required by Section 400.147(9), F.S. These forms may be obtained from the Agency for Health Care Administration, Long Term Care Unit, 2727 Mahan Drive, MS #33, Tallahassee, FL 32308.

History

Rulemaking Authority 400.147, 400.23 FS. Law Implemented 400.022, 400.102, 400.141, 400.147, 400.23 FS. History–New 4-1-82, Amended 9-5-82, 4-1-84, 8-1-85, 7-10-91, Formerly 10D-29.123, Amended 4-18-94, 5-5-02.

Fla. Admin. Code R. 59A-4.124 Housekeeping; Linen and Laundry

History

Rulemaking Authority 381.031(1)(g)7., 400.23 FS. Law Implemented 381.031, 400.102, 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.124, Repealed 4-18-94.

Fla. Admin. Code R. 59A-4.125 Vermin Control

History

Rulemaking Authority 381.031(1)(g)7., 400.23 FS. Law Implemented 381.031, 400.102, 400.141, 400.23, 482 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.125, Repealed 4-18-94.

Fla. Admin. Code R. 59A-4.126 Disaster Preparedness

(1) Each nursing home licensee must have a written plan with procedures to be followed in the event of an internal or externally caused disaster. The initiation, development, and maintenance of this plan is the responsibility of the facility administrator, and must be accomplished in consultation with the Division of Emergency Management, County Emergency Management Agency.

(2) The plan must include the following:

(a) Criteria as shown in Section 400.23(2)(g), F.S.; and,

(b) The Emergency Management Planning Criteria for Nursing Home Facilities, AHCA Form 3110-6006, April 2025, which is incorporated herein by reference and available at http://flrules.org/Gateway/reference.asp?No=Ref-18495 and from the Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop #24, Tallahassee, Florida 32308 or on the website at https://ahca.myflorida.com/health-quality-assurance/emergency-preparedness-resources.

(3) The facility must review and submit its emergency management plan on an annual basis and in accordance with section 408.821(1), F.S.

(4) A significant modification to a previously approved plan must be submitted within 30 days after the change. For the purpose of this rule, “significant modification” means a change to the information provided in support of the minimum required plan criteria, procedures, memorandums of understanding, contracts, or agreements identified in the plan, or appendices that alters the execution of the plan and the required arrangements made therein. Changes in spelling or grammar are not considered significant modifications for the purposes of this rule.

(a) Changes in the name, address, phone number, email address or position of staff identified in the plan are not considered significant modifications for the purpose of this rule. Changes to that information must be submitted to the county emergency management agency as part of the emergency management plan submitted annually.

(b) If a change to the emergency management plan is required to be submitted due to a significant modification, the change must be identified and described.

(c) A change to the emergency management plan due to a significant modification does not alter the annual review date unless the change is due to a change of ownership of the facility.

(5) If the licensee is advised by the county emergency management agency of necessary revisions to the plan, then those revisions must be made and the plan resubmitted to the county emergency management agency within 30 days of notification.

(6) The county emergency management agency shall be the final administrative authority for emergency plans developed by the nursing home licensee.

(7) The nursing home licensee must test the implementation of the emergency management plan annually, either in response to a disaster, an emergency, or in a planned drill. The outcome must be evaluated and documented and appropriate modifications to the plan to address deficiencies must be made within 30 days.

(8) The emergency management plan must be located in a designated area of the facility for immediate access by nursing home staff.

(9) If residents must be evacuated from the premises due to emergency conditions or a disaster, then the licensee must report the location and number of residents evacuated through an online database approved by the Agency to report information regarding the provider’s emergency status, planning or operations within 24 hours after the evacuation is complete. The administrator or designee is responsible for knowing the location of each resident until the resident has been discharged from the facility. The licensee must inform the appropriate Agency field office of a contact person(s) who will be available 24 hours a day, seven days a week, until the facility is reoccupied.

(10) A licensee may exceed its licensed capacity to act as a receiving facility in accordance with an emergency operations plan for residents of evacuating providers from geographic area where an evacuation order has been issued by a local authority having jurisdiction. While in an overcapacity status, each licensee must furnish or arrange for appropriate care and services including Fire/Life Safety Safeguards for all residents.

(11) The Agency must authorize requests for overcapacity which last in excess of 15 days. Approvals shall be based upon approved jurisdiction, need, and resident safety as provided by the receiving and sending facilities.

(12) If residents are evacuated from a nursing home during or after an emergency situation or disaster and there is no damage to the facility and all utilities and services are operating within normal parameters, the facility may be reoccupied and notice provided to the Agency within 24 hours of return to the facility. This notification may be through an online database approved by the Agency. However, if there has been water intrusion, interior damage, structural damage or if the facility is unable to operate under normal electrical power then a determination of whether or not the facility can be reoccupied must be made by the Agency. A determination may also require the review and approval from the local authority having jurisdiction. In those cases, the facility may not be occupied until all approvals are obtained.

(13) A facility with significant structural or systems damage must relocate residents out of the damaged facility until approval is received from the Agency’s Office of Plans and Construction to reoccupy the facility.

History

Rulemaking Authority 400.23, 408.821 FS. Law Implemented 400.23, 408.821 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.126, Amended 8-15-94, 12-21-15, 1-25-26, Technical Change 5-18-26.

Fla. Admin. Code R. 59A-4.1265 Emergency Environmental Control for Nursing Homes

(1) DETAILED NURSING HOME EMERGENCY POWER PLAN. Each nursing home shall prepare a detailed plan (“plan”), to serve as a supplement to its Comprehensive Emergency Management Plan, to address emergency power in the event of the loss of primary electrical power in that nursing home, which includes the following information:

(a) The acquisition of a sufficient alternate power source such as a generator(s), maintained at the nursing home, to ensure that current licensees of nursing homes will be equipped to ensure the protection of resident health, safety, welfare, and comfort for a minimum of ninety-six (96) hours in the event of the loss of primary electrical power. Safe indoor air temperatures in resident occupied areas shall be determined by the licensee to meet the clinical needs of residents, but shall not exceed eighty-one (81) degrees Fahrenheit.

Nursing Homes must comply with emergency power requirements outlined in Title 42 C.F.R. §483.90.
The required temperature must be maintained in an area or areas determined by the nursing home of sufficient size to maintain all residents safely at all times and is appropriate for the care needs and life safety requirements. For planning purposes, no less than thirty (30) net square feet per resident must be provided. This may include areas that are less than the entire nursing home if the nursing home’s comprehensive emergency management plan includes relocating residents to portions of the building where the health, safety, welfare, and comfort of the residents will be maintained as required by this rule. The plan shall include information regarding the area(s) within the nursing home where the required temperature will be maintained.
The alternate power source for the equipment necessary to maintain the safe indoor air temperature required by this rule may be provided by the essential electrical system required by the Florida Building Code for Nursing Home design and construction or onsite optional standby system as defined by NFPA 70 National Electrical Code supplying normal power to the nursing home maintained onsite at all times when the building is occupied. If an optional standby system is used, it must be connected and maintained in accordance with the manufacturer’s recommendations. The alternate power source and fuel supply shall be located in an area(s) in accordance with local zoning and the Florida Building Code.
Each nursing home is unique in size; the types of care provided; the physical and mental capabilities and needs of residents; the type, frequency, and amount of services and care offered; and staffing characteristics. Accordingly, this rule does not limit the types of systems or equipment that may be used to maintain the safe indoor air temperature required by this rule for a minimum of ninety-six (96) hours in the event of the loss of primary electrical power. The plan shall include information regarding the systems and equipment that will be used by the nursing home required to operate the systems and equipment.

a. A nursing home in an evacuation zone pursuant to Chapter 252, F.S., must maintain an alternative power source and fuel as required by this subsection at all times when the facility is occupied but is permitted to utilize a mobile generator(s) to enable portability if evacuation is necessary.

b. Facilities located on a single campus with other facilities licensed by the Agency under common ownership, may share fuel, alternative power resources, and resident space available on the campus if such resources are sufficient to support the requirements of each facility’s residents, as specified in this rule. Details regarding how resources will be shared and any necessary movement of residents must be clearly described in the emergency power plan.

c. A multistory facility, whose comprehensive emergency management plan is to move residents to a higher floor during a flood or surge event, must place its alternative power source and all necessary additional equipment so it can safely operate in a location protected from flooding or storm surge damage.

(b) The acquisition of sufficient fuel, and safe maintenance of that fuel onsite at the facility, to ensure that in the event of the loss of primary electrical power there is sufficient fuel available for the alternate power source required in paragraph (1)(a), to power life safety systems, critical systems, and equipment necessary to maintain safe indoor air temperatures as described in this rule for ninety-six (96) hours after the loss of electrical power during a declared state of emergency. The plan shall include information regarding fuel source and fuel storage.

A nursing home located in an area in a declared state of emergency area pursuant to Section 252.36, F.S., that may impact primary power delivery must secure ninety-six (96) hours of fuel. The nursing home may utilize portable fuel storage containers for the remaining fuel necessary for ninety-six (96) hours during the period of a declared state of emergency.
A nursing home must store a minimum of seventy-two (72) hours of fuel onsite.
Piped natural gas is an allowable fuel source and meets the onsite fuel requirement under this rule.
If county ordinances or other regulations that limit the amount of onsite fuel storage for the nursing home’s location and the nursing home does not have access to piped natural gas, then the nursing home must develop a plan that includes maximum onsite fuel storage allowable by the ordinance or regulation and a reliable method to obtain the maximum additional fuel at least 24 hours prior to depletion of onsite fuel.

(c) The acquisition of services necessary to install, maintain, and test the equipment and its functions to ensure the safe and sufficient operation of the alternate power source installed in the nursing home.

(2) SUBMISSION OF THE PLAN.

(a) Each new nursing home shall submit the plan required under this rule within 30 days after initial licensure or change of ownership.

(b) Each existing nursing home that undergoes additions, modifications, alterations, refurbishment, reconstruction or renovations that require modification of the systems or equipment affecting the nursing home’s compliance with this rule shall amend its plan and submit it to the county emergency management agency within 30 days after any significant modification for review and approval.

(3) PLAN REVIEW. Architectural and engineering plans are subject to review by the Agency’s Office of Plans and Construction. The county emergency management agency shall review the emergency power plan for compliance with the subsection and may rely on the technical review of the Office of Plans and Construction. Once the review is complete, the county emergency management agency shall:

(a) Report deficiencies in the plan to the nursing home for resolution. The nursing home must resubmit the plan within ten (10) business days.

(b) Report approval or denial of the plan to the Agency and the nursing home.

(4) APPROVED PLANS.

(a) Each nursing home must maintain a copy of its plan in a manner that makes the plan readily available at the licensee’s physical address for review by the authority having jurisdiction. If the plan is maintained in an electronic format, nursing home staff must be readily available to access and produce the plan. For purposes of this section, “readily available” means the ability to immediately produce the plan, either in electronic or paper format, upon request.

(b) Within 30 days of the approval of the plan from the county emergency management agency, the nursing home shall submit in writing proof of the approval to the Agency for Health Care Administration to ltcstaff@ahca.myflorida.com.

(c) The nursing home shall submit a consumer friendly summary of the emergency power plan to the Agency. The Agency shall post the summary and notice of the approval and implementation of the nursing home emergency power plans on its website within ten (10) business days of the plan’s approval by the county emergency management agency and update within ten (10) business days of implementation.

(5) POLICIES AND PROCEDURES.

(a) Each nursing home shall develop and implement written policies and procedures to ensure that each nursing home can effectively and immediately activate, operate and maintain the alternate power source and any fuel required for the operation of the alternate power source. The procedures shall be resident-focused to ensure that residents do not experience complications from heat exposure, and shall include a contingency plan to transport residents to a safe facility if the current nursing home’s plan to keep the residents in a safe and comfortable location within the nursing home at or below the indoor air temperature required by this rule becomes compromised.

(b) Each nursing home shall maintain its written policies and procedures in a manner that makes them readily available at the licensee’s physical address for review by the authority having jurisdiction. If the policies and procedures are maintained in an electronic format, nursing home staff must be readily available to access the policies and procedures and produce the requested information.

(c) The written policies and procedures must be readily available for inspection by each resident; each resident’s legal representative, designee, surrogate, guardian, attorney in fact, or case manager; each resident’s estate; and all parties authorized in writing or by law.

(6) REVOCATION OF LICENSE, FINES OR SANCTIONS. For a violation of any part of this rule, the Agency may seek any remedy authorized by Chapter 400, Part II, or Chapter 408, Part II, F.S., including but not limited to, license revocation, license suspension, and the imposition of administrative fines.

(7) COMPREHENSIVE EMERGENCY MANAGEMENT PLAN.

(a) Nursing homes whose comprehensive emergency management plan is to evacuate must comply with this rule.

(b) Once the plan has been approved, the nursing home shall submit the plan as an addendum with any future submissions for approval of its Comprehensive Emergency Management Plan.

(8) NOTIFICATION.

(a) Within three (3) business days, each nursing home must notify in writing, unless permission for electronic communication has been granted, each resident and the resident’s legal representative:

Upon submission of the plan to the local emergency management agency that the plan has been submitted for review and approval;
Upon final implementation of the plan by the nursing home following review by the State Fire Marshal or the Agency’s Office of Plans and Construction.

(b) The nursing home shall keep a copy of each written or electronic notification sent by the nursing home to the resident and resident’s representative on file.

History

Rulemaking Authority 400.23 FS. Law Implemented 400.23 FS. History–New 3-26-18, Amended 1-25-26.

Fla. Admin. Code R. 59A-4.127 Standards for Homes for Special Services

History

Rulemaking Authority 393.067, 400.23 FS. Law Implemented 393.067, 400.102, 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, Formerly 10D-29.127, Repealed 4-18-94.

Fla. Admin. Code R. 59A-4.128 Evaluation of Nursing Homes and Licensure Status

History

Rulemaking Authority 400.23 FS. Law Implemented 400.102, 400.19, 400.23 FS. History–New 4-1-82, Amended 4-1-84, 9-26-85, 7-21-87, Formerly 10D-29.128, Amended 8-15-94, 2-28-95, 10-13-96, 5-5-02, Repealed 11-15-15.

Fla. Admin. Code R. 59A-4.1282 Staff Education

History

Rulemaking Authority 400.23 FS. Law Implemented 400.102, 400.141, 400.23 FS. History–New 4-18-94, Amended 1-10-95, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.1285 Respite Services

History

Rulemaking Authority 400.011 FS. Law Implemented 400.141, 400.151 FS. History–New 7-21-87, Formerly 10D-29.1285, Amended 4-18-94, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.1287 Advance Directives

History

Rulemaking Authority 765.110 FS. Law Implemented 765.110 FS. History–New 1-11-93, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.1288 Exception

History

Rulemaking Authority 400.23 FS. Law Implemented 400.102, 400.141, 400.23 FS. History–New 4-18-94, Repealed 11-15-15.

Fla. Admin. Code R. 59A-4.129 Effective Date

History

Rulemaking Authority 400.23 FS. Law Implemented 381.031, 400.102, 400.23 FS. History–New 4-1-84, Formerly 10D-29.129, Repealed 4-18-94.

Fla. Admin. Code R. 59A-4.1295 Additional Standards for Homes That Admit Children 0 Through 20 Years of Age

(1) Nursing homes who accept children with a level of care of Intermediate I or II, skilled or medically fragile must meet the following standards as indicated. Intermediate I and II are defined in Rule 59G-4.180, F.A.C. Children considered skilled have a chronic debilitating disease or condition of one or more physiological or organ systems that generally make the child dependent upon 24 hour per day medical, nursing, or health supervision or intervention. Medically fragile children are medically complex and the medical condition is such that they are technologically dependent upon medical equipment or procedure(s) to sustain life and who can expire, without warning unless continually under observation.

(2) Each child must have an assessment upon admission by licensed physical, occupational, and speech therapists experienced in working with children. Therapies must be administered based upon the outcome of these assessments and the orders of the child’s physician.

(3) Admission criteria:

(a) The child must require intermediate, skilled or medically fragile nursing care, and be medically stable, as documented by the physician determining level of care.

(b) For nursing home placement a recommendation must be made in the form of a written order by the child’s attending physician in consultation with the parent(s) or legal guardian(s). For Medicaid certified nursing facilities, the recommendations for placement of a Medicaid applicant or recipient in the nursing home must be made by the Department of Health’s Children’s Medical Services Multidisciplinary Assessment Team (CMAT). Consideration must be given to relevant medical, emotional, psychosocial, and environmental factors.

(c) Each child admitted to the nursing home must have a plan of care developed by the interdisciplinary care plan team. The plan of care must consist of those items listed below.

Physician’s orders, diagnosis, medical history, physical examination and rehabilitative or restorative needs.
A preliminary nursing evaluation with physician orders for immediate care, completed on admission.
A comprehensive, accurate, reproducible, and standardized assessment of each child’s functional capability which is completed within 14 days of the child’s admission to the nursing home and every twelve months thereafter. The assessment must be:

a. Reviewed no less than once every 120 days;

b. Reviewed promptly after a significant change, which is a need to stop a form of treatment because of adverse consequences (e.g., an adverse drug reaction), or commence a new form of treatment to deal with a problem in the child’s physical or mental condition;

c. Revised as appropriate to assure the continued usefulness of the assessment.

The plan of care must also include measurable objectives and timetables to meet the child’s medical, nursing, mental and psychosocial needs identified in the comprehensive assessment. The care plan must describe the services that are to be furnished to attain or maintain the child’s highest practicable physical, mental, social and educational well-being. The care plan must be completed within 7 days after completion of the child’s assessments.
The facility must, upon admission and quarterly, conduct and include in the resident’s plan of care a comprehensive assessment of the resident’s functional capacity and a post-discharge plan of care that includes plans, actions and goals to transition the child to a home and community-based, non-institutional setting.
To enhance the quality of life of each child ages 3 years through 15 years, the nursing home must notify by certified mail the school board in the county in which the nursing home is located that there is a school-age child residing in the nursing home. Children ages 16 through 20 years may be enrolled in an education program according to their ability to participate. Program participation for each child regardless of age is predicated on his or her intellectual function, physical limitations, and medical stability. Collaborative planning with the public school system and community at-large is necessary to produce integrated and inclusive settings which meet each child’s needs. The failure or inability on the part of city, county, state, or federal school system to provide an educational program according to the child’s ability to participate shall not obligate the nursing home to supply or furnish an educational program or bring suit against any city, county, state, or federal organizations for their failure or inability to provide an educational program. Nothing contained herein is intended to prohibit, restrict or prevent the parents or legal guardian of the child from providing a private educational program that meets applicable state laws.
At the child’s guardian’s option, every effort must be made to include the child and his or her family or responsible party, including private duty nurse or nursing assistant, in the development, implementation, maintenance and evaluation of the child’s plan of care.
All employees of the nursing home who provide hands-on care, must be knowledgeable of, and have access to, the child’s plan of care.
A summary of the child’s plan of care must accompany each child discharged or transferred to another health care facility or must be forwarded to the facility receiving the child as soon as possible consistent with good medical practice.

(4) The child’s attending physician, licensed under rule Chapter 458 or 459, F.S., must maintain responsibility for the overall medical management and therapeutic plan of care and must be available for face-to-face consultation and collaboration with the nursing home medical and nursing director. The physician or his or her designee must:

(a) Evaluate and document the status of the child’s condition at least monthly;

(b) Review and update the plan of care every 60 days;

(d) Co-sign verbal orders no more than 72 hours after the order is given. Physician orders may be transmitted by facsimile machine. It is not necessary for a physician to re-sign a facsimile order when he or she visits a nursing home. Orders transmitted via computer mail are not acceptable. Verbal orders not co-signed within seventy-two (72) hours shall not be held against the nursing home if it has documented timely, good-faith efforts to obtain said co-signed orders.

(5) The following must be completed for each child. A registered nurse must be responsible for ensuring these tasks are accomplished:

(a) Informing the attending physician and medical director of beneficial and untoward effects of the therapeutic interventions;

(b) Maintaining the child’s record in accordance with nursing home policies and procedures; and,

(c) Instructing or arranging for the instruction of the parent(s), legal guardian(s), or other caretakers(s) on how to provide the necessary interventions, how to interpret responses to therapies, and how to manage unexpected responses in order to facilitate a smooth transition from the nursing home to the home or other placement. This instruction must cover care coordination and must gradually pass the role of care coordinator to the parent or legal guardian, as appropriate.

(6) In addition to the requirements of Rule 59A-4.133, F.A.C., the nursing home must provide the following:

(a) A minimum of 100 square feet in a single bedroom and 80 square feet per child in multiple bedrooms;

(b) Bathroom and bathing facilities appropriate to the child’s needs to allow for:

Toileting functions with privacy (a door to the bathroom must be provided); and,
Stall showers and tubs.

Encourage exploration and maximize the child’s capabilities;
Accommodate mobile and non-mobile children; and,
Support a range of activities for children and adolescents of varying ages and abilities.

(d) There must be an outdoor activity area that is:

Secure with areas of sun and shade;
Free of safety hazards; and,
Equipped with age appropriate recreational equipment for developmental level of children and has storage space for same.

(e) All furniture and adaptive equipment must be physically appropriate to the developmental and medical needs of the children;

(f) Other equipment and supplies must be made available to meet the needs of the children as prescribed or recommended by the attending physician or medical director and in accordance with professional standards of care.

(7) For those nursing homes who admit children age 0 through 15 years of age the following standards apply in addition to those above and throughout Chapter 59A-4, F.A.C.

(a) Each child must have an assessment upon admission by licensed physical, occupational, and speech therapists who are experienced in working with children. Therapies must be administered based upon the outcome of these assessments and the orders of the child’s physician.

(b) The nursing home must have a contract with a board certified pediatrician who serves as a consultant and liaison between the nursing home and the medical community for quality and appropriateness of services to children.

(c) The nursing home must essure that pediatric physicians are available for routine and emergency consultation to meet the children’s needs.

(d) The nursing home must ensure that children reside in distinct and separate units from adults.

(e) The nursing home must provide access to emergency and other forms of transportation for children.

(f) At least one licensed health care staff person with current Pediatric Advanced Life Support (PALS) certification for children must be on the unit where children are residing at all times.

(g) The nursing home must maintain an Emergency Medication Kit of pediatric medications, as well as adult dosages for those children who require adult doses. The contents in the Emergency Medication Kit must be determined by the children’s needs in consultation with the Medical Director, Director of Nursing, a registered nurse who has current experience working with children, and a Pharmacist who has pediatric expertise. The kit must be readily available and must be kept sealed. All items in the kit must be properly labeled. The nursing home must maintain an accurate log of receipt and disposition of each item in the Emergency Medication Kit. An inventory to include expiration dates of the contents of the Emergency Medication Kit must be attached to the outside of the kit. If the seal is broken, the kit must be restocked and resealed the next business day after use.

(h) Each nursing home must develop, implement, and maintain a written staff education plan which ensures a coordinated program for staff education for all nursing home employees who work with children. The plan must:

Be reviewed at least annually by the quality assurance committee and revised as needed.
Include both pre-service and in-service programs. In-service for each department must include pediatric-specific requirements as relevant to its discipline.
Ensure that education is conducted annually for all nursing home employees who work with children in the following areas:

a. Childhood diseases to include prevention and control of infection;

b. Childhood accident prevention and safety awareness programs; and,

Ensure that all employees of the nursing home complete an initial educational course on HIV and AIDS, preferably pediatric HIV and AIDS in accordance with Section 381.0035, F.S. If the employee does not have a certificate of completion at the time they are hired, they must have completed the course within six months of employment.

(i) All nursing home staff must receive in-service training in and demonstrate awareness of issues particular to pediatric residents annually.

(8) The nursing home must have at least one registered nurse for every 40 children. This registered nurse must be on duty, onsite, 24 hours per day on the unit where the children reside.

(9) A qualified dietitian with knowledge, expertise and experience in the nutritional management of medically involved children must evaluate the needs and special diet of each child at least every 60 days.

(10) The pharmacist must have access to appropriate knowledge concerning pediatric pharmaceutical procedures, i.e., total parenteral nutrition (TPN) infusion regime and be familiar with pediatric medications and dosages.

(11) The nursing home must maintain or contract as needed for pediatric dental services.

(12) Safety equipment, such as, child proof safety latches on closets, cabinets, straps on all seating services, locks on specific storage cabinets, bumper pads on cribs and car seats for transporting must be used whenever appropriate to ensure the safety of the child.

(13) Pediatric equipment and supplies must be available as follows:

(a) Suction machines, one per child requiring suction, plus one suction machine for emergency use;

(b) Oxygen, in portable tanks with age appropriate supplies;

(d) Spyhgmomanometers, stethoscopes, otoscopes; and,

(e) Apnea monitor and pulse oximeter.

(14) Other equipment and supplies must be made available to meet the needs of the children as prescribed or recommended by the attending physician or medical director and in accordance with professional standards of care.

(15) Prior to initiating or expanding services to pediatric residents, the nursing home licensee or applicant must receive written approval from the Agency. In order to convert existing nursing home beds to pediatric beds, nursing home licensees must:

(a) Have a standard license pursuant to Section 400.062, F.S.;

(b) Submit approval from the Office of Plans and Construction based upon submission of plans and specifications of the building for approval as outlined in Rule 59A-4.133, F.A.C.;

(c) Submit a completed Health Care Licensing Application, Nursing Homes, AHCA Form 3110-6001, as incorporated in Rule 59A-4.103, F.A.C., no less than 30 days prior to the anticipated date that services will be provided. The application must include the number and configuration of beds to be used to serve pediatric residents and a listing of services that will be provided.

(16) Approval to provide pediatric services shall be based upon demonstration of compliance with this rule and Chapter 400, Part II, F.S.

(17) Any changes in pediatric services, including cessation of services, must be reported to the Agency in writing at least 30 days prior to the change.

History

Rulemaking Authority 400.23(2), 408.819 FS. Law Implemented 400.23(5), 400.071, 408.806 FS. History–New 11-5-96, Amended 9-7-97, 12-4-16.

Fla. Admin. Code R. 59A-4.130 Fire Prevention, Fire Protection, and Life Safety, Systems Failure and External Emergency Communications

(1) Each nursing home licensee must provide fire protection through the elimination of fire hazards as evidenced by compliance with the fire codes adopted by the State Fire Marshall. The fire codes adopted by the State Fire Marshal for nursing homes is contained rule Chapter 69A-53, F.A.C., and is known as “Uniform Fire Safety Standards for Hospitals and Nursing Homes.”

(2) All fires or explosions shall be reported to the Agency’s Office of Plans and Construction by telephone at (850)412-4477 or by fax at (850)922-6483 by the next working day after the occurrence. The nursing home licensee shall complete and submit a Fire Incident Report, AHCA form 3500-0031, July 2014, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06023, to the Office of Plans and Construction and a copy to the appropriate Agency field office within 15 calendar days of the incident. All reports shall be complete and thorough and shall record the cause of the fire or explosion, the date and time of day it occurred, the location within the facility, how it was extinguished, any injuries which may have occurred and a description of the local fire department participation. The Fire Incident Report is available from the Agency for Health Care Administration, Office of Plans and Construction, 2727 Mahan Drive, Mail Stop #24, Tallahassee, Florida 32308 or at the web address: http://ahca.myflorida.com/plansandconstruction.

(3) If a system failure of the fire alarm system, smoke detection system, or sprinkler system occurs, the following actions shall be taken by the licensee:

(a) Immediately notify the local fire department and document the response and any instructions given by the local fire department.

(b) Notify the Agency’s Office of Plans and Construction and the appropriate Agency field office within one business day after the occurrence.

(c) Assess the extent of the condition, effect corrective action and document the estimated length of time for the corrective action. If the corrective action will take more than four hours, the following must be completed:

Implement a contingency plan to the facility fire plan containing a description of the problem, a specific description of the system failure, and the projected correction period. All staff on the shifts involved must have documented in-service training for the emergency contingency.
Begin a documented fire watch until the system is restored. Staff performing the fire watch must be trained in appropriate observations and actions, as well as be able to expeditiously contact the fire department. To maintain a fire watch, the licensee must utilize only certified public fire safety personnel, a security guard service, or facility staff. If facility staff are used for this function, they must meet the following criteria:

a. Be off duty from their regular facility position or assigned only to fire watch duty. The licensee must maintain compliance with direct care staffing requirements at all times;

b. Be trained and competent, as determined by the licensee, in the duties and responsibilities of a fire watch;

c. Have immediate access to two-way electronic communication.

If the projected correction period changes or the system is restored to normal operation, the licensee must notify the appropriate Agency’s field office and local fire authorities.

(4) External Emergency Communication. Each newly constructed facility that has not received a Preliminary Stage II Plan Approval from the Office of Plans and Construction by June 1, 2015, shall provide for external electronic communication not dependent on terrestrial telephone lines, cellular, radio, or microwave towers, such as an on-site radio transmitter, satellite communication systems or a written agreement with an amateur radio operator volunteer group. This agreement must provide for a volunteer operator and communication equipment to be relocated into the facility in the event of a disaster until communications are restored. Other methods that can be shown to maintain uninterrupted electronic communications not dependent on a land-based transmission must be approved by the Agency’s Office of Plans and Construction.

History

Rulemaking Authority 400.23 FS. Law Implemented 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, 8-1-85, Formerly 10D-29.119, 59A-4.119, Amended 12-21-15.

Fla. Admin. Code R. 59A-4.132 Construction Standards

History

Rulemaking Authority 381.031(1)(g)7., 400.23 FS. Law Implemented 381.031, 400.011, 400.021, 400.022, 400.102, 400.141, 400.23 FS. History–New 4-1-82, Amended 4-1-84, 8-1-85, 7-21-85, 7-21-87, Formerly 10D-29.121, 59A-4.121, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.133 Physical Plant Codes and Standards for Nursing Homes

(1) All construction of new nursing homes and all additions, alterations, refurbishing, renovations to and reconstruction of existing nursing homes shall be in compliance with the following codes and standards:

(a) The Florida Building Code (FBC) as adopted by the Florida Building Commission and incorporated by reference and obtainable from the International Code Council at www.iccsafe.org.

(b) The fire codes as adopted by the State Fire Marshall and described in Chapters 69A-53 and 69A-60, F.A.C., and incorporated herein by reference and obtainable from the National Fire Protection Association, 1 Batterymarch Park, P.O. Box 9101, Quincy, Massachusetts 02269-9101.

(2) No building shall be converted to a licensed nursing home unless it complies with the standards and codes set forth herein and with licensure requirements set forth in Chapter 400, Part II, F.S., and Chapter 59A-4, F.A.C.

(3) National Fire Protection Association (NFPA) 101A: Guide on Alternative approaches to Life Safety shall not be used to meet the required codes and standards for new construction or for conversion of newly licensed nursing homes.

(4) Where additions, modifications, alterations, refurbishing, renovations or reconstruction are undertaken within an existing facility, all such additions, modifications, alterations, refurbishing, renovations or reconstruction must comply with applicable sections of the codes for new facilities. Only that portion of the total facility affected by the project must comply with applicable sections of the referenced codes for new construction. Where existing major structural elements make total compliance impractical or impossible, the licensee or applicant for licensure may submit a request to the Office of Plans and Construction to utilize alternate materials, designs or methods which meet the intent of code provisions as permitted by the Florida Building Code.

(5) A licensed nursing home and any portion of a licensed nursing home that was reviewed and approved by the Agency for Health Care Administration prior to March 1, 2002, must be maintained in compliance with the requirements of this rule and the requirements of the NFPA 101 Life Safety code for Existing Health Care Occupancy, incorporated in Rule 69A-3.012, F.A.C., and the requirements of Tables I, II and III, effective March 1, 2002, which is incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06174 or at the web address at http://ahca.myflorida.com/plansandconstruction. The requirements in Table I identified by an asterisk do not apply.

(6) A licensed nursing home, and any portion of a licensed nursing home, that was reviewed and approved by the Agency for Health Care Administration after March 1, 2002, must be maintained in compliance with the requirements of the NFPA 101 Life Safety code for Existing Health Care Occupancies and the design requirements for Nursing Homes of the Florida Building Code in effect at the date of initial licensure.

(7) When a building or portion of a building is converted to a new licensed nursing home, it shall be in compliance with the requirements for a new nursing home set forth in subsection 59A-4.133(1), F.A.C. A change of ownership shall not constitute a change of occupancy.

(8) Other facilities or providers not owned or operated by the licensee of a nursing home may be fully integrated with the nursing home’s physical plant only after it has been successfully demonstrated to the Agency that all areas of the facility’s physical plant are designed and maintained in a manner that will ensure continued licensure compliance of the nursing home.

(9) All hazards to life and safety and all areas of noncompliance with applicable codes and regulations must be corrected in accordance with a plan of correction approved in advance by the Agency’s Office of Plans and Construction. Facility plans of correction will be approved only when the plan corrects all deficiencies or provides acceptable alternate systems, methods, or devises that provide equivalent or superior quality, strength, fire resistance, effectiveness, durability and safety as the requirements prescribed by code.

(10) Projects that have not received at least a Stage II Preliminary Plan approval from the Office of Plans and Construction by October 31, 2015, must conform to the requirements set forth in these rules.

History

Rulemaking Authority 400.23 FS. Law Implemented 400.23, 400.232 FS. History–New 4-1-82, Amended 4-1-84, 4-29-92, Formerly 10D-29.120, 59A-4.120, Amended 2-6-97, 10-21-99, 12-21-15.

Fla. Admin. Code R. 59A-4.134 Plans Submission and Fee Requirements

(1) No construction work, including demolition, shall be started until prior written approval has been provided by the Agency’s Office of Plans and Construction. This includes all construction of new facilities and all additions, modifications, alterations, renovations, and refurbishing to the site, facility, equipment or systems of all existing facilities.

(2) Approval to start construction only for demolition, site work, foundation, and building structural frame may be obtained prior to construction document approval when the following is submitted for review and approval:

(a) Preliminary Stage II approval letter from the Agency’s Office of Plans and Construction.

(b) Construction documents and specifications for all work to be undertaken.

(c) A life safety plan indicating temporary egress and detailed phasing plans indicating how the areas to be demolished or constructed are to be separated from all occupied areas when demolition or construction is in and around occupied buildings.

(3) Projects that have been submitted to the Agency for review will be considered abandoned and will be terminated after any of the following has occurred:

(a) Construction has not begun within one year after written approval of the construction documents from the Agency’s Office of Plans and Construction;

(b) No further plans have been submitted for Agency review within one year after a project has been initiated with the Agency’s Office of Plans and Construction;

(c) Construction has been halted for more than one year. After termination, resubmission as a new project will be required.

(4) When construction is planned, either for new buildings, additions, alterations or renovations to existing buildings, the plans and specifications must be prepared and submitted to the Agency’s Office of Plans and Construction for approval by a Florida registered architect and a Florida registered professional engineer. An architecture or engineering firm, not practicing as a sole proprietor, must provide proof of registration as an architecture or engineering firm with the Florida Department of Business and Professional Regulation.

(5) The initial submission of plans to the Agency’s Office of Plans and Construction for any new project must include a completed Application for Plan Review, AHCA Form 3500-0011, June 2014, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06024, and from the Agency for Health Care Administration, 2727 Mahan Drive, MS #24, Tallahassee, Florida 32308 or at the web address at http://ahca.myflorida.com/plansandconstruction, and a valid Certificate of Need or exemption as required by Sections 408.031 through 408.045, F.S. This information must accompany the initial submission. Approval will not be granted for any project without a Certificate of Need as required by Rule 59C-1.004, F.A.C.

(6) Plans and specifications submitted for review shall be subjected to plan review fees pursuant to Section 400.232, F.S. A non-refundable initial fee of $2,000 will be charged for all projects. The agency will also collect a fee, not to exceed 1 percent of the estimated construction cost or the actual cost of review, whichever is less, for the portion of the review which encompasses initial review through the initial revised construction document review. Additionally, the Agency will collect its actual costs on all subsequent portions of the review and construction inspections. All fees must be paid to the Agency for Health Care Administration, with notation of the Office of Plans and Construction facility log number and identified that it is for the Agency’s Health Care Trust Fund. Plan review fees must be included with the application.

(7) Plans and specifications may be submitted in three stages of development described in this rule. Approval of a Stage III submission is required to begin construction (except as permitted by subsection 59A-4.134(2), F.A.C.). These stages are as follows:

(a) Stage I, schematic plans.

(b) Stage II, preliminary plans or design development drawings.

(8) For each stage of submission, a program or scope of work must be submitted.

(9) For projects involving only equipment changes or system renovations, construction documents need to be submitted. These documents must include the following:

(a) Life safety plans showing the fire/smoke compartments in the area of renovation.

(b) Detailed phasing plans indicating how the new work will be separated from all occupied areas.

(10) Stage I, Schematic Plans – The following must be incorporated into the schematic plans:

(a) Single-line drawings of each floor that must show the relationship of the various activities or services to each other and each room arrangement. The function of each room or space must be noted in or near the room or space. The proposed roads and walkways, service and entrance courts, parking, and orientation must be shown on either a small plot plan or on the first floor plan. Provide a simple cross-section diagram showing the anticipated construction. Provide a schematic life safety plan showing smoke and fire compartments, exits, exit passageways and gross area of smoke and fire compartments. Provide information as to which areas have sprinklers, both new and existing.

(b) If the proposed construction is an addition or is otherwise related to existing buildings on the site, the schematic plans must show the facility and general arrangement of those other buildings.

(11) Stage II, Preliminary Plans – Stage II preliminary plans will be approved by the Agency upon successful demonstration that the construction will comply with applicable life safety code requirements, flood requirements and that the layout will accommodate all required functional space as evidenced by a thorough examination of the documents submitted as required by this subsection. Stage II preliminary plans must include:

(a) A vicinity map showing the major local highway intersections for new nursing home construction.

(b) Site development plans that:

Show existing grades and proposed improvement as required by the schematic submission.
Provide building locating dimensions.
Provide site elevations for both the 100 year flood elevations and hurricane category 3 surge inundation elevations if the project involves the construction of a new facility or is a new addition of a wing or floor to an existing facility.
Provide the location of the fire protection services water source to the building.

Floor plans, 1/8-inch scale minimum, showing door swings, windows, casework and millwork, fixed equipment and plumbing fixtures. Indicate the function of each space.
A large-scale plan of typical new bedrooms with tabulation of gross and net square footage of each bedroom. Tabulate the size of the bedroom window glass.
Typical large-scale interior and exterior wall sections to include typical rated fire and fire/smoke partitions and a typical corridor partition.
All exterior building elevations.
Equipment that is not included in the construction contract but that requires mechanical or electrical service connections or construction modifications must be identified to assure its coordination with the architectural, mechanical and electrical phases of construction.
If the project is located in an occupied facility, preliminary phasing plans indicating how the project is to be separated from all occupied areas.

(d) Life safety plans that include:

Single-sheet floor plans showing fire and smoke compartmentation, all means of egress and all exit signs. Additionally, depict and provide the dimension for the longest path of travel in each smoke compartment to the door(s) to the adjoining compartment, calculate the total area of the smoke compartment in square feet, and tabulate exit inches.
All sprinklered areas, fire extinguishers, fire alarm devices and pull station locations.
Fully developed life safety plans, if the project is an addition or conversion of an existing building.
Life safety plans of the floor being renovated and required exit egress floor(s) if the project is a renovation in an existing building.
When demolition or construction is to be undertaken in and around occupied buildings, a life safety plan indicating temporary egress and detailed phasing plans indicating how the areas to be demolished or constructed are to be separated from all occupied areas.

(e) Mechanical engineering plans that include:

Single-sheet floor plans with a one-line diagram of the ventilating system with relative pressures of each space. Provide a written description and drawings of the anticipated smoke control system, passive or active, and a sequence of operation correlated with the life safety plans.
The general location of all fire and smoke dampers, all duct smoke detectors and fire stats.
If the building is equipped with fire sprinklers, the location of the sprinkler system risers and the point of connection for the fire sprinkler system. State the method of design for the existing and new fire sprinkler systems.
The locations of all plumbing fixtures and other items of equipment requiring plumbing services and/or gas service.
The locations of any fume, radiological or chemical hoods.
The locations of all medical gas outlets, piping distribution risers, terminals, alarm panels, low pressure emergency oxygen connection, isolation/zone valves, and gas source locations.
The locations and relative size of major items of mechanical equipment such as chillers, air handling units, fire pumps, medical gas storage, boilers, vacuum pumps, air compressors and fuel storage vessels.
The locations of hazardous areas and the volume of products to be contained therein.
The location of fire pump, stand pipes, and sprinkler risers.

(f) Electrical engineering drawings that include:

A one-line diagram of normal and essential electrical power systems showing service transformers and entrances, switchboards, transfer switches, distribution feeders and over-current devices, panel boards and step-down transformers. The diagram must include a preliminary listing and description of new and existing, normal and emergency loads, preliminary estimates of available short-circuit current at all new equipment and existing equipment serving any new equipment, short-circuit and withstand ratings of existing equipment serving new loads and any new or revised grounding requirements.
Fire alarm zones and correlate with the life safety plan.

(g) Outline specifications are to include a general description of the construction, including construction classification and ratings of components, interior finishes, general types and locations of acoustical material, floor coverings, electrical equipment, ventilating equipment and plumbing fixtures, fire protection equipment, and medical gas equipment.

(h) Whenever an existing building is to be converted to a health care facility, the general layout of spaces of the existing structure must be submitted with the preliminary plans for the proposed facility.

(i) Whenever additions, modifications, alterations, renovations, and refurbishing to an existing building are proposed, the general layout of spaces of the existing facility must be submitted with the preliminary plans.

(12) Stage III, Construction Documents – The Stage III construction documents shall be an extension of the Stage II preliminary plan submission and shall provide a complete description of the contemplated construction. Stage III construction documents will be approved by the Agency upon successful demonstration that the construction will comply with all applicable codes and standards as evidenced by a thorough examination of the documents submitted as required by this subsection. Construction documents shall be signed, sealed, dated and submitted for written approval to the Agency’s Office of Plans and Construction submitted by a Florida registered architect and Florida registered professional engineer. An architecture or engineering firm, not practicing as a sole proprietor, must provide proof of registration as an architecture or engineering firm with the Florida Department of Business and Professional Regulation. The documents must consist of work related to civil, structural, mechanical, and electrical engineering, fire protection, lightning protection, landscape architecture and all architectural work. In addition to the requirements for Stage II submission, the following must be incorporated into the construction documents:

(a) Site and civil engineering plans that indicate building and site elevations, site utilities, paving plans, grading and drainage plans and details, locations of the two fire hydrants utilized to perform the water supply flow test, and landscaping plans.

(b) Life safety plans for the entire project.

Typical large-scale details of all typical interior and exterior walls and smoke walls, horizontal exist and exit passageways.
Comprehensive ceiling plans that show all utilities, lighting fixtures, smoke detectors, ventilation devices, sprinkler head locations and fire-rated ceiling suspension member locations where applicable.
Floor/ceiling and roof/ceiling assembly descriptions for all conditions.
Details and other instructions to the contract on the construction documents describing the techniques to be used to seal floor construction penetrations to the extent necessary to prevent smoke migration from floor to floor during a fire.

(d) Structural engineering plans, schedules and details.

(e) Mechanical engineering plans to include fire and smoke control plans. Show all items of owner furnished equipment requiring mechanical services. Provide a clear and concise narrative control sequence of operations for each item of mechanical equipment including: air conditioning, heating, ventilation, medical gas, plumbing, and fire protection and any interconnection of the equipment of the systems. Mechanical engineering drawings must depict completely the systems to be utilized, whether new or existing, from the point of system origination to its termination. Provide a tubular schedule giving the required air flow (as computed from the information contained on the ventilation rate table) in cubic feet per minute (cfm) for supply, return, exhaust, outdoor, and ventilation air for each space listed or referenced by note on the ventilation rate table as shown on the architectural documents. The schedule must also contain the Heating Ventilation and Air Conditioning (HVAC) system design air flow rates and the resulting space relative pressures. The schedule or portion of the schedule, as applicable, must be placed in the specifications or in the drawing set containing the spaces depicted.

(f) Fire protection plans, where applicable, that must include the existing system as necessary to define the new work.

(g) Electrical engineering plans that must describe complete power, lighting, alarm, communications and lightning protection systems and power system study.

(h) A power study that must include a fault study complete with calculations to demonstrate that over-current devices, transfer switches, switchboards, panel boards, motor controls, transformers and feeders are adequately sized to safely withstand available phase-to-phase and phase-to-ground faults. The study must also include an analysis of generator performance under fault conditions and a coordination study resulting in the tabulation of settings for all over-current device adjustable trips, time delays, relays and ground fault coordination. This must be provided for all new equipment and existing equipment serving any new equipment. Power studies for renovations of existing distribution systems must include only new equipment and existing equipment upstream to the normal and emergency sources of the new equipment. Renovations involving only branch circuit panel boards without modifications to the feeder will not require a full power study; instead, the power study will be limited to the calculation of new and existing loads of the branch circuit panel.

(i) A complete set of specifications of all work to be undertaken.

All project required contractor supplied testing and/or certification reports must be submitted in type written format, on standard forms, reviewed and accepted by the Engineer of Record prior to presenting to the Agency for review.
The specifications must require a performance verification test and balance air quality value report for two operating conditions for each air handling unit system. One operating condition must be with the specified air filters installed in the minimum pressure drop or clean state. The second operating condition must be at the maximum pressure drop and/or dirty state. The air quantities reported are acceptable if they are within ten percent of the design value and the space relative pressures are maintained. This requirement applies to any air-handling unit affected by the construction to be performed.

(j) Well-coordinated construction documents. In the case of additions to existing institutions, the mechanical and electrical, especially existing essential electrical systems and all other pertinent conditions must be a part of this submission.

(k) Signed, sealed and dated subsequent addenda, change orders, field orders and other documents altering the above must be submitted for review to the Agency’s Office of Plans and Construction. The Agency will either approve or disapprove the submission based on compliance with all applicable codes and standards and will provide a listing of deficiencies in writing.

(13) Initial submissions will be acted upon by the Agency within 60 days of the receipt of the initial payment of the plan review fee. The Agency will either approve or disapprove the submission and will provide a listing of deficiencies in writing. Each subsequent resubmission of documents for review on the project will initiate another 60-day response period. All deficiencies noted by the Agency must be satisfactorily corrected before final construction approval can be obtained for the project from the Agency.

(14) Additions that increase the scope of the project by greater than fifty percent or revisions that change greater than fifity percent of the original scope of a project will be required to be submitted as a new project.

(15) Within 60 days after final approval of the project has been obtained from the Agency, the licensee and the Agency’s Office of Plans and Construction must be provided with a complete set of record drawings electronically submitted as Portable Document Format (.pdf) files showing all of the construction, fixed equipment and the mechanical and electrical systems as installed. These electronically submitted .pdf files must include the life safety plans of the facility.

History

Rulemaking Authority 400.23 FS. Law Implemented 400.141, 400.232 FS. History–New 12-21-15.

Fla. Admin. Code R. 59A-4.150 Geriatric Outpatient Clinic

(1) Definitions:

(a) Appropriate Resources – those service providers who provide most effectively and efficiently the specific services needed by the geriatric patient.

(b) Geriatric Outpatient Clinic – a site in a nursing home treatment room for the provision of health care to geriatric patients on an outpatient basis which is staffed by a registered nurse or by a physician’s assistant or a licensed practical nurse under the direct supervision of a registered nurse, advanced practice registered nurse (APRN), physical assistant or a physician.

(d) Pre-established Protocols – a statement prepared by or with the responsible or attending physician and/or physician assistant and advanced practice registered nurse (APRN) defining the extent and limits of the medical services provided by the nurse. Such protocols are to be reviewed at periods not to exceed one year, to be dated and signed by the physician, and to be kept readily available.

(e) Responsible Physician – the licensed physician delegated by the supervising physician as responsible for the services rendered by the registered nurse, physician’s assistant, advanced practice registered nurse (APRN) or a licensed practical nurse under the direct supervision of a registered nurse, advanced practice registered nurse (APRN), physician assistant or a physician in the absence of the supervising physician.

(f) Routine Health Care – preventive care, detection of health problems, referral for medical care, and management of chronic illness within medical prescriptions.

(g) Substantive Change – a change in the patient’s condition indicating the need for change in treatment and/or medication orders.

(h) Supervising Physician – the licensed physician assuming responsibility and legal liability for the services rendered by the registered nurse, physician’s assistant, advanced practice registered nurse (APRN) or a licensed practical nurse under the direct supervision of a registered nurse, advanced practice registered nurse (APRN), physician assistant or a physician. (Sections 458.135(2)(e), and 459.151(2), (3), F.S.)

(i) Treatment Room – the room or suite of rooms set aside for the examination and care of patients.

(2) Applications.

(a) The nursing home licensee must submit a letter to the Agency for Health Care Administration, Long-Term Care Unit, 2727 Mahan Drive, Mail Stop #33, Tallahassee, FL 32308, stating intent to establish a geriatric outpatient clinic in compliance with Chapter 400, F.S., and this rule. Such notice may also be provided at the time of initial licensure or licensure renewal. This letter must be sent at least sixty (60) days prior to the anticipated date of the establishment of the clinic.

(b) The licensee must be compliant with Chapter 400, Part II, Chapter 408, Part II, F.S. this rule chapter and Florida Building Code during an inspection by the Agency.

(c) Receipt of the letter of notification stating compliance shall constitute authority to operate a geriatric outpatient clinic within the facility.

(d) Application for renewal of authority to operate a geriatric outpatient clinic must be submitted in the manner described above at the same time the application for the nursing home licensure renewal is submitted.

(e) Suspension or revocation of the nursing home license automatically suspends or revokes authority to operate the geriatric outpatient clinic.

(3) Treatment Rooms and Access Areas.

(a) Plant maintenance and housekeeping must be in accordance with Rule 59A-4.122, F.A.C.

(b) Every nursing home licensee conducting a geriatric outpatient clinic must:

Use an existing treatment room exclusively for the examination and treatment of patients.
Store supplies and equipment in such a manner that safeguards patients and staff from hazards.
Have a waiting area which does not interfere with regular in-patient functions.
Provide clinic patients with the most direct route to and from the treatment room.

(4) Administration.

(a) The business and administrative management of the geriatric outpatient clinic must be under the management control of the nursing home administrator. This must include, maintenance of the following written records;

An accident and incident record, containing a clear description of each accident and any other incident hazardous or deviant behavior of a patient or staff member with names of individuals involved, description of medical and other services provided, by whom such services were provided and the steps taken to prevent recurrence.
Personnel records for each clinic employee and/or contractual provider. Employees of a geriatric outpatient clinic must have a Level 2 background screening as required in Section 408.809, and Chapter 435, F.S. These records must be kept updated and include current Florida license and certificate numbers. The original application for the position, references furnished and an annual performance evaluation must be included.
A record of personnel policies, including statement of policies affecting personnel and a job description for each person providing clinic services.
Clinic Schedule.
Compliance with the requirements of Title VI of the Civil Rights Act of 1964, §2000, effective date July 2, 1964, is incorporated herein by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-06377 and http://www.gpo.gov/fdsys/pkg/USCODE-2008-title42/html/USCODE-2008-title42-chap21-subchapV.htm.

(b) The provision of health services through geriatric outpatient clinics must be under the direct management control of the registered nurse, physician’s assistant or a licensed practical nurse under the direct supervision of a registered nurse, advanced practice registered nurse (APRN), physician assistant or physician, providing those services. The licensee must oversee the provision of health services to ensure all health services are provided to protect the health, safety and well-being of the patients. The licensee must also:

Maintain the confidentiality of clinical records for each patient as required in this rule, Sections 400.022(m) and 400.0222, F.S., Title 42 Code of Federal Regulation §483.10, effective October 1, 2003, Title 45 Code of Federal Regulation Chapters 160, 162 and 164 with an effective date of August 14, 2002, which is incorporated by reference and available at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=%2Findex.tpl.
Develop and periodically review the written policies and protocols governing patient care, including emergency procedures.
Develop and periodically review the patient referral system.
Administer and handle drugs and biological as required in this rule, Chapter 400 Part II, F.S., Title 42 C.F.R. §§483.25(1) and 483.25(m), effective October 1, 2014 and incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-25.xml and at http://www.flrules.org/Gateway/reference.asp?No=Ref-06378; and 42 C.F.R. §483.60, effective October 1, 2014, which is incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-60.xml and http://www.flrules.org/Gateway/reference.asp?No=Ref-06379.
Maintain an individual and cumulative clinic census record.
Coordinate patient care with the attending physician and other community health and social agencies and/or facilities.
Maintain a safe and sanitary clinic environment.

(5) Fiscal Management.

(a) There must be a recognized system of accounting used to accurately reflect business details of the clinic operation, documentation of all transactions and services kept separate from the nursing home’s fiscal records.

(b) A reasonable fee, based on cost of operation and services, may be charged for clinic services rendered.

Pay any commission, bonus, rebate or gratuity to any organization, agency, physician, employee or other person for referral of any patients to the clinic.
Request or accept any remuneration, rebate, gift, benefit, or advantage of any form from any vendor or other supplier because of the purchase, rental, or loan, of equipment, supplies or services for the resident and/or patient.

(6) Personnel Policies.

(a) Staff in the geriatric outpatient nurse clinic must be governed by the personnel standards in this rule, Section 400.141, F.S., Title 42 Code of Federal Regulation §483.75, effective October 1, 2014, and incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-75.xml and http://www.flrules.org/Gateway/reference.asp?No=Ref-06382, 42 C.F.R. §483.30, effective October 1, 2014, which is incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-30.xml and http://www.flrules.org/Gateway/reference.asp?No=Ref-06383.

(b) Staff in the geriatric outpatient clinic must be qualified and sufficient in numbers to perform the necessary services.

(d) Staff in the geriatric outpatient clinic may be regularly employed or serve on a contractual basis.

(7) Personnel Functions and Responsibilities.

(a) The registered nurse, advanced practice registered nurse (APRN), physician assistant or a licensed practical nurse under the direct supervision of a registered nurse, APRN, physician assistant or physician staffing the geriatric outpatient clinic must:

(b) Be responsible for eliciting and recording a health history, observation and assessment nursing diagnosis, counseling and health teaching of patients and the maintenance of health and prevention of illness.

(d) Note findings and activities on the clinical record.

(e) Provide progress reports to the attending physicians about patients under the physician’s care when there is a substantive change in the patient’s condition, there are deviations from the plan of care, or at least every sixty (60) days.

(8) Patient Eligibility Criteria.

(a) Acceptance of patients and discharge policies must include the following:

(b) Patients must be accepted for clinic services on self-referral for nursing care, or upon a plan of treatment established by the patient’s attending physician.

(c) Patients with an attending physician will be held responsible for providing the clinic with a written medical plan of treatment reviewed and signed by their physician.

(d) When services are to be terminated, the patient must be notified of the date of termination and the reason for termination which shall be documented in the patient’s clinical record. A plan shall be developed for a referral made for any continuing care required.

(9) Patient’s Rights.

(a) The nursing home licensee must adopt, implement and make public a statement of the rights and responsibilities of the clinic patients and must treat such patients in accordance with the provisions of the statement. This statement must be conspicuously posted and available to clinic patients in pamphlet form. The statement must ensure each patient the following:

The right to have private communication with any person of his or her choice.
The right to present grievances on behalf of himself, herself, or others to the facility’s staff or administrator, to government officials, or to any person without fear of reprisal, and to join with other patients or individuals to work for improvements in patient care.
The right to be fully informed in writing, prior to or at the time of admission and during his or her attendance, of fees and services not covered under Title XVIII or Title XIX of the Social Security Act or other third party reimbursement agents.
The right to be adequately informed of his or her medical condition and proposed treatment unless otherwise indicated in the written medical plan of treatment by the physician, and to participate in the planning of all medical treatment, including the right to refuse medication and treatment, unless otherwise indicated in the written medical plan of treatment by the physician, and to know the consequences of such actions.
The right to receive adequate and appropriate health care consistent with established and recognized practice standards within the community and with the rules promulgated by the Agency.
The right to have privacy in treatment and in caring for personal needs and confidentiality of personal and medical records.
The right to be treated courteously, fairly, and with the fullest measure of dignity and to receive a written statement of the services provided by the nursing home licensee.

(b) Any violation of the patient’s rights set forth in this section shall constitute grounds for action by the Agency under the provisions of Section 400.102, F.S.

(10) The scope of services of the Geriatric Outpatient Clinic must include:

(a) Observation of signs and symptoms.

(b) Assessment of health status/progress.

(d) Nursing care of patients and counseling to maintain health and prevent disease, including diet counseling.

(e) Health instruction to control progression of disease and/or disability and self-care measures.

(f) Administration of medication and treatment as prescribed by a person licensed in this state to prescribe such medications and treatment.

(g) Provision of progress reports to the attending physician.

(h) Referral for additional services as needed.

(i) Follow-up on a regular basis by communication with the patient, the patient’s physician, and other agencies or persons to which referrals were made.

(j) When staffed by an APRN or physician’s assistant, additional services may be provided dependent upon their respective certification authority. (Sections 458.347 and 459.022, F.S.)

(11) Clinical Records.

(a) The clinic must maintain a clinical record for every patient receiving health services that contain the following:

Identification data including name, address, telephone number, date of birth, sex, social security number, clinic case number if used, next of kin or guardian and telephone number, name and telephone number of patient’s attending physician.
Assessment of problems.
A health care plan including diagnoses, type, and frequency of services and when receiving medications and medical treatments, the medical treatment plan and dated signature of the physician or designee licensed in this state to prescribe such medications and treatments.
Clinical notes, signed and dated by staff providing service.

a. Progress notes with changes in the patient’s condition.

b. Services rendered with progress reports.

c. Observations.

d. Instructions to the patient and family.

e. Referrals made.

f. Consultation reports.

g. Case conferences.

h. Reports to physicians.

i. Termination summary which must include:

(I) Date of first and last visit.

(II) Total number of visits by discipline.

(III) Reason for termination of service.

(IV) Evaluation of achievements of previously established goals at time of termination.

(V) Condition of patient on discharge.

j. Clinical records must be confidential. Information may be released by the nurse, APRN or physician’s assistant responsible for clinical services only in accordance with state and federal regulations related to patient records and confidentiality.

(12) Medications. The clinic shall have policies and procedures for the administration of medications by health care professionals acting within the scope of practice defined by the Department of Health, Chapter 464, Part I, F.S., and Rule 64B9-15.002, F.A.C., which must include the following:

(a) All prescriptions for medications must be noted on the patient record, and include the date, drug, dosage, frequency, method or site of administration, and the authorized health care professional’s signature.

(b) All verbal orders for medication or medication changes must be taken by the clinic registered nurse, APRN or physician’s assistant. Such must be in writing and signed by the authorized health care professional within eight (8) days and added to the patient’s record.

(c) The clinic registered nurse, APRN or physician’s assistant must record and sign for each medication administrated by drug, dosage, method, time and site on patient’s record.

(d) An emergency plan for reversal of drug reaction to include the nursing licensee’s pro re nata (P.R.N.) or “as needed” standing orders for medications available in the emergency drug kit.

(e) If there is not a separate emergency drug kit in the clinic, the nursing home licensee’s emergency drug kit must be immediately accessible for use in the outpatient clinic.

(f) A drug storage system which includes:

Prescribed medications for individual outpatients may be retained in the clinic. These medications must be stored separately from those of the nursing home in-patients for preventive measures and the treatment of minor illnesses.
Multi-dose containers must be limited to medications or biologicals commonly prescribed for preventive measures and the treatment of minor illnesses.
A list must be kept of patients receiving medication from multi-dose medication containers.

History

Rulemaking Authority 400.141, 400.23 FS. Law Implemented 400.141 FS. History–New 4-27-78, Formerly 10D-29.71, 10D-29.071, 59A-4.071, Amended 2-6-97, 12-21-15.

Fla. Admin. Code R. 59A-4.151 Definitions

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented 77-401, Sections 1, 2, 3, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.72, 10D-4.72, 59A-4.072, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.152 Application

History

Rulemaking Authority 381.031(1)(g)7., 11., 381.493-382.497, 400.141(3), 400.23(2) FS. Law Implemented 77-401, Sections 1, 2, 3, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Amended 8-28-78, Formerly 10D-29.73, 10D-4.073, 59A-4.073, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.153 Treatment Rooms and Access Areas

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented 77-401, Sections 1, 2, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.74, 10D-4.074, 59A-4.074, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.154 Administration

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented 77-401, Sections 1, 2, 3, 4, 5, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.75, 10D-4.075, 59A-4.075, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.155 Fiscal Management

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented 77-401, Sections 1, 2, 3, 4, 5, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.76, 10D-4.076, 59A-4.076, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.156 Personnel Policies

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented 77-401, Sections 1, 2, 3, 5, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.77, 10D-4.077, 59A-4.077, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.157 Personnel Functions and Responsibilities

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented 77-401, Sections 1, 2, 3, 5, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.78, 10D-4.078, 59A-4.078, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.158 Patient Eligibility Criteria

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented 77-401, Sections 1, 2, 5, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.79, 10D-4.079, 59A-4.079, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.159 Patient Rights

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented 77-401, Sections 1, 2, 5, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.80, 10D-4.080, 59A-4.080, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.160 Scope of Services

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented 77-401, Sections 1, 3, 5, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.81, 10D-4.081, 59A-4.081, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.161 Clinical Records

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented 77-401, Sections 1, 3, 5, Laws of Florida, 400.23(2), 405.01-.03 FS. History–New 4-27-78, Formerly 10D-29.82, 10D-4.082, 59A-4.082, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.162 Medications

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented 77-401, Sections 1, 3, 5, Laws of Florida, 400.23(2), 464.012 FS. History–New 4-27-78, Formerly 10D-29.83, 10D-4.083, Amended 10-5-92, Formerly 59A-4.083, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.163 Right of Inspection

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented 77-401, Sections 1, 3, 5, Laws of Florida, 400.23(2) FS. History–New 4-27-78, Formerly 10D-29.84, 10D-4.084, 59A-4.084, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.164 Patient Protection Trust Fund

History

Rulemaking Authority 381.031(1)(g)7., 11., 400.141(3), 400.23(2) FS. Law Implemented 400.063, 400.162, 400.23 FS. History–New 4-6-80, Formerly 10D-29.86, 10D-4.086, 59A-4.086, Repealed 2-6-97.

Fla. Admin. Code R. 59A-4.165 Nursing Home Guide

(1) Pursuant to Section 400.191 F.S., the Agency shall publish the Nursing Home Guide quarterly in electronic form to assist consumers and their families in comparing and evaluating nursing home facilities. The Nursing Home Guide or “Guide,” is available on the web at http://www.floridahealthfinder.gov/LandingPages/NursingHomeGuide.aspx.

(2) The electronic Guide shall include the following:

(a) The ability to search for a nursing home;

(b) General guidance about when a nursing home is the appropriate choice of care;

(d) Contact information such as phone numbers and web sites where questions can be answered, and further information can be obtained.

(e) A listing of all nursing home facilities in the State of Florida, including hospital based skilled nursing units. This listing shall include for each nursing home the following:

Name;
Address;
Telephone numbers;
Web address of facility;
A recognition if the nursing home licensee has been awarded a Gold Seal;
The current licensee;
Which calendar year the current licensee became the licensee;
Whether the licensee is a for-profit, or non-profit entity, and whether or not the nursing home is part of a retirement community;
Any corporate or religious affiliations;
The number of private, semi-private, and total beds at the nursing home;
The lowest daily charge for a semi-private room;
The payment forms accepted;
Any special services or amenities, or recreational programs provided;
Any non-English languages spoken by the administrator or staff of the nursing home.

(f) Details of each deficiency the nursing home has been cited for over the time period specified in Section 400.191, F.S.

(3) The format of the published Guide is shown in the Nursing Home Guide Methodology, which is located on the web at http://www.floridahealthfinder.gov/Comparecare/MethodologyNH.aspx.

(4) The Guide will employ a procedure for summarizing the deficiencies as follows:

(a) All deficiencies cited over the most recently available time period as specified in Section 400.191, F.S., prior to the publication of the Guide will be collected.

(b) Each citation will be assigned points based on the type of deficiency and its assigned severity and scope. For those nursing homes that are not federally certified, each citation will be assigned points based on the type of deficiency and its assigned class. Nursing homes that are federally certified have their deficiencies cited using federal F-Tags and K-Tags. Nursing homes that are not federally certified have their deficiencies cited using state N-Tags and K-Tags. For the non-federally certified nursing homes, each cited state N-Tag or K-Tag shall be reviewed by the Agency to determine which federal F-Tag or K-Tag the state tag is equivalent to. The points assigned to a state tag N-Tag or K-Tag shall be those that would be assigned to the equivalent federal F-Tag or K-Tag, if the nursing home were federally certified.

(c) A score for a nursing home will be computed by summing the points of all of its citations, and then dividing this sum by the number of recertification surveys conducted during the period as in paragraph (a) above. For those facilities that are not federally certified, the number of surveys will be used in place of the number of recertification surveys. For current non-federally certified nursing homes that become federally-certified nursing homes, a combination of the non-federally certified citation score and the federally-certified citation score will be utilized.

(d) For federally certified nursing homes, the above computations will reflect any changes resulting from the Informal Dispute Resolution process, or administrative or appellate proceedings; inasmuch as the federal Centers for Medicare and Medicaid Services concurs with such changes.

(e) The scores for the freestanding nursing homes will be ranked within each region. The regions are defined in the Nursing Home Guide Methodology.

(f) These ranks shall be presented numerically or symbolically in the Guide.

(g) Paragraphs (b) through (f) shall be repeated for Components of Inspection which are subsets of the citations. Components of inspection are discussed in the Nursing Home Guide Methodology. The subsetting of the tags for non-certified nursing homes shall be accomplished by using the equivalent federal F-Tags and K-tags.

History

Rulemaking Authority 400.191 FS. Law Implemented 400.191 FS. History–New 2-15-01, Amended 12-21-15.

Fla. Admin. Code R. 59A-4.166 Nursing Home Consumer Satisfaction Survey

History

Rulemaking Authority 400.0225 FS. Law Implemented 400.0225 FS. History–New 2-15-01, Repealed 5-15-12.

Fla. Admin. Code R. 59A-4.167 Consumer Satisfaction Survey

(1) Pursuant to s. 400.0225, F.S., the Agency is required to specify the protocols for conducting the consumer satisfaction surveys. Each nursing home facility shall use a vendor recognized by CoreQ to administer and upload survey data for the nursing home consumer satisfaction survey. As defined in s. 400.021(12), F.S., “nursing home facility” means any facility which provides nursing services as defined in part I of chapter 464 and which is licensed according to this part.

(2) Survey Reporting Period. The annual nursing home consumer satisfaction survey reporting period opens on March 1st and closes on March 31st each year. Data for the previous calendar year shall be submitted during the reporting period. The initial submission period shall begin on March 1, 2027, and end on March 31, 2027. The initial survey administration period shall begin as soon as reasonably possible following full adoption of the rule, but no later than August 1, 2026, and end on December 31, 2026.

(3) Administering the survey. Each nursing home facility shall use the CoreQ survey instrument endorsed by the National Quality Forum (NQF). The CoreQ survey instrument includes a technical manual, CoreQ Satisfaction Questionnaire & User’s Manual, which provides instructions on the methodology for collecting survey data, as well as other relevant information, such as exclusion criteria, minimum response rates, minimum sample sizes, and calculation of results. The results shall be configured to meet the submission standard set by the Agency to administer Short and Long-Stay Resident or Family Satisfaction surveys.

(a) Long-stay residents or family members shall be administered the Long-Stay Resident or Family Satisfaction Survey using AHCA Form 3130-8020, October 2025, which is hereby incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-18901 and at: https://ahca.myflorida.com/NHCSS.

(b) Short-stay residents shall be administered the Short-Stay Resident Satisfaction Survey using AHCA Form 3130-8018, October 2025, which is hereby incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-18903 and at: https://ahca.myflorida.com/NHCSS.

(4) Survey Data File Submission.

(a) Each nursing home facility shall have its vendor submit the Nursing Home Consumer Satisfaction Survey Data File, AHCA Form 3130- 8019, October 2025, incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-18902 and at https://ahca.myflorida.com/NHCSS.

(b) The Nursing Home Consumer Satisfaction Survey Data File, shall be submitted electronically only during the reporting period to an Agency-specific email inbox located on the Agency’s webpage at: https://ahca.myflorida.com/NHCSS.

(5) Survey Data File Publication. As defined in s. 400.0225(4), F.S., the Agency shall publish aggregate nursing home consumer satisfaction survey data in accordance with s. 400.191(2)(a)15, F.S.

History

Rulemaking Authority 400.0225, 400.191 FS. Law Implemented 400.0225, 400.191 FS. History–New 5-31-26.

Fla. Admin. Code R. 59A-4.200 Gold Seal

(1) Definitions.

(a) Agency means the Agency for Health Care Administration.

(b) Panel means the Panel on Excellence in Long Term Care.

(c) Parent company means an entity that owns, leases, or through any other device controls a group of two or more health care facilities or at least one health care facility and any other business. A related party management company is considered to be a parent company.

(d) Region means a geographical area of the state of Florida defined by a list of counties reflected by the Agency’s 11 inspection regions. The regions are defined, as part of the Nursing Home Guide Methodology which is located on the Agency website at http://www.floridahealthfinder.gov/Comparecare/MethodologyNH.aspx.

(e) Quality of Care score means all of the parameters included in the Nursing Home Guide that reflect the results of the overall inspection. These parameters are defined in the Nursing Home Guide Methodology, as specified in Rule 59A-4.165, F.A.C.

(2) Gold Seal Award.

(a) To be considered for recommendation for a Gold Seal Award, a nursing home licensee must submit to the Agency’s Long Term Care Unit:

A letter of recommendation,
A completed Application for Nursing Home Gold Seal Award, AHCA Form 3110-0007, June 2025, which is incorporated by reference and available at https://flrules.org/Gateway/reference.asp?No=Ref-18745. Copies of this form may be obtained from the Agency for Health Care Administration, Long Term Care Unit, 2727 Mahan Drive, MS #33, Tallahassee, FL 32308, or from the Agency website at https://ahca.myflorida.com/health-quality-assurance/bureau-of-health-facility-regulation/long-term-care-services-unit/governor-s-panel
The financial documentation required by subsection (5), of this rule,
The following information must be provided for the period of 30 months preceding application for the Gold Seal Award:

a. Evidence of the consumer satisfaction process which demonstrates that information is elicited from residents and their family members concerning satisfaction with the facility,

b. Evidence of family and community involvement in the facility; and,

c. Evidence of targeted in-service training in the facility.

The stable workforce documentation required by subsection (6), of this rule.
Disclosure of any federal and or state audit initiated against the applicant or its controlling interest.
Disclosure of ownership to include the name of each person holding ownership interest of any business entity that has a controlling interest in the licensee. This paragraph does not apply to a licensee that is publicly traded on a recognized stock exchange.

(b) During the effective dates of the award, a nursing home licensee may use the Gold Seal designation in facility advertising and marketing. All advertising and marketing of the Gold Seal designation must include the range of dates for which the Gold Seal was awarded and shall only represent the facility to which it has been designated. Within 90 days after termination or expiration of the Gold Seal award, the Gold Seal designation must be removed from all advertising and marketing materials.

(3) Review Process.

(a) A review process is established which provides submission deadlines for applications and Panel meeting timeframes to review applications. Facilities may submit applications at any time for review as follows.

(b) Review Period requires applications be submitted by September 15 each year to be eligible for review during this period. The quality of care score for this review period will be obtained from the preceding quarter ending June 30 and will be available by August 15 to ensure facilities qualify under this criterion prior to submitting an application. Application reviews will be complete by October 15. Site visits will be conducted after October 15 and a meeting will be held to determine those licensees to be recommended for the Gold Seal. This meeting must be held prior to December 15.

(c) Quality of care scoring information may be obtained by contacting the Long Term Care Unit at (850)412-4303, or from the Agency website at https://ahca.myflorida.com/health-quality-assurance/bureau-of-health-facility-regulation/long-term-care-services-unit/governor-s-panel under the heading Gold Seal Quality of Care Scores.

(d) Any nursing home licensee not meeting all requirements or having omissions in financial information will be notified to allow a licensee to submit additional information or withdraw the application. Licensees have 10 business days after the Agency’s request to provide required documentation to continue to be eligible for consideration.

(e) If the panel determines that an applicant has failed to meet all Gold Seal criteria and the application is not withdrawn, a recommendation to deny the Gold Seal award will be made to the Governor.

(4) Quality of Care.

(a) The Agency shall determine how a Gold Seal recommended licensee ranks relative to other licensees in the same region.

(b) The Agency shall compute a quality of care score and rank nursing home licensees, in accordance with the Nursing Home Guide Methodology, which is located on the web at http://www.floridahealthfinder.gov/CompareCare/MethodologyNH.aspx.

(c) To be considered further for a Gold Seal Award, the facility’s quality of care rank must be in the top 10% of facilities in the applicant’s region or top 5% statewide. The facility must also be ranked in the Nursing Home Guide as a five-star facility overall.

(5) Financial Requirements.

(a) To be eligible for a Gold Seal designation, a facility must have been in operation for a minimum of 30 months prior to the date of application and must provide evidence of financial soundness and stability. This subsection provides the criteria for use of financial statements. To demonstrate 30 months of financial soundness and stability prior to the date of the application:

The licensee of the facility shall submit financial statements prepared in accordance with Generally Accepted Accounting Principles (GAAP) for the three consecutive fiscal years immediately preceding the date of application. If the most recent fiscal year ended within 120 days prior to the application filing deadline and the audited financial statements are not yet available, then the prior fiscal year will be considered the most recent. Financial statements shall include a balance sheet, income statement and statement of cash flows and all relevant notes. The licensee concurrently shall submit a report from a certified public accountant (CPA) who has audited or reviewed these financial statements. A report of audited financial statements that contains an adverse or disclaimer of opinion will not be considered an acceptable submission for the purposes of this rule. A report on reviewed financial statements must be a standard report and must not contain any departure from GAAP. Financial statements that have been reviewed by a CPA may not be substituted for audited financial statements when the audit was conducted for the same financial accounting period. If the audit of the licensee is not available then the following submissions will satisfy the financial statement submission requirements:

a. Consolidated Financial Statements – For a licensee whose audited or reviewed financial statements are prepared as part of a consolidated entity, the licensee can satisfy the requirements for submitting financial statements by submitting the three most recent consecutive fiscal years of CPA audited or reviewed consolidated financial statements if the statements break out the balance sheet, income statement and statement of cash flows of the individual licensee.

b. Parent Financial Statements – A nursing home that is part of the same corporate entity that operates assisted living facilities and/or independent living facilities can satisfy the requirements for submitting financial statements by submitting the three most recent consecutive fiscal years of CPA audited or reviewed consolidated financial statements for the corporate entity.

c. Continuing Care Retirement Communities (CCRC) – A nursing home that is part of the same corporate entity as a CCRC licensed under Chapter 651, F.S., is considered to have met the evidence of financial soundness and stability requirement of Section 400.235(5)(b), F.S., if it meets its minimum liquid reserve as described in Section 651.035, F.S., and is accredited by a recognized accrediting organization as described in Section 651.028, F.S. In order to meet this requirement and be exempt from the ratio analysis described in paragraph (1)(b), of this rule, the applicant must provide a copy of its active certificate of authority, accreditation documentation, and documentation proving that the minimum liquid reserve is met.

Each licensee must meet at least two of the three financial soundness and stability thresholds listed below for at least two of three years of the statements, to include the most recent year submitted. Otherwise, its facilities cannot be recommended for the Gold Seal Award except as described in subsection (2), above.

a. A positive current ratio of at least one (1). The current ratio is determined by dividing current liabilities into current assets. Current assets are items on an entity’s balance sheet that are either cash, a cash equivalent, or which can be converted into cash within a year or less. Current liabilities are short-term obligations that are due and payable within a year or less.

b. A positive net worth as determined by the balance sheet and/or a positive total margin. Net worth shall be determined as equity (total assets less total liabilities). Total margin shall be considered the net profit or loss from all operations as shown on the income statement.

c. A cash flow to current liabilities ratio of 65 percent or greater. This shall be determined by dividing current liabilities by operating cash flow. Operating cash flow is cash flow generated by core operations and does not include cash flow generated by investing or financing activities as shown on the statement of cash flows on the financial statements.

(b) If the licensee can meet only one of the three financial ratios in paragraph (1)(b), above, for one of the two required years, the licensee may be recommended for a Gold Seal Award only if the most recent CPA prepared financial statements provided are for a period ending within six months of the date of the application and these financial statements meet all three of the financial criteria set forth in paragraph (1)(b), above.

(c) Neither the licensee nor its parent company shall have been the subject of bankruptcy proceedings during the period beginning 30 months prior to the date of the application and ending on the date of the award of the Gold Seal.

(6) Stable Workforce.

(a) An applicant for the Gold Seal Award must meet at least one of the following to demonstrate a stable workforce:

Have a turnover rate no greater than 40 percent for the most recent 12 month period ending on the last workday of the most recent calendar quarter prior to submission of an application. The turnover rate is the total number of terminations or resignations of certified nursing assistants (CNAs) and licensed nurses during the quarter divided by the number of CNAs and licensed nurses employed at the end of the quarter, or
Have a stability rate indicating that at least 50 percent of its staff have been employed at the facility for at least one year. The stability rate is the total number of CNAs and licensed nurses that have been employed for more than 12 months, divided by the total number of CNAs and licensed nurses employed at the end of the quarter.

(b) Each applicant for the Gold Seal Award must submit evidence of an effective recruitment and retention program.

(7) Termination and Frequency of Review.

(a) Termination of Gold Seal Designation. The occurrence of any one of the following events shall disqualify the licensee from continuing as a Gold Seal facility:

The filing of a petition by or against the owner or its parent company under the Bankruptcy Code,
The issuance of a citation for a Class I or Class II deficiency or the assignment of a conditional license, or
The nursing home has a survey, after receipt of the Gold Seal designation that results in an overall rank of less than five stars in the Nursing Home Guide.
A claim or action initiated by a government agency alleging a violation of the False Claims Act, the Anti-Kickback Statute, the Stark Law, or any other federal or state law involving criminal activity, fraud, anti-competitive behavior or patient-privacy. If the nursing home licensee obtains an acquittal or non-settlement judgment against the government agency, this provision will not apply.

(b) For federally certified facilities, if the disqualifying event is the issuance of a citation for a Class I or Class II deficiency or the assignment of a conditional license status, the Gold Seal Award shall be withdrawn only after the results of the federal Informal Dispute Resolution (IDR) process are considered, if an IDR is requested.

(c) The termination or correction of a disqualifying event does not cause the Gold Seal to be reinstated. The licensee shall resubmit a complete application package and must meet all the conditions necessary to be awarded a Gold Seal.

(d) Termination of Gold Seal Applicants. Prior to the Governor’s issuance of the Award, the occurrence of any of the following events shall disqualify the licensee from continuing as a Gold Seal applicant and the application will be denied:

The filing of a petition by or against the owner or its parent company under the Bankruptcy Code,
The licensee fails to maintain a qualifying Quality of Care rank as defined in paragraph (4)(c),
The issuance of a citation for a Class I or Class II deficiency or a licensee is assigned a conditional license status.
A claim or action initiated by a government agency alleging a violation of the False Claims Act, the Anti-Kickback Statute, the Stark Law, or any other federal or state law involving criminal activity, fraud, anti-competitive behavior or patient-privacy. If the nursing home licensee obtains an acquittal or non-settlement judgment against the government agency, this provision will not apply.

(e) If the applicant meets criteria for denial or termination, the Agency shall offer the opportunity for the applicant to withdraw the application.

(f) Frequency of Review. A Gold Seal licensee shall submit a complete renewal application every three years. The renewal application must be received by the Agency during the appropriate review period as provided in subsection (3), to ensure the licensee will not have a lapse in the Gold Seal designation.

History

Rulemaking Authority 400.235(9) FS. Law Implemented 400.235 FS. History–New 8-21-01, Amended 5-15-07, 10-29-15, 10-16-17, 7-5-26.

Fla. Admin. Code R. 59A-4.201 Gold Seal Award

History

Rulemaking Authority 400.235(9) FS. Law Implemented 400.235 FS. History‒New 8-21-01, Amended 5-15-07, 10-29-15, 1-18-17, Repealed 4-18-18.

Fla. Admin. Code R. 59A-4.2015 Review Process

History

Rulemaking Authority 400.235(9) FS. Law Implemented 400.235 FS. History–New 5-15-07, Amended 10-29-15, Repealed 4-18-18.

Fla. Admin. Code R. 59A-4.202 Quality of Care

History

Rulemaking Authority 400.235 FS. Law Implemented 400.235 FS. History‒New 8-21-01, Amended 5-15-07, 12-21-15, Repealed 4-18-18.

Fla. Admin. Code R. 59A-4.203 Financial Requirements

History

Rulemaking Authority 400.235 FS. Law Implemented 400.235 FS. History‒New 8-21-01, Amended 5-19-02, 3-21-04, 12-29-16, Repealed 4-18-18.

Fla. Admin. Code R. 59A-4.204 Turnover Ratio

History

Rulemaking Authority 400.235 FS. Law Implemented 400.235 FS. History‒New 8-21-01, Amended 5-15-07, 12-21-15, Repealed 4-18-18.

Fla. Admin. Code R. 59A-4.205 The State Long Term Care Ombudsman Council Review

History

Rulemaking Authority 400.235(9) FS. Law Implemented 400.235 FS. History‒New 8-21-01, Amended 5-15-07, Repealed 12-31-15.

Fla. Admin. Code R. 59A-4.206 Termination and Frequency of Review

History

Rulemaking Authority 400.235(9) FS. Law Implemented 400.235 FS. History‒New 8-21-01, Amended 5-15-07, 12-21-15, Repealed 4-18-18.

Chapter 59A-5 AMBULATORY SURGICAL CENTER LICENSURE

Fla. Admin. Code R. 59A-5.001 Scope

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055 FS. History–New 6-14-78, Formerly 10D-30.01, 10D-30.001, Amended 11-13-95, Repealed 9-15-96.

Fla. Admin. Code R. 59A-5.002 Definitions

In addition to definitions contained in Chapters 395 Part I, and 408 Part II, F.S. the following definitions shall apply specifically to ambulatory surgical centers.

(1) “Administrator” means a person who is delegated the responsibility of carrying out the policies and programs established by the governing board.

(2) “Agency” means the Agency for Health Care Administration.

(3) “Anesthesiologist” means a person currently licensed to practice medicine or osteopathy pursuant to Chapter 458 or 459, F.S., and who has completed an approved residency in the field of anesthesiology.

(4) “Anesthesiologist Assistant” means a person currently licensed pursuant to Chapter 458 or 459, F.S. as an anesthesiologist assistant.

(5) “Center” means an ambulatory surgical center.

(6) “Certified Registered Nurse Anesthetists” means a person currently licensed and certified pursuant to Chapter 464, F.S, and certified by the Council on Certification of Nurse Anesthetists.

(7) “Dentist” means a person currently licensed to practice dentistry pursuant to Chapter 466, F.S.

(8) “F.A.C.” means the Florida Administrative Code.

(9) “Governing board” means an individual owner, partnership, corporation or other legally established authority in whom the ultimate authority and responsibility for management of the ambulatory surgical center is vested.

(10) “Licensed Practical Nurse” means a person currently licensed as defined in Section 464.003(16), F.S.

(11) “Operating room” means a room designated and equipped for performing surgical operations that requires a restricted environment.

(12) “Operating room technician” means a person with specialized training in operation room techniques and considered by the governing board qualified to serve as part of the operating room staff.

(13) “Medical Staff” means a formal organization of physicians, dentists, podiatrists, or other health professionals, who are appointed by the governing board to attend patients within the ambulatory surgical center.

(14) “Patient” means a person admitted to the ambulatory surgical center.

(15) “Pharmacist” means a person currently licensed pursuant to Chapter 465, F.S.

(16) “Physician” means a person currently licensed to practice medicine or osteopathy pursuant to Chapter 458 or 459, F.S.

(17) “Podiatrist” means a person currently licensed to practice podiatric medicine pursuant to Chapter 461, F.S.

(18) “Procedure Room” means a room designated for the performance of special procedures that do not require a restricted environment but may use sterile instruments or equipment.

(19) “Recovery Bed” means an accommodation with support services used for post-operative recovery in an ambulatory surgical center.

(20) “Registered Professional Nurse” means a person currently licensed as defined in Section 464.003(22), F.S.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 6-14-78, Formerly 10D-30.02, Amended 2-3-88, 5-5-92, Formerly 10D-30.002, Amended 11-13-95, 9-17-14.

Fla. Admin. Code R. 59A-5.003 Licensure Procedure

(1) In addition to the licensure requirements contained in Chapters 395 Part I, and 408 Part II, F.S., all centers shall comply with the following:

(2) All persons requesting licensure for the operation of a center under the provisions of Chapter 395, F.S., shall make application to the Agency on Health Care Licensing Application, Ambulatory Surgical Centers, AHCA Form 3130-2001 September 2018, is incorporated by reference, and available at: http://www.flrules.org/Gateway/reference.asp?No=Ref-10296. Applicants for renewal and changes during licensure may submit the Health Care Licensing Online Application, Ambulatory Surgical Center, AHCA Form 3130-2001OL, September 2018, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-10297. The application forms are available online at http://www.ahca.myflorida.com/HQAlicensureforms or, for online submissions, at: http://apps.ahca.myflorida.com/SingleSignOnPortal. The center must obtain a standard license prior to the acceptance of patients for care or treatment.

(3) Each center applying for a license shall be designated by a distinctive name, and the name shall not be changed without first notifying the Agency and receiving approval in writing. Duplication of an existing center’s name is prohibited.

(4) In addition to the requirements found in Chapter 408 Part II, F.S., the following documents shall accompany the initial application:

(a) Proof of fictitious name registration if applicable;

(b) Articles of Incorporation or similarly titled document registered by the applicant with the Florida Department of State; and,

(5) The following documents shall be available for inspection at the center by the Agency area office at the initial licensure inspection:

(a) The governing board bylaws, rules and regulations, or other written organizational plan;

(b) Medical staff bylaws, rules and regulations;

(d) Nursing procedure manual;

(e) Roster of registered nurses and licensed practical nurses with current license numbers;

(f) The center’s fire plan; and,

(g) The Comprehensive Emergency Management Plan pursuant to Rule 59A-5.018, F.A.C.

(6) In addition to the requirements found in Chapter 408 Part II, F.S., all applications for a change of ownership shall include;

(a) A signed agreement with the Agency to correct physical plant deficiencies listed in the most recent licensure inspection that conforms to Florida Building Code;

(b) A copy of the closing documents, which must include an effective date and the signatures of both the buyer and the seller;

(c) Articles of Incorporation or similarly titled document registered by the applicant with the Florida Department of State;

(d) Proof of fictitious name registration if applicable;

(e) Evidence of payment of, or arrangement to pay, any liability to the state pursuant to Section 395.003(3), F.S.

(7) A license fee as prescribed on the application shall accompany an application for an initial, renewal, change during the licensure period, or change of ownership license.

(8) All permanent additions to the constructed center’s operating room capacity occurring after the issuance of the initial license shall require a new application for licensure.

(9) Each license shall specifically state the number of operating rooms, procedure rooms, and recovery beds in the center.

(10) There shall not be multiple ambulatory surgical center licenses for the same premises.

(11) Each center licensed under Chapter 395, F.S., shall establish an internal risk management program pursuant to Chapter 59A-10, F.A.C., as a part of its administrative function.

(12) Upon receipt of the required information in subsections (1) through (4) above, the Agency shall conduct a licensure inspection to determine compliance with Chapter 395 Part I, F.S., and Rules 59A-5.002 through 59A-5.022, F.A.C.

(13) When a center is in compliance with Chapter 395 Part I, and 408 Part II, F.S., and Rules 59A-5.002 through 59A-5.022, F.A.C., and has received all approvals required by law, the Agency shall issue, a single license which identifies the licensee and the name and location of the center.

(14) Separate licenses shall not be required for separate buildings on the same grounds when used by the same center.

(15) A license issued to a center shall be revoked or denied by the Agency in any case where the Agency finds there has been substantial failure to comply with provisions of Chapter 395 Part I, F.S., or Chapter 59A-5, F.A.C.

(16) A licensee shall notify the Agency of impending closure of a center not less than 30 days prior to such closure. The center shall be responsible for advising the Agency as to the disposition of medical records.

History

Rulemaking Authority 395.1055, 408.819 FS. Law Implemented 395.003, 395.004, 395.0161, 395.1055, 408.806, 408.809, 408.811 FS. History–New 6-14-78, Formerly 10D-30.03, Amended 2-3-88, Formerly 10D-30.003, Amended 11-13-95, 9-17-14, 4-17-19.

Fla. Admin. Code R. 59A-5.004 Validation, Licensure, & Life Safety Inspections and Complaint Investigations

(1) Inspections. The Agency shall conduct periodic inspections of ambulatory surgical centers in order to ensure compliance with all licensure requirements in accordance with Section 395.0161, F.S.

(2) Non-accredited ambulatory surgical centers. Centers which are not accredited by an accrediting organization shall be subject to a scheduled licensure inspection. The fee for conducting a licensure inspection shall be $400.00.

(3) Accredited ambulatory surgical centers. The Agency shall accept the report of an accrediting organization in lieu of a licensure inspection for accredited centers and for centers seeking accreditation, provided that the standards used by the accrediting organization are determined by the Agency to incorporate comparable state licensure requirements, found in Chapters 395 and 408, F.S., and Chapters 59A-5 and 59A-35, F.A.C., and the center does not meet the criteria specified under subparagraphs (c)1. and 2.

(a) Upon receipt of the accrediting organization’s report, the Agency will review the findings to determine if the center is in compliance with state licensure requirements.

(b) The Agency shall notify the center within 60 days of the receipt of the accrediting organization’s report regarding the Agency’s determination of the center’s compliance or non-compliance with state licensure requirements.

The center has been denied accreditation or has received a provisional or conditional accreditation from an accrediting organization on its most recent accreditation report, and has not submitted an acceptable plan of correction to the accrediting organization.
The center has received full accreditation, but has not authorized the release of the report to the Agency or has not ensured that the Agency received the accrediting organization’s report prior to the Agency’s scheduled inspection.

(d) The fee for a licensure inspection shall be $400.00 for any accredited center subject to inspection pursuant to paragraph (c).

(4) Life safety inspection fee. A separate fee of $40.00 shall be assessed for a life-safety inspection, except when conducted as part of a licensure or a Centers for Medicare and Medicaid Services certification inspection.

(5) Validation inspection. Each year, the Agency shall conduct validation inspections on a minimum of five percent of those centers that have undergone an accreditation inspection from an accrediting organization, to determine ongoing compliance with state licensure requirements.

(a) Upon completion of a validation inspection, the Agency will send a copy of its findings to the center. For those centers determined not to be in compliance with state licensure requirements the notification will include a statement of deficiencies.

(b) If the Agency determines, based on the results of validation inspection findings, that an accredited center is not in compliance with licensure requirements, the Agency shall report its findings to the accrediting organization and shall conduct a full licensure inspection on that center during the following year.

(c) The fee for conducting a licensure validation inspection shall be $400.00. A separate fee for a validation inspection will not be assessed when conducted in conjunction with a Centers for Medicare and Medicaid Services certification inspection.

(6) Complaint investigations. The Agency shall conduct investigations of complaints regarding violations of licensure, and life-safety standards in accordance with Sections 395.0161 and 408.811, F.S. Complaint investigations will be unannounced. An entrance conference shall be conducted upon arrival, by Agency personnel investigating the complaint, to inform the center’s administrator about the nature of the complaint investigation and to answer questions from the center’s staff. An exit conference shall be provided at the conclusion of the onsite investigation to inform the center of the scope of the investigation and to receive any additional information that the center wishes to furnish.

(a) Upon receipt of a complaint, the Agency shall review the complaint for allegations of non-compliance with licensure requirements, and shall take the following actions:

Complaints involving any center shall be reviewed and sent to the appropriate Agency local office for investigation, if it is determined that the allegations could constitute a violation of state licensure or federal certification;
If allegations are more appropriately addressed by another state agency or entity, the complaint will be referred accordingly.

(b) Upon a determination that investigation of a complaint is warranted, the Agency shall conduct an investigation.

(7) Conformance with accreditation standards. In all centers where the Agency does not conduct a licensure inspection, by reason of the center’s accreditation status, the center shall continue to conform to the standards of accreditation throughout the term of accreditation, or shall notify the Agency of the areas of non-conformance. Where the Agency is notified of non-conformance, it shall take appropriate action as specified under subsection (3).

(8) Sanctions. The Agency shall impose penalties pursuant to Section 395.1065, F.S., on those centers which fail to submit an acceptable plan of correction or implement actions to correct deficiencies identified by the Agency or an accrediting organization which are specified in an approved plan of correction or as identified as a result of a complaint investigation.

History

Rulemaking Authority 395.1055, 395.0161, 48.819 FS. Law Implemented 395.003, 395.0161, 395.1065, 408.811 FS. History–New 6-14-78, Formerly 10D-30.04, 10D-30.004, Amended 11-13-95, 9-17-14, 3-19-17.

Fla. Admin. Code R. 59A-5.005 Governing Board

(1) The center’s organization shall have an effective governing authority responsible for the legal and ethical conduct of the center. The governing board in fulfilling its responsibility shall be organized under approved written bylaws, rules and regulations which shall:

(a) State the qualifications for governing board membership, and the method of selecting members as well as the terms of appointment or election of members, officers and chairmen of committees. Where legally permissible, physicians who are members of the medical staff shall be eligible for, and should be included in, full membership of the centers’ governing board and its action committees in the same manner as are other knowledgeable and effective individuals. Also, any other member of the medical staff shall be considered eligible for membership of the governing board.

(b) Provide for the designation of officers, their duties, and for the organization of the governing board into essential committees with the number and type consistent with the size and scope of the center’s activities.

(c) Coordinate through an executive committee or the governing board as a whole, the policies and activities of the center and special committees established by the governing board.

(d) Specify the frequency of meetings, at regular stated intervals, with a majority of the members constituting a quorum and with the requirement that minutes be recorded and made available to all members of the governing board.

(e) Establish the position of administrator, the incumbent of which shall be responsible for operation and maintenance of the center as a functioning institution, and define the methods established by the governing board for holding such designated person responsible.

(f) Provide for the appointment, reappointment, or dismissal of members of the medical staff through a credentialing committee or its equivalent and a procedure for hearing and appeal. No action on appointment, reappointment or dismissal shall be taken without prior referral to the credentialing committee for their recommendation, provided that the governing board may suspend an medical staff member pending final determination of any reappointment or dismissal. The governing board shall only appoint members of the medical staff as recommended by the credentialing committee.

(g) Provide for the approval of the bylaws, rules and regulations of the medical staff.

(h) Require that every patient shall be admitted by and remain under the care of a member of the medical staff.

(i) Require that all medications, treatments and procedures shall be administered upon specific orders of a member of the medical staff.

(j) Require that all attending medical staff members who do not have admitting privileges at an acute care general hospital document a written agreement with a physician who has staff privileges with one or more acute care general hospitals licensed by the state to accept any patient who requires continuing care; or

(k) Ensure that there is a written center agreement, with one or more acute care general hospitals licensed by the state, which will admit any patient referred who requires continuing care.

(l) Provide for a formal and official means of liaison among the medical staff, the governing board, and the administrator to provide a channel for administrative advice.

(m) Specify the classification of services to be provided in the center and list authorized surgical procedures.

(2) Where a physician serves as the licensee and governing board, the articles of incorporation or other written organizational plan shall describe the manner in which the licensee executes the governing board responsibility.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.0191, 395.1055 FS. History–New 6-14-78, Amended 3-3-80, Formerly 10D-30.05, 10D-30.005, Amended 11-13-95, 9-17-14.

Fla. Admin. Code R. 59A-5.006 Medical Services

History

Rulemaking Authority 395.07 FS. Law Implemented 395.02, 395.07 FS. History–New 6-14-78, Formerly 10D-30.06, Amended 2-3-88, Formerly 10D-30.006, Repealed 11-13-95.

Fla. Admin. Code R. 59A-5.0065 Patient Rights

Each center shall develop and adopt policies and procedures to ensure the protection of patient rights; which shall include those patient rights specified in Sections 381.026, 395.301 and 395.3025, F.S.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.301, 395.1055, 395.3025 FS. History–New 11-13-95, Amended 2-23-16.

Fla. Admin. Code R. 59A-5.007 Organized Medical Staff

(1) Each center shall have an organized medical staff organized under written bylaws approved by the governing board and responsible to the governing board of the center for the quality of all medical care provided to patients in the center and for the ethical and professional practices of its members.

(2) Committees – The structure of committee organization shall be determined by the organized medical staff provided the following required committee functions are carried out with sufficient periodicity to assure that objectives are achieved by separate committee, combined committees, or committee of the whole:

(a) Approval of the policies, procedures, and the activities of all departments and services.

(b) Interim decision making for the organized medical staff between staff meetings, under such limitations as shall be set by the medical staff.

(d) Review of all applications for appointment and biennially review reappointment of all categories of medical staff pursuant to Sections 395.0191 and 395.0193, F.S.

(e) Medical records currently maintained describing the condition, treatment, and progress of patient in sufficient completeness to assure comprehension of transfer of patient information at any time.

(f) Clinical evaluation of the quality of medical care provided to all categories of patients on the basis of documented evidence.

(g) Review of center admissions with respect to need for admission, discharge practices and evaluation of the services ordered and provided.

(h) Surveillance of the center’s infection potentials and cases and the promotion of a preventive and corrective program designed to minimize these hazards.

(i) Surveillance of pharmacy policies and procedures, and standards of practice are maintained, including review of at least monthly on-site consultant pharmacist visits, and proper disposal of outdated prescription and controlled drugs in accordance with Rules 64B16-28.702, 64B16-28.110, 64B16-28.303, F.A.C., and Chapters 465 and 893, F.S.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.0191, 395.0193, 395.1055 FS. History–New 6-14-78, Formerly 10D-30.07, Amended 2-3-88, Formerly 10D-30.007, Amended 11-13-95, 2-23-16.

Fla. Admin. Code R. 59A-5.008 Surgical Department

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055 FS. History–New 6-14-78, Formerly 10D-30.08, Amended 2-3-88, Formerly 10D-30.008, Amended 11-13-95, Repealed 9-15-96.

Fla. Admin. Code R. 59A-5.0085 Departments and Services

(1) Surgical department. This department shall be organized under written policies and procedures relating to surgical staff privileges, anesthesia, functioning standards, staffing patterns and quality maintenance of the surgical suite.

(a) A qualified person designated by the administrator shall be responsible for the daily functioning and maintenance of the surgical suite.

(b) A surgery record shall be maintained on a current basis that contains the following information:

Patient’s name, patient number, pre-operative diagnosis, post-operative diagnosis, surgical procedure, anesthetic, and complications, if any; and,
Name of each member of the surgical team, including the surgeon, first assistant, anesthesiologist, nurse anesthetist, anesthesiologist assistant, circulating nurse and operating room technician.

(c) Each center shall ensure, prior to any surgery being performed, that the signed informed consent for the procedure, verification of the identity of patient, operative site, and operative procedure to be performed are in the patient’s medical record.

(d) All infections of surgical cases shall be recorded and reported to the governing board or its designee and a procedure shall exist for the investigation of such cases.

(e) Emergency equipment shall be provided as needed commensurate with the services of the center, maintained in functional condition, and capable of providing and maintaining cardiorespiratory functioning.

(f) Written procedures in implementation of policies shall relate specifically to the functional activities of the surgical suite and include the following:

Surgical asepsis: preparation, handling, and maintenance of sterile equipment and supplies.
Medical asepsis: patients, staff, equipment, traffic, and equipment flow patterns.
Sterilization and disinfection standards and controls; equipment and supplies.
Housekeeping.

(2) Anesthesia service. This service shall be organized under written policies and procedures relating to anesthesia staff privileges, the administration of anesthesia, and the maintenance of strict safety controls.

(a) All anesthesia shall be administered by an anesthesiologist, a credentialed and privileged physician, certified registered nurse anesthetist or anesthesiologist assistant, except for local anesthesia administered by a podiatrist, and except for local anesthesia administered by a dentist, and such other anesthesia administered by a dentist in accordance with Section 466.017, F.S., and Chapter 64B5-14, F.A.C.

(b) An anesthesiologist or other physician or a certified registered nurse anesthetist under the on-site medical direction of a licensed physician or an anesthesiologist assistant under the direct supervision of an anesthesiologist, shall be in the center during the anesthesia and post-anesthesia recovery period until all patients are cleared for discharge.

(d) Prior to the administration of anesthesia, patients shall have a history and physical examination including laboratory analysis when indicated.

(e) Written policies and procedures relative to the administration of anesthesia shall be developed by the anesthesia service, approved by the medical staff and the governing board, and be reviewed annually, dated at time of each review, revised as necessary, and enforced.

(f) Anesthetic safety regulations shall be developed, posted and enforced. Such regulations shall include the following requirements:

All operating room electrical and anesthesia equipment shall be inspected on no less than a semi-annual basis, and a written record of the results and corrective actions be maintained;
Flammable anesthetic agents shall not be employed in centers;
Electrical equipment in anesthetizing areas shall be on an audiovisual line isolation monitor, with the exception of radiologic equipment and fixed lighting more than 5 feet above the floor;
Each anesthetic gas machine shall have pin-index system or equivalent safety system and a minimum oxygen flow safety device; and,
All reusable anesthesia equipment in direct contact with the patient shall be cleaned or sterilized as appropriate after each use;
The following monitors shall be applied to all patients receiving conduction or general anesthesia:

a. Blood pressure cuff;

b. A continuous temperature device, readily available to measure the patient’s temperature;

c. Pulse Oximeter; and,

d. Electrocardiogram.

e. An Inspired Oxygen Concentration Monitor and a Capnograph shall be applied to all patients receiving general anesthesia.

(3) Nursing service. This service shall be organized under written policies and procedures relating to patient care, establishment of standards for nursing care and mechanisms for evaluating such care, and nursing services.

(a) A registered professional nurse designated by the administrator shall be responsible for coordinating and supervising all nursing services.

(b) There shall be a sufficient staffing pattern of registered professional nurses to provide quality nursing care to each surgical patient from admission through discharge. Such additional trained nursing service personnel shall be on duty as may be needed commensurate with the service of the center.

(c) A registered professional nurse shall be assigned as the circulating nurse for one patient at a time for the duration of the surgical procedure for any procedure performed in the center.

(d) A registered professional nurse shall be present in the recovery area at all times when a patient is present.

(e) A record shall be currently maintained of all nursing personnel and include regular and relief as well as full-time and part-time staff. The record shall include the current license number of each licensed person.

(f) A current job description delineating duties and responsibilities shall be maintained for each nursing service position.

(g) Written procedures in implementation of policies and to assure quality nursing care shall relate specifically to the functional activities of nursing service and include the following:

Patient admission;
Pre- and Post-Operative care;
Medical orders from physicians and other members of the medical staff;
Standing orders with required signatures;
Medications; storage and administration;
Treatments;
Surgical asepsis;
Medical asepsis;
Sterilization and disinfection;
Documentation: medical records and center records;
Patient discharge;
Patient transfer;
Emergency measures;
Isolation measures;
Incident reports;
Personnel orientation;
Inservice education record;
Equipment and supplies: availability and maintenance; and,
Visitors.

(4) Clinical laboratory services. The ambulatory surgical center laboratory, and any contracted laboratory providing services for ambulatory surgical center patients, must be certified by the Centers for Medicare and Medicaid Services under the federal Clinical Laboratory Improvement Amendments (CLIA) and the federal rules adopted thereunder in all specialties or subspecialties in which testing is performed.

(5) Radiological services. Each center shall provide within the institution, or through arrangement, radiological services commensurate with the needs of the center.

(a) If radiological services are provided by center staff, the service shall be maintained free of hazards for patients and personnel.

(b) New installations of radiological equipment, and subsequent inspections for the identification of radiation hazards shall be made as required by Chapter 64E-5, F.A.C.

(c) Personnel monitoring shall be maintained for each individual working in the area of radiation. Readings shall be on at least a monthly basis and reports kept on file and available for review.

Personnel – The center shall have a licensed practitioner, as defined in Section 468.301(11), F.S., to supervise the service and to discharge professional radiological services.
A technologist shall be on duty or on call at all times when there are patients within the center.
The use of all radiological apparatus shall be limited to appropriately licensed personnel; and use of fluoroscopes shall be limited to appropriately licensed, credentialed and privileged personnel.

(d) If provided under arrangement with an outside provider, the radiological services must be directed by a qualified radiologist and meet the standards as required by Chapter 64E-5, F.A.C.

(6) Housekeeping service. The Housekeeping Service shall be organized under effective written policies and procedures relating to personnel, equipment, materials, maintenance, and cleaning of all areas of the center.

(7) Pediatric services.

(a) A center providing surgical services to patients under the age of 18 years (pediatric) must include age- and size-appropriate criteria in written policies and procedures regarding admissions, surgical services, anesthesia services, post-operative recovery, and discharge planning. The policies and procedures must be approved by the medical staff and the governing board, and be reviewed annually, dated at the time of each review, revised as necessary, and enforced.

All patients shall meet admission and preoperative clearance criteria established by the medical staff and approved by the governing board. However, no patient may be admitted prior to age 30 days.
Patients who were born less than 37 completed weeks gestation (premature) must be at least 60 weeks of age post conception, weaned off apnea monitors, and cleared by an anesthesiologist or certified registered nurse anesthetist under the on-site medical direction of a licensed physician.
Patients must not be oxygen dependent at baseline.

(b) Accommodations must be made for the parent or guardian to remain at the center from admission through discharge.

(d) Each center must include its pediatric cases in the quality assessment and improvement system as described in Rule 59A-5.019, F.A.C. that includes peer review, multidisciplinary review and the monitoring of processes and outcomes.

(e) One or more persons currently certified in Pediatric Advanced Life Support (PALS) must be present and available to the pediatric patient who is sedated, anesthetized, recovering from anesthesia, or receiving perioperative opioids.

(f) Each center providing surgical services requiring a length of stay past midnight must be staffed with the following professionals with specialized training and expertise in the treatment of pediatric patients:

A surgeon who is board-certified or eligible in a pediatric surgical subspecialty or a board-certified or eligible surgeon with additional training and expertise with pediatric patients acceptable to the governing board.
An anesthesiologist or other physician or a certified registered nurse anesthetist under the on-site medical direction of a licensed physician or an anesthesiologist assistant under the direct supervision of an anesthesiologist shall be present in the room with the pediatric patient throughout all general anesthesia, regional anesthesia and monitored anesthesia care.
Nursing and other direct care staff must have specialized training and experience with pediatric patients. Nursing personnel must be PALS and/or Advanced Cardiac Life Support certified. There must be at least one registered professional nurse on duty at all times.

(g) Each center providing surgical services requiring a length of stay past midnight must have facilities and equipment available to store ready-to-eat foods and beverages. Equipment must include handwashing facilities and a refrigerator.

(h) Age- and size-appropriate equipment and resources related to the care of pediatric patients must be available on site, including

Operating tables;
Pre- and post-operative beds;
Anesthesia equipment and supplies;
Resuscitation devices;
Oxygen saturation monitors;
Pharmacologic supplies; and
Blood pressure cuffs.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.009, 395.1055, 395.1011 FS. History–New 12-12-96, Amended 9-28-14, 4-7-21, 2-26-26.

Fla. Admin. Code R. 59A-5.009 Anesthesia Service

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055, 464.012, 466.017 FS. History–New 6-14-78, Formerly 10D-30.09, Amended 2-3-88, Formerly 10D-30.009, Amended 11-13-95, Repealed 12-12-96.

Fla. Admin. Code R. 59A-5.010 Nursing Service

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055 FS. History–New 6-14-78, Formerly 10D-30.10, Amended 2-3-88, Formerly 10D-30.010, Amended 11-13-95, Repealed 12-12-96.

Fla. Admin. Code R. 59A-5.011 Surveillance, Prevention, and Control of Infection

(1) Each center shall establish an Infection Control Program involving members of the medical staff, nursing staff, other professional and administrative staff as appropriate. The program shall provide for:

(a) The surveillance, prevention, and control of infection among patients and personnel;

(b) The establishment of a system for identification, reporting, evaluating and maintaining records of infections;

(d) Development and coordination of training programs in infection control for all center personnel.

(2) Each center shall have written policies and procedures reflecting the scope of the infection control program outlined in subsection (1). The written policies and procedures shall be reviewed at least every two years by the infection control program members, dated at the time of each review, revised as necessary, and enforced.

(3) The policies and procedures devised by the infection control program shall be approved by the governing board, and shall contain at least the following:

(a) Specific policies for the shelf life of all stored sterile items.

(b) Specific policies and procedures related to occupational exposure to blood and body fluids.

(c) Specific policies related to the handling and disposal of biomedical waste in accordance with Chapter 64E-16, F.A.C., and OSHA 29 CFR Part 1910.1030, Bloodborne Pathogens.

(d) Specific policies related to the selection, storage, handling, use and disposition of disposable items.

(e) Specific policies related to decontamination and sterilization activities performed at the center, including but not limited to a requirement that steam, gas (ETO) and hot air sterilizers be tested with live bacterial spores at least weekly.

(f) Specific policies regarding the indications for universal precautions, body substance isolation, CDC isolation guidelines, or equivalent and the types of isolation to be used for the prevention of the transmission of infectious diseases.

(g) A requirement that soiled linen be collected in such a manner as to minimize microbial dissemination into the environment.

(h) A requirement that all cases of communicable diseases as set forth in Chapter 64D-3, F.A.C., be promptly and properly reported in accordance with the provisions of that rule;

(4) The individuals involved in the infection control program shall meet at least quarterly, shall maintain written minutes of all meetings, and shall make a report at least annually to the quality assurance committee and the governing board.

(5) Each center shall establish an employee health policy to minimize the likelihood of transmission of communicable disease by both employees and patients. Such policies shall include, but not be limited to, work restrictions for an employee whenever it is likely that communicable disease may be transmitted, until such time as a medical practitioner certifies that the employee may return to work.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 6-14-78, Formerly 10D-30.11, Amended 2-3-88, Formerly 10D-30.011, Amended 11-13-95, 2-23-16.

Fla. Admin. Code R. 59A-5.012 Medical Records

(1) Each center shall establish processes to obtain, manage, and utilize information to enhance and improve individual and organizational performance in patient care, management, and support processes. Such processes shall:

(a) Be planned and designed to meet the center’s internal and external information needs;

(b) Provide for confidentiality, integrity and security;

(c) Provide education and training in information management principles to decision-makers and other center personnel who generate, collect, and analyze information; and,

(d) Provide for information in a timely and accurate manner;

(2) Each center shall have a medical records service, patient information system or similarly titled unit with administrative responsibility for medical records.

(3) The administrator shall appoint in writing a qualified person responsible for the medical records service. This person shall meet the qualifications established for this position, in writing, by the governing board.

(4) A current job description delineating duties and responsibilities shall be maintained for each medical records service position.

(5) The medical records service shall:

(a) Maintain a system of identification and filing to ensure the prompt location of a patient’s medical record. Patient records may be stored on electronic medium such as computer, microfilm or optical imaging;

(b) Maintain a current and complete medical record for every patient admitted to the center.

(c) All clinical information pertaining to the patient’s medical treatment shall be centralized in the patient’s medical record.

(d) Ensure that each medical record shall contain the following, as appropriate to the service provided:

Identification data;
Chief complaint;
Present illness;
Past personal history;
Family medical history;
Physical examination report;
Provisional and pre-operative diagnosis;
Clinical laboratory reports;
Radiology, diagnostic imaging, and ancillary testing reports;
Consultation reports;
Medical and surgical treatment notes and reports;
The appropriate informed consent signed by the patient;
Record of medication and dosage administered;
Tissue reports;
Physician orders;
Physician and nurse progress notes;
Final diagnosis;
Discharge summary; and,
Autopsy report, if appropriate.

(e) Ensure that:

Operative reports signed by the surgeon shall be recorded in the patient’s record immediately following surgery or that an operative progress note is entered in the patient record to provide pertinent information; and,
Postoperative information shall include vital signs, level of consciousness, medications, blood or blood components, complications and management of those events, identification of direct providers of care, discharge information from post-anesthesia care area.

(f) Index, and maintain on a current basis, all medical records according to surgical procedure and physician.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055, 395.3025 FS. History–New 6-14-78, Formerly 10D-30.12, 10D-30.012, Amended 11-13-95, 9-17-14.

Fla. Admin. Code R. 59A-5.013 Laboratories

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.009, 395.1055, 483.051 FS. History–New 6-14-78, Formerly 10D-30.13, 10D-30.013, Amended 11-13-95, Repealed 12-12-96.

Fla. Admin. Code R. 59A-5.014 Radiological Services

History

Rulemaking Authority 395.045, 395.07 FS. Law Implemented 395.02, 395.07 FS. History–New 6-14-78, Formerly 10D-30.14, 10D-30.014, Repealed 12-12-96.

Fla. Admin. Code R. 59A-5.015 Housekeeping Service

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1011, 395.1055 FS. History–New 6-14-78, Formerly 10D-30.15, Amended 2-3-88, Formerly 10D-30.015, Amended 11-13-95, Repealed 12-12-96.

Fla. Admin. Code R. 59A-5.016 Physical Plant Maintenance

(1) Each ambulatory surgical center shall establish written policies and procedures designed to maintain the physical plant and overall ambulatory surgical center environment in such a manner that the safety and well-being of patients is assured. The building and mechanical maintenance program shall be under the supervision of a qualified person.

(2) All mechanical and electrical equipment shall be maintained in working order, and shall be accessible for cleaning and inspection.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 6-14-78, Formerly 10D-30.16, 10D-30.016, Amended 11-13-95.

Fla. Admin. Code R. 59A-5.017 Fire Control

(1) Each ambulatory surgical center shall provide fire protection through the elimination of fire hazards; the installation of necessary safeguards such as extinguishers, sprinkling devices, and fire and smoke barriers as described in Rule 59A-5.022, F.A.C., to insure rapid and effective fire control; and the adoption of written fire control plans rehearsed four (4) times a year by all personnel. To safeguard patients, the ambulatory surgical center shall have:

(a) Written evidence of regular inspection by local fire control agencies.

(b) Stairwells kept closed by fire doors equipped with self-closing devices.

(d) “No Smoking” signs prominently displayed in those areas where smoking is not permitted.

(e) Fire regulations and evacuation route prominently posted for each floor and department.

(2) Written fire control plan approved by the appropriate local fire authority shall contain provisions for prompt reporting of all fires; extinguishing fires; protection of patients, personnel and guests; evacuation; and cooperation with fire fighting authorities.

(3) There shall be rigidly enforced written rules and regulations governing proper routine methods of handling and storing oxidizing, combustible, and flammable explosive agents.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055 FS. History–New 6-14-78, Formerly 10D-30.17, Amended 2-3-88, Formerly 10D-30.017, Amended 11-13-95.

Fla. Admin. Code R. 59A-5.018 Comprehensive Emergency Management Plan

(1) Each center shall develop and adopt a written comprehensive emergency management plan for emergency care during an internal or external disaster or emergency which it shall review and update annually.

(2) The emergency management plan shall be developed in conjunction with other agencies and providers of health care services within the local community pursuant to Section 252.32(2), F.S., and in accordance with the “Emergency Management Planning Criteria for Ambulatory Surgical Centers”, AHCA FORM 3130-2003 July 94, which is incorporated by reference. The form is available at: http://www.flrules.org/Gateway/reference.asp?No=Ref-04454 and available from the Agency for Health Care Administration at:

http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/forms/ASC_CEMP_Reconstructed_122104.pdf

The plan shall include:

(a) Provisions for internal and external disasters, and emergencies;

(b) A description of the center’s role in a community wide comprehensive emergency management plan;

(c) Information about how the center plans to implement specific procedures outlined in its comprehensive emergency management plan;

(d) Precautionary measures, including voluntary cessation of center operations, to be taken by the center in preparation and response to warnings of inclement weather, including hurricanes and tornadoes, or other potential emergency conditions.

(e) Provisions for the management of patients, including the discharge or transfer of patients and staff to a hospital or subacute care facility, at the direction of the center’s administrator, in the event of an evacuation order, or when a determination is made by the Agency that the condition of the center is sufficient to render it a hazard to the health and safety of patients and staff, pursuant to Chapter 59A-5, F.A.C. Such provisions shall address the role and responsibility of the physician in the decision to move or relocate patients;

(f) Provisions for coordinating with hospitals that would receive patients to be transferred;

(g) Provisions for the management of staff, including the distribution and assignment of responsibilities and functions, and the assignment of staff to accompany patients to a hospital or subacute care facility;

(h) A provision that a verification check will be made to ensure patients transferred to a hospital arrive at the designated hospital;

(i) A provision that ensures that copies of medical records and orders accompany patients transferred to a hospital;

(j) Provisions for the management of patients who may be treated at the center during an internal or external disaster or emergencies, including control of patient information and medical records, individual identification of patients, transfer of patients to hospital(s) and treatment of mass casualties;

(k) Provisions for contacting relatives and necessary persons advising them of patient location changes. A procedure must also be established for responding to inquiries from patient families and the press;

(l) A provision for educating and training personnel in carrying out their responsibilities in accordance with the adopted plan;

(m) Identification of mutual aid agreements or statements of understanding for services; and,

(n) Provisions for coordination with designated agencies.

(3) The plan, including appendices, as required by the “Emergency Management Planning Criteria for Ambulatory Surgical Centers”, shall be submitted annually to the county emergency management agency for review and approval. A fee may be charged for the review of the plan as authorized by Sections 252.35(2)(m) and 252.38(1)(e), F.S.

(a) The county emergency management agency has 60 days upon receipt of the plan, in which to review and approve the plan, or advise the center of necessary revisions. If the county emergency management agency advises the center of necessary revisions to the plan, those revisions shall be made as authorized by Section 395.1055(1)(c), F.S., and the plan shall be resubmitted to the county emergency management agency within 30 days of notification by the county emergency management agency.

(b) The county emergency management agency shall be the final administrative authority for emergency management plans developed by centers.

(4) The center shall test the implementation of the emergency management plan semiannually, either in response to an emergency or in a planned drill, and shall evaluate and document the center’s performance. This documentation must be on file at the center and available for inspection by the county emergency management agency and the Agency.

(5) The emergency management plan shall be available for immediate access by the staff.

(6) If a center evacuates during or after an emergency, the center shall not be reoccupied until a determination is made by the center’s administrator that the center can meet the needs of the patients. A center with significant structural damage shall not be reoccupied until approval is received from the Agency’s Office of Plans and Construction that the center can be safely occupied as required by the Florida Building Code.

(7) A center that must evacuate the premises due to a disaster or an emergency condition, shall report the evacuation to the Agency’s local area health facility regulation office within 24 hours or as soon as practical. The names and destination of patients relocated shall be provided to the county emergency management agency or its designee having responsibility for tracking the population at large. The licensee shall inform the Agency’s local area office of a contact person who will be available 24 hours a day, seven days a week, until the center is reoccupied.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 6-14-78, Formerly 10D-30.18, 10D-30.018, Amended 12-28-94, 9-17-14.

Fla. Admin. Code R. 59A-5.019 Quality Assessment and Improvement

(1) General Provisions. Each ambulatory surgical center shall have an ongoing quality assessment and improvement system designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, and opportunities to improve its performance to enhance and improve the quality of care provided to the public.

(b) Each system for quality assessment and improvement, which shall include utilization review, must be defined in writing, approved by the governing board, and enforced, and shall include:

A written delineation of responsibilities for key staff;
A policy for all members of the organized medical staff, whereby staff members do not initially review their own cases for quality assessment and improvement program purposes;
A confidentiality policy;
Written, measurable criteria and norms;
A description of the methods used for identifying problems;
A description of the methods used for assessing problems, determining priorities for investigation, and resolving problems;
A description of the methods for monitoring activities to assure that the desired results are achieved and sustained; and,
Documentation of the activities and results of the program.

(2) Each center shall have in place a systematic process to collect data on process outcomes, priority issues chosen for improvement, and the satisfaction of the patient. Processes measured shall include:

(a) Appropriate surgical procedures;

(b) Preparation of patient for the procedure;

(d) Provision of post-operative care;

(e) Use of medications including administration and monitoring of effects;

(f) Risk management activities;

(g) Quality assessment and improvement activities including clinical laboratory services and radiology services;

(h) Results of autopsies if needed.

(3) Each center shall have a process to assess data collected to determine:

(a) The level and performance of existing activities and procedures,

(b) Priorities for improvement, and,

(4) Each center shall have a process to incorporate quality assessment and improvement activities in existing ambulatory surgical center processes and procedures.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 11-13-95, Amended 2-23-16.

Fla. Admin. Code R. 59A-5.020 Codes and Standards for Physical Plant of New or Existing Ambulatory Surgical Facility

History

Rulemaking Authority 395.07 FS. Law Implemented 395.02, 395.07 FS. History–New 6-14-78, Formerly 10D-30.20, Amended 2-3-88, Formerly 10D-30.020, Repealed 9-15-96.

Fla. Admin. Code R. 59A-5.021 Plans Submission and Fee Requirements

(1) No construction work, including demolition, shall be started until prior written approval has been given by the Office of Plans and Construction. This includes all construction of new facilities and any and all additions, modifications, renovations, or refurbishment of the site, building, equipment or systems of all existing facilities. Approval to start construction will be granted by the Agency when the design complies with all applicable codes and standards as evidenced by a thorough examination of the documents submitted to the Agency as required for Stage III construction documents.

(b) Construction documents, specifications and construction details for all work to be undertaken.

(c) A letter from the facility holding the agency harmless for any changes that may occur to the project as a result of the final construction document review.

(d) An infection control risk assessment (ICRA) and a life safety plan indicating temporary egress and detailed phasing plans indicating how the area(s) to be demolished or constructed is to be separated from all occupied areas shall be submitted when demolition or construction in and around occupied buildings is to be undertaken. Submissions that fail to provide an ICRA or depict the safety measures prescribed by the ICRA will not be approved.

(3) Construction must commence within 12 months of receiving approval from the Office of Plans and Construction to begin construction. Once construction begins construction activities should be continuous until the completion of the project. Failure to commence construction within 12 months of plan approval or periods of construction inactivity exceeding 12 months following commencement of construction will result in termination of the project. Restarting a terminated project will require resubmission of the construction documents accompanied by a new plan review application and will be subject to all fees prescribed by Section 395.0163, F.S. Projects which have not received approval to begin construction will be considered abandoned following 12 months of inactivity and the project will be terminated.

(4) When construction is planned, either for new buildings or additions, alterations or renovations to existing buildings, the plans and specifications shall be prepared and submitted to the Office of Plans and Construction for approval by the appropriate Florida-registered design professionals as required by the Florida Building Code, Chapters 471, and 481, F.S. All architecture or engineering firms not practicing as a sole proprietor shall also be registered as an architecture or engineering firm with the Florida Department of Business and Professional Regulation.

(5) The initial submission of plans to the Office of Plans and Construction for any new project shall include a completed Application for Plan Review, AHCA Form 3500-0011, June 2014, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-05456, and a valid Certificate of Need if required by the agency. This information shall accompany the initial submission. Projects requiring a Certificate of Need will not be approved to begin construction without a valid Certificate of Need. Applications for Plan Review are available from the Agency for Health Care Administration, Office of Plans and Construction, 2727 Mahan Drive, Mail Stop #24, Tallahassee, Florida 32308, or at the web address at: http://ahca.myflorida.com/MCHQ/HQALicensureForms/index.shtml.

(6) Plans and specifications submitted for review shall be subject to plan review fees prescribed by Section 395.0163, F.S. All fees shall be payable to the Agency for Health Care Administration and shall annotate the Office of Plans and Construction and the facility log number. Fees are not refundable.

(7) Plans and specifications may be submitted for review at any of the three stages of development described in this rule.

(9) For projects involving only equipment changes or system renovations, only Stage III, construction documents will be accepted. These documents shall include the following:

(a) Life safety plans showing the fire/smoke compartments in the area of renovation.

(b) Detailed phasing plans indicating how the new work will be separated from all occupied areas.

(10) Stage I, Schematic Plans.

(a) The following shall be incorporated into the schematic plans:

Single-line drawings of each floor that indicates the relationship of the various activities or services to each other and the room arrangement in each.
The function of each room or space shall be noted in or near the room or space.
The proposed roads and walkways, service and entrance courts, parking, and orientation shown on either a small plot plan or on the first floor plan.
A simple cross-section diagram showing the anticipated construction.
A schematic life safety plan showing smoke and fire compartments, exits, exit passageways and gross areas of required smoke and fire compartments.
Indicate which areas are sprinklered, both new and existing.

(b) If the proposed construction is an addition or is otherwise related to existing buildings on the site, the schematic plans shall show the facilities and general arrangement of those buildings.

(11) Stage II, Preliminary Plans.

The following shall be incorporated into the preliminary plans.

(a) A Vicinity Map. For new ambulatory surgical center construction, provide a vicinity map showing the major local highway intersections.

(b) Site Development Plans.

(d) Building location dimensions.

(e) Location of the fire protection services water source to the building.

(f) Architectural Plans.

Floor plans, 1/8-inch scale minimum, showing door swings, windows, case work and mill work, fixed equipment and plumbing fixtures. Indicate the function of each space.
Typical large-scale interior and exterior wall sections to include typical rated fire and fire/smoke partitions and a typical corridor partition.
All exterior building elevations.

(g) Equipment which is not included in the construction contract that requires mechanical or electrical service connections or construction modifications shall be identified to assure coordination with the architectural, mechanical and electrical phases of construction.

(h) If the project is located in an occupied facility, preliminary phasing plans indicating how the project is to be separated from all occupied areas.

(i) Life Safety Plans.

Life safety plans must include the following:

b. All sprinklered areas.

c. All fire extinguishers.

d. All fire alarm devices and pull station locations.

If the project is an addition, or conversion of an existing building, fully developed life safety plans must be submitted.
If the project is a renovation in an existing building, life safety plans of the floor being renovated and the required exit egress floor(s) must be submitted.
When demolition or construction in and around occupied buildings will be undertaken, a life safety plan indicating temporary egress, and detailed phasing plans indicating how the area(s) to be demolished or constructed will be separated from all occupied areas must be submitted.

(j) Mechanical Engineering Plans.

Single-sheet floor plans with a one-line diagram of the ventilating system with relative pressures of each space. Provide a written description and drawings of the anticipated smoke control system, passive or active, and a sequence of operation correlated with the life safety plans.
The general location of all fire and smoke dampers, all duct smoke detectors and fire stats.
If the building is equipped with fire sprinklers, indicate the location of the sprinkler system risers and the point of connection for the fire sprinkler system. State the method of design for the existing and new fire sprinkler systems.
The locations of all plumbing fixtures and other items of equipment requiring plumbing services and/or gas services.
The locations of any fume, radiological or chemical hoods.
The locations of all medical gas outlets, piping distribution risers, terminals, alarm panel(s), low pressure emergency oxygen connection, isolation/zone valve(s), and gas source location(s).
The locations and relative size of major items of mechanical equipment such as chillers, air handling units, fire pumps, medical gas storage, boilers, vacuum pumps, air compressors and fuel storage vessels.
The locations of hazardous areas and the volume of products to be contained therein.
The location of fire pump, stand pipes, and sprinkler riser(s).

(k) Electrical Engineering Drawings.

A one-line diagram of normal and essential electrical power systems showing service transformers and entrances, switchboards, transfer switches, distribution feeders and over-current devices, panel boards and step-down transformers. The diagram shall include a preliminary listing and description of new and existing, normal and emergency loads, preliminary estimates of available short-circuit current at all new equipment and existing equipment serving any new equipment, short-circuit and withstand ratings of existing equipment serving new loads and any new or revised grounding requirements.
Show fire alarm zones and correlate with the life safety plan.

(l) Outline Specifications. Outline specifications must include a general description of the construction, including construction classification and ratings of components, interior finishes, general types and locations of acoustical material, floor coverings, ventilating equipment, plumbing fixtures, fire protection equipment, medical gas equipment and electrical equipment.

(m) Whenever an existing building is to be converted to a health care facility, the general layout of spaces of the existing structure shall be submitted with the preliminary plans for the proposed facility.

(n) Whenever an addition, alteration, renovation or remodeling to an existing facility is proposed, the general layout of spaces of the existing facility shall be submitted with the preliminary plans.

(12) Stage III, Construction Documents.

The Stage III, construction documents shall be an extension of the Stage II, preliminary plan submission and shall provide a complete description of the contemplated construction. Construction documents shall be signed, sealed and dated and submitted for written approval to the Office of Plans and Construction by a Florida-registered architect and Florida-registered professional engineer. These documents shall consist of work related to civil, structural, mechanical, and electrical engineering, fire protection, lightning protection, landscape architecture and all architectural work. In addition to the requirements for Stage II submission, the following shall be incorporated into the construction documents:

(b) Life safety plans for the entire project. Projects located on floors above or below the exit discharge level must also include life safety plans for the exit discharge serving the project area.

Typical large-scale details of all typical interior and exterior walls and smoke walls, horizontal exits and exit passageways.
Comprehensive ceiling plans that show all utilities, lighting fixtures, smoke detectors, ventilation devices, sprinkler head locations and fire-rated ceiling suspension member locations where applicable.
Floor/ceiling and roof/ceiling assembly descriptions for all conditions.
Details and other instructions to the contractor on the construction documents describing the techniques to be used to seal floor construction penetrations necessary to prevent smoke migration from floor to floor during a fire.

(d) Structural engineering plans, schedules and details.

(e) Mechanical engineering plans including fire and smoke control plans. Include all equipment that requires mechanical utilities. Provide a clear and concise narrative control sequence of operations for each item of mechanical equipment including but not limited to air conditioning, heating, ventilation, medical gas, plumbing, and fire protection and any interconnection of the equipment of the systems. Mechanical engineering drawings shall depict completely the systems to be utilized, whether new or existing, from the point of system origination to termination. Provide a tabular schedule giving the required air flow (as computed from the information contained on the ventilation rate table) in cubic feet per minute (cfm) for supply, return, exhaust, outdoor, and ventilation air for each space, as applicable, shown on the architectural documents. The schedule shall also contain the HVAC system design air flow rates and the resulting space relative pressures. The schedule or portion of the schedule as applicable shall be placed on each floor plan drawing sheet containing the spaces depicted on the drawing.

(g) Electrical engineering plans describing complete power, lighting, alarm, communications and lightning protection systems and power system study.

(13) A complete set of specifications for all work to be undertaken.

(a) All project required contractor supplied testing and/or certification reports shall be submitted in writing, on standard forms, reviewed and accepted by the Engineer of Record prior to presenting to the agency for review.

(a) All subsequent addenda, change orders, field orders and other documents altering the above shall also be signed, sealed and dated and submitted in advance to the Office of Plans and Construction for review. The Agency will either approve or disapprove the submission based on compliance with all applicable codes and standards and shall provide a listing of deficiencies in writing.

(b) All submissions will be acted upon by the agency within 60 days of the receipt of properly executed construction documents and the initial payment of the plan review fee. The Agency will either approve or disapprove the submission and shall provide a listing of deficiencies in writing. All deficiencies noted by the agency must be satisfactorily corrected before final approval will be provided from the Agency.

(16) Record Drawings. Within 60 days after final approval of the project has been obtained from the agency, the Office of Plans and Construction shall be provided with a complete set of legible record drawings showing all of the construction, fixed equipment and the mechanical and electrical systems as installed. These drawings shall include the life safety plans. Record drawings may be submitted electronically in Portable Document Format (PDF). If record drawings are not received within this time frame specified in this section, only the construction document and project file will be retained.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.0163, 471.025, 481.221, 553.73, 633.033 FS. History–New 6-14-78, Formerly 10D-30.21, Amended 2-3-88, 5-6-92, Formerly 10D-30.021, Amended 11-12-96, 7-9-15.

Fla. Admin. Code R. 59A-5.022 Physical Plant Requirements for Ambulatory Surgical Centers

(1) The Agency provides technical assistance to the Florida Building Commission and the State Fire Marshal in developing and maintaining standards for the design and construction of ambulatory surgical centers. These standards are included in the following:

(a) The building codes in Rule 61G20-1.001, F.A.C.; as adopted by the Florida Building Commission.

(b) The fire codes in Chapter 69A-60, F.A.C.; as adopted by the State Fire Marshal.

(c) The handicap accessibility standards in Chapter 553, Part V, F.S., and Rule 61G20-4.002, F.A.C; as adopted by the Florida Building Commission.

(2) No building shall be converted to a licensed ambulatory surgical center unless it complies with the standards and codes in effect when the building is converted.

(3) Local codes which set more stringent standards or add additional requirements shall take precedence over these standards and requirements as set forth in this section. Contact the Office of Plans and Construction when conflicts occur.

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 6-14-78, Formerly 10D-30.22, Amended 2-3-88, Formerly 10D-30.022, Amended 6-11-97, 7-9-15.

Fla. Admin. Code R. 59A-5.023 Details and Finishes

History

Rulemaking Authority 395.07 FS. Law Implemented 395.02, 395.07, 395.09 FS. History–New 6-14-78, Formerly 10D-30.23, Amended 2-3-88, Formerly 10D-30.023, Repealed 6-11-97.

Fla. Admin. Code R. 59A-5.024 Elevators Where Required

History

Rulemaking Authority 395.07 FS. Law Implemented 395.02, 395.07 FS. History–New 6-14-78, Formerly 10D-30.24, Amended 2-3-88, Formerly 10D-30.024, Repealed 6-11-97.

Fla. Admin. Code R. 59A-5.025 Water Supply and Sewage Disposal

History

Rulemaking Authority 395.07 FS. Law Implemented 381.031(1)(g)3., 395.02, 395.07 FS. History–New 6-14-78, Formerly 10D-30.25, Amended 2-3-88, Formerly 10D-30.025, Repealed 6-11-97.

Fla. Admin. Code R. 59A-5.026 Incinerators

History

Rulemaking Authority 395.06 FS. Law Implemented 395.02, 395.07 FS. History–New 6-14-78, Formerly 10D-30.26, 10D-30.026, Repealed 6-11-97.

Fla. Admin. Code R. 59A-5.027 Air Conditioning, Heating and Ventilating Systems

History

Rulemaking Authority 395.07 FS. Law Implemented 381.031(1)(g)3., 395.02, 395.07 FS. History–New 6-14-78, Formerly 10D-30.27, Amended 2-3-88, Formerly 10D-30.027, Repealed 6-11-97.

Fla. Admin. Code R. 59A-5.028 Plumbing Fixtures

History

Rulemaking Authority 395.07 FS. Law Implemented 381.031(1)(g)3., 395.02, 395.07 FS. History–New 6-14-78, Formerly 10D-30.28, Amended 2-3-88, Formerly 10D-30.028, Repealed 6-11-97.

Fla. Admin. Code R. 59A-5.029 Electrical Requirements

History

Rulemaking Authority 395.07 FS. Law Implemented 395.02, 395.07 FS. History–New 6-14-78, Formerly 10D-30.29, Amended 2-3-88, Formerly 10D-30.029, Amended 11-13-95, Repealed 6-11-97.

Fla. Admin. Code R. 59A-5.030 Nurses’ Calling System and Fire Alarm System

History

Rulemaking Authority 395.07 FS. Law Implemented 295.02, 395.07 FS. History–New 6-14-78, Formerly 10D-30.30, Amended 2-3-88, Formerly 10D-30.030, Repealed 6-11-97.

Fla. Admin. Code R. 59A-5.031 Emergency Electric System

History

Rulemaking Authority 395.07 FS. Law Implemented 295.02, 395.07 FS. History–New 6-14-78, Formerly 10D-30.31, Amended 2-3-88, Formerly 10D-30.031, Repealed 6-11-97.

Fla. Admin. Code R. 59A-5.032 Price Transparency and Patient Billing

(1) Website. Each center shall make available to patients and prospective patients price transparency and patient billing information on its website regarding the availability of estimates of costs that may be incurred by the patient, financial assistance, billing practices, and a hyperlink to the Agency’s service bundle pricing website. The content on the center’s website shall be reviewed at least every 90 days and updated as needed to maintain timely and accurate information. For the purpose of this rule, service bundles means the reasonably expected center services and care provided to a patient for a specific treatment, procedure, or diagnosis as posted on the Agency’s website. In accordance with Section 395.301, F.S., the center’s website must include:

(c) A statement informing patients and prospective patients of their right to request a personalized estimate from the center;

(d) A statement informing patients of the center’s financial assistance policy, charity care policy, and collection procedure;

(e) A list of names and contact information of health care practitioners and medical practice groups contracted to provide services within the center, grouped by specialty or service; and,

(f) A statement informing patients to contact the health care practitioners anticipated to provide services to the patient while in the center regarding a personalized estimate, billing practices and participation with the patient’s insurance provider or health maintenance organization (HMO) as the practitioners may not participate with the same health insurers or HMO as the center.

(2) Estimate. The center shall provide an estimate upon request of the patient, prospective patient, or legal guardian for nonemergency medical services.

A statement informing the requestor to contact their health insurer or HMO for anticipated cost sharing responsibilities,
A statement advising the requestor that the actual cost may exceed the estimate,
The web address to financial assistance policies, charity care policy, and collection procedure,
A description and purpose of any facility fees, if applicable,
A statement that services may be provided by other health care providers who may bill separately,
A statement, including a web address if different from above, that contact information for health care practitioners and medical practice groups that are expected to bill separately is available on the center’s website; and,
A statement advising the requestor that the patient may pay less for the procedure or service at another facility or in another health care setting.

(b) If the center provides a non-personalized estimate, the estimate shall include a statement that a personalized estimate is available upon request.

(3) Itemized statement or bill. The center shall provide an itemized statement or bill upon request of the patient or the patient’s survivor or legal guardian. The itemized statement or bill shall be provided within 7 business days after the patient’s discharge or release, or 7 business days after the request, whichever is later. The itemized statement or bill must include:

(a) A description of the individual charges from each department or service area by date, as prescribed in Section 395.301(1)(d), F.S.;

(b) Contact information for health care practitioners or medical practice groups that are expected to bill separately based on services provided; and,

History

Rulemaking Authority 395.301 FS. Law Implemented 395.301 FS. History–New 2-19-18.

Chapter 59A-6 MULTIPHASIC HEALTH TESTING CENTER LICENSURE

Fla. Admin. Code R. 59A-6.020 Licensure Procedure

History

Rulemaking Authority 408.033, 408.819, 483.291 FS. Law Implemented 408.033, 408.805, 408.806, 408.809, 408.810, 408.811, 483.285, 483.291, 483.30, 483.302 FS. History–New 3-20-94, Amended 5-1-96, 9-28-14, 11-12-19, Repealed by Chapter 2020-156, L.O.F.

Fla. Admin. Code R. 59A-6.021 Surveys and Evaluations

History

Rulemaking Authority 483.291 FS. Law Implemented 483.294 FS. History–New 3-20-94, Repealed 5-7-12.

Fla. Admin. Code R. 59A-6.022 Standards of Performance

History

Rulemaking Authority 483.291 FS. Law Implemented 483.291, 483.308, 483.314 FS. History–New 3-20-94, Amended 5-1-96, 5-27-18, Repealed by Chapter 2020-156, L.O.F.

Fla. Admin. Code R. 59A-6.026 Records and Reports

History

Rulemaking Authority 483.291 FS. Law Implemented 483.291 FS. History–New 3-20-94, Repealed by Chapter 2020-156, L.O.F.

Fla. Admin. Code R. 59A-6.027 Collection and Transmittal of Specimens

History

Rulemaking Authority 483.291 FS. Law Implemented 483.291, 483.314 FS. History–New 3-20-94, Repealed by Chapter 2020-156, L.O.F.

Fla. Admin. Code R. 59A-6.032 Advertising and Promotional Material

History

Rulemaking Authority 483.291 FS. Law Implemented 483.305 FS. History–New 3-20-94, Repealed 5-7-12.

Fla. Admin. Code R. 59A-6.033 Fees

History

Rulemaking Authority 483.291 FS. Law Implemented 483.291 FS. History–New 3-20-94, Repealed 1-4-16.

Fla. Admin. Code R. 59A-6.034 Administrative Enforcement

History

Rulemaking Authority 483.291 FS. Law Implemented 483.317, 483.32 FS. History–New 3-20-94, Repealed 2-20-12.

Chapter 59A-7 CLINICAL LABORATORIES

Fla. Admin. Code R. 59A-7.019 Application of Act – Exemption and Exclusions

History

Rulemaking Authority 483.051 FS. Law Implemented 483.031, 483.041, 483.051 FS. History–New 11-20-94, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.020 Definitions

History

Rulemaking Authority 483.051 FS. Law Implemented 483.035, 483.041, 483.051, 483.191, 483.245 FS. History–New 11-20-94, Amended 8-13-95, 12-27-95, 6-22-06, 3-31-10, 7-19-17, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.021 Laboratory Licensure – Qualifications, Licensure, Operation and Application

History

Rulemaking Authority 483.051, 408.819 FS. Law Implemented 483.051, 483.101, 483.111, 483.172, 483.221, 408.805, 408.806, 408.807, 408.812, 408.813 FS. History–New 11-20-94, Amended 7-4-95, 12-27-95, 3-25-03, 3-1-10, 12-29-10, 6-16-15, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.022 Laboratory Construction

History

Rulemaking Authority 483.051 FS. Law Implemented 483.051 FS. History–New 11-20-94, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.023 Laboratory Safety and Sanitary Conditions

History

Rulemaking Authority 483.051 FS. Law Implemented 483.041, 483.051 FS. History–New 11-20-94, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.024 Clinical Laboratories, Collection Stations, Collection, Storage and Shipment of Specimens

History

Rulemaking Authority 483.051 FS. Law Implemented 483.051, 483.106, 483.191, 483.201, 483.221, 483.23 FS. History–New 11-20-94, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.025 Participation in Proficiency Testing

History

Rulemaking Authority 483.051 FS. Law Implemented 483.051, 483.201, 483.221 FS. History–New 11-20-94, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.026 Approval of Proficiency Testing Programs

History

Rulemaking Authority 483.051 FS. Law Implemented 483.051 FS. History–New 11-20-94, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.027 Proficiency Testing Programs by Specialty and Subspecialty

History

Rulemaking Authority 483.051 FS. Law Implemented 483.051 FS. History–New 11-20-94, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.028 Patient Test Management

History

Rulemaking Authority 483.051 FS. Law Implemented 483.051, 483.181 FS. History–New 11-20-94, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.029 General Quality Control Requirements for Non-waived Testing

History

Rulemaking Authority 483.051 FS. Law Implemented 483.051 FS. History–New 11-20-94, Amended 6-22-06, 2-27-17, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.030 Special Requirements for Licensure: Specialties and Subspecialties

History

Rulemaking Authority 483.051 FS. Law Implemented 483.051 FS. History–New 11-20-94, Amended 12-27-95, 6-22-06, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.031 Quality Assurance

History

Rulemaking Authority 483.051 FS. Law Implemented 483.051 FS. History–New 11-20-94, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.032 Inspection of Laboratories

History

Rulemaking Authority 483.051 FS. Law Implemented 483.061, 483.221 FS. History–New 11-20-94, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.033 Acceptance of Accreditation Inspections

History

Rulemaking Authority 483.051 FS. Law Implemented 483.051, 483.061 FS. History–New 11-20-94, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.034 Alternate-Site Testing

History

Rulemaking Authority 483.051, 408.819 FS. Law Implemented 408.806, 408.813, 408.814, 408.816, 483.051, 483.181, 483.201, 483.221, 483.23 FS. History–New 12-27-95, Amended 12-8-09, 12-29-10, 10-30-11, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.035 Staffing Requirements

History

Rulemaking Authority 483.051 FS. Law Implemented 483.035, 483.051, 483.111 FS. History–New 11-20-94, Amended 12-27-95, 7-27-09, 5-13-12, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.036 Fees

History

Rulemaking Authority 483.051 FS. Law Implemented 483.051, 483.172 FS. History–New 11-20-94, Amended 3-25-03, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.037 Rebates Prohibited – Penalties

History

Rulemaking Authority 483.051 FS. Law Implemented 483.221, 483.245 FS. History–New 11-20-94, Amended 12-27-95, Repealed 9-9-18.

Fla. Admin. Code R. 59A-7.038 Administrative Hearings

History

Rulemaking Authority 483.051 FS. Law Implemented 483.051 FS. History–New 11-20-94, Repealed 2-20-12.

Fla. Admin. Code R. 59A-7.039 Administrative Enforcement

History

Rulemaking Authority 483.051 FS. Law Implemented 483.201, 483.221 FS. History–New 11-20-94, Repealed 2-20-12.

Chapter 59A-8 MINIMUM STANDARDS FOR HOME HEALTH AGENCIES

Fla. Admin. Code R. 59A-8.001 Purpose

History

Rulemaking Authority 400.497 FS. Law Implemented 400.497 FS. History–New 4-19-76, Formerly 10D-68.01, 10D-68.001, Amended 10-27-94, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.002 Definitions

(1) “Accrediting organization” means the Community Health Accreditation Partner, The Joint Commission, or Accreditation Commission for Health Care.

(2) “AHCA” means Agency for Health Care Administration.

(3) “Assistance with activities of daily living” means a certified nursing assistant or a home health aide provides to the patient individual assistance with activities of daily living, including the following:

(a) Ambulation. Providing physical support to enable the patient to move about within or outside of the patient’s place of residence. Physical support includes holding the patient’s hand, elbow, under the arm, or holding on to a support belt worn by the patient to assist in providing stability or direction while the patient ambulates.

(b) Bathing. Helping the patient in and out of the bathtub or shower being available while the patient is bathing. Can also include washing and drying the patient.

(d) Eating. Helping with feeding patients who require assistance in feeding themselves.

(e) Personal hygiene. Helping the patient with shaving. Assisting with oral, hair, skin and nail care.

(f) Toileting. Reminding the patient about using the toilet, assisting him to the bathroom, helping to undress, positioning on the commode, and helping with related personal hygiene, including assistance with changing of an adult brief. Also includes assisting with positioning the patient on the bedpan, and helping with related personal hygiene.

(g) Assistance with physical transfer. Providing verbal and physical cueing, physical assistance, or both while the patient moves from one position to another, for example between the following: a bed, chair, wheelchair, commode, bathtub or shower, or a standing position. Transfer can also include use of a mechanical lift, if a home health aide is trained in its use.

(h) Assistance with self-administered medication, as defined in subsection 59A-8.0095(5), F.A.C.

(4) “Caregiver” means a person who has been entrusted with or has assumed the responsibility for frequent and regular care of or services to a disabled adult or an elderly person on a temporary or permanent basis and who has a commitment, agreement, or understanding with that person or that person’s guardian that a caregiver role exists. Caregivers include, for example, relatives, household members, guardians, friends, neighbors, and employees and volunteers of facilities.

(5) “Case management” means the initial assessment of the patient and caregiver for appropriateness of and acceptance for home health services; establishment and periodic review of a plan of care; implementation of medical treatment when ordered; referral, follow-up, provision of, evaluation of and supervision of care; coordination of services given by other health care providers; discharge of the patient upon conclusion of services; and documentation of all activities and findings.

(6) “Dietetics and nutrition practice” means assessing nutrition needs and status using appropriate data; recommending dietary regimens, nutrition support, and nutrient intake; improving the patient’s health status through nutrition counseling and education.

(7) “Dietitian/Nutritionist” means a person licensed to engage in dietetics and nutrition practice pursuant to Chapter 468, F.S.

(8) “Drop-off site” means any location in any county within the geographic service area of the main office, pursuant to subsection 59A-8.003(7), F.A.C.

(9) “Emergency Management Plan” means a comprehensive plan developed by the home health agency describing how the agency will prepare for and respond in an emergency, pursuant to Rule 59A-8.027, F.A.C.

(10) “Employee leasing company” means a company licensed and regulated under Chapter 468, Part XI, F.S. An employee leased to a home health agency by an employee leasing company shall be deemed to be an employee of the home health agency for licensure purposes pursuant to Section 468.534, F.S.

(11) “Full-time equivalent” means when an employee works between 37 to 40 hours per week.

(12) “Geographic service area” means one or more counties within a health service planning district defined in Section 408.032(5), F.S., as specified on the license, in which the home health agency may send its personnel to provide home health services to patients in their places of residence.

(13) “Home infusion therapy services” means teaching, assessment, evaluation and clinical services related to the administration of intravenous substances provided by a professional licensed under Chapter 464, 458 or 459, F.S.

(14) “Main office” means the primary office established in the county which houses all components of the home health agency including the administration, fiscal management, service provision and supplies.

(15) “Nursing care” means treatment of the patient’s illness or injury by a registered nurse or a licensed practical nurse that is ordered as required in Section 400.487(2), F.S. and included in the plan of care.

(16) “Nutrition assessment” means the evaluation of the nutrition needs of the patient using appropriate data to determine nutrient needs or status and make nutrition recommendations for the patient.

(17) “Nutrition counseling” means advising and assisting the patient on appropriate nutrition intake by integrating information from the nutrition assessment.

(18) “Occupational therapist” means a person licensed to practice occupational therapy pursuant to Chapter 468, F.S.

(19) “Occupational therapy assistant” means a person licensed to assist in the practice of occupational therapy pursuant to Chapter 468, F.S.

(20) “Patient” means an individual who receives home health services in one’s place of residence.

(21) “Plan of Care” means a coordinated plan, which includes the treatment orders, prepared by the case manager in collaboration with each professional discipline providing service to the patient and caregiver.

(22) “Physical therapist” means a person licensed to practice physical therapy pursuant to Chapter 486, F.S.

(23) “Physical therapy assistant” means a person licensed to assist in the practice of physical therapy pursuant to Chapter 486, F.S.

(24) “Physician” means a doctor of medicine, osteopathy, podiatry, or chiropractic legally authorized to practice in the state pursuant to Chapter 458, 459, 460 or 461, F.S. Physicians working in Veterans Administration hospitals and clinics are exempt from state licensure according to Chapter 458, F.S.

(25) “Quality assurance plan” means a plan which is developed and implemented by a home health agency to review and evaluate the effectiveness and appropriateness of service provision to patients and, upon identification of problems, requires specific action to correct the problems and deficiencies.

(26) “Respiratory therapist” means a person licensed to practice respiratory therapy pursuant to Chapter 468, F.S.

(27) “Satellite office” means a related office established in the same geographic service area as the main office, pursuant to subsection 59A-8.003(5), F.A.C.

(28) “Social Worker” means a person who has a degree in social work and who works with patients and families to help them adjust to the social and emotional factors related to the patient’s health problems.

(29) “Special needs patients” pursuant to Section 252.355, F.S., means those persons who have physical or mental conditions that require limited medical and nursing oversight during emergency evacuations. They are medically dependent individuals who are not acutely ill.

(30) “Special needs registry” pursuant to Section 252.355, F.S., means a registry maintained by the local emergency management agency of persons who need assistance during evacuations and sheltering because of physical or mental handicaps.

(31) “Speech pathologist” means a person licensed to practice speech pathology or audiology pursuant to Chapter 468, F.S.

(32) “Treatment orders” means written orders signed by a physician, physician assistant, or advanced practice registered nurse, acting within his or her respective scope of practice, which authorizes the provision of care or treatment to a patient in his place of residence by registered nurses, licensed practical nurses, physical therapists, occupational therapists, speech therapists, or dietitians/nutritionists.

History

Rulemaking Authority 400.497 FS. Law Implemented 400.462, 400.487 FS. History–New 4-19-76, Formerly 10D-68.02, Amended 4-30-86, 8-10-88, 5-30-90, 5-27-92, Formerly 10D-68.002, Amended 4-27-93, 10-27-94, 1-17-00, 7-18-01, 9-22-05, 8-15-06, 3-29-07, 7-11-13, 7-27-16, 1-5-21, 5-5-26.

Fla. Admin. Code R. 59A-8.0025 Telephone Reporting

History

Rulemaking Authority 400.497 FS. Law Implemented 400.497 FS. History–New 5-30-90, Formerly 10D-68.0025, Amended 10-27-94, 1-17-00, 7-18-01, Repealed 5-14-12.

Fla. Admin. Code R. 59A-8.0028 Agencies Exempt from Licensure as Home Health Agencies

History

Rulemaking Authority 400.497 FS. Law Implemented 400.462 FS. History–New 10-27-94, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.003 Licensure Requirements

(1) The issuance of a home health agency license shall be based upon compliance with Chapters 400, Part III, and 408, Part II, F.S., and rule Chapters 59A-8 and 59A-35, F.A.C., and an inspection as required in Sections 400.471(2) and 408.806(7), F.S. An application for initial, change of ownership, or renewal licensure, or for the addition of skilled services by a home health agency that is currently licensed to provide services other than skilled services, shall be submitted as required by Rules 59A-35.040 and 59A-35.060, F.A.C.

(2) Surveys of Home Health Agencies:

(a) Home health agencies will be surveyed by AHCA or an accrediting organization as defined in Rule 59A-8.002, F.A.C., pursuant to Sections 400.471(2), 408.806 and 408.811, F.S. Home health agencies will be surveyed prior to initial licensure, and at least every 36.9 months on an unannounced basis thereafter. Follow up surveys may be conducted to verify correction of deficiencies at any time on an unannounced basis.

(b) It is the responsibility of the home health agency to request exemption from state licensure surveys pursuant to Section 400.471(2), F.S., by submitting documentation of accreditation by an approved accrediting organization and the most recent accreditation survey report from the accrediting organization to the AHCA Laboratory and In-Home Services Unit.

(c) Home health agencies that complete paragraph (a), will not be subject to licensure surveys by AHCA except under the following circumstances:

The home health agency has been denied accreditation, has received a preliminary determination of denial of accreditation, or has received a provisional, conditional, or deferred accreditation report from the accrediting organization on its most recent survey, or
The home health agency has received accreditation but has not authorized the release of the accreditation survey report to the AHCA, or has not ensured that AHCA has received the accrediting organization’s survey report.
If the home health agency elects to give up its accreditation, the home health agency will inform AHCA by providing a copy of the letter it sent to its accrediting organization that shows the accreditation termination date.

(3) AHCA will conduct investigations of complaints regarding licensure violations as required in Section 408.811, F.S.

(4) An application for a change of ownership shall be made on the forms prescribed by AHCA, as referenced in subsection (1) of this rule.

(a) At the time of the transfer of ownership all patient or client records held by the current licensee shall be transferred to the applicant.

(b) AHCA will accept the most recent successful licensure inspection conducted no more than 36.9 months prior to the effective date of the change of ownership as satisfaction of the inspection requirement in Section 408.806(7), F.S. related to an application associated with a change in ownership of a licensed home health agency. Acceptance of the inspection does not alter the survey timeframes established in paragraph (3)(a).

(c) Failure to apply for a change of ownership of a licensed home health agency as required by Section 408.806(2)(b), F.S., shall result in a fine pursuant to Sections 400.474(1), (2)(a) and 408.813(3)(b), F.S. This is also applicable to owners who incorporate and do not report this change of ownership to the home health agency.

(5) A licensed home health agency may operate a satellite office. A satellite office must be located in the same geographic service area as the agency’s main office and share administration, fiscal management, supervision, and service provision with the main office; it is not separately licensed. Supplies and records can be stored at a satellite office and phone business can be conducted the same as in the main office. The administrator at the main office is responsible for the staffing, patients, and operation of any satellite office. Signs and advertisements can notify the public of the satellite office location. If the agency wants to open an office outside of the geographic service area where the main office is located, the office must be separately licensed.

(6) A home health agency that operates a satellite office must:

(a) Ensure coverage of the professional staff which takes into account the projected number of clients to be served at the satellite office;

(b) Coordinate care and services by staff;

(d) Maintain a system of communication and integration of services between the main office and the satellite office;

(e) Provide access to patient records at the satellite office;

(f) Monitor the daily activities (clinical and administrative) and the management of services, as well as personnel and administrative issues at the satellite office;

(g) Ensure periodic onsite visits to each satellite office by the home health agency’s administrator;

(h) Make the satellite office’s hours of operation available to the public if different than the hours of operation maintained by the main office.

(7) A licensed home health agency may operate a drop-off site in any county within the geographic service area specified on the license. A drop-off site may be used for pick-up or drop-off of supplies or records, for agency staff to use to complete paperwork or to communicate with the main office, existing or prospective agency staff, or the agency’s existing patients or clients. Prospective patients or clients cannot be contacted and billing cannot be done from this location. The drop-off site is not a home health agency office, but merely a work station for direct care staff in large areas where the distance is too great for staff to drive back frequently to the home health agency office. Training of home health agency staff can be done at a drop-off site. A drop-off site shall not require a license. No other business shall be conducted at these locations, including housing of records. The agency name cannot appear at the location, unless required by law or by the rental contract, nor can the location appear on agency letterhead or in advertising.

(8) If a change of address is to occur, or if a home health agency intends to change the counties served within the geographic service area, or open or close a satellite office or drop-off site, the home health agency must complete and submit the Health Care Licensing Application within the timeframe prescribed in paragraph 59A-35.040(2)(b), F.A.C. For an address change of the main office or satellite office, the home health agency must submit to the AHCA evidence that the location is zoned for a home health agency business for the new address and evidence of legal right to occupy the property in accordance with Section 408.810(6), F.S.

(9) A home health agency has the following responsibility in terms of hours of operation:

(a) The home health agency administrator and director of nursing, or their alternates, must be available to the public for any eight consecutive hours between 7:00 a.m. and 6:00 p.m., Monday through Friday of each week, excluding legal and religious holidays. Available to the public means being readily available on the premises or by telecommunications.

(b) When the administrator and the director of nursing are not on the premises during designated business hours, a staff person must be available to answer the phone and the door and must be able to contact the administrator and the director of nursing by telecommunications. This individual can be a clerical staff person.

(c) If an AHCA surveyor arrives on the premises to conduct an unannounced survey and the administrator, the director of nursing, or a person authorized to give access to patient records, are not available on the premises they, or the designated alternate, must be available on the premises within an hour of the arrival of the surveyor. A list of current patients must be provided to the surveyor within two hours of arrival if requested.

(d) The home health agency shall have written policies and procedures governing 24 hour availability to licensed professional nursing staff by active patients of the home health agency receiving skilled care. These procedures shall describe an on-call system whereby designated nursing staff will be available to directly communicate with the patient. A home health agency that does not provide skilled services shall have written policies and procedures which address the availability of a registered nurse supervisor during hours of patient service.

(e) Failure to be available or to respond during a survey or inspection will be grounds for denial or revocation of the agency license in accordance with Section 408.806(7), F.S.

(10) Upon revocation, suspension, voluntary or involuntary termination of a license, the home health agency shall return its license to AHCA. If the provider voluntarily chooses to terminate the license, the provider must notify AHCA, as required in Section 408.810(4)(a), F.S. This includes submitting a letter to the AHCA Laboratory and In-Home Services Unit, 2727 Mahan Drive, Mail Stop #32, Tallahassee, Florida 32308, officially declaring the closure date of the home health agency.

History

Rulemaking Authority 400.497, 408.819 FS. Law Implemented 400.464, 400.471, 400.474, 400.484, 400.497, 408.806, 408.807, 408.810 FS. History–New 4-19-76, Formerly 10D-68.03, Amended 4-30-86, 8-10-88, 5-30-90, 6-12-91, Formerly 10D-68.003, Amended 4-27-93, 10-27-94, 1-30-97, 1-17-00, 7-18-01, 9-22-05, 8-15-06, 3-29-07, 7-11-13, 6-16-15, 7-27-16, 1-5-21, 1-26-26.

Fla. Admin. Code R. 59A-8.0035 License Fees

History

Rulemaking Authority 400.497 FS. Law Implemented 400.491 FS. History–New 10-27-94, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.0038 Application for Licensure

History

Rulemaking Authority 400.497 FS. Law Implemented 400.491 FS. History–New 10-27-94, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.004 Licensure Procedure

History

Rulemaking Authority 400.497 FS. Law Implemented 400.471, 400.512, 408.810, 408.806, 408.8065, 408.809 FS. History–New 4-19-76, Formerly 10D-68.04, Amended 4-30-86, 8-10-88, 5-30-90, 6-12-91, 10-6-91, Formerly 10D-68.004, Amended 4-27-93, 10-27-94, 1-30-97, 1-17-00, 7-18-01, 9-22-05, 8-15-06, 3-29-07, 7-11-13, 6-16-15, Repealed 2-1-18.

Fla. Admin. Code R. 59A-8.005 Certificates of Exemption and Exempt Status

(1) Persons, organizations, and entities, hereafter referred to as entities, exempt from home health agency license requirements are set forth in Section 400.464(5), F.S. An entity is not required to have, but may voluntarily apply for a certificate of exemption.

(2) Entities that claim an exemption, either by filing an application for a certificate of exemption with the AHCA and receiving a certificate of exemption, or self-determining, must maintain an exempt status at all times of operation.

(3) An applicant for a certificate of exemption from the home health agency licensure requirements must apply as required by Rules 59A-35.040 and 59A-35.060, F.A.C.

(4) The applicant for a certificate of exemption must affirm:

(a) The specific exemption sought pursuant to Section 400.464(5), F.S.;

(b) The qualifying requirements for obtaining and maintaining an exempt status;

(c) The current existence of applicable exemption-qualifying health care practitioner licenses, qualified ownership, qualified certifications or registration of the entity;

(d) The federal employer identification number;

(e) Proof of legal existence and fictitious name, when the entity and name are required to be filed with the Division of Corporations, Department of State; and

(f) Other satisfactory proof required by the form adopted by this rule.

(5) The fee for issuance of a certificate of exemption is required to be submitted to AHCA with the application.

(a) Applications received without the requisite fee shall be returned to the applicant unprocessed.

(b) When the payment of a certificate fee has been dishonored, the applicant has 10 days from the date of notification to remit to AHCA the certificate fee plus any applicable fees as provided by law in the form of a money order or cashier’s check. If the certificate fee is not paid, the application will be withdrawn or the certificate will be revoked.

(6) Upon receipt of an application for a certificate of exemption, AHCA shall examine the application and, within 30 days after receipt, notify the applicant in writing of any apparent errors or omissions and request any additional information required.

(7) Requested information omitted from an application for a certificate of exemption must be filed with AHCA within 21 days after AHCA’s request for omitted information or the application shall be deemed incomplete and shall be withdrawn from further consideration and the fees shall be forfeited.

(8) An application for a certificate of exemption from home health agency licensure shall be approved or denied by AHCA within 60 days of receipt of a completed application.

(9) A certificate of exemption, unless sooner surrendered or revoked, shall automatically expire two years from the date of issuance, and shall be renewable biennially, provided that the person, organization or entity continues to meet the requirements established under Chapter 400, Part III, F.S., and Rule 59A-8.005, F.A.C.

(10) An application for renewal of the certificate of exemption must be submitted to AHCA 60 to 120 days prior to the date of expiration of the certificate of exemption.

(11) An application to change the name or address of the certificate of exemption must be submitted to AHCA 21 to 120 days in advance of the requested effective date.

(12) Whenever an entity discontinues operation, the entity shall notify AHCA in writing, prior to the discontinuance of operation, by submitting a letter to the AHCA Laboratory and In-Home Services Unit, 2727 Mahan Drive, Mail Stop #32, Tallahassee, Florida 32308 or via email at HQAHomeHealth@ahca.myflorida.com, including the effective date of closure. The entity shall remain responsible for retaining and appropriately distributing all medical records.

(13) If the applicant is required to register or file with the Florida Secretary of State, Division of Corporations, the principal, fictitious name and mailing addresses submitted on the application for the applicant must be the same as the information registered with the Division of Corporations.

(14) An entity becomes a “home health agency” as defined in Section 400.462(12), F.S., when the provision of home health services and staffing services no longer meet any of the qualifications for an exemption under Section 400.464(5), F.S. An entity’s exempt status expires when a change occurs that negates an entity’s qualification for exemption. In such a case, the home health agency must file a license application with AHCA as required in Sections 400.471 and 408.806, F.S., and shall be subject to all provisions applicable to an unlicensed home health agency. Failure to timely file an application for licensure may render the home health agency unlicensed and subject the entity to sanctions under Sections 400.484 and 408.812, F.S.

(15) AHCA will deny or revoke a certificate of exemption for the following actions by the applicant or owner:

(a) False representation of a material fact in the application or omission of any material fact from the application.

(b) Failure to meet exemption criteria in Section 400.464(5), F.S.

(16) Certificates of exemption are not transferable, directly or indirectly. They are valid only for the person, organization, or entity, licenses, registrations, certifications and services provided under specific statutory exemptions and are valid only to the specific exemption claimed and granted. In order for a certificate of exemption to be valid the entity must apply for and receive an amended certificate of exemption for changes of name or location.

History

Rulemaking Authority 400.497 FS. Law Implemented 400.464(5), 400.464(6) FS. History–New 5-9-19, Amended 2-27-22, 6-11-25, 1-26-26.

Fla. Admin. Code R. 59A-8.007 Geographic Service Area

(1) An applicant for initial licensure, change of ownership, or the addition of skilled care services must apply for one or more counties within a geographic service area in which the main office is located on the Health Care Licensing Application, Home Health Agency, AHCA Form 3110-1011, July 2024, incorporated by reference in paragraph 59A-35.060(3)(k), F.A.C., pursuant to Sections 408.032(5) and 400.497(9), F.S.

(2) In any request for expansion of the geographic service area, the home health agency’s previous history of survey results and administrative actions including fines, suspensions, revocations or injunctions will be reviewed to establish the home health agency’s ability to provide quality services within the requested area. In addition, the application for an expanded geographic service area must include a plan for:

(a) Coverage of the professional staff which takes into account the projected number of clients in the requested geographic service area; and,

(b) Supervision of the staff in the requested geographic service area.

(3) The counties listed on the home health agency license should reflect counties in which the home health agency expects to provide services. If an agency refuses to serve patients or clients residing in a specific county and that county is listed on the agency’s license, AHCA shall remove that county from the agency’s license. Refusal to provide services to a patient or client solely based on their residence in a specific county must be verified by AHCA prior to removing the county from the license. A home health agency shall not provide services to patients or clients residing in a county that is not listed on the agency’s license.

History

Rulemaking Authority 400.497 FS. Law Implemented 400.497 FS. History–New 10-27-94, Amended 1-17-00, 7-18-01, 6-16-15, 7-27-16, 1-12-21, 6-11-25, 7-8-26.

Fla. Admin. Code R. 59A-8.008 Scope of Services

(1) In cases of patients requiring only nursing, or in cases requiring nursing and physical, respiratory, occupational or speech therapy services, or nursing and dietetic and nutrition services, the agency shall provide case management by a licensed registered nurse who is a direct employee of or is under contract with the agency.

(2) In cases of patients receiving only physical, speech, respiratory or occupational therapy services, or in cases of patients receiving only one or more of these therapy services and home health aide services, case management shall be provided by the licensed therapist, who is a direct employee of or is under contract with the agency.

(3) In cases of patients receiving only dietetic and nutrition services, case management shall be provided by the licensed dietitian/nutritionist who is a direct employee of or is under contract with the agency.

(4) The agency’s application for licensure shall state explicitly what services will be provided directly by agency employees or by contracted personnel, if services are provided by contract. The home health agency shall provide at least one service directly to patients.

(5) A home health agency which directly contracts with a resident of an assisted living facility or adult family care home to provide home health services shall coordinate with the facility or home regarding the resident’s condition and the services being provided in accordance with the policy of the facility or home and if agreed to by the resident or the resident’s representative. The home health agency shall retain responsibility for the care and services it provides and it shall avoid duplication of services by not providing care the assisted living facility is obligated, by resident contract, to provide to the patient.

(6) If a home health agency occupies space within a licensed assisted living facility, and this space is not licensed as a home health agency, the home health agency must notify AHCA, in writing, whether the space is a satellite office or a drop-off site, as defined in Rule 59A-8.002, F.A.C.

History

Rulemaking Authority 400.487, 400.497, 400.509 FS. Law Implemented 400.497 FS. History–New 4-19-76, Formerly 10D-68.08, Amended 4-30-86, 8-10-88, 5-30-90, Formerly 10D-68.008, Amended 10-27-94, 1-17-00, 7-18-01, 9-22-05, 5-5-26.

Fla. Admin. Code R. 59A-8.0086 Denial, Suspension, Revocation of License and Imposition of Fines

History

Rulemaking Authority 400.497 FS. Law Implemented 120.59, 400.474, 400.484 FS. History–New 10-27-94, Amended 1-17-00, 7-18-01, 9-22-05, 8-15-06, 3-29-07, Repealed 10-2-11.

Fla. Admin. Code R. 59A-8.0088 Right of Inspection

History

Rulemaking Authority 400.497 FS. Law Implemented 400.484 FS. History–New 10-27-94, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.009 Personnel Policies

History

Rulemaking Authority 400.478, 400.497 FS. Law Implemented 400.497 FS. History–New 4-19-76, Formerly 10D-68.09, Amended 4-30-86, 8-10-88, 5-30-90, 6-21-91, Formerly 10D-68.009, Amended 4-27-93, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.0095 Personnel

(1) Administrator.

(a) The administrator of the agency shall:

Meet the criteria as defined in Sections 400.462(1) and 400.476(1), F.S.
Designate, in writing a direct employee or an individual covered under a management company contract to manage the home health agency or an employee leasing contract that provides the agency with full control over all operational duties and responsibilities to serve as an on-site alternate administrator during absences of the administrator. This person will be available during designated business hours, when the administrator is not available. Available during designated business hours means being readily available on the premises or by telecommunications. During the absence of the administrator, the alternate administrator will have the responsibility and authority for the daily operation of the agency. The alternate administrator must meet the criteria as defined in Section 400.462(1), F.S.
An alternate administrator may be the alternate administrator for up to five home health agencies if all five home health agencies have identical controlling interests as defined in s. 408.803 and are located within one agency geographic service area or within an immediately contiguous county.

(b) If an agency changes administrator or alternate administrator, the agency shall notify AHCA as required in subsection 59A-35.110(1), F.A.C., by submitting the application forms referenced in subsection 59A-8.003(1), F.A.C. Level 2 background screening compliance is required pursuant to Section 408.809, F.S., and Rule 59A-35.090, F.A.C.

(2) Director of Nursing.

(a) The director of nursing of the agency shall:

Meet the criteria as defined in Sections 400.462(10) and 400.476(2), F.S.;
Supervise or manage, directly or through qualified subordinates, all personnel who provide direct patient care;
Ensure that the professional standards of community nursing practice are maintained by all nurses providing care; and,
Maintain and adhere to agency procedure and patient care policy manuals.

(b) The director of nursing, the administrator, or alternate administrator shall establish policies and procedures on biomedical waste for home health agencies providing nursing and physical therapy services. The Department of Health website has information on biomedical waste handling and the requirements at www.doh.state.fl.us/Environment/Community/biomedical.

Establish policies and procedures that are consistent with recommended Centers for Disease Control (CDC) and Occupational Safety and Health Agency (OSHA) guidelines for safety, universal precautions and infection control procedures;
Employ and evaluate nursing personnel;
Coordinate patient care services;
Set or adopt policies for, and keep records of criteria for admission to service, case assignments and case management; and
Establish and adopt policies and procedures for the delegation process of nursing tasks and activities as specified in Chapter 64B9-14, F.A.C.

(d) Pursuant to Section 400.497(5)(a), F.S., the director of nursing shall establish a process to verify that skilled nursing and personal care services were provided. When requested by an AHCA employee, the director of nursing shall provide a certified report that lists the home health services provided by a specified direct service staff person or contracted staff person for a specified time period as permitted in Section 400.497(5)(b), F.S. A certified report shall be in the form of a written or typed document or computer printout and signed by the director of nursing. The report must be provided to the surveyor within two hours of the request, unless the time period requested is longer than one year, then the report must be provided within three hours of the request.

(e) The director of nursing shall establish and conduct an ongoing quality assurance program. The program shall include at least quarterly, documentation of the review of the care and services of a sample of both active and closed clinical records by the director of nursing or his or her delegate. The director of nursing assumes overall responsibility for the quality assurance program. The quality assurance program is to assure that:

The home health agency accepts patients whose home health service needs can be met by the home health agency;
Case assignment and management is appropriate, adequate, and consistent with the plan of care, medical regimen and patient needs. Plans of care are individualized based on the patient’s needs, strengths, limitations and goals;
Nursing and other services provided to the patient are coordinated, appropriate, adequate, and consistent with plans of care;
All services and outcomes are completely and legibly documented, dated and signed in the clinical service record;
The home health agency’s policies and procedures are followed;
Confidentiality of patient data is maintained; and,
Findings of the quality assurance program are used to improve services.

(f) In an agency with less than a total of 10 full time equivalent employees and contracted personnel, the director of nursing may also be the administrator.

(g) If the director of nursing serves as the director of nursing for more than two licensed home health agencies, then the director of nursing shall designate, in writing, an alternate director of nursing to serve during the director of nursing’s absence. This person will be available during designated business hours, when the director of nursing is not available. Available during designated business hours means being readily available on the premises or by telecommunications. The alternate director of nursing must meet the criteria as defined in Sections 400.462(10) and 400.476(2), F.S.

(h) If an agency changes the director of nursing or alternate director of nursing, the agency shall notify AHCA as required in Section 400.476(2)(b), F.S., by submitting the application forms referenced in paragraph 59A-35.060(3)(k), F.A.C. Level 2 background screening compliance is required pursuant to Section 408.809, F.S., and Rule 59A-35.090, F.A.C.

(i) An agency that does not provide skilled care is not required to have a director of nursing.

(3) Registered Nurse.

(a) A registered nurse shall be currently licensed to practice in the state, pursuant to Chapter 464, F.S. or hold an active multistate license under s. 464.0095 to practice professional nursing, and:

Be the case manager in all cases involving nursing or both nursing and therapy care;
Be responsible for the clinical record for each patient receiving nursing care;
Assure that progress reports are made to the physician, physicians assistant or advanced practice registered nurse for patients receiving nursing services when the patient’s condition changes or there are deviations from the plan of care; and
Provide nursing services within the scope of practice authorized by the license issued by the State of Florida for a registered nurse or an active multistate license under s. 464.0095 to practice professional nursing.

(b) Each home health agency that provides skilled care or non-skilled care may have an RN assign personal care tasks to licensed practical nurses, certified nursing assistants and home health aides. The registered nurse maintains full responsibility for personal care tasks assigned to home health aides or CNAs and must ensure the home health aide or CNA is qualified to carry out those assignments based on their training and experience.

(c) Each home health agency that provides skilled care or non-skilled care must have an RN provide supervisory visits of unlicensed assistive personnel, as defined in subsection 64B9-14.001(1), F.A.C., who are employed by or under contract with the home health agency, in accordance with Section 400.487(3), F.S. The agency must obtain written consent from the patient, or the patient’s guardian or legal representative, to send an RN into the home to conduct supervisory visits.

(d) The RN must provide on-site supervision as needed, based upon the severity of patient’s medical condition and the home health aide’s or CNA’s training and experience. Supervisory visits must be documented in patient files.

(e) Delegation of tasks for which additional training and validation is required. If the home health agency provides skilled care, an RN may delegate tasks in addition to assigned personal care tasks, including medication administration, to a home health aide or CNA qualified to perform the task pursuant to Rules 59A-8.0097, 59A-8.0219 and 59A-8.0216, F.A.C.

(4) Licensed Practical Nurse.

(a) A licensed practical nurse shall be currently licensed in the state, pursuant to Chapter 464, F.S., and provide nursing care assigned by and under the direction of a registered nurse who provides on-site supervision as needed, based upon the severity of patients medical condition and the nurse’s training and experience. Supervisory visits will be documented in patient files. Provision shall be made in agency policies and procedures for annual evaluation of the LPN’s performance of duties by the registered nurse.

(b) A licensed practical nurse shall:

Prepare and record clinical notes for the clinical record;
Report any changes in the patient’s condition to the registered nurse with the reports documented in the clinical record;
Provide care to the patient including the administration of treatments and medications within the scope of practice authorized by the license issued by the State of Florida for a licensed practical nurse; and,
Perform other duties assigned by the registered nurse.

(5) Home Health Aide and Certified Nursing Assistant.

(a) A home health aide or a certified nursing assistant (CNA) shall provide personal care services assigned by and under the supervision of a registered nurse. When only physical, speech, or occupational therapy is furnished, in addition to home health aide or CNA services, supervision can be supplied by a licensed therapist directly employed by the home health agency or by an independently contracted employee.

(b) Prior to a CNA providing services, the home health agency shall have documentation of the CNA’s current State of Florida certification. A CNA that is currently certified in another state may work as a home health aide in a home health agency in Florida if they present a copy of their current certificate as a nursing assistant from that state.

(c) Prior to a home health aide providing services, a home health agency shall have on file documentation of the home health aide’s successful completion of at least forty hours of training in the following subject areas or successful passage of the competency test as stated in section (i), pursuant to Section 400.497(1), F.S. Home health aide training must be performed by or under the general supervision of a registered nurse who possesses a minimum of two years nursing experience, one of which must have been in the provision of home health care. The training may be conducted in person, online, or through a hybrid program but must require the aide to demonstrate, in person, that he or she is able to perform the necessary skills associated with the subject areas listed below.

Communication skills;
Observation, reporting and documentation of patient or client status and the care or services provided;
Reading and recording vital signs to include temperature, pulse and respiration, and blood pressure;
Basic infection control procedures such as hand hygiene, personal protective equipment (PPE), bag technique, and equipment disinfection;
Basic elements of body functions that must be reported to the registered nurse supervisor including observation of new conditions or change in condition;
Maintenance of a clean and safe environment;
Recognition of emergencies and applicable follow-up within the home health aide scope of performance;
Physical, emotional, and developmental characteristics of the populations served by the agency, including the need for respect for the patient or client, his privacy, and his property;
Appropriate and safe techniques in personal hygiene and grooming, including bed bath, sponge, tub, or shower bath; shampoo, sink, tub, or bed; basic nail care to include filing and polishing the nails, but not clipping nails; basic skin care including washing, moisturizing, and applying lotion with positioning to prevent skin breakdown; oral hygiene; care of dentures; toileting including use of bedpan or urinal;
Safe transfer techniques, including use of appropriate equipment, and ambulation;
Assistance with basic range of motion exercises and positioning to prevent complications of immobility;
Basic nutrition and fluid intake, including following the prescribed diet, assistance with eating and drink, observing for signs of dehydration or inadequate intake and promoting regular eating and drink schedule;
Cultural differences in families;
Food preparation and household chores;
Assistance with self-administered medication. Home health aides and CNAs assisting with self-administered medication, pursuant to Section 400.488, F.S., must receive a minimum of 2 hours of training (which can be part of the 40 hour home health training) prior to assuming this responsibility. Training must cover state law and rule requirements with respect to the assistance with self-administration of medications in the home, procedures for assisting the patient with self-administration of medication, common medications, recognition of side effects and adverse reactions and procedures to follow when patients appear to be experiencing side effects and adverse reactions. Training must include verification that each CNA and home health aide can read the prescription label and any instructions. Individuals who cannot read must not be permitted to assist with prescription medications. Other courses taken in fulfillment of this requirement must be documented and maintained in the home health aide’s and the CNA’s personnel file.
Other topics pertinent to home health aide services.

(d) A home health aide seeking employment with a Medicare or Medicaid certified home health agency may be required to provide evidence of additional training incorporated within the Medicare Conditions for Participation, 42 C.F.R., Part 484, and available at https://ecfr.io/Title-42/Part-484.

(e) An individual may complete home health aide training through a home health agency licensed under Chapter 400, Part III, F.S., for the purpose of employment with the agency. If the home health aide completes the 40 hours of training in paragraph (5)(c) through a home health agency, and wishes to be employed at another agency, the individual must present the documentation of successful completion of the training to the employing home health agency.

(f) A home health aide who is licensed, certified or trained in another state must provide documentation of course completion to the employing home health agency as evidence of the required 40 hours of training in paragraph (5)(c). The course must include validation of the aide’s competency in person. Acceptable documentation includes a certificate, transcripts or other documentation that includes the issuing agency or institution name and address, school license number issued by the state, student name, course curriculum, total number of hours of training, number of hours for each topic, signature and qualifications of person directing or approving the training, and date the training was completed.

(g) A home health aide who successfully completes training through a vocational school or a nonpublic post-secondary career school approved by Florida Department of Education (Department) must provide documentation of course completion to the employing home health agency as evidence of the required 40 hours of training in paragraph (5)(c). The course must include validation of the aide’s competency in person. Acceptable documentation includes a certificate, transcripts or other documentation that includes the issuing agency or institution name and address, school license number issued by the Department, student name, course curriculum, total number of hours of training, number of hours for each topic, signature and qualifications of person directing or approving the training, and date the training was completed.

(h) A home health agency that teaches the home health aide course to their employees pursuant to Section 400.497(1), F.S., but is not classified as a nonpublic post-secondary career school by the Florida Department of Education, must issue the following documentation to individuals at the time of successful completion of the training course. The training must include validation of the aide’s competency in person. The documentation must include the following: the title “Home Health Aide Training Documentation;” the name, address, phone number, and license number of the home health agency; the student’s name, address, phone number, and social security number; total number of clock hours completed in the training; the number of clock hours for each unit or topic of training; signature and qualifications of the person who directed the training; and the date the training was completed. It must be stated in the documentation that Section 400.497(1), F.S., permits the home health agency which is conducting this training to provide such documentation. The home health agency cannot charge a fee for the training and cannot use the words “diploma,” “certificate,” “certification of completion,” or “transcript” on the training documentation. The home health agency cannot advertise that they are offering training for home health aides. The agency can indicate they are hiring home health aides with the intention of providing training.

(i) A licensed home health agency may choose to administer the Home Health Aide Competency Test, AHCA 3110-1007, September 2025 in lieu of the forty hours of training required in paragraph 59A-8.0095(5)(d), F.A.C. This test is designed for home health agencies to determine competency of potential employees. Home health agencies may obtain the form by sending a request to HQAHOMEHEALTH@ahca.myflorida.com and including the name, address, and license number of the home health agency requesting the test.

Home health agencies that choose to administer the test, must maintain documentation of the aide’s successful passage of the competency test. However, if the home health aide does not pass the test, it is the decision of the home health agency giving the test as to whether the aide may take the test again. The home health agency may also provide training or arrange for training in the areas that were not passed on the test prior to the aide re-taking the test.

a. The Home Health Aide Competency Test has two parts: a practical part in which competency is determined through observation of the performance of tasks and a written part with questions to answer. Successful passage of the test means the accurate performance of all 14 tasks on the practical part plus correctly answering 90 of the 104 questions on the written part.

b. Successful passage of the competency test alone does not permit a home health aide to assist with self-administration of medication as described in Section 400.488, F.S. Any home health aide that will assist patients with self-administration of medications must have completed two hours of training on assistance with self-administered medication as required in subparagraph 59A-8.0095(5)(d)15., F.A.C.

Any staff person of a home health agency may administer the written portion of the test, but the practical competency test must be administered and evaluated by a registered nurse or a licensed practical nurse under the supervision of a registered nurse. The staff person, registered nurse, or licensed practical nurse may also be responsible for grading the written test.
When a home health aide completes the competency test through the employing agency and wishes to be employed at another agency, the home health agency shall furnish documentation of successful passage of the test to the requesting agency pursuant to Section 400.497(1), F.S. Documentation of successful passage may be provided in a format established by the home health agency, except as prohibited in paragraphs (5)(f)-(g), that specifies limitations on the manner in which a home health agency may describe home health aide training. The documentation, at minimum, should include the home health aide’s name, address and social security number; the home health agency’s name and address; date the test was passed; the signature of the person providing the documentation; and any other information necessary to document the aide’s passage of the test.

(j) When the home health aide training is provided by another institution, school, or home health agency it is the responsibility of the employing home health agency to validate the aide’s competency of training.

(k) Home health aides and CNA’s must receive in-service training each calendar year. Medicare and Medicaid agencies should check federal regulations for additional in-service training requirements. Home health aides and CNAs must also obtain and maintain current cardiopulmonary resuscitation (CPR) certification. Documentation of CPR certification from an instructor or training provider approved to provide CPR by the American Red Cross, the American Heart Association, the National Safety Council, or an organization whose training is accredited by the Commission on Accreditation for Pre-Hospital Continuing Education in which the student is required to demonstrate, in person, that he or she is able to perform cardiopulmonary resuscitation satisfies this requirement.

(l) Responsibilities of the home health aide and CNA shall include:

The performance of all personal care activities contained in a written assignment by a licensed health professional employee or contractor of the home health agency and which include assisting the patient or client with personal hygiene, ambulation, eating, dressing, shaving, physical transfer, and other duties as assigned.
Maintenance of a clean, safe and healthy environment, which may include light cleaning and straightening of the bathroom, straightening the sleeping and living areas, washing the patient’s or client’s dishes or laundry, and such tasks to maintain cleanliness and safety for the patient or client.
Other activities as taught by a licensed health professional employee or contractor of the home health agency for a specific patient or client and are restricted to the following:

a. Assisting with reinforcement of dressing;

b. Applying and removing anti-embolism stockings and hosiery prescribed for therapeutic treatment of the legs;

c. Assisting with tasks associated with elimination and toileting:

(I) Assisting with non-invasive medical devices for managing urinary incontinence.

(II) Assisting with the use of the bedpan and urinal.

(III) Providing catheter care including changing the urinary catheter bag.

(IV) Collecting urinary and/or stool specimens using non-invasive collection methods.

(V) Emptying urostomy or colostomy bags or changing bags that do not adhere to the skin.

(VI) Assisting with the placement and removal of colostomy bags, excluding the removal of the flange or manipulation of the stoma’s site.

d. Assisting with the use of devices for aid to daily living, such as a mechanical lift, wheelchair or walker;

e. Assisting with prescribed range of motion exercises;

f. Assisting with prescribed ice cap or collar;

g. Performing simple urine tests for sugar, acetone or albumin;

h. Assisting with the use of a glucometer to perform blood glucose testing;

i. Measuring and preparing prescribed or special diets;

j. Measuring intake and output of fluids, and,

k. Measuring vital signs including temperature, pulse, respiration or blood pressure.

l. Assisting with oxygen nasal cannulas and continuous positive airway pressure (CPAP) devices, excluding the titration of the prescribed oxygen levels.

Keeping records of personal health care activities.
Observing appearance and gross behavioral changes in the patient or client, reporting to the registered nurse.
Supervision of self-administered medication in the home is limited to the following:

a. Obtaining the medication container from the storage area for the patient or client;

b. Ensuring that the medication is prescribed for the patient or client;

c. Reminding the patient or client that it is time to take the medication as prescribed; and,

d. Observing the patient or client self-administering the medication.

(m) In cases where a home health aide or a CNA will provide assistance with self-administered medications in accordance with section 400.488, F.S., a review must be conducted by a registered nurse to ensure the patient is medically stable with the self-administration of routine, regularly scheduled medications. The Registered Nurse must review and reconcile all currently prescribed and over-the-counter medications to ensure the home health aide or CNA can provide assistance in accordance with their training.

(n) A licensed health care professional shall inform the patient, or the patient’s caregiver, that the patient may receive assistance with self-administered medication by an unlicensed person. The patient, or the patient’s caregiver, must give written consent for this arrangement, pursuant to Section 400.488(2), F.S.

(o) In providing assistance with self-administered medication, in addition to the requirements outlined in Section 400.488, F.S., a home health aide or CNA may:

Prepare necessary items such as juice, water, cups, or spoons to assist the patient in the self-administration of medication;
Open and close the medication container or tear the foil of prepackaged medications;
Assist the patient in the self-administration process. Examples of such assistance include the steadying of the arm, hand, or other parts of the patient’s body so as to allow the self-administration of medication;
Assist the patient by placing unused doses of solid medication back into the medication container.

(p) Responsibilities of the home health aide and CNA shall not include:

The performance of any therapeutic service that requires licensure as a health care professional;
Changing sterile dressings;
Irrigating body cavities such as giving an enema;
Performing irrigation of any wounds (such as vascular ulcers, diabetic ulcers, pressure ulcers, surgical wounds) or apply agents used in the debridement of necrotic tissues in wounds of any type;
Performing a gastric irrigation or enteral feeding;
Catheterizing a patient;
Administering any controlled substance listed in Schedule II, Schedule III, or Schedule IV of s. 893.03 or 21 U.S.C. s. 812.;
Applying heat by any method;
Caring for a tracheotomy tube;
Providing any personal health service which has not been included in the plan of care; or
Filling and removing medications from a pill organizer or electronic medication dispenser.

(q) Individuals who have graduated from an accredited school of nursing, and are waiting to take their boards for licensure in Florida, may work as a home health aide. RNs or LPNs who can show proof they are licensed in another state or in Florida, may work as a home health aide in Florida.

(r) Pursuant to Section 381.0035, F.S., all home health agency employees, with the exception of employees subject to the requirements of Section 456.033, F.S., must complete a one-time education course on HIV and AIDS, within 30 days of employment.

(6) Physical Therapist and Physical Therapist Assistant.

(a) The physical therapist shall be currently licensed in the state, pursuant to Chapter 486, F.S. The physical therapist assistant shall be currently licensed in the state, pursuant to Chapter 486, F.S.

Services provided by the physical therapist shall be performed within the scope of practice authorized by the license issued by the State of Florida for the practice of physical therapist.
Services provided by the physical therapist assistant will be provided under the general supervision of a licensed physical therapist and shall not exceed any of the duties authorized by the license issued by the State of Florida for the practice of physical therapist assistant. General supervision means the supervision of a physical therapist assistant shall not require on-site supervision by the physical therapist. The physical therapists shall be accessible at all times by two way communication, which enable the physical therapist to be readily available for consultation during the delivery of care.

(b) The responsibilities of the physical therapist are:

To provide physical therapy services as prescribed by a physician, physician assistant, or advanced practice registered nurse, acting within their scope of practice, which can be safely provided in the home and assisting the physician, physician assistant, or advanced practice registered nurse in evaluating patients by applying diagnostic and prognostic muscle, nerve, joint and functional abilities test;
To observe and record activities and findings in the clinical record and report to the physician, physician assistant, or advanced practice registered nurse the patient’s reaction to treatment and any changes in patient’s condition, or when there are deviations from the plan of care;
To instruct the patient and caregiver in care and use of physical therapy devices;
To instruct other health team personnel including, when appropriate, home health aides and caregivers in certain phases of physical therapy with which they may work with the patient; and,
To instruct the caregiver on the patient’s total physical therapy program.

(7) Speech Pathologist. The speech pathologist shall be currently licensed in the state, pursuant to Chapter 468, F.S., and shall:

(a) Assist the physician, physician assistant, or advanced practice registered nurse in evaluating the patient to determine the type of speech or language disorder and the appropriate corrective therapy;

(b) Provide rehabilitative services for speech and language disorders;

(c) Record activities and findings in the clinical record and to report to the physician, physician assistant, or advanced practice registered nurse the patient’s reaction to treatment and any changes in the patient’s condition, or when there are deviations from the plan of care; and,

(d) Instruct other health team personnel and caregivers in methods of assisting the patient to improve and correct speech disabilities.

(8) Occupational Therapist and Occupational Therapist Assistant.

(a) The occupational therapist shall be currently licensed in the state, pursuant to Chapter 468, F.S., and the occupational therapist assistant shall be currently licensed in the state, pursuant to Chapter 468, F.S. Duties of the occupational therapist assistant shall be directed by the licensed occupational therapist and shall be within the scope of practice authorized by the license issued by the State of Florida for the practice of occupational therapist assistant.

(b) The duties of the occupational therapist are:

To provide occupational therapy services as prescribed by a physician, physician assistant, or advanced practice registered nurse, acting within their scope of practice, which can be safely provided in the home and to assist the physician, physician assistant, or advanced practice registered nurse in evaluating the patient’s level of function by applying diagnostic and therapeutic procedures;
To guide the patient in the use of therapeutic, creative and self-care activities for the purpose of improving function;
To observe and record activities and findings in the clinical record and to report to the physician, physician assistant, or advanced practice registered nurse the patient’s reaction to treatment and any changes in the patient’s condition, or when there are deviations from the plan of care; and,
To instruct the patient, caregivers and other health team personnel, when appropriate, in therapeutic procedures of occupational therapy.

(9) Respiratory Therapist.

(a) The respiratory therapist shall be currently licensed by the state pursuant to Chapter 468, F.S., and have at least one year of experience in respiratory therapy.

(b) The responsibilities of the respiratory therapist are:

To provide respiratory therapy services, prescribed by a physician, physician assistant, or advanced practice registered nurse, acting within their scope of practice, which can be safely provided in the home and to assist the physician, physician assistant, or advanced practice registered nurse in evaluating patients through the use of diagnostic testing related to the cardiopulmonary system;
To observe and record activities and findings in the clinical record and report to the physician, physician assistant, or advanced practice registered nurse the patient’s reaction to treatment and any changes in the patient’s condition, or when there are deviations from the plan of care;
To instruct the patient and caregiver in care and use of respiratory therapy devices;
To instruct other health team personnel including, when appropriate, home health aides and caregivers in certain phases of respiratory therapy in which they may assist the patient; and,
To instruct the patient and caregiver on the patient’s total respiratory therapy program.

(10) Social Worker.

(a) The social worker shall be a graduate of an accredited school of social work with one year of experience in social services and shall:

Assist the physician, physician assistant, or advanced practice registered nurse and other members of the health team in understanding significant social and emotional factors related to the patient’s health problems;
Assess the social and emotional factors in order to estimate the patient’s capacity and potential to cope with problems of daily living;
Help the patient and caregiver to understand, accept and follow medical recommendations and provide services planned to restore the patient to optimum social and health adjustment;
Assist patients and caregivers with personal and environmental difficulties which predispose toward illness or interfere with obtaining maximum benefits from medical care; and,
Identify resources, such as caregivers and community agencies, to assist the patient to resume life in the community, including discharge planning, or to learn to live within his disability.

(b) The social worker shall not provide clinical counseling to patients or caregivers unless licensed pursuant to Chapter 491, F.S.

(11) Dietitian/Nutritionist.

(a) The dietitian/nutritionist shall be currently licensed in this state, pursuant to Chapter 468, F.S., with at least 1 year of experience in dietetics and nutrition practice.

(b) The responsibilities of the dietitian/nutritionist are:

To evaluate the nutrition needs of individuals in the home, using appropriate data to determine nutrient needs or status, and to make nutrition recommendations to the patient to maximize the patient’s health and well-being;
To provide dietetics and nutrition counseling in the home, as prescribed by a physician, physician assistant, or advanced practice registered nurse, acting within their scope of practice;
To observe and record activities and findings in the clinical record and report to the physician, physician assistant, or advanced practice registered nurse, the patient’s reaction to treatment and any changes in a patient’s condition;
To instruct the patient, caregiver(s), and other health team personnel in various phases of dietetic and nutrition treatment.

(12) Homemakers and Companions.

(a) The homemaker shall:

Maintain the home in an optimum state of cleanliness and safety depending upon the client’s and the caregiver’s resources;
Perform the functions generally undertaken by the customary homemaker, including such duties as preparation of meals, laundry, shopping, household chores, and care of children;
Perform casual, cosmetic assistance, such as brushing the client’s hair and assisting with make-up, filing and polishing nails but not clipping nails;
Stablize the client when walking, as needed, by holding the client’s arm or hand;
Report to the appropriate supervisor any incidents or problems related to his work or to the caregiver;
Report any unusual incidents or changes in the client’s behavior to the case manager; and,
Maintain appropriate work records.
If requested by the client or his responsible party, the homemaker may verbally remind the client that it is time to for the client to take his or her medicine.

(b) The companion shall:

Provide companionship for the client;
Accompanying the client to doctors appointments, recreational outings, or shopping;
Provide light housekeeping tasks such as preparation of a meal or laundering the client’s personal garments;
Perform casual, cosmetic assistance, such as brushing the client’s hair and assisting with make-up, filing and polishing nails but not clipping nails;
Stabilize the client when walking, as needed, by holding the client’s arm or hand;
Maintain a chronological written record of services; and,
Report any unusual incidents or changes in the patient’s behavior to the case manager.
If requested by the client or his responsible party, the companion may verbally remind the client that it is time for the client to take his or her medicine.

History

Rulemaking Authority 400.488, 400.497 FS. Law Implemented 400.476, 400.487, 400.488, 400.497 FS. History–New 1-20-97, Amended 1-17-00, 7-18-01, 9-22-05, 8-15-06, 7-11-13, 4-16-23, 5-31-26.

Fla. Admin. Code R. 59A-8.0097 Medication Training and Validation

(1) Home health aides and Certified Nursing Assistants (CNA) must receive training prior to providing services and each calendar year thereafter as required. Home health aides and CNAs performing tasks delegated by a registered nurse (RN), including medication administration, may require additional training and validation to be qualified to perform the tasks in the home setting. Training may be provided as in-service training unless otherwise specified in statute. Medicare and Medicaid agencies should check federal regulations for additional in-service training requirements.

(2) Definitions

(a) A medication administration route is the path through which medication is delivered to a patient. For the proposes this rule, routes of administration are defined as follows:

“Buccal” means medication is placed in the mouth between the cheek and gum.
“Enteral” means medication is delivered by oral route, sublingual or buccal route, or rectal route.
“Inhaled” means medication is administered as nose drops or nose spray, or medication is inhaled by mouth, such as with an inhaler or nebulizer.
“Ophthalmic” means solution or ointment medication is instilled into the eye or applied on or around the eyelid.
“Oral” means medication including, but not limited to, tablet, capsule, liquid, or powder form is introduced into the gastrointestinal tract by mouth.
“Otic” means solutions or ointment medication is placed in the outer ear canal or applied around the outer ear.
“Parenteral” means medication is injected into the body through some route other than the digestive tract, such as subcutaneous, intra-dermal, intra-muscular, or intravenous administration.
“Rectal” means any medication including, but not limited to, capsule, enema, gel, or suppository administered via the rectum.
“Sublingual” means medication is placed in the mouth under the tongue.
“Topical” means medication including, but not limited to, salve, lotion, ointment, cream, spray, shampoo, or solution applied locally to a body part.
“Transdermal” means a patch containing a pre-measured or measured amount of topical medication that is absorbed into the body via the epidermis (outer layer of skin).
“Vaginal” means any medication including, but not limited to, capsule, cream, or ointment that is administered via the internal vagina. This route does not include medications applied to the epidermis external to the vagina.

(3) Medication Training Course Curriculum.

(a) Home health aides and CNAs administering medication pursuant to Sections 400.489, 400.490 and 464.2035, F.S. must complete an initial 6-hour basic medication administration training course prior to assuming this responsibility and a 2-hour in-service medication training course annually thereafter.

(b) Basic medication administration training must be provided by an RN licensed under Chapter 464, F.S. or a physician licensed under Chapter 458 or 459, F.S. who has been in practice for at least 2 years.

(c) The training curriculum must require the home health aide or CNA to demonstrate the following in person, which must include, at minimum the ability to:

Read and understand a prescription label;
Administer oral, transdermal, ophthalmic, otic, inhaled, and/or topical medication routes;
Measure liquid medications, break scored tablets, and crush tablets in accordance with prescription directions;
Recognize the need to obtain clarification of an “as needed” prescription order;
Recognize a medication order which requires the judgment or discretion of an RN, and to advise the patient and the supervising RN of the inability to assist in the administration of such orders;
Complete a medication administration record (MAR) and fulfill related record keeping requirements;
Recognize the general signs of adverse reactions to medications and report such reactions;
Promote safety, sanitation and hand hygiene while administering medication; and
Medication error prevention and error reporting.

(4) Validation for Routes of Medication Administration.

(a) A home health aide or CNA must be assessed and validated as competent to administer medication by an RN after succsessfully completing required medication training.

(b) Successful validation requires the home health aide or CNA to demonstrate their capability to administer medication in a safe, sanitary and responsible manner in an on-site, patient-setting using the patient’s prescribed medications.

(c) The home health aide or CNA must achieve a score of 100% proficiency in the validation prior to administering medication.

(d) Validation must take place within 90 days of completing required medication training.

(e) Validation for medication administration includes a demonstration of the following:

The ability to comprehend and follow medication instructions on a prescription label, physician’s order, and properly complete a medication administration record form;
The ability to administer medication by oral, transdermal, ophthalmic, otic, inhaled, or topical administration routes, including prefilled insulin syringes if applicable;
The ability to obtain pertinent medication information, including the purpose of the medication, its common side effects, and symptoms of adverse reactions to the medication, either from the package insert that comes from the pharmacy, or other professionally recognized medication resource, and to maintain this information for easy access and future reference;
The ability to fulfill medication record keeping requirements; and
The ability to effectively communicate in a manner that permits health care providers and emergency responders to adequately and quickly respond to emergencies.

(5) Validations expire 1 year from the effective date of the validation. A home health aide or CNA must be revalidated within 60 days prior to the expiration of their validation to continue to administer medications as delegated by an RN.

(6) Documentation demonstrating completion of required training and validations by home health aides and CNAs must be kept on file by the home health agency.

History

Rulemaking Authority 400.489, 464.0156, 464.2035 FS. Law Implemented 400.489, 400.490, 464.0156, 464.2035 FS. History–New 5-24-23.

Fla. Admin. Code R. 59A-8.0099 Minimum Training Requirements for Home Health Aides for Medically Fragile Children

(1) A licensed home health agency that provides skilled care and accepts Medicaid may train and employ any person 18 years of age or older as a home health aide for medically fragile children as defined in section 400.462, F.S., hereafter referred to as an “AMFC,” that meets the eligibility requirements of section 400.4765, F.S., and has successfully completed required training.

(2) Home Health Agency Personnel. An AMFC is considered an employee of the home health agency pursuant to section 400.4765, F.S. An AMFC may only provide services to an eligible relative as defined in section 400.462, F.S., as assigned or delegated by, and under the supervision of, a registered nurse (RN). As an employee of the home health agency, the AFMC must complete a one-time educational course on HIV and AIDS, within 30 days of employment pursuant to section 381.0035, F.S. Additionally, the AFMC must obtain and maintain cardiopulmonary resuscitation (CPR) certification as described in paragraph 59A-8.0095(5)(k), F.A.C.

(a) Prior to an AMFC providing services, the home health agency shall have on file documentation of the aide’s successful completion of an approved training program as outlined by this rule.

(b) An AMFC shall provide services within the scope of their training as outlined by this rule and sections 400.4765 and 400.489, F.S., and may provide other services as taught by a licensed health professional employee or contractor of the home health agency for an eligible relative. A home health aide may be trained to become an AMFC provided they meet the requirements of sections 400.462 and 400.4765, F.S., and complete an approved training program as outlined by this rule. The home health agency must maintain policy and procedures regarding the services the AMFC may provide as taught and delegated by a RN per this rule and Rule 59A-8.0216, F.A.C.

(c) An RN employed or contracted with the home health agency must conduct supervisory visits of the AMFC at least every 60 days, or more frequently for federally certified agencies as described in 42 C.F.R. ss. 484.80. The home health agency must maintain documentation of such visits.

(d) Home health agencies that offer training in accordance with the minimum requirements outlined by this rule must document their course curriculum to be made available for review as requested by the Agency during an inspection. The training must be performed by an RN who possesses the qualifications as outlined by this rule and may not be performed by other staff under the general supervision of the RN. The training may be conducted in person, online, or through a hybrid program but must require the aide to demonstrate, in person, that he or she is able to perform the necessary skills associated with this rule and Rules 59A-8.0097, 59A-8.0216 and 59A-8.0219, F.A.C.

(e) A Medicare or Medicaid certified home health agency that employs an AMFC may be required to provide evidence of additional training incorporated within the Medicare Conditions for Participation, 42 C.F.R., Part 484, and available at https://ecfr.io/Title-42/Part-484.

(3) Approved AMFC Training Curriculum: Minimum Curriculum Requirements. The training curriculum must total at least 76 hours according to paragraphs (3)(a), (3)(b), and (3)(c) below. The home health agency shall be responsible for evaluating the AMFC’s competency and identifying any learning needs in accordance with the patient’s individualized plan of care. The home health agency must ensure that the aide receives sufficient training and instruction to address identified learning needs and to safely and effectively perform all tasks delegated under the plan of care. At minimum, the training curriculum must include the following sections:

(a) A minimum of forty (40) hours of home health aide training described in section 400.497, F.S. and Rule 59A-8.0095, F.A.C. The AFMC must present documentation of successful completion of training in the subject areas listed in paragraph 59A-8.0095(5)(c) F.A.C. This section of training must be performed by or under the general supervision of a qualified RN with a minimum of two years nursing experience, with at least one year in home health care. Acceptable documentation of training must meet the requirements in subsection 59A-8.0095(5) F.A.C. The Home Health Aide Competency Test shall not be administered in lieu of, nor shall prior passage substitute for, any portion of the training outlined by this rule.

(b) A minimum of twenty (20) hours of skills training in nursing specific to the care of the medically fragile pediatric patient as specified in the provider’s plan of care. This section of training must be conducted in person by a qualified RN with a minimum of two years nursing experience, with at least one year in pediatric nursing. The home health agency is responsible for determining that the skills training conforms to the delegable tasks under section 464.0156(1), F.S. This section of training may include the following as applicable to the child’s care needs per the individualized plan of care:

An overview of seizure disorders, epilepsy, seizure emergencies, and related first aid and rescue therapies.
Tracheostomy care including suctioning, regular cleaning or replacement of inner cannula, trach site care, dressing change, trach change and emergency management of desaturation, mucus plugging and dislodgement of trach tube.
Respiratory management including oxygen use and safety excluding the titration of the prescribed oxygen levels.
Enteral care and therapy. Instruction may cover different enteral feeding tubes specific to the child including nasogastric, nasoduodenal, nasojejunal, gastrostomy, jejunostomy, and gastrojejunal tubes, and gastronomy buttons. Instruction may cover related equipment, potential complications, and feeding methods to include:

a. Administering enteral feedings: bolus intermittent, cyclic intermittent, intermittent drip, and continuous infusion.

b. Equipment including syringes, feeding bags, and feeding pumps.

c. Formula types and preparation.

d. Complications including tube-related mechanical, infectious, gastrointestinal, aspiration pneumonia, and metabolic complications, and complications associated with tube placement.

Assisting with prescribed medical equipment, supplies and devices including oxygen, walkers, wheelchairs, hospital beds, ventilator, C-Pap and BiPap machines, peak flow meters, nebulizers, CPT vests, and apnea monitoring equipment, excluding the titration of the prescribed oxygen levels.
Skin care including pressure sore prevention and wound care.
Ostomies including ileostomies, colostomies and urostomies, maintaining a healthy stoma and emptying and changing the ostomy pouch or bag. Assisting with the placement and removal of colostomy bag, excluding the removal of the flange or manipulation of the stoma’s site.
Tasks associated with elimination and toileting, including assistance with the use of a bedpan, urinal and other non-invasive elimination devices.
Urinary catheter care including catheter position, hydration, hygiene, complications, emptying the bag, changing the catheter bag, removing and inserting a foley catheter.
End-of-life care and postmortem care.
Intravenous assistive care activities including care and maintenance of the device and signs and symptoms of complications, and assistance with total parenteral nutrition (TPN).
Measuring and preparing prescribed or special diets.
Measuring intake and output of fluids.
Performing simple urine tests for sugar, acetone, or albumin.
Observing appearance and reporting physical or behavioral changes in the patient or client to the registered nurse.
Recognition of emergencies and emergency procedures, including dialing 911.
Assisting with the use of a glucometer to perform blood glucose testing.
Basic restorative care and rehabilitation including the application of AFOs (ankle foot orthosis) and other orthopedic braces.
Keeping records of personal health care activities.

(c) A minimum of sixteen (16) hours of clinical competency training and validation. Validation of medication routes pursuant to Rule 59A-8.0097, F.A.C., does not count toward the 16 hours required by this section. Validation must be conducted on site with an actual patient and supervised by a qualified RN with a minimum of two years nursing experience, with one year in pediatric nursing. Successful validation requires the AMFC to demonstrate, in person, the skills outlined in paragraph (3)(b) to include procedures for the following as applicable to the child per the individualized plan of care:

Skin care, pressure sore prevention, and wound care.
Tracheostomy care.
Enteral care and therapy.
Intravenous and TPN assistive care activities.
Urinary catheter care and foley catheterization.
Ostomy care and maintenance.
Appropriate use of prescribed medical equipment, supplies and devices.
Measuring intake and output of fluids.

(4) Validation. An AMFC must be assessed and validated as competent to provide services by an RN after successfully completing required training.

(a) An AMFC must achieve a score of 100% proficiency in validation of skills prior to providing services.

(b) Validation must take place within 90 days of completing required training.

(c) Validations expire 1 year from the effective date of the validation. An AMFC must be revalidated no more than within 60 days prior to the expiration of their validation to continue providing services.

(5) Pursuant to section 400.4765, F.S., an AMFC that allows 24 consecutive months to pass without providing services to an eligible relative must complete an approved training program as outlined by this rule to resume providing services.

(6) Pursuant to section 400.489, F.S., medication administration training may be provided in addition to the 76 hour curriculum outlined in subsection (3). An AMFC may administer medication as delegated by an RN in accordance with s. 464.0156, F.S. if they complete the basic medication administration training pursuant to Rule 59A-8.0097, F.A.C. and the requirements of Rules 59A-8.0219 and 59A-8.0216, F.A.C, are met.

(a) To meet the needs of medically fragile pediatric patients, an AMFC may administer medications via additional routes with written instructions from the delegating RN as prescribed by the patient’s health care provider. The following routes require the AMFC to complete additional medication training specified in paragraph (3)(b):

Oral medications to be crushed, diluted, or mixed with foods or liquid.
Medications in a liquid form or pills crushed into a powder form via enteral feeding tube.
Medications by injection via subcutaneous, intra-dermal, or intra-muscular route.
Medication that is inserted rectally.
Inhaled medications administered via a tracheostomy tube with a metered-dose inhaler or nebulizer.

(b) Medication Training for Additional Routes of Administration. In addition to the initial 6 hours of training required by Rule 59A-8.0097, F.A.C., the AMFC must complete an additional 4 hours of training to administer medications via the routes described in section (3)(a). The additional training must be provided by an RN with at least two years of experience and must cover the following:

Administration of medications utilizing standardized measuring devices for children including oral syringes, special medication dosing spoons, or medication cups.
Measuring liquid medication, including conversions of teaspoon/tablespoon to milliliter or cubic centimeter (cc).
Indications and procedures for oral medications to be diluted or mixed with foods or liquid.
Indications and contraindications to crushing oral medications.
Procedure to crush oral medications and mix with foods or liquid.
Procedures for medications administered via enteral feeding tubes.
Procedures for medications inserted rectally.
Procedure for the administration of inhaled medications via a tracheostomy tube utilizing a metered-dose inhaler or nebulizer.
Recognition of serious adverse reactions and how to handle the event.
Medication errors and reporting to the RN, including when the child does not take all of medication mixed with food or liquids.
Infection control measures for administration of medication to pediatric patients.

(c) An AMFC that completes the training outlined in section (3)(b) must be validated in accordance with Rule 59A-8.0097, F.A.C. prior to administering medication via additional routes.

(7) Adverse Incident Reporting.

(a) An adverse incident, as defined in subsection 400.54(2), F.S., is an event over which home health agency personnel could exercise control and which is associated in whole or in part with medical intervention, rather than the patient's condition for which such intervention occurred, and results in the adverse incident.

(b) Home health agencies must electronically submit adverse incident reports for incidents occurring under the care of a home health aide for medically fragile children to the Agency within 48 hours after the occurrence of the incident as required in section 400.54, F.S. The adverse incident must be reported on Home Health Agency Adverse Incident Report, AHCA Form 3110-0011 OL, August 2025, which is hereby incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-19116, and through the Agency’s adverse incident reporting system which can only be accessed through the Agency’s Single Sign On Portal located at: https://apps.ahca.myflorida.com/SingleSignOnPortal.

History

Rulemaking Authority 400.4765, 400.489, 400.497 FS. Law Implemented 400.54, 400.476, 400.4765, 400.489, 400.497 FS. History–New 7-23-24, Amended 5-31-26.

Fla. Admin. Code R. 59A-8.010 Administrator

History

Rulemaking Authority 400.497 FS. Law Implemented 400.471 FS. History–New 4-19-76, Formerly 10D-68.10, Amended 4-30-86, 8-10-88, Formerly 10D-68.010, Amended 10-27-94, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.011 Nursing Director

History

Rulemaking Authority 400.497 FS. Law Implemented 400.462, 400.471, 400.497 FS. History–New 4-19-76, Formerly 10D-68.11, Amended 4-30-86, 8-10-88, Formerly 10D-68.011, Amended 10-27-94, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.012 Registered Nurse

History

Rulemaking Authority 400.497 FS. Law Implemented 400.471, 400.497 FS. History–New 4-19-76, Formerly 10D-68.12, Amended 4-30-86, 8-10-88, Formerly 10D-68.012, Amended 10-27-94, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.013 Administrator

History

Rulemaking Authority 400.497 FS. Law Implemented 400.471 FS. History–New 4-19-76, Formerly 10D-68.10, Amended 4-30-86, 8-10-88, Formerly 10D-68.010, Amended 10-27-94, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.014 Home Health Aide

History

Rulemaking Authority 400.497 FS. Law Implemented 400.471, 400.487 FS. History–New 4-19-76, Formerly 10D-68.14, Amended 4-30-86, 8-10-88, 5-30-90, 6-12-91, 5-27-92, Formerly 10D-68.014, Amended 10-27-94, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.015 Physical Therapist and Physical Therapist Assistant

History

Rulemaking Authority 400.497(2) FS. Law Implemented 400.462, 400.471, 400.497 FS. History–New 4-19-76, Formerly 10D-68.15, Amended 4-30-86, 8-10-88, Formerly 10D-68.015, Amended 10-27-94, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.016 Speech Pathologist

History

Rulemaking Authority 400.497 FS. Law Implemented 400.471, 400.497 FS. History–New 4-19-76, Formerly 10D-68.16, Amended 4-30-86, 8-10-88, Formerly 10D-68.016, Amended 10-27-94, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.017 Occupational Therapist and Occupational Therapist Assistant

History

Rulemaking Authority 400.497 FS. Law Implemented 400.471, 400.497 FS. History–New 4-19-76, Formerly 10D-68.17, Amended 4-30-86, 8-10-88, Formerly 10D-68.017, Amended 10-27-94, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.0175 Respiratory Therapist

History

Rulemaking Authority 400.497 FS. Law Implemented 400.471, 400.497 FS. History–New 10-27-94, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.018 Social Worker

History

Rulemaking Authority 400.497 FS. Law Implemented 400.471, 400.497 FS. History–New 4-19-76, Formerly 10D-68.18, Amended 4-30-86, 8-10-88, Formerly 10D-68.018, Amended 10-27-94, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.0185 Personnel Policies

History

Rulemaking Authority 400.497 FS. Law Implemented 400.471, 400.497 FS. History–New 10-27-94, Amended 1-17-00, 7-18-01, 9-22-05, 8-15-06, Repealed 10-2-11.

Fla. Admin. Code R. 59A-8.019 Homemakers, Companions, and Sitters Employed by Home Health Agencies

History

Rulemaking Authority 400.497 FS. Law Implemented 400.471, 400.497 FS. History–New 4-19-76, Formerly 10D-68.19, Amended 4-30-86, 8-10-88, Formerly 10D-68.019, Amended 10-27-94, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.020 Acceptance of Patients or Clients

(1) When a home health agency accepts a patient or client for service, there shall be a reasonable expectation that the services can be provided safely to the patient or client in his place of residence. This includes being able to communicate with the patient, or with another person designated by the patient, either through a staff person or interpreter that speaks the same language, or through technology that translates so that the services can be provided. The responsibility of the agency is also to assure that the patient or client receives services as defined in a specific plan of care, for those patients receiving care under a physician, physician assistant, or advanced practice registered nurse’s treatment orders, or in a written agreement, as described in subsection (3), below, for clients receiving care without a physician, physician assistant, or advanced practice registered nurse’s orders. This responsibility includes assuring the patient receives all assigned visits.

(2) At the start of services a home health agency must establish a written agreement between the agency and the patient or client or the patient’s or client’s legal representative, including the information described in Section 400.487(1), F.S. This written agreement must be signed and dated by a representative of the home health agency and the patient or client or the patient’s or client’s legal representative. A copy of the agreement must be given to the patient or client and the original must be placed in the patient’s or client’s file.

(3) The written agreement, as specified in subsection (2) above, shall serve as the home health agency’s service provision plan, pursuant to Section 400.491(2), F.S., for clients who receive homemaker and companion services or home health aide services which do not require a physician, physician assistant, or advanced practice registered nurse’s treatment order. The written agreement for these clients shall be maintained for one year after termination of services.

(4) When the agency terminates services for a patient or client needing continuing home health care, as determined by the patient’s physician, physician assistant, or advanced practice registered nurse, for patients receiving care under a physician, physician assistant, or advanced practice registered nurse’s treatment order, or as determined by the client or caregiver, for clients receiving care without a physician, physician assistant, or advanced practice registered nurse’s treatment order, a plan must be developed and a referral made by home health agency staff to another home health agency or service provider prior to termination. The patient or client must be notified in writing of the date of termination, the reason for termination, pursuant to Section 400.491, F.S., and the plan for continued services by the agency or service provider to which the patient or client has been referred, pursuant to Section 400.497(8), F.S. This requirement does not apply to patients paying through personal funds or private insurance who default on their contract through non-payment. The home health agency should provide social work assistance to patients to help them determine their eligibility for assistance from government funded programs if their private funds have been depleted or will be depleted.

History

Rulemaking Authority 400.497 FS. Law Implemented 400.487 FS. History–New 4-19-76, Formerly 10D-68.20, Amended 4-30-86, 8-10-88, Formerly 10D-68.020, Amended 10-27-94, 1-17-00, 7-18-01, 9-22-05, 8-15-06.

Fla. Admin. Code R. 59A-8.0205 Advance Directives

History

Rulemaking Authority 765.110 FS. Law Implemented 765.110 FS. History–New 1-11-93, Repealed 1-20-97.

Fla. Admin. Code R. 59A-8.021 Patient Care Plan and Plan of Treatment

History

Rulemaking Authority 400.497 FS. Law Implemented 400.487 FS. History–New 4-19-76, Formerly 10D-68.21, Amended 4-30-86, 8-10-88, Formerly 10D-68.021, Repealed 10-27-94.

Fla. Admin. Code R. 59A-8.0215 Plan of Care

(1) A plan of care shall be established in consultation with the physician, physician assistant, or advanced practice registered nurse, pursuant to Section 400.487, F.S., and the home health agency staff who are involved in providing the care and services required to carry out the physician, physician assistant, or advanced practice registered nurse’s treatment orders. The plan must be included in the clinical record and available for review by all staff involved in providing care to the patient. The plan of care shall contain a list of individualized specific goals for each skilled discipline that provides patient care, with implementation plans addressing the level of staff who will provide care, the frequency of home visits to provide direct care and case management.

(2) Home health agency staff must follow the physician, physician assistant, or advanced practice registered nurse’s treatment orders that are contained in the plan of care. If the orders cannot be followed and must be altered in some way, the patient’s physician, physician assistant, or advanced practice registered nurse must be notified and must approve of the change. Any verbal changes are put in writing and signed and dated with the date of receipt by the nurse or therapist who talked with the physician, physician assistant, or advanced practice registered nurse’s office.

(3) The patient, caregiver or guardian must be informed by the home health agency personnel that:

(a) He has the right to be informed of the plan of care;

(b) He has the right to participate in the development of the plan of care; and,

History

Rulemaking Authority 400.497 FS. Law Implemented 400.487 FS. History–New 10-27-94, Amended 1-17-00, 7-18-01, 8-15-06.

Fla. Admin. Code R. 59A-8.0216 RN Delegation of Tasks

(1) A registered nurse (RN) may delegate tasks to a home health aide or certified nursing assistant (CNA) in accordance with Sections 400.489, 400.490, 464.0156 and 464.2035, F.S., provided the following criteria are met:

(a) The home health agency is licensed to provide skilled care;

(b) The home health aide or CNA has met the training and validation pursuant to Section 400.489 and 464.2035, F.S., and Rule 59A-8.0097, F.A.C.;

(c) The registered nurse delegating the task determines that the home health aide or CNA is competent to perform the task, and

(d) The task meets criteria in section (3) of this rule.

(2) A home health aide or CNA should only accept a delegation that the aide is appropriately trained and educated to perform.

(3) A registered nurse shall follow the delegation process outlined in Rule 64B9-14.002, F.A.C. when delegating a task to a home health aide or CNA.

(4) A registered nurse delegating a task to a home health aide or CNA shall document the following:

(a) Name of the patient and task being performed;

(b) The expected or desired outcome;

(d) The nature of the supervision required;

(e) Verification of the home health aide’s or CNA’s understanding of the task; and

(f) Periodic inspection and assessment of the home health aide or CNA’s performance of the task in accordance with Rule 64B9-14.002, F.A.C.

(5) The registered nurse maintains accountability for the patient.

(6) The home health agency must obtain written, dated consent of the patient, or the patient’s guardian, legal representative, or designated health care surrogate, to accept performance of delegated tasks, including medication administration, by a home health aide or CNA, prior to services being provided. The consent must be maintained in the patient’s medical record and must contain the following:

(a) Name of the patient;

(b) The task(s) being performed;

(d) The nature of the supervision required; and

(e) Signature of the patient, or the patient’s guardian, legal representative, or designated health care surrogate.

(7) The home health agency must maintain documentation that the home health aide or CNA has completed a medication administration course and is currently validated in accordance with Rule 59A-8.0097, F.A.C.

(8) Pursuant to Section 464.0156, F.S., a registered nurse may not delegate tasks that:

(a) Are not within the delegating or supervising nurse’s scope of practice.

(b) Require the use of the nursing process including assessment, diagnosis, planning, implementation and evaluation.

History

Rulemaking Authority 400.489, 464.0156, 464.2035 FS. Law Implemented 400.489, 400.490, 464.0156, 464.2035 FS. History–New 5-24-23.

Fla. Admin. Code R. 59A-8.0218 Service Provision Plan

History

Rulemaking Authority 400.497 FS. Law Implemented 400.487 FS. History–New 10-27-94, Amended 1-17-00, Repealed 7-18-01.

Fla. Admin. Code R. 59A-8.0219 Medication Administration

(1) Medication Administration. The supervising or delegating nurse maintains responsibility for any medication administration task delegated to a home health aide or CNA pursuant to Sections 464.0156, 464.2035, 400.489, and 400.490, F.S.

(a) Medication administration includes conducting any examination, including vital signs (temperature, blood pressure, heart rate, and/or respirations) for the proper administration of medication that the patient cannot perform personally and that can be performed by a licensed health care practitioner, or a home health aide or CNA as delegated by an RN.

(b) A home health aide or CNA may not administer medication to patients unless they have successfully completed a medication administration training course and obtained a current validation for the route by which the medication is administered in accordance with Rule 59A-8.0097, F.A.C.

(c) In cases wherein a home health aide or a CNA is delegated to administer medications, an assessment of the medications for which administration is to be provided shall be conducted by the registered nurse (RN) who delegated the task prior to the home health aide or CNA performing the task and upon any change in the patient’s medication regiment. The assessment shall be documented in the patient’s medical record for patients receiving medication administration from a home health aide or CNA.

The delegating nurse must ensure the home health aide or CNA administers the medication in accordance with their training and competency, and with the medication prescription.
Home health aides and CNAs who are validated to administer whole (not crushed) oral medication may give the medication in any dietary or nutritional food substance that facilitates swallowing, is tolerated by the patient and is not contrary to any prescribed diet, label warnings or known contraindications for the medication being given.
The home health aide or CNA must notify the supervising or delegating nurse of changes in the dosage, frequency or route of a medication. The nurse must verify the change and update the Medication Administration Record (MAR).
The supervising or delegating nurse is required to review the MAR every 60 days, or more frequently if needed, for each patient receiving medication administration from a home health aide or CNA. The MAR must be kept on record by the home health agency.
The home health aide and/or CNA must communicate changes in a patient's condition to the supervising or delegating nurse. The nurse must assess for unusual reactions to the medication or a significant change in the patient’s health or behavior that may be caused by the medication, and must document such in the patient’s record to be reported immediately to the patient’s health care provider. Contact with the health care provider must also be documented in the patient’s medical record.

(2) Medication Administration Procedures. Home health aides and CNAs must:

(a) Only administer medication as prescribed or ordered by the patient’s health care practitioner and which are properly labeled and dispensed in accordance with Chapters 465 and 499, F.S.;

(b) Comply with new or changed orders for a specific medication, which override the previous orders for that medication. No order to discontinue the previous order is necessary;

(c) Comply with the time limit as provided for in time-limited orders (i.e. those that are ordered for a specific number of doses or days). Such orders do not require an order to discontinue at the completion of the time allotted in the time-limit;

(d) Before administering medication to any patient initially, review the patient’s medical history and medication background with the delegating RN, and again thereafter as determined by the delegating RN.

(e) Perform appropriate hand hygiene measures consistent with current guidence from the Centers for Disease Control and Prevention (CDC) before administering medication to the patient.

(f) Immediately report torn, damaged, illegible, or mislabeled prescription labels to the dispensing pharmacist and, if a patient is residing in a residential facility, notify the facility supervisor;

(g) Check the directions and expiration date of each medication to ensure that expired medications (those which are no longer current) or those no longer prescribed are not administered;

(h) Administer medication as prescribed and via the route instructed by the patient’s prescribing health care professional. Each time medication is administered:

Verify the correct medication is administered to the correct patient, at the correct time, dosage, route, and for the correct reason, as prescribed by the health care practitioner.
Observe complete ingestion of oral medication before leaving the patient and before recording or documenting the administration of the medication on the MAR.

(i) PRN medications. The supervising or delegating nurse maintains responsibility for the appropriate administration of PRN medications based on the patient’s health condition and prescribing health care practitioner orders.

Prior to the administration of an “as needed” or “PRN” medication to a patient, the home health aide or CNA must consult with the supervising or delegating nurse to determine the appropriateness of administration of the PRN medication.
Administration of medications which require nursing judgement or assessment to evaluate the effectiveness of the medication shall not be delegated, including medications for pain and psychotropic medications. PRN medications must include specific written instructions with specific parameters for administration as prescribed by the patient’s health care practitioner.
Administration of PRN medication must be documented on the MAR with the reason for the administration of the PRN medication, monitoring of the patient, and outcome of the medication.

(j) Ensure that the prescription for a medication is promptly refilled so that a patient does not miss a prescribed dosage of medication. If the home health aide or CNA is not responsible for routine refills of a medication, they must notify the individual responsible for refilling the patient’s prescriptions and document this notification;

(3) In the administration of medications, a home health aide or CNA must not:

(a) Administer medications, including PRN and OTC medications or medication samples without a written order and instructions for preparation and use from the patient’s physician, PA, or APRN.

(b) Administer medications for which the health care provider’s prescription or order does not specify the medication schedule, medication amount, dosage, route of administration, purpose for the medication, or with medication that would require professional medical judgment by the home health aide or CNA.

(c) Crush, dilute, or mix crushed medications without written instructions from the delegating RN as prescribed by the patient's health care provider.

(d) Administer medications via a medication route for which the home health aide or CNA has not been validated.

(e) Prepare syringes for a patient’s use during the self-administration of medication via a parenteral, subcutaneous, intra-dermal, intra-muscular or intravenous route.

(f) Administer medications by injection via a parenteral, subcutaneous, intra-dermal, intra-muscular or intravenous route, with the exception of an epi-pen administered in an emergency situation. This prohibition does not include the administration of prefilled insulin syringes.

(g) Administer medication that is inserted vaginally, or administered via a tracheostomy.

(h) Administer medications for which the health care provider’s prescription or order does not specify the medication schedule, medication amount, dosage, route of administration, purpose for the medication, or with medication that would require professional medical judgment by the home health aide or CNA.

(4) Home health aides and CNAs must not:

(a) Continue to provide services as a home health aide or CNA if they fail to maintain required validation.

(b) Provide services as a home health aide or CNA while not currently authorized to do so by the State of Florida.

(c) Provide services as a home health aide or CNA after the home health agency has determined the home health aide or CNA must not continue to provide assistance with medication administration or administer medication as delegated by an RN.

(5) If a home health aide or CNA violates any provision of Section 400.489, 400.490, 464.0156 or 464.2035, F.S. or this rule, the home health agency must:

(a) Prohibit the home health aide or CNA from providing medication administration services to patients of the agency;

(b) Require the home health aide or CNA to:

Successfully complete the Basic Medication Administration Course and corresponding validation;
Participate in and successfully complete a corrective action plan; and
Comply with remediation requests.

(6) Medication Errors.

(a) The RN must document medication errors and all interventions in the patient's medical record.

(b) The home health agency must incorporate documented medication errors into their Quality Assurance program for systemic analysis in order to prevent a future occurrence and improve provision of services to patients.

(7) Medication Storage and Disposal.

(a) Home health aides and CNAs must:

Maintain medications in their original containers labeled by the dispensing health care practitioner or pharmacy with the patient’s name, the practitioner’s name, and the directions for administering the medication;
Maintain OTC medications in their original containers;
Ensure medications in a patient’s residence are organized and returned to the patient’s preferred location for storage and retrieval following administration.

(b) A home health aide or CNA may not transport medications away from the patient’s residence or dispose of the patient’s medications.

(c) Disposal of medications must be conducted by licensed health care professional and consistent with applicable federal, state, and local regulations.

History

Rulemaking Authority 400.489, 464.0156, 464.2035 FS. Law Implemented 400.489, 400.490, 464.0156, 464.2035 FS. History–New 5-24-23.

Fla. Admin. Code R. 59A-8.022 Clinical Records

(1) A clinical record must be maintained for each patient receiving nursing or therapy services that includes all the services provided directly by the employees of the home health agency and those provided by contracted individuals or agencies.

(2) No information may be disclosed from the patient’s file without the written consent of the patient or the patient’s guardian. All information received by any employee, contractor, or AHCA employee regarding a patient of the home health agency is confidential and exempt from Chapter 119, F.S.

(3) If the patient transfers to another home health agency, a copy of his record must be transferred at his request.

(4) All clinical records must be retained by the home health agency as required in Section 400.491, F.S. Retained records can be stored as hard paper copy, microfilm, computer disks or tapes and must be retrievable for use during unannounced surveys as required in Section 408.811, F.S.

(5) Clinical records must contain the following:

(a) Source of referral;

(b) Physician, physician assistant, or advanced practice registered nurse’s verbal orders initiated by the physician, physician assistant, or advanced practice registered nurse prior to start of care and signed by the physician, physician assistant, or advanced practice registered nurse as required in Section 400.487(2), F.S.

(d) Statement of patient or caregiver problems;

(e) Statement of patient’s and caregiver’s ability to provide interim services;

(f) Identification sheet for the patient with name, address, telephone number, date of birth, sex, agency case number, caregiver, next of kin or guardian;

(g) Plan of care or service provision plan and all subsequent updates and changes;

(h) Clinical and service notes, signed and dated by the staff member providing the service which shall include:

Initial assessments and progress notes with changes in the person’s condition;
Services rendered;
Observations;
Instructions to the patient and caregiver or guardian, including administration of and adverse reactions to medications;

(i) Home visits to patients for supervision of staff providing services;

(j) Reports of case conferences;

(k) Reports to physicians, physician assistants, or advanced practice registered nurses;

(l) Termination summary including the date of first and last visit, the reason for termination of service, an evaluation of established goals at time of termination, the condition of the patient on discharge and the disposition of the patient.

(6) The following applies to signatures in the clinical record:

(a) Facsimile Signatures. The plan of care or written order may be transmitted by facsimile machine. The home health agency is not required to have the original signature on file. However, the home health agency is responsible for obtaining original signatures if an issue surfaces that would require certification of an original signature.

(b) Alternative Signatures. Home health agencies that maintain patient records by computer rather than hard copy may use electronic signatures. However, all such entries must be appropriately authenticated and dated. Authentication must include signatures, written initials, or computer secure entry by a unique identifier of a primary author who has reviewed and approved the entry. The home health agency must have safeguards to prevent unauthorized access to the records and a process for reconstruction of the records in the event of a system breakdown.

History

Rulemaking Authority 400.497 FS. Law Implemented 400.491, 400.494 FS. History–New 4-19-76, Amended 2-2-77, Formerly 10D-68.22, Amended 4-30-86, 8-10-88, Formerly 10D-68.022, Amended 10-27-94, 1-17-00, 7-18-01, 9-22-05, 8-15-06, 3-29-07, 7-11-13.

Fla. Admin. Code R. 59A-8.024 Administration of Drugs and Biologicals

History

Rulemaking Authority 400.497 FS. Law Implemented 400.497 FS. History–New 4-19-76, Formerly 10D-68.24, Amended 4-30-86, 8-10-88, Formerly 10D-68.024, Amended 10-27-94, 1-17-00, Repealed 7-18-01.

Fla. Admin. Code R. 59A-8.0245 Advance Directives

(1) Each home health agency shall have written policies and procedures, which delineate the agency’s position with respect to the state law and rules relative to advance directives. The policies shall not condition treatment or admission upon whether or not the individual has executed or waived an advance directive. In the event of conflict between the agency’s policies and procedures and the patient’s advance directive, provision should be made in accordance with Chapter 765, F.S.

(2) The home health agency’s policy shall include:

(a) Providing each adult patient, in advance of receiving services, with a copy of “Health Care Advance Directives – The Patients’ Right to Decide,” as prepared by the Agency for Health Care Administration, revised April 2006, and available at http://www.floridahealthfinder.gov/reports-guides/reports-guides.aspx, which is hereby incorporated by reference (http://www.flrules.org/Gateway/reference.asp?No=Ref-03070), or with a copy of a document drafted by a person or organization other than AHCA which is a written description of Florida’s state law regarding advance directives;

(b) Providing each adult patient, in advance of receiving services, with written information concerning the home health agency’s policies respecting advance directives; and,

(c) The requirement that documentation of whether or not the patient has executed an advance directive shall be contained in the patient’s medical record and not kept solely at another location in the agency. If an advanced directive has been executed, a copy of that document shall be made a part of the patient’s medical record. If the home health agency does not receive a copy of the advanced directive for a patient, the agency must document that it has requested a copy in the patient’s record.

(d) A home health agency shall be subject to revocation of their license and a fine of not more than $500 per incident, or both, pursuant to Section 400.474(1), F.S., if the home health agency, as a condition of treatment or admission, requires an individual to execute or waive an advance directive, pursuant to Section 765.110, F.S.

(3) Pursuant to Section 400.487(7), F.S., a home health agency may honor a DNRO as follows:

Cardiopulmonary resuscitation may be withheld or withdrawn from a patient only if a valid Do Not Resuscitate Order (DNRO) is present, executed pursuant to Section 401.45, F.S. The Department of Health has developed a DNRO form that is described and available to the public as stated in Rule 64J-2.018, F.A.C.

History

Rulemaking Authority 400.487, 765.110 FS. Law Implemented 400.487, 765.110 FS. History–New 10-27-94, Amended 1-17-00, 9-22-05, 7-11-13.

Fla. Admin. Code R. 59A-8.0248 Excellence in Home Health

(1) Excellence in Home Health Award.

(a) To be considered for an Excellence in Home Health Award, a home health agency licensee eligible under section 400.52(3), F.S., must apply using the Excellence in Home Health Award Application, AHCA Form 3110-9002, January 2023, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-15408 or at http://www.ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Lab_HomeServ/HHA/index.shtml.

(b) Unless an exception is noted pursuant to section 400.52(5), F.S., an awarded licensee may use the Excellence in Home Health designation in advertising and marketing. Use of the Excellence in Home Health designation in advertising and marketing must include the effective and expiration date of the award and be used expressly for the awarded licensee. Within 90 days after termination or expiration of the award, the Excellence in Home Health designation must be removed from all advertising and marketing materials.

(2) Initial application. An applicant for initial Excellence in Home Health award may apply during the following reivew periods:

(a) Review Period 1 requires initial applications be submitted to AHCA by March 15. Application reviews will be concluded by May 15 to determine those licensees to be considered for the Excellence in Home Health award designation. The award decisions will be issued no later than June 15.

(b) Review Period 2 requires initial applications be submitted to AHCA by September 15 to be eligible for review during this period. Application reviews will be concluded by November 15 to determine those licensees to be considered for the Excellence in Home Health award designation. The award decisions will be issued no later than December 15.

(c) Renewal application. An applicant for renewal of an Excellence in Home Health award designation must submit a completed application in conjunction with the home health agency’s license renewal application.

Pursuant to section 400.52(4), the Excellence in Home Health award designation expires on the same date as the home health agency’s license.
The award designation will not be issued until all the requirements for relicensure pursuant to Chapters 400, Part III, 408, Part II, F.S., and applicable rules have been met.

(d) Upon receipt of an application for an award, AHCA will examine the application and notify the applicant in writing of any apparent errors or omissions and request any additional information required.

(e) Requested information omitted from an Excellence in Home Health award application must be filed with the agency within 21 days after the agency’s request for omitted information or the application will be deemed incomplete and will be withdrawn from further consideration.

(f) If the applicant is approved for the Excellence in Home Health award, the applicant’s home health agency license will be issued specifying the award designation.

(3) Minimum Award Criteria. In addition to the requirements of section 400.52(3), F.S., and the application form required by section (1)(a) of this rule, applicants for the Excellence in Home Health award must submit documentation demonstrating they meet and maintain the following:

(a) Development, maintenance and implementation of a Continuous Quality Improvement (CQI) program consistent with national industry standards that includes, at minimum:

Evidence-based practices that address reduction of preventable, unplanned patient or client emergency care for wound infections resulting from, related to, or identified during the provision of home health services.
Evidence-based practices that address reduction of preventable, unplanned patient or client admission or readmission to an acute care hospital resulting from, related to, or identified during the provision of home health services.
Evidence-based practices that address patient improvement in the activities of daily living resulting from, related to, or identified during the provision of home health services.
Evidence-based practices that address reduction of preventable medication errors resulting from, related to, or identified during the provision of home health services.
Evidence of a survey process to assess patient or client willingness to recommend the home health agency to family and friends.
Evidence of a survey process to assess patient or client satisfaction with communication and interaction between the home health agency and the patient or client and/or their representative(s).
Development of Quantitative metric tools to capture and calculate data, and assess risk for 1. through 6. above.

(b) Quantitative metric tools required by subsection (a)7. must include, at a minimum, quality measures to calculate the required data for the most recent 12 month period ending on the last business day of the most recent calendar quarter prior to application for the award. Data must demonstrate the applicant ranks within the following ranges compared to the current state-wide average:

Average quality score which is at or above the top 95th percentile state-wide for prevention of, unplanned patient or client emergency care for wound infections resulting from, related to, or identified during the provision of home health services.
Average quality score which is at or above the top 95th percentile state-wide for prevention of, unplanned patient or client admission or readmission to an acute care hospital resulting from, related to, or identified during the provision of home health services.
Average quality score which is at or above the top 95th percentile state-wide for patient improvement in the activities of daily living resulting from, related to, or identified during the provision of home health services.
Average quality score which is at or above the top 98th percentile state-wide for prevention of medication errors resulting from, related to, or identified during the provision of home health services.
Average quality score which is at or above the top 90th percentile state-wide survey of patient or client willingness to recommend the home health agency to family and friends.
Average quality score which is at or above the top 95th percentile state-wide for survey of patient or client satisfaction with the communication and interaction between the home health agency and the patient or client and/or their representative(s).

(d) Evidence of the employee satisfaction process which demonstrates that information is obtained from employees concerning satisfaction with the home health agency.

(e) Stable Workforce. For the purposes of this rule, the term “direct care worker” means a certified nursing assistant, a home health aide, a personal care assistant, a companion services or homemaker services provider, or another individual who provides personal care as defined in section 400.462, F.S., to individuals who are elderly, developmentally disabled, or chronically ill. An applicant for the Excellence in Home Health Award must demonstrate a stable workforce according to the following:

Have a turnover rate no greater than 50 percent for the most recent 12 month period ending on the last workday of the most recent calendar quarter prior to submission of an application. The turnover rate is the total number of terminations or resignations of direct care workers and licensed nurses during the quarter divided by the number of direct care workers and licensed nurses employed at the end of the quarter; or
Have a stability rate indicating that at least 50 percent of its staff have been employed at the home health agency for at least one year. The stability rate is the total number of direct care workers and licensed nurses that have been employed for more than 12 months, divided by the total number of direct care workers and licensed nurses employed at the end of the quarter.
An applicant must submit evidence of an effective recruitment and retention program.

(4) An accredited home health agency applying for the award must submit with the application the most recent accreditation survey report, including any plan of correction and follow up survey reports as evidence of compliance history.

(5) Termination.

(a) Termination of the Excellence in Home Health Designation. An awarded licensee that fails to maintain eligibility pursuant to section 400.52(3), F.S., will be terminated from participation in the Excellence in Home Health Program and their award designation will be revoked.

(b) A licensee that has been terminated from the Excellence in Home Health program may reapply within the timeframes specified in section (2) of this rule and must meet all conditions necessary to be reconsidered for an Excellence in Home Health award.

(c) Denial of Excellence in Home Health Applicants. Prior to issuance of the award, any occurrence of the following will disqualify the licensee from continuing as an Excellence in Home Health applicant from the award process and the application will be denied:

The applicant fails to maintain eligibility pursuant to section 400.52(3), F.S.;
The applicant fails to maintain the minimum award criteria according to section (3) of this rule; and/or
The applicant fails to apply within the timeframes specified in section (2) of this rule.

(d) If the applicant meets criteria for denial at any time during the review process outlined in section (2) of this rule, AHCA will offer the opportunity for the applicant to withdraw the application.

History

Rulemaking Authority 400.52 FS. Law Implemented 400.52 FS. History–New 7-25-23.

Fla. Admin. Code R. 59A-8.025 Registration Requirements for Homemaker and Companion Services Providers

(1) Before any organization or individual shall directly or indirectly provide homemaker and companion services for elderly or disabled adults, it shall make application for and become registered by the AHCA. Licensed home health agencies and nurse registries are exempt from registration for provision of homemaker and companion services.

(2) An application for renewal of registration or change of ownership, must be submitted to AHCA at least 60 days prior to the date of the expiration of the registration as required in Section 408.806(2), F.S.

(3) Application for initial, renewal and change of ownership registration to provide homemaker and companion services shall be made to the AHCA on the Health Care Licensing Application, Homemaker and Companion Services Provider, AHCA Form 3110-1003, December 2014, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-05421. These forms may be obtained online at http://ahca.myflorida.com/HQAlicensureforms. The application shall be filed biennially as required in Section 408.806, F.S.

(4) A non-refundable fee shall accompany each application for registration. State, county or municipal agencies applying for registration as an agency providing homemaker and companion services shall be exempt from payment of registration fees.

(5) The AHCA shall issue a registration valid for no more than two years, upon verification that all requirements for registration have been met.

(6) An application for initial or change of ownership registration must include the specific geographic area to be served. Homemaker and companion services providers may apply for a geographic service area which encompasses one or more of the counties within the health service planning district, as defined in Section 408.032(5), F.S., in which the address of record is located. Any homemaker and companion services provider holding a current registration from the AHCA, as of July 1, 2015, may continue to serve clients in the counties listed on its registration if a plan for supervision of staff working in counties outside of the primary geographic service area is documented.

(7) Diligent effort shall have been made, to comply with the provisions of Section 400.509(4)(b), F.S., if the homemaker and companion services provider has documented two attempts to verify employment or contractual history or, in the case of a disconnected number, the attempt to find current contact information.

(8) All homemaker and companion services providers must maintain a confidential client record which shall include, but not be limited to the following:

(a) The client’s full legal name, address, telephone number, age, disability if basis for client receiving service;

(b) The name and telephone number of the client’s emergency contact, next of kin or legal guardian, and physician;

(d) Services provided including the duration and frequency of visits;

(e) Dietary restrictions, if the homemaker and companion services provider prepares, orders or accompanies the client to meals;

(f) Food allergies;

(g) Activity limitations pertaining to service delivery; and,

(h) Copy of any written termination notices, if the homemaker and companion services provider is terminating services.

(9) When a client is accepted, there shall be a reasonable expectation that the requested services will be provided adequately and safely in their residence. The homemaker and companion services provider is responsible for obtaining all needed information pertaining to service delivery and for supplying employees or independent contractors capable of delivering contracted or agreed upon services, including all visits.

History

Rulemaking Authority 400.497, 400.509, 408.819 FS. Law Implemented 400.462, 400.509, 408.805, 408.806, 408.809, 408.810 FS. History–New 4-30-86, Amended 8-10-88, 5-30-90, Formerly 10D-68.025, Amended 10-27-94, 6-16-15, 7-27-16.

Fla. Admin. Code R. 59A-8.026 Penalties

History

Rulemaking Authority 400.478, 400.497 FS. Law Implemented 400.462, 400.467, 400.474, 400.505 FS. History–New 4-30-86, Amended 8-10-88, Formerly 10D-68.026, Repealed 10-27-94.

Fla. Admin. Code R. 59A-8.027 Emergency Management Plans

(1) Pursuant to Section 400.492, F.S., each home health agency shall prepare and maintain a written comprehensive emergency management plan, in accordance with criteria shown in the “Comprehensive Emergency Management Plan (CEMP),” AHCA Form 3110-1022, Revised March 2013, incorporated by reference (http://www.flrules.org/Gateway/reference.asp?No=Ref-02767). This document is available from the Agency for Health Care Administration at http://ahca.myflorida.com/MCHQ/Emergency_Activities/index.shtml and shall be used as the format for the home health agency’s emergency management plan. The plan shall describe how the home health agency establishes and maintains an effective response to emergencies and disasters.

(2) The plan, once completed, will be forwarded electronically for approval to the contact designated by the Department of Health.

(3) The agency shall review its emergency management plan on an annual basis and make any substantive changes.

(4) Changes in the telephone numbers of those staff who are coordinating the agency’s emergency response must be reported to the agency’s county office of Emergency Management and to the local County Health Department. For agencies with multiple counties on their license, the changes must be reported to each County Health Department and each county Emergency Management office. The telephone numbers must include numbers where the coordinating staff can be contacted outside of the agency’s regular office hours. All home health agencies must report these changes, whether their plan has been previously reviewed or not, as defined in subsection (2), above.

(5) When an agency goes through a change of ownership the new owner shall review its emergency management plan and make any substantive changes, including changes noted in subsection (4), above. Those agencies which previously have had their plans reviewed, as defined in subsection (2), above, will need to report any substantive changes to the reviewing entity.

(6) In the event of an emergency the agency shall implement the agency’s emergency management plan in accordance with Section 400.492, F.S. Also, the agency must meet the following requirements:

(a) All staff who are designated to be involved in emergency measures must be informed of their duties and be responsible for implementing the emergency management plan.

(b) If telephone service is not available during an emergency, the agency shall have a contingency plan to support communication, pursuant to Section 400.492, F.S. A contingency plan may include cell phones, contact with a community based ham radio group, public announcements through radio or television stations, driving directly to the employee’s or the patient’s home, and, in medical emergency situations, contact with police or emergency rescue services.

(7) Home health agencies which are exempt from this requirement are listed in Section 400.497(8)(e), F.S.

(8) On admission, each home health agency shall, pursuant to Section 252.355, F.S., inform patients and patient caregivers of the special needs registry maintained by their county Emergency Management office. The home health agency must document in the patient’s file if the patient plans to evacuate or remain at home; if during the emergency the patient’s caregiver can take responsibility for services normally provided by the home health agency; or if the home health agency needs to continue services to the patient. If the patient is a resident of an assisted living facility or an adult family care home, the home health agency must contact the assisted living facility or adult family care home administrator or designated emergency management personnel and find out the plan for evacuation of the resident in order to document the resident’s plans in the home health agency’s file for the patient. If it is determined the home health agency needs to provide continued services, it will be the responsibility of the home health agency to provide the same type and quantity of care for the patient in the special needs shelter during and after the emergency, equal to the care received prior to the shelter assignment as specified in Section 400.492, F.S., except in certain situations as specified in Section 400.492(3), F.S.

(9) Upon eminent threat of an emergency or disaster the home health agency must contact those patients needing ongoing services and confirm each patient’s plan during and immediately following an emergency. The home health agency must also contact every assisted living facility and adult family care home where patients are served to confirm the plans during and immediately following the emergency.

(10) During emergency situations, when there is not a mandatory evacuation order issued by the local Emergency Management agency, some patients may decide not to evacuate and will stay in their homes. The home health agency must establish procedures, prior to the time of an emergency, which will delineate to what extent the agency will continue care during and immediately following an emergency. The agency shall also ascertain which patients remaining at home will need care from the home health agency and which patients have plans to receive care from their family or caregivers. The agency shall designate staff to continue the services specified in the treatment orders to residents in the assisted living facility or adult family care home during and following the emergency. If the assisted living facility or adult family care home does relocate the residents to another assisted living facility or adult family care home within the geographic service area the home health agency is licensed to serve, the agency will continue to provide services to the residents, except in certain situations as specified in Section 400.492(3), F.S. If the residents should go to a special needs shelter outside of the geographic service area the home health agency is licensed to serve, the home health agency may provide services to the residents at the shelter pursuant to Section 400.492(4), F.S.

(11) If the agency at some point ceases operation, as defined in Section 400.492(3), F.S., the agency must inform those patients whose services will be discontinued during the emergency. The agency must also notify assisted living facilities and adult family care homes where residents are served and make arrangements for nursing personnel to continue essential services, such as insulin and other injections, as ordered in treatment orders to residents. If the agency has assisted living facility, adult family care home or other patients in special needs shelters, then the agency will call the local emergency operation center as soon as possible after the disaster and report on the status of the agency’s damage, if any, and the post-disaster availability to continue serving their patients in the special needs shelters and during discharge from the special needs shelters.

(12) When a home health agency is unable to continue services to special needs patients registered under Section 252.355, F.S., that patient’s record must contain documentation of the efforts made by the home health agency to comply with their emergency management plan in accordance with Section 400.492(3), F.S. Documentation includes, but is not limited to, contacts made to the patient’s caregivers, if applicable; contacts made to the assisted living facility and adult family care home, if applicable; and contacts made to local emergency operation centers to obtain assistance in reaching patients and contacts made to other agencies which may be able to provide temporary services.

(13) Each home health agency is required to collect registration information for special needs patients who will need continuing care or services during a disaster or emergency, pursuant to Section 252.355, F.S. This registration information shall be submitted, when collected, to the county Emergency Management office, or on a periodic basis as determined by the home health agency’s county Emergency Management office.

(14) Home health agency staff shall educate patients registered with the special needs registry that special needs shelters are an option of last resort and that services may not be equal to what they have received in their homes.

(15) The prioritized list of patients maintained by the home health agency shall be kept current and shall include information as defined in Section 400.492(2), F.S. The prioritized list shall also include residents in assisted living facilities and adult family care homes who require nursing services. This list will assist home health agency staff during and immediately following an emergency which requires implementation of the emergency management plan. This list also shall be furnished to local County Health Departments and to the county Emergency Management office, upon request.

(16) The patient record for each person registered as a special needs patient shall include information as listed in Section 400.492(1), F.S.

(17) The home health agency is required to maintain in the home of the special needs patient a list of patient-specific medications, supplies and equipment required for continuing care and service should the patient be evacuated. The list must include the names of all medications, their dose, frequency, route, time of day and any special considerations for administration. The list must also include any allergies; the name of the patient’s physician and the physician’s phone number(s); the name, phone number and address of the patient’s pharmacy. If the patient permits, the list can also include the patient’s diagnosis.

History

Rulemaking Authority 400.497 FS. Law Implemented 400.492, 400.497 FS. History–New 7-18-01, Amended 8-15-06, 3-29-07, 7-11-13, 7-27-16.

Chapter 59A-9 ABORTION CLINICS

Fla. Admin. Code R. 59A-9.018 Purpose

History

Rulemaking Authority 390.012 FS. Law Implemented 381.0012, 382, 390.011, 390.012, 390.013 FS. History–New 6-13-90, Formerly 10D-72.018, Amended 9-25-06, Repealed 5-14-12.

Fla. Admin. Code R. 59A-9.019 Definitions

The following definitions shall apply specifically to abortion clinics.

(1) “Clinical staff” means the individuals employed full or part time by an abortion clinic who are licensed or certified to provide care prior to, during, or after an abortion.

(2) “Facility” means those objects, including physical plant, equipment, and supplies necessary for providing required services.

(3) “Licensed” means that person or facility to which the term is applied has a current or valid license, certificate or registration issued by the State of Florida to follow his profession or vocation within the State of Florida, and when applied to a health care facility means that the facility has a current license issued by the Agency.

(4) “Medical Director” means a physician currently licensed to practice medicine or osteopathy pursuant to Chapter 458 or 459, F.S., who has admitting privileges at or has a transfer agreement with a hospital licensed by the state located within reasonable proximity to the abortion clinic.

(5) “Patient” means any woman receiving services in an abortion clinic.

(6) “Period of gestation” means one of three trimesters as defined in Section 390.011, F.S., corresponding to the age of the fetus at the time of abortion.

(7) “Premises” means those buildings, beds, and facilities of the clinic and all other buildings, beds, and facilities for the performance of abortions located at the main address of the licensee and appear to the public to be under the domain and the control of the licensee.

(8) “Reasonable proximity” means a distance not to exceed thirty (30) minutes transport time by emergency vehicle.

(9) “Volunteer” means a person who is not employed by the clinic who interacts with patients on behalf of the abortion clinic.

History

Rulemaking Authority 390.012 FS. Law Implemented 390.011, 390.012 FS. History–New 6-13-90, Amended 4-17-91, Formerly 10D-72.019, Amended 8-24-94, 9-25-06, 1-6-15, 4-5-17.

Fla. Admin. Code R. 59A-9.020 Licensure Procedures

(1) All applicants requesting licensure for the operation of an abortion clinic under the provisions of Chapters 408 and 390, F.S., shall make application for a license to the Agency on the Health Care Licensing Application, Abortion Clinic, AHCA Form 3130-1000, July 2016, which is incorporated by reference. The form can be obtained at https://www.flrules.org/Gateway/reference.asp?No=Ref-07596, and from the Agency for Health Care Administration, Hospital and Outpatient Services Unit, Mail Stop #31, 2727 Mahan Drive, Tallahassee, Florida 32308, or on the Agency website at: http://ahca.myflorida.com/HQAlicensureforms. Applicants for renewal of an abortion clinic license may submit the Health Care Licensing Online Application, Abortion Clinics, AHCA Form 3130-1000OL, July 2016, incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-07597. The application forms are available online at: http://www/ahca.myflorida.com/HQAlicensureforms or for online renewal submissions at: http://apps.ahca.myflorida.com/SingleSignOnPortal.

(2) A licensure fee as listed on the application shall accompany each application for a license. The licensure fee shall be made payable to the Agency and is not refundable. The licensure fee will be established as prescribed by Sections 408.805 and 390.014, F.S.

(3) A current license shall be posted in a conspicuous place within the licensed premises where it can be viewed by patients.

(4) A license, unless sooner suspended or revoked, shall automatically expire two years from the date of issuance, and shall be renewable biennially upon application for renewal and payment of the fee prescribed by the application, provided that the applicant and abortion clinic meet the requirements established under Chapters 408 and 390, F.S., and Chapters 59A-35 and 59A-9, F.A.C.

History

Rulemaking Authority 390.012, 390.014(3), 408.033, 408.819 FS. Law Implemented 390.012, 390.014, 390.015, 408.033, 408.805, 408.806, 408.809, 408.810, 408.815 FS. History–New 6-13-90, Amended 4-17-91, 10-9-91, Formerly 10D-72.020, Amended 8-24-94, 9-25-06, 1-6-15, 4-5-17.

Fla. Admin. Code R. 59A-9.021 Investigations and License and Validation Inspections

(1) The Agency has the right to enter upon the premises of any abortion clinic or applicant to make or cause to be made such inspections and investigations as are necessary to:

(a) Assure compliance with the licensure requirements and standards as specified in statute and rule;

(b) Respond to complaints and investigate allegations of unlicensed activity;

(2) Representatives of the Agency shall conduct inspections with the least possible disruption to clinic activities and in a manner considerate of the privacy and confidentiality of any patient who is present therein.

History

Rulemaking Authority 390.012, 408.819 FS. Law Implemented 390.012, 408.811 FS. History–New 6-13-90, Amended 4-17-91, 10-9-91, Formerly 10D-72.021, Amended 9-25-06, 1-6-15, 4-5-17.

Fla. Admin. Code R. 59A-9.022 Physical Plant Requirements for Abortion Clinics When Providing Second Trimester Abortions

The following are minimum standards of construction and specified minimum essential physical plant requirements which must be met when providing second trimester abortions.

(1) Consultation room(s) with adequate private space specifically designated for interviewing, counseling, and medical evaluations;

(2) Dressing rooms designated for staff and patients;

(3) Handwashing station(s) equipped with a mixing valve and wrist blades and located in each patient exam/procedure room or area;

(4) Private procedure room(s) with light and ventilation for abortion procedures;

(5) Post-procedure recovery room(s) equipped to meet the patient’s needs;

(6) Emergency exits wide enough to accommodate a standard stretcher or gurney;

(7) Cleaning and sterilizing area(s) for the cleaning and sterilizing of instruments;

(8) Secure storage area(s) for the storage of medical records and necessary equipment and supplies; and,

(9) If not otherwise required by the Florida Building Code, at least one general use toilet room equipped with a hand washing station.

History

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(a) FS. History–New 9-25-06, Amended 4-5-17.

Fla. Admin. Code R. 59A-9.0225 Clinic Supplies and Equipment Standards for Second Trimester Abortions

Each abortion clinic providing second trimester abortions shall provide essential clinic supplies and equipment as required in subsections (1) through (7) when performing second trimester abortions.

(1) The following equipment shall be maintained in functional condition:

(a) A surgical or gynecological examination table(s);

(b) A bed or recliner(s) suitable for recovery;

(d) Mechanical suction;

(e) Resuscitation equipment to include resuscitation bags and oral airways;

(f) Emergency medications, intravenous fluids, and related supplies and equipment;

(g) Sterile suturing equipment and supplies;

(h) Adjustable examination light;

(i) Containers for soiled linen and waste materials with covers; and,

(j) Appropriate equipment for the administering of general anesthesia, if applicable.

(2) Emergency equipment shall be provided for immediate use, maintained in functional condition, and capable of providing the following services:

(a) Inhalation therapy;

(b) Defibrillation;

(d) Suctioning; and,

(e) Maintenance of patient airway.

(3) Anesthesia.

(a) The clinic shall have anesthesia equipment maintained in proper working order for the appropriate administering of general and local anesthesia, analgesia, and sedation if ordered by the physician.

(b) All reusable anesthesia equipment in direct contact with the patient shall be cleaned or sterilized as appropriate after each use and such cleaning and sterilization shall be documented.

(4) Resuscitative Medications Required.

The clinic shall have a crash cart at the location the anesthetizing is being carried out. The crash cart must include those emergency medications to support the procedures performed as determined by the medical director.

(5) Sterilization Equipment.

Sterilizing equipment of adequate capacity shall be available to properly sterilize instruments and materials. The sterilizing equipment shall have approved control and safety features.

(6) Ultrasound equipment shall be located in the clinic.

(7) Equipment Maintenance.

(a) When patient monitoring equipment is utilized, a written preventive maintenance program shall be developed and implemented. This equipment shall be checked and/or tested in accordance with manufacturer’s specifications at periodic intervals, not less than annually, to insure proper operation, and a state of good repair. After repairs and/or alterations are made to any equipment, the equipment shall be thoroughly tested for proper calibration before returning it to service. Records shall be maintained on each piece of equipment to indicate its history of testing and maintenance.

(b) All anesthesia and surgical equipment shall have a written preventive maintenance program developed and implemented. Equipment shall be checked and tested in accordance with the manufacturer’s specifications at designated intervals, not less than annually, to ensure proper operation and a state of good repair.

(c) All surgical instruments shall have a written preventive maintenance program developed and implemented. Surgical instruments shall be cleaned and checked for function after use to ensure proper operation and a state of good repair.

History

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(b) FS. History–New 9-25-06, Amended 4-5-17.

Fla. Admin. Code R. 59A-9.023 Clinic Personnel

Abortions shall be performed only by a licensed physician who has admitting privileges at a hospital within reasonable proximity to the clinic. Physician admitting privileges are optional if the clinic has a written transfer agreement with a hospital within reasonable proximity. At the time of transfer the clinic shall provide to the receiving hospital a copy of the patient’s medical records related to the pregnancy being terminated. Each abortion clinic providing second trimester abortions shall have a staff that is adequately trained and capable of providing appropriate service and supervision to the patients. The clinic will have a position description for each position delineating duties and responsibilities and maintain personnel records for all employees performing or monitoring patients receiving a second trimester abortion.

(1) Physicians.

The clinic shall designate a licensed physician to serve as a medical director. Only physicians authorized by the medical director and the clinic shall perform abortions.

(2) Nursing Personnel.

Nursing personnel in the clinic shall be governed by written policies and procedures relating to patient care, establishment of standards for nursing care and mechanisms for evaluating such care, and nursing services.

(3) Allied health professionals, working under appropriate direction and supervision, may be employed to work only within areas where their competency has been established.

(4) Orientation. Each clinic shall have and execute a written orientation program to familiarize each new staff member, including volunteers, with the clinic and its policies and procedures, to include fire safety, medical emergencies, and infection control.

(5) In-service Training. In-service training programs shall be planned and provided for all employees including full time, part time and contract employees, at the beginning of employment and no less than annually thereafter and will also apply to all volunteers to insure and maintain their understanding of their duties and responsibilities. Records shall be maintained to reflect program content and individual attendance. The following training shall be provided no less than annually, and for surgical assistants and volunteers, must include training in counseling, patient advocacy and specific responsibilities associated with the services they provide:

(a) Infection control, to include universal precautions against blood-borne diseases, general sanitation, personal hygiene such as hand washing, use of masks and gloves, and instruction to staff if there is a likelihood of transmitting a disease to patients or other staff members.

(b) Fire protection, to include evacuating patients, proper use of fire extinguishers, and procedures for reporting fires;

(d) Licensing regulations; and,

(e) Incident reporting.

History

Rulemaking Authority 390.012 FS. Law Implemented 390.0111(2), 390.012 FS. History–New 6-13-90, Amended 4-17-91, Formerly 10D-72.023, Amended 9-25-06, 4-5-17.

Fla. Admin. Code R. 59A-9.024 Clinic Policies and Procedures for Second Trimester Abortions

An abortion clinic providing second trimester abortions shall have written policies and procedures to assure that quality patient care shall relate specifically to the functional activities of clinic services. These written procedures shall apply to second trimester abortions and shall be available and accessible to clinic personnel and shall be reviewed and approved annually by the clinic’s medical director. These policies and procedures shall include:

(1) Patient admission;

(2) Pre- and post-operative care;

(3) Physician’s orders;

(4) Standing orders with required signatures;

(5) Medications, storage and administration;

(6) Treatments;

(7) Surgical asepsis;

(8) Medial asepsis;

(9) Sterilization and disinfection;

(10) Documentation: Medical records and clinic records;

(11) Patient discharge;

(12) Patient transfer;

(13) Emergency measures;

(14) Incident reports;

(15) Personnel orientation;

(16) Inservice education record;

(17) Anesthesia;

(18) Equipment and supplies: availability and maintenance;

(19) Volunteers; and,

(20) Visitors.

History

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012 FS. History–New 9-25-06, Amended 4-5-17.

Fla. Admin. Code R. 59A-9.025 Medical Screening and Evaluation of Patients Receiving Second Trimester Abortions

(1) Each abortion clinic that provides second trimester abortions shall formulate and adhere to written patient care policies and procedures designed to ensure professional and safe care for patients undergoing second trimester abortions and shall maintain a medical record for each such patient that records history, care and services. Any abortion clinic that performs second trimester abortions shall comply with these patient care policies and procedures for patients undergoing second trimester abortions, to include the following:

(a) Admission criteria and procedures;

(b) Identification in the medical record of physician(s) and nurse(s) involved in providing the services offered for patients undergoing second trimester abortions;

History and physical examination, to include verification of pregnancy, period of gestation, identification of any past surgeries, preexisting conditions or complications; including allergies to medications, antiseptic solutions, or latex; and a complete obstetric and gynecological history.
Special examinations, lab procedures, and/or consultations required, to include ultrasonography to confirm period of gestation, and a physical examination including a bimanual examination estimating uterine size and palpation of the adnexa. The physician shall keep original prints of each ultrasound examination of a patient in the patient’s medical history file. Urine or blood tests for pregnancy shall be performed before the abortion procedure.

(2) Laboratory Services.

(a) Laboratory services shall be provided onsite or through contractual arrangement with a laboratory that holds the appropriate federal Clinical Laboratory Improvement Amendments (CLIA) certificate.

(b) All laboratory services provided onsite shall be performed in compliance with federal CLIA provisions.

(3) Laboratory Equipment and Supplies.

(a) All equipment and supplies for the collection, storage, and testing of specimens shall meet the federal CLIA provisions, and shall be maintained according to manufacturer’s instructions and in a manner that ensures accurate test results.

(b) Temperature controlled spaces for the storage of specimens or testing supplies shall be monitored and recorded to ensure that the proper storage temperature is maintained.

(d) Adequate facilities and supplies for the collection, storage and transportation of laboratory specimens shall be available onsite.

(4) Rh blood type D. Rh testing shall be performed on all patients, unless results of previous testing is available and documented in the medical record.

(5) All laboratory test reports shall be placed in the patient’s medical record.

(6) All laboratory test and storage areas, records and reports shall be available for inspection by the Agency.

(7) If a person who is not a physician performs an ultrasound examination, that person shall have documented evidence that he or she has completed a course in the operation of ultrasound equipment. Such documentation shall be retained on file at the clinic.

(8) A test for anemia shall be performed.

(9) Each abortion clinic must be in compliance with Section 390.0111, F.S.

History

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(d) FS. History–New 9-25-06, Amended 1-2-14, 4-5-17, 12-27-18.

Fla. Admin. Code R. 59A-9.026 Second Trimester Abortion Procedure

Any abortion clinic which is providing second trimester abortions must be in compliance with the following standards relative to second trimester abortion procedures.

(1) A physician, registered nurse, licensed practical nurse, advanced practice registered nurse, or physician assistant shall be available to all patients throughout the abortion procedure.

(2) The abortion procedure will be performed in accordance with obstetric standards and in keeping with established standards of care regarding the estimation of the period of gestation of the fetus.

(3) Anesthesia service shall be organized under written policies and procedures relating to anesthesia staff privileges, the administration of anesthesia, and the maintenance of strict safety controls.

(4) Prior to the administration of anesthesia, patients shall have a history and physical examination by the individual administering anesthesia, including laboratory analysis when indicated.

(5) Appropriate precautions, such as the establishment of intravenous access for patients undergoing post-first trimester abortions.

(6) Appropriate monitoring of the patient’s vital signs by professionals licensed and qualified to assess the patient’s condition will occur throughout the abortion procedure and during the recovery period until the patient’s condition as specified by the type of abortion procedure performed, is deemed to be stable in the recovery room.

History

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(e) FS. History–New 9-25-06, Amended 4-5-17.

Fla. Admin. Code R. 59A-9.027 Recovery Room Standards for Second Trimester Abortions

Each abortion clinic which is providing second trimester abortions shall comply with the following recovery room standards when providing second trimester abortions.

(1) Following the procedure, post-procedure recovery rooms will be supervised and staffed to meet the patient’s needs. A physician or physician assistant, a licensed registered nurse, a licensed practical nurse or an advanced practice registered nurse who is trained in the management of the recovery area shall be available to monitor the patient in the recovery room until the patient is discharged. The individual must be certified in basic cardiopulmonary resuscitation. A patient in the post-operative or recovery room shall be observed for as long as the patient’s condition warrants.

(2) The clinic shall arrange hospitalization if any complication beyond the medical capability of the staff occurs or is suspected. The clinic shall ensure that equipment and services are readily accessible to provide appropriate emergency resuscitative and life support procedures pending the transfer of the patient or a viable fetus to the hospital. A physician shall sign the discharge order and be readily accessible and available until the last patient is discharged to facilitate the transfer of emergency cases if hospitalization of the patient or viable fetus is necessary. The clinic medical records documenting care provided shall accompany the patient. These records will include the contact information for the physician who performed the procedure at the clinic.

(3) A physician shall discuss Rho (D) immune globulin with each patient for whom it is indicated and will ensure that it is offered to the patient in the immediate post-operative period or that it will be available to the patient within 72 hours following completion of the abortion procedure. If the patient refuses the Rho (D) immune globulin, refusal shall be documented on Refusal to Permit Administration of Rho (D) Immune Globulin, AHCA Form 3130-1002, July 2016, which is incorporated by reference. The form can be obtained at https://flrules.org/Gateway/reference.asp?No=Ref-07598 and from the Agency for Health Care Administration, Hospital and Outpatient Services Unit, Mail Stop #31, 2727 Mahan Drive, Tallahassee, Florida 32308, or on the Agency website at: https://ahca.myflorida.com/applications. The form shall be signed by the patient, physician, and a witness, and shall be included in the patient’s medical record.

(4) Written instructions with regard to post-abortion coitus, signs of possible medical complications, and general aftercare shall be given to each patient. Each patient shall have specific written instructions regarding access to medical care for complications, including a telephone number to call for medical emergencies. The physician will ensure that either a registered nurse, licensed practical nurse, advanced practice registered nurse, or physician assistant from the abortion clinic makes a good faith effort to contact the patient by telephone, with the patient’s consent, within 24 hours after surgery to assess the patient’s recovery. A contact for post-operative care from the facility shall be available to the patient on a 24-hour basis.

(5) Clinic procedures must specify the minimum length of time for recovery as warranted by the procedure type and period of gestation.

History

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(f) FS. History–New 9-25-06, Amended 4-5-17, Technical Change 3-26-26.

Fla. Admin. Code R. 59A-9.028 Post Procedure Follow-up Care for Patients Receiving Second Trimester Abortions

Each abortion clinic which is providing second trimester abortions shall comply with the following post procedure follow-up care requirements when providing a second trimester abortion.

(1) The clinic shall offer a post-abortion medical visit that includes a medical examination and a review of the results of all laboratory tests.

(2) A urine pregnancy test will be obtained at the time of the follow-up visit to rule out continuing pregnancy. If a continuing pregnancy is suspected, the patient shall be evaluated and a physician who performs abortions shall be consulted.

(3) The clinic shall provide for the education of the patient in post procedure care, including specific instructions in case of emergency.

History

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(g) FS. History–New 9-25-06, Amended 4-5-17.

Fla. Admin. Code R. 59A-9.029 Abortion Clinic Incident Reporting for Second Trimester Abortions

This section shall apply to incidents involving patients receiving second trimester abortions in any abortion clinic providing second trimester abortions. An abortion clinic shall maintain a record of each incident that results in serious injury as defined in Section 390.012(3)(h)1., F.S., to a patient or a viable fetus.

(1) Each incident must be reported to the Agency within 10 days after the incident occurs.

(2) The report must be submitted on the Abortion Clinic Incident Report, AHCA Form 3130-1003OL, March 2019, which is hereby incorporated by reference. The form is only accepted electronically and is available at: https://apps.ahca.myflorida.com/SingleSignonPortal/Login.aspx. A copy of the form can also be found at: https://flrules.org/Gateway/reference.asp?No=Ref-10855.

(3) If a patient death occurs the abortion clinic shall report the death to the Department and the appropriate regulatory board not later than the next workday. The report to the Department shall be filed as required by Rule 64V-1.0061, F.A.C.

History

Rulemaking Authority 390.012(1) FS. Law Implemented 390.012(3)(h) FS. History–New 9-25-06, Amended 4-5-17, 8-29-19, Technical Change 3-26-26.

Fla. Admin. Code R. 59A-9.030 Disposal of Fetal Remains

Fetal remains shall be disposed of in a sanitary and appropriate manner and in accordance with standard health practices and Chapters 381 and 390, F.S., and Chapter 64E-16, F.A.C.

(1) Storage of Fetal remains at a clinic shall:

(a) Not exceed 30 days;

(b) Be in an interior restricted access location of the clinic; and,

(2) Packages or containers of fetal remains shall be labeled to include:

(a) The name and address of the clinic;

(b) One of the following phrases: Biomedical Waste, Biohazardous Waste, Biohazard, Infectious Waste or Infectious Substance.

History

Rulemaking Authority 390.012 FS. Law Implemented 381.0098, 382, 390.0111 FS. History–New 6-13-90, Amended 4-17-91, Formerly 10D-72.030, Amended 9-25-06, 4-5-17.

Fla. Admin. Code R. 59A-9.031 Clinical Records

(1) A permanent individual clinical record shall be kept on each clinic patient. Clinical records shall be complete, accurately documented, and systematically organized to facilitate storage and retrieval.

(a) Clinical records shall contain a printed image of the ultrasound used to determine the period of gestation.

(b) Clinical records shall be kept confidential and secure.

(c) Operative reports signed by the physician performing the second trimester abortion shall be recorded in the clinical record immediately following the procedure or that an operative progress note is entered in the clinical record to provide pertinent information.

(2) Clinical records shall be kept on file for a minimum of five years from the date of the last entry.

History

Rulemaking Authority 390.012 FS. Law Implemented 381.012 FS. History–New 6-13-90, Amended 4-17-91, Formerly 10D-72.031, Amended 9-25-06, 4-5-17.

Fla. Admin. Code R. 59A-9.034 Reports

(1) Pursuant to Section 390.0112, F.S., an abortion clinic and any medical facility in which abortions are performed, including a physician’s office must submit a report each month to the Agency, regardless of the number of abortions, and regardless of method used. Monthly reports must be received by the Agency within 30 days following the preceding month. Failure to submit this report so that it is timely received by the Agency will result in an administrative fine being imposed pursuant to Section 390.0112, F.S.

(2) Monthly reports for abortions must be submitted on the Monthly Report of Induced Terminations of Pregnancy, AHCA Form 3130-1010 OL, July 2022, which is hereby incorporated by reference. This form is only accepted electronically and is available at: https://apps.ahca.myflorida.com/SingleSignOnPortal/Login.aspx?ReturnUrl=%2fSingleSignOnPortal. A copy of the form can also be found at: http://www.flrules.org/Gateway/reference.asp?No=Ref-14931.

(3) Each clinic shall maintain a log of all abortions, recording the date of the procedure and period of gestation.

(4) When a physician attempts to induce the live birth of an unborn baby, regardless of gestational age, to treat the preterm premature rupture of membranes or premature rupture of membranes, and the unborn baby does not survive, the incident does not constitute an abortion and shall not be reported pursuant to this rule.

(5) The treatment of an ectopic pregnancy shall not be considered an abortion and shall not be reported pursuant to this rule.

(6) The treatment of a trophoblastic tumor shall not be considered an abortion and shall not be reported pursuant to this rule.

History

Rulemaking Authority 390.012 FS. Law Implemented 390.0112, 390.012 FS. History–New 6-13-90, Formerly 10D-72.034, Amended 8-24-94, 9-25-06, 7-13-08, 5-19-16, 9-26-16, 1-16-17, 12-20-22, 11-19-24.

Fla. Admin. Code R. 59A-9.035 Abortion Referral or Counseling Agency Registration

(1) Registration pursuant to this rule is only required of registrants who are not exempt from registration pursuant to Section 390.025(4), F.S., and who are paid for the particular purpose of providing advice or assistance to persons in obtaining abortions or in pursuing alternatives to abortion.

(2) All applicants requesting registration of an abortion referral or counseling agency under the provisions of Chapter 390, F.S., shall make application to the Agency on the Health Care Registration, Abortion Referral or Counseling Agency, AHCA Form 3130-1020, February 2017, which is incorporated by reference. The form can be obtained at https://flrules.org/Gateway/reference.asp?No=Ref-08458, and from the Agency for Health Care Administration, Hospital and Outpatient Services Unit, Mail Stop #31, 2727 Mahan Drive, Tallahassee, Florida 32308, or on the Agency website at: https://ahca.myflorida.com/applications.

(3) A registration fee as listed on the application shall accompany each application for initial or renewal registration. The fee shall be made payable to the Agency and is not refundable.

(4) Each registration shall be valid only for the registrant to whom it is issued and shall not be subject to sale, assignment, or other transfer, voluntary or involuntary, nor shall a registration be valid for any premises other than for which it was originally issued.

(5) A current registration shall be posted in a conspicuous place within the premises where it can be viewed by patients.

(6) A registration, unless sooner suspended or revoked, shall automatically expire two years from the date of issuance, and shall be renewable biennially upon application for renewal and payment of the fee prescribed by the application, provided that the applicant and abortion referral or counseling agency meet the requirements established under Chapter 390, F.S., and rule Chapter 59A-9, F.A.C.

History

Rulemaking Authority 390.025(5) FS. Law Implemented 390.025 FS. History‒New 10-24-16, Amended 7-30-17, Technical Change 3-26-26.

Chapter 59A-10 INTERNAL RISK MANAGEMENT PROGRAM

Fla. Admin. Code R. 59A-10.002 Definitions

As used in this rule chapter:

(1) “Accident prevention” means those risk management techniques that seek to reduce the frequency and/or severity of incidents.

(2) “Accredited institution of higher learning” means universities, colleges, community colleges and junior colleges which are accredited by an accrediting agency.

(3) “Accrediting agency” means those accrediting agencies belonging to the Council on Higher Education Accreditation.

(4) “Agency” means the Agency for Health Care Administration.

(5) “Ambulatory surgical center” means an ambulatory surgical center licensed under chapters 395 and 408, F.S., and rule chapters 59A-5 and 35, F.A.C.

(6) “Basic risk manager” means a person who has a degree, awarded by an accredited institution of higher learning, in risk management or insurance.

(7) “Community interrelationships” means community networks, liaisons and associations that are necessary to promote continuity of care or enhance the delivery of patient care and aid in the prevention and control of health care risks.

(8) “Departmental organization and management” means the organizational structure, goals, objectives, philosophy, policies, procedures, and job descriptions which govern organizational operations of the health care risk management program as it functions within the licensed health care facility.

(9) “General risk management administration” means the establishment, direction and evaluation of procedures, programs and other methods to reduce or minimize personal injury and financial losses. The term includes management of an incident reporting system and reporting of appropriate statistics for hospital and state maintenance.

(10) “Health care administrator” means a person who has a masters degree, awarded by an accredited institution of higher learning, in health or healthcare administration, healthcare management, or other such education which included successful completion of graduate level courses in the management and administration of various healthcare organizations, health care finance, legal and ethical issues related to healthcare, risk management, and health information management.

(11) “Health care facility” or “facility” means an ambulatory surgical center or hospital, as defined in subsections (5) and (13).

(12) “Health care professional” means a physician licensed pursuant to chapter 458, F.S., an osteopath licensed pursuant to chapter 459, F.S., a chiropractor licensed pursuant to chapter 460, F.S., a podiatrist licensed pursuant to chapter 461, F.S., a pharmacist licensed pursuant to chapter 465, F.S., a nurse licensed pursuant to chapter 464, F.S., a radiologic technologist certified pursuant to chapter 468, F.S., a respiratory therapist licensed pursuant to chapter 468, F.S., a physical therapist licensed pursuant to chapter 486, F.S., an occupational therapist licensed pursuant to chapter 468, F.S., and an emergency medical technician or paramedic certified pursuant to chapter 401, F.S.

(13) “Hospital” means a hospital licensed under chapters 395 and 408, F.S., and rule chapters 59A-3 and 35, F.A.C.

(14) ICD-10-CM means the International Classification of Diseases, 10th Edition, Clinical Modification and shall be abbreviated as ICD-10-CM in these rules.

(15) “Incident report” means a factual written statement about a particular incident detailing particulars as to time, location, all persons directly involved including functional titles, and the nature of event including description of injuries. The report shall contain a listing of witnesses to the event.

(16) “Incident reporting system” means a series of systematized procedures for detecting, reporting, collating, analyzing, and summarizing incidents.

(17) “Internal risk management program” means the policies and procedures of a health care facility which constitute the internal risk management program as defined in section 395.0197 or 641.55, F.S.

(18) “Investigation” or “investigate” means the identification, analysis and evaluation of an incident by a risk manager or his designee or by a representative of the Agency.

(19) “Licensed health care risk manager” means an individual licensed under section 395.10974, F.S.

(20) “Medical care” means that care and treatment rendered by or under the direction of licensed health care professionals.

(21) “Medical intervention” means actions of any health care facility or personnel of the facility, in the provision of health care.

(22) “Medical terminology” means terms and abbreviations most commonly found in medical usage as well as prefixes and suffixes which are employed as elements of medical words.

(23) “Patient care” means those services provided or rendered to meet the patient’s physical, emotional and spiritual needs.

(24) “Patient grievance” means any complaint by a patient relating to patient care or the quality of medical services, except for those matters pertaining to the cost of care.

(25) “Personal and social care” means those human resources and services which are available to meet the individual psychosocial needs of patients to promote well-being and continuity of care.

(26) “Personnel” for purposes of this rule means any employee or independent contractor of a facility or member of a facility’s medical staff.

(27) “Personnel directly involved” for the purposes of reporting to the Agency means personnel as described in subsection (26) who could exercise control over the event which is reportable as an adverse or untoward incident.

(28) “Risk management” means the identification, investigation, analysis, and evaluation of risks and the selection of the most advantageous method of correcting, reducing or eliminating identifiable risks.

(29) “Risk Manager designee” means any person appointed by the facility to work with the licensed health care risk manager or to act as his representative in carrying out risk management activities. This appointment must be in writing.

History

Rulemaking Authority 395.0197, 395.1073 FS. Law Implemented 395.0197 FS. History–New 8-28-79, Formerly 10D-75.02, Amended 3-25-86, 12-28-89, Formerly 10D-75.002, Amended 9-16-92, 8-2-16.

Fla. Admin. Code R. 59A-10.0055 Incident Reporting System

(1) Incident Reporting. An incident reporting system shall be established for each facility. Procedures shall be detailed in writing and disseminated to all employees of the facility. All new employees, within 30 days of employment, shall be instructed about the operation of the system and responsibilities of it. At least annually all nonphysician personnel of the facility working in clinical areas and providing patient care shall receive 1 hour risk management and risk prevention education and training including the importance of accurate and timely incident reporting.

(2) Incident Reports. The incident reporting system shall include the prompt, within 3 calendar days, reporting of incidents to the risk manager, or his designee. Reports shall be on a form developed by the facility for the purpose and shall contain at least the following information:

(a) The patient’s name, locating information, admission diagnosis, admission date, age and sex;

(b) A clear and concise description of the incident including time, date, exact location; and elements as needed for the annual report based on ICD-10-CM;

(c) Whether or not a physician was called; and if so, a brief statement of said physician’s recommendations as to medical treatment, if any;

(d) A listing of all persons then known to be involved directly in the incident, including witnesses, along with locating information for each;

(e) The name, signature and position of the person completing the reports, along with date and time that the report was completed.

(3) Incident Report Review and Analysis. The risk manager shall be responsible for the regular and systematic reviewing of all incident reports including 15-day incident reports for the purpose of identifying trends or patterns as to time, place or persons: and upon emergence of any trend or pattern in incident occurrence shall develop recommendations for corrective actions and risk management prevention education and training. Summary data thus accumulated shall be systematically maintained for 3 years.

(a) At least quarterly or more often as may be required by the governing body, the risk manager shall provide a summary report to the governing body which includes information about activities of risk management as defined herein.

(b) Evidence of the incidents reporting and analysis system and copies of summary reports, incident reports filed within the facility, and evidence of recommended and accomplished corrective actions shall be made available for review to any authorized representative of the Agency upon request during normal working hours.

History

Rulemaking Authority 395.0197 FS. Law Implemented 395.0197 FS. History–New 1-2-97.

Fla. Admin. Code R. 59A-10.0065 Fifteen Day Reports

History

Rulemaking Authority 395.0197 FS. Law Implemented 395.0197 FS. History–New 3-25-86, Amended 12-28-89, Formerly 10D-75.0065, Amended 9-16-92, 2-12-96, Repealed 11-28-18.

Fla. Admin. Code R. 59A-10.031 Purpose

History

Rulemaking Authority 395.10973(1) FS. Law Implemented 395.10974 FS. History–New 7-9-86, Formerly 4-65.001, 4-217.010, Repealed 5-14-12.

Fla. Admin. Code R. 59A-10.032 Definitions

History

Rulemaking Authority 395.10973 FS. Law Implemented 395.10974 FS. History–New 7-9-86, Formerly 4-65.002, 4-217.015, Amended 4-4-01, Repealed 12-4-16.

Fla. Admin. Code R. 59A-10.033 General Licensure Qualifications for Health Care Risk Managers

History

Rulemaking Authority 395.10973(1), 408.819 FS. Law Implemented 395.10974, 408.805, 408.806, 408.809, 408.810 FS. History–New 7-9-86, Formerly 4-65.003, 4-217.020, Amended 5-4-15, Repealed 7-1-18.

Fla. Admin. Code R. 59A-10.034 Qualification by Completion of a Training Program

History

Rulemaking Authority 395.10973(1) FS. Law Implemented 395.10974 FS. History–New 7-9-86, Formerly 4-65.004, 4-217.025, Repealed 7-1-18.

Fla. Admin. Code R. 59A-10.035 Qualification by College Level Studies

History

Rulemaking Authority 395.10973(1) FS. Law Implemented 395.10974 FS. History–New 7-9-86, Formerly 4-65.005, 4-217.030, Repealed 7-1-18.

Fla. Admin. Code R. 59A-10.036 Qualification by Practical Experience

History

Rulemaking Authority 395.10973(1) FS. Law Implemented 395.10974 FS. History–New 7-9-86, Formerly 4-65.006, 4-217.035, Amended 8-2-16, Repealed 7-1-18.

Fla. Admin. Code R. 59A-10.037 Educational Programs

History

Rulemaking Authority 395.10973(1) FS. Law Implemented 395.10974 FS. History–New 7-9-86, Formerly 4-65.007, 4-217.040, Amended 8-2-16, Repealed 7-1-18.

Chapter 59A-11 BIRTH CENTER STANDARDS AND LICENSURE

Fla. Admin. Code R. 59A-11.001 Purpose

History

Rulemaking Authority 383.309 FS. Law Implemented 383.309 FS. History–New 3-4-85, Formerly 10D-90.01, 10D-90.001, Repealed 9-17-96.

Fla. Admin. Code R. 59A-11.002 Definitions

(1) “Accrediting Organization” means a recognized organization whose standards are comparable to the licensure regulations required by this state, including:

(a) the Accreditation Association for Ambulatory Health Care (AAAHC);

(b) the Commission for the Accreditation of Birth Centers (CABC); and,

(2) “Agency” means the Agency for Health Care Administration.

(3) “CABC” means the Commission for the Accreditation of Birth Centers.

(4) “CLIA certification” means having applied for and received a federal Clinical Laboratory Improvement Amendments (CLIA) certificate documenting compliance with Title 42, Chapter IV, Subchapter G, Part 493 of the Code of Federal Regulations.

(5) “Local hospital” means a hospital licensed under Chapter 395, F.S., providing emergency care, obstetric services, and newborn intensive care located not more than 30 minutes transport time by emergency vehicle.

(6) “Qualified personnel” means an individual trained and competent in the services which he or she provides and is licensed or certified when required by statute or professional standard.

(7) Resonable proximity means a distance not to exceed thirty (30) minutes transport time by emergency vehicle.

History

Rulemaking Authority 383.309 FS. Law Implemented 383.309 FS. History–New 3-4-85, Formerly 10D-90.02, 10D-90.002, Amended 9-17-96, 5-15-14, 12-10-18, 6-9-26.

Fla. Admin. Code R. 59A-11.003 Licensure Procedures

(1) An applicant or licensee requesting licensure for the operation of a birth center or advanced birth center under the provision of Chapter 383, F.S., shall make application to the Agency as required in Rule 59A-35.040 and Rule 59A-35.060, F.A.C.

(2) Each birth center or advanced birth center applying for a license shall be designated by a distinctive name. Duplication of an existing birth center or advanced birth center’s name is prohibited.

(3) There shall not be multiple birth center or advanced birth center licenses for the same premises.

History

Rulemaking Authority 383.309, 408.819 FS. Law Implemented 383.305, 408.805, 408.806, 408.809, 408.810 FS. History–New 3-4-85, Formerly 10D-90.03, 10D-90.003, Amended 9-27-94, 2-12-96, 9-17-96, 9-28-14, 1-16-19, 5-19-22, 6-9-26.

Fla. Admin. Code R. 59A-11.004 Investigations and License, Life Safety and Validation Inspections

(1) The Agency shall make or cause to be made such inspections and investigations as are necessary to:

(a) Assure compliance with the licensure and life safety requirements;

(b) Respond to complaints; and,

(2) The Agency shall conduct scheduled periodic inspections of both birth and advanced birth centers in order to ensure compliance with all licensure and life safety requirements to the Agency.

(3) Non-accredited birth or advanced birth centers. Those birth or advanced birth centers which are not accredited by an accrediting organization shall be subject to scheduled licensure and life safety inspections by the Agency.

(a) The fee for conducting a licensure inspection shall be $250.

(b) The fee for conducting a life safety inspection shall be $250.

(4) Accreditation.

(a) The Agency shall accept the survey report of an accrediting organization in lieu of a licensure inspection for accredited birth centers and for birth centers seeking accreditation, provided that the standards used by the accrediting organization are determined by the Agency to incorporate comparable state licensure requirements found in Chapters 383 and 408, Part II, F.S., and Chapters 59A-11 and 59A-35, F.A.C. and the birth center does not meet the criteria specified under subparagraphs 59A-11.004(4)(g)1. and 2., F.A.C.

(b) The Agency will not accept the survey report of an accrediting organization in lieu of state licensure inspections for advanced birth centers until such time the accrediting organization(s) document their standards meet or exceed the advanced birth center state licensure requirements.

(c) Upon receipt of the accrediting organization’s survey report, the Agency will review the findings to determine if the birth center is in compliance with state licensure requirements.

(d) The Agency shall notify the birth center within 60 days of the receipt of the accrediting organization’s survey report regarding the Agency’s determination of the birth center’s compliance or non-compliance with state licensure requirements.

(e) Accredited birth centers are subject to scheduled life safety inspections.

(f) The fee for conducting a life safety inspection shall be $250.

(g) Accredited birth centers shall be subject to licensure inspections under the following circumstances:

The birth center has been denied accreditation or has received a provisional or conditional accreditation from an accrediting organization on its most recent accreditation survey, and has not submitted an acceptable plan of correction to the accrediting organization and the Agency.
The birth center has received full accreditation, but has not authorized the release of the report or has not ensured that the Agency received the accrediting organization’s survey report prior to the Agency’s scheduled survey.

(h) If a licensure inspection is required pursuant to paragraph (4)(g), the fee for conducting a licensure inspection shall be $250.

(5) Validation Inspection. Every three (3) years, the Agency shall conduct validation inspections of those birth centers that have undergone an accreditation inspection from an approved accrediting organization, to determine ongoing compliance with state licensure requirements. The fee for conducting a validation inspection shall be $250.

(6) Complaint investigations. The Agency shall conduct investigations of complaints regarding violations of licensure and life safety standards in accordance with Section 383.324, F.S. Complaint investigations will be unannounced.

(7) Conformance with accreditation standards. In all birth centers where the Agency does not conduct a licensure inspection, by reason of the birth center’s accreditation status, the birth center shall continue to conform to the standards of accreditation throughout the term of accreditation, or shall notify the Agency of the areas of non-conformance.

History

Rulemaking Authority 383.309, 408.819 FS. Law Implemented 383.324, 408.811 FS. History–New 3-4-85, Formerly 10D-90.04, 10D-90.004, Amended 2-12-96, 9-17-96, 5-15-14, 6-15-17, 6-9-26.

Fla. Admin. Code R. 59A-11.005 Requirements for Licensure

In addition to other requirements specified in these rules, all licensed birth centers or advanced birth centers shall have at least the following:

(1) A governing body organized under and have written bylaws, rules and regulations, which it reviews at least every two years, denotes dates to indicate time of last review, and revises as necessary and enforces. The governing body bylaws shall state the role and purpose of the birth center or advanced birth center, including an organizational chart defining the lines of authority.

(2) An administrator or other similarly titled official to whom the governing body delegates the full-time authority for the operation of the center in accordance with the established policy of the governing body;

(3) An organized clinical staff to which the governing body delegates responsibility for maintaining proper standards of medical and other health care.

(4) Birth centers. The clinical staff of the birth center shall be responsible for maintaining quality of care provided to the clients.

(a) At least one clinical staff member must be available for every two clients in labor in a birth center.

(b) A clinical staff member or qualified personnel must be available on-site during the entire time the client is in the birth center. Services during labor and delivery shall be provided by physicians or by certified nurse midwives or licensed midwives, assisted by at least one other staff member, under protocols developed by the clinical staff and approved by the governing body in accordance with accepted standards of care.

(c) All qualified personnel and clinical staff of the birth center shall be trained in infant and adult resuscitation. Clinical staff or qualified personnel who have demonstrated ability to perform neonatal resuscitation procedures shall be present during each birth.

(d) Clinical records describing the history, conditions, treatment and progress of the client shall be maintained in sufficient completeness and accuracy to assure transferable comprehension of the case at any time.

(e) Clinical record reviews must evaluate the quality of clinical care on the basis of documented evidence.

(f) The administrator or delegated clinical staff must review admissions with respect to eligibility, course of pregnancy and outcome, evaluation of services, condition of mother and newborn on discharge, or transfer to other providers.

(g) The administrator or delegated clinical staff must review infection risk and cases and the promotion of a preventive and corrective program designed to minimize these hazards.

(5) Services of a consultant physician are required in those birth centers which do not have a physician on the clinical staff who is certified or eligible for certification by the American Board of Obstetrics and Gynecology, the American Board of Osteopathic Obstetricians and Gynecologists or has hospital obstetrical privileges.

(6) The responsibilities and functions of the consultant physician shall be specifically described in the policy and procedure manual and the client care protocols.

(7) The governing body shall maintain in writing a consultation agreement, signed within the current license year, with each consultant who agrees to provide advice and services to the birth center as requested.

(8) The birth center or advanced birth center shall have a defined client record system, policies and procedures which provide for identification, security, confidentiality, control, retrieval, and preservation of client care data and information. A current and complete clinical record for each client accepted for care in the birth center or advanced birth center shall include the following data:

(a) Identifying information including client’s name, address and telephone number;

(b) Initial history and physical examination including laboratory findings and dates;

(d) The dates and topics of the educational sessions attended;

(e) The date and time of the onset of labor;

(f) The course of labor including all pertinent examinations and findings;

(g) The exact date and time of birth, the presenting part, the sex of the newborn, the numerical order of birth in the event of more than one newborn, to include filing of the birth certificate, and the Apgar score at one minute and five minutes;

(h) Time of expulsion and condition of placenta;

(i) All treatments rendered to the mother and newborn including prescribing prescriptions, the time, type, and dose of eye prophylaxis;

(j) Copy of the metabolic screening report;

(k) Condition of the mother and newborn including any complications and action taken;

(l) All medical consultations relevant to the client specifically;

(m) Referrals for medical care and transfers to hospitals including that information germane to the circumstances;

(n) Examinations of the newborn and postpartum mother; and,

(o) Information and instructions given to the client regarding postpartum care as outlined in Rule 59A-11.016, F.A.C.

All entries shall be dated and signed by the attending clinical staff members.
The clinical record is confidential and shall not be released without the written consent of the client except under the following conditions:

a. When the client is transferred to another source of care; and,

b. For audit by the agency during licensure inspection or complaint investigation.

The clinical records shall be kept on file for a minimum of seven years from the date of last entry.
The clinical record shall be immediately available at the time of the client’s admission to the birth center in labor and to the practitioner or hospital when the client is transferred.

(9) A policy requiring that all clients be accepted on the authority of and under the care of a member of the organized clinical staff;

(10) A procedure for providing care and transfer in an emergency;

(a) The birth center or advanced birth center shall have a written protocol which shall include:

The name, address, telephone numbers and contact persons of the licensed ambulance service, the hospital licensed to provide emergency obstetrical and neonatal services, and other hospitals in the vicinity;
The conditions specified in the arrangements between the birth center or advanced birth center and the ambulance service and the hospital, including financial responsibility for services rendered; and,
Criteria to determine risk status which require medical consultation or transfer to a hospital of the newborn or the mother for any conditions such as:

a. Premature labor, meaning labor occurring at less than 37 weeks gestation;

b. Estimated fetal weight less than 2,500 grams or greater than 4,000 grams;

c. Hypertension;

d. Pre-eclampsia;

e. Failure to progress in labor;

f. Evidence of an infectious process;

g. Premature rupture of the membranes, meaning rupture occurring more than 12 hours before onset of active labor;

h. Suspected placenta praevia or abruptio;

i. Non-vertex presentation;

j. Hemorrhage of greater than 500 cc of blood;

k. Anemia consisting of less than 10 grams of hemoglobin per 100 milliliters of blood or 30 percent hematocrit;

Persistent fetal tachycardia (heart rate more than 160 beats per minute), repetitive fetal bradycardia (heart beat less than 120 beats per minute) or undiagnosed abnormalities of the fetal heart tones; and,

m. Persistent hypothermia in the newborn.

Criteria to determine risk status which require immediate emergency transfer to a hospital of the newborn or mother for any condition such as:

a. Prolapsed cord;

b. Uncontrolled hemorrhage;

c. Placenta abruptio;

d. Convulsions;

e. Major anomaly of the newborn;

f. Apgar score four or less at five minutes;

g. Fetal heart rate of 90 or less beats per minute for three minutes;

h. Thick meconium staining;

i. Respiratory distress in the newborn; and,

j. Weight less than 2,000 grams.

The criteria and protocols for transfer shall be readily accessible to clinical staff members at all times.

(b) The names and telephone numbers of the ambulance service, neonatal transport service, and hospital shall be clearly posted at each telephone in the birth center.

(c) A written report of the transfer shall be documented and available for quality assurance review and agency inspection. The report shall include:

The client’s name;
The date of the event;
The reason for transfer;
The provider and mode of transportation to the hospital;
The exact time of the initial call, any subsequent calls;
Arrival of the emergency personnel;
Departure of the client;
Arrival at the hospital;
Name of the hospital;
Initiation of emergency medical services;
The condition of the client at the time of transfer; and,
Any information regarding the medical care of the client and outcome.

(d) The clinical staff, consultants, and governing body shall review and evaluate the criteria, protocols, and emergency transfer reports annually. The findings of the evaluation shall be documented.

(11) A method and policy for infection control.

(a) There shall be an Infection Control Committee, composed of the clinical staff and consultants, delegated responsibility for developing and maintaining current written policies and procedures for the prevention, control and investigation of infection in the birth center, and for assuring the effectiveness of current procedural techniques.

(b) There shall be current written policies and procedures to assure, define, and validate infection control for any of the following subjects and areas:

Medical asepsis;
Surgical asepsis;
Sterilization and disinfection;
Housekeeping;
Clean and soiled utility areas;
Linen;
Traffic flow patterns;
Staff health status requirements;
Infection control inservice education for all personnel;
Recording and reporting of all potential infections;
Bacteriological testing of potential infections, recording results and reporting to Infection Control Committee;
Management of clients with specific or suspected infections;
Postpartum follow-up system; and,
Reporting of notifiable communicable disease in an infectious stage.

(12) An ongoing program to enhance the quality of client care and review the appropriateness of utilization of services. To ensure the program is effective, the following will be accomplished:

(a) An interdisciplinary committee shall be appointed to do periodic quality assurance review. Two members of the committee shall have clinical expertise in maternal-infant care such as a physician or registered nurse. All members of the committee will be health care providers who are involved in the care or treatment of the clients being audited.

(b) Clinical records shall be audited by the clinical staff at least every three months and a sample audited by the quality assurance committee at least every six months. The audit shall evaluate the following:

Initial history, physical examination, risk assessments and laboratory tests;
Documentation of clinical observations, examinations and treatments;
Evidence that appropriate actions have been taken in response to clinical findings;
Counseling, education, consultation, and referral activities are recorded;
Consent forms are signed as required by subsections 59A-11.010(2), and (3), F.A.C.; and,
All entries are legible, dated, and signed.

(c) The quality assurance committee shall analyze the incidence of maternal and perinatal morbidity and mortality, obstetrical risk assessments, pre-term labor risk assessments, consultants’ referrals and outcomes, and transfers of care and outcomes.

(13) Laboratory testing shall be provided by qualified staff within a laboratory that holds the appropriate federal Clinical Laboratory Improvement Amendments (CLIA) certificate.

(a) Each birth center shall have the capability of ordering laboratory tests as required by this rule.

(b) The laboratory must be located onsite.

(c) The birth center must obtain and maintain the appropriate CLIA certificate if testing is to be performed by clinic staff, including tests classified as waived.

History

Rulemaking Authority 383.309 FS. Law Implemented 383.307, 383.308, 383.309, 383.313, 383.315, 383.316, 383.318, 383.32, 383.327 FS. History–New 3-4-85, Formerly 10D-90.05, 10D-90.005, Amended 2-12-96, 9-17-96, 12-10-18, 6-9-26.

Fla. Admin. Code R. 59A-11.006 Governing Body

History

Rulemaking Authority 383.309 FS. Law Implemented 383.307, 383.308, 383.309 FS. History–New 3-4-85, Formerly 10D-90.06, 10D-90.006, Amended 2-12-96, Repealed 9-17-96.

Fla. Admin. Code R. 59A-11.007 Building Construction and Fire Safety

History

Rulemaking Authority 383.309 FS. Law Implemented 20.42(2)(a), 383.302, 383.307, 383.309, 383.315, 383.335 FS. History–New 3-4-85, Formerly 10D-90.08, 10D-90.008, Amended 9-27-94, 2-12-96, Repealed 9-17-96.

Fla. Admin. Code R. 59A-11.009 Risk Status Criteria for the Acceptance of Clients and Continuation of Care

(1) Birth center clients are limited to those women who are initially determined to be at low maternity risk and who are evaluated regularly throughout pregnancy to assure that they remain at low risk for a poor pregnancy outcome.

(2) Each birth center shall establish a written risk assessment system which shall be a part of the policy and procedure manual. The individual risk assessment shall be included in the client’s clinical record.

(3) The general health status and risk assessment shall be determined by a physician, certified nurse midwife, licensed midwife, licensed physician assistant or advanced practice registered nurse after obtaining a detailed medical history, performing a physical examination, and taking into account family circumstances and other social and psychological factors.

(4) The following criteria shall be used as a minimum baseline upon which the risk status of clients shall be determined. These criteria shall be applied to all clients prior to acceptance for birth center services and throughout the pregnancy for continuation of services. Clients with any of the following risk factors shall be referred to a physician for continuing maternity care and hospital delivery:

(a) Age limits to be determined on an individual basis.

(b) Major medical problems including but not limited to:

Chronic hypertension, heart disease, or pulmonary embolus;
Congenital heart defects assessed as pathological by a cardiologist, placing mother and/or fetus at risk;
Severe renal disease;
Drug addiction or required use of anticonvulsant drugs;
Diabetes mellitus or thyroid disease which is not maintained in a euthyroid state, or
Bleeding disorder or hemolytic disease.

Rh sensitization;
Previous uterine wall surgery including Caesarean section;
Seven or more term pregnancies;
Previous placenta abruptio.

(d) Significant signs or symptoms of:

Hypertension;
Preeclampsia;
Poly or oligo hydramnios;
Abruptio placenta;
Chorioamnionitis;
Severe fetal anomalies;
Multiple gestation;
Intrauterine growth restriction;
Non-reassuring fetal status;
Alcoholism or drug addiction;
Thrombophlebitis, or
Pyelonephritis.

(5) Acceptance for and continuation of care throughout pregnancy and labor is limited to those women for whom it is appropriate to give birth in a setting where anesthesia is limited to local infiltration of the perineum or a pudendal block and where analgesia is limited.

History

Rulemaking Authority 383.309 FS. Law Implemented 383.309, 383.31 FS. History–New 3-4-85, Formerly 10D-90.09, Amended 7-20-92, Formerly 10D-90.009, Amended 2-21-17, 12-10-18.

Fla. Admin. Code R. 59A-11.010 Informed Consent

(1) Before admission to services, a client shall be informed of:

(a) The qualifications of the birth center clinical staff;

(b) The risks related to out-of-hospital childbirth;

(d) The possibility of referral or transfer if complications arise during pregnancy or labor with additional costs for services rendered.

(2) The birth center clinical staff shall obtain the client’s written consent for birth center services using form Consent to Deliver in a Birth Center, AHCA Form 3130-3003 November 2013, which is incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-04100, and available from the Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop #31, Tallahassee, Florida 32308, or at the web address at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/birthing.shtml.

(3) The signed consent form shall be included with the client’s individual clinical record.

History

Rulemaking Authority 383.309 FS. Law Implemented 383.31 FS. History–New 3-4-85, Formerly 10D-90.10, Amended 7-20-92, Formerly 10D-90.010, Amended 9-27-94, 5-15-14.

Fla. Admin. Code R. 59A-11.011 Client Orientation and Preparation for Childbirth

History

Rulemaking Authority 383.309 FS. Law Implemented 383.311 FS. History–New 3-4-85, Formerly 10D-90.11, 10D-90.011, Repealed 5-14-12.

Fla. Admin. Code R. 59A-11.012 Prenatal Care

(1) Initial Visit shall include:

(a) A comprehensive health history shall be completed which includes medical, emotional, dietary, and obstetrical data including a pre-term delivery risk assessment.

(b) A physical examination shall be completed by a physician, or certified nurse midwife or advanced practice registered nurse, or licensed midwife, which includes measurement of height and weight, vital signs including blood pressure and examination of the skin, head and neck, heart and lungs, breasts, abdomen, pelvis and neurologic reactions.

Hemoglobin or hematocrit, urinalysis by dipstick for protein, sugar, and ketones; serological test for syphilis; cervical cytology, and Rh determination and blood type. Results of a cervical cytology done within one year is acceptable. The hemoglobin test and urinalysis may be performed by a clinical staff member or qualified personnel.

(2) Return visits shall include:

(a) Measurements of the weight, blood pressure, fundal height, and fetal heart rate when applicable;

(b) Urinalysis by dipstick for protein and sugar;

(c) Hemoglobin or hematocrit should be repeated at least twice and more often if indicated during the course of the pregnancy;

(d) Review of signs and symptoms of complications of pregnancy and risk status; and,

(e) Examination to determine the estimated weeks of gestation, fetal position and presentation.

(3) Return prenatal visits shall be scheduled at least every four weeks until the 32nd week, every two weeks until the 36th week and then every week until delivery unless the client’s condition requires more frequent visits.

(4) A prenatal delivery risk assessment shall be performed during the initial visit and repeated at 28 weeks gestation.

(5) All clients shall receive specific instruction regarding pre-term labor including the potential hazards, preventive measures, symptoms, detection and timing of contractions, and the need for prompt notification of the health provider.

(6) All clients found to be at high obstetrical risk pursuant to criteria described in Rule 59A-11.009, F.A.C., shall be referred to a qualified physician for continued care.

History

Rulemaking Authority 383.309 FS. Law Implemented 383.312, 383.313 FS. History–New 3-4-85, Formerly 10D-90.12, 10D-90.012, Amended 9-27-94, 9-17-96, 2-21-17.

Fla. Admin. Code R. 59A-11.013 Intrapartum Care

(1) A clinical staff member shall be present or available to the client at all times throughout her stay in the birth center.

(2) The clinical staff shall monitor the progress of labor and condition of the mother and fetus at intervals sufficiently frequent to identify abnormalities or complications at the earliest possible time.

(3) The client shall be transferred to a local hospital if complications occur requiring medical or surgical intervention pursuant to the criteria listed in subsections of this chapter.

(4) The family or support persons shall be instructed as needed to assist the client during labor and delivery.

History

Rulemaking Authority 383.309 FS. Law Implemented 383.309, 383.313, 383.316 FS. History–New 3-4-85, Formerly 10D-90.13, 10D-90.013, Amended 2-12-96, 6-9-26.

Fla. Admin. Code R. 59A-11.014 Surgical Services

No surgical procedures shall be performed at a birth center except episiotomy, repair of episiotomy or laceration, or circumcision.

History

Rulemaking Authority 383.309 FS. Law Implemented 383.313 FS. History–New 3-4-85, Formerly 10D-90.14, 10D-90.014, Amended 12-10-18, 6-9-26.

Fla. Admin. Code R. 59A-11.015 Use of Analgesics and Anestetics

History

Rulemaking Authority 383.309 FS. Law Implemented 383.313, 383.335 FS. History–New 3-4-85, Formerly 10D-90.15, 10D-90.015, Repealed 9-17-96.

Fla. Admin. Code R. 59A-11.016 Postpartum Care

(1) A cord blood sample shall be secured for laboratory testing for type, Rh determination, and direct Coombs test when the mother is Rh negative.

(2) The newborn shall be weighed, measured, inspected for abnormalities and examined for complications. An identification tape shall be placed on the newborn if more than one newborn is at the center at the same time.

(3) One half milligram of Vitamin K shall be administered to the newborn within 24 hours after birth. If no one on the birth center staff is licensed to administer this medication, the parents shall be instructed to take the infant to a private physician or clinic for the injection.

(4) The newborn shall be referred to physician or hospital care if the following conditions occur:

(a) Low birthweight (under 2500 grams);

(b) Apgar score of six or less at five minutes;

(d) Jaundice;

(e) Persistent hypothermia consisting of a body temperature of less than 97 degrees Fahrenheit for more than two hours after birth;

(f) Respiratory difficulties;

(g) Major congenital anomalies;

(h) Exaggerated tremors; and,

(i) Any other condition requiring medical care.

(5) The condition of the mother shall be monitored frequently to detect signs of hemorrhage, or other complications, requiring prompt transfer to a physician or hospital.

(6) The maximum length of stay at a birth center or advanced birth center shall not exceed the timeframes established by Section 383.318, F.S.

(7) Each discharge from a birth center exceeding 24 hours after birth, and each discharge from an advanced birth center exceeding 48 hours after vaginal delivery or 72 hours after cesarean section shall be reported to the Agency.

(a) The report shall be submitted within 48 hours after birth at a birth center or within 48 hours after the scheduled discharge time at an advanced birth center using the online health care facility complaint form located at https://apps.ahca.myflorida.com/hcfc/.

(b) The circumstances and reasons must be described in the narrative section of the form.

The mother is in a deep sleep when the timeframe established by Section 383.318, F.S. has elapsed. In this case the mother shall be discharged as soon after waking as feasible; or
The timeframe established by Section 383.318, F.S. elapses during the middle of the night.

(8) A postpartum examination shall be performed within 72 hours after delivery and at approximately four to six weeks after delivery.

(a) The examination within 72 hours shall include at a minimum:

Interval history;
Mental health screening;
Blood pressure measurement; and,
Observation of the breasts, perineum and abdomen.

(b) The examination at four to six weeks shall include all of the above and also:

Weight;
Hemoglobin or hematocrit; and,
Bi-manual pelvic examination.

(9) The mother shall be counseled regarding breast feeding, perineal care, family planning, signs of common complications, postpartum depression including the provision of the telephone number of the Family Health Line operated pursuant to Section 383.011, F.S., activities and exercises, sex relations, care and feeding of the newborn, and changing family relationships.

(10) The metabolic screening test shall be performed on the newborn in accordance with Section 383.14, F.S.

(11) The parents shall be referred to providers of pediatric care and instructed about immunization.

(12) If complications in the mother or newborn occur during the postpartum period, a consultation or referral shall be made to the appropriate source of secondary or tertiary care.

(13) If the mother refuses to permit eye prophylaxis on account of religious beliefs contrary to the use of drugs, Vitamin K injection, or metabolic screening test, a waiver indicating this decision shall be signed by the mother, witnessed by a clinical staff member, and filed with the clinical record.

(14) Infant (postnatal) screening shall be offered and documented in accordance with the following statute and rule administered by the Department of Health: Section 383.14, F.S., and Chapter 64C-7, F.A.C.

History

Rulemaking Authority 383.309 FS. Law Implemented 383.318 FS. History–New 3-4-85, Formerly 10D-90.16, 10D-90.016, Amended 9-27-94, 2-12-96, 1-16-19, 6-9-26.

Fla. Admin. Code R. 59A-11.017 Management of Emergencies

History

Rulemaking Authority 383.309 FS. Law Implemented 383.316, 383.318, 383.327 FS. History–New 3-4-85, Formerly 10D-90.17, 10D-90.017, Repealed 9-17-96.

Fla. Admin. Code R. 59A-11.018 Clinical Records

History

Rulemaking Authority 383.309 FS. Law Implemented 383.32 FS. History–New 3-4-85, Formerly 10D-90.18, 10D-90.018, Repealed 9-17-96.

Fla. Admin. Code R. 59A-11.019 Reports

(1) Each birth center shall submit a Birth Center Annual Report on AHCA Form 3130-3004OL, January 2022, which is incorporated by reference. The form is only accepted electronically and is available at: https://apps.ahca.myflorida.com/SingleSignOnPortal/Login.aspx. A copy of the form can also be found at: http://www.flrules.org/Gateway/reference.asp?No=Ref-14117. The report shall include a summary of client information for the period from July 1 of the previous year to June 30 of the current year. The report shall be due July 30th each year. Failure to submit this report so that it is timely received by the Agency will result in an administrative fine being imposed pursuant to Section 383.33, F.S.

(2) Each birth center shall report any client death immediately to the Agency by recording the information in the Birth Center Annual Report for the current reporting period.

(a) Report any maternal deaths by providing the date, location, cause of death, and confirm whether the death was reported to the medical examiner.

(b) Report the death of any newborn delivered at the birth center who died within seven days of life. Do not report a newborn death if the client was transferred more than 48 hours before birth. Provide the date, birth weight, location, cause of death, and confirm whether the death was reported to the medical examiner.

(c) Report any stillborn/fetal death delivered at the birth center by providing the date, birth weight, time, cause of death, and confirm whether the death was reported to the medical examiner.

(d) If the Birth Center Annual Report system is offline, the required information must be reported to the Hospital and Outpatient Services Unit by phone at (850)412-4549 on the same day, or no later than the next business day if the time of death is after regular business hours.

History

Rulemaking Authority 383.309 FS. Law Implemented 383.327 FS. History–New 3-4-85, Formerly 10D-90.19, 10D-90.019, Amended 9-27-94, 2-12-96, 3-16-16, 6-13-19, 4-7-22, 6-11-25.

Fla. Admin. Code R. 59A-11.020 Quality Assurance

History

Rulemaking Authority 383.309 FS. Law Implemented 383.32 FS. History–New 3-4-85, Formerly 10D-90.20, 10D-90.020, Amended 2-12-96, Repealed 9-17-96.

Fla. Admin. Code R. 59A-11.021 Minimum Staffing

History

Rulemaking Authority 383.309 FS. Law Implemented 383.307, 383.309 FS. History–New 3-4-85, Formerly 10D-90.21, 10D-90.021, Repealed 9-17-96.

Fla. Admin. Code R. 59A-11.022 Infection Control

History

Rulemaking Authority 383.309 FS. Law Implemented 383.309 FS. History–New 3-4-85, Formerly 10D-90.22, 10D-90.022, Repealed 9-17-96.

Fla. Admin. Code R. 59A-11.023 Physical Environment, Water Supply and Fire Safety

(1) All birth centers shall comply with all design and construction standards for birth centers as required by the Florida Building Code.

(2) Laundry.

(a) Where laundry facilities are provided, clean clothing, bed linens, and towels shall be available for the clients.

(b) Carts used for transporting dirty clothes, linens, and towels shall not be used for transporting clean articles unless they have been thoroughly cleaned.

(3) Bedding. Beds and beddings shall be kept in good repair, cleaned and sanitized whenever soiled. Mattresses and pillows shall have cleanable covers which shall be cleaned and sanitized between use by different clients. Clean sheets shall be used for each client. Blankets shall be washed or dry cleaned whenever soiled. Sheets, blankets, and clean clothing shall be stored in a clean, dry place between laundering and use.

(4) Insect and Rodent Control. All pesticides used to control insects or rodents shall be applied as required by the label directions for use and as required by Chapter 482, F.S.

(5) Poisonous or Toxic Substances. Poisonous or toxic compounds are to be stored apart from food and other areas that would constitute a hazard to the residents.

(6) Water Supply. Water supplies shall be adequate to serve the demands of the birth center or advanced birth center and shall be constructed, operated and maintained as required by Chapter 62-555 or 64E-8, F.A.C.

(7) Sewage Disposal. All sewage and liquid waste shall be disposed of in manners as required by Chapter 62-600 or 64E-6, F.A.C.

(8) Waste Disposal.

(a) All garbage, trash and rubbish from residential areas shall be collected daily and taken to storage facilities. Garbage shall be removed from storage frequently enough to prevent a potential hazard or at least twice per week. Wet garbage shall be collected and stored in impervious, leak proof, fly tight containers pending disposal. All containers, storage areas and surrounding premises shall be kept clean and free of vermin.

(b) If public or contract garbage collection service is available, the birth center or advanced birth center shall subscribe to these services unless the volume makes on-site disposal feasible. If garbage and trash are disposed of on premises, the method of disposal shall be operated in a manner as required by Chapter 62-701, F.A.C.

(9) Fire Control. Each birth center shall provide fire protection through the adoption of written fire control plans rehearsed four times a year by all personnel.

(10) To safeguard all clients, the birth center shall have:

(a) Written evidence of regular inspection by local fire control agencies;

(b) Annual check of fire extinguishers for type, replacement, and renewal dates.

History

Rulemaking Authority 383.309 FS. Law Implemented 383.308, 383.309 FS. History–New 3-4-85, Formerly 10D-90.23, 10D-90.023, Amended 2-12-96, 9-17-96, 5-15-14, 6-9-26.

Fla. Admin. Code R. 59A-11.024 Food Service

(1) Each birth center may serve only ready-to-eat foods and beverages to clients and support persons, or allow clients and support persons to bring in their own ready-to-eat foods and beverages.

(2) Each birth center must have kitchen facilities and equipment available to store ready-to-eat foods and beverages. Equipment must include handwashing facilities and a refrigerator.

(3) Ready-to-eat foods and beverages requiring refrigeration must be stored at 41 degrees Fahrenheit or below.

(4) Kitchen refrigerator(s) must have a thermometer to display the temperature of the unit.

(5) Only food and beverages shall be stored in the kitchen refrigerator(s).

History

Rulemaking Authority 383.309 FS. Law Implemented 383.308, 383.309 FS. History–New 3-4-85, Formerly 10D-90.24, 10D-90.024, Amended 11-6-19.

Fla. Admin. Code R. 59A-11.025 Water Supply, Waste and Sewage Disposal

History

Rulemaking Authority 383.309 FS. Law Implemented 383.308, 383.309 FS. History–New 3-4-85, Formerly 10D-90.25, 10D-90.025, Repealed 9-17-96.

Fla. Admin. Code R. 59A-11.026 Fire Control

History

Rulemaking Authority 383.309 FS. Law Implemented 383.308, 383.309 FS. History–New 3-4-85, Formerly 10D-90.26, 10D-90.026, Repealed 9-17-96.

Fla. Admin. Code R. 59A-11.027 Disaster Plan

Each birth center shall develop a written disaster plan which shall be rehearsed by personnel at least twice a year and shall cover internal casualty producing incidents. The plan shall include provisions for complete evacuation during an actual disaster.

History

Rulemaking Authority 383.309 FS. Law Implemented 383.309 FS. History–New 3-4-85, Formerly 10D-90.27, 10D-90.027, Amended 6-9-26.

Fla. Admin. Code R. 59A-11.028 Equipment and Supplies

(1) Equipment shall be clean and free from safety hazards and in sufficient supply to meet the needs of the clients and staff.

(2) Equipment shall include at a minimum:

(a) Examining table and stool;

(b) Examination light;

(d) Clinical thermometer;

(e) Fetoscope or doppler unit;

(f) Adult beam scale;

(g) Infant scale;

(h) Sweep second hand clock;

(i) Mechanical suction or bulb suction;

(j) Oxygen with flow meter and mask or equivalent;

(k) Resuscitation equipment to include resuscitation bags and oral airways; laryngoscopes and endotracheal tubes appropriate for the newborn;

(l) Emergency medications and intravenous fluids with supplies and equipment appropriate for administration;

(m) Sterile suturing equipment and supplies;

(n) Bassinet; and,

(o) A firm surface suitable for resuscitation.

(3) Emergency equipment shall be readily available to the birth rooms; and other equipment and supplies shall be stored in a convenient and suitable place.

(4) Oxygen shall be stored in a clean dry place with no flammable materials or machinery capable of producing sparks in the immediate vicinity. Oxygen supplies shall be purchased from a licensed dealer.

History

Rulemaking Authority 383.309 FS. Law Implemented 383.308, 383.309 FS. History–New 3-4-85, Formerly 10D-90.28, 10D-90.028.

Fla. Admin. Code R. 59A-11.029 Record System and Procedures

History

Rulemaking Authority 383.309 FS. Law Implemented 383.309 FS. History–New 3-4-85, Formerly 10D-90.29, 10D-90.029, Repealed 9-17-96.

Fla. Admin. Code R. 59A-11.030 Pharmaceuticals and Anesthetics

(1) There shall be written prescriptions or protocols signed by a practitioner legally authorized to prescribe for all drugs administered to clients within the birth center. Systemic analgesics and local anesthetics may be administered under the following conditions:

(a) The clinical staff member who administers the systemic analgesic or local anesthetic is legally authorized to do so and shall be present in the birth center during the use of intravenous analgesics;

(b) The dosage and drugs are specifically noted in the protocols for clinical services; and,

(2) General, conduction, and local anesthesia may only be administered at advanced birth centers.

(3) There shall be policies and procedures addressing the receiving, transcribing, and implementing of orders for administration of drugs.

(4) Written policies shall be established addressing the type and intended use of any drug to be used by clients within the birth center.

(5) Anesthetic agents other than systemic analgesics and local anesthetics for pudendal blocks shall not be used at a birth center.

(6) Drugs shall be administered only by personnel or clinical staff licensed to administer drugs.

(7) Drugs, medications, and chemicals kept anywhere in the center shall be handled pursuant to Chapters 465 and 499, F.S., and rules promulgated thereunder.

(8) Drugs, chemicals, and medications shall be stored and secured in specifically designated cabinets, closets, drawers, or storerooms and made accessible only to authorized persons pursuant to the provisions in Chapters 465 and 499, F.S., and rules promulgated thereunder.

(9) Poisonous chemicals, caustic materials, or drugs shall show appropriate warning or poison labels and shall be stored separately from other drugs. Drugs for external use shall be separated from drugs for internal use.

History

Rulemaking Authority 383.309 FS. Law Implemented 383.308, 383.309, 383.313 FS. History–New 3-4-85, Formerly 10D-90.30, 10D-90.030, Amended 9-17-96, 12-10-18, 6-9-26.

Fla. Admin. Code R. 59A-11.031 Compliance

History

Rulemaking Authority 383.309 FS. Law Implemented 383.309 FS. History–New 3-4-85, Formerly 10D-90.31, 10D-90.031, Repealed 1-25-17.

Fla. Admin. Code R. 59A-11.035 Advanced Birth Centers

(1) A birth center that seeks designation as an advanced birth center must meet all of the criteria as a birth center in addition to the criteria listed below.

(2) Qualified Patients

(a) The advanced birth center:

May perform trial of labor after cesarean deliveries (TOLAC) for screened patients with no other risk factors pursuant to subsection 59A-11.009(4), F.A.C. TOLAC patients must not have had any uterine incisions other than low transverse incisions;
May perform planned low-risk cesarean deliveries;
May perform vaginal deliveries for laboring patients from the beginning of the 37th week of gestation through the end of the 41st week of gestation;
In the event that a cervical ripening agent is used or labor is induced or augmented, a minimum of two registered nurse (RN)s must be present in the facility at the time any such medication is administered to the patient;

(b) Patients must be low-risk. Low risk indicates that they do not have the risk criteria outlined pursuant to subsection 59A-11.009(4), F.A.C. and

Any cardiac conditions, chronic health conditions, gestational diabetes, auto-immune conditions, previous neonatal death or injury, advanced maternal age (aged 35 years or older), or infectious diseases, elevated BMI of 30 or greater, anemia, risk for postpartum hemorrhage or multiple gestation.
History of adverse birth related events defined as events of low birth weight, preterm birth, stillbirth, or perinatal deaths. Low birth weight (LBW) is defined as a newborn weighing less than 2,500 grams; preterm birth (PTB) is defined as a live infant delivery before 37 weeks of gestation; stillbirth is defined as a baby who passes away after 20 weeks as defined in section 382.002(17), F.S. Birth defects or congenital disorder is defined as a structural or functional abnormalities present at birth.

(c) Risk assessment including a postpartum hemorrhage assessment, must be completed on each prenatal visit at the advanced birth centers.

(d) The advanced birth center must follow the following guidelines for prenatal visits: In the first 28 weeks of pregnancy, prenatal visits must be every 4 weeks. From 28-36 weeks of pregnancy, prenatal visits must be every 2 weeks. From 36 weeks of pregnancy until birth, prenatal visits must be weekly.

(e) The advanced birth center must have a policy for assessing, recognizing and responding to clinical signs of increased risk. Must educate all staff and enforce this policy.

(3) Notification

(a) The advanced birth center must communicate with Emergency Medical Services (EMS) within the county(ies) served that they are licensed to provide services only to patients who are not experiencing an emergency.

(b) The advanced birth center must include a statement in their patient contracts and on any advertisements, including facility websites, describing the limitations of their services as a low-risk birthing center.

(4) Departments and Services

(a) Surgical department. This department shall be organized under written policies and procedures relating to surgical staff privileges, anesthesia, functioning standards, staffing patterns and quality maintenance of the surgical suite.

A qualified person designated by the administrator shall be responsible for the daily functioning and maintenance of the surgical suite.
A surgery record shall be maintained on a current basis that contains the following information:

a. Patient’s name, patient number, pre-operative diagnosis, post-operative diagnosis, surgical procedure, anesthetic, and complications, if any; and,

b. Name of each member of the surgical team, including the surgeon, first assistant, anesthesiologist, nurse anesthetist, anesthesiologist assistant, circulating nurse and operating room technician.

Each center shall ensure each patient signs an informed consent for treatment at an advanced birth center acknowledging that only low-risk pregnancies and births are performed. Prior to any surgery being performed, signed informed consent for the procedure, verification of the identity of patient, operative site, and operative procedure to be performed must be in the patient’s medical record.
All infections of surgical cases shall be recorded and reported to the governing body or its designee and a procedure shall exist for the investigation of such cases.
Emergency equipment shall be provided as needed commensurate with the services of the center, maintained in functional condition, and capable of providing and maintaining cardiorespiratory functioning.
Written procedures in implementation of policies shall relate specifically to the functional activities of the surgical suite and include the following:

a. Surgical asepsis: preparation, handling, and maintenance of sterile equipment and supplies.

b. Medical asepsis: patients, staff, equipment, traffic, and equipment flow patterns.

c. Sterilization and disinfection standards and controls: equipment and supplies.

d. Housekeeping.

(b) Anesthesia service. This service shall be organized under written policies and procedures relating to anesthesia staff privileges, the administration of anesthesia, and the maintenance of strict safety controls.

All anesthesia shall be administered by an anesthesiologist, a credentialed and privileged physician, certified registered nurse anesthetist or anesthesiologist assistant.
An anesthesiologist or other physician or a certified registered nurse anesthetist under the on-site medical direction of a licensed physician or an anesthesiologist assistant under the direct supervision of an anesthesiologist, shall be in the center during the anesthesia and post-anesthesia recovery period until all patients are cleared for discharge.
At least one registered nurse shall be in the recovery area during the patient’s recovery period.
Prior to the administration of anesthesia, patients shall have a history and physical examination including laboratory analysis when indicated.
Written policies and procedures relative to the administration of anesthesia shall be developed by the anesthesia service, approved by the medical staff and the governing body, and be reviewed annually, dated at time of each review, revised as necessary, and enforced.
Anesthetic safety regulations shall be developed, posted and enforced. Such regulations shall include the following requirements:

a. All operating room electrical and anesthesia equipment shall be inspected on no less than a semi-annual basis, and a written record of the results and corrective actions be maintained;

b. Flammable anesthetic agents shall not be employed in centers;

c. Electrical equipment in anesthetizing areas shall be on an audiovisual line isolation monitor, with the exception of radiologic equipment and fixed lighting more than 5 feet above the floor;

d. Each anesthetic gas machine shall have pin-index system or equivalent safety system and a minimum oxygen flow safety device; and,

e. All reusable anesthesia equipment in direct contact with the patient shall be cleaned or sterilized in the manner prescribed by current medical standards;

The following monitors shall be applied to all patients receiving conduction or general anesthesia:

a. Blood pressure cuff;

b. A continuous temperature device, readily available to measure the patient’s temperature;

c. Pulse oximeter;

d. Electrocardiogram; and,

e. An inspired oxygen concentration monitor and a capnograph shall be applied to all patients receiving general anesthesia.

(c) Nursing service. This service shall be organized under written policies and procedures relating to patient care, establishment of standards for nursing care and mechanisms for evaluating such care, and nursing services.

A registered nurse designated by the administrator shall be responsible for coordinating and supervising all nursing services.
There shall be a sufficient staffing pattern of registered nurses to provide quality nursing care to each surgical patient from admission through discharge. Such additional trained nursing service personnel shall be on duty as may be needed commensurate with the service of the center.
A registered nurse shall be assigned as the circulating nurse for one patient at a time for the duration of the surgical procedure for any procedure performed in the center.
A registered nurse shall be present in the recovery area at all times when a patient is present.
A record shall be currently maintained of all nursing personnel and include regular and relief as well as full-time and part-time staff. The record shall include the current license number of each licensed person.
A current job description delineating duties and responsibilities shall be maintained for each nursing service position.
Written procedures in implementation of policies and to assure quality nursing care shall relate specifically to the functional activities of nursing service and include the following:

a. Patient admission;

b. Pre- and Post-Operative care;

c. Medical orders from physicians and other members of the medical staff;

d. Standing orders with required signatures;

e. Medications: storage and administration;

f. Treatments;

g. Surgical asepsis;

h. Medical asepsis;

i. Sterilization and disinfection;

j. Documentation: medical records and center records;

k. Patient discharge;

l. Patient transfer;

m. Emergency measures;

n. Isolation measures;

o. Incident reports;

p. Personnel orientation;

q. Inservice education record;

r. Equipment and supplies: availability and maintenance; and,

s. Visitors.

(d) Clinical laboratory services. The center laboratory, and any contracted laboratory providing services for center patients, must be certified by the Centers for Medicare and Medicaid Services under the federal Clinical Laboratory Improvement Amendments (CLIA) and the federal rules adopted thereunder in all specialties or subspecialties in which testing is performed. Each advanced birth center shall have a laboratory onsite, either directly or by contract.

Routine and stat laboratory testing shall be available at all times.
CLIA specialties and subspecialties shall include diagnostic immunology including syphilis serology and general immunology; hematology, including coagulation studies; chemistry, including routine chemistry and urinalysis, immunohematology, including ABO Group and Rh type, antibody detection, and compatibility testing; and additional specialties and subspecialties as determined by the center’s govering body.

(e) Radiological services. Each center shall provide within the institution, or through arrangement, radiological services commensurate with the needs of the center.

If radiological services are provided by center staff, the service shall be maintained free of hazards for patients and personnel.
New installations of radiological equipment, and subsequent inspections for the identification of radiation hazards shall be made as required by Chapter 64E-5, F.A.C.
Personnel monitoring shall be maintained for each individual working in the area of radiation. Readings shall be on at least a monthly basis and reports kept on file and available for review.

a. Personnel – The center shall have a licensed practitioner, as defined in Section 468.301(11), F.S., to supervise the service and to discharge professional radiological services.

b. A technologist shall be on duty or on call at all times when there are patients within the center.

c. The use of all radiological apparatus shall be limited to appropriately licensed personnel.

If provided under arrangement with an outside provider, the radiological services must be directed by a qualified radiologist and meet the standards as required by Chapter 64E-5, F.A.C.

(f) Housekeeping service. The housekeeping service shall be organized under effective written policies and procedures relating to personnel, equipment, materials, maintenance, and cleaning of all areas of the center.

(g) Pediatric services.

A center providing surgical services to patients under the age of 18 years (pediatric) must include age- and size- appropriate criteria in written policies and procedures regarding admissions, surgical services, anesthesia services, post-operative recovery, and discharge planning. The policies and procedures must be approved by the medical staff and the governing body, and be reviewed annually, dated at the time of each review, revised as necessary, and enforced.
All patients shall meet admission and preoperative clearance criteria established by the medical staff and approved by the governing body.
Accommodations must be made for the parent or guardian to remain at the center from admission through discharge.
Surgical services may be provided to patients for conditions that are not emergency medical conditions.
Each center must include its pediatric cases in the quality assessment and improvement system as described in paragraph 59A-11.035(12)(i), F.A.C. that includes peer review, multidisciplinary review and the monitoring of processes and outcomes.
One or more persons currently certified in Pediatric Advanced Life Support (PALS) must be present and available to the pediatric patient who is sedated, anesthetized, recovering from anesthesia, or receiving perioperative opioids.
Each center providing surgical services requiring a length of stay past midnight must be staffed with the following professionals with specialized training and expertise in the treatment of pediatric patients:

a. A surgeon who is board-certified or eligible in a pediatric surgical subspecialty or a board-certified or eligible surgeon with additional training and expertise with pediatric patients acceptable to the governing body.

b. An anesthesiologist or other physician or a certified registered nurse anesthetist under the on-site medical direction of a licensed physician or an anesthesiologist assistant under the direct supervision of an anesthesiologist shall be present in the room with the pediatric patient throughout all general anesthesia, regional anesthesia, and monitored anesthesia care.

c. Nursing and other direct care staff must have specialized training and experience with pediatric patients. Nursing personnel must be PALS and/or Advanced Cardiac Life Support certified. There must be at least one registered nurse on duty at all times.

Each center providing surgical services requiring a length of stay past midnight must have facilities and equipment available to store ready-to-eat foods and beverages. Equipment must include handwashing facilities and a refrigerator.
Age- and size-appropriate equipment and resources related to the care of pediatric patients must be available on site, including

a. Operating tables;

b. Pre- and post-operative beds;

c. Anesthesia equipment and supplies;

d. Resuscitation devices;

e. Oxygen saturation monitors;

f. Pharmacologic supplies; and,

g. Blood pressure cuffs.

(5) Surgical Services

(a) Except for surgical management of immediate complications, the advanced birth center shall conduct a risk-benefit analysis before performing any surgical procedures or cesarean deliveries.

(b) Each advanced birth center shall have the capability onsite to perform patient blood type testing, provide transfusion services, and have a protocol for the receipt, storage, administration, and recordkeeping of blood and blood products consistent with the requirements described in Title 42 CFR Part 493.

(c)The facility must have an electronic fetal monitoring and an infant warmer in the operating room as well as emergency supplies for maternal and newborn patients.

(6) Infection Control

(a) Each center shall establish an infection control program involving members of the medical staff, nursing staff, other professional and administrative staff as appropriate. The program shall provide for:

The surveillance, prevention, and control of infection among patients and personnel;
The establishment of a system for identification, reporting, evaluating, and maintaining records of infections;

(b) The individuals involved in the infection control program shall meet at least quarterly, shall maintain written minutes of all meetings, and shall make a report at least annually to the quality assurance committee and the governing body.

(c) Each center shall establish an employee health policy to minimize the likelihood of transmission of communicable disease by both employees and patients. Such policies shall include, but not be limited to, work restrictions for an employee whenever it is likely that communicable disease may be transmitted, until such time as a medical practitioner certifies that the employee may return to work.

(d) The policies and procedures devised by the infection control program shall be approved by the governing body, and shall contain at least the following:

Specific policies for the shelf life of all stored sterile items.
Specific policies and procedures related to occupational exposure to blood and body fluids.
Specific policies related to the handling and disposal of biomedical waste in accordance with Chapter 64E-16, F.A.C. and, OSHA 29 CFR Part 1910.1030, Bloodborne Pathogens.
Specific policies related to the selection, storage, handling, use and disposition of disposable items.
Specific policies related to decontamination and sterilization activities performed at the center, including but not limited to a requirement that steam, gas (ETO) and hot air sterilizers be tested with live bacterial spores at least weekly.
Specific policies regarding the indications for universal precautions, body substance isolation, CDC isolation guidelines, or equivalent and the types of isolation to be used for the prevention of the transmission of infectious diseases.
A requirement that soiled linen be collected in such a manner as to minimize microbial dissemination into the environment.
A requirement that all cases of communicable diseases as set forth in Chapter 64D-3, F.A.C., be promptly and properly reported in accordance with the provisions of that rule;

(7) Patient Rights

(a) Patients have the right to:

Civil and religious liberties
Be free from physical, verbal, sexual, and mental abuse and neglect.
Dignity
Privacy, with their communication, health care information, and personal privacy.
Be informed about their medical care and treatment.
Refuse any treatment.
Know what facility rules and regulations apply to patient conduct.
Express grievances to a health care provider, a health care facility, or the appropriate state licensing agency regarding alleged violations of patients’ rights. A patient has the right to know the health care provider’s or health care facility’s procedures for expressing a grievance.
Treatment for any emergency medical condition that will deteriorate from failure to provide such treatment.
Refuse participation in experimental research.
Access their medical records.
Know what their rights and responsibilities are.

(b) Each center shall develop and adopt policies and procedures to ensure the protection of patient rights and safety. Patient safety policies and procedures must include, at a minimum:

A policy for maternal and fetal monitoring which incorporates a maternal early warning/rapid response system to identify clinical indications for transfer to a hospital and prenatal visits at established intervals as established in paragraph (2)(e) to determine the continued low-risk status of the pregnant woman and a policy for responding to any neonatal complication including stabilization and transfers as clinically indicated.
Policies for responding to obstetric emergencies to include, but not limited to: obstetric hemorrhage, severe hypertension/preeclampsia, sepsis, assessment and screening for substance use during labor and delivery, a policy to transfer patients presenting in labor and positive for substances known to affect neonatal transition to life, policies for identifying and reporting harm to a child defined in section 39.01(37)(g)1., F.S. The policy for responding to obstetric hemorrhage must include provisions relating to transfusion services.
An advanced birth center is prohibited from the intentional delivery of a fetus with known exposure to maternal use of a controlled substance (as defined by section 893.02(4), F.S.) and must make and document efforts to identify and transfer a patient suspected of positive substance use presenting for delivery to a facility capable of treating a substance-exposed newborn.

(8) Organized Medical Staff

(a) The obstetric medical director shall ensure at least one obstetrician, who has prvileges at a hospital with a transfer agreement in place, is available on-site or on-call, within a reasonable proximity as defined in subsection 59A-11.002(7), F.A.C., at all times during which a patient is in active labor. An advanced birth center must have either a pediatric-trained physician or a neonatal advanced practice provider contracted to provide education, consultation and to be available by on-call, who can arrive within 30 minutes to assist with neonatal resuscitation and stabilization.

(b) The anesthesia medical director shall ensure at least one anesthesiologist or a certified registered nurse anesthetist under the on-site medical direction of a licensed physician or an anesthesiologist assistant under the direct supervision of an anesthesiologist, is available on-site, at all times during which a patient is in active labor or post-anesthesia recovery.

(c) For early labor, (defined as 0-6cm in cervical dialation) there must be at least 2 clinical staff present for each patient in active labor through the 4th stage of labor (defined as the period 3 hours immediately following the deliver of the placenta).

(d) For cesarean sections, there must be at least 3 clinical staff in the operating room. The clinical staff must include one for the patient, one for the care and treatement of the baby, and one to assist the surgeon.

(e) At least two of the clinical staff must be a registered nurse certified in the Neonatal Resuscitation Program or the Neonatal Support program, and shall be present in the advanced birth center at all times with the ability to stabilize and transfer clients, including newborns, as needed. All clinical staff shall have Basic Life Support (BLS) and Advanced Cardiac Life Support (ACLS) certifications.

(f) Each center shall have an organized medical staff organized under written bylaws approved by the governing body and responsible to the governing body of the center for the quality of all medical care provided to patients in the center and for the ethical and professional practices of its members.

(g) Committees – The structure of committee organization shall be determined by the organized medical staff provided the following required committee functions are carried out with sufficient periodicity to assure that objectives are achieved by separate committee, combined committees, or committee of the whole:

Approval of the policies, procedures, and the activities of all departments and services.
Interim decision making for the organized medical staff between staff meetings, under such limitations as shall be set by the medical staff.
Follow-up and appropriate disposition of all reports dealing with the various staff functions.
Medical records currently maintained in sufficient completeness to assure comprehension of transfer of patient information at any time.
Clinical evaluation of the quality of medical care provided to all patients on the basis of documented evidence.
Review of center admissions with respect to need for admission, discharge practices and evaluation of the services ordered and provided.
Surveillance of the center’s infection potentials and cases and the promotion of a preventive and corrective program designed to minimize these hazards.
Surveillance of pharmacy policies and procedures, and standards of practice are maintained, including review of at least monthly on-site consultant pharmacist visits, and proper disposal of outdated prescription and controlled drugs in accordance with Rules 64B16-28.702, 64B16-28.110, 64B16-28.303, F.A.C. and Chapters 465 and 893, F.S.
All transfers to a higher level of care must be reviewed monthly for quality assurance and risk reduction planning.

(h) The facility must notify the patients pediatrician of choice of the newborns status within 4 hours of birth and require that a newborn appointment be made with the pediatrician prior to discharge.

(9) Physical Plant Maintenance

(a) Each center shall establish written policies and procedures designed to maintain the physical plant and overall center environment in such a manner that the safety and well-being of patients is assured. The building and mechanical maintenance program shall be under the supervision of a qualified person.

(b) All mechanical and electrical equipment shall be maintained in working order, and shall be accessible for cleaning and inspection.

(10) Fire Control

(a) Each center shall provide fire protection through the elimination of fire hazards; the installation of necessary safeguards such as extinguishers, sprinkling devices, and fire and smoke barriers as described in paragraph 59A-11.035(12)(i), F.A.C., to insure rapid and effective fire control; and the adoption of written fire control plans rehearsed four (4) times a year by all personnel. To safeguard patients, the center shall have:

(b) Written evidence of regular inspection by local fire control agencies.

(d) Annual check of fire extinguishers for type, replacement, and renewal dates.

(e) “No Smoking” signs prominently displayed in those areas where smoking is not permitted.

(f) Fire regulations and evacuation route prominently posted for each floor and department.

(g) Written fire control plan approved by the appropriate local fire authority shall contain provisions for prompt reporting of all fires; extinguishing fires; protection of patients, personnel and guests; evacuation; and cooperation with fire fighting authorities.

(h) There shall be rigidly enforced written rules and regulations governing proper routine methods of handling and storing oxidizing, combustible, and flammable explosive agents.

(11) Quality Assessment and Improvement

(a) Each center shall have an ongoing quality assessment and improvement system designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, and opportunities to improve its performance to enhance and improve the quality of care provided to the public.

(b) Each center shall have in place a systematic process to collect data on process outcomes, priority issues chosen for improvement, and the satisfaction of the patient. Processes measured shall include:

Appropriate surgical procedures;
Preparation of patient for the procedure;
Performance of the procedure and monitoring of the patient;
Provision of post-operative care;
Use of medications including administration and monitoring of effects;
Risk management activities;
Quality assessment and improvement activities including clinical laboratory services and radiology services;
Results of autopsies if needed.
Number and type of lacerations, and treatment for lacerations;
Number and indication for cesarean sections;
Newborn Appearance, Pulse, Grimace, Activity and Respiration (APGAR) Score less than 7 and outcome;
Maternal and newborn transfers.

The level and performance of existing activities and procedures,
Priorities for improvement, and,
Actions to improve performance.

(12) Plans Submission and Fee Requirements

(a) No construction work, including demolition, shall be started until prior written approval has been given by the Office of Plans and Construction. This includes all construction of new facilities and any and all additions, modifications, renovations, or refurbishment of the site, building, equipment or systems of all existing facilities. Approval to start construction will be granted by the Agency when the design complies with all applicable codes and standards as evidenced by a thorough examination of the documents submitted to the Agency as required for Stage III construction documents.

(b) Approval to start construction limited to demolition, site work, foundation, and building structural frame may be obtained prior to the approval of Stage III construction documents when the following is submitted for review and approval:

A preliminary Stage II approval letter from the Office of Plans and Construction granted by the Agency when the design complies with applicable life safety code requirements, flood requirements, and the layout will accommodate all required functional spaces as evidenced by a thorough examination of the documents submitted to the Agency as required in this rule for Stage II preliminary plans.
Construction documents, specifications and construction details for all work to be undertaken.
A letter from the facility holding the agency harmless for any changes that may occur to the project as a result of the final construction document review.
An Infection Control Risk Assessment (ICRA) and a life safety plan indicating temporary egress and detailed phasing plans indicating how the area(s) to be demolished or constructed is to be separated from all occupied areas shall be submitted when demolition or construction in and around occupied buildings is to be undertaken. Submissions that fail to provide an ICRA or depict the safety measures prescribed by the ICRA will not be approved.

(c) Construction must commence within 12 months of receiving approval from the Office of Plans and Construction to begin construction. Once construction begins construction activities should be continuous until the completion of the project. Failure to commence construction within 12 months of plan approval or periods of construction inactivity exceeding 12 months following commencement of construction will result in termination of the project. Restarting a terminated project will require resubmission of the construction documents accompanied by a new plan review application and will be subject to all fees prescribed by section 395.0163, F.S. Projects which have not received approval to begin construction will be considered abandoned following 12 months of inactivity and the project will be terminated.

(d) When construction is planned, either for new buildings or additions, alterations or renovations to existing buildings, the plans and specifications shall be prepared and submitted to the Office of Plans and Construction for approval by the appropriate Florida-registered design professionals as required by the Florida Building Code, Chapters 471, and 481, F.S. All architecture or engineering firms not practicing as a sole proprietor shall also be registered as an architecture or engineering firm with the Florida Department of Business and Professional Regulation.

(e) The initial submission of plans to the Office of Plans and Construction for any new project shall include a completed Application for Plan Review, AHCA Form 3500-0011, June 2014, incorporated by reference and available at https://flrules.org/Gateway/reference.asp?No=Ref-19185. This information shall accompany the initial submission. Applications for Plan Review are available from the Agency for Health Care Administration, Office of Plans and Construction, 2727 Mahan Drive, Mail Stop #24, Tallahassee, Florida 32308, or at the web address at: https://ahca.myflorida.com/applications.

(f) Plans and specifications submitted for review shall be subject to plan review fees prescribed by Section 395.0163, F.S. All fees shall be payable to the Agency for Health Care Administration and shall annotate the Office of Plans and Construction and the facility log number. Fees are not refundable.

(g) Plans and specifications may be submitted for review at any of the three stages of development described in this rule.

(h) For each stage of submission, a program or scope of work shall be submitted. It shall consist of a detailed written description of all contemplated work and any required phasing and shall identify the types of medical services to be provided.

(i) For projects involving only equipment changes or system renovations, only Stage III, construction documents will be accepted. These documents shall include the following:

Life safety plans showing the fire/smoke compartments in the area of renovation.
Detailed phasing plans indicating how the new work will be separated from all occupied areas.
Engineering plans and specifications for all of the required work.

(j) Stage I, Schematic Plans.

The following shall be incorporated into the schematic plans:

a. Single-line drawings of each floor that indicates the relationship of the various activities or services to each other and the room arrangement in each.

b. The function of each room or space shall be noted in or near the room or space.

c. The proposed roads and walkways, service and entrance courts, parking, and orientation shown on either a small plot plan or on the first floor plan.

d. A simple cross-section diagram showing the anticipated construction.

e. A schematic life safety plan showing smoke and fire compartments, exits, exit passageways and gross areas of required smoke and fire compartments.

f. Indicate which areas are sprinklered, both new and existing.

If the proposed construction is an addition or is otherwise related to existing buildings on the site, the schematic plans shall show the facilities and general arrangement of those buildings.
If the project involves increasing, decreasing, relocating or transferring licensed beds, a schedule showing the total number of beds, types of bedrooms and types of ancillary spaces must be provided.

(k) Stage II, Preliminary Plans. The following shall be incorporated into the preliminary plans.

A Vicinity Map. For new center construction, provide a vicinity map showing the major local highway intersections.
Site Development Plans.
Plans depicting existing grades and proposed improvements.
Building location dimensions.
Location of the fire protection services water source to the building.
Architectural Plans.

a. Floor plans, 1/8-inch scale minimum, showing door swings, windows, case work and mill work, fixed equipment and plumbing fixtures. Indicate the function of each space.

b. Typical large-scale interior and exterior wall sections to include typical rated fire and fire/smoke partitions and a typical corridor partition.

c. All exterior building elevations.

Equipment which is not included in the construction contract that requires mechanical or electrical service connections or construction modifications shall be identified to assure coordination with the architectural, mechanical and electrical phases of construction.
If the project is located in an occupied facility, preliminary phasing plans indicating how the project is to be separated from all occupied areas.
Life Safety Plans. Life safety plans must include the following:

b. All sprinklered areas.

c. All fire extinguishers.

d. All fire alarm devices and pull station locations.

If the project is an addition, or conversion of an existing building, fully developed life safety plans must be submitted.
If the project is a renovation in an existing building, life safety plans of the floor being renovated and the required exit egress floor(s) must be submitted.
When demolition or construction in and around occupied buildings will be undertaken, a life safety plan indicating temporary egress, and detailed phasing plans indicating how the area(s) to be demolished or constructed will be separated from all occupied areas must be submitted.
Mechanical Engineering Plans.

a. Single-sheet floor plans with a one-line diagram of the ventilating system with relative pressures of each space. Provide a written description and drawings of the anticipated smoke control system, passive or active, and a sequence of operation correlated with the life safety plans.

b. The general location of all fire and smoke dampers, all duct smoke detectors and fire stats.

c. If the building is equipped with fire sprinklers, indicate the location of the sprinkler system risers and the point of connection for the fire sprinkler system. State the method of design for the existing and new fire sprinkler systems.

d. The locations of all plumbing fixtures and other items of equipment requiring plumbing services and/or gas services.

e. The locations of any fume, radiological or chemical hoods.

f. The locations of all medical gas outlets, piping distribution risers, terminals, alarm panel(s), low pressure emergency oxygen connection, isolation/zone valve(s), and gas source location(s).

g. The locations and relative size of major items of mechanical equipment such as chillers, air handling units, fire pumps, medical gas storage, boilers, vacuum pumps, air compressors and fuel storage vessels.

h. The locations of hazardous areas and the volume of products to be contained therein.

i. The location of fire pump, standpipes, and sprinkler riser(s).

Electrical Engineering Drawings.

a. A one-line diagram of normal and essential electrical power systems showing service transformers and entrances, switchboards, transfer switches, distribution feeders and over-current devices, panel boards and step-down transformers. The diagram shall include a preliminary listing and description of new and existing, normal and emergency loads, preliminary estimates of available short-circuit current at all new equipment and existing equipment serving any new equipment, short-circuit and withstand ratings of existing equipment serving new loads and any new or revised grounding requirements.

b. Show fire alarm zones and correlate with the life safety plan.

Outline Specifications. Outline specifications must include a general description of the construction, including construction classification and ratings of components, interior finishes, general types and locations of acoustical material, floor coverings, ventilating equipment, plumbing fixtures, fire protection equipment, medical gas equipment and electrical equipment.
Whenever an existing building is to be converted to a health care facility, the general layout of spaces of the existing structure shall be submitted with the preliminary plans for the proposed facility.
Whenever an addition, alteration, renovation or remodeling to an existing facility is proposed, the general layout of spaces of the existing facility shall be submitted with the preliminary plans.

(l) Stage III, Construction Documents. The Stage III, construction documents shall be an extension of the Stage II, preliminary plan submission and shall provide a complete description of the contemplated construction. Construction documents shall be signed, sealed and dated and submitted for written approval to the Office of Plans and Construction by a Florida-registered architect and Florida-registered professional engineer. These documents shall consist of work related to civil, structural, mechanical, and electrical engineering, fire protection, lightning protection, landscape architecture and all architectural work. In addition to the requirements for Stage II submission, the following shall be incorporated into the construction documents:

Site and civil engineering plans indicating building and site elevations, site utilities, paving plans, grading and drainage plans and details, locations of the two fire hydrants utilized to perform the water supply flow test, and landscaping plans.
Life safety plans for the entire project. Projects located on floors above or below the exit discharge level must also include life safety plans for the exit discharge serving the project area.
Architectural Plans.

a. Typical large-scale details of all typical interior and exterior walls and smoke walls, horizontal exits and exit passageways.

b. Comprehensive ceiling plans that show all utilities, lighting fixtures, smoke detectors, ventilation devices, sprinkler head locations and fire-rated ceiling suspension member locations where applicable.

c. Floor/ceiling and roof/ceiling assembly descriptions for all conditions.

d. Details and other instructions to the contractor on the construction documents describing the techniques to be used to seal floor construction penetrations necessary to prevent smoke migration from floor to floor during a fire.

Structural engineering plans, schedules, and details.
Mechanical engineering plans including fire and smoke control plans. Include all equipment that requires mechanical utilities. Provide a clear and concise narrative control sequence of operations for each item of mechanical equipment including but not limited to air conditioning, heating, ventilation, medical gas, plumbing, and fire protection and any interconnection of the equipment of the systems. Mechanical engineering drawings shall depict completely the systems to be utilized, whether new or existing, from the point of system origination to termination. Provide a tabular schedule giving the required air flow (as computed from the information contained on the ventilation rate table) in cubic feet per minute (cfm) for supply, return, exhaust, outdoor, and ventilation air for each space, as applicable, shown on the architectural documents. The schedule shall also contain the HVAC system design air flow rates and the resulting space relative pressures. The schedule or portion of the schedule as applicable shall be placed on each floor plan drawing sheet containing the spaces depicted on the drawing.
Fire protection system layout documents as defined by the Department of Business and Professional Regulation in Rule 61G15-32.002, F.A.C., where applicable, that shall include the existing system as necessary to define the new work. These documents shall be signed and sealed by a Florida-registered professional engineer.
Electrical engineering plans describing complete power, lighting, alarm, communications and lightning protection systems and power system study.
A power study that shall include a fault study complete with calculations to demonstrate that over-current devices, transfer switches, switchboards, panel boards, motor controls, transformers and feeders are adequately sized to safely withstand available phase-to-phase and phase-to-ground faults. The study shall also include an analysis of generator performance under fault conditions and a coordination study resulting in the tabulation of settings for all over-current device adjustable trips, time delays, relays and ground fault coordination. This must be provided for all new equipment and existing equipment serving any new equipment. Power studies for renovations of existing distribution systems shall include only new equipment and existing equipment upstream to the normal and emergency sources of the new equipment. Renovations involving only branch circuit panel boards without modifications to the feeder do not require a full power study; instead, the power study shall be limited to the calculation of new and existing loads of the branch circuit panel.

(m) A complete set of specifications for all work to be undertaken.

All project required contractor supplied testing and/or certification reports shall be submitted in writing, on standard forms, reviewed and accepted by the Engineer of Record prior to presenting to the agency for review.
The specifications shall require a performance verification test and balance air quantity values report with the specified air filters installed for each air handling unit system operating in the minimum pressure drop condition (clean filter state) and at the maximum pressure drop condition (dirty filter state).

(n) All construction documents shall be coordinated to provide consistency of design intent throughout the documents and phasing plans shall be clear and provide continuity of required services. It is specifically required that in the case of additions to existing institutions, the mechanical and electrical, especially existing essential electrical systems and all other pertinent conditions shall be a part of this submission.

All subsequent addenda, change orders, field orders and other documents altering the above shall also be signed, sealed and dated and submitted in advance to the Office of Plans and Construction for review. The Agency will either approve or disapprove the submission based on compliance with all applicable codes and standards and shall provide a listing of deficiencies in writing.
All submissions will be acted upon by the agency within 60 days of the receipt of properly executed construction documents and the initial payment of the plan review fee. The Agency will either approve or disapprove the submission and shall provide a listing of deficiencies in writing. All deficiencies noted by the agency must be satisfactorily corrected before final approval will be provided from the Agency.

(o) Additions or revisions that increase the scope of the project work greater than fifty percent or change the original scope of the project more than fifty percent will be required to be submitted as a new project.

(13) Physical Plant Requirements

(a) The Agency provides technical assistance to the Florida Building Commission and the State Fire Marshal in developing and maintaining standards for the design and construction of advanced birth centers. These standards are included in the following:

The building codes in Rule 61G20-1.001, F.A.C.; as adopted by the Florida Building Commission.
The fire codes in Chapter 69A-60, F.A.C.; as adopted by the State Fire Marshal.
The handicap accessibility standards in Chapter 553, Part V, F.S. and Rule 61G20-4.002, F.A.C; as adopted by the Florida Building Commission.

(b) No building shall be converted to a licensed advanced birth center unless it complies with the standards and codes in effect when the building is converted.

(c) Local codes which set more stringent standards or add additional requirements shall take precedence over these standards and requirements as set forth in this section. Contact the Office of Plans and Construction when conflicts occur.

(14) Price Transparency and Patient Billing

(a) Website. Each center shall make available to patients and prospective patients price transparency and patient billing information on its website regarding the availability of estimates of costs that may be incurred by the patient, financial assistance, billing practices, and a hyperlink to the Agency’s service bundle pricing website. The content on the center’s website shall be reviewed at least every 90 days and updated as needed to maintain timely and accurate information. For the purpose of this rule, service bundles means the reasonably expected center services and care provided to a patient for a specific treatment, procedure, or diagnosis as posted on the Agency’s website. The center’s website must include:

A hyperlink to the Agency’s pricing website upon implementation of the same that provides information on payments made to the facilities for defined service bundles and procedures. The Agency’s pricing website is located at: http://pricing.floridahealthfinder.gov;
A statement informing patients and prospective patients that the service bundle information is a non-personalized estimate of costs that may be incurred by the patient for anticipated services and that actual costs will be based on services actually provided to the patient;
A statement informing patients and prospective patients of their right to request a personalized estimate from the center;
A statement informing patients of the center’s financial assistance policy, charity care policy, and collection procedure;
A list of names and contact information of health care practitioners and medical practice groups contracted to provide services within the center, grouped by specialty or service; and,
A statement informing patients to contact the health care practitioners anticipated to provide services to the patient while in the center regarding a personalized estimate, billing practices and participation with the patient’s insurance provider or health maintenance organization (HMO) as the practitioners may not participate with the same health insurers or HMO as the center.

(b) Estimate. The center shall provide an estimate upon request of the patient, prospective patient, or legal guardian for nonemergency medical services.

An estimate or an update to a previous estimate shall be provided within 7 business days from receipt of the request. Unless the patient requests a more personalized estimate, the estimate may be based upon the average payment received for the anticipated service bundle. Every estimate shall include:

a. A statement informing the requestor to contact their health insurer or HMO for anticipated cost sharing responsibilities,

b. A statement advising the requestor that the actual cost may exceed the estimate,

c. The web address to financial assistance policies, charity care policy, and collection procedure,

d. A description and purpose of any facility fees, if applicable,

e. A statement that services may be provided by other health care providers who may bill separately,

f. A statement, including a web address if different from above, that contact information for health care practitioners and medical practice groups that are expected to bill separately is available on the center’s website; and,

g. A statement advising the requestor that the patient may pay less for the procedure or service at another facility or in another health care setting.

If the center provides a non-personalized estimate, the estimate shall include a statement that a personalized estimate is available upon request.
A personalized estimate must include the charges specific to the patient’s anticipated services.

(c) Itemized statement or bill. The center shall provide an itemized statement or bill upon request of the patient or the patient’s survivor or legal guardian. The itemized statement or bill shall be provided within 7 business days after the patient’s discharge or release, or 7 business days after the request, whichever is later. The itemized statement or bill must include:

A description of the individual charges from each department or service area by date;
Contact information for health care practitioners or medical practice groups that are expected to bill separately based on services provided; and,
The center’s contact information for billing questions and disputes.

(15) Pharmaceuticals

(a) Advanced birth centers must have emergency medications in stock and available that are commonly used in the treatment of postpartum hemorrhage emergencies. Medication commonly used for treatment of obstetric hemorrhage including Tranexamic acid (TXA), and Uterotonics (Oxytocin, methylergonovine and carboprost) must be available.

(b) Medications must be in stock and available that will allow for local and conscious sedation medication for emergency Cesarean sections.

(c) And medications for the emergency medical treatment of anaphylactic syndrome of pregnancy, intrapartum, and cardiac emergencies.

(d) And for the treatment of malignant hyperthermia including dantrolene.

(16) Comprehensive Emergency Management Plan

(a) Each center shall develop and adopt a written comprehensive emergency management plan for emergency care during an internal or external disaster or emergency which it shall review and update annually. The comprehensive emergency management plan must be approved by the local emergency management agency.

(b) The plan shall include:

Provisions for internal and external disasters, and emergencies;
Information about how the center plans to implement specific procedures outlined in its comprehensive emergency management plan;
Precautionary measures, including voluntary cessation of center operations, to be taken by the center in preparation and response to warnings of inclement weather, including hurricanes and tornadoes, or other potential emergency conditions;
Provisions for the management of patients, including the discharge or transfer of patients and staff to a hospital, at the direction of the center’s administrator, in the event of an evacuation order, or when a determination is made by the Agency that the condition of the center is sufficient to render it a hazard to the health and safety of patients and staff. Such provisions shall address the role and responsibility of the physician in the decision to move or relocate patients;
Provisions for coordinating with hospitals that would receive patients to be transferred;
Provisions for the management of staff, including the distribution and assignment of responsibilities and functions, and the assignment of staff to accompany patients to a hospital or subacute care facility;
A provision that a verification check will be made to ensure patients transferred to a hospital arrive at the designated hospital;
A provision that ensures that copies of medical records and orders accompany patients transferred to a hospital;
Provisions for the management of patients who may be treated at the center during an internal or external disaster or emergencies, including control of patient information and medical records, individual identification of patients, transfer of patients to hospital(s) and treatment of mass casualties;
Provisions for contacting relatives and necessary persons advising them of patient location changes. A procedure must also be established for responding to inquiries from patient families and the press;
A provision for educating and training personnel in carrying out their responsibilities in accordance with the adopted plan;
Identification of mutual aid agreements or statements of understanding for services; and,
Provisions for coordination with designated agencies.

(c) The center shall test the implementation of the emergency management plan semiannually, either in response to an emergency or in a planned drill, and shall evaluate and document the center’s performance. This documentation must be on file at the center and available for inspection by the county emergency management agency and the Agency.

(d) The emergency management plan shall be available for immediate access by the staff.

(e) If a center evacuates during or after an emergency, the center shall not be reoccupied until a determination is made by the center’s administrator that the center can meet the needs of the patients. A center with significant structural damage shall not be reoccupied until approval is received from the Agency’s Office of Plans and Construction that the center can be safely occupied as required by the Florida Building Code.

(f) A center that must evacuate the premises due to a disaster or an emergency condition, shall report the evacuation to the Agency’s local area health facility regulation office within 24 hours or as soon as practical. The names and destination of patients relocated shall be provided to the county emergency management agency or its designee having responsibility for tracking the population at large. The licensee shall inform the Agency’s local area office of a contact person who will be available 24 hours a day, seven days a week, until the center is reoccupied.

(17) Transfer Agreements

(a) An advanced birth center shall have a transfer agreement with a local hospital providing neonatal intensive care service that includes provisions for the transport of newborns.

(b) An advanced birth center shall have an agreement with an emergency transport service/ambulance for emergency transport.

(c) The agreement must inlcude an emergency transfer plan to expedite the transfer of emergent medical conditions requiring a higher level of care.

(d) A review of the transfer agreement, criteria and outcomes must be conducted annually.

(e) All transfers must be logged and reviewed monthly for quality assurance and risk reduction planning.

(18) Audits/Trainings

(a) Conduct regular audits to ensure compliance and review safety protocols.

(b) Conduct regular obstetric emergency training drills based on audits or other factors.

(19) Food Service

(a) Each advanced birth center shall have a Food and Nutrition Service department, service or other similarly titled unit which shall be organized, directed and staffed, and integrated with other units and departments of the advanced birth center in a manner designed to assure the provision of appropriate nutritional care and quality food service.

(b) The Food and Nutrition Services department shall be directed on a full-time basis by Certified Dietary Manager or other individual with equivalent education or specialized training and experience in food service management, who shall be responsible to the administrator or designee for the operations of the dietetic department.

(c) The Food and Nutrition Services department must employ a registered dietitian at a minimum on a part-time or consulting basis to supervise the nutritional aspects of patient care and assure the provision of quality nutritional care to patients. The consulting dietitian shall regularly submit reports to the administrator concerning the extent of services provided.

(d) The Food and Nutrition Services department shall employ sufficient qualified personnel under competent supervision to meet the nutritional needs of patients.

(e) The Food and Nutrition Services department, service or other similarly titled unit shall be guided by written policies and procedures that cover food procurement, preparation and service. Food and Nutrition Services department policies and procedures shall be developed by the director of the Food and Nutrition Services department with nutritional care policies and procedures developed by a registered dietitian, shall be subject to annual review, revised as necessary, dated to indicate the time of last review, and enforced. Written dietetic policies shall include the following:

A description of food purchasing, storage, inventory, preparation, service, and disposal policies and procedures.
A requirement that the proper use and adherence to standards for nutritional care, including dietary reference intakes are specified by the provider’s diet manual, which must be current within the last five years and relevant to maternal and infant nutrition.
Menus.
Therapeutic and modified diets.
Food safety and sanitation in accordance with the standards set forth in the latest edition of the US Public Health Service, Food and Drug Administration Food Code.

(f) Personnel in the Food and Nutrition Service department shall receive, as appropriate to their level of responsibility, orientation and inservice training in:

Food safety and sanitation;
Food preparation and service;
Therapeutic and modified diets;

(g) Nothing in this section shall prevent a center from employing an outside food management company for the provision of Food and Nutrition Services services, provided the requirements of this section are met, and the contract specifies this compliance.

(20) Medical Records

(a) Each center shall establish processes to obtain, manage, and utilize information to enhance and improve individual and organizational performance in patient care, management, and support processes. Such processes shall:

Be planned and designed to meet the center’s internal and external information needs;
Provide for confidentiality, integrity and security;
Provide education and training in information management principles to decision-makers and other center personnel who generate, collect, and analyze information; and,
Provide for information in a timely and accurate manner;

(b) Each center shall have a medical records service, patient information system or similarly titled unit with administrative responsibility for medical records.

(c) The administrator shall appoint in writing a qualified person responsible for the medical records service. This person shall meet the qualifications established for this position, in writing, by the governing body.

(d) A current job description delineating duties and responsibilities shall be maintained for each medical records service position.

(e) The medical records service shall:

Maintain a system of identification and filing to ensure the prompt location of a patient’s medical record. Patient records may be stored on electronic medium such as computer, microfilm or optical imaging;
Maintain a current and complete medical record for every patient admitted to the center.
All clinical information pertaining to the patient’s medical treatment shall be centralized in the patient’s medical record.
Ensure that each medical record shall contain the following, as appropriate to the service provided:

a. Identification data;

b. Chief complaint;

c. Present illness;

d. Past personal history;

e. Family medical history;

f. Physical examination report;

g. Provisional and pre-operative diagnosis;

h. Clinical laboratory reports;

i. Radiology, diagnostic imaging, and ancillary testing reports;

j. Consultation reports;

k. Medical and surgical treatment notes and reports;

l. The appropriate informed consent signed by the patient;

m. Record of medication and dosage administered;

n. Tissue reports;

o. Physician orders;

p. Physician and nurse progress notes;

q. Final diagnosis;

r. Discharge summary; and,

s. Autopsy report, if appropriate.

Ensure that:

a. Operative reports signed by the surgeon shall be recorded in the patient’s record immediately following surgery or that an operative progress note is entered in the patient record to provide pertinent information; and,

b. Postoperative information shall include vital signs, level of consciousness, medications, blood or blood components, complications and management of those events, identification of direct providers of care, discharge information from post-anesthesia care area.

Index, and maintain on a current basis, all medical records according to surgical procedure and physician.

(21) Reporting

(a) Policies for reporting requirements identified in Chapter 383, F.S.

(b) Adverse Incident Reporting.

For purposes of reporting to the agency pursuant to this section, the term “adverse incident” means an event over which health care personnel could exercise control and which is associated in whole or in part with medical intervention, rather than the condition for which such intervention occurred, and which results in one of the following injuries:

a. Death;

b. Brain or spinal damage;

c. Permanent disfigurement;

d. Fracture or dislocation of bones or joints;

e. A resulting limitation of neurological, physical, or sensory function which continues after discharge from the facility;

f. Any condition that required specialized medical attention or surgical intervention resulting from nonemergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed consent; or,

g. Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care.

Any of the following adverse incidents, whether occurring in the licensed facility or arising from health care prior to admission in the licensed facility, shall be reported by the facility to the agency within 15 calendar days after its occurrence on Advanced Birth Center Adverse Incident, AHCA Form 3140-2005 OL, August 2025, which is hereby incorporated by reference and available at: https://flrules.org/Gateway/reference.asp?No=Ref-19209, and through the Agency’s adverse incident reporting system which can only be accessed through the Agency’s Single Sign On Portal located at: https://apps.ahca.myflorida.com/SingleSignOnPortal:

a. The death of a patient;

b. Brain or spinal damage to a patient;

c. Permanent disfigurement;

d. Fracture or dislocation of bones or joints;

e. A resulting limitation of neurological, physical, or sensory function which continues after discharge from the facility;

g. Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care.

History

Rulemaking Authority 383.3081, 383.309 FS. Law Implemented 383.3081, 383.309 FS. History–New 6-9-26.

Chapter 59A-12 HEALTH MAINTENANCE ORGANIZATIONS AND PREPAID HEALTH CLINICS

Fla. Admin. Code R. 59A-12.001 Scope

History

Rulemaking Authority 641.56 FS. Law Implemented 641.48 FS. History–New 1-28-88, Formerly 10D-100.001, Repealed 1-18-17.

Fla. Admin. Code R. 59A-12.002 Definitions

(1) All terms defined in the Health Maintenance Organization Act, Chapter 641, F.S., which are used in these rules shall have the same meaning as in the act.

(2) HMO. Health Maintenance Organization shall be abbreviated as HMO in these rules.

(a) Individual Practice Assocation (IPA) Model HMO. A type of health care provider organization composed of a group of independent practicing physicians who maintain their own offices and band together for the purpose of contracting their services to HMOs.

(b) Staff Model HMO. Physicians and medical professionals are employees of the HMO and have offices in HMO owned or leased buldings. The physicians and medical professionals only see members of the HMO employer.

(3) PHC. Prepaid Health Clinic shall be abbreviated as PHC in these rules.

(4) PCP. Primary Care Provider shall be abbreviated as PCP in these rules.

(5) Emergency Services. Services which are needed immediately because of an injury or unforeseen medical condition as provided for in the subscriber’s contract. These must be provided or arranged to be provided on a 24-hour basis by the HMO or PHC, but also may cover inpatient services or outpatient services that are furnished by an appropriate source other than the HMO or PHC when the time required to reach HMO or PHC providers, or alternatives authorized by the HMO or PHC, would mean the risk of permanent damage to the subscriber’s health. Notwithstanding the above, these services are considered to be emergency services only as long as transfer of the subscriber to the HMO’s or PHC’s source of health care or designated alternative is precluded because of risk to the subscriber’s health or because transfer would be unreasonable given the distance involved in the transfer and the nature of the medical condition.

(6) Medical Staff of the HMO or PHC. A formal organization of physicians in an HMO or PHC with responsibility to maintain acceptable standards concerning the delivery of health care and to plan for continued betterment of that care.

(7) Minimum Services. Minimum services include the following:

(a) Emergency Care. Emergency inpatient, outpatient and physician services shall be available on a 24-hour, 7-day a week basis, either by the HMO or PHC through its own facilities or through arrangements with providers. Emergency resuscitation supplies shall be available. In addition, emergency services, as defined in these rules, shall be covered by the HMO or PHC;

(b) Inpatient Hospital Services. Inpatient hospital services shall be available on a 24-hour, 7-day a week basis either through the HMO’s own facility or through arrangements with hospitals. Inpatient hospital services shall include, for example: room and board, general nursing care, meals and special diets when medically necessary, use of operating room and related facilities, use of intensive care unit and services, x-ray services, laboratory and other diagnostic tests, drugs, medications, biologicals, anesthesia and oxygen services, radiation therapy, inhalation therapy, and administration of whole blood and blood plasma;

(c) Physician Care. Physician care, provided or supervised by physicians licensed under Chapter 458, 459, 460 or 461, F.S., to include PCPs and specialists to adequately provide for the contracted services. Physician care shall include consultant and referral services by a physician;

(d) Ambulatory Diagnostic Treatment. Outpatient diagnostic treatment services with an emphasis directed toward primary care. Ambulatory diagnostic treatment shall include diagnostic laboratory and diagnostic radiological services; and,

(e) Preventive Health Care Services. A program of health evaluation, education and immunizations which is designed to prevent illness and disease and to improve the general health of HMO or PHC subscribers. This program shall include at least the following:

Well-child care from birth;
Periodic health evaluations for adults;
Eye and ear screenings by a physician for children through age 21 to determine the need for vision or hearing correction; and,
Pediatric and adult immunizations, in accord with accepted medical practice.

(8) Peer Review. Ongoing evaluation of services by Florida licensed health care professionals to achieve and maintain high standards of professional practice within the discipline.

(9) Quality of Care. The prevailing professional standard of care for a given health care provider shall be that level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers in the community.

(10) Health Care Personnel Engaged to Provide Health Care Services. A health care professional obligated in advance by written contract to provide health care services to an HMO or PHC subscriber. Said contract must include specific hold harmless language relieving the subscriber of any obligation to the provider for unpaid health care costs for covered benefits.

(11) ICD-10-CM. The International Classification of Diseases, 10th Revision, Clinical Modifications shall be abbreviated as ICD-10-CM in these rules.

(12) Second medical opinion. A consultation by a physician other than the member’s primary care physician, whose specialty is appropriate to the need, and whose services are obtained when the member disputes the appropriateness or necessity of a surgical procedure, is subject to a serious injury or illness, including failure to respond to the current treatment plan.

(13) Serious Injury or Illness. An injury or illness, the natural history of which, if untreated, is likely to result in death, to progress to a more severe form, or to develop complications.

History

Rulemaking Authority 641.56 FS. Law Implemented 641.47, 641.49, 641.495, 641.51, 641.513, 641.515, 641.51, 641.55 FS. History–New 1-28-88, Amended 3-11-92, Formerly 10D-100.002, Amended 4-10-03, 11-13-17.

Fla. Admin. Code R. 59A-12.003 Administration, Forms, Fees

(1) Application. “Application for Health Care Provider Certificate,” AHCA Form 3002-0001, February 2026, obtained from the Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop #28, Tallahassee, Florida 32308 or by visiting https://ahca.myflorida.com/health-quality-assurance/bureau-of-health-facility-regulation/certificate-of-need-and-commercial-managed-care-unit/commercial-managed-care/commercial-health-maintenance-organizations-chmos, which forms are incorporated herein by reference at https://flrules.org/gateway/reference.asp?No=Ref-19457, must be completed in the manner specified within the application in order for each individual item to be considered complete for the purpose of determining that a properly completed application has been filed. The application shall be accompanied by a filing fee of $1,000.00 payable to AHCA and shall be completed by each entity desiring to obtain a Health Care Provider Certificate as an HMO or PHC. The application shall specify the contact person or persons for the HMO or PHC. During the review of the entity only contact persons specified within the application shall be allowed access to the application materials submitted.

(2) Application Review Process for Health Care Provider Certificate. Upon receipt of the Application for Health Care Provider Certificate from a proposed HMO or PHC, AHCA shall review the application within 30 days of receipt. AHCA shall provide notification to the proposed HMO or PHC of deficiencies in the application within this 30-day period. The applicant has 90 days from the date of the filing of the application to file any additional information requested by AHCA. By the end of the 90-day period if the additional information has not been received the application will be denied in accordance with Chapter 120, F.S. Within 90 days after the application has been completed AHCA shall approve or deny the application.

(3) Certificate of Authority. The application for a Health Care Provider Certificate must include a copy of the letter from the Office of Insurance Regulation accepting the receipt of an application for a Certificate of Authority submitted by the organization.

(4) Geographic Service Area Expansions. The HMO or PHC may not change its geographic area unless it follows the applicable requirements set forth in Section 641.495(2), F.S. Each HMO or PHC shall submit the required notarized Request For Expansion Of Geographic Service Area, AHCA Form 3160-1005, February 2026, which is hereby adopted and incorporated by reference at https://flrules.org/gateway/reference.asp?No=Ref-19458. Copies may be obtained by writing AHCA, 2727 Mahan Drive, Mail Stop #28, Tallahassee, Florida 32308 or by visiting https://ahca.myflorida.com/health-quality-assurance/bureau-of-health-facility-regulation/certificate-of-need-and-commercial-managed-care-unit/commercial-managed-care/commercial-health-maintenance-organizations-chmos.

(5) Annual Assessment. The Agency for Health Care Administration shall determine the regulatory assessment percentage necessary to be imposed for each calendar year. AHCA Form “Regulatory Assessment Worksheet for Health Maintenance Organizations, Prepaid Health Clinics, and Exclusive Provider Organizations”, AHCA Form 3160-1004, July 1995, which is hereby adopted and incorporated by reference, will be provided to the organization for calculating the annual regulatory assessment percentage and premium volume. Copies may be obtained by writing the Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop #28, Tallahassee, Florida 32308. The annual regulatory assessment shall not exceed the statutory limitations and must be paid by the date specified in the Administrative Assessment Order.

History

Rulemaking Authority 641.36, 641.41, 641.56, 641.58 FS. Law Implemented 120.60(2), 641.21, 641.22, 641.47, 641.495 FS. History–New 1-28-88, Formerly 10D-100.003, Amended 4-10-03, 8-18-26.

Fla. Admin. Code R. 59A-12.004 Governing Body

(1) Each HMO or PHC shall have a governing body that sets policy and has overall responsibility for the organization including the following:

(a) Adopting organizational bylaws, rules and regulations or similar form of document which provides a clear concise statement of the mission, goals, and objectives of the organization;

(b) Adopting a quality assurance program that monitors the key areas of health care delivery to identify problems and insure the early recognition of opportunities to improve the delivery of quality health care services; and,

(c) Maintaining ultimate responsibility for ongoing quality assurance, risk management programs and credentialing programs.

(2) Nothing in this rule shall prohibit the designation of qualified management personnel to implement the provisions of subsection (1), and to manage the operation of the HMO or PHC in the geographic area or areas serviced. The relationship between management personnel and the governing body shall be set forth in writing including each person’s authority, responsibilities and functions.

History

Rulemaking Authority 641.56 FS. Law Implemented 641.22, 641.49, 641.49(3) FS. History–New 1-28-88, Formerly 10D-100.004, Amended 4-10-03.

Fla. Admin. Code R. 59A-12.005 Medical Records System

Each HMO or PHC shall maintain or assure its providers maintain a medical records system which is consistent with professional standards and which:

(1) Permits prompt retrieval of information and provides legible and timely information accurately documented and readily available to appropriate or authorized health care practitioners;

(2) Protects the confidentiality of patient records;

(3) Records in the medical record a summary of significant surgical procedures, past and current diagnoses or problems and allergies and untoward reactions to drugs and current medications;

(4) Identifies the patient as follows:

(a) Name;

(b) Member identification number;

(d) Sex.

(5) Indicates in the medical record for each visit the following information as appropriate:

(a) Date;

(b) Chief complaint or purpose of visit;

(d) Diagnosis or medical impression;

(e) Studies ordered, for example: lab, x-ray, EKG, and referral reports;

(f) Therapies administered and prescribed;

(g) Name and profession of practitioner rendering services, for example: M.D., D.O., D.C., P.D.M., R.N., O.D., etc., including signature or initials of practitioner;

(h) Disposition, recommendations, instructions to the patient and evidence of whether there was follow-up; and,

(i) Outcome of services.

(6) The HMO or PHC administrator shall be responsible for requesting consent of subscribers for release of medical records and for obtaining all documents and medical records from contracted providers necessary to carry out the provisions of Chapter 641, Part III, F.S., and Chapter 59A-12, F.A.C.

History

Rulemaking Authority 641.56 FS. Law Implemented 641.495 FS. History–New 1-28-88, Amended 3-11-92, Formerly 10D-100.005.

Fla. Admin. Code R. 59A-12.006 Quality of Care

Each HMO or PHC shall:

(1) Make available to each member an appropriate health assessment in accordance with preventive health guidelines and professional standards in the community.

(2) Provide for or arrange the following services as a minimum:

(a) Coordination of all necessary care contracted for with the subscriber;

(b) Acute episodic care, with appropriate ancillary services necessary for proper evaluation and treatment, for example:

Laboratory studies,
Diagnostic radiology,
Treatment plan; and,
Specialty consultation referrals.

Periodic update of history and physical examination,
Hypertension follow-up; and,
Diabetes follow-up.

(d) Health risk appraisal and prevention measures, for example:

Dietary counseling,
Smoking cessation education,
Stress reduction counseling; and,
Substance abuse education.

(e) Family planning services.

(3) Ensure that the health care services it provides or arranges for are accessible to the subscriber with reasonable promptness. Such services shall include, at a minimum:

(a) Establishment of an appointment system;

(b) A method to distinguish among emergency, urgent, and routine cases.

Emergencies will be seen immediately,
Urgent cases will be seen within 24 hours,
Routine symptomatic cases will be seen within two weeks; and,
Routine non-symptomatic cases will be seen as soon as possible.

(c) A provision that patients with appointments should have a professional evaluation within one hour of scheduled appointment time. If a delay is unavoidable, patient shall be informed and provided an alternative;

(d) Average travel time from the HMO geographic services area boundary to the nearest primary care delivery site and to the nearest general hospital under arrangement with the HMO to provide health care services of no longer than 30 minutes under normal circumstances. Average travel time from the HMO geographic services area boundary to the nearest provider of specialty physician services, ancillary services, specialty inpatient hospital services and all other health services of no longer than 60 minutes under normal circumstances. AHCA shall waive this requirement if the HMO provides sufficient justification as to why the average travel time requirement is not feasible or necessary in a particular geographic service area;

(e) Provision of accessible hours of operation and after hours emergency services;

(f) Maintenance of staffing patterns within generally accepted HMO or PHC industry norms for meeting projected subscriber needs and for expeditiously satisfying the requirements of the benefit package as offered by the HMO or PHC; and,

(g) Maintenance of a professional staff or arrangements with providers, duly licensed as required to practice in Florida.

(4) Make grievance files available during normal business hours for inspection by the agency. The files shall contain a written summary of the actions taken by the HMO or PHC including actions taken through the review by the quality improvement process, with the exception of protected peer review information.

(5) Coordinate the overall health care of each member, and, when possible, provide this coordination through a single health care professional, who will maintain a unified health record on the member.

(6) Assure that services provided members through referral sources are reported to the HMO or PHC or a designated health care professional in order that all appropriate medical information is filed in the member’s medical record in a timely manner.

(7) Provide a system whereby a member may request and obtain a second medical opinion if the member feels that he is not responding to the current treatment plan in a satisfactory manner after a reasonable lapse of time for the condition being treated. The primary care physician must be so informed by the member, and a request for a consultation initiated. Such a consultation shall be provided upon authorization by the Medical Director.

(8) Inform subscribers of their rights and responsibilities set forth in Section 381.026, F.S., as well as the rights and responsibilities of the managed care organization incorporated in the member’s handbook.

History

Rulemaking Authority 641.56 FS. Law Implemented 641.49, 641.495(3), 641.515, 641.54 FS. History–New 1-28-88, Amended 3-11-92, Formerly 10D-100.006, Amended 4-10-03.

Fla. Admin. Code R. 59A-12.007 Quality Assurance

(1) Each HMO or PHC shall have an ongoing quality assurance program designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care and resolve identified problems at the prevailing professional standard of care.

(2) The quality assurance plan shall be in writing and shall describe the program’s objectives, organization and problem solving activities.

(3) The scope of the program shall include, at a minimum, the following:

(a) Evaluation of clinical performance (peer review);

(b) Review of medication usage;

(d) Evaluation of subscriber grievances;

(e) A utilization review process;

(f) Evaluation of outcomes of care using criteria developed by physicians and other health professionals to evaluate patient care patterns and clinical performance for health services provided; and,

(g) Written procedures for taking appropriate remedial action whenever, as determined under the quality assurance program, inappropriate or substandard services have been provided or services which should have been provided were not.

(4) All findings, conclusions, recommendations, actions taken and results of actions taken shall be documented and reported through organizational channels that have been established.

History

Rulemaking Authority 641.56 FS. Law Implemented 641.49(3)(o), 641.495, 641.51 FS. History–New 1-28-88, Amended 3-11-92, Formerly 10D-100.007, Amended 4-10-03.

Fla. Admin. Code R. 59A-12.0071 Accreditation

As a condition of doing business in the state, each HMO or PHC shall apply for accreditation within 1 year and be accredited within 2 years of the organization’s receipt of its Certificate of Authority. HMOs and PHCs with existing Certificates of Authority must apply for accreditation within 1 year and be accredited within 2 years of the effective date of this rule. All HMOs and PHCs must undergo reaccreditation not less than once every 3 years. Accreditation and reaccreditation must be awarded by an accreditation organization approved by the agency pursuant to Rule 59A-12.0072, F.A.C.

(1) The agency will provide technical assistance, upon request by an HMO or PHC, in order to assist new or existing organizations to develop and maintain quality assurance systems.

(2) The agency will monitor and determine the accreditation status of all existing HMOs and PHCs on an ongoing basis and group them into the following categories:

(a) Three year accreditation;

(b) Less than three year accreditation;

(d) Applied for accreditation but not surveyed within the appropriate time frame;

(e) Surveyed, findings of the accreditation agency not final;

(f) Failed accreditation survey;

(g) New HMO or PHC, accreditation not currently due.

(3) The agency shall verify the compliance of HMOs and PHCs with the accreditation requirement with the accreditation organizations and shall initiate action for HMOs and PHCs classified under paragraphs (2)(c), (d) and (f), above. For those HMOs and PHCs under paragraph (2)(e), above, the agency shall not take administrative action until receipt of the final determination of accreditation from either the HMO, PHC or the accrediting body.

(4) The agency shall file an administrative order to show cause against those HMOs and PHCs under paragraphs (2)(c), (d) and (f), which are not in compliance with the accreditation requirement.

(5) The penalties to be assessed against organizations not achieving accreditation will be as follows:

ACCREDITATION STATUS

PENALTY

Not applied for accreditation within the time frames of this rule.

Suspension of enrollment for a period not to exceed one year or until accreditation is received if less than one year; Two counts of willful violation as specified under Section 641.52(5), F.S.

Applied, not surveyed within the time frames of this rule.

Suspension of enrollment for a period not to exceed one year or until accreditation is received if less than one year; One count of willful violation as specified under Section 641.52(5), F.S.

Failed initial or renewal accreditation survey. Failed follow-up accreditation survey conducted subsequent to a failed accreditation survey.

No fine; Suspension of enrollment beyond the current enrollment level for a period not to exceed one year or until accreditation is received if less than one year; Revocation of the Health Provider Certificate.

(6) For those HMOs and PHCs failing an accreditation survey the agency shall assess the need to mitigate the penalties specified under subsection (5), based upon:

(a) The financial viability of the organization as determined by the Department of Financial Services pursuant to Sections 641.225 and 641.2261, F.S.; and,

(b) The extent of the organization’s efforts to initiate corrective action.

(7) Those HMOs and PHCs classified under paragraph (2)(c), (d) or (f), will be surveyed by the agency to ensure compliance with minimum standards for a Health Provider Certificate specified in Chapter 59A-12, F.A.C.

(8) For those HMOs and PHCs failing the initial accreditation survey the agency shall require the HMO or PHC to enter into a corrective action process for the purpose of achieving accreditation.

(9) The agency shall monitor the progress of those organizations not in compliance in cooperation with the accreditation organization to ensure that HMOs and PHCs come into compliance with the accreditation requirement.

(10) Those HMOs and PHCs failing an initial or renewal accreditation survey must receive at least accreditation under paragraph (2)(b), during a subsequent accreditation survey by the original accrediting organization. Accreditation must be received within one year of the final accreditation decision by the accrediting agency or within a time frame mutually agreeable to the agency, the accreditation organization, and the HMO or PHC. An HMO or PHC may, at any time, seek accreditation from another accreditation organization provided that the HMO or PHC enters into a corrective action process under subsection (8), to achieve accreditation with the original accreditation organization.

History

Rulemaking Authority 641.56 FS. Law Implemented 641.495, 641.512, 641.515(1), 641.52(1)(e), (g) FS. History–New 3-11-92, Formerly 10D-100.0071, Amended 11-21-94, 4-10-03.

Fla. Admin. Code R. 59A-12.0072 Accreditation Organizations

The accreditation organization must have nationally recognized experience in HMO accreditation activities and in the appraisal of medical practice and quality assurance in an HMO setting. As a minimum requirement for approval of the accreditation organization, the following criteria must be met:

(1) The accreditation organization must allow representatives from the agency to accompany the accreditation organization throughout the accreditation process, but the agency representatives shall not participate in the final accreditation or assessment determination.

(2) The accreditation organization must have at least 3 years of experience in reviewing all of the types of HMOs commonly found doing business in the State of Florida.

(3) The accreditation organization must have experience in conducting accreditation reviews for HMOs in at least 5 states of the United States or 2 regions of the Health Care Financing Administration, United States Department of Health and Human Services.

(4) Standards for accreditation must be developed with the input of the medical community, the HMO industry and health care consumers.

(5) The accreditation program shall, at a minimum, include standards for the following aspects of HMO operations:

(a) Quality Assurance Program;

(b) Provider Credentialing;

(d) HMO Member Rights and Responsibilities;

(e) Medical Records;

(f) HMO Governance; and,

(g) Preventive Health Services.

(6) The accreditation program may include standards for the following services:

(a) Clinical laboratory services;

(b) Diagnostic and therapeutic radiology services;

(d) Plant, technology, and safety management; and,

(e) Surgical and anesthesia services.

(7) The standards for accreditation shall be reviewed and updated at regular intervals not to exceed 2 years by the accreditation organization.

(8) The accreditation organization shall be required to submit its standards for HMO accreditation to the agency every 3 years for approval.

(9) Accreditation review teams shall include at least 1 physician experienced in HMO quality assurance program management. Reviewers shall undergo formal training in using the established standards for the HMO reviews.

(10) The accreditation organization shall maintain an internal quality assurance program to ensure the quality and continuity of the review program.

(11) The accreditation organization shall not currently be involved in the operation of the HMO or PHC, nor in the delivery of health care services to its subscribers.

(12) The accreditation organization shall not have contracted with or conducted consultations with the HMO or PHC seeking accreditation within the last 2 years for other than accreditation purposes.

History

Rulemaking Authority 641.56 FS. Law Implemented 641.512 FS. History–New 3-11-92, Formerly 10D-100.0072, Amended 4-10-03.

Fla. Admin. Code R. 59A-12.0073 HMO and PHC Penalty Categories

(1) Purpose. The purpose of this rule is to establish penalty categories that specify varying ranges of monetary fines for willful and nonwillful violations of applicable provisions of Chapter 641, Parts II and III, F.S., or rules promulgated thereunder.

(2) Scope. This rule developed by the Agency for Health Care Administration governs the issuance of penalties against health maintenance organizations and prepaid health clinics pursuant to the authority set forth in Chapter 641, F.S. It applies to all violations of the provisions of Chapter 641, Parts II and III, F.S., or rules promulgated thereunder.

(3) Definitions. All terms defined in the Health Maintenance Organization Act, Chapter 641, F.S., which are used in this rule shall have the same meaning as in the act:

(a) “Action” means an event or events leading to the commission of a violation.

(b) “Harm” means any physical or economic damages to a subscriber, member, covered person, or provider.

(c) “HMO” means a health maintenance organization as defined in Section 641.19(13), F.S., and licensed pursuant to the provisions of Chapter 641, F.S.

(d) “Investigation,” “examination,” “inspection” means any official Agency review, analysis, inquiry, or research into referrals, complaints, or inquiries to determine the existence of a violation pursuant to Section 641.515, F.S.

(e) “Knowing and Willful” means any act or omission, which is committed intentionally as opposed to accidentally and which is committed with knowledge of the act’s unlawfulness or with reckless disregard as to the unlawfulness of the act.

(f) “Mitigating Factors” means a condition that moderates, lessens, or alleviates a determination of penalties for violations not listed in this rule.

(g) “PHC” means a prepaid health clinic as defined in Section 641.02(5), F.S., and licensed pursuant to the provisions of Chapter 641, F.S.

(h) “Provider” means any physician, hospital, or other institution, organization, or person that furnishes health care services and is licensed or otherwise authorized to practice in the state.

(i) “Repeat Violations” means a second or subsequent offense of any given violation under this rule within the preceding four years.

(j) “Subscriber” means an individual who has contracted, or on whose behalf a contract has been entered into, with a HMO or PHC for health care services.

(k) “Violation” means any finding by the Agency of noncompliance by a HMO or PHC with any applicable provisions of Chapter 641, Parts II and III, rules or orders of the Agency governing HMOs or PHCs.

(4) General Provisions:

(a) Rule and Statutory Violations Included. This rule applies whether the violation is of an applicable statute or Agency rule, or an order implementing such a statute or rule.

(b) Relationship to Other Rules. The provisions of this rule shall be subordinated in the event that any other rule more specifically addresses a particular violation or violations.

(c) Other Licensees. The imposition of a penalty upon any HMO or PHC in accordance with this rule shall in no way be interpreted as barring the imposition of a penalty upon any agent, or other licensee in connection with the same conduct.

(5) Aggravating Factors. The following aggravating factors are considered in determining penalties for violations not listed in this rule, and, as to listed violations, the placement of the penalty within the range specified. The factors are not necessarily listed in order of importance:

(a) Willfulness and knowledge of the violation.

(b) Actual harm or damage to any recipient, subscriber, claimant, applicant, or other person or entity caused by the violation, as determined by the Agency’s examination, inspection, or investigation.

(c) Degree of harm to which any recipient, subscriber, claimant, applicant, or other person or entity was exposed by the violation, as determined by the Agency’s examination, inspection, or investigation.

(d) Whether the HMO or PHC reasonably should have known of the action’s unlawfulness.

(e) Financial gain or loss to the HMO or PHC or its affiliates from the violation.

(f) Whether the violation is a repeat violation.

(g) The number of occurrences of a violation found during an examination, inspection, or investigation.

(6) Mitigating Factors. Examples of mitigating factors are as follows:

(a) Whether corrective activities were actually and substantially initiated (not just planned) and implemented by the HMO or PHC before the violation was noted by or brought to the attention of the Agency and before the HMO or PHC was made aware that the Agency was investigating the alleged violation. Such corrective activities must be implemented to assure that the violation does not recur and may include the following: personnel changes, reorganization or discipline, and making any injured party whole as to harm suffered in relation to the violation.

(b) Destruction of records by fire, hurricane, or other natural disaster.

(d) Error ratios of less than 5%.

(7) Penalty Categories and Fines Assessed. Violations are divided into three categories. Category I violations are the most serious and Category III violations are the least serious. Category I violations are violations that will cause harm; Category II violations are violations that have the potential to cause harm; and, Category III violations are violations that would cause no harm. The Agency will use the factors in subsections (5) and (6), above, and any similar or analogous violation listed in this rule to determine, within the penalty ranges specified below, the fine for each violation within a category.

(a) Category I. When a fine is imposed within this category for a knowing and willful violation, the amount shall not exceed $20,000.00 per violation. Additionally, fines for knowing and willful violations may not exceed an aggregate amount of $250,000.00 for all such violations arising out of the same action. When a fine is imposed for a nonwillful violation within this category, the fine shall not exceed $2,500.00 per violation. Additionally fines for non-willful violations may not exceed an aggregate amount of $25,000.00 for all such violations arising out of the same action.

Violation by the HMO or PHC of any lawful rule or order of the Agency.
Failure by the HMO or PHC to acquire a health care provider certificate from the Agency pursuant to Section 641.49, F.S.
Failure by the HMO or PHC to notify the Agency at least 60 days prior to the date it plans to begin providing health care services in a new geographic area pursuant to Section 641.495, F.S.
Failure of the HMO or PHC to provide health care services to subscribers as required by Sections 641.495 and 641.51, F.S.
Failure by the HMO or PHC to provide referrals to out-of-network specially qualified providers or for ongoing specialty care to subscribers pursuant to Sections 641.51(6) and (7), F.S.
Failure by the HMO or PHC to allow subscribers access to a grievance process for the purpose of addressing complaints and grievances pursuant to Section 641.511, F.S.
Failure by the HMO or PHC to notify subscribers of appeal rights under the plan’s grievance process pursuant to Section 641.511(10), F.S.
Failure of the HMO or PHC to provide or otherwise cover emergency services and care to subscribers pursuant to Section 641.513, F.S.

(b) Category II. If the violation is knowing and willful, the fine assessed shall not exceed $10,000.00 per violation. If the violation is nonwillful, the fine assessed shall not exceed $1,000.00 per violation.

Failure by the HMO or PHC to provide to the subscriber the right to a second medical opinion pursuant to Section 641.51(5), F.S.
Failure by the HMO or PHC to take appropriate action as prescribed by the written policies and procedures of the HMO or PHC whenever inappropriate or substandard services have been provided or services that should have been provided have not been provided as determined under the quality assurance program pursuant to Section 641.51, F.S.
Failure by the HMO or PHC to investigate and analyze as prescribed by the written policies and procedures of the HMO or PHC, the frequency and causes of adverse incidents causing injury to patients pursuant to Section 641.55, F.S.
Failure by the HMO or PHC to analyze patient grievances relating to patient care and quality of medical services pursuant to Section 641.55, F.S.
Failure by the HMO or PHC to pay a claim pursuant to Section 641.513, F.S. Assignment by the HMO or PHC of claim processing to a third party administrator or other entity does not relieve the managed care plan of its responsibilities to pay claims. Assignment by the HMO or PHC of payment to a third party administrator or other entity does not relieve the managed care plan of its responsibilities to pay claims.

(c) Category III. If the violation is knowing and willful, the fine assessed shall not exceed $2,500.00 per violation. If the violation is nonwillful, the fine assessed shall not exceed $500.00 per violation.

Failure by the HMO or PHC to timely and accurately submit data to the Agency pursuant to Section 641.51(9), F.S. and Rule 59B-13.001, F.A.C. The penalty period will begin on the first day following the due date at $200.00 a day for purposes of penalty assessments.
Failure by the HMO or PHC to resolve a grievance within the statutory requirements pursuant to Section 641.511, F.S.
Failure by the HMO or PHC to file with the Agency a copy of the quarterly grievance report pursuant to Section 641.511(7), F.S. The penalty period will begin on the first day following the due date at $200.00 a day for purposes of penalty assessments.
Failure by the HMO or PHC to report to the Agency any adverse or untoward incident within the mandated time frames pursuant to Section 641.55(6), F.S. In addition to any penalty imposed, the Agency may impose an administrative fine not to exceed $5,000 per violation pursuant to Section 641.55(7), F.S.
Failure by the HMO or PHC to timely pay the regulatory assessment as required by Section 641.58, F.S., by April 1. The penalty period will begin on the first day following the due date and continue until such time as the assessment is received by the Agency. During such penalty period the HMO or PHC shall be penalized at a rate of $200.00 per day for each calendar day during the penalty period. The failure to timely pay will be classified as non-willful for the first 30 days that payment has not been received. Willful violations will be penalized at the rate of $500.00 a day unless the HMO or PHC can show mitigating factors as defined under paragraph 59A-12.0073(3)(f), F.A.C., and listed in subsection 59A-12.0073(6), F.A.C.

History

Rulemaking Authority 641.56 FS. Law Implemented 641.52(5) FS. History–New 12-9-03, Amended 5-11-04.

Fla. Admin. Code R. 59A-12.008 Referral Procedures

Each HMO or PHC must have in place:

(1) A system to facilitate referral of subscribers to contracted or non-contracted physician and hospital providers; and, in the case of non-contracted providers, include a procedure for prior authorization and written notification regarding such referral to the subscriber.

(2) A means for notifying the subscribers of the referral system, including the procedures for the subscribers to obtain a second medical opinion. Such notification shall be clearly stated in either the subscriber contract, member handbook or other written communication.

History

Rulemaking Authority 641.56 FS. Law Implemented 641.51(4), 641.495(3) FS. History–New 1-28-88, Amended 3-11-92, Formerly 10D-100.008.

Fla. Admin. Code R. 59A-12.009 Examination by the Agency for Health Care Administration

The AHCA shall conduct examinations and investigate complaints regarding the quality of health care services being provided by the HMO or PHC as frequently as necessary to carry out the provisions of Chapter 641, Part III, F.S., and Chapter 59A-12, F.A.C.

History

Rulemaking Authority 641.56 FS. Law Implemented 641.515 FS. History–New 1-28-88, Amended 3-11-92, Formerly 10D-100.009.

Fla. Admin. Code R. 59A-12.010 Subscriber Grievance Procedure

Each HMO or PHC shall establish a subscriber grievance procedure as specified under Section 641.511, F.S.

History

Rulemaking Authority 641.56 FS. Law Implemented 641.311, 641.511 FS. History–New 1-28-88, Formerly 10D-100.010, Amended 4-10-03.

Fla. Admin. Code R. 59A-12.011 Hospital and Physician Information Disclosure

The current list required by Section 641.54, F.S., must include the date on which it was prepared or updated.

History

Rulemaking Authority 641.56 FS. Law Implemented 641.54 FS. History–New 1-28-88, Formerly 10D-100.011.

Fla. Admin. Code R. 59A-12.012 Internal Risk Management Program

(1) Every health maintenance organization certified under Part III of Chapter 641, F.S., shall, as a part of its administrative function, establish an internal risk management program as defined in Section 641.55, F.S:

(2) The risk management program shall be the ultimate responsibility of the governing body of the HMO.

(3) Every Staff Model and Mixed Model HMO certified under this part which has an annual premium volume of $10 million or more shall employ or contract with a risk manager who shall be responsible for implementation and oversight of the organization’s internal risk management program. A part-time risk manager shall not be responsible for risk management programs in more than four organizations or facilities. Every IPA Model and every HMO with an annual premium volume of less than $10 million shall designate an officer or employee of the HMO to serve as risk manager.

(4) As part of the internal risk management program an incident reporting system shall be established for each HMO. Procedures shall be detailed in writing and disseminated to all employees of the HMO. Within 30 days of employment all new employees shall be instructed in the operation and responsibilities of the incident reporting system. All non-physician personnel who provide direct patient care in clinical areas of a Staff or Mixed Model HMO shall receive 1 hour annually of risk management and risk prevention education and training including the importance of accurate and timely incident reporting. The incident reporting system shall include the prompt, within 3 business days, reporting of incidents to the risk manager. Incident reports shall be on a form developed by the HMO for the purpose and shall contain at least the following information:

(a) The patient’s name, date of birth, sex, physical findings or diagnosis and, if hospitalized; locating information, admission time and date, and the facility’s name;

(b) A clear and concise description of the incident including time, date, exact location, and coding elements as needed for the annual report based on ICD-10-CM;

(c) Whether or not a physician was called and, if so, a brief statement of said physician’s recommendations as to medical treatment, if any;

(d) A listing of all persons known to be involved directly in the incident, including witnesses, along with locating information for each; and,

(e) The name, signature and position of the person completing the report, along with date and time that the report was completed.

(5) The HMO shall be responsible for regular and systematic review of all incident reports and written patient grievances for the purpose of identifying trends or patterns as to time, place or persons and, upon emergence of any trend or pattern in incident occurrence, shall develop recommendations for appropriate corrective action and risk management prevention education and training. Summary data shall be systematically maintained for 3 years.

(b) Evidence of the incident reporting and analysis system and copies of summary reports and evidence of recommended and accomplished corrective actions shall be made available for review by the Agency upon request during normal business hours.

(6) Annual reports must be submitted to the Agency summarizing the incident reports that were filed in the organization during the preceding calendar year pertaining to services rendered on the premises of the organization as as defined in Section 641.55, F.S. Annual reports must be submitted electronically to the Agency as required in Section 641.55, F.S., on Annual Report, AHCA Form 3140-5002 OL, May 2018, https://www.flrules.org/Gateway/reference.asp?No=Ref-12147, which is hereby incorporated by reference and may be obtained from the Agency’s annual reporting system located at: https://apps.ahca.myflorida.com/adverseincidentreport/.

(7) All adverse or untoward incidents, whether occurring in the facilities of the Staff Model or Mixed Model organization or arising from health care prior to admission to the facilities of the organization or in the facility of one of its providers must be reported to the Agency as defined in Section 641.55, F.S. Adverse incident reports must be submitted electronically to the Agency within 3 working days after its occurrence, with a more detailed followup within 10 days of the first report as required in Section 641.55, F.S., on Health Maintenance Organization Adverse Incident Report, HMO Adverse Incident, AHCA Form 3140-5003 OL, April 2017, which is hereby incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-08776, and may be obtained from the Agency’s adverse incident reporting system which can only be accessed through the Agency’s Single Sign On Portal located at https://apps.ahca.myflorida.com/SingleSignOnPortal.

History

Rulemaking Authority 641.55, 641.56 FS. Law Implemented 641.55 FS. History–New 1-28-88, Amended 3-11-92, Formerly 10D-100.012, Amended 11-13-17, 10-7-20.

Fla. Admin. Code R. 59A-12.013 Advance Directives

(1) Each health maintenance organization shall have written policies and procedures, which delineate the health care facility’s position with respect to the state law and rules relative to advance directives. The policies shall not condition treatment or admission upon whether or not the individual has executed or waived an advance directive. In the event of conflict between the facility’s policies and procedures and the individual’s advance directive, provision should be made in accordance with Section 765.308, F.S.

(2) The facility’s policy shall include:

(a) Providing each adult individual, at the time of enrollment of the individual with the organization, with a copy of “Health Care Advance Directives – The Patients’ Right to Decide,” as prepared by the Agency for Health Care Administration, 2727 Mahan Drive, Tallahassee, FL 32308, effective 1-11-93, which is hereby incorporated by reference, or with a copy of some other substantially similar document which is a written description of Florida’s state law regarding advance directives;

(b) Providing each adult individual, at the time of enrollment of the individual with the organization, with written information concerning the health care facility’s policies respecting advance directives; and,

(c) The requirement that documentation of the existence of an advance directive be contained in the medical record. A health care facility which is provided with the individual’s advance directive shall make the advance directive or a copy thereof a part of the individual’s medical record.

History

Rulemaking Authority 765.110 FS. Law Implemented 765.110 FS. History–New 1-11-93.

Fla. Admin. Code R. 59A-12.014 Statewide Subscriber Assistance Program

History

Rulemaking Authority 641.36 FS. Law Implemented 641.311(1)(a), (2) FS. History–New 7-8-87, Amended 2-22-88, Formerly 4-31.081, Amended 5-28-92, Formerly 4-191.081, Repealed 8-26-99.

Fla. Admin. Code R. 59A-12.015 Practices and Procedures of the Statewide Subscriber Assistance Panel

History

Rulemaking Authority 641.36 FS. Law Implemented 641.311(1)(a), (2) FS. History–New 2-22-88, Amended 10-25-89, Formerly 4-31.082, Amended 5-28-92, Formerly 4-191.082, Repealed 8-26-99.

Fla. Admin. Code R. 59A-12.016 Definitions for the Managed Care Ombudsman Committees

History

Rulemaking Authority 641.70 FS. Law Implemented 641.70 FS. History–New 12-13-98, Repealed 9-6-18.

Fla. Admin. Code R. 59A-12.017 The Agency for Health Care Administration’s Responsibilities

History

Rulemaking Authority 641.70 FS. Law Implemented 641.70 FS. History–New 12-13-98, Repealed 9-6-18.

Fla. Admin. Code R. 59A-12.018 The District Managed Care Ombudsman Committees Responsibilities

History

Rulemaking Authority 641.70 FS. Law Implemented 641.70 FS. History–New 12-13-98, Repealed 9-6-18.

Fla. Admin. Code R. 59A-12.019 The Statewide Managed Care Ombudsman Committee Responsibilities

History

Rulemaking Authority 641.70 FS. Law Implemented 641.70 FS. History–New 12-13-98, Repealed 9-6-18.

Fla. Admin. Code R. 59A-12.020 Statewide Provider and Subscriber Assistance Program Forms

History

Rulemaking Authority 408.15 FS. Law Implemented 408.7056 FS. History–New 9-17-00, Repealed 9-6-18.

Fla. Admin. Code R. 59A-12.030 Statewide Provider and Health Plan Claim Dispute Resolution Program

(1) Definitions.

(a) “Contracted provider” means a provider who is under a contractual agreement with a health plan.

(b) “Disputed Claim” means a claim that has been submitted by a provider to the health plan or by a health plan to a provider for payment and has been denied in full or in part, or is presumed to have been underpaid or overpaid.

(c)“Disputed Claim Amount” means the difference between the expected reimbursement amount and the reimbursement received.

(d) “Health Plan” as defined in Section 408.7057(1)(b), F.S., or a managed care or long term care plan procured pursuant to Section 409.966, F.S.

(e) “Non-contracted provider” means a provider that does not have a contractual agreement with a health plan.

(f) “Provider” as defined in Section 641.19(15), F.S., means any physician, hospital, institution, organization, or person that furnishes health care services and is licensed or otherwise authorized to practice in the state. Includes both contracted and non-contracted providers.

(g) “Professional services” means occupations that require special training or holding a professional license not classified as hospital inpatient or outpatient services.

(h) “Resolution organization” means a qualified independent third-party claim-dispute resolution entity selected by and contracted with the Agency for Health Care Administration.

(2) Purpose.

(a) To establish a program to provide assistance to providers and health plans for resolution of claim disputes that are not resolved by the provider and the health plans.

(b) The following claim disputes can be submitted by providers or health plans:

Claims disputed for services rendered after October 1, 2000.
Claims disputes related to payment amounts only, provider disputes payment amount received, or health plan disputes regarding payback amount.
Providers are required to aggregate claims by type of service to meet certain minimum thresholds in accordance with paragraph 59A-12.030(5)(c), F.A.C.

(c) The resolution organization shall provide assistance to providers and health plans for resolution of claim disputes within the parameters of Section 408.7057, F.S.

(d) The resolution organization shall hear submitted claims disputes in accordance with the provisions of Section 408.7057, F.S., and this rule.

(3) Resolution Organization.

(a) The resolution organization shall determine, based on a desk review, whether the claim disputes submitted by the health plans or providers meet the statutory requirements of Section 408.7057(2), F.S.

(b) The resolution organization shall inform the Agency on the status of all claim disputes.

(4) Claim Dispute Review.

(a) The entity that does not prevail in the agency’s final order must pay the review costs.

(b) In the event that both parties prevail in part, the review fee shall be apportioned in proportion to the final judgement. The apportionment shall be based on the disputed claim amount.

(c) If the non-prevailing party or parties fail to pay the ordered review costs within 35 days after the agency’s final order, the non-paying party or parties are subject to a penalty of $500 per day.

(5) Jurisdictional Amounts and Methods of Aggregation for Claim Disputes.

(a) Claims submitted for dispute resolution shall be submitted separately by the following claim categories:

Hospital inpatient services claims.
Hospital outpatient services claims.
Professional services claims.

(b) Either the provider or the health plan may make an offer to settle the claim dispute.

(c) Entities filing a request for dispute resolution shall be permitted to aggregate claims. The minimum disputed claim amounts for claims submitted to the resolution organization shall be as follows:

Hospital inpatient services. Disputed individual claim amounts must be aggregated to a total amount of $25,000.00 for health plan contracted hospitals and $10,000.00 for non-contracted hospitals.
Hospital outpatient services. Disputed individual claim amounts must be aggregated to a total amount of $10,000.00 for health plan contracted hospitals, and $3,000.00 for non-contracted hospitals.
Professional services. Disputed individual claim amounts shall be aggregated to a minimum amount of $500.00.

(d) Rural hospitals as defined in Section 395.602(2)(e), F.S., filing requests for claim dispute resolution, are exempt from the minimum disputed claim amounts specified in subparagraphs (5)(c)1. and 2. of this rule.

(e) The offer to settle the claim dispute must state the total amount and the party to whom it is directed has 15 days to accept the offer once it is received.

(f) If the party receiving the offer does not accept the offer and the final order amount is more than 90 percent or less than 110 percent of the offer amount, the party receiving the offer must pay the final order amount to the offering party and is deemed a non-prevailing party for purposes of this section.

(g) The amount of an offer made by a provider to settle an alleged underpayment by the health plan must be greater than 110 percent of the reimbursement amount the provider received.

(h) The amount of an offer made by a health plan to settle an alleged overpayment to the provider must be less than 90 percent of the alleged overpayment amount by the health plan.

(i) Both parties may agree to settle the disputed claim at any time, for any amount, regardless of whether an offer to settle was made or rejected.

(6) Application Process.

(a) The resolution organization shall review claim disputes filed by either the providers or health plans. A request for dispute resolution and supporting documentation must be submitted in hard copy or electronically to the resolution organization in a format prescribed by the resolution organization.

(b) A complete copy of the request, including all supporting documentation, must be submitted to the adverse party at the same time.

(c) The resolution organization must review all requests for claim dispute resolution within 10 days after receipt to determine whether the request meets the statutory and rule criteria for submission to the resolution organization as specified in Sections 408.7057(2)(b)1.-7. and (d), F.S.

(d) If the resolution organization determines that the dispute resolution request does not meet the statutory and rule criteria, the request shall be returned to the entity filing the request.

(7) Hearing Process.

(a) Either party may request that the resolution organization conduct an evidentiary hearing in which both sides can present evidence and examine witnesses, and for which the cost of hearing is equally shared by the parties.

(b) In the event witnesses are called to testify, it is the responsibility of both parties to pay for its own witnesses.

(8) Resolution Organization Review and Decision Process.

(a) The resolution organization must review and consider all documentation submitted by both the health plan and the provider. The resolution organization must notify the entity requesting the dispute resolution and the adverse party electronically or by mail that the request for dispute resolution has been accepted for review.

(b) If the resolution organization determines that the documentation provided with the initial application is not sufficient, it may request additional documents from the entity filing the request for dispute resolution. The resolution organization shall require the health plan or provider submitting the claim dispute to submit any supporting documentation to the resolution organization within 15 days after receipt by the health plan or provider of a request from the resolution organization for documentation in support of the claim dispute. Failure to submit the supporting documentation within such time period shall result in the dismissal of the submitted claim dispute. Any additional documentation submitted to the resolution organization must be submitted to the adverse party at the same time.

(c) The resolution organization shall require the respondent in the claim dispute to submit all documentation in support of its position within 15 days after receiving a request from the resolution organization for supporting documentation. The resolution organization may extend the time. Failure to submit the supporting documentation within such time period shall result in a default against the health plan or provider. In the event of such a default, the resolution organization shall issue its written recommendation to the Agency that a default be entered against the defaulting entity. The written recommendation shall include a recommendation to the Agency that the defaulting entity shall pay the entity submitting the claim dispute the full amount of the claim dispute, plus all accrued interest, and shall be considered a nonprevailing party for the purposes of this section. Any additional information submitted by the adverse party to the resolution organization must be submitted to the entity filing the request for dispute resolution at the same time.

(d) The resolution organization may not communicate ex parte either with the health plan or the provider during the dispute resolution.

(e) The resolution organization shall issue a written recommendation, including findings of fact relating to the calculation under Section 641.513(5), F.S., for the recommended amount due for the disputed claim, including any evidence relied upon.

(f) The resolution organization shall issue a written recommendation, which includes findings of fact, to the Agency within 60 days after the requested information is received by the resolution organization within the timeframes specified by the resolution organization. In no event shall the review time exceed 90 days following receipt of the initial claim dispute submission by the resolution organization.

(g) Within 30 days after receipt of the recommendations issued by the resolution organization the Agency shall adopt the recommendation as a final order.

(h) The final order is subject to judicial review pursuant to Section 120.68, F.S.

History

Rulemaking Authority 408.7057, 409.961 FS. Law Implemented 408.7057, 409.967 FS. History–New 10-23-00, Amended 3-28-01, 11-11-02, 8-10-17.

Chapter 59A-13 PRESCRIBED PEDIATRIC EXTENDED CARE CENTERS (PPEC)

Fla. Admin. Code R. 59A-13.001 Purpose

History

Rulemaking Authority 391.214 FS. Law Implemented 391.201, 391.202 FS. History–New 3-8-89, Formerly 10D-102.001, Amended 2-27-94, Repealed 5-24-98.

Fla. Admin. Code R. 59A-13.002 Definitions

History

Rulemaking Authority 391.214 FS. Law Implemented 391.202, 391.214(2)(a) FS. History–New 3-8-89, Formerly 10D-102.002, Amended 2-27-94, Repealed 5-24-98.

Fla. Admin. Code R. 59A-13.003 License Required

History

Rulemaking Authority 391.214 FS. Law Implemented 391.203, 391.205, 391.214 FS. History–New 3-8-89, Formerly 10D-102.003, Amended 2-27-94, Repealed 5-24-98.

Fla. Admin. Code R. 59A-13.004 License Procedure

(1) Except as provided in Sections 400.903 and 400.905, F.S., no person, firm, association, partnership, or corporation shall either directly or indirectly operate a PPEC center in this state without first applying for and receiving a license from the Agency.

(2) Application for a license to operate a PPEC center must be submitted by the owner or administrator as required by Rule 59A-35.040 and Rule 59A-35.060, F.A.C. In addition to a completed application, applicants for initial, renewal and change of ownership must submit the following:

(a) Biennial licensure fees in the amount of $1,512.35 payable to the Agency for Health Care Administration. A license for an initial or change of ownership application will not be issued until the application fee has been received by the Agency and all associated checks have cleared. If a check for the renewal licensure fee is dishonored and returned to the Agency, the license holder will have ten (10) calendar days to pay the full amount plus any applicable fees as provided by law. Such payment must be made by cashier’s check or money order. Failure to pay the licensure and processing fee may result in suspension of the license until all fees are paid in full.

(b) Documentation of compliance with subsection 59A-13.022(1), F.A.C., regarding fire safety conducted within the previous three months.

(3) Separate licenses are required for buildings located on separate premises.

(4) Licensees must not operate a PPEC center with a census greater than the number of children indicated on the face of the license.

(5) Licenses issued for the operation of a PPEC center are limited as provided in Section 400.905, F.S., and unless revoked, will expire two years from the date of issuance.

(6) No other licensed or certified health care or business entity may be located within a PPEC center except for a health care or business entity that provides care or services only to clients of the PPEC.

(7) Whenever the licensee of a PPEC center seeks to increase the licensed capacity, the licensee must submit an application to the Agency 60 days prior to the requested effective date. Upon successful completion of a health and life safety survey, the license will be modified accordingly.

History

Rulemaking Authority 400.905, 400.914(1), 408.819 FS. Law Implemented 400.905, 400.906, 400.9065, 400.914, 408.805, 408.806, 408.810 FS. History–New 3-8-89, Formerly 10D-102.004, Amended 2-27-94, 5-24-98, 6-22-06, 9-28-14, 4-28-26.

Fla. Admin. Code R. 59A-13.005 Administration and Management

(1) The licensee of each PPEC center shall have full legal authority and responsibility for the operation of the center.

(2) Each PPEC center must be organized in accordance with a written table of organization, which describes the lines of authority and communication down to the child care level. The organizational structure must be designed so as to ensure an integrated continuum of services to the children.

(3) Center supervision.

(a) The licensee of each center must designate one person as administrator who is responsible and accountable for the overall management of the center.

(b) The center administrator must designate in writing a person to be responsible for the center when the administrator is absent from the center for more than 24 hours.

Maintain the following written records and any other records required by Section 400.914, F.S., and these rules. The records must be kept in a place, form, and system in accordance with medical and business practices and available in the center for inspection by the Agency during normal business hours:

a. A daily census record, which must indicate the number of children currently receiving services in the center;

b. A record of all accidents or unusual incidents involving any child or staff member that caused, or had the potential to cause, injury or harm to any person or property within the center. Such records must contain a clear description of each accident or incident, the names of the persons involved, a description of all medical or other services provided to these persons specifying who provided such services, and the steps taken, to prevent recurrence of such accident or incidents in the future;

c. A copy of current agreements with third party providers;

d. A copy of current agreements with each consultant employed by the center and documentation of each consultant’s visits and required written, dated reports; and,

e. A personnel record for each employee, which must include: a current copy of a Florida certificate and/or license as applicable; the original employment application, references, employment history for the preceding five (5) years if applicable; and a copy of all job performance evaluations.

Develop and maintain a current job description for each employee.
Provide each employee access to written personnel policies governing conditions of employment.
Conduct annual written job performance evaluations that note strengths and weaknesses and include plans to correct any job performance weakness. Performance evaluations must be reviewed with the employee.
Assign duties to employees that are consistent with their job descriptions and with their levels of education, preparation and experience.
Provide necessary qualified personnel and ancillary services to ensure the health, safety, and proper care of each child.
Develop and implement infection control policies and procedures. These policies and procedures must be included in the PPEC center’s policy manual.

History

Rulemaking Authority 400.914(1) FS. Law Implemented 400.914(1)(h) FS. History–New 3-8-89, Formerly 10D-102.005, Amended 5-24-98, 6-22-06.

Fla. Admin. Code R. 59A-13.006 Advisory Board

History

Rulemaking Authority 391.214 FS. Law Implemented 391.214(1)(d) FS. History–New 3-8-89, Formerly 10D-102.006, Repealed 5-24-98.

Fla. Admin. Code R. 59A-13.007 Admission, Transfer, and Discharge Policies

(1) Each PPEC center must have written policies and procedures governing the admission, transfer, and discharge of children.

(2) The admission of each child to a PPEC center must be under the supervision of the center administrator or designee, and must be in accordance with the center’s child care policies and procedures.

(3) Each child admitted to a PPEC center must be admitted upon prescription by a licensed physician and must remain under the care of the licensed physician for the duration of the child’s stay in the center.

(4) Each child admitted for service to a PPEC center must meet at least the following criteria:

(a) Infants and children considered for admission to the PPEC center will be those who are medically or technologically dependent.

(b) The infants and children must not, prior to admission, present significant risk of infection to other children or personnel. The medical and nursing directors must review, on a case-by-case basis, any child with a suspected infectious disease to determine appropriateness of admission.

(c) The child must be medically stabilized, require skilled nursing care, or other interventions, and be appropriate for outpatient care.

(d) If the child meets the preceding criteria, the medical or nursing director of the PPEC center must implement a preadmission plan which delineates services to be provided and appropriate sources for such services.

If the child is hospitalized at the time of referral, pre-admission planning will include the parents or guardians, relevant hospital medical, nursing, social services and developmental staff to assure that the hospital discharge plans will be implemented upon admission to the PPEC center.
A consent form outlining the purpose of a PPEC center, family responsibilities, authorized treatment and appropriate liability release, and emergency disposition plans must be signed by the parents or guardians and witnessed prior to admission to the PPEC center. The parents or guardians must be provided a copy of the consent form. A copy of the signed consent form must be maintained in the child’s medical record. Confidentiality of the PPEC records must be maintained in accordance with applicable state and federal laws.

History

Rulemaking Authority 400.914(1) FS. Law Implemented 400.914(1)(a), (h) FS. History–New 3-8-89, Formerly 10D-102.007, Amended 6-22-06.

Fla. Admin. Code R. 59A-13.008 Child Care Policies

(1) Each PPEC center must develop, implement, and maintain written policies and procedures governing all child care and related medical or other services provided.

(2) Child care policies and procedures must be developed, maintained and implemented by a group of professional PPEC center staff personnel comprised of at least the medical director or medical consultant, the center’s administrator, and the director of nursing services. All child care policies and procedures must be reviewed at least annually and revised as needed.

(3) The child care policies and procedures developed must, at a minimum, ensure compliance with the provisions of Section 400.914, F.S., and the standards contained in these rules.

History

Rulemaking Authority 400.914(1) FS. Law Implemented 400.914(1)(a) FS. History–New 3-8-89, Formerly 10D-102.008, Amended 6-22-06.

Fla. Admin. Code R. 59A-13.009 Medical Director

A board certified pediatrician must serve as the medical director for the PPEC center. Responsibilities of the medical director include:

(1) Periodic review of services to assure acceptable levels of quality of care and services.

(2) Maintenance of a liaison role with the medical community.

(3) Advisement on the development of new programs and modifications of existing programs.

(4) Assurance that medical consultation will be available in the event of the medical director’s absence.

(5) Serving on committees as defined and required by these rules and by the center’s policies.

(6) Consulting with the center’s administrator on the health status of the center’s personnel.

(7) Reviewing reports of all accidents or unusual incidents occurring on the premises and identifying to the center’s administrator hazards to health and safety.

(8) Development and implementation of a policy and procedure for the delivery of emergency services and the delivery of regular physician’s services when the child’s attending physician or designated alternative is not available.

History

Rulemaking Authority 400.914(1) FS. Law Implemented 400.914(1)(f) FS. History–New 3-8-89, Formerly 10D-102.009, Amended 6-22-06.

Fla. Admin. Code R. 59A-13.010 Nursing Services

(1) A registered nurse (RN) will serve full-time as the Director of Nursing. The Director of Nursing must have at least the following qualifications:

(a) Hold a current Florida registered nurse license.

(b) Hold a current certification in Cardiopulmonary Resuscitation (CPR).

(c) Have a minimum of two (2) years general pediatric nursing experience of which at least six (6) months must have been spent caring for medically fragile infants or children in a pediatric intensive care, neonatal intensive care, PPEC or similar care setting during the previous five (5) years.

(2) The Director of Nursing is responsible for the daily operation of the PPEC center.

(3) Registered nurse staffing standards:

(a) The registered nurse must have at least the following qualifications and experience:

Licensed as a registered nurse in Florida, pursuant to Chapter 464, F.S.
Current certification in CPR.

(b) The registered nurse staff must provide:

Nursing interventions; educational services to increase the parent’s or guardian’s confidence and competence in caring for the child with special needs; assistance to facilitate coping with the effects of chronic illness on the child and family and support effective relationships among siblings and the ill child; interventions to foster normal development and psychosocial adaptation.
Information regarding availability and access to community resources.
A collaborative relationship with the interdisciplinary health team.

(4) Licensed practical nurse (LPN) staffing standards:

Licensed practical nurses working in a PPEC center must be supervised by a registered nurse and have the following qualifications and experience;

(a) Hold a current Florida licensed practical nurse license pursuant to Chapter 464, F.S.; and

(b) Hold a current certification in CPR.

(5) Direct care personnel staffing standards. For the purposes of this subsection, other direct care personnel include: nursing assistants, nursing assistants certified pursuant to Chapter 464, F.S., patient care technicians, medical assistants, Emergency Medical Technicians (EMT) or Paramedics licensed pursuant to Chapter 401, F.S., and individuals with training and experience in education, social services or child care related fields.

(a) Direct care personnel must meet the following requirements:

Have one (1) year experience in the care of infants and toddlers,
Employment references documenting skill in the care of infants or children, and,
Hold a current certification in CPR.

(b) Direct care personnel must work under the supervision of the registered nurse and be responsible for providing direct care to PPEC center children.

(6) Total staffing for nursing services and direct care must, at a minimum, meet the following ratios:

Children

Total Staff

RN or LPN

Direct Care, or Licensed Nurse (RN or LPN)

2-6

7-9

10-12

13-15

16-18

19-21

22-24

25-27

28-30

31-33

34-36

37-39

40-42

43-45

If the PPEC center has a census of more than 45 children, the staffing must increase by one staff for every three (3) children alternating between a direct care staff and licensed nurse.

History

Rulemaking Authority 400.914(1) FS. Law Implemented 400.914(1)(d) FS. History–New 3-8-89, Formerly 10D-102.010, Amended 6-22-06, 1-7-20.

Fla. Admin. Code R. 59A-13.011 Ancillary Professional Staffing Standards

History

Rulemaking Authority 391.214 FS. Law Implemented 391.214(1)(d), (f) FS. History–New 3-8-89, Formerly 10D-102.011, Repealed 5-24-98.

Fla. Admin. Code R. 59A-13.012 Educational Services

History

Rulemaking Authority 391.214 FS. Law Implemented 391.214(1)(f) FS. History–New 3-8-89, Formerly 10D-102.012, Repealed 5-24-98.

Fla. Admin. Code R. 59A-13.013 In-service Training for Staff, Parents and Guardians

Each PPEC center must develop staff, parent and guardian training programs.

(1) Staff training must include:

(a) Quarterly staff development programs appropriate to the category of personnel.

(b) Documentation of all staff development programs, and required participation.

(2) Each new employee will participate in orientation to acquaint the employee with the philosophy, organization, program, practices, and goals of the PPEC center.

(3) A comprehensive orientation to acquaint the parent or guardian with the philosophy and services will be provided at the time of the child’s admission to the PPEC center.

History

Rulemaking Authority 400.914(1) FS. Law Implemented 400.914(1)(f) FS. History–New 3-8-89, Formerly 10D-102.013, Amended 6-22-06.

Fla. Admin. Code R. 59A-13.014 Medical Record

(1) A medical record must be developed at the time of admission, must be maintained for each child, signed by authorized personnel and contain at least the following:

(a) A medical plan of treatment and a nursing protocol of care.

(b) All details of the referral, admission, correspondence and papers concerning the child.

(d) Flow chart of medications and treatments administered.

(e) Concise, accurate information and initialed case notes reflecting progress toward achievement of care goals or reasons for lack of progress.

(f) Documentation of nutritional management and special diets, as appropriate.

(g) Documentation of physical, occupational, speech and other special therapies.

(2) The individualized nursing care protocol must be developed within ten (10) working days of admission. The protocol must be reviewed monthly and revised quarterly, and include any recommendations and revisions to the plan based on consultation with other professionals involved in the child’s care.

(3) Medical history, including allergies and special precautions.

(4) Immunization record.

(5) A discharge order written by the primary physician will be documented and entered in the child’s record. A discharge summary, which includes the reason for discharge, will also be included.

History

Rulemaking Authority 400.914(1) FS. Law Implemented 400.914(1)(h) FS. History–New 3-8-89, Formerly 10D-102.014, Amended 6-22-06.

Fla. Admin. Code R. 59A-13.015 Quality Assurance Committee

All PPEC centers must have a quality assurance program and must conduct quarterly reviews of the PPEC center’s medical records for at least half of the children served by the PPEC center at the time of the quality assurance review. The quarterly review sample must be randomly selected so each child served at the center has an equal opportunity to be included in the review.

(1) The quality assurance committee must include the following: the medical director, administrator, director of nursing, and three (3) other committee members as determined by each PPEC center.

(2) The quality assurance review will be conducted by two (2) members of the quality assurance committee. Within 15 calendar days of its review, the quality assurance committee must furnish copies of its report to the PPEC center medical and nursing directors.

(3) Each quarterly quality assurance review must include:

(a) A review of the goals in each child’s nursing protocol.

(b) A review of the steps, process, and success in achieving the goals.

(c) Identification of goals not being achieved as expected, reasons for lack of achievement and plans to promote goal achievement.

(d) Evidence that the protocol has been revised to accommodate the findings of the quality assurance report will be forwarded to the quality assurance committee within then (10) calendar days of receipt of the quality assurance committee report.

(e) Implementation of revisions to the protocol must be documented in the child’s record.

(4) The quality assurance review will also ascertain and assure the presence of the following documents in each child’s medical record:

(a) A properly executed consent form.

(b) A medical history for the child, including notations from visits to health care providers.

History

Rulemaking Authority 400.914(1) FS. Law Implemented 400.914(1)(f), (h) FS. History–New 3-8-89, Formerly 10D-102.015, Amended 6-22-06.

Fla. Admin. Code R. 59A-13.016 Dietary Services

History

Rulemaking Authority 391.214 FS. Law Implemented 391.214(1)(f) FS. History–New 3-8-89, Formerly 10D-102.016, Repealed 5-24-98.

Fla. Admin. Code R. 59A-13.017 Physical Environment

History

Rulemaking Authority 391.214 FS. Law Implemented 391.214(1)(b), (c), (e), 391.215 FS. History–New 3-8-89, Formerly 10D-102.017, Repealed 5-24-98.

Fla. Admin. Code R. 59A-13.018 Furniture and Linens

History

Rulemaking Authority 391.214 FS. Law Implemented 391.214(1)(e) FS. History–New 3-8-89, Formerly 10D-102.018, Repealed 5-24-98.

Fla. Admin. Code R. 59A-13.019 Equipment

History

Rulemaking Authority 391.214 FS. Law Implemented 391.214(1) FS. History–New 3-8-89, Formerly 10D-102.019, Repealed 5-24-98.

Fla. Admin. Code R. 59A-13.020 Infection Control

Infection control requirements must include at least the following:

(1) The PPEC center must have an isolation room with one (1) large glass area for observation of the child.

(2) Isolation procedures must be used to prevent cross-infections.

(3) All cribs and beds must be labeled with the individual child’s name. Linens must be removed from the crib for laundering purposes only.

(4) Bed linens must be changed when soiled and as necessary, but not less than twice weekly.

(5) Antimicrobial soap and disposable paper towels must be at each sink.

(6) Staff must wash their hands after direct contact with each child, using appropriate hand washing techniques to prevent the spread of infection from one child to another.

(7) Children suspected of having a communicable disease, which may be transmitted through casual contact, as determined by the center’s medical director, must be isolated; the parents or guardians must be notified of the condition; and the child must be removed from the PPEC center as soon as possible. When the communicable disease is no longer present, as evidenced by a written physician’s statement, the child may return to the PPEC center.

(8) PPEC center staff members suspected of having a communicable disease must not return to the PPEC center until the signs and symptoms related to the communicable disease are no longer present, as evidenced by a written physician’s statement.

History

Rulemaking Authority 400.914(1) FS. Law Implemented 400.914(1)(e) FS. History–New 3-8-89, Formerly 10D-102.020, Amended 6-22-06.

Fla. Admin. Code R. 59A-13.021 Transportation Services

History

Rulemaking Authority 391.214 FS. Law Implemented 391.214(1)(f), (g) FS. History–New 3-8-89, Formerly 10D-102.021, Repealed 5-24-98.

Fla. Admin. Code R. 59A-13.022 Fire Safety and Emergency Procedures

(1) All PPEC centers must conform to state standards prepared by the State Fire Marshal: Chapter 69A-36, F.A.C., Uniform Fire Safety Standards for Child Care Facilities, and must be inspected annually. A copy of the current annual fire inspection report, conducted by the local authority having jurisdiction over fire safety or the State Fire Marshal, must be on file at the PPEC center. Documentation of a satisfactory fire safety inspection shall be provided at the time of the licensee’s annual survey.

(2) There must be a working telephone, which is neither locked nor a pay station, in the PPEC center.

(3) Emergency telephone numbers must be posted on or in the immediate vicinity of all telephones.

(4) An emergency generator must exist, with sufficient generating power to continue function of medical equipment in the event of a power failure. The emergency generator must be tested every 30 days and satisfactory mechanical operation must be documented on a log designed for that purpose and signed by the person conducting the test.

(5) Emergency transportation must be performed by a licensed E.M.S. provider, with a PPEC center staff member accompanying each child.

(6) The PPEC center must have an emergency kit available to provide basic first aid and cardiopulmonary resuscitation.

History

Rulemaking Authority 400.914(1) FS. Law Implemented 400.914(1)(f) FS. History–New 3-8-89, Formerly 10D-102.022, Amended 6-22-06.

Chapter 59A-15 PRIVATE UTILIZATION REVIEW

Fla. Admin. Code R. 59A-15.002 Definitions

History

Rulemaking Authority 395.037 FS. Law Implemented 395.0172 FS. History–New 2-18-92, Formerly 10D-111.002, Repealed 3-29-11.

Fla. Admin. Code R. 59A-15.004 Registration Requirements

History

Rulemaking Authority 395.1055 FS. Law Implemented 395.0199 FS. History–New 2-18-92, Formerly 10D-111.004, Amended 3-18-96, Repealed 3-29-11.

Fla. Admin. Code R. 59A-15.009 Confidentiality

History

Rulemaking Authority 395.037 FS. Law Implemented 395.0172 FS. History–New 2-18-92, Formerly 10D-111.009, Repealed 3-29-11.

Chapter 59A-16 ADULT DAY CARE

Fla. Admin. Code R. 59A-16.001 Purpose

History

Rulemaking Authority 400.562 FS. Law Implemented 400.55 FS. History–New 7-8-81, Formerly 10A-6.01, 10A-6.001, Transferred to 58A-6.001.

Fla. Admin. Code R. 59A-16.002 Definitions

History

Rulemaking Authority 400.562 FS. Law Implemented 400.55, 400.562 FS. History–New 7-8-81, Amended 2-27-84, Formerly 10A-6.02, 10A-6.002, Transferred to 58A-6.002.

Fla. Admin. Code R. 59A-16.003 Licensure

History

Rulemaking Authority 400.562 FS. Law Implemented 400.555, 400.556, 400.5565, 400.557, 400.558, 400.562 FS. History–New 7-8-81, Amended 2-27-84, Formerly 10A-6.03, 10A-6.003, Transferred to 58A-6.003.

Fla. Admin. Code R. 59A-16.004 Unlicensed Centers

History

Rulemaking Authority 400.562 FS. Law Implemented 400.558, 400.559 FS. History–New 7-8-81, Amended 2-27-84, Formerly 10A-6.04, 10A-6.004, Transferred to 58A-6.004.

Fla. Admin. Code R. 59A-16.005 Closing of a Center

History

Rulemaking Authority 400.562 FS. Law Implemented 400.558, 400.559, 400.562 FS. History–New 7-8-81, Amended 2-27-84, Formerly 10A-6.05, 10A-6.005, Transferred to 58A-6.005.

Fla. Admin. Code R. 59A-16.006 Governing Authority, Administration and Staffing

History

Rulemaking Authority 381.031, 400.562 FS. Law Implemented 381.031(1)(g)1., 400.562 FS. History–New 7-8-81, Amended 2-27-84, Formerly 10A-6.06, 10A-6.006, Transferred to 58A-6.006.

Fla. Admin. Code R. 59A-16.007 Standards for Participant Care

History

Rulemaking Authority 400.562 FS. Law Implemented 400.562 FS. History–New 7-8-81, Amended 2-27-84, Formerly 10A-6.07, 10A-6.007, Transferred to 58A-6.007.

Fla. Admin. Code R. 59A-16.008 Program Requirements

History

Rulemaking Authority 400.562 FS. Law Implemented 400.562 FS. History–New 7-8-81, Formerly 10A-6.08, 10A-6.008, Transferred to 58A-6.008.

Fla. Admin. Code R. 59A-16.009 Basic Services

History

Rulemaking Authority 400.562 FS. Law Implemented 400.55, 400.562 FS. History–New 7-8-81, Amended 2-27-84, Formerly 10A-6.09, 10A-6.009, Transferred to 58A-6.009.

Fla. Admin. Code R. 59A-16.010 Supportive and Optional Services

History

Rulemaking Authority 400.562 FS. Law Implemented 400.55, 400.562 FS. History–New 7-8-81, Formerly 10A-6.10, 10A-6.010, Transferred to 58A-6.010.

Fla. Admin. Code R. 59A-16.011 Participant and Program Data, Emergency Procedures

History

Rulemaking Authority 400.562 FS. Law Implemented 400.562 FS. History–New 7-8-81, Amended 2-27-84, Formerly 10A-6.11, 10A-6.011, Transferred to 58A-6.011.

Fla. Admin. Code R. 59A-16.012 Fiscal Standards

History

Rulemaking Authority 400.562 FS. Law Implemented 400.562 FS. History–New 7-8-81, Formerly 10A-6.12, 10A-6.012, Transferred to 58A-6.012.

Fla. Admin. Code R. 59A-16.013 Physical Plant, Sanitary Conditions, Housekeeping Standards and Maintenance

History

Rulemaking Authority 400.562 FS. Law Implemented 400.562 FS. History–New 7-8-81, Amended 2-27-84, Formerly 10A-6.13, 10A-6.013, Transferred to 58A-6.013.

Fla. Admin. Code R. 59A-16.101 Definitions

(1) The following terms are defined in Sections 429.901 and 429.918, F.S., and are applicable to this rule chapter: “ADRD Participant,” “Adult Day Care Center,” or “Center,” “Agency,” “Basic Services,” “Department,” “Multiple or Repeated Violations,” “Operator,” “Owner,” “Participant,” “Specialized Alzheimer’s Services,” and “Supportive and Optional Services.”

(2) Additional definitions applicable in this rule chapter are as follows:

(a) “Activities of Daily Living” or “ADL” shall mean the functions or tasks for self-care and shall include: ambulation, bathing, dressing, eating, grooming, transferring, and toileting, self-administration of medications, and other personal hygiene activities.

(b) “Adult” shall mean any person 18 years of age or older.

(c) “Applicant for Licensure” shall mean the Owner or Operator of a Center or, if the Owner is a business entity, the person (i.e., corporate officer, general or limited partner) acting on behalf of the entity.

(d) “Assistant Operator” shall mean an individual designated in writing by the Owner or Operator as having full responsibility and authority for the daily operation of the facility when the Owner or Operator is not onsite. The Assistant Operator shall meet the same minimum qualifications as the Operator.

(e) “Participant Capacity” shall mean the number of Participants for which a Center is licensed to provide care to at any given time and shall be based upon required net floor space.

(f) “Comprehensive Emergency Management Plan” shall mean a plan developed by the Adult Day Care Center describing how the Center will prepare for and respond to an emergency, pursuant to subsection 59A-16.107(10), F.A.C.

(g) “Congregate Space” shall mean climatically controlled living rooms, dining rooms, specialized activity rooms, or other rooms to be commonly used by all Participants.

(h) “Daily Attendance” shall mean the number of Participants who, during any one calendar day, attend the Center. This count is not dependent upon, nor does it include, the number of types of services a Participant receives, but is an actual, individual, and unduplicated census count.

(i) “Functional Impairment” means a physical, mental, social, or cognitive condition or deficit that restricts an individual’s ability to perform the tasks and Activities of Daily Living and that impedes the individual’s capability for self-care and independent living without assistance or supervision from others on a recurring or continuous basis for extended periods of time.

(j) “Governing Authority” shall mean the organization, person, or persons designated to assume full legal responsibility for the determination of policy, management, operation, and financial viability of the Center.

(k) “Major Incident” shall mean any incident for which the Agency, Center, Staff member or other person associated with the Center may be liable, or which has resulted in serious injury, death or extensive property damage. Major Incidents include, but are not limited to, the following:

Death of a Participant from other than natural causes while in the care of the Center,
Threats or occurrences of riots, bombings, or other extreme violence,
Disappearance of a Participant from the Center,
Assaults or batteries on or by a Participant, resulting in severe injury or death, including, but not limited to, sexual assaults or rape,
Property damage from any cause that would interrupt routine operations or disrupt service delivery,
Auto accidents with injuries involving participants,
Involuntary Center closure,
Incidents of abuse, neglect, exploitation or fraud,
Employee work conduct which results in a criminal law violation,
Attempted suicide by a participant while under Center supervision.

(l) “Net Floor Space” shall mean the actual climatically controlled occupied area, not including accessory unoccupied areas such as hallways, stairs, closets, storage areas, bathrooms, kitchen or thickness of walls, set aside for the use of the Participants.

(m) “Operator” shall mean an individual who has daily administrative charge of an Adult Day Care Center and who shall be designated in writing as such by the owner or Governing Authority. An Operator of a Specialized Alzheimer’s Services Adult Day Care Center must meet the educational or experiential requirements in Section 429.918(5), F.S.

(n) “Orientation and Training Plan” shall mean a written plan developed and reviewed at least annually, and implemented throughout the year, which describes a coordinated program for Staff training for each service and for orientation of each new Staff member on Center policies, procedures, assigned duties and responsibilities. The orientation and training provided for by the Orientation and Training Plan shall begin no later than the first day of employment.

(o) “Over the Counter Products” or “OTC Products” shall mean medications and related products that can be purchased legally without a prescription, including, but not limited to, medications, vitamins, nutritional supplements and nutraceuticals.

(p) “Participant Care Plan” shall mean a written record documenting adult day health services, as required by paragraph 59A-16.106(6)(d), F.A.C.

(q) “Participant File” shall mean a record, prepared and kept by the Center which shall include: a Participant Care Plan, documenting adult day health services provided to the Participant, if any; medical and social history or copies of an examination completed by a physician; diagnosis; disabilities and limitations; rehabilitation potential; short and long-term goals; recommended activities; orders for medication or modified diet, including Supervision of Self-administered Medication; special needs for health or safety; permitted levels of physical activity; frequency of attendance at the Center; and notes as required in this rule chapter.

(r) “Personal Supervision of a Participant” shall mean observation of the Participant to maintain safety and well-being, including Supervision of Self-administered Medications.

(s) “Respite Care” or “Respite” in an Adult Day Care Center is defined as a service provided to relieve the caregiver.

(t) “Responsible Person” shall mean any person who has assumed the responsibility to manage the affairs and protect the rights of any Participant of a Center. The Responsible Person is not a legal entity, but may be a caregiver or friend and shall in no case be affiliated with the facility, its operations, or its personnel, unless so ordered by a court.

(u) “Significant Change” shall mean: a deterioration or improvement in ability to carry out Activities of Daily Living; a deterioration in behavior or mood to the point where daily problems arise, or an improvement to the point that these problems are eliminated; or a substantial deterioration in health status or reversal of such condition. Ordinary day-to-day fluctuations in functioning and behavior and acute short-term illness such as a cold are not considered Significant Changes unless such fluctuations persist to the extent that a trend is established.

(v) “Staff” shall mean any employee, independent contractor, or volunteer included in the minimum Staff ratio, who provides direct or indirect services to the Participants.

(w) “Staff Providing Direct Care for ADRD Participants” means Staff providing personal or Specialized Alzheimer’s Services to ADRD Participants or Participants with dementia-related disorders, including, but not limited to, Owners, Operators, and Assistant Operators providing such services.

(x) “Staff in Direct Contact with ADRD Participants” means all Staff who are not Staff Providing Direct Care to ADRD Participants or Participants with dementia-related disorders, but whose duties may require them to interact with ADRD Participants or Participants with dementia-related disorders on a daily basis.

(y) “Supervision of Self-administered Medication” shall mean the performance of the following tasks: reminding Participants to take medication at the time indicated on the prescription; opening or closing medication container(s) or assisting in the opening of prepackaged medication; reading the medication label to Participants; observing Participants while they take medication; checking the self-administered dosage against the label of the container; reassuring Participants that they have obtained and are taking the dosage as prescribed; keeping daily records of when Participants received supervision pursuant to this subsection; and immediately reporting apparent adverse effects on a Participant’s condition to the Participant’s physician and responsible person. No Center is required to provide Supervision of Self-administered Medication to Participants who are capable of administering their own medication.

(z) “Supervision of Staff” shall mean guidance by a qualified person for a Staff member’s performance of job-related functions and activities, with initial direction and periodic onsite inspection of the performance. Supervision of Participants shall mean guidance and care necessary for the health, safety and well-being of Participants.

(aa) “Supportive and Optional Services” shall mean optional activities and services provided by a Center, in accordance with Rule 59A-16.106, F.A.C.

(bb) “Transportation Services” shall mean the conveyance of Participants between the Center and a designated location, as well as to and from services provided directly or indirectly by the Center. No Participant’s transportation to and from a designated location and the Center shall exceed two hours if the transportation is provided or arranged by the Center.

(cc) “Volunteer” shall mean an individual not on the payroll of the Adult Day Care Center, whose qualifications shall be determined by the Center, for whom a written job description and Orientation and Training Plan shall be provided and implemented.

History

Rulemaking Authority 429.929 FS. Law Implemented 429.918, 429.929 FS. History–New 7-8-81, Amended 2-27-84, Formerly 10A-6.02, 10A-6.002, 59A-16.002, Amended 11-9-95, 3-29-98, 10-23-01, 8-3-15, Formerly 58A-6.002, 7-1-19.

Fla. Admin. Code R. 59A-16.102 Governing Authority, Administration and Staffing

(1) The Center shall have a Governing Authority which shall establish policies in compliance with this rule chapter. Governing Authority, as defined in this rule chapter, may consist of one or more people, and designation of its membership or composition shall be determined by the Owner or Operator. The Governing Authority shall be responsible for ensuring compliance with standards requiring that:

(a) Admission criteria shall be determined by the Owner, Operator or Governing Authority and it may limit Participant eligibility to adults with Functional Impairments, in need of a protective environment or a program of therapeutic social and health activities and services as defined in this rule chapter. The Operator will assure that the admission of each Participant shall be reviewed within the confines of specific requirements set forth below:

Within forty-five days prior to admission to the Center, each person applying to be a Participant shall provide a statement signed by a physician licensed under Chapters 458 and 459, F.S., a Florida licensed health care provider under the direct supervision of a physician, or a county public health unit. The statement must be signed within forty-five days prior to admission to the Center, and must state that the applicant is free from tuberculosis in the communicable form and free from signs and symptoms of any other communicable disease. Any Participant who is diagnosed as having a communicable disease shall be excluded from participation until deemed non-infectious. However, Participants who have Human Immunodeficiency Virus (HIV) infection may be admitted to the Center, provided that they would otherwise be eligible according to this rule.
No Participant shall be admitted or retained in a Center if he or she requires services from the Center that are beyond those that the Center is licensed to provide.
No Participant who requires medication during the time spent at the Center and who is incapable of self-administration of medication shall be admitted or retained unless there is a Staff member licensed according to Florida law to administer medications who will provide this service. A person licensed according to Florida law includes: a physician licensed under Chapters 458 and 459, F.S.; an advanced registered nurse practitioner certified under Chapter 464, F.S.; a dentist licensed under Chapter 466, F.S.; a registered nurse or licensed practical nurse licensed under Chapter 464, F.S.; or a physician’s assistant, licensed under Chapter 458, F.S.

(b) Provision is made for a safe physical plant equipped and staffed to maintain the Center and services provided as defined in this rule chapter.

(2) The Governing Authority shall ascertain that the Owner or Operator or the designated responsible person shall be on the premises during the Center’s hours of operation.

(3) Each Center shall be under the administrative control of the Operator or Assistant Operator. The Operator may supervise more than one Center, provided that a qualified, responsible Assistant Operator, duly appointed in writing, is in charge of each facility during the Operator’s absence.

(4) The Center shall employ qualified Staff to provide the services, personal assistance and safety measures required by the Participants.

(5) The Owner or Operator shall:

(a) Develop a written job description for each Staff member containing a list of qualifications, duties, responsibilities and accountability required of each Staff member.

(b) Establish and maintain a personnel file for each Staff member to include:

Name, home address, phone number,
Education and experience,
Job assignment,
Evaluation of performance at least yearly,
Dates of employment and termination,
Character references, including former employers and supervisors,
A signed statement from a Florida licensed physician, a Florida licensed health care provider under the direct supervision of a physician, or a county public health unit, that the employee is free from tuberculosis in a communicable form, and free from apparent signs and symptoms of other communicable diseases. The statement must be signed no less than forty-five days prior to beginning work in the Center.
Training certificates or copies of training certificates as required by subsection 58A-6.016(7), F.A.C.

(6) The Owner or Operator shall also be responsible for the administration of all components of the facility and accountable for the implementation and enforcement of all policies and procedures, standards of care, and program development in accordance with the social, physical and mental capabilities and needs of the Participants served.

(7) The Owner or Operator shall ensure that each employee:

(a) Maintains personal cleanliness and hygiene;

(b) Refrains from abusive, immoral or other unacceptable conduct such as the use of alcohol, illegal use of narcotics or other impairing drugs, and behavior or language which may be injurious to Participants;

(c) Who is diagnosed as having a communicable disease after beginning work in the Center shall be excluded from working until deemed non-infectious in the work setting.

(8) The Owner or Operator or Assistant Operator shall be responsible for enforcing the following minimum personnel staffing for Adult Day Care Centers and shall designate substitute Staff to be available in emergencies.

(a) A minimum Staff ratio of one Staff member who provides direct services for every six Participants shall be present in the Center at all times.

(b) No less than two Staff members, one of whom has a certification in an approved first aid course and CPR, shall be present in the Center at all times.

(c) At all times staffing shall be maintained to meet the needs of the Participants as required by the Participant Files, including Centers which serve persons with Alzheimer’s disease and related disorders, persons with physical handicaps, or other special target populations.

(d) The Owner or Operator may serve in dual capacity as a registered nurse, occupational therapist, physical therapist, speech-language pathologist, or social worker, if licensed as required by Florida law and qualified to provide such services.

(e) The Owner or Operator may be counted as one of the required Staff members provided the Owner or Operator provides direct services and is included in the work schedule for the Center. However, the Owner or Operator shall not be counted more than once in the Staff/Participant ratio, calculated on the basis of daily census.

(9) Center Staff whose conduct constitutes abuse, neglect, or exploitation of a Participant shall immediately be terminated from employment and shall be reported to the Department of Children and Families in accordance with section 415.103, F.S.

(10) No administrator who has been terminated pursuant to the provisions of subsection (9), shall accept employment in an Adult Day Care Center and no Owner or Operator of a Center shall knowingly employ any person who has been terminated pursuant to subsection (9).

(11) The Governing Authority shall establish policies and procedures to facilitate reporting of abuse, neglect or exploitation as defined in Section 415.102, F.S., and in accordance with Section 415.103, F.S., and shall ensure that the statewide toll free telephone number of the Department of Children and Families central abuse hotline, accompanied by the words “To Report the Abuse, Neglect, or Exploitation of an Elderly or Disabled Person, Please Call the Toll Free Number 1(800)96-ABUSE” is posted in a prominent place in the Center and made clearly visible.

History

Rulemaking Authority 429.929 FS. Law Implemented 429.929 FS. History–New 7-8-81, Amended 2-27-84, Formerly 10A-6.06, 10A-6.006, 59A-16.006, Amended 11-9-95, 3-29-98, 10-23-01, 8-3-15, Formerly 58A-6.006, 7-1-19.

Fla. Admin. Code R. 59A-16.103 Participant Care Standards

(1) The Center shall make a statement or summary statement of policies and procedures for Participant care available to Participants, to the responsible person, to the public, and to each member of the Center Staff. The statement or summary statement shall be displayed in a conspicuous place in the facility.

(2) The Center Staff shall be trained to implement these policies and procedures, as specified in the Orientation and Training Plan.

(3) Participant care, policies, and procedures shall ensure that, as a minimum, all Participants admitted to the Center:

(a) Are informed of provisions for service as evidenced by written acknowledgment from the Participant or responsible party prior to or at the time of admission, given a statement or summary statement of the Center’s policies and procedures, given an explanation of the Participant’s responsibility to comply with these policies and procedures and respect the personal rights and private property of other Participants;

(b) Are informed, and are given a written statement prior to or at the time of admission and during stay, of services available at the Center, and any related charges, including charges for services that are not provided free, not covered by third party payments, or not covered by the facility’s basic per diem rate. This statement shall include the payment, fee, deposit, and refund policy of the Center;

(d) Are informed during the admission process, in writing, of the Center’s Comprehevsive Emergency Management Plan;

(e) Are informed during the admission process of the local emergency management agency’s registry of disabled persons who need assistance during evacuations or when in shelters because of physical or mental handicaps and the assistance provided by Center staff to register such persons with the local emergency management agency;

(f) Are allowed to retain the services of their personal physician at their own expense or under a health care plan; are informed of the services provided by the Center, and are offered the opportunity to participate in the planning of their care;

(g) Are free from abuse, neglect, and exploitation as defined in Section 415.102, F.S., and free from chemical and physical restraints. Drugs and other medications shall not be used for punishment, convenience of Staff, or in quantities that interfere with a Participant’s rehabilitation or Activities of Daily Living;

(h) Are given privacy in the treatment of their personal and medical records;

(i) Are treated with consideration, respect, and full recognition of their dignity, individuality, and right to privacy;

(j) Are not required to perform services for the Center;

(k) Are permitted to associate and communicate privately with persons of their choice, join with other Participants or individuals within or outside the Center to work for improvements in Participant care, and, upon his or her request, shall be given assistance in the reading and writing of correspondence;

(l) Are permitted to participate in social, religious, community, or group activities of their choice while at the Center;

(m) Are permitted to exercise civil and religious liberties, including the right to independent personal decisions. No religious beliefs or practices, or any attendance at religious services, shall be imposed upon any Participant. The Center shall encourage and assist in the exercise of these rights;

(n) Are not the object of discrimination with respect to participation in activities which include recreation, meals, leisure, other social activities because of age, race, religion, sex, or nationality as defined in Title VI of the Civil Rights Act of 1964, or the Americans with Disabilities Act of 1990;

(o) Are not deprived of any constitutional, civil, or legal right solely by reason of admission to the Center;

(p) For protection of the Participants, are allowed to discharge themselves from the Center upon presentation of a request, preferably in writing; or, if the Participant is an adjudicated mental incompetent, upon the written consent of his next of kin, sponsor, guardian, or responsible person. However, if assessed by social workers, center Staff, or responsible persons at the time of intake as confused, the Participant shall not be allowed to discharge himself until after the Center notifies the Participant’s guardian, spouse, or person having durable power of attorney;

(q) Are informed of the right to report abusive, neglectful, exploitative or fraudulent practices.

(4) The Center shall not be required to accept or retain any applicant or Participant whose behavior and physical limitations are deemed hazardous to the safety of the individual or other Participants. Such conditions shall constitute a basis for termination of Center participation. Participation may be terminated after reasonable alternatives have failed, and upon written notification of the Participant, guardian and responsible person. Fifteen calendar days shall be allowed for arranging for alternative services for the Participant except in cases of emergency as determined by the Governing Authority or Operator of the center.

(5) All ADRD Participants involuntarily discharged from a Center designated as a Specialized Alzheimer’s services adult day care center pursuant to Section 429.918, F.S., must be:

(a) Informed of any Significant Change in the ADRD participant’s condition such as a deterioration or improvement in the ability to carry out Activities of Daily Living; a deterioration in behavior or mood to the point where daily problems arise or an improvement to the point that these problems are eliminated; or a substantial deterioration in health status or reversal of such status, as documented in the ADRD Participant’s case file notes;

(b) Informed that the Center is unable to meet the ADRD Participant’s needs, as determined by the Owner or Operator;

(c) Provided with an appropriate discharge plan, including suggested transition options for the ADRD Participant to facilitate and ensure continuity of care. Fifteen (15) calendar days shall be allowed for arranging for alternative services for the ADRD Participant except in cases of emergency as determined by the Governing Authority of the Center.

(d) Informed of monthly health assessments and monthly updates, in each ADRD Participant’s file regarding the ADRD Participant’s status or progress toward meeting the goals indicated in his or her individualized plan of care.

History

Rulemaking Authority 429.929, 429.918(12) FS. Law Implemented 429.918 FS. History–New 7-8-81, Amended 2-27-84, Formerly 10A-6.07, 10A-6.007, 59A-16.007, Amended 11-9-95, 3-29-98, 10-23-01, 8-3-15, Formerly 58A-6.007, 7-1-19.

Fla. Admin. Code R. 59A-16.104 Program Requirements

(1) Each Center shall offer a planned program of varied activities and services promoting and maintaining the health of Participants and encouraging leisure activities. Opportunities for interaction and communication among Participants shall be available on a daily basis at each Center in order to enhance the Participant’s well-being and to maximize individual functioning. Such activities and services shall be available during at least 60 percent of the time the Center is open to Participants and shall be documented in accordance with subsection (5).

(2) The Center shall make available Basic Services as defined in Section 429.901(3), F.S., and Rule 59A-16.105, F.A.C., and may make available other Supportive and Optional Services.

(3) The Center shall provide for family consultation or referral service to community agencies, clinics, or physicians when the Participant or family is observed to be in need of intensive counseling, health, or mental health services.

(4) There shall be a written description of the range of services to be provided to Participants.

(5) A monthly schedule of daily activities shall be maintained on a current basis and displayed in a conspicuous place.

(6) The Center shall provide programs and information to increase the Participant’s awareness of the following factors related to emergency preparedness and emergency management:

(a) The registration process for persons who need assistance during evacuations or when in shelter;

(b) The Center’s activities and Staff available to assist in Participant’s registration efforts; and,

(7) If a Participant needs assistance when evacuating or when in an emergency shelter, the Center shall register the person with the local emergency management agency as a person with special needs.

History

Rulemaking Authority 429.929 FS. Law Implemented 429.901(3), 429.929 FS. History–New 7-8-81, Formerly 10A-6.08, 10A-6.008, 59A-16.008, Amended 11-9-95, 3-29-98, 8-3-15, Formerly 58A-6.008, 7-1-19.

Fla. Admin. Code R. 59A-16.105 Basic Services

(1) To be licensed as an Adult Day Care Center, the following minimum Basic Services shall be provided:

(a) A protective environment that promotes a non-institutional atmosphere where supervision for the health, safety and well-being of adults who have Functional Impairments is provided;

(b) A variety of therapeutic, social and health activities and services which help to restore, remediate, or maintain optimal functioning of the Participants and to increase interaction with others. Examples of such programs include exercise, health screening, health education, interpersonal communication, and behavior modification;

(c) Leisure-time activities or spectator or Participant programs designed to assist Participants’ self-expression, enhance self-esteem and provide mental stimulation or social participation. Examples of such programs include opportunities for arts and crafts; daily exercise as can be tolerated by the Participant or as prescribed by the Participant’s physician; development of hobbies; excursions or outings to points of interest to the Participants; and other outside activities which may include picnics and cookouts;

(d) Self-care training activities designed to assist Adults with Functional Impairments to restore or maintain the ability to perform Activities of Daily Living;

(e) Rest or period of relaxation or inactivity during the day, that meets the needs of the individual Participants;

(f) Nutritional services or food provided or prepared in a central location in a Center or by formal agreement with a third party; the activities performed and the resources utilized in the planning, processing, preparing, and serving of meals or snacks; nutritional education; and nutritional counseling.

(g) In-facility Respite Care for Adults with Functional Impairments for the purpose of relieving the primary caregiver.

(2) To be licensed as an Adult Day Care Center, the following nutrition services shall be provided by the Center:

(a) Participants attending or in transit to the Center for four or more hours daily shall be served a meal which shall adhere to the U.S. Department of Health and Human Services and U.S. Department of Agriculture’s Dietary Guidelines for Americans 2010 (DGAs) and provides at least one-third of the Dietary Reference Intakes as referenced in the DGAs, adjusted for age, sex and activity. Modified diets, if required, shall meet these nutritional standards to the extent medically possible. Menus approved and provided by Title III-C of the Older Americans Act or the Adult Care Food Program of USDA shall be evidence of meeting the one-third of the Dietary Reference Intakes requirement.

(b) The Dietary Reference Intakes Requirement shall be met by offering a variety of foods adapted to the food habits, preferences, and physical abilities of the Participants and shall be prepared using standardized recipes. A copy of the DGAs, which are hereby incorporated by reference, shall be available at no cost by writing to the Department of Elder Affairs, 4040 Esplanade Way, Tallahassee, Florida 32399-7000 or at: http://www.flrules.org/Gateway/reference.asp?No=Ref-05616.

(c) Participants in the Center three hours before the noon meal or two hours after the noon meal, must be provided a snack consisting of at least two servings from the following four food groups: milk, bread or bread alternate, meat or meat alternate, and vegetables or fruits.

(d) When food service is provided by the Center, the following requirements shall be met:

The Owner or Operator or person designated by the Owner or Operator shall be responsible for the total food service and the day-to-day supervision of food services Staff.
The Owner or Operator shall be responsible for: coordinating food services with other services; developing work assignments; purchasing food; and orienting, training and supervising food service employees.
The Owner or Operator or the person designated by the Owner or Operator as responsible for food service shall perform their duties in a safe and sanitary manner, be knowledgeable of foods that meet regular diet requirements, participate in on-going orientation and training, and participate in biennial in-service provided by a registered dietitian.
Menus not approved by or meeting the requirements of Title III-C of the Older Americans Act or the Adult Care Food Program of USDA shall be reviewed by a registered or Florida licensed dietitian or a dietetic technician supervised by a registered or Florida licensed dietitian to ensure that the menus are commensurate with the Dietary Reference Intakes as referenced in the DGA, adjusted for age, sex and activity. Documentation of review of the menus shall be maintained in the Center files and shall include the signature and registration or license number of the reviewer and date reviewed. Menus shall be kept on file for one year and shall be accessible to Participants and families of Participants.

(e) If food is catered from outside sources, no warewashing may take place onsite. Catered food, once delivered to an Adult Day Care Center, must be adequately protected. In order to provide catered meals through a third party, there must be a formal contract between the Center and the third party provider containing assurances that the provider will meet all food service and dietary standards.

(f) Duty Assignments for the people designated by the Owner or Operator as responsible for food service shall be posted in the kitchen area in Centers having five or more food service Staff.

History

Rulemaking Authority 429.929 FS. Law Implemented 429.901(3), 429.929 FS. History–New 7-8-81, Amended 2-27-84, Formerly 10A-6.09, 10A-6.009, 59A-16.009, Amended 11-9-95, 3-29-98, 8-3-15, Formerly 58A-6.009, 7-1-19.

Fla. Admin. Code R. 59A-16.106 Supportive and Optional Services

In addition to the minimum Basic Services, the Center may choose to provide Supportive and Optional Services. If provided, such services must be administered by Staff qualified to provide such services and within the criteria established by relevant Florida Statutes. The following are examples of such services:

(1) Health or social services such as assessment, counseling, treatment and referral.

(2) Speech therapy provided by or under the supervision of an individual licensed under Chapter 468, Part I, F.S., who has a certification of clinical competence from the American Speech and Hearing Association, and who has completed the equivalent education requirements and work experience necessary for certification, or who has completed the academic program and is acquiring supervised work experience to qualify for the certificate. Progress notes shall be maintained and must be written in the Participant’s File and signed by the speech therapist as services are provided.

(3) Physical therapy must be provided by, or under the supervision of, an individual who is a graduate of a program of physical therapy approved by both the Council on Medical Education of the American Medical Association and the American Therapy Association, or the equivalent, and licensed by the State. Progress notes shall be maintained and must be written in the Participant’s File and signed by the physical therapist as services are provided.

(4) Occupational therapy as an adjunct to treatment of persons with physical and mental limitations must be provided by, or under the supervision of, an individual who is registered by the American Occupational Therapy Association; or a graduate of a program approved by the Council on Medical Education of the American Medical Association and engaged in the supplemental clinical experience required before registration by the American Occupational Therapy Association. Progress notes shall be written in the Participant’s File and signed by the occupational therapist as services are provided.

(5) Modified diets or diets based on the normal diet and designed to meet the requirements of a given situation such as altering individual nutrients, caloric values, consistency, flavor, techniques of service or preparation, content of specific foods, or a combination of these factors, may be provided as an optional service. When modified diets are provided, a physician’s written or documented oral order for each Participant receiving a modified diet shall be on file. A menu including types and amounts of food to serve will be on file in the food service area. Diets shall be prepared and served as ordered by the physician.

(6) Adult day health care services for disabled adults or aged persons, provided the Center complies with the following:

(a) Make services available for a minimum of five hours per day five days per week, excluding legal holidays as posted by the facility. For purposes of this subsection, legal holiday shall mean any day which, by the laws of this state or the United States, is designated or recognized as a legal or public holiday or any day on which businesses or institutions are customarily closed.

(b) Provide or coordinate, in addition to the Basic Services specified in Rule 59A-16.105, F.A.C., and Supportive and Optional Services, pursuant to subsections (1), (2), (3), (4) and (5), the following adult day health care services:

Medical screening emphasizing prevention and continuity of care which includes routine blood pressure checks or blood glucose diabetic maintenance checks,
Nursing services including a configuration of services at different levels of intensity as determined by the nursing assessment, Participant Care Plan, and physician’s orders. Services shall include:

a. Health education and counseling including nutritional advice, liaison with the Participant’s personal physician, and notification of the Participant’s physician, as well as the caregiver or family of any changes in the Participant’s health status,

b. Coordination of the provision of other health services provided outside the Center,

c. Supervision of health services provided by program aides.

Social services including: counseling for Participants’ families and caregivers; compilation of a social history and psychosocial assessment of formal and informal support systems; mental and emotional status; caregiver data; information on planning for discharge; and referral for persons not appropriate for adult day care.
Additional medical services such as dental, ophthalmological, optometric, hearing aid, or laboratory services.
Transportation Services to and from the adult day health care services.

The Operator shall: have a minimum of a Bachelor’s degree in a health or social services or related field, with one year of supervisory experience in a social or health service setting; hold a registered nurse license with one year of supervisory experience; or have 5 years of supervisory experience in a social or health service setting.
A registered nurse (RN) or licensed practical nurse (LPN) shall be on-site during the primary hours of program operation and on-call during all hours the Center is open. Arrangements shall be formalized for obtaining the services of an LPN or RN in anticipation of potential absences, planned and unplanned, of the regular nursing Staff.
A social worker with a minimum of a Bachelor’s degree in social work or a case worker with a minimum of a Bachelor’s degree in sociology, psychology, nursing, or gerontology, or a Bachelor’s degree with at least two years of experience in a human service field. Services provided by program aides in this service area must be provided under the direct supervision of a social worker or case manager who meets or exceeds these standards (e.g., a Master’s degree in a related field).
An activity director or Recreational Therapist with a Bachelor’s degree in a social or health service field or an Associate’s degree in a related field plus 2 years of experience. All services provided by program aides must be provided under the direct supervision of the activity director or recreation therapist. The recreation therapist may be retained as a consultant.

(d) Documentation of services provided under this section must be in the Participant Care Plan and stored in the Participant File. Participant Care Plans must be reviewed at least quarterly by a multidisciplinary team. At a minimum, narrative nursing, social work, and activity notes must be entered in the participant’s record quarterly, indicating the Participant’s progress toward achieving health goals. More frequent notes are required if indicated by the Participant’s condition.

History

Rulemaking Authority 429.929 FS. Law Implemented 429.929 FS. History–New 7-8-81, Formerly 10A-6.10, 10A-6.010, 59A-16.010, Amended 11-9-95, 3-29-98, 8-3-15, Formerly 58A-6.010, 7-1-19.

Fla. Admin. Code R. 59A-16.107 Participant and Program Data, Comprehensive Emergency Management Plan

(1) The Owner or Operator shall establish, maintain and make available and ready for immediate use to the Agency, complete and accurate social, medical and fiscal records which fully disclose the extent of services to be maintained by the Center for a period of two years.

(2) The Participant File shall include a Participant Data Sheet which shall be completed for each Participant within forty-five days prior to or twenty-four hours after admission to the Center and which shall include:

(a) Full name, birthday, address;

(b) Date admitted as a Participant and services to be provided;

(d) Guardian or Responsible Person and address and phone number of that person;

(e) Medicaid and Medicare identification and other health insurance numbers;

(f) Emergency contact person, home or office address and phone numbers of such person;

(g) Name and telephone number of attending physician to be contacted when there appears to be significant deviation from normal appearance or state of well-being of a Participant; physician’s or hospital discharge statement no older than forty-five days indicating prescribed medications and dosage which is updated as changes are made by physicians or, until a statement is received, a dated and signed statement by the Participant, guardian or responsible person, stating that specific medication may be given as ordered by the attending physician; notation of physical and emotional conditions requiring care and medications administered; diet and mobility restrictions; and a statement that the Participant is free from tuberculosis in a communicable form;

(h) The Participant File shall be updated when there is a Significant Change in the Participant, or at least quarterly;

(i) The Owner or Operator or Staff designated by the Owner or Operator shall review and approve each Participant care plan.

(3) The Operator shall be responsible for the recording, reporting and availability of Participant data, including those records required for each Center Participant, and program data, including those records required for services made available to and provided to Participants by the Adult Day Care Center. Such records shall include:

(a) Number of Participants enrolled to current date;

(b) Average Daily Attendance as defined in this rule chapter, based upon attendance through the end of the preceding month;

(c) Hours of travel time current through the previous month, if Transportation Services are provided or arranged by the Center.

(d) Business hours of operation shall be posted in a conspicuous place. Business hours shall mean a time period established by the Center, as defined in its policies, and shall be no less than five hours per day on week days of Center operation and may include a reduced schedule of weekend hours.

(4) Documentation shall be made of services, medication and special diets provided or administered to the Participants and shall be kept current in the Participant’s File. Such documentation shall consist of a written, signed and dated notation or statement.

(5) A record shall be kept of Staff assignments.

(6) If the Center accepts fee-for-service Participants, there shall be a signed agreement documenting the amount of fee, hours and days of attendance, services to be provided, and frequency of payment. This agreement shall be signed by the Owner, Operator, or the Owner or Operator’s designee, the Participant or Responsible Person, and recorded in the Participant’s File. Financial records shall be maintained and shall be current through the last payment period.

(7) A written record shall be kept of Major Incidents affecting Participants, Staff, Volunteers or the Center.

(8) Major Incidents, as defined in this rule chapter shall be reported immediately to the Agency’s Complaint Administration Unit at the following website: http://ahca.myflorida.com/MCHQ/Field_Ops/CAU.shtml. Reports shall be made by the individual having first-hand knowledge of the incident and performing functions and responsibilities as an authorized agent and may include paid, emergency and temporary Staff, Volunteers and student interns.

(9) In case of emergency, such as acute illness, if family or Responsible Person 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.

(10) Pursuant to Section 429.929(1)(g), F.S., as a part of the licensure process, each Center shall develop and follow a written Comprehensive Emergency Management Plan for emergency care during an internal or external disaster in accordance with Emergency Management Planning Criteria for Adult Day Care Facilities, dated July 2001, incorporated by reference. A copy of the July 2001 Emergency Management Planning Criteria for Adult Day Care Facilities may be obtained from the Agency’s website at: http://www.fdhc.state.fl.us/MCHQ/Health_Facility_Regulation/Assisted_Living/docs/adcc/ADCC_CEMP_2008.pdf.

(a) The Comprehensive Emergency Management Plan shall include the following:

Provisions for both internal and external disasters and emergencies which could include hurricanes, tornadoes, fires, power outages, floods, bomb threats, acts of terrorism, bio-terrorism, hazardous materials and nuclear disasters.
Provisions for care and services to Participants during the emergency including: pre-disaster preparation, notification of family members or responsible parties, securing the Center, supplies, staffing and emergency equipment.
Provisions for care and services, including emergency evacuation transportation, to Participants who must remain in the Center and those who must evacuate during the emergency.
Identification of Staff positions responsible for implementing each aspect of the Plan.
Identification of and coordination with designated agencies including the Red Cross and the local emergency management agency.
Post-disaster activities including responding to family inquiries, obtaining necessary emergency medical attention or intervention for Participants, transportation and re-entry to the Center.

(b) The Plan shall be available for immediate access by Center Staff.

(c) The initial Plan shall be reviewed by the local Emergency Management Agency to ensure compliance with the Emergency Management Planning Criteria for Adult Day Care Facilities, dated July 2001.

(d) The local emergency management agency has 60 days in which to review and determine if the Plan satisfies the Emergency Management Planning Criteria or advise the Center of necessary revisions. Any revisions must be made and resubmitted to the local emergency management agency within 30 days of receiving notification from the local emergency management agency that the Plan must be revised.

(e) The Center shall review and update its Plan on an annual basis. The Plan shall be submitted annually, or more often if needed, to the local emergency management agency.

(11) Fire safety protection shall be governed by the local fire code applicable to Adult Day Care Centers. In areas where no local fire code applies, the standards contained in Chapter 69A-40, F.A.C., Uniform Fire Safety Standards for Assisted Living Facilities, may be used to determine compliance with fire safety standards. In every instance, a Center shall comply with local and state standards before a license may be issued.

(a) A fire evacuation drill shall be conducted once a month for the Staff and once every three months for Participants;

(b) A written record of each fire drill, indicating the date, hour and general description of each drill, the extent of Staff involvement, and the name of the person in charge shall be maintained and available for review;

History

Rulemaking Authority 429.929 FS. Law Implemented 429.929 FS. History–New 7-8-81, Amended 2-27-84, Formerly 10A-6.11, 10A-6.011, 59A-16.011, Amended 11-9-95, 3-29-98, 10-23-01, 8-3-15, Formerly 58A-6.011, 7-1-19.

Fla. Admin. Code R. 59A-16.108 Fiscal Standards

(1) The center shall establish and maintain a record of all funds held in trust, if any, and the participant funds shall be kept separate from the center funds. Such funds shall be used or expended only at the request of the participant, the participant’s representative, designee, surrogate, guardian, or attorney-in-fact, if applicable.

(2) The center shall furnish at least annually, a complete verified statement of such funds or property to the participant or to the guardian or responsible person, detailing the amount and items received with sources and disposition. Such a report also shall be made at termination or transfer from the center.

(3) Any agency, governmental or private, contributing funds or property to the account of a participant, shall, upon request, be entitled to receive such a statement annually and upon termination or transfer.

(4) Centers shall maintain liability insurance coverage in force at all times. On the renewal date of the center’s policy or whenever a center changes policies, the center shall file documentation with the AHCA, ADC Program, 2727 Mahan Drive, Tallahassee, FL 32308. Such documentation shall be issued by the insurance company, shall include the name of the center, dates of coverage and shall meet the criteria of this chapter.

History

Rulemaking Authority 429.929 FS. Law Implemented 429.929 FS. History–New 7-8-81, Formerly 10A-6.12, 10A-6.012, 59A-16.012, Amended 11-9-95, 3-29-98, Formerly 58A-6.012, 7-1-19.

Fla. Admin. Code R. 59A-16.109 Physical Plant, Sanitary Conditions, Housekeeping Standards and Maintenance

(1) The 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 receiving federal funds shall meet regulations for access to the handicapped in compliance with the Americans With Disabilities Act of 1990.

(2) The Participant Capacity shall be determined by the total amount of Net Floor Space available for all of the Participants. Centers licensed prior to the effective date of this rule shall provide 30 square feet of net floor area per Participant. For Centers initially licensed after November 9, 1995, there shall not be less than 45 square feet of net floor area per Participant. Centers shall be required to provide additional floor space for special target populations to accommodate activities required by Participant care plans. A change in space usage that increases or decreases the Participant Capacity must continue to comply with all requirements of Part III of Chapter 429, F.S., and this rule.

(3) The Participant Capacity of facilities that are exempt from licensure as an Adult Day Care Center pursuant to Section 429.905, F.S., shall be determined by the total amount of Congregate Space available to the Participants. Such Facilities shall utilize separate space over and above the minimum requirement needed to meet their own licensure certification approval requirements.

(4) The Center shall have available and shall make accessible to the Agency written policies and procedures for the cleaning of the physical plant and equipment and for the maintenance of such.

(5) Center facilities shall consist of, but not be limited to, the following:

(a) Bathrooms;

(b) Dining areas;

(d) Rest areas; and,

(e) Recreation and leisure time areas.

(6) A private area shall be available for the provision of first aid, special care and counseling services when provided, or as necessary for other services required by Participants. This area shall be appropriately furnished and equipped.

(7) Each Participant shall be provided with adequately padded, clean, comfortable seating, with support meeting the needs of each Participant. Rest areas shall be provided for at least one-fourth of the Participants who are present for four or more hours a day, or as needed by the Participants. Seating options may include:

(a) Bed and mattress, or

(b) Recliner, or

(d) Chair with back and arm support.

(8) Bathrooms shall be ventilated and have hot and cold running water, supplying hot water at a minimum of 105 degrees Fahrenheit and a maximum of 115 degrees Fahrenheit. Facilities licensed prior to the effective date of this rule are exempt from the requirement for hot running water only.

(9) Recreation and leisure time areas shall be provided where a Participant may read and engage in socialization or other leisure time activities. The recreation areas also may be utilized for dining areas.

(10) All areas used by Participants shall be suitably lighted and ventilated and maintained at a minimum inside temperature of 72 degrees Fahrenheit, when outside temperatures are 65 degrees Fahrenheit or below, and all areas used by Participants must not exceed 90 degrees Fahrenheit. Mechanical cooling devices must be provided when indoor temperatures exceed 84 degrees Fahrenheit. The facility shall have a thermometer which accurately identifies the temperature.

(11) The kitchen or food preparation areas shall comply with subsection 59A-16.105(3), F.A.C.

(12) Medicines, cleaning supplies, flammables and other potentially poisonous or dangerous supplies shall be stored out of the Participant’s reach, and in such manner as to ensure the safety of Participants.

(a) No prescription drug shall be brought into the Center unless it has been legally dispensed and labeled by a licensed pharmacist for the person for whom it is prescribed.

(b) Participants who can self-administer medications may bring and be responsible for their own medications.

The preservation of medicines requires refrigeration;
Medication is determined, and documented by the physician, to be hazardous if kept in the personal possession of the person for whom it was prescribed;
Because of physical arrangements and the conditions or habits of other persons in the Center, the medications are determined by the Operator or physician to be a safety hazard to others.

(d) Centrally stored medications shall be:

Kept in a locked cabinet or container, and refrigerated, if required;
Accessible only to the authorized Staff responsible for distribution of medication;
Located in an area free from dampness and abnormal temperatures.

(e) Each container of medication shall be labeled according to state law, and shall include the name of the person for whom it is prescribed, the name of the drug, and instructions for use.

(f) No person other than the dispensing pharmacist shall:

Alter the prescription label;
Transfer medication from one storage container to another.

(g) Prescription medications which are not taken with the person upon discharge shall be destroyed or disposed of by the Operator or designee in the presence of one other Staff member.

(h) There shall be a Staff person available at all times who has access to the centrally stored medications and is responsible for the distribution thereof.

(i) The container of centrally stored medication shall be given to the Participant for whom it is prescribed, at the time indicated by the prescription, for the Participant to take as prescribed.

(j) In no instance shall a medication prescribed for one person be taken by any other person.

(k) In no instance shall medication be administered by a person other than one licensed, according to Florida law, to administer medication including a physician, a dentist, a nurse, or a physician’s assistant.

(13) Centers that provide their own laundry services shall have a sufficient area and the appropriate equipment for the laundry to be processed by the Center.

(14) Furniture to be used by Participants shall be sturdy, clean, comfortable and in good repair.

(15) Every Center shall be maintained for the comfort and safety of the Participants and shall have an effective written maintenance plan that ensures preventive maintenance as well as immediate attention to and correction of hazardous or potentially hazardous conditions. The plan shall provide for:

(a) Keeping the building in good repair and free of hazards such as: cracks in floors, walls, or ceilings; warped or loose boards, tile, linoleum, handrails or railings; broken window panes; and any similar hazards.

(b) Keeping all heating, air conditioning, electrical, mechanical, water supply, fire protection and sewage disposal systems in a safe and functioning condition. Electrical wiring cords and appliances shall be maintained in a safe condition. Emergency generators, where existing, shall be tested monthly.

(c) Keeping all plumbing fixtures in good repair, properly functioning and satisfactorily provided with protection to prevent infiltration and contamination of the water supply.

(d) Painting the interior and exterior of the building as needed to keep it reasonably attractive. Loose, cracked or peeling wallpaper or paint shall be promptly replaced or repaired to provide a satisfactory finish.

(e) Keeping all furniture and furnishings clean and in good repair.

(f) Keeping the grounds and buildings in a safe, sanitary and presentable condition. Grounds and buildings shall be kept free from refuse, litter, and insect and rodent breeding areas.

History

Rulemaking Authority 429.929 FS. Law Implemented 429.929 FS. History–New 7-8-81, Amended 2-27-84, Formerly 10A-6.13, 10A-6.013, 59A-16.013, Amended 11-9-95, 3-29-98, 8-3-15, Formerly 58A-6.013, 7-1-19.

Fla. Admin. Code R. 59A-16.110 Adult Day Care Center Staff Training Requirements

History

Rulemaking Authority 429.917(1) FS. Law Implemented 429.917(1) FS. History–New 1-1-04, Amended 8-3-15, Formerly 58A-6.015, Amended 7-1-19, Repealed 3-5-24.

Fla. Admin. Code R. 59A-16.111 Specialized Alzheimer’s Services Adult Day Care Center Staff Training Requirements

History

Rulemaking Authority 429.918(6)(b), 429.929(1) FS. Law Implemented 429.918(6)(a) FS. History–New 8-3-15, Formerly 58A-6.0151, Amended 7-1-19, Repealed 3-5-24.

Chapter 59A-17 TRANSITIONAL LIVING FACILITIES FOR THE SPINAL CORD-INJURED, HEAD-INJURED PERSONS

Fla. Admin. Code R. 59A-17.101 Licensure

(1) Definitions.

(a) Facility. A free-standing building, a complex of adjoined buildings, pods, or wings, or a complex of separate or adjoined buildings located within one campus.

(b) Client. A person with a spinal-cord or head injury, as specified in section 400.9973(3), Florida Statutes, who is housed in a Transitional Living Facility.

(2) Licensure.

(a) An initial, renewal, or change of ownership applicant for licensure as a transitional living facility shall use the Health Care Licensing Application, Transitional Living Facility, AHCA Form 3110-9001, January 2018, which is incorporated by reference and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-09321.

(b) The application forms are available online at http://www.ahca.myflorida.com/HQAlicensureforms or, for online renewal submissions, at: http://apps.ahca.myflorida.com/SingleSignOnPortal.

History

Rulemaking Authority 400.9982 FS. Law Implemented 400.9972 FS. History–New 9-28-92, Amended 10-19-94, 5-9-18.

Fla. Admin. Code R. 59A-17.102 Licensure

History

Rulemaking Authority 400.805, 408.819 FS. Law Implemented 400.805, 408.805, 408.819 FS. History–New 9-28-92, Amended 10-19-94, 5-24-98, 8-28-14, Repealed 9-6-18.

Fla. Admin. Code R. 59A-17.118 Dietary and Nutrition Services

(1) The licensee must ensure proper nutritional care for its clients, whether provided by the licensee or a third party, and shall provide education and training in proper nutrition and planning and preparation of meals consistent with the individualized client rehabilitation plan.

(2) Meals provided by the licensee must be planned based on the current USDA Dietary Guidelines for Americans, 2015-2020, Eighth Edition, herein incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-09326. Menus must be planned to offer clients a variety of food choices and to accommodate their religious, cultural and ethnic needs.

(3) Menu items may be substituted with items of comparable nutritional value based on the seasonal availability of fresh produce or the preferences of the clients.

(4) Regular and therapeutic menus must be dated, and planned at least one week in advance for both regular and therapeutic diets. Clients must be encouraged to participate in menu planning. Planned menus must be posted or easily available to clients. Regular and therapeutic menus as served, with substitutions noted before or when the meal is served, must be kept on file for six months. Portion sizes must be indicated on the menus or on a separate sheet.

(5) Therapeutic diets must be prepared and served as ordered by the health care provider.

(6) All regular and therapeutic menus to be used by the licensee must be reviewed annually by a licensed dietitian and/or nutritionist to ensure the meals meet the nutritional standards established in this rule. The annual review must be documented in the facility files and include the original signature of the reviewer, license number, and date reviewed.

(7) Food must be served attractively at safe and palatable temperatures which is an appetizing temperature as determined by the type of food to ensure resident’s satisfaction, while minimizing the risk for scalding and burns. All clients must be encouraged to eat at tables in the dining areas. A supply of eating ware sufficient for all clients must be on hand, including adaptive equipment if needed by any client.

(8) No more than 14 hours shall lapse between the end of an evening meal and the beginning of the following morning meal containing a protein food. Intervals between other meals shall be not less than four hours and no more than 6 hours. For clients without access to kitchen facilities, snacks must be offered at least once per day. Snacks are not considered to be meals for the purposes of calculating the time between meals.

(9) A one week supply of non-perishable food based on the number of weekly meals the licensee has contracted to serve, must be on hand at all times.

(10) When food service is provided by the licensee, the administrator, or an individual designated in writing by the administrator, must be responsible for total food services and the day-to-day supervision of food services staff.

(11) When food service is contracted by the facility, the facility must ensure that the contracted food service meets all dietary standards imposed by subsection 64E-12.004(4), F.A.C., as required by the Department of Health and this rule. The facility must maintain:

(a) A copy of the current contract between the licensee and the food service contractor.

(b) A copy of the annually issued certificate or license authorizing the operation of the food service contractor issued by the applicable regulating agency. The license or certificate must provide documentation of the food service contractor’s compliance with food service regulatory requirements.

History

Rulemaking Authority 400.805, 400.9982 FS. Law Implemented 400.9982 FS. History–New 9-28-92, Amended 10-19-94, 5-14-15, 5-9-18.

Fla. Admin. Code R. 59A-17.119 Physical Plant Standards

Each transitional living facility licensee must establish and implement written policies designed to maintain the physical plant and overall transitional living facility environment to assure the safety and well-being of clients.

History

Rulemaking Authority 400.9982 FS. Law Implemented 400.9982 FS. History–New 9-28-92, Amended 10-19-94, 8-28-14, 5-9-18.

Fla. Admin. Code R. 59A-17.125 Administration of Medications to Clients by Unlicensed Direct Care Service Staff

(1) It is the responsibility of the licensee to ensure that individual unlicensed direct care service staff (UDC) who will be administering medication to clients meet all requirements of this rule.

(2) UDC may administer only prescribed, prepackaged, premeasured oral, topical nasal, and ophthalmic medications.

(3) UDC may administer over the counter (OTC) medications as currently prescribed by the client’s health care professional.

(4) UDCs may not:

(a) Administer medications by injection including intramuscular, intravenous or subcutaneous;

(b) Administer medication vaginally or rectally; or

(5) UDCs may administer medications to a client only after the following requirements are met for that client:

(a) A current informed consent has been signed by the client or client’s representative. The consent must acknowledge and permit UDCs to administer specifically listed medications prescribed by a licensed health care professional to the client. The informed consent must be updated and signed at least annually;

(b) A written report for the client that indicates the client’s behavior and any past medication reactions must be documented on the Medication Administration Record (MAR). The written report and MAR must be updated if the client’s behavior or medication reactions change. Information included in the written report can be provided by the client or client’s representative, or another UDC or direct care staff person who is familiar with the client. The person administering medications must be familiar with the information included in the written report and MAR prior to administering medications to clients; and,

(c) A determination is made that the client to whom medication will be administered has not been deemed capable of self-administration of his or her medications. The determination is to be made by the facility through assessment and interdisciplinary team (IDT) review.

(6) Administration of medication by UDCs must be under the supervision of a registered nurse or Advanced Practice Registered Nurse (APRN).

(a) Supervision includes weekly monitoring of medication and 24-hour availability of a registered nurse or APRN via telephone or paging device.

(b) Prior to assigning tasks to a UDC, the supervisory nurse must verify the training and validation of the unlicensed direct care service staff as required by this rule chapter.

(d) Monitoring and supervision of the completion of the assignment must be documented by the supervising nurse.

(e) The supervising nurse must participate in performance evaluations of the UDC relative to performance of medication administration.

(7) Requirements governing acquiring, receiving, dispensing, administering, disposing, labeling, and storage of medication by UDCs include:

(a) Outdated medication must be properly destroyed, as required by rules 64B16-28.301 and 64B16-28.303, F.A.C., as required by the Department of Health, by the supervising nurse. The disposal will be witnessed by one other staff of the facility and a record of the medication disposal must be maintained by the facility and signed by the supervising nurse and witness.

(b) Torn, damaged, illegible or mislabeled prescription labels should be reported immediately to the dispensing pharmacy or pharmacist.

(c) Clients must not miss the administration of medications due to delays in refilling a prescription. It shall be the responsibility of the supervising nurse to ensure that refills are ordered and obtained in a timely manner.

(d) No client shall be administered a prescription or OTC medication or treatment, except upon the written order of the client’s prescribing health care professional.

(8) When administering medications to clients; the UDC must:

(a) Wash his or her hands with soap and water prior to administration of medication, or supervising the self-administration of medication to clients. They must also wash their hands between the administration of medication to each client and when there is a change in route of administration.

(b) Prepare medications for one individual client at a time in a quiet location that is free from distraction.

(c) Administer medications to one client at a time. To complete a client’s medication process, the medication of one client must be returned to the portable or permanent medication storage unit and documentation made in the MAR before administering medications to, or supervising the self-administration of, medication for another client.

(d) Administer medications to each client, at the time, with the dosage, and by the route prescribed by the client’s health care professional. Each time medication is administered:

Conduct a triple-check of the dosage and time of administration against the original medication container label and the MAR before administering or supervising the self-administration of the medication;
Confirm the client to whom the medication is to be administered is the same client for whom the medication has been prescribed or ordered;
Administer as prescribed and via the route instructed by the client’s prescribing health care professional;
Ensure to not crush, dilute or mix medications without written directions or instructions from the client’s prescribing health care professional.
Check the expiration date before administering each medication. Medications with an expiration date preceding the current date must not be administered.
Facilitate the correct positioning and use any adaptive equipment or techniques required for that client for the proper administration of medications.

(e) Ensure the oral medication administered or supervised during self-administration has been completely ingested before leaving the client. Directly observe the client for a period of at least twenty minutes following the administration of a new medication ordered by the client’s prescribing health care professional. This observation period is to immediately detect and react to possible side effects of the medication or to document the effectiveness of the medication. UDCs must review the MAR for special instructions regarding required observation of medications and the UDC must monitor for side effects and effectiveness of all administered drugs.

(f) Immediately record the administration of the medication in the MAR.

History

Rulemaking Authority 400.9977(4) FS. Law Implemented 400.9977 FS. History‒New 7-28-16.

Fla. Admin. Code R. 59A-17.126 Training and Validation Required for Unlicensed Direct Care Service Staff

(1) Required medication administration training must include criteria to ensure that competency is demonstrated through validation of the qualification of the unlicensed direct care services staff (UDC) and all requirements of UDC specified in this rule chapter.

(2) Medication administration training will be conducted by a registered nurse, pharmacist or physician for UDCs and will be provided by the transitional living facility (TLF) licensee. Any person providing medication administration training sessions or conducting skills validation tests must first complete a trainer orientation session, which includes requirements of this rule and information to be covered during medication administration training sessions. Documentation of the trainer’s completed orientation will be provided to each UDC that he or she trains or validates.

(3) Medication administration training must include the following topics:

(a) Basic knowledge and skills necessary for medication administration charting on the Medication Administration Record (MAR);

(b) Roles of the physician, nurse, pharmacist and direct care staff in medication supervision;

(d) Interpretation of common abbreviations used in the administration and charting of medications;

(e) Knowledge of facility medication systems;

(f) Safety precautions used in medication administration;

(g) Methods and techniques of medication administration;

(h) Problems and interventions in the administration of medications;

(i) Observation and reporting of anticipated side effects, adverse effects and desired positive outcome; and,

(j) Each duty of UDCs as required in this rule chapter.

(4) Validation of the effective completion of the training is required for each UDC to assess that competency has been achieved after completion of required training. To become validated, the UDC must be able to successfully demonstrate, in a practical setting, his or her ability to correctly administer or supervise the self-administration of medications to clients in a safe and sanitary manner and to correctly and accurately document actions related to the administration of medications, in accordance with the requirements of this rule chapter. At completion of the training, a UDC must attain an overall score of 100% on knowledge tests that cover the training and facility specific questions. The UDC will have three attempts to achieve a 100% score. If after the third attempt a score of 100% is not achieved, the UDC must repeat the training and may not administer medication to clients until such time as a score of 100% is achieved. Additionally, a UDC must be able to state the purpose, common side effects, and signs and symptoms of adverse reactions for a list of commonly used medications from memory or demonstrate how they obtain that information and maintain it for easy access.

(5) Validation of competency will be conducted by an RN, physician, or pharmacist. The TLF licensee will maintain documentation containing the following information:

(a) The name and address of the validator;

(b) Validation date, with expiration date of 365 days from the validation;

(d) Validating health care professional’s license number, with license expiration date.

(6) All training curricula, handouts, testing materials, and documents used to comply with the medication administration training and skills requirements of this rule will be kept on file for five years in the TLF.

(7) The following must be validated for each UDC:

(a) Demonstration of the ability to read and follow medication instructions on a prescription label, physician’s order or MAR;

(b) Demonstration of the ability to write legibly, complete required documentation, and convey accurate and discernible information;

(d) Demonstration of the ability to state the purpose, common side effects, and signs and symptoms of adverse reactions for a list of commonly used medications from memory or demonstrate how they obtain that information and maintain it for easy access.

(8) UDCs and the TLF licensee must maintain a copy of the UDC’s current skills validation document, and documentation of orientation for their medication administration trainer and validator. UDCs are responsible for maintaining a copy of these documents and providing copies to the TLF, if requested.

(9) If requested, a UDC will have available a copy of their signed skills validation documentation to provide to the client or client’s representative. UDCs will also have available, if requested, a copy of their annual skills revalidation documentation, within five working days of the revalidation date.

(10) UDCs who have not successfully renewed their validation prior to the expiration date will not be eligible to administer medications to clients until medication administration retraining and revalidation of skills have been successfully completed.

History

Rulemaking Authority 400.9977(4) FS. Law Implemented 400.9977 FS. History‒New 7-28-16.

Chapter 59A-18 NURSE REGISTRIES STANDARDS AND LICENSING

Fla. Admin. Code R. 59A-18.001 Purpose

History

Rulemaking Authority 400.497, 400.506 FS. Law Implemented 400.497, 400.506 FS. History–New 2-9-93, Amended 12-24-00, Repealed 5-14-12.

Fla. Admin. Code R. 59A-18.002 Definitions

When used in this rule chapter, unless the context otherwise requires, the term:

(1) “AHCA” means Agency for Health Care Administration.

(2) “Assistance with activities of daily living” means a certified nursing assistant or a home health aide providing an individual assistance with activities promoting self-care and independence, to include the following:

(b) Bathing. Helping the patient in and out of the bathtub or shower, adjusting water temperatures, washing and drying portions of the body which are difficult for the patient to reach, and being available while the patient is bathing. Can also include washing and drying the patient who is bed-bound.

(d) Eating. Helping with feeding patients who require assistance with feeding themselves.

(e) Personal hygiene. Helping the patient with shaving and with oral, hair, skin and nail care.

(f) Toileting. Reminding the patient about using the toilet, assisting to the bathroom, helping to undress, positioning on the commode, and helping with related personal hygiene, including assistance with changing of an adult brief. Also includes assisting with positioning the patient on the bedpan, and helping with related personal hygiene.

(3) “Caregiver” means a registered nurse, licensed practical nurse, certified nursing assistant, home health aide, homemaker or companion that is referred by a nurse registry to provide services to patients.

(4) “Entity” means a partnership, corporation, or other business organization.

(5) “Financial instability” means the nurse registry cannot meet its financial obligation. The issuance of bad checks or an accumulation of delinquent bills or liens or failure to pay any outstanding fines unless the fine has been appealed is evidence of financial instability.

(6) “Geographic Service Area” means one or more of the counties within the health service planning district, as specified on the license, in which the nurse registry may refer its independent contractors to provide services to patients or clients in their homes or to provide staffing in facilities.

(7) “Independent Contractor” means a person who contracts through a referral from a nurse registry. The independent contractor maintains control over the method and means of delivering the services provided, and is responsible for the performance of such services. An independent contractor is not an employee of the nurse registry.

(8) “Licensed Practical Nurse,” as defined in Section 464.003(16), F.S., means a person who is currently licensed to practice nursing pursuant to Chapter 464, F.S.

(9) “Main Office” means the primary office established in a geographic service area which houses all components of the nurse registry operational site including the administration, fiscal management, service provision and supplies.

(10) “Nurse registry services” means referral of independent contractors to provide health care related services to a patient or client in the person’s home or place of residence or through staffing in a health care facility by an independent contractor referred through a nurse registry. Such services shall be limited to:

(a) Nursing care provided by licensed registered nurses or licensed practical nurses, or

(b) Care and services provided by certified nursing assistants or home health aides, or

(11) “Plan of treatment” means written plan of care and treatment, including a medical plan of treatment, signed within 30 days by the physician, advanced practice registered nurse, or physician assistant to assure the delivery of safe and adequate care provided by a licensed nurse to a patient in the home.

(12) “Registered Nurse,” as defined in Section 464.003(22), F.S., means a person who is currently licensed to practice pursuant to Chapter 464, F.S.

History

Rulemaking Authority 400.497, 400.506 FS. Law Implemented 400.497, 400.506 FS. History–New 2-9-93, Amended 1-27-94, 12-24-00, 3-15-07, 5-4-15, 8-9-16.

Fla. Admin. Code R. 59A-18.004 Licensure Requirements, Procedures, and Fees

(1) In order to operate a nurse registry as defined under Section 400.462, F.S., the owner shall make application for a license as required by Rule 59A-35.060, F.A.C. The application shall be accompanied by a $2,000 licensure fee. The receipt of a license from AHCA shall be based upon compliance with all applicable rules and laws, as evidenced by a signed application and upon the results of a survey conducted by AHCA representatives.

(2) For renewal and change of ownership licensure, the application forms and licensure fee must be submitted as required in Section 408.806(2), F.S. and Rule 59A-35.060, F.A.C.

(3) A license shall not be granted to anyone under 18 years of age.

(4) Evidence of financial ability to operate for initial licensure and change of ownership applications must be submitted with the application, which shall consist of the completion of the financial schedules contained in a form as prescribed in subsection 59A-35.062(2), F.A.C.

(5) Satellite offices – A satellite office shares administration, fiscal management, and services with the main operational site; it is not separately licensed and is exempt from the requirements in paragraphs 59A-18.004(9)(a) and (b), F.A.C. A satellite office must be listed on the license of the nurse registry operational site. A nurse registry that operates a satellite office must:

(a) Maintain a system of communication and integration of services between the nurse registry operational site and the satellite office;

(b) Provide access to patient records at the satellite office;

(d) Make the satellite office’s hours of operation available to the public if different than the hours of operation maintained by the nurse registry operational site.

(6) Evidence of compliance with local zoning authorities for the main operational site of the nurse registry and any satellite offices must be submitted with the application.

(7) All nurse registries must apply for a geographic service area on their initial license application. Nurse registries may apply for a geographic service area which encompasses one or more of the counties within the health services planning district, pursuant to Sections 408.032(5) and 400.497(9), F.S., in which the main operational site is located. However, any agency holding a current nurse registry license from AHCA, as of December 24, 2000, may continue to serve patients or clients in those counties listed on its current license.

(8) If a change of address is to occur, or if a nurse registry intends to change the counties served within the geographic service area, or open or close a satellite office, the nurse registry must complete and submit the Health Care Licensing Application, Nurse Registry, AHCA Form 3110-7004, August 2023, within the timeframe prescribed in paragraph 59A-35.040(2)(b), F.A.C. For changes of address and addition of satellite offices, the nurse registry must submit, with the application, evidence that the location is zoned for a nurse registry for the new address and evidence of legal right to occupy the property in accordance with Sections 400.506(1)(c) and 408.810(6), F.S.

(9) A nurse registry has the following responsibility in terms of hours of operation:

(a) The nurse registry administrator, or his alternate, must be available to the public for any eight consecutive hours between 7:00 a.m. and 6:00 p.m., Monday through Friday of each week, excluding legal and religious holidays. Available to the public means being readily available on the premises or by telecommunications.

(b) When the administrator, or the designated alternate, are not on the premises during designated business hours, pursuant to paragraph 59A-18.004(9)(a), F.A.C., a staff person must be available to answer the phone and the door and must be able to contact the administrator, or the alternate, by telecommunications during the designated business hours. This individual can be a clerical staff person.

(c) If an AHCA surveyor arrives on the premises to conduct a survey and the administrator, or a person authorized to give access to patient records, is not available on the premises he, or his alternate, must be available on the premises within two hours.

(d) The nurse registry shall provide to the patient or the patient’s representative a list of telephone numbers to be called if a replacement caregiver is needed along with local emergency numbers as determined by the nurse registry.

History

Rulemaking Authority 400.497, 400.506, 408.810(8), 408.819 FS. Law Implemented 400.497, 400.506, 400.512, 408.806, 408.809, 408.810, 408.811 FS. History–New 2-9-93, Amended 1-27-94, 12-24-00, 8-10-06, 3-15-07, 5-4-15, 8-9-16, 8-17-26.

Fla. Admin. Code R. 59A-18.005 Registration Policies

(1) Each nurse registry shall disseminate the following rules and statutes to each applicable independent contractor at the time of registration. The rules and statutes may be provided by paper copy, by email or other means of electronic communication.

(a) Registered nurses and licensed practical nurses shall receive for their use and reference:

Rule 59A-18.005, F.A.C., Registration Policies.
Rule 59A-18.007, F.A.C., Registered Nurses and Licensed Practical Nurses.
Rule 59A-18.011, F.A.C., Medical Plan of Treatment.
Rule 59A-18.012, F.A.C., Clinical Records.
Rule 59A-18.013, F.A.C., Administration of Biologicals.
Sections 400.506, 408.809, 400.484, 400.462, 400.488 and 408.810(5), F.S., with the telephone numbers referred to in the law.
Rule 59A-18.018, F.A.C., Emergency Management Plans.

(b) Certified nursing assistants and home health aides shall receive for their use and reference:

Rule 59A-18.005, F.A.C., Registration Policies.
Rule 59A-18.0081, F.A.C., Certified Nursing Assistant and Home Health Aide.
Sections 400.506, 408.809, 400.484, 400.462, 400.488 and 408.810(5), F.S., with the telephone numbers referred to in the law.
Rule 59A-18.018, F.A.C., Emergency Management Plans.

Rule 59A-18.009, F.A.C., Homemakers or Companions.
Sections 400.506, 408.809, 400.484, 400.462 and 408.810(5), F.S., with the telephone numbers referred to in the law.
Rule 59A-18.018, F.A.C., Emergency Management Plans.
Rule 59A-18.005, F.A.C., Registration Policies.

(2) Each nurse registry shall establish written procedures for the selection, documentation, screening and verification of credentials for each independent contractor referred by the registry.

(3) Each nurse registry shall confirm a new independent contractor’s licensure or certification with the issuing board or department. A screen print from the Department of Health website that shows a clear and active license or certification for each nurse and certified nursing assistant is sufficient for documentation.

(4) Each nurse registry shall, at least annually, reconfirm the licensure or certification of all of its independent contractors who are licensed or certified. If the nurse registry cannot confirm the licensure of any registered nurse, licensed practical nurse or certification of any certified nursing assistant, the nurse registry shall take the actions specified in Section 400.506(19), F.S. This includes reporting the individual to the Florida Board of Nursing, Department of Health as specified at its website: http://www.floridahealth.gov/licensing-and-regulation/enforcement/report-unlicensed-activity/file-a-complaint.html.

(5) Each nurse registry shall confirm the identity of the independent contractor prior to referral. Identification shall be verified by using the individual’s current driver’s license or other photo identification, including the professional license or certificate.

(6) Prior to contact with patients or clients, each independent contractor referred for client care must furnish to the registry a statement from a health care professional licensed under Chapters 458 or 459, F.S., a physician’s assistant, or an advanced practice registered nurse or a registered nurse licensed under Chapter 464, F.S., under the supervision of a licensed physician, or acting pursuant to an established protocol signed by a licensed physician, dated within the last six months, that the contractor is free from communicable diseases. The independent contractor will provide this statement to the nurse registry when first referred.

(7) Registration folders on each independent contractor must contain the information required in Section 400.506(8), F.S., and the following:

(a) For home health aides, evidence of completion of a home health aide training course or certification from the Florida Board of Nursing, Department of Health as a certified nursing assistant;

(b) Evidence of a contract with the nurse registry;

(8) Each nurse registry shall establish a system for the recording complaints involving individuals they refer. If the complaints are violations of state law, the nurse registry shall take the actions specified in Section 400.506(19), F.S. Records of complaints and actions taken by the nurse registry shall be kept in the individual’s registration file or retained in the central files of the nurse registry.

History

Rulemaking Authority 400.497, 400.506 FS. Law Implemented 400.497, 400.506 FS. History–New 2-9-93, Amended 1-27-94, 12-24-00, 8-10-06, 3-15-07, 5-4-15.

Fla. Admin. Code R. 59A-18.006 Administrator

The administrator of the nurse registry shall:

(1) Be a licensed physician, an advanced practice registered nurse, a registered nurse, or an individual with training and experience in health service administration and at least one year of supervisory or administrative experience in the health care field;

(2) Have knowledge, through training, experience or education, with the work requirements and the prerequisites for licensure or certification in each of the health care disciplines and specialties for which the registry is providing referrals;

(3) Have knowledge with the rules of AHCA and maintain them in the nurse registry;

(4) Be available, or have the alternate administrator available, at all times during operating hours as stated in paragraph 59A-18.004(8)(a), F.A.C., and be responsible for the total operation of the nurse registry. Available during operating hours means being readily available on the premises or by telecommunications during the above operating hours;

(5) Designate in writing a qualified individual to serve as the alternate administrator during absences of the administrator. During such absences, the on-site alternate administrator will have the responsibility and authority for the daily operation of the registry. The alternate administrator must meet qualifications as stated in subsection 59A-18.006(1), F.A.C.;

(6) Be responsible for the completion, maintenance and submission of such reports and records as required by AHCA;

(7) Be responsible for making sure that the nurse registry advises the patient, the patient’s family, or any other person acting on behalf of the patient at the time the referral is made that:

(a) The caregiver is an independent contractor and that it is not the obligation of a nurse registry to monitor, supervise, manage or train the caregiver as required in Section 400.506(6)(e), F.S.; and,

(b) Registered nurses are available to make visits to the patient’s home for an additional cost when a certified nursing assistant or home health aide is referred as required in Section 400.506(6)(c), F.S.

History

Rulemaking Authority 400.497, 400.506 FS. Law Implemented 400.497, 400.506 FS. History–New 2-9-93, Amended 1-27-94, 12-24-00, 5-4-15.

Fla. Admin. Code R. 59A-18.007 Registered Nurse and Licensed Practical Nurse

The registered nurse and the licensed practical nurse shall:

(1) Be responsible for the clinical records for their patients. The clinical records shall be filed with the nurse registry, for each patient or client to whom they are giving care in the home or place of residence. Clinical notes and clinical records related to care given under a staffing arrangement are maintained by the facility where the staffing contract is arranged;

(2) Be responsible for maintaining the medical plan of treatment with clinical notes and filing the initial medical plan of treatment, any amendments to the plan, any additional order or change in orders, and a copy of the clinical notes at the office of the nurse registry.

History

Rulemaking Authority 400.497, 400.506 FS. Law Implemented 400.497, 400.506 FS. History–New 2-9-93, Amended 1-27-94, 12-24-00, 5-4-15.

Fla. Admin. Code R. 59A-18.0081 Certified Nursing Assistant and Home Health Aide

The certified nursing assistant (CNA) and the home health aide shall:

(1) Be limited to assisting a patient in accordance with Section 400.506(6)(b), F.S.;

(2) Be responsible for documenting services provided to the patient or client and for filing said documentation with the nurse registry on a regular basis. These service logs will be stored by the nurse registry in the client’s file. The service logs shall include the name of the patient or client and a listing of the services provided;

(3) Be responsible for observing appearance and gross behavioral changes in the patient and reporting these changes to the patient’s health care surrogate or other person designated by the patient and the nurse registry or to the responsible facility employee if staffing in a facility;

(4) Be responsible to maintain a clean, safe and healthy environment, which may include light cleaning and straightening of the bathroom, straightening the sleeping and living areas, washing the patient’s dishes or laundry, and such tasks to maintain cleanliness and safety for the patient;

(5) Perform other activities as taught and documented by a registered nurse, concerning activities for a specific patient and restricted to the following:

(a) Assisting with the placement or removal of a colostomy bag, excluding the removal of the flange or manipulation of the stoma’s site;

(b) Assisting with the application and removal of anti-embolism stockings and hosiery prescribed for therapeutic treatment of the legs.

(d) Assisting with prescribed range of motion exercises;

(e) Assisting with prescribed ice cap or collar;

(f) Administer simple urine tests for sugar, acetone or albumin;

(g) Assisting with the use of a glucometer to perform blood glucose testing;

(h) Measuring and preparing special diets;

(i) Measuring intake and output of fluids;

(j) Measuring vital signs, including temperature, pulse, respiration or blood pressure;

(k) Assisting with oxygen nasal cannulas and continuous positive airway pressure (CPAP) devices, excluding the titration of the prescribed oxygen levels; and

(l) Assisting with the reinforcement of dressing.

(6) A home health aide or CNA shall not perform the following activities:

(a) Administer any nursing or therapeutic service that requires licensure as a health care professional;

(b) Change sterile dressings.

(d) Perform irrigation of any wounds (such as vascular ulcers, diabetic ulcers, pressure ulcers, surgical wounds) or apply agents used in the debridement of necrotic tissues in wounds of any type;

(e) Perform a gastric irrigation or enteral feeding;

(f) Catheterize a patient;

(g) Administer medications;

(h) Apply heat by any method;

(i) Care for a tracheotomy tube;

(j) Provide any service which has not been included in the plan of treatment; or,

(k) Providing assistance with a pill organizer, such as removing medication from a pill organizer and placing the medication in the patient’s hand or filling a pill organizer with the patient’s medication(s).

(7) CNA Qualifications.

(a) For every CNA, a nurse registry shall have on file a copy of the person’s State of Florida certification.

(b) Individuals who earn their CNA certificate in another state must contact the Florida Department of Health, Board of Nursing to inquire about taking the written examination prior to working as a CNA in Florida, pursuant to chapter 464, part II, F.S.

(8) Home Health Aide Qualifications.

(a) For every home health aide registered with the nurse registry since May 4, 2015, a nurse registry shall have on file a certificate or documentation of successful completion of at least forty hours of home health aide training, pursuant to section 400.506(6)(a), F.S., from a public vocational technical school or a nonpublic post-secondary educational institution approved by the Florida Department of Education, Commission for Independent Education.

(b) Home health aides registered with the nurse registry since May 4, 2015 who complete their training in another state must provide a certificate of completion of home health aide training from a vocational technical school or a post-secondary educational institution licensed in that state.

(9) CNAs and home health aides referred by nurse registries must maintain a current cardiopulmonary resuscitation (CPR) certification from an instructor or training provider that is approved to provide training by the American Heart Association, the American Red Cross, or the Health and Safety Institute, and that provides CPR training in which the student is required to demonstrate, in person, that he or she is able to perform cardiopulmonary resuscitation.

(10) Licensed practical nurses and registered nurses that are licensed in Florida or another state may work as home health aides. Also, persons who have completed the licensed practical nurse or registered nurse training from a public school, college, or university or a nonpublic post-secondary educational institution approved by the Florida Department of Education, Commission for Independent Education but are not yet licensed may work as home health aides.

(11) CNAs and home health aides referred by nurse registries may assist with self-administration of medication as described in Section 400.488, F.S.

(a) Home health aides and CNAs assisting with self-administered medication, as described in Section 400.488, F.S., shall have received a minimum of 2 hours of training covering the following content:

Training shall cover state law and rule requirements with respect to the assistance with self-administration of medications in the home, procedures for assisting the resident with self-administration of medication, common medications, recognition of side effects and adverse reactions and procedures to follow when patients appear to be experiencing side effects and adverse reactions. Training must include verification that each CNA and home health aide can read the prescription label and any instructions.
Individuals who cannot read shall not be permitted to assist with prescription medications.

(b) Documentation of training on assistance with self-administered medication from one of the following sources is acceptable:

Documentation of 2 hours of training in compliance with subsection 59A-8.0095(5), F.A.C., from a home health agency if the home health aide or CNA previously worked for the home health agency;
A training certificate for assisted living facility staff in compliance with Section 429.52(6), F.S.;
A training certificate for at least 2 hours of training from a post-secondary educational institution approved by the Florida Department of Education;
Documentation of at least 2 hours of training by a provider approved by the Florida Department of Health, Board of Nursing.

(c) Documentation of the training must be maintained in the file of each home health aide and CNA. who assists patients with self-administered medication.

(d) In cases where a home health aide or a CNA will provide assistance with self-administered medications as described in Section 400.488, F.S., and paragraph (e) below, an RN shall conduct an assessment of the patient and patient’s medications for which assistance is to be provided to ensure that a patient receiving such assistance is medically stable and has regularly scheduled medications that are intended to be self administered as required in s. 400.488(2), F.S. and the CNA and home health aide are able to assist in accordance with their training and with the medication prescription. If the patient will not consent to a visit by the nurse to conduct an assessment, a written list with the dosage, frequency and route of administration shall be provided by the patient or the patient’s health care surrogate, family member, or person designated by the patient to the home health aide or CNA to have reviewed by the nurse. The patient or the patient’s surrogate, guardian, or attorney in fact must give written consent for a home health aide or C.N.A. to provide assistance with self-administered medications, as required in Section 400.488(2), F.S.

(e) The trained home health aide and CNA may also provide the following assistance with self-administered medication, as needed by the patient and as described in Section 400.488, F.S.:

Prepare necessary items such as juice, water, cups, or spoons to assist the patient in the self-administration of medication,
Open and close the medication container or tear the foil of prepackaged medications,
Assist the resident in the self-administration process. Examples of such assistance include the steadying of the arm, hand, or other parts of the patient’s body so as to allow the self-administration of medication,
Assist the patient by placing unused doses of solid medication back into the medication container.

(12) Pursuant to section 400.506(19), F.S., a nurse registry may not monitor, supervise, manage, or train a registered nurse, licensed practical nurse, certified nursing assistant, companion or homemaker, or home health aide referred for contract under this chapter. In the event of violation of state laws that comes to the attention of the nurse registry, the nurse registry shall take action in accordance with section 400.506(19), F.S. A nurse registry is not prohibited from reviewing records and may do so per section 400.506(20), F.S.

History

Rulemaking Authority 400.488, 400.497, 400.506 FS. Law Implemented 400.488, 400.497, 400.506 FS. History–New 1-27-94, Amended 12-24-00, 8-10-06, 3-15-07, 5-4-15, 2-8-16, 1-11-24.

Fla. Admin. Code R. 59A-18.009 Homemakers or Companions

(1) The homemaker shall have the following responsibilities:

(a) To maintain the home in the optimum state of cleanliness and safety depending upon the client’s and the caregiver’s resources;

(b) To perform the functions generally undertaken by the natural homemaker, including such duties as preparation of meals, laundry, and shopping;

(c) To perform casual, cosmetic assistance, such as brushing the client’s hair, assisting with make-up, filing and polishing nails, with the exception of clipping nails for diabetic patients;

(d) To stabilize the client when walking, as needed, by holding the client’s arm or hand; and,

(e) To report any unusual incidents or changes in the patient’s or client’s behavior to the person(s) designated by the client.

(2) The companion shall have the following responsibilities:

(a) To provide companionship for the patient or client;

(b) To provide escort services such as taking the patient or client to the health care provider;

(d) To perform casual, cosmetic assistance, such as brushing the client’s hair, assisting with make-up, filing and polishing nails, with the exception of clipping nails for diabetic patients;

(e) To stabilize the client when walking, as needed, by holding the client’s arm or hand; and,

(f) To report any unusual incidents or changes in the patient’s or client’s behavior to the person(s) designated by the client.

(3) Homemakers and companions shall be responsible for providing to patient and nurse registry copies of any documentation which reflects the services provided. This will be stored by the nurse registry in the client’s file. The nurse registry is not obligated to review patient or client records per Section 400.506(20), F.S., but the nurse registry is not prohibited from reviewing the records and may do so.

History

Rulemaking Authority 400.497, 400.506 FS. Law Implemented 400.497, 400.506 FS. History–New 2-9-93, Amended 1-27-94, 12-24-00, 5-4-15.

Fla. Admin. Code R. 59A-18.010 Acceptance of Patients or Clients

Policies for acceptance of patients or clients and termination of services to patients or clients shall include, for example, the following conditions:

(1) No patient or client shall be refused service because of age, race, color, sex or national origin, pursuant to chapter 760, F.S.

(2) When a patient or client is accepted for referrals of independent contractors, there shall be a reasonable expectation that the requested services can be provided adequately and safely in their residence. The responsibility of the registry is to refer independent contractors capable of delivering services as defined in a specific medical plan of treatment for a patient or services requested by a client, including all visits.

(3) When medical treatments or medications are administered, physician’s, advanced practice registered nurse’s, or physician assistant’s orders in writing that are signed and dated shall be included in the clinical record; and,

(4) When services are to be terminated, the patient or client, or the person designated by the patient or client shall be notified of the date of termination and the reason for termination, and these shall be documented in the patient or client’s record.

History

Rulemaking Authority 400.497, 400.506 FS. Law Implemented 400.497, 400.506 FS. History–New 2-9-93, Amended 12-24-00, 3-15-07, 5-4-15.

Fla. Admin. Code R. 59A-18.011 Medical Plan of Treatment

(1) When the delivery of skilled care to a patient in the home is under the direction or supervision of a physician or when a physician, physician’s assistant or advanced practice registered nurse is responsible for the medical care of the patient, a medical plan of treatment must be established for each patient receiving care or treatment provided by the licensed nurse in the home or residence.

(2) The licensed nurse providing care to the patient is responsible for having the medical plan of treatment signed by the physician, physician assistant, or advanced practice registered nurse, acting within his or her respective scope of practice, within 30 days from the initiation of services and reviewed by the physician, physician assistant, or advanced practice registered nurse in consultation with the licensed nurse at least every 2 months.

(3) The licensed nurse responsible for delivering care to the patient is responsible for the medical plan of treatment which shall include, at a minimum, the following:

(a) Diagnoses;

(b) Activities permitted when indicated;

(d) Medication, treatments, and equipment required; and,

(e) Dated signature of physician, physician assistant, or advanced practice registered nurse.

(4) The delivery of care pursuant to a medical plan of treatment must be substantiated by the nursing notes or documentation made by the nurse in compliance with nursing practices established under Chapter 464, F.S.

(5) The initial medical plan of treatment, any amendment to the plan, additional orders or change in orders, and copy of clinical notes must be filed in the office of the nurse registry, pursuant to Section 400.506(13)(b), F.S., within 30 days, pursuant to Section 400.497(8), F.S.

(6) The nurse registry shall inform nurse registrants that the shift nurse that communicates with the physician’s office, the physician assistant or the advanced practice registered nurse about any changes in the orders should update the plan of treatment.

(7) The patient, caregiver or guardian must be informed by independent contractors of the nurse registry that:

(a) They have the right to be informed of the medical plan of treatment;

(b) They have the right to participate in the development of the medical plan of treatment;

(d) The caregiver being referred is an independent contractor of the registry.

History

Rulemaking Authority 400.497, 400.506 FS. Law Implemented 400.497, 400.506 FS. History–New 2-9-93, Amended 1-27-94, 12-24-00, 8-10-06, 5-4-15.

Fla. Admin. Code R. 59A-18.012 Clinical Records

The licensed nurse responsible for the delivery of skilled patient care shall maintain a clinical record, pursuant to Section 400.497(8), F.S., for each patient receiving nursing services in the home that shall include, at a minimum, the following:

(1) Identification sheet containing the patient’s name, address, telephone number, date of birth, sex, and caregiver or guardian;

(2) Before information can be released, an authorization for such release must be dated and signed by the patient, caregiver, or guardian;

(3) Plan of treatment as required in Section 400.506(13), F.S.;

(4) Clinical and service notes, signed and dated by the nurse providing the service which shall include:

(a) Any assessments by a registered nurse;

(b) Progress notes with changes in the person’s condition;

(d) Observations; and,

(e) Instructions to the patient and caregiver;

(5) Reports to physicians;

(6) Termination summary including:

(a) The date of the first and last visit;

(b) The reason for termination of services;

(d) The condition of the patient at the time of termination of services; and,

(e) The referral for additional services when the patient requires continuing services.

(7) Each nurse registry shall keep clinical records received from the independent contractor licensed nurse for 5 years following the termination of service. Retained records can be stored as hard paper copy, microfilm, computer disks or tapes and must be retrievable for use during unannounced surveys.

(8) The nurse registry is not obligated to review patient or client records per Section 400.506(20), F.S., but the nurse registry is not prohibited from reviewing records and may do so. In the event of violation of state law which comes to the attention of the nurse registry, the nurse registry shall take the actions specified in Section 400.506(19), F.S.

History

Rulemaking Authority 400.497, 400.506 FS. Law Implemented 400.497, 400.506 FS. History–New 2-9-93, Amended 1-27-94, 12-24-00, 8-10-06, 5-4-15.

Fla. Admin. Code R. 59A-18.013 Administration of Drugs and Biologicals

(1) Each nurse registry shall disseminate to its independent contractor nurses the procedures required by Chapter 464, F.S., and the rules of the Agency for Health Care Administration governing the administration of drugs and biologicals to patients.

(2) The procedures shall include the following:

(a) An order for medications to be administered by the licensed nurse shall be dated and signed by the attending physician, physician assistant, or advanced practice registered nurse as required in Section 400.506(13), F.S.;

(b) An order for medications shall contain the name of the patient, the name of the drug, dosage, frequency, method or site of injection, and order from the physician, physician assistant, or advanced practice registered nurse if the patient or caregiver are to be taught to give the medication; and,

(c) A verbal order for medication or change in the medication orders from the physician, physician assistant, or advanced practice registered nurse shall be taken by a licensed registered nurse, reduced to writing, to include the patient’s name, the date, time, order received, signature and title. The physician, physician assistant, or advanced practice registered nurse shall acknowledge the telephone order within 30 days by signing and dating the orders. A verbal order or change in medication order shall be on file in the clinical record at the nurse registry within 30 days.

History

Rulemaking Authority 400.497, 400.506 FS. Law Implemented 400.497, 400.506 FS. History–New 2-9-93, Amended 1-27-94, 12-24-00, 3-15-07, 5-4-15.

Fla. Admin. Code R. 59A-18.015 Surveys and Inspections

History

Rulemaking Authority 400.497, 400.506 FS. Law Implemented 400.481, 400.484, 400.506 FS. History–New 2-9-93, Amended 1-27-94, 12-24-00, 3-15-07, Repealed 5-14-12.

Fla. Admin. Code R. 59A-18.016 Penalties

History

Rulemaking Authority 400.497, 400.506 FS. Law Implemented 400.497, 400.506 FS. History–New 2-9-93, Amended 1-27-94, 12-24-00, 3-15-07, Rpealed 5-14-12.

Fla. Admin. Code R. 59A-18.017 Supplemental Staffing for Health Care Facilities

(1) Each nurse registry may provide staffing services as defined in Section 400.462(29), F.S.

(2) Each independent contractor shall carry their professional license or certification with them at all times during their working hours at a health care facility, and shall produce such a record for review by the health care facility, upon request.

(3) Each nurse registry shall establish a system for the recording complaints involving individuals they referred to health care facilities or other business entity, and such records shall be kept in the individual’s registration file. The nurse registry is not obligated to review records per Section 400.506(20), F.S., but the nurse registry is not prohibited from reviewing records and may do so.

(4) Each nurse registry shall provide to the independent contractor, the name of the appropriate person at the health care facility who will be responsible for orientation to the facility.

(5) Each nurse registry shall, upon receiving licensure and certification information, inform the health care facility or other business entity, if a licensed or certified individual being referred to the facility is on probation with their professional licensing board or certifying agency or has any other restrictions placed on their license or certification. The registry shall also advise the licensed or certified individual that this information has been given to the health care facility or other business entity and keep a copy of this information in the independent contractor’s file.

(6) Each nurse registry shall maintain on file the name and address of facilities to whom the independent contractor is referred for contract, the amount of the fee charged, the title of the position, and the amount of the fee received by the registry.

(7) Each nurse registry shall maintain files in an organized manner and such files will be made available for inspection by the agency during the hours the registry is in operation. The nurse registry is not obligated to review patient or client records per Section 400.506(20), F.S., but the nurse registry is not prohibited from reviewing records and may do so.

(8) The nurse registry is not obligated to monitor, manage or supervise a referred independent contractor pursuant to Section 400.506(19), F.S. In the event of violation of state law which comes to the attention of the nurse registry, the nurse registry shall take the actions specified in Section 400.506(19), F.S.

History

Rulemaking Authority 400.497, 400.506 FS. Law Implemented 400.497, 400.506 FS. History–New 2-9-93, Amended 1-27-94, 12-24-00, 8-10-06, 5-4-15.

Fla. Admin. Code R. 59A-18.018 Emergency Management Plans

(1) Pursuant to Section 400.506(12), F.S., each nurse registry shall prepare and maintain a written comprehensive emergency management plan, in accordance with the Comprehensive Emergency Management Plan for Nurse Registries, AHCA Form 3110-1017, May 2015, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-05234. This document is available from the Agency for Health Care Administration at http://ahca.myflorida.com/MCHQ/Emergency_Activities/index.shtml. The plan shall describe how the nurse registry establishes and maintains an effective response to emergencies and disasters. The plan, once completed, will be sent electronically to the contact designated by the Department of Health as required in Section 400.506(12), F.S.

(2) The nurse registry shall review its emergency management plan on an annual basis and make any substantive changes. Plans with any substantive changes will be forwarded for review to the entities identified in subsection (1).

(3) Changes in the telephone numbers of those administrative staff who are coordinating the nurse registry’s emergency response must be reported to the county emergency management office and to the county health department. For nurse registries with multiple counties on their license, the changes must be reported to each county health department and each county emergency management office. The telephone numbers must include numbers where the coordinating staff can be contacted outside of the nurse registry’s regular office hours. All nurse registries must report these changes, whether their plan has been previously reviewed or not, as defined in subsection (1).

(4) When a nurse registry goes through a change of ownership, the new owner shall review the registry’s emergency management plan and make any substantive changes, including changes noted in subsection (3). Those nurse registries will need to report any substantive changes in their plans to the reviewing entity in subsection (1).

(5) In the event of an emergency, the nurse registry shall implement the nurse registry’s emergency management plan pursuant to Section 400.506(12), F.S. Also, the registry must meet the following requirements:

(a) All administrative staff shall be informed of responsibilities for implementing the emergency management plan.

(b) If telephone service is not available during an emergency, the registry shall have a contingency plan to support communication, pursuant to Section 400.506(12)(f), F.S. A contingency plan may include cell phones, contact with a community based ham radio group, public announcements through radio or television stations, driving directly to the patient’s home, and, in medical emergency situations, contact with police or emergency rescue services.

(6) Nurse registries shall assist patients who would need assistance and sheltering during evacuations because of physical, mental, or sensory disabilities in registering with the local emergency management agency, as required in Section 400.506(11), F.S.

(a) Upon initial contract for services, and at a minimum on an annual basis, each nurse registry shall, pursuant to sections 400.506(12) and 252.355, F.S., inform the patient and the patient’s family member or other person acting on behalf of the patient, by the best method possible as it pertains to the person’s disability, of the special needs registry and procedures for registration at the special needs registry maintained by their county emergency management office.

(b) If the patient is to be registered at the special needs registry, the nurse registry shall assist the patient with registering, pursuant to Sections 400.506(12), F.S., and must document in the patient’s file if the patient plans to evacuate or remain at home; if the patient’s family or other person that provides care to the patient can take responsibility during the emergency for services normally provided by independent contractors referred by the registry; or if the registry needs to make referrals in order for services to continue. If the patient has a case manager through the Community Care for the Elderly or the Medicaid Waiver programs or any other state funded program designated in law to help patients and clients register with the special needs registry, then the nurse registry will check with the case manager to verify if the patient has already been registered. If so, a note will be made in the patient’s file by the nurse registry that the patient’s need for registration has already been reviewed and handled by the other program’s case manager.

(c) The independent contractors referred by the nurse registry, or registry staff, shall inform patients registered with the special needs registry that special needs shelters are an option of last resort and that services may not be equal to what they have received in their homes.

(d) This registration information, when collected, shall be submitted, pursuant to Section 400.506(12), F.S., to the county emergency management office.

(7) The person referred for contract to a patient registered with the special needs registry, which shall include special needs registry patients being served in assisted living facilities and adult family care homes, shall ensure that the same type and quantity of continuous care is provided in the special needs shelter that was provided prior to the emergency as specified in Section 400.506(12), F.S., unless circumstances beyond the control of the independent contractor as described in Section 400.506(12)(d), F.S., make it impossible to continue services.

(8) When a nurse registry is unable to continue services to special needs patients registered under Section 252.355, F.S., that patient’s record must contain documentation of the efforts made by the registry to comply with their emergency management plan in accordance with Section 400.506(12), F.S. Documentation includes but is not limited to contacts made to the patient’s family or other person that provides care, if applicable, contacts made to the assisted living facility and adult family care home if applicable; contacts made to local emergency operation centers to obtain assistance in reaching patients and contacts made to other agencies which may be able to provide temporary services.

(9) When a state of emergency has been declared by executive order or proclamation of the Governor, pursuant to Section 252.36(2), F.S., the nurse registry must contact those patients needing ongoing services pursuant to Section 400.506(12)(a), F.S., and confirm each patient’s plan during and immediately following an emergency. The nurse registry shall contact the assisted living facility and adult family care home patients and confirm their plans during and immediately following an emergency.

(10) If the independent contractor is unable to provide services to special needs registry patients, including any assisted living facility and adult family care home special needs registry patients, due to circumstances beyond their control pursuant to Section 400.506(12)(d), F.S., then the nurse registry will contact the independent contractors it has available for referral to find another independent contractor for the patient, pursuant to Section 400.506(12), F.S.

(11) During emergency situations, when there is not a mandatory evacuation order issued by the local county emergency management office, some patients, registered pursuant to Section 252.355, F.S., may decide not to evacuate and will stay in their homes. The nurse registry must establish procedures, prior to the time of an emergency, which will delineate to what extent the registry will continue to arrange for care during and immediately following an emergency pursuant to Section 400.506(12)(a), F.S. The registry shall also contact the patients who need continuing services by calling the patient at home or calling the assisted living facility or adult family care home the patient resides in to determine if the patient still needs services from the registry and which patients have plans to receive care from their family or other persons. If the assisted living facility or adult family care home does relocate the residents to another assisted living facility or adult family care home in the geographic area served by the nurse registry, the registry will continue to provide services to the residents. If the patients relocated outside the area served by the registry, the registry will assist the assisted living facility and adult family care home in obtaining the services of another registry already licensed for that area until the patient returns back to their original location.

(12) The prioritized list of registered special needs patients maintained by the nurse registry shall be kept current and shall include information, as defined in Sections 400.506(12)(b) and (c), F.S. This list also shall be furnished to county health departments and to the county emergency management office, upon request.

(13) The independent contractor from the nurse registry is required to maintain in the home of the special needs patient a list of patient-specific medications, supplies and equipment required for continuing care and service should the patient be evacuated as per Section 400.506(12)(c), F.S. The list must include the names of all medications, their dose, frequency, route, time of day and any special considerations for administration. The list must also include any allergies; the name of the patient’s physician, physician assistant, or advanced practice registered nurse and the physician, physician assistant or advanced practice registered nurse’s phone number; and the name, phone number and address of the patient’s pharmacy. If the patient permits, the list can also include the patient’s diagnosis.

(14) The patient record for each person registered as a special needs patient shall include the list described in subsection (13) above, and information as listed in Sections 400.506(12)(a) and (b), F.S.

History

Rulemaking Authority 400.506, 408.821(4) FS. Law Implemented 400.506 FS. History–New 8-10-06, Amended 3-15-07, 5-4-15.

Chapter 59A-20 RADIATION THERAPY CENTERS

Fla. Admin. Code R. 59A-20.0085 Licensure Standards

History

Rulemaking Authority 455.239, 455.25(2) FS. Law Implemented 455.236, 455.239, 455.241, 455.25 FS. History–New 3-10-94, Amended 9-15-96, Repealed 11-3-09.

Chapter 59A-22 MINIMUM STANDARDS FOR BACKGROUND SCREENING

Fla. Admin. Code R. 59A-22.002 Definitions

History

Rulemaking Authority 400.497, 400.512 FS. Law Implemented 400.462, 400.512, 400.497 FS. History–New 1-5-95, Repealed 5-16-12.

Fla. Admin. Code R. 59A-22.003 Required Screening Documents and Fees

History

Rulemaking Authority 400.512, 400.497 FS. Law Implemented 400.512, 400.497 FS. History–New 1-5-95, Repealed 5-16-12.

Fla. Admin. Code R. 59A-22.004 Requirements for Screening of Employees and Administrators

History

Rulemaking Authority 400.497, 400.512 FS. Law Implemented 400.497, 400.512 FS. History–New 1-5-95, Amended 1-30-96, Repealed 5-16-12.

Fla. Admin. Code R. 59A-22.006 Results of Screening and Notification

History

Rulemaking Authority 400.497, 400.512 FS. Law Implemented 400.497, 400.512 FS. History–New 1-5-95, Amended 1-30-96, Amended 8-29-96, Repealed 5-16-12.

Fla. Admin. Code R. 59A-22.008 Finding of Disqualification

History

Rulemaking Authority 400.497, 400.512 FS. Law Implemented 400.497, 400.512 FS. History–New 1-5-95, Repealed 5-16-12.

Fla. Admin. Code R. 59A-22.009 Exemption From Disqualification

History

Rulemaking Authority 400.497, 400.512 FS. Law Implemented 400.497, 400.512 FS. History–New 1-5-95, Amended 1-30-96, Repealed 5-16-12.

Fla. Admin. Code R. 59A-22.010 Section 120.57(1), F.S., Appeal of Exemption Denial

History

Rulemaking Authority 400.497, 400.512 FS. Law Implemented 400.497, 400.512 FS. History–New 1-5-95, Repealed 5-16-12.

Fla. Admin. Code R. 59A-22.011 Confidentiality of Screening Records

History

Rulemaking Authority 400.497, 400.512 FS. Law Implemented 400.497, 400.512 FS. History–New 1-5-95, Amended 8-29-96, Repealed 5-16-12.

Chapter 59A-23 WORKERS COMPENSATION MANAGED CARE ARRANGEMENTS

Fla. Admin. Code R. 59A-23.001 Scope

History

Rulemaking Authority 440.134(2)(a) FS. Law Implemented 440.134 FS. History–New 9-12-94, Repealed 1-18-17.

Fla. Admin. Code R. 59A-23.002 Definitions

(1) “Agency” means the Agency for Health Care Administration.

(2) “Case files” means a system for managing medical information and return to work information regarding the injured employee, whether in electronic or paper format.

(3) “Complaint” means any dissatisfaction expressed by an injured worker as defined in section 440.134(1)(b), F.S. An initial request for services, such as a request for medical services, second opinions, or a change in providers, is not considered a complaint.

(4) “Delegated entity” means a unit or single organization authorized by written agreement to act on behalf of the insurer to provide managed care services.

(5) “Credentialing” means the process for validating and evaluating the qualifications of a licensed health care provider to participate in a workers’ compensation managed care arrangement provider network.

(6) “Division” means the Division of Workers’ Compensation of the Florida Department of Labor and Employment Security.

(7) “External case management” means face-to-face medical care coordination performed by a qualified rehabilitation provider pursuant to section 440.491, F.S.

(8) “Grievance” means a written expression of dissatisfaction with medical care by an injured worker as defined in section 440.134(1)(d), F.S. Initial written requests for medical services, second opinions, or changes in providers are not grievances.

(9) “Insurer” means an entity which contracts to provide workers’ compensation insurance coverage as defined under section 440.134(1)(e), F.S.

(10) “Internal case management” means a process for telephonically coordinating, facilitating, and monitoring all aspects of the medical care coordination of the injured employee in consultation with the treating physician and the medical care coordinator.

(11) “Medical care coordination” means active case management and coordination of the health care services for an injured employee involving a medical care coordinator to ensure the delivery of necessary services in a manner which will return the individual to work as soon as feasible.

(12) “Peer review” means the evaluation of the treatment plan or clinical performance of providers by one or more licensed professionals with the same authority or similar specialty when potential quality of care issues have been identified through case management or quality assurance processes.

(13) “Quality assurance” means a formal set of activities, which review and safeguard the quality of medical services provided to the injured employee. Quality assurance includes assessment and implementation of corrective actions to address any deficiencies identified in the quality of care and services provided to the injured employee.

(14) “Second medical opinion” means a consultation by a health care provider authorized by the medical care coordinator that requires at a minimum a history, an examination, and a straightforward medical decision to confirm or offer alternatives.

(15) “Service area” means a geographic area consisting of a county or group of counties which shall not be subdivided for purposes of authorizing a workers’ compensation managed care arrangement.

(16) “Utilization management” means the examination and evaluation of health care services to determine the appropriate use of the resources and components available within the workers’ compensation managed care arrangement including, retrospective, concurrent, and prospective care reviews.

(17) “Urgent” means that in the judgment of the primary care physician or medical care coordinator, the injured employee’s clinical condition requires a response within 72 hours, and the clinical condition is at significant risk of deterioration if a response is not made within that timeframe.

(18) “Written agreement” means an express, legally executed, written contract between two or more parties which specifies the following: the parties to the contract; the effective date of the contract; duties of the respective parties; reporting and or oversight of the responsibilities to be performed; performance standards; termination and expiration terms of the contract.

(19) “Workers’ Compensation managed care arrangement” means those arrangements as defined under section 440.134(1)(g), F.S.

History

Rulemaking Authority 440.134 FS. Law Implemented 440.134(1)(g), (5)(a), (6)(b), (c), (c)4., 6.-9., (9), (10), (14)(b), (d), (16), (17), (25)(b), (c), (d), (g) FS. History–New 9-12-94, Amended 10-8-01, 1-22-02.

Fla. Admin. Code R. 59A-23.003 Authorization Procedures

(1) General Provisions. All insurers offering a managed care arrangement for the provision of health services for the treatment of persons filing workers’ compensation claims shall obtain an authorization from the agency in accordance with the following procedures:

(a) Applications for an initial authorization, amendment of the authorized plan of operation, or renewal shall be submitted with the following:

A completed copy of AHCA Form 3160-0004, November 2000, incorporated by reference herein;
Required attachments as specified in AHCA Form 3160-0004, November 2000; and,
Written agreements linking the entities within the managed care arrangement and specifying the duties of each entity.

Application forms are available from and shall be submitted to the Agency for Health Care Administration, Division of Managed Care and Health Quality, Bureau of Managed Health Care, 2727 Mahan Drive, Mail Stop #45, Tallahassee, Florida 32308.

(b) An initial application for authorization shall be submitted to the agency at least 90 days prior to the intended date of implementation of services. An amendment application shall be submitted to the agency 60 days prior to the effective date of the proposed change in the plan of operation. Upon receipt of the application the agency shall review the content to determine compliance with the requirements of sections 440.134(5)-(15), F.S.

(c) The agency shall notify applicants for initial or renewal authorization in writing via certified mail of any deficiencies in the application within 30 days of the receipt of the application. The applicant shall provide information necessary to complete the application within 30 days of receipt of the written notice. Failure to timely submit the necessary information shall result in denial of the application unless the applicant needs an extension of time due to circumstances beyond its control and requests the extension within 30 days of its receipt of the written notice of deficiencies. No extensions shall exceed 90 days or the expiration date of the workers’ compensation managed care arrangement.

(d) The agency shall provide notice to the applicant of its right to administrative review under sections 120.569 and 120.57, F.S., with its written notice of intent to deny an application.

(e) Applications to amend an approved plan of operation by replacing the delegated managed care organization or provider network shall address the continuity of care and coordination of medical services for injured employees during the transition. The applicant shall submit information that identifies the activities to be conducted, persons involved, and dates for completion of the following tasks:

The identification and authorization of out of network services for injured employees whose current primary treating physician is not in the new provider network and who prefer to continue with their current provider;
The transfer of injured employees’ current medical care management information to the newly contracted entity; and,
The notification of employers and employees of the requirements of the new network arrangements and the contact persons via the educational materials required under sections 440.134(14)(a)-(d), F.S.

(f) Examination. The agency shall conduct an on-site survey of the managed care arrangement, within the first year of operation and no less than every two years thereafter, to determine compliance with the requirements of section 440.134, F.S. The agency shall verify through subsequent survey that any deficiency identified during a previous survey is corrected. The agency may verify the correction without on-site resurvey if written documentation has been received from the insurer or delegated entity and is accepted by the agency. The agency shall also investigate on-site any alleged pattern of non-compliance with the requirements of Section 440.134, F.S.

(2) Fees. All initial and renewal applications for authorization of a workers’ compensation managed care arrangement shall be accompanied by a fee of $1,000 made payable to the agency. Applications to amend an existing authorized workers’ compensation managed care arrangement do not require submission of a fee.

(3) Authorization for a workers’ compensation managed care arrangement shall not be sold, assigned, or otherwise transferred either voluntarily or involuntarily and is valid only for the legal entity to which it was originally issued.

(4) Validity. Each authorization shall be valid for a period of two years only for:

(a) The entity to which it is issued as specified on the authorization letter; and,

(b) The service area approved by the agency.

(5) Service areas. Each application shall indicate the geographic service area or areas in which the insurer or delegated entity will provide managed care services. The insurer shall offer a managed care arrangement only to those employers whose place of business or business operations are located in a service area approved by the agency to provide services under a workers’ compensation managed care arrangement. A service area shall be approved if there is a sufficient number and type of providers adequate to meet the needs of the geographic area in addition to other requirements specified under rules 59A-23.003, 59A-23.004, 59A-23.005 and 59A-23.006, F.A.C.

(6) Travel Times. Each application shall provide information which indicates the ability of the insurer or delegated entity to provide geographic access to health services for injured employees. Average travel time for injured employees from the employee’s usual employment site to the nearest primary care delivery site and to the nearest general acute care hospital in the provider network shall be no longer than 30 minutes under normal circumstances. Average travel time from the employee’s usual employment site to the nearest provider of specialty physician services, ancillary services, specialty inpatient hospital services and all other health services shall be no longer than 60 minutes under normal circumstances.

(7) Provider Network.

(a) Medical services shall be available for injured employees in the geographic area in which they are employed through directly or indirectly contracted network(s) of health care providers. The hours of operation and availability of after-hour care must reflect usual practices in the community and the insurer must demonstrate that:

All medically necessary services are available and accessible;
Medically necessary referrals are provided within the network or, if unavailable, outside the network;
There are written agreements describing specific delegated duties for provision of medical services. Delegation of the provision of medical services by the insurer must be specifically described in the written agreement linking the insurer with the delegated entity;
Written agreements for arrangements in which the insurer is indirectly linked with a provider network shall contain language requiring the insurer’s approval in advance of a change in the provider network; and,
There are written agreements with providers prohibiting such providers from billing or otherwise seeking reimbursement from or recourse against any injured employee except as specified under section 440.13, F.S.

(b) The insurer or delegated entity, shall establish and implement a policy and procedure regarding access to services which reflects usual and customary practices in the community and addresses access times for emergency, initial, and continuing care including referrals to specialty services.

(c) The agency shall examine provider networks at least annually. The insurer or delegated entity, shall file with the agency an updated list of providers by county, by specialty, semiannually. The list shall be submitted within six months of the initial network approval date and every six months thereafter in a format approved or prescribed by the agency.

(d) The insurer or delegated entity shall develop and implement a policy and procedure for credentialing and recredentialing network providers as needed, but at a minimum every two years. The credentialing criteria shall be specified in the policy and shall include the core credentialing data specified under section 455.557(2)(d), F.S., and verification of education of providers as required by section 440.134(8), F.S.

(e) The recredentialing process shall monitor and incorporate quality assurance findings and information on individual providers including sanctions, complaints and grievances, medical record audits, provider profiling, and employee satisfaction.

(f) If the insurer delegates all or part of the credentialing process to other organizations, the insurer shall specify the activities of the delegated entity and the oversight and reporting requirements in the written agreement. The insurer shall perform oversight of the delegated credentialing activities annually.

(g) The insurer or delegated entity shall designate one or more physicians as a medical care coordinator to manage medical care for injured workers. A medical care coordinator shall be assigned for each injured employee. The medical care coordinator shall be licensed under chapters 458 or 459, F.S., and be board certified by the American Board of Medical Specialties, or the American Osteopathic Association, or have two years experience as a participating provider in a workers’ compensation managed care arrangement network. The medical care coordinator shall have experience or training in workers’ compensation and be responsible for the following:

Management of the medical treatment plan;
Participation in the quality improvement process and evaluation of outcomes of care;
Review of grievances; and,
Authorization of referrals to specialty providers for second opinions, evaluation of treatment, including changes to another specialty provider pursuant to section 440.134(10)(c), F.S.

(h) Nothing in this rule prohibits the use by a medical or osteopathic physician of advanced practice registered nurses licensed under section 464.012, F.S., or physician’s assistants licensed under chapters 458 or 459, F.S., in accordance with and within the scope of their professional licenses in Florida Statutes. An injured employee shall be evaluated or treated by the physician supervising the advanced practice registered nurse or physician assistant if specifically requested by the injured employee.

(i) The insurer or delegated entity, may direct injured employees to a single primary care provider or a selected group of primary care providers within the provider network for assessment and initial treatment. However, the employee shall have the right to select a primary care provider and thereafter, to request one change of primary care provider and of each authorized treating specialty provider during the course of treatment for each injury. The injured employee shall select a primary care provider from a current list of all primary care providers in the approved service area within 30 minutes average travel time of the employee’s employment site.

(j) Initial and network change applications shall contain information on the numbers, types, and locations of health care providers which are included in the managed care network. The types of providers to be included shall comply with those listed on AHCA Form 3160-0005, November 2000, WCMCA Service Area Network Checklist, incorporated herein by reference. This form is available from the agency by contacting the Agency for Health Care Administration, Division of Managed Care and Health Quality, Bureau of Managed Health Care, 2727 Mahan Drive, Mail Stop #45, Tallahassee, Florida 32308.

(8) Delegation. The insurer shall conduct oversight of the delegated functions of the workers’ compensation managed care arrangement. The insurer is responsible for the performance of all functions associated with the delivery of medical services to injured employees under section 440.134(1)(g), F.S., regardless of whether the function has been delegated, by written agreement, to other entities. The insurer shall specify, in the written agreement, the oversight and reporting requirements for monitoring the performance of delegated functions. Reports of subcontractors shall be evaluated no less than quarterly, and the findings incorporated into the insurer’s quality assurance program.

History

Rulemaking Authority 440.134(25) FS. Law Implemented 120.57, 440.134(1)(g), (2)(a), (3), (4), (5), (6), (10), (12), (13), (14) FS. History–New 9-12-94, Amended 4-30-98, 5-8-01.

Fla. Admin. Code R. 59A-23.004 Quality Assurance

(1) Each insurer or delegated entity shall have an ongoing quality assurance program designed to objectively and systematically monitor and evaluate the quality of patient care, based upon the prevailing standards of medical practice in the community.

(2) The scope of the quality assurance program shall include the following:

(a) Peer review;

(b) Satisfaction survey;

(d) Case management;

(e) Complaints and grievances;

(f) Credentialing and recredentialing;

(g) Medical records;

(h) Return to work;

(i) Cost analysis;

(j) Data collection;

(k) Outcome studies;

(l) Education; and,

(m) Provider dispute resolution.

(3) The quality assurance plan shall be in writing, updated annually, and shall describe the program’s objectives, organization and problem-solving activities for improvement of medical services. The plan shall specify:

(a) Those specific activities under subsection (1) that will be conducted;

(b) The timeframes and the responsible individual for each quality assurance activity; and,

(4) The insurer or delegated entity shall have a quality assurance committee that meets quarterly to review the progress of quality assurance activities, completion of the written work plan, findings, and to develop recommendations for corrective action and follow-up. The committee shall keep minutes of meetings to document the committee’s activities. Activities of the committee shall include:

(a) Identification of data to be collected;

(b) Evaluation of data collected;

(d) Communication of the committee’s findings to accountable authorities for implementation of improvements; and,

(e) Evaluation and documentation of the results of the implementation of improvements.

(5) The insurer or delegated entity shall perform a quality assurance review of the processes and outcomes of care, at least annually, using current state and nationally recognized practice guidelines.

(6) All findings, conclusions, recommendations, actions taken and results of actions taken shall be documented, shared with contracted entities and reported through organizational channels that have been established within the workers’ compensation managed care arrangement.

(7) The insurer or delegated entity shall provide, as part of the quality assurance program, an ongoing peer review process which:

(a) Resolves issues regarding provision of medical services; and,

(b) Evaluates clinical performance at least annually. The evaluation process shall include: medical record audits of a representative sample of providers to evaluate medical necessity; provision of medical service(s) appropriate to the diagnosis; use of current state and nationally accepted practice parameters; timeliness and access to treatment; and the development and use of a plan of care. The insurer or delegated entity shall have a written methodology for determining the size and scope of the medical record audits that shall reflect the volume and complexity of services provided by the provider network.

(8) Utilization Management. The insurer or delegated entity shall have written policies and procedures for approving or denying requests for care in accordance with the agency’s practice parameters and with nationally recognized standards based on medical necessity. The program shall evaluate quality of care and services, and provide review prospectively, concurrently, and retrospectively including pre-certification mechanisms for elective admissions and non-emergency surgeries.

(a) The utilization management program shall ensure that:

All elective admissions and non-emergency services must be precertified;
Utilization management policies and procedures are clearly defined in writing and any advisory responsibilities are assigned to individuals with training and education in a health care field sufficient to evaluate the consistency of the proposed treatment with the relevant standards;
The utilization management program uses nationally recognized written criteria based on clinical evidence to determine medical necessity. Treating providers shall have access to the criteria used for determining medical necessity upon request;
The medical care coordinator is involved in the decision process and consultation regarding decisions with the treating physician. Any decision to deny a request for treatment shall be made by a licensed medical or osteopathic physician. A physician not involved in the initial decision shall review any denial based on medical necessity;
Decisions are made in a timely manner to accommodate the clinical urgency of the situation. There are policies and procedures and a process for making timely decisions including those involving urgent care;
The utilization management program documents and communicates the reasons for each denial of requested medical services to treating providers and the injured employees;
The information obtained through the quality assurance program is considered in evaluating the timeliness and necessity of medical services;
There is a procedure for handling requests for experimental procedures;
There is a procedure for resolution of provider disputes regarding reimbursement and utilization review;
There is a procedure for ensuring that referrals are made to network providers who are available and accessible within the service area. The insurer or delegated entity shall monitor the utilization of network and out-of-network services to improve network access; and,
There is a procedure for authorization of out-of-network services.

(b) Utilization management is responsible for:

Selection and application of nationally recognized review criteria and protocols;
Recommendation of general utilization management program policies;
Overall program monitoring; and,
Review of all appeals of denials of requests for treatment or referrals.

(9) Case Management. The insurer or delegated entity shall develop and implement policies and procedures for aggressive medical care coordination, which may be provided via internal and external case management services in association with utilization management activities. The insurer or delegated entity shall specify the types and severity of injuries which require internal and external case management.

(a) Internal case management activities shall include:

Coordinating, facilitating, and monitoring all aspects of the ongoing medical care of the injured employee;
Communicating utilization management decisions to the medical care coordinator and treating providers;
Assisting the injured employee in resolving complaints and obtaining medically necessary services;
Educating injured employees regarding their rights, responsibilities, and limitations of the workers’ compensation managed care arrangement;
Coordinating, facilitating, and monitoring the injured employee’s return to work status including communicating to the claims representative the services required pursuant to section 440.491, F.S.; and,
Communicating the injured employee’s status to the employer and to the injured employee.

(b) Internal case management activities shall be performed in consultation with the treating physician and the medical care coordinator.

(c) Internal case management services shall be provided by individuals with the experience and training required to perform their assigned responsibilities.

(d) External case management shall be provided for catastrophic injuries as defined under section 440.02(37), F.S., and for such other injuries as determined by the insurer or delegated entity. External case management services shall be performed by certified rehabilitation providers approved pursuant to section 440.491, F.S.

(e) The insurer or delegated entity shall develop and implement procedures for communication of information regarding medical services and return to work between internal and external case management, the medical care coordinator, claims administration, the employer, and injured employee.

History

Rulemaking Authority 440.134(25) FS. Law Implemented 440.134(6)(c)1.-8., 11., (7), (9), (10)(d), (11), (14)(a), (d), (15) FS. History–New 9-12-94, Amended 10-8-01, 1-22-02.

Fla. Admin. Code R. 59A-23.005 Medical Records and Case Files

(1) The insurer or delegated entity shall implement a system for managing electronic and paper medical information necessary to promote the prompt delivery of medical services in order to return the injured employee to work as soon as medically feasible.

(2) Provider Medical Records. The insurer or delegated entity shall maintain or assure that its providers maintain a medical records system, which is consistent with professional standards, pursuant to section 456.057, F.S. The insurer or delegated entity shall develop and implement policies and procedures that:

(a) Permit prompt retrieval of legible and timely information, which is accurately documented and readily available if requested by a health care practitioner with written authorization and consent from the patient when required by statute;

(b) Protect the confidentiality and security of paper and electronic patient records including:

Transfer, storage, and faxing of records; and,
Handling of records containing information on HIV, substance abuse, and mental health, in accordance with statutory requirements;

(c) Provide for the training and education of administrative staff and providers on medical record documentation, policies and procedures, storage and confidentiality of patient records;

(d) Document in the medical record a summary, related to work injury or illness, of significant procedures, past and current diagnoses or problems and allergies and adverse reactions to current medications;

(e) Identify the patient as follows:

Name;
Social Security, alien identification number, or other identification number;
Date of Birth; Employer; home and work telephone numbers;
Sex; and,
Date of work injury or illness.

(f) Indicate in the medical record for each visit the following information:

Date;
Chief complaint, unresolved problems or complaints from prior interventions and purpose of visit;
Objective findings of practitioner;
Diagnosis or medical impression;
Studies ordered, for example: lab, x-ray, EKG, and referral reports;
Therapies administered and prescribed;
Name and profession of practitioner rendering services, for example: M.D., D.O., D.C., D.P.M., R.N., O.D., etc., including signature or initials of practitioner;
Disposition, recommendations, instructions, and education to the patient. Evidence of whether there was follow-up and the specific time of return is noted in weeks, months or as needed;
Outcome of services;
Work status, release for return to work, work restrictions; and,
Evidence of coordination of care and any injured employee non-compliance with treatment.

(g) Require the insurer or delegated entity to request written consent of patients for release of medical records that are subject to the limitations in sections 381.004 and 456.057, F.S., and for obtaining and sharing all documents and medical records from providers necessary to carry out the provisions of section 440.134, F.S.; and,

(h) Address transfer and retrieval of records, and provision of copies when requested by the patient, designated representative, or the Agency pursuant to section 440.13(4)(c), F.S. The insurer or delegated entity shall communicate its policy to providers via provider educational materials.

(3) Case Files. The insurer or delegated entity shall maintain electronic or paper medical information necessary to ensure the efficient functioning of the care coordination process. The insurer or delegated entity shall develop and implement a policy and procedure that protects the confidentiality and security of case file information including the transfer and storage of paper and electronic information, and the handling of information on HIV, substance abuse, and mental health. Case files shall contain necessary information for the coordination of quality patient care between providers, insurers, employees, and employers including:

(a) The information from the notice of injury required by section 440.13(4)(a), F.S.;

(b) The current primary care physician, primary care physician changes and the designated medical care coordinator;

(d) Medical reports and information necessary to support the coordination of medical care;

(e) The injured employee’s work status, work restrictions, date of maximum medical improvement, and permanent impairment ratings; and,

(f) Efforts toward rehabilitation and reemployment of the injured employee.

(4) Audits of provider records. The insurer or delegated entity shall implement an ongoing process for conducting medical record audits to determine compliance with the medical record standards specified under paragraphs (2)(d), (e) and (f). The insurer or delegated entity shall have a written methodology for determining the size and scope of the medical record audits that shall reflect the volume and complexity of services provided by the provider network. The insurer or delegated entity shall develop and implement an annual work plan for the medical record audits. The results of the audits shall be reported quarterly to the quality assurance committee and shall include the following:

(a) Number of physicians reviewed by county and by specialty;

(b) Areas where specific improvements in record keeping are indicated;

(d) Recommendations for education and feedback to providers; and,

(e) Extent to which the physician’s treatment plan was implemented.

History

Rulemaking Authority 440.134(25) FS. Law Implemented 440.134(5)(c), (6)(c)1.-4., 8., (7), (8) FS. History–New 9-12-94, Amended 10-8-01, 1-22-02.

Fla. Admin. Code R. 59A-23.006 Grievance Procedures

(1) Each insurer or delegated entity shall develop and implement a grievance procedure to resolve complaints and written grievances by employees and providers.

(2) A detailed description of the employee complaint and grievance procedure shall be provided by the insurer or delegated entity to employees pursuant to rule 59A-23.009, F.A.C. A detailed description of the employee complaint and written grievance procedures shall be included in educational materials provided to injured employees. A detailed description of the provider complaint and grievance procedure shall be included in educational materials given to providers.

(3) A copy of the grievance procedure and forms for filing a written grievance shall be made available to providers, employees, or their designated representative within seven calendar days of receipt of a request. Copies of the form required for filing a grievance shall also be available at the same location as the compensation notice required under rule 69L-6.007, F.A.C. The insurer or delegated entity shall not charge the employer, employee, or provider for administering the grievance process.

(4) The grievance procedure shall include the following:

(a) Requests for services. The insurer or delegated entity shall implement a procedure to address initial requests for services. Initial requests for services, such as a request for medical services, second opinions, or a change in providers, are not considered a complaint or grievance. The insurer or delegated entity shall evaluate requests for medical services within seven calendar days of receipt and shall notify the injured employee of the decision to grant the request, to deny it, or to request additional information. When the insurer or delegated entity denies a request it shall notify the injured employee in writing of the denial and the right to file a grievance. The insurer or delegated entity shall provide the employee with a copy of AHCA Form No. 3160-0019 (November 2000) which is incorporated by reference. If the insurer or delegated entity fails to respond within seven calendar days of receipt of the request, the injured employee may make a complaint or file a written grievance.

(b) Complaint Procedure. The insurer or delegated entity shall implement a procedure to address complaints about medical issues and employees’ rights under section 440.134, F.S., in a timely manner in order to expedite the resolution of issues of providers and injured employees.

The insurer or delegated entity shall investigate and resolve a complaint within ten calendar days of receipt unless the parties and the insurer or delegated entity mutually agree to an extension. The ten days shall commence upon receipt of a personal or telephone contact by the insurer or delegated entity from the injured employee, provider, designated representative, the Agency, or the Division.
If a complaint is denied, or remains unresolved after ten days of receipt, the insurer or delegated entity shall notify the affected parties in writing of the right to file a written grievance. If the insurer or delegated entity denies a complaint, it shall notify the injured employee of the reason for the denial. The written notification shall include the name, title, address, and telephone number of the grievance coordinator. In addition, the insurer or delegated entity shall advise the injured employee of the right to contact the Division’s Employee Assistance Office for additional information on rights and responsibilities and the dispute resolution process under chapter 440, F.S., and related administrative rules; and,

(c) Written Grievance. The procedure for written grievances shall commence upon receipt of a signed grievance form AHCA Form No. 3160-0019 (November 2000) by the insurer or delegated entity, from the injured employee, provider, or their designated representative. A written grievance may be submitted or withdrawn at any time. The injured employee or provider is not required to make a complaint prior to filing a written grievance. The procedure shall include notice to the employer when a grievance has been filed. The insurer or delegated entity shall notify the injured employee and employer in writing of the resolution of the written grievance, and the reasons therefore within seven days of the final determination.

The insurer or delegated entity shall implement an expedited procedure for urgent grievances to render a determination and notify the injured employee within three calendar days of receipt. If the insurer or delegated entity has initiated an expedited grievance procedure, the injured employee shall be considered to have exhausted all managed care grievance procedures after three days from receipt.
Upon receipt of a written grievance, the grievance coordinator shall gather and review medical and related information pertaining to the issues being grieved. The grievance coordinator shall consult with appropriate parties and shall render a determination on the grievance within 14 calendar days of receipt. If the determination is not in favor of the aggrieved party the grievance coordinator shall notify the aggrieved party that the grievance is being forwarded to the grievance committee for further consideration unless withdrawn in writing by the employee or provider.
The grievance committee shall consist of not less than three individuals, of whom at least one must be a physician other than the injured employee’s treating physician, who is licensed under chapters 458 or 459, F.S., and has professional expertise relevant to the issue. The committee shall review information pertaining to the issues being grieved and render a determination within 30 calendar days of receipt of the grievance by the committee unless the grieving party and the committee mutually agree to an extension that is documented in writing. If the grievance involves the collection of additional information from outside the service area, the insurer or delegated entity will have 14 additional calendar days to render a determination. The insurer or delegated entity shall notify the employee in writing within seven days of receipt of the grievance by the committee if additional information is required to complete the review of the grievance.
The insurer or delegated entity may allow but may not require arbitration as part of the grievance process. A grievance which is arbitrated pursuant to chapter 682, F.S., is permitted an additional time limitation not to exceed 210 calendar days from the date the insurer or delegated entity receives a written request for arbitration from the injured employee. Arbitration provisions in a workers’ compensation managed care arrangement shall not preclude the employee from filing a request for assistance with the Division of Workers’ Compensation relating to non-medical issues.
An injured employee or provider grievance shall be submitted on AHCA Form No. 3160-0019, November 2000. The insurer or delegated entity shall provide assistance to an injured employee unable to complete the grievance form and to those persons who have improperly filed a grievance.
The claimant or provider shall be considered to have exhausted all managed care grievance procedures if a determination on a grievance has not been rendered within the required timeframe specified in this section or other timeframe, as mutually agreed to in writing by the grieving party and the insurer or delegated entity.
Upon completion of the grievance procedure, the insurer or delegated entity shall provide written notice to the employee of the right to file a petition for benefits with the Division pursuant to section 440.192, F.S.

(5) The insurer or delegated entity shall designate at least one grievance coordinator who is responsible for the implementation of the grievance procedure. The insurer or delegated entity shall ensure that the grievance coordinator’s role in the grievance procedure is identified in the grievance coordinator’s job description.

(6) The insurer or delegated entity shall provide specified phone numbers in the provider and employee educational materials for the employee or provider to contact the grievance coordinator. Each phone number shall be toll free within the injured employee’s or provider’s geographic service area and shall provide access without undue delays. There must be an adequate number of phone lines to handle incoming complaint calls.

(7) The insurer or delegated entity shall provide a current mailing address in employee and provider educational materials that indicate where to file a grievance.

(8) Physician involvement in reviewing medically related grievances. This involvement shall not be limited to the injured employee’s primary care physician, but shall include at least one other physician.

(9) A meeting between the insurer or delegated entity and the injured employee or provider during the written grievance process if requested by the injured employee or provider. The insurer or delegated entity shall offer to meet with the injured employee or provider at a location within the service area convenient to the injured employee or provider.

(10) A record of each written grievance. The insurer or delegated entity will maintain a record of each written grievance to include the following:

(a) A description of the grievance, the injured employee’s or provider’s name and address, the names and addresses of any treating workers’ compensation providers relevant to the grievance, and the managed care arrangement name and address;

(b) A complete description of the findings, including supportive documentation, conclusions and final disposition of the grievance; and,

(11) The insurer or delegated entity shall maintain a list of all grievance files that contains the identity of the injured employee, the individual filing the grievance, the date filed, the nature of the grievance, the resolution, and the resolution date.

(12) The insurer or delegated entity shall be responsible for regular and systematic review and analysis of all written grievances for the purpose of identifying trends or patterns, and, upon emergence of any pattern, shall develop and implement recommendations for corrective action.

(13) An annual report of all grievances filed by employees and providers shall be submitted to the Agency pursuant to section 440.134(15)(g), F.S. The report shall list the number, nature, and resolution of all written employee and provider grievances. This report shall be submitted no later than March 31 for grievances filed during the previous calendar year in a format prescribed by the Agency on AHCA Form No. 3160-0012 (July 1997). This form is hereby incorporated by reference and is available by contacting AHCA, 2727 Mahan Drive, Tallahassee, Florida 32308, Bureau of Managed Health Care, Workers’ Compensation Managed Care Unit. It is also available at www.fdhc.state.fl.us/Managed Health Care/WCMC.

History

Rulemaking Authority 440.134(25) FS. Law Implemented 440.134(1)(b), (d), (5)(c), (e), (6)(b), (c), (7), (8), (10)(c), (14)(d), (15) FS. History–New 9-12-94, Amended 10-8-01, 1-22-02.

Fla. Admin. Code R. 59A-23.007 Examination by the Agency for Health Care Administration

History

Rulemaking Authority 440.134(2)(a) FS. Law Implemented 440.134(2)(a) FS. History–New 9-12-94, Repealed 9-2-18.

Fla. Admin. Code R. 59A-23.009 Education Procedures

(1) Employee Education.

(a) The insurer or delegated entity in conjunction with the employer, shall develop and implement procedures for the education of employees about the managed care process and requirements. The education procedures shall include:

Orientation of all existing and new employees to the requirements and limitations of the workers’ compensation managed care arrangement. The employer shall display a telephone number for obtaining information about the workers’ compensation managed care arrangement in a prominent location in the workplace;
Provision of detailed employee education materials about the requirements and limitations of the workers’ compensation managed care arrangement to the injured employees; and,
Ongoing education of employees about changes in the workers’ compensation managed care arrangement.

(b) The insurer or delegated entity shall provide, either directly or indirectly, employee educational materials written in language common to the workforce in the geographic service area. Whether or not the employer has provided educational materials previously, the educational material shall be provided to an injured employee within three calendar days of the date that the notice of injury is filed by the insurance carrier or the employer. The content of the employee educational material shall include:

The rights and responsibilities of the injured employee;
A description of the process for accessing medical care including the use of network providers, the primary care provider, medical care coordinator, case management, and the procedure to request a referral to a specialist;
The possible effect to the injured employee’s health and benefits for failure to use network providers or obtaining authorization for specialty care;
A description of the process for changing primary care and other specialty providers once within the same specialty as the authorized treating physician during the course of treatment for a work-related injury;
A description of the procedure for obtaining a second opinion;
A description of the complaint and grievance process including the procedure to file a complaint or grievance, timeframes for completion of a complaint or grievance, and the availability of a grievance form;
The toll free telephone number of the grievance coordinator; and,
The telephone number of the Division of Workers’ Compensation, Employee Assistance Office toll free hotline.

(c) The insurer or delegated entity shall ensure that all injured employees are provided a current list of network providers within the service area in which the individual is employed. The insurer or delegated entity shall provide a copy of the list to the employee or designated representative within five calendar days of receipt of a request.

(2) Provider Education. The insurer or delegated entity shall ensure that the health care providers within the provider network have received training and education on the provisions of chapter 440, F.S., and related administrative rules. This shall be accomplished by a provider education program or verification that providers have previously received certification from the Division pursuant to section 440.13, F.S.

(a) The provider education program shall address the following:

The mission and goals of workers’ compensation managed care;
Roles, rights, and responsibilities;
Provider network procedures;
Case management procedures;
Practice guidelines;
Utilization management procedures;
Peer review procedures;
Dispute resolution and grievance procedures;
Communication procedures between managed care components;
Medical records and case file procedures;
Workers’ compensation managed care statutes and regulations relating to remedial treatment; and,
The health care provider’s role in successful return to work.

(b) The insurer or delegated entity shall identify those ancillary providers who require training on the provisions of workers’ compensation medical services and shall provide and document the staff training and education program.

(c) The insurer or delegated entity shall provide such ongoing provider education at least annually to keep providers informed of changes in the processes of the workers’ compensation managed care arrangement and to correct problems and implement recommendations of the quality assurance program. The insurer or delegated entity shall document the provision of training.

(3) Administrative Staff Education.

The insurer or delegated entity shall develop and implement a policy and procedure, and implement a process, to identify and train those administrative staff who require training on the provisions of chapter 440, F.S., and related administrative rules. Administrative staff shall include case managers, the grievance coordinator, and claims representatives. The insurer or delegated entity shall document the staff training and education program. The program content shall address the following:

(a) The mission and goals of workers’ compensation managed care;

(b) Roles, rights, and responsibilities;

(d) Case management procedures;

(e) Practice guidelines;

(f) Utilization management procedures;

(g) Peer review procedures;

(h) Dispute resolution and grievance procedures;

(i) Communication procedures between managed care components; and,

(j) Medical records and case files procedures.

History

Rulemaking Authority 440.134(25) FS. Law Implemented 440.134(1)(b), (d), (g), (i), (j), (k), (3), (5)(a), (c), (e), (6)(b), (c)2., 3., 4., 6.-10., (7), (8), (10)(a)-(d), (11), (12), (14)(a)-(d), (15)(a)-(f), (17) FS. History–New 10-8-01.

Chapter 59A-24 DRUG-FREE WORKPLACE STANDARDS

Fla. Admin. Code R. 59A-24.001 Title

History

Rulemaking Authority 112.0455(13)(a) FS. Law Implemented 112.0455 FS. History–New 3-15-90, Amended 6-28-91, Formerly 10E-18.001, Repealed 5-1-96.

Fla. Admin. Code R. 59A-24.002 Scope of the Rules

History

Rulemaking Authority 112.0455(13)(a) FS. Law Implemented 112.0455 FS. History–New 3-15-90, Amended 6-28-91, Formerly 10E-18.002, Amended 5-1-96, Repealed 12-4-96.

Fla. Admin. Code R. 59A-24.003 Definitions

In addition to the definitions set forth in Section 112.0455(5), F.S., as used in this rule chapter the following terms shall mean:

(1) “Agency” means the Agency for Health Care Administration.

(2) “Aliquot” means a portion of a specimen used for testing.

(3) “Approved Proficiency Testing Provider” means a private non-profit proficiency testing organization that meets the following requirements:

(a) Supplies a shipment of no less than 10 drug of abuse proficiency testing samples for screening and confirmation testing at least 3 times per year. Samples shall consist of a combination of negative specimens and a selection of positive specimens containing the drugs or metabolites of the substances listed in Section 112.0455(5)(a), F.S.

(b) Evaluates proficiency testing sample results using statistical methods based on results obtained from participant peer group comparisons.

(c) Provides no communication with the participant laboratory regarding the drug content of the samples prior to the issuance of the proficiency testing report.

(d) Provides explanatory information to assist the participant laboratory in the interpretation of the proficiency testing results.

(4) “Collection Site” means a place owned, operated, or contracted by a laboratory licensed under this rule chapter, or a site prepared by a collector authorized under Section 112.0455, F.S., and Chapter 59A-24, F.A.C., where individuals present themselves for the purpose of providing a specimen or specimens to be analyzed for the presence of drugs.

(5) “Collection Site Person” or “Collector” means a person who instructs and assists donors at a collection site and who collects or receives and makes an initial observation of the specimen provided by those donors. The laboratory is responsible to ensure that the collector(s) is trained to carry out his or her responsibilities under this rule chapter.

(6) “Donor” means a job applicant or employee who present themselves to a collection site for the purpose of submitting to a drug test.

(7) “Forensic Toxicology Laboratory” or “Laboratory” means a place where examinations are performed on specimens taken from the human body to provide information regarding the presence or absence of drugs or their metabolites for the purpose of promoting a drug free workplace under the provisions of Section 112.0455, F.S.

(8) “Mandatory Guidelines for Federal Workplace Drug Testing Programs” means the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs, currently published in the Federal Register and available at: https://www.samhsa.gov/substance-use/drug-free-workplace/forms.

(9) “Mandatory Guidelines using Urine” means the guidelines established by the Department of Health and Human Services (HHS), currently published in the Federal Register and available at: https://www.samhsa.gov/workplace/forms-guidelines.

(10) “Mandatory Guidelines using Oral Fluid” means the guidelines established by the Department of Health and Human Services (HHS), currently published in the Federal Register and available at: https://www.samhsa.gov/workplace/forms-guidelines.

(11) “Medical Review Officer” or “MRO” means a licensed physician qualified under paragraphs 59A-24.008(1)(a)-(e), F.A.C., who evaluates a donor’s test result, together with his or her medical history or any other biomedical information, and makes the final determination of the donor’s test results.

(12) “Prescription or Nonprescription Medication” means a drug or medication obtained pursuant to a prescription as defined by Section 893.02(17), F.S., or a medication that is authorized pursuant to federal or state law for general distribution and use without a prescription in the treatment of human diseases, ailments, or injuries.

(13) “Reason to Believe” means a belief by the collection site person that a particular individual intends to alter or has altered or substituted a specimen. Reason to believe includes, for example:

(a) A urine specimen temperature falling outside the specified range of 90o-100o degrees fahrenheit.

(b) Unusual urine color or signs of contaminants in the urine.

(d) Unusual behavior or appearance by the individual.

(14) “Peer reviewed literature” includes literature approved for publication.

(15) “Run” or “batch” means an interval in which tests are performed within which the accuracy and precision of a testing system is expected to be stable. This interval shall not exceed 24 hours; nor shall it exceed the stability limits indicated by the instrument manufacturer.

(16) “Split sample” means a specimen that is divided into two separate containers, for the purpose of using one container for immediate testing and the other being tested at the donor's request if the first sample tested results in a confirmed positive test.

History

Rulemaking Authority 112.0455(13)(a) FS. Law Implemented 112.0455 FS. History–New 3-15-90, Amended 6-28-91, Formerly 10E-18.003, Amended 5-1-96, 3-11-98, 4-6-26.

Fla. Admin. Code R. 59A-24.004 Drugs to be Tested/Body Specimens

(1) Notwithstanding the definition of drug in Section 112.0455(5)(a), F.S., the only hallucinogen to be tested for is phencyclidine (PCP), the only synthetic narcotics to be tested for are methadone and propoxyphene, and there will be no designer drugs tested for until standard testing procedures are developed for such drugs.

(2) Body Specimens.

(a) Urine. Urine will be used for the initial test for all drugs except alcohol and for the confirmation for all drugs except alcohol.

(b) Blood. Blood will be used as the initial and confirmation specimen for alcohol.

(c) Oral Fluid. Oral fluid may be used for the initial test for all drugs except alcohol and for the confirmation for all drugs except alcohol.

History

Rulemaking Authority 112.0455(13)(a) FS. Law Implemented 112.0455 FS. History–New 3-15-90, Amended 6-28-91, Formerly 10E-18.004, Amended 5-1-96, 4-6-26.

Fla. Admin. Code R. 59A-24.005 Collection Site and Specimen Collection Procedures

(1) Designation of Collection Sites. For urine, blood, oral fluid and hair specimen collection, each laboratory, that has a contract or agreement for testing services with an employer, shall provide collection sites under contract and training for collectors, or shall provide a trained collector to collect specimens for the employer at any time designated by the employer in his contract or agreement with the laboratory. The collector shall be responsible to the laboratory for implementing collection procedures and chain of custody procedures as designated in Chapter 59A-24, F.A.C. The laboratory shall provide to the collection site, or collector, specimen collection kits which, as applicable, shall contain chain of custody forms, as required by subsection 59A-24.005(2), F.A.C., mailing boxes or containers, specimen identification labels, laboratory address labels, urine specimen bottles, FDA approved oral fluid collection devices, external temperature strips, tamper-proof plastic sealable bags and forensic tamper-proof tape to seal the specimen container(s). Kits for alcohol testing must have a 7ml blood vial that contains an anticoagulant and a preservative of sodium fluoride. An oral fluid collection device must not be used if the device’s expiration date has passed. Employers who do not use hair testing for their drug-free workplace program shall not be required to maintain collection facilities and personnel as described in Section 112.0455(13)(b)3.a., F.S. Employers that choose to use hair as a specimen for testing shall meet the requirements found in Section 112.0455(13)(b)3.a., F.S.

(2) Chain of Custody Form and Procedures. Chain of custody refers to the methodology of documenting the tracking of specified materials or substances for the purpose of maintaining control and accountability from initial collection to final disposition of all such materials or substances and providing for accountability at each stage in handling, testing, storing and reporting of the test results.

(a) A chain of custody form shall be completed for each donor tested.

(b) Each laboratory licensed under these rules shall provide chain-of-custody forms to be used for each donor.

(c) All chain of custody forms shall provide a unique identifier which shall not be used to identify any other Florida Drug Free Workplace specimen. The employer is permitted to assign an employee identification number for use with each donor tested.

(d) The design of the chain of custody forms shall meet the following requirements:

Prominently indicate the name and address of the laboratory performing the drug test(s).
A section to be completed by the collector or employer respresentative that solicits the following information:

a. Employer name and address;

b. Medical review officer name and address;

c. Employee identification number;

d. Reason for the test(s); and,

e. Test(s) to be performed.

A section which indicates the temperature of urine specimens taken within 4 minutes of collection. This shall not be required for chain-of-custody forms for blood, oral fluid, or hair specimens.
A section to be completed by the collector that indicates the following:

a. The collection facility name, address and telephone number;

b. A designation that a split sample was or was not collected;

c. A remarks section;

d. A statement for the collector to sign incorporating the following language: I certify that the specimen identified on this form is the specimen presented to me or collected by me from the donor providing certification on Copy 4 of this form, that it bears the same identification number as set forth above, and that it has been collected, labeled and sealed in accordance with the Florida Drug-Free Workplace as found in Sections 112.0455, 440.102, F.S., and Chapter 59A-24, F.A.C.; and,

e. A place for the collector to print his name, a place for the collector’s signature and the date and time.

A section to be initiated by the collector and completed as necessary thereafter that documents the transfer of the specimen for the purpose of maintaining control and accountability for the specimen. At a minimum, this section shall indicate:

a. Date of transfer;

b. Signature and name of the person releasing the specimen;

c. Signature and name of the person receiving the specimen; and,

d. Purpose of the transfer.

A section to be completed by the laboratory which indicates the following:

a. An indication as to whether the specimen was received with intact specimen seals;

b. The test results;

c. Contains the following statement for the certifying scientist to sign: I certify that the specimen identified by the laboratory accession number on this form is the same specimen that bears the specimen identification number set forth above, that the specimen has been examined upon receipt, handled and analyzed in accordance with the Florida Drug-Free Workplace Program requirements as found in Sections 112.0455, 440.102, F.S., and Chapter 59A-24, F.A.C., and that the results set forth are for that specimen; and,

d. A place for the certifying scientist to print his name, the signature of the certifying scientist and the date.

A section to be completed by the Medical Review Officer including the following:

a. The statement: I have reviewed the laboratory test(s) for the specimen identified by this form in accordance with the Florida Drug-Free Workplace Program as found in Sections 112.0455, 440.102, F.S., and Chapter 59A-24, F.A.C.;

b. A space for determination of test results as one of the following:

I. Negative;

II. Positive;

III. Test not performed; and,

IV. Test canceled.

c. A place for remarks;

d. The signature of the Medical Review Officer; and,

e. The name of the Medical Review Officer and the date.

The chain of custody form shall be comprised of the following copies for distribution:

a. Original laboratory copy (Copy 1) which shall be routed to the laboratory with the specimen; the laboratory will retain upon the completion of testing.

b. Second Original Laboratory copy (Copy 2) which shall be routed to the laboratory with the specimen; as a means of reporting the test result, the laboratory will forward the copy to the Medical Review Officer.

c. Split specimen copy (Copy 3) which must accompany the split portion to the laboratory. Split sample testing is optional.

d. Medical Review Officer copy (Copy 4) which shall be routed directly to the MRO by the collection site personnel; this form copy is not to be sent to the laboratory.

e. Donor copy (Copy 5) which shall be given to the donor by the collector. Do not send to the laboratory.

f. Collector copy (Copy 6) which shall be retained by the collector. Do not send to the laboratory.

g. Employer copy (Copy 7) which shall be forwarded to the employer.

(e) The form shall contain no information which can be traceable to the donor except the unique identifier, the employee identification number, if used, and the laboratory’s specimen identification number.

(f) The form shall also contain the following list of over-the-counter and prescription drugs which could alter or affect a test result. Due to the large number of obscure brand names and constant marketing of new products, this list, as follows, is not intended to be all-inclusive.

Alcohol

All liquid medications containing ethyl alcohol (ethanol). Please read the label for alcohol content. As an example, Vick’s Nyquil is 25% (50 proof) ethyl alcohol, Comtrex is 20% (40 proof), Contact Severe Cold Formula Night Strength is 25% (50 proof) and Listerine is 26.9% (54 proof).

Amphetamines

Obetrol, Biphetamine, Desoxyn, Dexedrine, Didrex, Ionamine, Fastin.

Cannabinoids

Marinol (Dronabinol, THC).

Cocaine

Cocaine HCl topical solution (Roxanne).

Phencyclidine

Not legal by prescription.

Methaqualone

Not legal by prescription.

Opioids

Paregoric, Parepectolin, Donnagel PG, Morphine, Tylenol with Codeine, Empirin with Codeine, APAP with Codeine, Aspirin with Codeine, Robitussin AC, Guiatuss AC, Novahistine DH, Novahistine Expectorant, Dilaudid (Hydromorphone), M-S Contin and Roxanol (morphine sulfate), Percodan, Vicodin, Tussi-organidin, etc.

Barbiturates

Phenobarbital, Tuinal, Amytal, Nembutal, Seconal, Lotusate, Fiorinal, Fioricet, Esgic, Butisol, Mebaral, Butabarbital, Butalbital, Phrenilin, Triad, etc.

Benzodiazepines

Ativan, Azene, Clonopin, Dalmane, Diazepam, Librium, Xanax, Serax, Tranxene, Valium, Verstran, Halcion, Paxipam, Restoril, Centrax.

Methadone

Dolophine, Metadose.

Propoxyphene

Darvocet, Darvon N, Dolene, etc.

(g) Handling and transportation of a specimen from one authorized individual or place to another shall always be accomplished through the chain of custody form and procedures. The chain of custody form shall be used for maintaining control and accountability of each specimen from the point of collection to final disposition of the specimen at the laboratory. The purpose of the transfer of possession, the name and signature of the person releasing and receiving the specimen, and the date shall be documented on the form each time a specimen is handled or transferred and every individual in the chain shall be identified. Since the specimen and the chain of custody form are sealed in tamper-proof sealable plastic bags that would indicate any tampering during transit to the laboratory, and since couriers, express carriers and postal service personnel do not have access to the chain of custody forms, there is no requirement that such personnel document chain of custody for the shipping container during transit. Nor is there a requirement that there be a chain of custody entry when a specimen which is sealed in such a shipping container is placed in or taken out of secure storage at the collection site prior to pickup by such personnel. A test shall not be canceled because couriers, express carriers, postal service personnel or other persons involved solely with the transportation of a specimen to a laboratory have not documented their participation in the chain of custody or because the chain of custody does not contain entries related to placing the specimen in or removing it from secure temporary storage at the collection site.

(h) Once the specimen has arrived at the laboratory, an internal chain of custody form shall be used by the laboratory until the laboratory has finalized the test results.

(i) Every effort shall be made to minimize the number of persons handling the specimens.

(3) Security Procedures and Specimen Collection. Collection site security and specimen collection security are the responsibility of the collector through contract with the licensed laboratory. Security procedures shall provide for the designated collection site to be secure including the providing of privacy for the donor and the integrity of the specimen.

(a) Access to Authorized Personnel Only. No unauthorized personnel shall be permitted in any part of the designated collection site when specimens are collected or stored.

(b) Privacy. Procedures for collecting urine specimens shall allow individual privacy unless there is reason to believe that a particular individual intends to alter or has altered or substituted the specimen to be provided.

(c) Integrity and Identity of Specimen. The collection site person shall take precautions to ensure that a specimen not be adulterated or diluted during the collection procedure and that information on the collection bottle and on the chain of custody form can identify the individual from whom the specimen was collected. The following minimum precautions shall be taken to ensure that unadulterated specimens are obtained and correctly identified.

To prevent specimen contamination at the collection site:

a. For urine specimens, toilet bluing agents shall be placed in toilet tanks so the reservoir of water in the toilet bowl always remains blue. There shall be no other source of water in the enclosure or partitioned area where urination occurs. All other sources of water shall be controlled by the collector.

b. For oral fluid specimens, there shall be no source of water or other fluids in the area where collection occurs. All sources of water shall be controlled by the collector.

When a donor arrives at the collection site, the collection site person shall request the donor to present a photo identification. If the donor does not have the proper photo identification, the collection site person shall contact the employer who can positively identify the donor. If the donor’s identity cannot be established, the collection site person shall not proceed with the collection. The collection site person shall document the reason for not collecting the specimen and provide the donor with a copy of this documentation.
Before collecting a specimen, the collection site person shall check to see that the donor has a chain of custody form or has a letter from the employer authorizing the drug test. If a letter is used, the letter shall contain the following information:

a. The name of the individual to be tested;

b. The name of the employer and the employer’s address, phone number, and fax number;

c. The name, address and phone number of the laboratory with which the employer has contracted or established an agreement for testing services;

d. The name, address, phone number, and secured fax number of the employer’s Medical Review Officer;

e. The reason for the test (i.e., either job applicant, reasonable suspicion, routine fitness, or follow-up to treatment);

f. The drugs for which the laboratory will test; and,

g. The signature of the employer’s representative authorizing the testing.

If a collection time is assigned by the employer or collection site, and the donor fails to arrive at the collection site at the assigned time, the collection site person shall notify the employer of the missed appointment.
The collection site person shall ask the individual to remove any unnecessary outer garments, such as a coat or jacket, and to empty all clothing pockets. The collection site person shall ensure that all personal belongings, such as a purse or briefcase, remain with the outer garments. The individual may retain his or her wallet, provided that the collection site person shall check it for possible contaminants.
For urine specimens, the individual shall be instructed to wash and dry his or her hands prior to urination. After washing hands, the individual shall remain in the presence of the collection site person and shall not have access to any water fountain, faucet, soap dispenser, cleaning agent or any other materials which could be used to adulterate the specimen. The individual may provide his or her urine specimen in a stall or otherwise partitioned enclosure that allows for individual privacy. The collection site personl shall remain in the restroom or area, but outside the stall or partitioned enclosure.
For oral fluid specimens, the individual must remain in the presence of the collector and shall not have access to any water fountain, faucet, or any other materials which could be used to adulterate the specimen.

a. The collector shall inspect the individual’s oral cavity to ensure that it is free of any items that could impede or interfere with the collection of an oral fluid specimen (e.g., candy, gum, food, tobacco, abnormally colored saliva) or could be used to adulterate, substitute, or dilute the specimen. If an item is present that appears to have been brought to the collection site with the intent to adulterate, substitute, or dilute the specimen, or if the individual refuses to remove an item, this is considered a refusal to test and the collector must stop the collection and report the refusal to test.

b. If the individual has abnormally colored saliva or claims to have dry mouth, the collector can give the individual up to 4 ounces of water to rinse the oral cavity with. The collector must wait 10 minutes before collecting the specimen. If the individual refuses to rinse, this is a refusal to test.

c. If the individual is unable to provide an adequate specimen within 15 minutes of using the collection device, the collector can give the individual up to 8 ounces of water and wait an additional 10 minutes before collecting the specimen.

d. A period of 1 hour must be provided or until the individual has provided a sufficient oral fluid specimen. If the individual needs more time before attempting to provide an oral fluid specimen, the individual is not required to drink any fluids during the 1 hour wait time. The collector must inform the individual that the individual must remain at the collection site in an area designated by the collector during the wait period.

Upon receiving the specimen from the individual, the collection site person shall determine that:

a. Urine specimens contain at least 30 milliliters (mL) of urine. The approximate volume of the specimen shall be documented by the collector at the time of collection. If there is less than 30 mL of urine in the container, another urine specimen shall be collected in a separate container. Collected specimens which contain less than 30 mL of urine shall not be submitted to the laboratory for testing. Such specimens shall be discarded in the presence of the donor and such procedure shall be annotated by the collector on the chain of custody form. The collector is permitted to give the donor water to drink for the purpose of providing another urine specimen not to exceed an 8 ounce glass of water every 30 minutes for up to 2 hours. If the donor still fails to provide 30 mL of urine, the collection site person shall reschedule another collection within 24 hours and notify the employer as soon as possible of such rescheduling.

b. Blood alcohol specimens shall be collected using aseptic venipuncture technique. The venipuncture site for blood alcohol shall be cleansed with a non-alcoholic antiseptic substance prior to collection. Blood specimens shall contain 7 mL of blood which shall be collected in one tube containing an anticoagulant and a preservative of sodium fluoride. Immediately after collection, the collection site person shall rock the tube gently to mix the anticoagulant and preservative substance with the blood.

c. Oral fluid specimens contain at least 1 milliliter (mL) of undiluted (neat) oral fluid for each specimen.

d. A quantity of hair shall be collected as described in Section 112.0455(13)(b)3.f.(IV), F.S.

After a urine specimen has been provided and submitted to the collection site person, the individual shall be allowed to wash his or her hands.
No longer than 4 minutes following collection, the collection site person shall measure and record the temperature of the urine specimen, as indicated, on the chain of custody form. The temperature measuring device must be placed on the outside of the container to prevent contamination. If the temperature measurement exceeds 4 minutes, the specimen shall be rendered invalid and shall be rejected. A second specimen shall be collected and a new chain of custody form generated.
If the temperature of a urine specimen is outside the range of 90o-100o degrees fahrenheit, there is reason to believe that the donor may have altered or substituted the specimen and another urine specimen shall be collected under direct observation by an observer of the same gender as the donor, as specified in subparagraph 59A-24.005(3)(c)13., F.A.C. The reason for the observed collection and the identity of the direct observer shall be documented on the chain of custody form.
Immediately after a urine specimen is collected, the collection site person shall also inspect the specimen to determine its color and look for any signs of contaminants. Any unusual findings shall be noted on the chain of custody form.
Whenever a collection site person has reason to believe that a particular individual may alter or has altered or substituted a urine specimen, a higher level supervisor at the collection site or at the laboratory shall review the decision and concur in advance with the collection of a second specimen under the direct observation of an observer of the same gender as the donor. Once approved by a higher level supervisor, the collector shall require the individual to provide another specimen under direct observation. If the same gendered observer is not the collector, the observer shall be identified on the chain of custody form. The observer, if different from the collector, shall not handle the specimen and the specimen shall be handed to the collector by the donor in the observer’s presence. The observer shall keep the specimen in sight at all times prior to it being sealed. A new chain of custody form shall be executed to accompany any specimen collected under direct observation. Information regarding a specimen collected under direct observation shall be included on both the new chain of custody form and on the original form in the remarks section. In addition, the new chain of custody specimen identification number shall be annotated on the original form. Both specimens shall be sent to the laboratory to be analyzed.
The individual being tested, the collection site person, and the observer if used for direct observation, shall keep the specimen in view at all times prior to its being sealed and labeled.
The collection site person shall place securely on the specimen bottle, tube, or container an identification label containing the donor’s specimen number, which matches the specimen number on the chain of custody form, and the date.
The employee (donor) and the collector shall initial the identification label on the specimen bottle, tube, or container for the purpose of certifying that it is the specimen collected from the donor.
The collector shall enter on the chain of custody form all required information.
The individual shall be asked to sign a statement on the chain of custody form certifying that the specimen identified as having been collected from him or her is in fact that specimen he or she provided. It shall be noted and signed on the chain of custody form by the collection site person, with a witness’ signature, if the individual refuses to sign this statement.
The collection station is permitted to store unrefrigerated urine specimens up to 72 hours after collection, provided they are sealed for shipment as described in subparagraph 59A-24.005(3)(c)21., F.A.C., and kept in locked, secure temporary storage. Hair specimens shall be stored at all times in unrefrigerated locked, secured storage.
While any part of the above chain of custody procedures is being performed, it is essential that the specimen and the chain of custody form be under the control of the collection site person. If the collection site person leaves his or her work station momentarily, the specimen and the chain of custody form shall be taken with him or her or shall be secured in a locked room, drawer, file cabinet, etc. After the collection site person returns to the work station, the chain of custody process will continue. If the collection site person is leaving for an extended period of time, the specimen shall be packaged for shipment before he or she leaves the site.
The collection site person shall arrange to send the collected specimens by express shipment, courier, or U.S. Mail to the drug testing laboratory which is designated by the employer. The specimens shall be placed in containers designed to minimize the possibility of damage during shipment. Prior to shipping or storage, the collection site person shall ensure that:

a. The specimen container is sealed with forensic tamper-proof tape;

b. The forensic tamper-proof tape contains the initials of the donor, the date the specimen was sealed in the specimen container; and,

c. The completed chain of custody form and specimen container is enclosed and sealed in a tamper-proof sealable plastic bag before packaging for shipment to the drug testing laboratory.

This rule chapter does not prohibit the use of split samples provided that such samples are collected in the same manner as required in the Mandatory Guidelines for Federal Workplace Drug Testing Programs, Mandatory Guidelines using Urine, or Mandatory Guidelines using Oral Fluid as defined in Rule 59A-24.003, F.A.C.

History

Rulemaking Authority 112.0455(13)(a), 440.102(10) FS. Law Implemented 112.0455, 440.102 FS. History–New 3-15-90, Amended 6-28-91, Formerly 10E-18.005, Amended 5-1-96, 3-11-98, 3-29-00, 5-9-18, 4-9-26.

Fla. Admin. Code R. 59A-24.006 Drug Testing Laboratories – Standards and Licensure

Laboratories shall be licensed by the agency in accordance with Sections 112.0455, 440.102, and Chapter 408, Part II, F.S., and this rule chapter in order to collect or analyze specimens for an employer’s drug testing program.

(1) Laboratory Personnel.

(a) Qualifications of Director. The laboratory shall have a qualified director to assume professional, technical, educational, and administrative responsibilities for the laboratory’s drug testing. The director shall meet one of the following requirements:

Is duly licensed as a physician in the state in which he or she practices medicine; and is licensed under Chapter 458 or 459, F.S., if the laboratory is located in the State of Florida; and has had at least four years of experience in forensic analytical toxicology; or
Holds a doctoral degree from an accredited institution with Chemistry, Toxicology or Pharmacology as a major subject of study; and has had at least four years of experience in forensic analytical toxicology; and shall be licensed as a director under Chapter 483, Part I, F.S., in the specialty of clinical chemistry, if the laboratory is located in the State of Florida.

(b) Responsibilities of Director. The director shall be responsible for the following:

The director shall be engaged in and responsible for the day-to-day management of the drug testing laboratory.
The director shall be engaged in and responsible for ensuring that there are sufficient personnel with adequate training and experience to supervise and conduct the work of the drug testing laboratory. He or she shall assure the continued competency of laboratory personnel by documenting their inservice training, reviewing their work performance, and verifying their skills.
The director shall ensure that the laboratory has a procedure manual which is complete, up-to-date, available to the personnel performing tests. All such procedures must, at a minimum, meet the requirements stipulated in this rule chapter. The director shall ensure that the procedures are followed by personnel performing tests. The procedure manual shall be reviewed, signed, and dated by this director whenever procedures are first placed into use, or changed, or when a new director assumes responsibility of the drug testing laboratory.
The director shall be responsible for maintaining a quality assurance program to assure the proper performance and reporting of all test results; for maintaining acceptable analytical performance for all controls and standards; for maintaining quality control testing; and for assuring and documenting the validity, reliability, accuracy, precision, and performance characteristics of each test and test system.
The director shall be responsible for taking all remedial actions necessary to maintain satisfactory operation and performance of the laboratory. The director shall ensure that sample results are not reported until all corrective actions have been taken and that he or she can assure that the tests results provided are accurate and reliable.

(c) Certifying Scientists. The laboratory shall have a qualified individual who serves as certifying scientist. This individual reviews all pertinent data and quality control results in order to attest to the validity of the laboratory’s test reports. A laboratory may designate more than one person to perform this function.

The certifying scientist(s) shall have a minimum of 2 years experience in forensic analytical toxicology and be qualified as a director or licensed as a supervisor under the provisions of Chapter 483, Part I, F.S., in the specialty of clinical chemistry if the laboratory is located in the State of Florida.
The laboratory director is permitted to designate technical personnel to certify results that are negative on the initial screening test. These individuals shall be technologists licensed in the specialty of clinical chemistry in accordance with the provisions of Chapter 483, Part I, F.S., if the laboratory is located in the State of Florida.

(d) Laboratory Operation and Supervision.

The laboratory’s drug testing facility shall have an individual(s) responsible for day-to-day operation of the laboratory and the supervision of the technical analysts. This individual(s) shall be licensed as a laboratory supervisor in the specialty of clinical chemistry or qualified as a director in accordance with Chapter 483, Part I, F.S., in the specialty of clinical chemistry if the laboratory is located in the State of Florida; and,
Have a minimum of 2 years experience in forensic analytical toxicology.

(e) Technical and Non-Technical Personnel.

Technical personnel shall have the training and skills to conduct forensic toxicology testing and shall be licensed in accordance with Chapter 483, Part I, F.S., if the laboratory is located in the State of Florida. Documentation of such training and skills shall be maintained by the laboratory and available upon request by the agency.
Non-technical personnel, including all persons collecting specimens under these rules shall have the necessary training and skills for the tasks assigned but shall not perform drug testing.

(f) Collection Site Person or Persons Collecting Specimens. A specimen for a drug test shall be taken or collected by:

A physician, a physician’s assistant, a registered professional nurse, a licensed practical nurse, a nurse practitioner, or a certified paramedic who is present at the scene of an accident for the purpose of rendering emergency medical service or treatment.
A qualified person employed by a licensed laboratory who has the necessary training and skills for the assigned tasks.

(2) Training. The laboratory’s drug testing program shall make available continuing education programs to meet the needs of laboratory personnel.

(3) Files. Laboratory personnel files shall include: resume of training and experience; certification or license, if any; references; job descriptions; records of performance evaluations and advancement; incident reports; and results of tests which establish employee competency for the position he or she holds, such as a test for color blindness, if appropriate.

(4) Specimen Security and Analysis Procedures.

(a) Specimen Security and Internal Chain of Custody.

Drug testing laboratories shall be secure at all times. They shall have in place sufficient security measures to control access to the premises and to ensure that no unauthorized personnel handle specimens or gain access to the laboratory processes or to areas where records or specimens are stored. Access to these secured areas shall be limited to specifically authorized individuals whose authorization is documented. For the purposes of subparagraph 59A-24.006(4)(a)1., F.A.C., authorized individuals means those persons designated by the laboratory to have access to the drug testing laboratory. All authorized visitors, including maintenance and service personnel, shall be escorted by laboratory personnel at all times. Documentation of individuals accessing these areas, dates, time of entry and egress, and purpose of entry must be maintained for no less than 2 years.
Laboratories shall use internal chain of custody procedures to maintain control and accountability of specimens from receipt through completion of testing, reporting of results, during storage, and continuing until final disposition of specimens. The date and purpose shall be documented on the internal chain of custody form each time a specimen is handled or transferred, and every individual in the chain shall be identified. Accordingly, authorized personnel shall be responsible for each specimen or aliquot in their possession and shall sign and complete internal chain of custody forms for those specimens or aliquots as they are received. Aliquots and internal chain of custody forms shall be used by laboratory personnel for conducting both initial and confirmation tests.

(b) Receiving Specimens. When a shipment of specimens is received, laboratory personnel shall inspect each package for evidence of possible damage or tampering and compare information listed on specimen containers within each package to the information on the accompanying chain of custody forms. The laboratory shall establish written standards for the rejection or acceptance of specimens. In addition, any evidence of tampering, mismatched or omitted specimen identification numbers, spillage, damage or other discrepancies in the information on specimen containers and the chain of custody form shall render a specimen invalid and shall be rejected by the laboratory for testing. The laboratory shall immediately report any rejection to the employer and shall note such rejection on the chain of custody form.

(c) Short-Term Refrigerated Storage. Urine, blood, or oral fluid specimens that do not receive an initial test within 72 hours of arrival at the laboratory shall be placed in locked, secure refrigerated units. Temperatures of these units shall not exceed 6 degrees Celsius. Emergency power equipment shall be available and used in case of power failure.

(d) Specimen Testing Requirements. A laboratory must be capable of testing for all drugs listed in Section 112.0455(5)(a), F.S., and be capable of conducting testing to ensure that a specimen has not been diluted or adulterated. The laboratory shall test and report drug test results no more than 3 working days after the receipt of the specimen in the laboratory.

(e) Initial Test. The initial screen for all drugs using urine or oral fluid shall be an immunoassay except that the initial test for alcohol shall be an enzyme oxidation methodology.

Levels on initially screened urine specimens which are equal to or exceed the drug cutoff levels published in Subpart C, Section 3.4 of the Mandatory Guidelines Using Urine shall be considered to be presumptively positive and submitted for confirmation testing.
The only specimen for alcohol testing shall be blood and the initially screened specimen shall be considered presumptively positive and submitted for confirmation testing if the level is equal to or exceeds 0.04 g/dL.
Levels on initially screened undiluted (neat) oral fluid specimens which are equal to or exceed the drug cutoff levels published in Subpart C, Section 3.4 in the Mandatory Guidelines Using Oral Fluid shall be considered to be presumptively positive and submitted for confirmation testing.
Levels which exceed the following for hair specimens shall be considered presumptively positive on initial screening and submitted for confirmation testing:

Marijuana

10 pg/10 mg of hair

Cocaine

5 ng/10 mg of hair

Opiate/synthetic narcotics and metabolites

5 ng/10 mg of hair

Phencyclidine

3 ng/10 mg of hair

Amphetamines

5 ng/10 mg of hair

Laboratories are permitted to use multiple screening tests for the same drug or drug class to eliminate any possible presumptive positives due to structural analogs, provided that such tests meet the requirements of this rule chapter.

(f) Confirmation Test. All specimens identified as presumptively positive on the initial test shall be confirmed using mass spectrometry/mass spectrometry (MS/MS) or gas chromatography/mass spectrometry (GC/MS), except that alcohol will be confirmed using gas chromatography. All confirmations shall be done by quantitative analysis.

Levels on confirmation testing for urine specimens which are equal to or exceed the drug cutoff levels published in Subpart C, Section 3.4 of the Mandatory Guidelines Using Urine shall be reported as positive.
The alcohol level on confirmation testing for blood which is equal to or exceeds 0.04 g/dL shall be reported as positive.
Levels on confirmation testing for oral fluid specimens which are equal to or exceed the drug cutoff levels published in Subpart C, Section 3.4 of the Mandatory Guidelines Using Oral Fluid shall be reported as positive.
Levels for hair specimens on confirmation testing which are equal to or exceed the following shall be reported as positive:

Marijuana Metabolites

1 pg/10 mg of hair

Cocaine

5 ng/10 mg of hair

Opiate/synthetic narcotics and metabolites

5 ng/10 mg of hair

Phencyclidine

3 ng/10 mg of hair

Amphetamines

5 ng/10 mg of hair

The urine and oral fluid drug and biomarker test analytes and cutoff levels for initial and confirmatory drug and biomarker tests, published in the Federal Register are available at https://www.samhsa.gov/workplace.

(g) Reporting Results.

The laboratory shall report all test results to the MRO indicated on the chain of custody form. Before any test result is reported by the laboratory, the results of initial tests, confirmation tests, and quality control data of such tests shall be reviewed by the certifying scientist and the test certified as an accurate report. The report, at a minimum, shall identify the drugs or metabolites tested for, the results of the drug test either positive or negative, the specimen number assigned on the chain of custody form, the name and address of the laboratory performing the testing, and the drug testing laboratory’s specimen accession number.
The following criteria shall be used when reporting drug testing results for urine, blood, oral fluid and hair specimens.

a. Specimens that test negative on the initial test shall be reported as negative. If an employer wishes to retest a negative specimen under the provisions of Section 112.0455(9)(a), F.S., such testing is authorized to be conducted only once and must be requested no more than 7 working days from the time the original negative test result was reported to the employer by the MRO. Hair specimens may be re-collected only once to perform repeat confirmation testing under the provisions of Section 112.0455(9)(a), F.S.

b. Specimens that test positive on initial immunoassay tests, but test negative on confirmation shall be reported as negative.

c. The laboratory is permitted to report drug test results for specimens that do not meet the adulteration/dilution criteria of the laboratory. Reports on specimens that do not meet the laboratory’s adulteration/dilution requirements shall not indicate the actual results of the adulteration/dilution tests, but the report shall indicate the adulteration/dilution test results in non-quantitative terms.

d. The laboratory report shall indicate solely that the test(s) resulted in a positive drug test result or resulted in a negative drug test result.

The MRO may request from the laboratory, and the laboratory shall provide, detailed quantification of initial and confirmation test results.
The laboratory may transmit results to the MRO by various electronic means (for example, teleprinter, facsimile, or computer) in a manner designed to ensure confidentiality of the information. The laboratory and MRO must ensure the security of the data transmission and restrict access to any data transmission, storage, and retrieval system to only those individuals authorized under these rules to obtain such information.
The laboratory shall send the MRO a copy of the original chain of custody form (Copy 2) signed by the certifying scientist responsible for attesting to the validity of the test report.
The laboratory shall make available copies of all analytical results of donor testing upon request by the MRO or the agency.
Unless otherwise specified in this rule chapter, all records pertaining to a given specimen shall be retained by the drug testing laboratory for a minimum of 2 years.

(h) Storage of Specimens. Drug testing laboratories shall retain and place all confirmed positive urine and oral fluid specimens in locked, secured long-term frozen storage (-20o degrees Celsius or less) and confirmed positive blood specimens in locked, secured long-term refrigerated storage (2-8o degrees Celsius) for a minimum of 210 days. Within this 210 day period an employer, employee, job applicant, or MRO is permitted to request in writing that the laboratory retain the specimen for an additional period of time. If no such request is received, the laboratory is permitted to discard the specimen after 210 days of storage. When notified in writing, the laboratory shall be required to maintain any specimens under legal challenge until such challenge is resolved. To maintain applicable storage temperatures for stored specimens, emergency power equipment shall be available and used in the case of power failure. After the required retention time has passed, laboratories are permitted to either discard the specimens or pool all or part of these specimens for use in the laboratory’s internal quality control program.

When an employee or job applicant undertakes an administrative or legal challenge to the test result, it shall be the employee’s or job applicant’s responsibility to notify the employer and laboratory in writing of such challenge and such notice shall include reference to the chain of custody specimen identification number. After such notification, the sample shall be retained by the laboratory until the case or administrative appeal is settled.
During a 180 day period after written notification of a positive test result, the employee or job applicant who has provided the specimen shall be permitted by the employer to have a portion of the specimen retested, at the employee or job applicant’s expense. The laboratory which performed the original test for the employer shall be responsible for transferring a portion of the specimen to be retested at a second laboratory licensed under these rules, selected by the employee or job applicant, and shall be responsible for the integrity of the specimen and for the chain of custody during such transfer.
Urine and oral fluid specimens that test negative shall be stored in locked, secured refrigerated (2-8o degrees Celsius) or frozen storage (-20o degrees Celsius or less). Blood specimens that test negative shall be stored in locked, secured, refrigerated storage (2-8o degrees Celsius). These specimens shall be retained for no less than 7 working days after the test result has been reported to the employer by the MRO. After the required retention time has passed, laboratories are permitted to either discard the specimens or pool all or part of these specimens for use in the laboratory’s internal quality control program.
The laboratory is permitted to discard or pool specimens that test negative immediately after the negative test result is transmitted to the MRO, provided that the laboratory has written authorization from the employer that specimens which test negative are not to be retained for retesting under Section 112.0455(9)(a), F.S.
Under no circumstances shall a laboratory be required to retain a specimen, which has been reported as negative, for a period longer than 14 working days after receipt of that specimen in the laboratory unless a confirmation test has been requested by the employer under the provisions of Section 112.0455(9)(a), F.S.

(i) Retesting Specimens. As some analytes deteriorate or are lost during freezing, refrigeration, or storage, quantification for a retest is not subject to a specific cutoff requirement but must provide data sufficient to detect the presence of the drug or metabolite.

(5) Subcontracting. Drug testing laboratories shall not subcontract, except for collection sites, and shall perform all analysis with their own personnel and equipment. The laboratory must be capable of performing testing for the classes of drugs defined in Section 112.0455(5)(a), F.S., using the specimens indicated in Section 112.0455(5)(k), F.S., and initial and confirmation methods specified in paragraphs 59A-24.006(4)(e) and (f), F.A.C.

(6) Contracted Collection Sites. Collection sites or collectors shall contract with laboratories licensed under this rule chapter to collect specimens for analysis. Such contracts shall be in writing and include the utilization of all the necessary facilities, personnel, materials, equipment, or other supplies, as needed, to collect specimens as required in Rule 59A-24.005, F.A.C. For the purposes of Section 112.0455(8)(e), F.S., persons collecting specimens under contract with a forensic drug testing laboratory shall be deemed to be employees of the licensed laboratory. In addition, the collectors shall be trained by, and shall be accountable to, the licensed laboratory. However, after an accident, if an employee is taken to a facility for medical treatment and the facility does not have a contract with the laboratory, an individual authorized in paragraph 59A-24.006(1)(f), F.A.C., is permitted to collect a specimen provided that this collector utilize, and complete to the fullest extent possible, a chain of custody form. In addition, the collector shall follow the collection procedures found in Rule 59A-24.005, F.A.C., to the fullest extent possible and shall maintain full control of the specimen until the specimen is sealed and packaged for shipment to the employer’s selected laboratory.

(7) Inspections. The agency shall conduct announced or unannounced inspections of the laboratory at any reasonable time for the purpose of determining compliance with this rule chapter. The right of entry and inspection shall also be extended to any collection sites under contract with the laboratory. Inspections shall document the overall quality of the laboratory setting for the purpose of licensure to conduct drug free workplace testing. Inspection reports shall also contain any requirements of the laboratory to correct deficiencies noted during the inspections.

(a) Prior to laboratory licensure and biennially thereafter, an on-site inspection of the laboratory shall be conducted.

(b) Laboratories certified by the United States Department of Health and Human Services (HHS) to participate in Federal Workplace Drug Testing Programs shall submit an inspection report of the HHS National Laboratory Certification performed within the previous 24 months in lieu of the required on-site inspection. In addition, such laboratories shall:

Maintain a policy to conduct the testing of all specimens authorized under Section 112.0455, F.S., in the same manner as required for those drugs included under the Mandatory Guidelines for Federal Workplace Drug Testing Programs, Mandatory Guidelines using Urine, and Mandatory Guidelines using Oral Fluid. This policy must be in writing and contained in the laboratory’s policy and procedure manual.
Submit to the agency all reports of such inspections, post inspection activities and reports including any corrective action taken by the laboratory within 45 days of the receipt of the initial evaluation report in the laboratory.
Request in writing that the inspection report be accepted in lieu of an on-site inspection by the agency.

(c) Laboratories that are accredited by a nationally recognized accreditation organization may submit an accreditation survey report performed within the previous 24 months and proof of non-provisional accreditation or reaccreditation in lieu of the on-site inspection.

(8) Documentation. Laboratories shall maintain and make available for at least 2 years all documentation of the testing process. Except that the laboratory shall be required to maintain documents and records for any specimen(s) under legal challenge until such challenge is resolved. The required documentation shall include:

(a) Personnel files on all individuals authorized to have access to specimens;

(b) Chain of custody documents;

(d) Quality control records;

(e) Procedure manuals;

(f) All test data, calibration curves and any calculations used in determining test results;

(g) Donor test reports;

(h) Proficiency testing records; and,

(i) Computer generated data used for testing and reporting specimen results.

(9) Additional Requirements for Laboratory Licensure.

(a) Standards and Controls. Laboratory standards shall be prepared with pure drug standards which are properly labeled as to content and concentration. The standards shall be labeled with dates indicating when received, when prepared or opened, when placed in service, and the expiration date.

(b) Instruments and Equipment.

Volumetric pipettes and measuring devices shall be certified for accuracy or be checked by gravimetric, colorimetric, or other verification procedures on a quarterly basis. Automatic pipettes and dilutors shall be checked for accuracy and reproducibility before being placed in service and checked quarterly thereafter.
There shall be written procedures for instrument setup and normal operation, a schedule for checking critical operating characteristics for all instruments, tolerance limits for acceptable function checks and instructions for major trouble shooting, repair, and maintenance in accordance with manufacturer’s specifications. Manufacturer’s specifications for, and records of preventive and regular maintenance shall be maintained for as long as the instrument is in use and for at least 2 years after the instrument is discontinued from use and shall be available upon request by the agency.

(c) Remedial Actions. There shall be written procedures for the actions to be taken when test systems are not operating correctly or errors are detected. There shall be documentation that these procedures are followed and that all necessary corrective actions are taken. There shall also be in place systems to verify all stages of testing and reporting and documentation that these procedures are followed.

(d) Personnel Available to Testify at Proceedings. A laboratory director shall assure that technical personnel, including the director, be available to testify in an administrative or disciplinary proceeding regarding any employee or a job applicant when that proceeding is based on a test result which was analyzed and reported by the laboratory.

(10) Quality Assurance and Quality Control. Quality assurance and quality control for hair analyses shall be conducted in accordance with Section 112.0455(13)(b)4., F.S.

(a) General. Drug testing laboratories shall have a quality assurance program which encompasses all aspects of the testing process including but not limited to specimen acquisition, chain of custody, security and reporting of results, initial and confirmation testing and validation of analytical procedures. Quality assurance procedures shall be designed, implemented, and reviewed to monitor the conduct of each step of the process of testing for drugs.

(b) Laboratory Quality Control Requirements for Initial and Confirmation Tests. At a minimum, each analytical run of specimens for an initial or confirmation test shall include the following quality control samples:

Negative specimens certified to contain no drug;
Urine and oral fluid specimens fortified with known standards; and,
Positive controls with the drug or metabolite at or near the threshold (cutoff).
At least 1 percent of each initial screening run, with a minimum of one sample per run, shall consist of a blind sample(s) of known concentration. Such samples shall appear as ordinary test specimens to the laboratory analysts.

(11) Proficiency Testing. Proficiency testing is required as a continuing assessment of laboratory performance necessary to maintain continued licensure.

(a) General Considerations.

The laboratory must successfully participate in proficiency testing surveys, as described in subsection 59A-24.006(11), F.A.C.
Proficiency testing specimens are permitted to consist of negative specimens as specified in subparagraphs 59A-24.006(4)(e)1. and 3., F.A.C., and positive specimens, as specified in paragraph 59A-24.006(4)(f), F.A.C.
Proficiency testing specimens are permitted to contain interfering substances.
Proficiency testing specimens are permitted to be identified for screening or confirmation testing only.
All procedures associated with the laboratory’s handling and testing of any proficiency testing specimens shall be carried out in the same manner as the laboratory tests donor samples.
The laboratory shall report results of proficiency testing samples using the same criteria applied to routine drug testing specimens.
In addition to the proficiency testing requirements, any licensed laboratory shall be subject to blind performance testing by the agency. Blind performance testing means proficiency test samples which are shipped to a laboratory in a manner such that the samples appear to be actual drug testing samples.

(b) Continued Licensure. In order to remain licensed, the laboratory shall participate in three proficiency testing surveys supplied by an approved proficiency testing organization as defined in subsection 59A-24.003(3), F.A.C. per year. Failure to meet the applicable grading criteria established by an approved proficiency testing organization shall be considered unsuccessful proficiency testing participation. The laboratory shall submit the reports of proficiency testing results and any corrective action taken with regards to unsuccessful results within 14 days of their receipt in the laboratory.

(12) Administrative Enforcement and Hearings.

(a) The agency shall enforce the provisions of Sections 112.0455(12) and (13), and Chapter 408, Part II, F.S., and Chapter 59A-24, F.A.C., by administering remedies for statutory and rule violations as provided in Sections 408.813, 408.814, 408.815 and 408.816, F.S.

(b) Grounds for Disciplinary Action. The following actions shall result in the agency taking administrative action:

Failure to accurately analyze and report donor drug tests;
Failure to participate in or unsuccessful participation in proficiency testing surveys;
Permitting unauthorized persons to perform technical procedures or issue reports;
Demonstrating incompetence or making consistent errors in the performance and reporting of drug free workplace testing or proficiency testing samples;
Performing a test and rendering a report thereon to a person not authorized by law to receive such services;
Knowingly having professional connection with or knowingly lending the use of the name of the licensed forensic toxicology laboratory or the license of the director to an unlicensed forensic toxicology laboratory;
Violating or aiding and abetting in the violation of any provision of this part or the rules promulgated hereunder;
Failing to file any report required by the provisions of this part or the rules promulgated hereunder;
Reporting a drug test result when no such test was performed;
Knowingly advertising false services or credentials;
Failure to correct deficiencies within the time required by the agency;
Failing to maintain a secured area for toxicology tests; or
Any other cause which affects the ability of the laboratory to ensure the full reliability and accuracy of drug tests and the accurate reporting of results.
Failure to submit statistical reports as required in subsection 59A-24.006(14), F.A.C.

(13) Licensure

(a) Laboratories seeking licensure or requesting a change of licensure information must complete and submit an application for initial, change of ownership, renewal licensure or change during the licensure period on the forms referenced in subsection 59A-35.060(1), F.A.C. The application forms are available online at https://ahca.myflorida.com/health-quality-assurance/hqa-applications-for-licensure or, for online initial, renewal or change during the licensure period submissions, at: https://apps.ahca.myflorida.com/SingleSignOnPortal/Login.aspx?ReturnUrl=%2fSingleSignOnPortal.

(b) Initial, change of ownership, and biennial licensure renewal fees shall be $16,435 and shall be made payable to the Agency for Health Care Administration.

(14) Statistical Information Reporting.

(a) The laboratory shall submit statistical information on drug testing to the agency. No statistical information reported to the agency shall reveal the names of the persons tested, nor shall it reveal the employer’s identity. This data shall contain the following information on specimens received for all drug testing conducted under Section 112.0455 or 440.102, F.S.:

The total number of specimens received for testing.
The total number of specimens that tested positive on the initial screening.
The total number of specimens that were confirmed and reported as positive for each drug class tested.
The total number of samples that were received but not tested.

(b) Statistical summaries shall be submitted to the agency on a monthly basis no later than 14 working days after the end of a reporting month. Reporting is required even if no Florida Drug Free Workplace testing has been done for that reporting month.

(c) Failure of a laboratory to submit the statistical reports as required in Section 112.0455(12)(d) or 440.102(9)(d), F.S., shall result in administrative action pursuant to paragraph 59A-24.006(12)(a), F.A.C.

History

Rulemaking Authority 112.0455(13)(a), 408.819, 440.102(10) FS. Law Implemented 112.0455(12), (13), 408.805, 408.806, 408.813, 408.814, 408.815, 408.816, 440.102 FS. History–New 3-15-90, Amended 6-28-91, Formerly 10E-18.006, Amended 5-1-96, 12-5-96, 3-11-98, 3-29-00, 5-25-10, 6-16-15, 4-6-26.

Fla. Admin. Code R. 59A-24.007 Confidentiality

History

Rulemaking Authority 112.0455(11)(a) FS. Law Implemented 112.0455 FS. History–New 3-15-90, Amended 6-28-91, Formerly 10E-18.007, Repealed 5-1-96.

Fla. Admin. Code R. 59A-24.008 Review of Test Results

Prior to the transmission of test results to the employer, both positive and negative test results shall be reviewed and verified by a medical review officer (MRO) qualified under subsection 59A-24.008(1), F.A.C. The MRO is permitted to use a language interpreter to assist in communicating the results of drug tests with employees and job applicants. Such language interpreters are subject to the confidentiality provisions of Section 112.0455(11), F.S. After the results have been reviewed and verified by the MRO, the test result is reported to the employer.

(1) Qualifications of Medical Review Officers.

(a) Persons serving as medical review officers shall be medical or osteopathic physicians duly licensed in the state in which he or she practices medicine.

(b) The MRO shall have knowledge of substance abuse disorders, laboratory testing procedures, chain of custody procedures, collection procedures, and have the appropriate knowledge regarding pharmacology and toxicology of illicit drugs and medical training to interpret and evaluate an individual’s drug test result together with the individual’s medical history or any other biomedical information.

(c) Medical review officers shall be certified as medical review officers by the American Association of Medical Review Officers, American Society of Addiction Medicine or the Medical Review Officer Certification Council.

(d) The MRO shall be employed by or contracted by the employer and shall not be employed or contracted by a drug testing laboratory performing drug free workplace testing under Section 112.0455, F.S. The drug testing laboratory is permitted to assist the employer in locating qualified medical review officers.

(e) An employer shall not serve as the MRO for his or her own employees and job applicants.

(2) Responsibilities of Medical Review Officer. The MRO shall evaluate the drug test result(s), which is reported out by the laboratory, to verify by checking the chain of custody form that the specimen was collected, transported, and analyzed under proper procedures, as specified in these rules, and to determine if any alternative medical explanations caused a positive test result. This determination could include conducting a medical interview with the individual, review of the individual’s medical history, or the review of any other relevant bio-medical factors. The MRO shall review all medical records made available by the tested individual. The MRO shall not consider the results of samples that are not obtained or processed in accordance with these rules.

(a) Negative Results. To verify that a negative test result was properly analyzed and handled according to these rules, the MRO shall:

Receive and review the test result(s) from the laboratory;
Verify the laboratory report by checking the chain of custody form for required signatures, procedures, and information;
Ensure that the donor’s specimen identification number on copy 2 of the laboratory test report and on copy 4 of the chain of custody form which was sent to the MRO by the collection site accurately identifies the donor with the negative test result; and,
Notify the employer in writing of the negative test result no more than 7 working days after the specimen was received by the laboratory, and appropriately file Copy 2 and 4 of the chain of custody form under confidential procedures for a period of 2 years.
Within 24 hours of notification of the employer of a negative test result, notify the testing laboratory that the negative test result has been submitted to the employer.

(b) Positive Results. To verify that a positive test result was properly analyzed and handled according to these rules, the MRO shall:

Receive and review the test result(s) from the laboratory;
Verify the laboratory report by checking the chain of custody form for required signatures, procedures, and information;
Ensure that the donor’s specimen identification number on Copy 2 of the laboratory test report and on Copy 4 of the chain of custody form which was sent to the MRO by the collection site accurately identifies the donor with the positive test result;
Notify the employee or job applicant of a confirmed positive test result, within 3 days of receipt of the test result from the laboratory, and inquire as to whether prescriptive or over-the-counter medications could have caused the positive test result;
Within 5 days of notification to the donor of the positive test result, provide an opportunity for employee or job applicant to discuss the positive test result and to submit documentation of any prescriptions relevant to the positive test result;
Review any medical records provided by the employee or job applicant, or authorized by the employee or job applicant and released by the individual’s physician, to determine if the positive test result was caused by a legally prescribed medication. If the donor does not have prescribed medication, the MRO shall inquire about over-the-counter medications which could have caused the positive test result. The donor shall be responsible for providing all necessary documentation, (i.e., a doctor’s report, signed prescription, etc.) within the 5 day period after notification of the positive test result;
Notify the employer in writing of the verified test result, either negative, positive, or unsatisfactory, no more than 7 working days after the specimen was received by the laboratory, and appropriately file the chain of custody form under confidential procedures for 2 years;
If the MRO determines that there is a legitimate medical explanation for the positive test result, based on the medical judgment of the MRO and accepted standards of practice, the MRO shall report a negative test result to the employer;
Process any employee or job applicant requests for a retest of the original specimen, within 180 days of notice of the positive test result, at another licensed laboratory selected by the employee or job applicant. The donor requesting the additional test shall be required to pay for the costs of the retest, including handling and shipping expenses. The MRO shall contact the original testing laboratory to initiate the retest; and,
The MRO shall not declare a confirmed positive as verified, until the MRO receives Copy 2 of the chain of custody form from the drug testing laboratory and Copy 4 from the collection site.

(3) Chain of Custody Procedures. A strict chain of custody procedure, initiated at the time of specimen collection, is mandatory for the validation of any test result. The MRO shall be responsible, before reporting either positive or negative test result(s) to the employer, to review all signatures, procedures, and information as required on the chain of custody form to determine that the specimen was under authorized control both before and during laboratory analysis. If proper chain of custody procedures have not been followed, the MRO shall declare the test result as unsatisfactory, due to an unacceptable chain of custody procedure.

(4) Verification for Opioids. Before a positive test for opioids is verified, the MRO shall determine that there is clinical evidence in addition to the urine, blood, oral fluid or hair test, of illegal use of any opium, opiate, or opium derivative (e.g., morphine/codeine). This requirement does not apply if the GC/MS confirmation test for opioids confirms the presence of 6-monoacetylmorphine.

(5) Reanalysis Authorized. Should any question arise as to the accuracy or validity of a test result which has been collected and analyzed in accordance with these rules, the MRO may order a reanalysis of the original sample at any licensed laboratory licensed under these rules.

(6) Scientifically Unsatisfactory Results. The MRO, based on a review of the chain of custody form, quality control data, multiple samples and other pertinent results, is permitted to determine that the result is scientifically unsatisfactory for further action and may request the donor to provide another sample or request a reanalysis of the original sample before making such decision. The MRO is permitted to request that the reanalysis be performed by the same laboratory or, that an aliquot of the original specimen be sent to another licensed laboratory. The laboratory shall assist in this review process as requested by the MRO and shall make available appropriate personnel to provide consultation as required by the MRO. The MRO shall report all findings based on the unsatisfactory specimen, as required by this rule chapter, but shall not include any personal identifying information in such reports.

(7) Contacting Donors Who Test Positive.

(a) If the MRO is unable to contact a donor who tested positive within 3 working days of receipt of the test results from the laboratory, the MRO shall contact the employer and request that the employer direct the donor to contact the MRO as soon as possible. If the MRO has not been contacted by the donor within 2 working days from the request to the employer, the MRO shall verify the report as positive.

(b) As a safeguard to employees and job applicants, once a MRO verifies a positive test result, the MRO may change the verification of the result if the donor presents information to the MRO which documents that a serious illness, injury, or other circumstance unavoidably prevented the employee from contacting the MRO within the specified time frame and if the donor presents information concerning a legitimate explanation for the positive test result.

(c) If the donor declines to talk with the MRO regarding a positive test result, the MRO shall validate the result as positive and annotate such decline in the remarks section.

(8) Identification of Donor. Prior to providing an employee or job applicant with the opportunity to discuss a test result, the MRO shall confirm the identity of the employee or job applicant. At a minimum, to confirm the identity of the donor, the MRO shall ask the donor to respond with the following information:

(a) If the request is in person, the MRO shall request a picture identification.

(b) If the request is over the telephone, the MRO shall request:

An employee identification number or social security number;
Date of birth;
Employer’s name; and,
Work telephone number.

(9) Information for Donor. Once the donor’s identification has been established, and before any additional information is solicited from the donor, the MRO shall:

(a) Inform the donor that the MRO is an agent of the employer whose responsibility is to make a determination on test results and report them to the employer;

(b) Inform the donor that medical information revealed during the MRO’s inquiry will be kept confidential; unless the donor is in a safety sensitive or special risk position and the MRO believes that such information is relevant to the safety of the donor or to other employees. Any additional release of information shall be solely pursuant to a written consent form signed voluntarily by the donor, except where such release is compelled by a hearing officer or a court of competent jurisdiction pursuant to an appeal, or where deemed appropriate by a professional or occupational licensing board in a related disciplinary proceeding.

(d) If the donor voluntarily admits to the use of the drug in question without a proper prescription, the MRO shall advise the donor that a verified positive test report will be sent to the employer.

(10) Verification Signature. After the MRO reviews the chain of custody forms from the laboratory and the collection site (Copy 2 from the laboratory and Copy 4 from the collection site) and, in the case of a positive test result, has contacted the donor who tested positive, the MRO shall:

(a) On Copy 2 of the chain of custody form, mark the appropriate box if the verified result is positive or negative and if positive, write in for which drug(s). If the test was not performed or the test was canceled, mark the appropriate box. The reason for the cancellation or non-performance of the test shall be explained in the remarks section.

(b) On Copy 2 of the chain of custody form, sign and date the verification of the final test result.

(c) Prepare and sign a verification letter to the employer revealing the final verified test result. Copies of the laboratory report form or chain of custody are not suitable for this purpose.

History

Rulemaking Authority 112.0455(13)(a) FS. Law Implemented 112.0455 FS. History–New 6-28-91, Formerly 10E-18.008, Amended 5-1-96, 3-11-98, 2-3-05, 4-6-26.

Fla. Admin. Code R. 59A-24.009 Statistical Information Reporting

History

Rulemaking Authority 112.0455(12)(c) FS. Law Implemented 112.0455 FS. History–New 6-28-91, Formerly 10E-18.009, Amended 5-1-96, Repealed 12-4-96.

Chapter 59A-25 MINIMUM STANDARDS FOR HOME MEDICAL EQUIPMENT PROVIDERS

Fla. Admin. Code R. 59A-25.001 Definitions

In addition to definitions contained in Chapters 400, Part VII, and 408, Part II, F.S., the following terms shall apply to this rule chapter:

(1) “AHCA” means Agency for Health Care Administration.

(2) “Central Service Center” means the licensed premises that are in charge of taking consumer orders, dispatching the orders to licensed distribution centers owned and operated by the same licensee that provide home medical equipment services, and maintaining consumer and personnel records. The central service center is responsible for the operation of its designated distribution centers.

(3) “Distribution centers” means those licensed premises that are not located at the address of the central service center but are owned and operated by the same licensee, receive orders from the central service center and are utilized to provide home medical equipment services.

(4) “HME” means home medical equipment.

History

Rulemaking Authority 400.935, 408.819 FS. Law Implemented 400.935, 408.804 FS. History–New 6-4-00, Amended 10-6-02, 3-13-07, 5-4-15.

Fla. Admin. Code R. 59A-25.002 Licensure Requirements

(1) Home medical equipment locations requiring a license are any locations that sell, rent, or distribute, or offer to sell or rent to or for a consumer any home medical equipment that requires services. These locations can be identified as follows:

(a) Any location providing or distributing home medical equipment requiring services to consumers in Florida;

(b) Any location where an intake person takes calls from consumers in Florida and offers to sell or rent home medical equipment requiring services;

(c) Any location where a consumer in Florida may call in response to a provider advertising to sell or rent home medical equipment requiring services, e.g., television advertisements, toll-free telephone numbers, phone books, newspapers, flyers or any other forms of public advertisement;

(d) Any location out of state that offers to sell or rent home medical equipment requiring services to consumers in Florida;

(e) Any location in state or out of state, with sales representatives working in Florida, that offers to sell or rent home medical equipment requiring services to consumers in Florida, i.e., the sales representatives themselves do not need to be licensed; and,

(f) Any buildings, that are not located at the licensed central service center address, called shops, warehouses, distribution centers, or called by any other name, are required to have a license if that site location provides selection (via telephone, showroom or sales representative), delivery, set up, consumer instruction or maintenance of equipment to consumers in Florida.

A central service center must provide the names and locations of all of its designated distribution centers on the licensure application.
A distribution center must submit a separate licensure application and must specify the name of its central service center on the application.
Each licensed distribution center is required to meet all standards for licensure but may be determined to meet the standards through the activities of its designated central service center as referenced in paragraph 59A-25.005(1)(b), F.A.C.

(2) Home medical equipment locations that do not require a license: Diabetic monitors and disposable supplies, e.g., diabetic, ostomy, urological and wound care supplies have been identified as equipment and supplies that do not require services as defined in Section 400.925(9), F.S.; therefore, locations that supply these items only will not require a HME license.

(3) Licensing application and fees:

An application for initial, change of ownership and renewal licensure must be made on the Health Care Licensing Application, Home Medical Equipment Provider, AHCA Form 3110-1005, October 2014, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-05267, and the Health Care Licensing Application Addendum prescribed in subsection 59A-35.060(1), F.A.C. These forms are available online at http://ahca.myflorida.com/HQAlicensureforms. An application for initial, change of ownership and renewal licensure must be accompanied by a non-refundable $304.50 biennial licensing fee and, if required, a $400 inspection fee per location. Businesses with a central service center having distribution centers are required to submit an application and a $304.50 biennial licensing fee for each location, but shall submit only one $400 inspection fee with the application of the central service center.

(4) Initial and change of ownership applicants must submit proof of financial ability to operate pursuant to Sections 408.8065(1) and 408.810(8), F.S., and Rule 59A-35.062, F.A.C. for each location to be licensed

(5) Each licensed HME provider location must obtain and maintain professional and commercial liability insurance as referenced in Sections 400.931(3) and 408.810(7), F.S. A corporation can provide a blanket policy, which indicates that each of its licensed locations is insured under one policy, verifying not less than $250,000 per claim for each location.

(6) Initial applicants and providers requesting to change the address of record must provide proof of compliance with local zoning requirements. Physical location cannot be a post office box. The licensee must have all county licenses and permits that are applicable.

(7) If a change of name and/or address of record is to occur, the provider must submit Home Medical Equipment Provider, Request to Amend License for Change of Name and/or Address, AHCA Form 3110-1020, October 2014, https://www.flrules.org/Gateway/reference.asp?No=Ref-05268, incorporated by reference, and available online at http://ahca.myflorida.com/HQAlicensureforms, according to the timeframes as required in subsection 59A-35.040(2), F.A.C., and accompanied by a fee as required in subsection 59A-35.050(4), F.A.C.

History

Rulemaking Authority 400.935, 408.805, 408.810(8), 408.819 FS. Law Implemented 400.925, 400.93, 400.931, 400.933, 400.935, 400.953, 408.803, 408.806, 408.8065, 408.807, 408.809, 408.810, 408.815 FS. History–New 6-4-00, Amended 10-6-02, 4-13-03, 3-13-07, 5-4-15.

Fla. Admin. Code R. 59A-25.003 Scope of Services

(1) Minimum standards: Each home medical equipment provider must:

(a) Have a visible sign with the name of the business, business hours, and a phone number where the business can be contacted during business hours.

(b) Maintain personnel records that must include the following: employment history for the past 5 years, proof of background screening including a signed copy of the good moral character form and a license of any professional that may work from that location. A distribution center will not be required to maintain personnel records but its central service center shall be responsible for maintaining personnel records.

(c) Provide management and consumer instruction regarding the use of home medical equipment requiring services, as referenced in Section 400.925(11), F.S. Delivery services include transportation of equipment and supplies to and from consumer homes, equipment setup, and record keeping.

(d) Coordinate services with another provider in the event the HME cannot ensure the provision of equipment and services as required in Section 400.935(7), F.S.

(e) Be ultimately responsible for the management of all equipment and services even if a contractor is involved.

(f) Honor all express warranties regarding assistive technology devices. The duration of the express warranty must be at least one year after first delivery of the assistive technology device to the consumer as required in Section 427.803, F.S.

(g) Honor all warranties as required in Section 400.934(9), F.S., and warranty used equipment at least 30 days.

(h) Provide the consumer with user instructions as required in Section 400.934(13), F.S.

(i) Be able to demonstrate the safety and infection control measures that follow:

Procedures that identify safety precautions to be followed in the handling and use of each type of equipment and its related supplies;
Equipment is routinely inspected for safety and stability prior to delivery;
The electrical adequacy and safety of a home is assessed prior to placing any electrical or electronic equipment, and instructions are provided to consumers regarding applicable precautions and safety measures;
Compliance with bedding and mattress reuse regulations;
Specific cleaning or sanitizing requirements between usage for each type of equipment according to the manufacturers’ guidelines;
Storage of unclean equipment separate from clean equipment;
Transportation of unclean equipment separate from clean equipment;
Storage of equipment to prevent dust accumulation, water damage, and vermin contact; and,
Equipment is safely maintained and installed based upon the manufacturers’ instructions.

(2) Home medical equipment includes oxygen and related respiratory equipment, customized wheelchairs and related seating and positioning as referenced in Section 400.925(8), F.S. In addition to the home medical equipment referenced in Section 400.925(8), F.S., other examples of equipment requiring services include the following:

(a) All equipment defined in Section 400.925(13), F.S., as life-supporting or life-sustaining equipment, which includes suctioning equipment.

(b) Continuous positive airway pressure machines, all electrostimulation equipment such as bone, muscle and transcutaneous electrical nerve stimulators, hospital beds, intermittent positive pressure breathing machines, motorized scooters, nebulizers, passive motion devices, patient lifts, phototherapy (billirubin) light with photometer, pressure ulcer care equipment, specialty prescribed cribs (child safety), trapeze equipment, ventilator equipment (that is non-life supporting), wheelchairs, and walkers. All of the equipment referenced here in paragraph (b), including the custom wheelchairs and seating as referenced in Section 400.925(8), F.S., is considered non-life supporting equipment.

(3) Minimum service standards required for equipment are as follows:

(a) Services for all home medical equipment must be based upon the current recommended manufacturers’ standards.

(b) The provider must prioritize consumer service needs based upon the urgency of the situation. Any equipment utilized to provide a therapy treatment, as prescribed by the consumer’s physician, shall require urgent attention. Also, any equipment in general that is completely non-functional shall be serviced with urgency. Any equipment that is functional, but needs minor repair may be serviced in a less urgent time frame. All service requests must be responded to in a timely manner that satisfies the consumer’s needs.

(c) Service must be provided for life-supporting or life-sustaining equipment 24 hours, 7 days per week. Emergency service requests, as referenced in Section 400.934(8), F.S., must be responded to with a telephone call, within 30 minutes and back up service provided at the consumer’s home within two hours or less due to equipment failure or power outages. Providers must offer assistance regarding registration with emergency management services for consumers who use life-supporting or life-sustaining equipment.

(d) Services may be provided for non-life supporting or life-sustaining equipment during regular business hours. Requests for consumer instruction or any needed repair shall be responded to by telephone within the same working day. The consumer may bring to the provider’s place of business any small equipment item requiring consumer instruction or repair.

(e) Life-support or life-sustaining equipment and related supplies must be provided to the consumer in the home environment based on initial and periodic reassessments of the consumer’s equipment needs. Life supporting or life sustaining equipment shall be provided based upon physician orders including any physician order for medically necessary back-up equipment and supplies.

(4) Consumer records:

(a) A record must be maintained for each consumer that documents the home medical equipment and any services received as required in Section 400.94(1), F.S.

(b) Consumer information may not be disclosed from the consumer’s file without the written consent of the consumer, the consumer’s guardian or the consumer’s power of attorney. All information received by any employee, contractor or AHCA employee regarding a consumer of the HME is confidential.

(c) Consumer records must be made available to AHCA representatives when an inspection or a complaint investigation is done.

(d) Retained records can be stored as hard paper copy, microfilm, computer discs or tapes as long as they are retrievable for use during unannounced inspections or complaint investigations.

(5) Contracts: Services provided by contract for consumers must be through a written agreement between the provider and the business providing any equipment and services for a consumer, herein referred to as the contractor. Contracts must be retained for a minimum of 5 years. The contract must include the following at a minimum:

(a) A description of any of the equipment or services to be provided by the contractor;

(b) Designation if the HME provider or the contractor is responsible for monitoring the equipment and services provided by the contractor;

(c) Charges for any contracted equipment and services and designation of who will be billing the consumer, the HME provider or the contractor;

(d) Responsibility of the HME provider to retain and maintain all records of consumers served by a contractor;

(e) Evidence that the contractor has professional and commercial liability insurance coverage (the licensee is responsible for making sure that the contractor has liability insurance);

(f) Period of the contract between the HME provider and the contractor;

(g) Procedures for reporting service and maintenance notes and any clinical or progress notes by the contractor to the HME provider;

(h) Date and signatures of all parties, and,

(i) Contracts must be retained for a minimum of five years.

History

Rulemaking Authority 400.935 FS. Law Implemented Chapter 400, Part VII, 400.92-.957 FS. History–New 6-4-00, Amended 10-6-02, 3-13-07.

Fla. Admin. Code R. 59A-25.004 Minimum Qualifications for Personnel

The provider must be in compliance with and make available to AHCA surveyors the information referenced in this section.

(1) General Manager, as defined in Section 400.925(7), F.S.:

(a) Qualifications: A minimum of two years experience in business management or a college degree in business or a health care related field can substitute for the required experience year for year.

(b) Duties: The general manager is responsible for the following areas either directly or by clear delegation in writing:

Assuring the maintenance of consumer records including equipment repair and maintenance records as referenced in Section 400.94, F.S.;
Maintain job descriptions of staff;
Assuring trained and qualified staff essential to the services provided as referenced in Sections 400.934(4), (5), (15), F.S.;
Keeping program personnel up to date with health care information and practices;
Directing staff in performance of their duties;
Assuring that staff can accommodate consumer’s language;
Assuring an adequate inventory of equipment and supplies to provide consumers currently being served;
Assuring that policies are developed and implemented as required in state law and rule;
Maintaining and updating procedure manuals related to business functions;
Maintain customer service complaint records containing the specifics related to the complaint and how the complaint was resolved as referenced in Sections 400.934(8) and (10), F.S.;
Evaluating services, and personnel;
Establishing and maintaining effective channels of communication;
Maintaining training manuals and records verifying all training that personnel has received or is scheduled to receive thus assuring staff development including orientation, in-service education, and continuing education; and,
Assuring adequate staff supervision during all service hours.

(2) Licensed health care professionals, such as respiratory therapists, certified respiratory therapy technicians, registered nurses, and licensed practical nurses that may be on staff or contracted with as needed for service provision:

(a) Qualifications: Current professional license(s);

(b) Training: Clinical staff must have required experience or training relative to the specific service they are providing; and,

(c) Duties: Provider policies must clearly identify that the respective duties of each type of clinical professional worker are within the scope of the described clinical responsibilities.

(3) Delivery personnel:

(a) Qualifications: A driver’s license as required by law for the vehicle being driven and the physical capacity to handle the equipment assigned. Delivery persons must be able to accommodate the consumer’s language and have the ability to work without continuous direct supervision;

(b) Training: Delivery and equipment service staff shall have successfully completed a documented training program covering all components of their assigned jobs including training for each type of equipment they are responsible for delivering; and,

(c) Duties: Delivery personnel are responsible for providing safe and clean transport of equipment and supplies to and from consumer homes, setting up equipment safely, and record keeping of the equipment delivered. They must provide in writing to the consumer a telephone number for use during business hours and an emergency number for after business hours when life supporting or life sustaining equipment is provided.

(4) Maintenance personnel:

(a) Qualifications: The ability to maintain and coordinate the repair of all equipment and to work without continuous direct supervision;

(b) Training: Attend any training required by the manufacturer regarding equipment maintenance; and,

(c) Duties: Coordinate maintenance of equipment, complete and sign maintenance logs that verify equipment has been maintained and repaired as required by manufacturer standards.

History

Rulemaking Authority 400.935 FS. Law Implemented Chapter 400, Part VII, 400.92-.957 FS. History–New 6-4-00, Amended 10-6-02, 3-13-07.

Fla. Admin. Code R. 59A-25.005 Compliance

(1) The survey or inspection:

(a) Except as described in paragraphs (b) and (c), each separately licensed home medical equipment provider location must be in compliance with and shall be surveyed in accordance with Chapters 400 Part VII, and 408, Part II, F.S., Chapter 59A-35, F.A.C. and these rules.

(b) If a provider is operating with a central service center that has one or more distribution centers, the central service center shall be the premises where the survey will be initiated. A surveyor will inspect at least one of the distribution centers associated with the central service center. The distribution center will be held accountable for equipment and services provided but will not be responsible for maintaining patient or personnel records.

(c) All providers must have available, at the time of survey, at least one category of equipment that is provided directly, filling orders from its own inventory as referenced in Section 400.934(2), F.S. Failure to have, at the time of survey, at least one category of equipment that is provided directly will result in the provider’s application being denied or the provider’s license being revoked. A licensed central service center may be determined to meet this standard through the inventory available at its designated distribution center.

(2) AHCA will conduct investigations of complaints regarding violations of licensure requirements. Complaint investigations will be unannounced. Distribution centers will be allowed forty-eight hours to obtain patient or personnel records from its central service center and to submit the records to the area office when related to a complaint investigation.

(3) Adverse action: Denial, Suspension, Revocation, and Administrative Fines.

(a) AHCA shall deny, suspend or revoke an application for license, or impose a fine for the reasons in Section 400.932, Part II of Chapter 408, F.S., Chapter 59A-35, F.A.C., and for the following reasons:

(a) If the provider fails to submit an application for a change of ownership within the time frames specified in Sections 408.806 and 408.807, F.S., a $50 fine per day, not to exceed 50% percent of the licensure fee, shall be levied. If the application is received after the required filing date and, exhibits a hand-canceled postmark from a United States Post Office dated on or before the required filing date, no fine will be levied;

(b) If the provider is cited for a Class I violation as defined in Section 408.813(2)(a), F.S., the agency shall impose an administrative fine in the amount of $5,000 for each occurrence and each day that the deficiency exists. In addition, the agency shall immediately revoke the license, deny the renewal of a license or impose a moratorium on accepting new consumers until the factors causing the deficiency have been corrected;

(c) If the provider is cited for a Class II violation as defined in Section 408.813(2)(b), F.S., the agency shall impose an administrative fine in the amount of $1,000 for each occurrence and each day that the deficiency exists. In addition the agency shall revoke the license, deny the renewal of a license or impose a moratorium of new consumers until the deficiency has been corrected;

(d) If the provider is cited for a Class III violation as defined in Section 408.813(2)(c), F.S., the agency shall impose an administrative fine not to exceed $500 for each occurrence and each day that the uncorrected or repeated deficiency exists;

(e) If the provider is cited for a Class IV violation as defined in Section 408.813(2)(d), F.S., the agency shall impose an administrative fine not to exceed $200 for each occurrence and each day that the uncorrected or repeated deficiency exists;

(f) If the provider is not available for inspection during the office hours indicated on its licensure application, AHCA shall deny an initial, renewal or change of ownership application or impose a $500 fine upon a licensed provider;

(g) If the central service center’s license is revoked, the revocation includes the licenses of all distribution centers;

(h) Failure of a provider to provide records to AHCA during an inspection shall result in a $500 fine; and,

(i) Failure of a distribution center to provide records to AHCA within forty-eight hours shall result in a $500 fine.

History

Rulemaking Authority 400.935, 408.819 FS. Law Implemented 400.932, 400.933, 400.934, 400.935, 408.806, 408.807, 408.811, 408.812, 408.813, 408.815 FS. History–New 6-4-00, Amended 10-6-02, 3-13-07, 5-4-15.

Fla. Admin. Code R. 59A-25.006 Emergency Management Planning

(1) Pursuant to Section 400.934(20)(a), F.S., each home medical equipment provider must prepare and maintain a written comprehensive emergency management plan, that meets the minimum criteria in these rules and the Comprehensive Emergency Management Plan (CEMP) Format for Home Medical Equipment (HME) Providers, AHCA Form 3110-1019, December 2006, incorporated by reference. This document is available from the Agency for Health Care Administration at http://ahca.myflorida.com under Licensing & Certification, Home Medical Equipment Provider. The CEMP Format contains the minimum criteria that must be included in each home medical equipment provider emergency management plan, as required in Section 400.934(20), F.S. The plan must describe how the home medical equipment provider establishes and maintains an effective response to emergencies and disasters. The completed plan will be e-mailed or mailed to the local county health department for each county listed on the home medical equipment provider’s license as required in Section 400.934(20)(b), F.S., unless the county health department does not require submission of home medical equipment provider emergency management plans per Section 381.0303(7), F.S.

(2) The home medical equipment provider must review its emergency management plan on an annual basis, make any substantive changes and inform their staff of those changes. For the purposes of this section, ‘substantive changes’ would include, but not be limited to, change of address, change of administrative staff who are responsible for coordinating the home medical equipment provider‘s emergency response or their contact telephone numbers and change of type of equipment or equipment services provided.

(3) The substantive changes as defined in subsection 59A-25.006(2), F.A.C., must be reported to the county emergency management office and to the county health department. For home medical equipment providers with multiple counties on their license, the changes must be reported to each county health department and each county emergency management office designated on the license. The telephone numbers must include numbers where the coordinating staff can be contacted outside of the home medical equipment provider’s regular office hours. All home medical equipment providers must report these changes, whether their plan has been previously reviewed or not, as defined in subsection (1).

(4) When a home medical equipment provider goes through a change of ownership, the new owner must review the emergency management plan and make any substantive changes, including changes noted in subsection (3). Those home medical equipment providers will need to report any substantive changes in their plans to the reviewing entity in subsection (1).

(5) In the event of an emergency, the home medical equipment provider must implement the emergency management plan pursuant to Section 400.934(20), F.S.

(6) Home medical equipment providers must assist consumers receiving HME services who would need assistance and sheltering during evacuations because of physical, mental, cognitive impairment, or sensory disabilities in registering with the local emergency management agency, as required in Section 252.355(1), F.S., and as determined by the established procedures of the local emergency management agency related to special needs registration.

(a) Each home medical equipment provider must, pursuant to Sections 400.934 and 252.355, F.S., inform consumers and consumer caregivers, by the best method possible as it pertains to the person’s disability, of the special needs registry and procedures for registration at the special needs registry maintained by their county emergency management office.

(b) If the consumer is to be registered with the special needs registry, the home medical equipment provider must assist the consumer with registering, pursuant to Sections 400.934 and 252.355, F.S., and the established procedures of the local emergency management agency. The home medical equipment provider must document in the consumer’s file if the consumer plans to evacuate or remain at home and if the consumer’s caregiver or family can take responsibility during the emergency for equipment services normally provided by HME staff or independent contractors referred by the home medical equipment provider or if the home medical equipment provider needs to make referrals in order for equipment services to continue. If the consumer is also receiving services through any other licensed health care provider or federal or state funded program designated in Section 252.355, F.S., to help clients register with the special needs registry, then the home medical equipment provider will check with the other service provider or program case manager to verify if the consumer has already been registered. If so, a note will be made in the consumer’s file by the home medical equipment provider that the consumer’s need for registration has already been reviewed and handled by the other provider or program. Home medical equipment providers are not required to assist consumers residing in skilled nursing facilities, assisted living facilities or adult family care homes with special needs registration as those licensed facilities are responsible for evacuation and alternative sheltering of their clients.

(c) The collected registration information must be furnished to the county emergency management agency pursuant to Section 400.934, F.S., and as determined by the established procedures of the local emergency management agency related to special needs registration.

(7) The home medical equipment provider must provide the same type and quantity of equipment services to its consumers, which must include those being served in assisted living facilities and adult family care homes, who evacuate to special needs shelters which were being provided prior to evacuation, pursuant to Section 400.934(20)(a), F.S. Home medical equipment providers are not required to continue to provide services to consumers in emergency situations that are beyond their control and that make it impossible to provide services, such as when roads are impassable or when consumers do not go to the location specified in their consumer records.

(8) If the home medical equipment provider is unable to provide equipment services to consumers who are special needs registry patients, including any assisted living facility and adult family care home special needs registry patients, then the provider will make reasonable efforts to find another resource for the consumer, pursuant to Section 400.934(20)(a), F.S. This would include arranging for services for consumers who have been forced to relocate outside of the geographic service area of the home medical equipment provider.

(9) During emergency situations, when there is not a mandatory evacuation order issued by the local county emergency management office, some consumers, registered pursuant to Section 252.355, F.S., may decide not to evacuate and will stay in their homes. The home medical equipment provider must establish procedures, prior to the time of an emergency, which will delineate to what extent the provider will continue to arrange for essential equipment services during and immediately following an emergency pursuant to Section 400.934(20)(a), F.S.

History

Rulemaking Authority 400.925, 400.934, 400.935 FS. Law Implemented 400.925, 400.934, 400.935 FS. History–New 3-13-07.

Chapter 59A-26 MINIMUM STANDARDS FOR INTERMEDIATE CARE FACILITIES FOR THE DEVELOPMENTALLY DISABLED

Fla. Admin. Code R. 59A-26.001 Definitions

(1) Administrator – The person who is responsible for the overall management of an Intermediate Care Facilities for the Developmentally Disabled (hereinafter referred to as ICF/DD) licensed under this part and certified under 42 CFR 483 Subpart I. The Administrator must meet the following criteria:

(a) Be a Qualified Intellectual Disability Professional (QIDP); or

(b) Be a licensed nursing home administrator; or

(c) Have a bachelor’s degree in a human services field and at least one year of experience working with persons with developmental disabilities or related conditions; or

(d) Have five years of experience working with persons with developmental disabilities or related conditions is sufficient. This requirement is for administrators who become effective after the date of this rule.

(2) Advanced Practice Registered Nurse (APRN) – A person duly licensed to practice as an advanced practice registered nurse in accordance with Chapter 464, F.S.

(3) Certified Behavior Analyst – A person who is certified under the Florida Behavior Certification Program in accordance with Section 393.17, F.S.

(4) Client Representative – The person authorized or designated to act on behalf of a client, which may include a guardian, guardian advocate, or other legally appointed representative, a parent, or if unavailable, another family member.

(5) Day Program – A program that provides day services for individuals in a non-residential setting. The array of services may include pre-school, pre-vocational and vocational training, behavior management, adult education, recreation, semi-independent and independent skills development training, and individual therapies.

(6) Dental Hygienist – A person duly licensed to practice as a dental hygienist in accordance with Chapter 466, F.S.

(7) Dentist – A person duly licensed to practice dentistry in accordance with Chapter 466, F.S.

(8) Facility – The total administrative unit officially licensed and certified as an ICF/DD, which may consist of a number of living units.

(9) Health Care Professional – A physician, physician assistant or advanced practice registered nurse.

(10) Interdisciplinary Team (IDT) – The IDT shall be composed of client or client’s representative, Qualified Intellectual Disability Professional, social worker, a licensed nurse, the client’s physician and other staff in disciplines determined by the individual client’s needs to develop a care plan to include prevention and management interventions with measurable goals. The team will determine that it is safe for the resident to self-administer drugs before the resident may exercise that right.

(11) Level of Care – The type of care required by a Medicaid applicant or recipient based on medical and related needs as defined by the criteria established in rule 59G-4.170, F.A.C.

(12) Licensed Nurse – A person duly licensed to practice nursing as a licensed practical nurse, registered nurse or APRN in accordance with Chapter 464, F.S.

(13) Licensed Practical Nurse – A person duly licensed to practice as a practical nurse in accordance with Chapter 464, F.S.

(14) Over-the-Counter Medication (OTC) – Medication that is authorized, pursuant to federal or state law, for general distribution and use without a prescription in the treatment of human diseases, ailments, or injuries.

(15) Ophthalmic Medication – Eye solution (eye drops) or ointment to be instilled in the eye or applied around the eyelid.

(16) Oral Medication – Any medication, tablet, capsule, or liquid introduced into the gastrointestinal tract by mouth.

(17) Otic Medication – Solutions or ointments to be applied in the outer ear canal or around the outer ear.

(18) Pharmacist – A person duly licensed to practice pharmacy in accordance with Chapter 465, F.S.

(19) Physician – A person duly licensed to practice medicine in accordance with Chapter 458 or 459, F.S.

(20) Physician’s Assistant – A person duly licensed to practice medicine in accordance with Chapter 458 or 459, F.S.

(21) Prescribed Medication – A drug or medication obtained pursuant to a prescription, as defined in Section 465.003, F.S.

(22) Psychologist – A person duly licensed to practice as a psychologist in accordance with Chapter 490, F.S.

(23) Qualified Intellectual Disabilities Professional (QIDP) – A person who meets the requirements for a QIDP as required by 42 C.F.R. Part 483, Subpart I, Section 483.430, F.S.

(24) Registered Dietitian – A person registered by the Commission on Dietetic Registration of the American Dietetic Association.

(25) Registered Nurse (RN) – A person duly licensed to practice as a registered nurse in accordance with Chapter 464, F.S.

(26) Unlicensed Medication Assistant (UMA) – An unlicensed direct care service staff member employed in an ICF/DD who has completed the required medication administration training and has met skills validation requirements for the administration of medications to an ICF/DD client.

History

Rulemaking Authority 400.967, 400.9685 FS. Law Implemented 400.967, 400.9685 FS. History–New 12-21-15.

Fla. Admin. Code R. 59A-26.002 Licensure Procedure, Fees and Exemptions

(1) Application for licensure to operate an Intermediate Care Facility for the Developmentally Disabled (ICF/DD) must be submitted on the Health Care Licensing Application, Intermediate Care Facilities for the Developmentally Disabled, AHCA Form 3110-5003, April 2021 which is incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-13996 and must be accompanied by the Health Care Licensing Application Addendum referenced in subsection 59A-35.060(1), F.A.C. Applicants for renewal of an ICF/DD license or for a change during the licensure period can submit the Health Care Licensing Online Application, Intermediate Care Facilities for the Developmentally Disabled. AHCA Form 3110-5003OL, April 2021, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-13997. These forms are available at: http://ahca.myflorida.com/HQAlicensureforms or, for online submissions at http://apps.ahca.myflorida.com/SingleSignOn Portal.

(a) Successful completion of a licensure survey by the Agency to determine compliance with the requirements of Chapter 400, Part VIII, Chapter 408, Part II, F.S., Chapter 59A-35, F.A.C., and this rule chapter must occur prior to issuing a license.

(b) A license will not be issued until the application fee has been received by the Agency and all monies owed to the Agency have been paid as specified in Section 408.831(1), F.S.

(2) Applicants for initial licensure must submit to the Agency:

(a) An approved plan review and on-site construction survey conducted by the Agency showing compliance with Chapter 400, Part VIII, F.S. and this rule chapter, and a certificate of occupancy from the local building authority;

(b) A completed licensure application using the forms referenced in subsection (1) of this rule;

(c) If the facility is managed by an entity other than the licensee, a copy of any and all letters of intent, agreements, memoranda of understanding, or contracts between licensee and management company;

(d) An approved fire inspection report from the local fire authority completed no more than three months prior to the date of receipt by the Agency of the initial licensure application;

(e) Documentation of compliance with the community residential home requirements as required by Chapter 419, F.S., if applicable;

(f) Satisfactory current proof that the applicant possesses the financial ability to operate the facility as required by Section 408.810, F.S;

(g) A copy of the Certificate of Need issued by the Agency for the facility to be licensed; and,

(h) Proof of the licensee’s current right to occupy the ICF/DD building, such as, a copy of a lease, sublease agreement or deed.

(3) Applicants applying for renewal of a license must submit a completed licensure application using the forms referenced in subsection (1) of this rule.

(4) Applicants applying for a change of ownership must submit:

(a) A completed application for licensure using the forms referenced in subsection (1) of this rule; and,

(b) All documents and fees required for initial licensure in subsection (1) of this rule, with the exception of paragraphs (2)(a), (d), (e), and (g).

(5) In addition to the provisions of Chapter 400, Part VIII, Chapter 408, Part II, Chapter 409, F.S. and rule Chapter 59G-4, F.A.C., a license may be suspended, revoked or denied in any case where the Agency finds that there has been failure to comply with certification or re-certification requirements as a Medicaid provider.

History

Rulemaking Authority 400.967, 408.819 FS. Law Implemented 400.962, 400.967, 408.804, 408.805, 408.806, 408.807, 408.809, 408.810, 408.811, FS. History–New 12-21-15, Amended 2-27-22, 6-11-25.

Fla. Admin. Code R. 59A-26.003 Classification of Deficiencies

(1) Violations of Chapter 400, Part VIII, and Chapter 408, Part II, F.S., shall be classified according to the nature of the violation and the gravity of its probable effect on clients as required in Section 408.813(2), F.S. Violations shall be classified on the written notice as follows:

(a) A class I deficiency is subject to a civil penalty of $5,000 for an isolated deficiency, $7,500 for a patterned deficiency and $10,000 for a widespread deficiency. A fine may be levied notwithstanding the correction of the deficiency.

(b) A class II deficiency is subject to a civil penalty of $1,000 for an isolated deficiency, $3,000 for a patterned deficiency and $5,000 for a widespread deficiency. A citation for a class II deficiency shall specify the time within which the deficiency must be corrected.

(c) A class III deficiency is subject to a civil penalty of $500 for an isolated deficiency, $750 for a patterned deficiency and $1,000 for a widespread deficiency. A citation for a class III deficiency shall specify the time within which the deficiency must be corrected. If a class III deficiency is corrected within the time specified, no civil penalty shall be imposed, unless it is a repeated offense.

(d) A class IV deficiency is subject to a civil penalty of $100 for an isolated deficiency, $300 for a patterned deficiency and $500 for a widespread deficiency. If a class IV violation is corrected within the time specified, a fine may not be imposed.

History

Rulemaking Authority 400.967, 408.813, 408.819 FS. Law Implemented 400.967(3), 408.813, 408.815 FS. History–New 12-21-15.

Fla. Admin. Code R. 59A-26.004 Responsibilities for Operation

The licensee must ensure compliance with state regulations in Chapters 400, Part VIII, 408, Part II, 409, F.S., and Chapter 59G-4, F.A.C.

History

Rulemaking Authority 400.967 FS. Law Implemented 400.967 FS. History– New 12-21-15.

Fla. Admin. Code R. 59A-26.005 Fiscal Standards

The licensee must maintain fiscal records as required by Chapter 409, Part III, F.S., Rules 59G-5.020 and 59G-6.040, F.A.C. There must be a system of accounting used to accurately reflect details of the ICF/DD operation, including clients’ funds held in trust and other client property. The fiscal and client fund records must be supported by documentation of all transactions. Documentation of quarterly reconciliation for client fund records must be kept on file for five years and must be provided to the Agency for review when requested. The licensee must:

(1) Refund any amount or portion of prepayment in excess of the amount or portion obligated for services already furnished if a client leaves the facility prior to the end of any prepayment period.

(2) Maintain financial and statistical records in accordance with Title 42 CFR, Sections 483.420(b)(1)-(2), effective October 1, 2014, as incorporated by reference and located at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-420.xml and http://www.flrules.org/Gateway/reference.asp?No=Ref-06401.

(3) Comply with requirements of Rules 59G-6.040 and 59G-6.045, F.A.C.

(4) Keep complete and accurate records of all clients’ funds, other effects, and property.

(5) Deposit and maintain in an interest bearing account with a financial institution on behalf of each client, all money and interest on money held for that client. A copy of the client’s bank account statements and expenditure detail must be provided to the client or client’s representative within seven calendar days of written request.

(5) Protect clients’ funds from theft, negligence or abuse. Should loss of a client’s funds occur, the licensee will be responsible for reimbursing the client for the full amount of funds to which he or she is entitled within 30 calendar days of confirmation of the theft, negligence or abuse of client funds.

(7) Make a final accounting of all personal effects and money belonging to the client held by the licensee upon the discharge or death of a client within 30 calendar days after the client’s discharge or death.

History

Rulemaking Authority 400.967 FS. Law Implemented 400.967(2)(e) FS. History–New 12-21-15.

Fla. Admin. Code R. 59A-26.006 Admission Policies and Requirements

(1) The admission of an individual to an ICF/DD must be under the supervision of the administrator of the facility.

(2) Individuals shall only be admitted after completion of a written admission agreement. The agreement must be in effect at all times while the individual is a client of the facility. The agreement must be reviewed bi-annually for revisions by the licensee and the client or client’s representative. Either party may initiate revision to the agreement at any time. No agreement or any provision thereof shall be construed to relieve any licensee of any requirement or obligation imposed upon it by Chapters 400, Part VIII, and 408, Part II, F.S., and this rule. Such agreements must be maintained by the licensee for at least five years after each client’s discharge from the facility, and assess no additional charges, expenses or other financial liabilities in excess of the provisions included in the admission contract. All charges for services not covered by Title XIX of the Social Security Act or not covered by the basic per diem rates of the licensee, for which the client or the client’s representative may be responsible for payment, must be specified in the admission contract.

(3) The licensee must comply with the admission agreement. The admission agreement must include a description of the program and services to be provided, including:

(a) The daily, weekly, or monthly rate and refund provisions for unused portions thereof;

(b) Board;

(d) Residential and nursing services;

(e) Linen and furnishings;

(f) Sufficient seasonal clothing as required by the client and applicable to the client’s needs for instances when the client or client’s representative does not provide sufficient clothing. Sufficient seasonal clothing must be provided and include a basic wardrobe for the client, including a five-day supply of sleepwear, socks, shoes, undergarments, outer clothing to include shirts, pants, or dresses; a winter coat; raingear; and personal grooming and hygiene items. The licensee must maintain an inventory of the client’s clothing and provide a copy of the inventory to the client or client’s representative within fourteen calendar days of a written request;

(g) Training and assistance as required with activities of daily living;

(h) The provision and maintenance of walkers, wheelchairs, dentures, eyeglasses, hearing aids and other orthotic, prosthetic or adaptive equipment as prescribed;

(i) Therapies prescribed by the client’s individual habilitation or support plan including medical and nutritional therapies;

(j) Transportation services including vehicles with lifts or other adaptive equipment when needed;

(k) Other services prescribed in the client’s individual habilitation or support plan; and,

(l) Provisions for providing a duplicate of the agreement to the client or client’s representative.

(4) The following conditions apply to admission and retention of all clients:

(a) Individuals must not be admitted to or retained in a facility if the licensee cannot provide, or arrange for the provision of, all services prescribed in the individual habilitation or support plan.

(b) Clients who have been voluntarily admitted must not be held in a facility against their will.

(c) The licensee must develop procedures to be implemented in the event that a voluntarily admitted client should decide to leave the facility against the recommendations of the interdisciplinary team. Procedures must include:

Counseling by the facility social worker or QIDP with referrals made to the Agency for Persons with Disabilities and other professionals or advocates, as appropriate.
If a client insists on leaving, the licensee will assist the client in locating an appropriate alternative placement.

(5) Individuals who have a communicable disease must be evaluated by a physician prior to admission. If the physician’s evaluation finds the disease would endanger other clients of the facility, then the admission should be postponed until the communicable period has passed or appropriate precautions have been implemented by the facility staff.

(6) A registered nurse must assess each newly admitted client within four hours after admission.

(7) If a pre-existing medical condition exists, if medical problems are identified by the nursing admissions assessment, or if a client is admitted who does not have a complete medical record including medical history, positive physical findings, diagnosis, and signed physician’s orders for treatment, nursing care or diets, the client must be examined by the admitting physician within 96 hours of admission.

History

Rulemaking Authority 400.967 FS. Law Implemented 400.967(2)(f) FS. History–New 12-21-15.

Fla. Admin. Code R. 59A-26.007 Personnel Standards

(1) Each new staff member employed by the facility to provide direct services to clients must have a medical examination at the time of employment and prior to contact with clients. Annually thereafter, staff must submit a physician’s statement that, based on test results, the employee does not constitute a threat of communicating diseases to clients. If any staff is found to have or is suspected of having a communicable disease, then he or she must be removed from all duties that require contact with clients until certification is received from a physician that such risk no longer exists.

(2) Background screening shall be performed as required by Chapters 400, Part VIII, and 435, Section 408.809, F.S., and Rule 59A-35.090, F.A.C.

(3) Regardless of the organization or design of client living units, the minimum overall direct care staff-client ratios must comply with those specified in 42 CFR 483.430(d)(3), dated October 1, 2014, as incorporated by reference and available at http://www.gpo.gov/fdsys/pkg/CFR-2014-title42-vol5/xml/CFR-2014-title42-vol5-sec483-430.xml and http://www.flrules.org/Gateway/reference.asp?No=Ref-06402.

(4) The licensee must have an administrator, licensed nurses to care for each client’s health care needs, and QIDPs to ensure each client’s active treatment program is integrated, coordinated and monitored.

(5) All staff must receive training within 30 days of employment and annually thereafter on the licensee’s emergency disaster procedures that include the staff’s role before, during, and after the emergency.

(6) The licensee must ensure that 50% of its staff on duty at all times are certified in cardio-pulmonary resuscitation (CPR) and have received basic first aid training.

(7) All staff must receive training and demonstrate competency in the prevention and minimal use of restraint and seclusion within 30 days of employment. Competency in these methods must be demonstrated and documented annually thereafter. Training must include:

(a) The emotional and physical effects of restraint and seclusion on clients and staff;

(b) History of trauma, impact on clients and the potential for retraumatization;

(d) Applicable legal and clinical requirements governing behavioral services, restraints and seclusion;

(e) Safe and appropriate initiation of physical contact and application and monitoring of restraints and seclusion; and,

(f) Approaches to facilitate the earliest possible release from restraints or seclusion.

History

Rulemaking Authority 400.962, 400.967 FS. Law Implemented 400.964, 400.967(2)(b), 400.967(2)(h), 408.809, FS. History–New 12-21-15.

Fla. Admin. Code R. 59A-26.008 Training, Habilitation, Active Treatment, Professional, Special Programs and Services

(1) Programs, services, functions and the pattern of staff organization within the facility must be focused upon serving the individual needs of each client and the facility must provide for:

(a) Comprehensive diagnosis and evaluation of each client as a basis for planning, programming and management of the client so that the client’s abilities, preferences, needs, behavior assessment, behavior intervention plan and level of functioning are comprehensive in scope and adequately addressed in the habilitation plan or support plan.

The QIDP is responsible for the integration, coordination, monitoring and review of each client’s active treatment program, which may require the involvement of other personnel, including other agencies serving the client.
For school age clients, when services are provided by the local school district, the licensee must include the school system, the client, and client’s representative in the habilitation planning process. The licensee’s individual program plan shall be in addition to any individual education plan prepared by the school district.

(b) Freedom of movement consistent with the protection of the health, safety, and welfare of individual clients within and outside of the facility.

(c) Routine and ongoing monitoring of each client’s conditions for early detection of health or nutrition risks, which, when found, must be analyzed by the IDT to identify probable causes and to implement appropriate intervention strategies.

(d) Recognition and resolution of client care problems through participation of professional staff and consulting personnel.

(e) Consideration of every reasonable alternative, least restrictive and most effective procedures, prior to the use of invasive treatment.

(f) Proper positioning of clients who cannot position themselves in appropriate body alignment.

(g) Documentation of observed evidence of progress that each client demonstrates in attaining goals and objectives specified in the habilitation plan, support plan or individual program plans.

(h) Each client’s active treatment program plan must be reviewed and revised by the IDT annually and when there is a substantial reduction of active treatment or routine physical care in response to health care needs as indicated by a loss of acquired skills or significant worsening of undesirable behavior.

(i) All clients shall have the opportunity to eat orally and receive therapeutic services necessary to maintain or improve eating skills and abilities, unless this is not possible as assessed by the IDT. For clients who receive enteral and/or parenteral feedings, the IDT must evaluate and review these clients’ potential to return to oral eating at least quarterly.

(j) Client rights as required by the Bill of Rights of Persons Who Are Developmentally Disabled, Sections 393.13(3) through 393.13(4)(j), F.S.

(k) Equipment essential to ensure the health, safety and welfare of each client.

(2) Staff responsible for providing client care must be knowledgeable in the physical and nutritional management skills appropriate to the clients served.

(3) The licensee must provide instruction, information, assistance and equipment to help ensure that the essential physical and nutritional management of each client is continued in educational, day treatment and acute care facilities.

(4) Licensed practical nurses working in an ICF/DD must be supervised by a registered nurse, APRN or physician. Nursing physical assessments must be conducted by a registered nurse, APRN or physician.

(5) Nursing service documentation in client records must include a comprehensive nursing assessment and client specific medications, treatments, dietary information, and other significant nursing observations of client conditions and responses to client programs. For those clients with stable conditions, nursing progress summaries are adequate in lieu of shift documentation, as long as significant events are also recorded.

(6) Standing orders for medications, and pro re nata (p.r.n. or “as needed”) orders are prohibited for the use of psychotropic medication including hypnotics, antipsychotics, antidepressants, antianxiety agents, sedatives, lithium, and psychomotor stimulants. The client’s physician must review medication orders at least every 60 calendar days except for clients having a Level of Care 9, in which case medication orders must be reviewed by the physician at least every 30 calendar days.

(7) For clients using medication to manage behavior, the client’s individual program plan must specify observable and measurable symptoms to be alleviated by the medication, intervals for re-evaluating the continued use of the medications by the IDT and consideration of the reduction and elimination of the medication.

(8) When a psychotropic medication is initiated based upon a recommendation by the IDT, a physician, APRN, registered nurse or pharmacist must ensure or make provisions for the instruction of the facility staff regarding side effects and adverse effects of the prescribed medication including when to notify the physician if undesirable side effects or adverse effects are observed. The staff must document in the progress notes that these instructions have been given. Any time a psychotropic medication is initiated, changed, increased or decreased, the facility must assure the physician writes a progress note. The facility must ensure the physician makes a progress note every 30 calendar days. The effect of the medication on targeted symptoms must be reviewed and monitored at least quarterly by the IDT.

(9) Psychologists or certified behavior analysts must provide consultation and in-service training to staff concerning:

(a) Principles and methods of understanding and changing behavior in order to devise the most optimal and effective program for each client.

(b) Principles and methods of individual and program evaluation, for the purposes of assessing client response and measuring program effectiveness.

(10) If a physical restraint is used on a client, the client must be placed in a position that allows airway access and does not compromise respiration. Airway access and respiration must not be blocked or impeded by any material placed in or over the client’s mouth or nose. A client must be placed in a face-up position while in restraints. Hand-cuffs or shackles must not be used for the purposes of restraints.

(a) Restraints and seclusion must not be used for the convenience of staff.

(11) The licensee must develop and implement policies and procedures to reduce, and whenever possible, eliminate the use of restraints and seclusion. Policies must include:

(a) Debriefing activities as follow-up to use of restraints and seclusion;

(b) A process for addressing client’s concerns and complaints about the use of restraint and seclusion; and,

(12) Recreation required by each client’s habilitation plan or support plan must be provided as a purposeful intervention through activities that modify or reinforce specific physical or social behaviors.

(13) Leisure activities for clients for whom recreation services are not a priority in the client’s individual program plan, must be provided in accordance with individual preferences, abilities, and needs, and with the maximum use of community resources.

History

Rulemaking Authority 400.962, 400.967 FS. Law Implemented 400.967(2)(d),(f),(h) FS. History–New 12-21-15.

Fla. Admin. Code R. 59A-26.009 Dietary Services

(1) A registered dietician must oversee dietary services and must provide medical nutritional therapy.

(2) Menus must be prepared in advance, followed, and made accessible to clients and staff.

(3) Menus must be approved by the registered dietitian.

(4) Each client must receive food prepared by methods that conserve nutritive value, flavor and appearance.

(5) Each client must receive food that is palatable, attractive and at the proper temperature.

(6) Substitutes offered must be of similar nutritive value.

(7) As required by the Department of Health, all matters pertaining to food service must comply as required by the following regulations based on the number of beds to be licensed:

(a) For facilities with 25 or more beds the provisions of rule Chapter 64E-11, F.A.C., Food Hygiene.

(b) For facilities with 24 beds or fewer the provisions of rule Chapter 64E-12, F.A.C., Community Based Residential Facilities.

History

Rulemaking Authority 400.967 FS. Law Implemented 400.967(2)(c),(f) FS. History–New 12-21-15.

Fla. Admin. Code R. 59A-26.010 Dental Services

(1) Comprehensive dental diagnostic services must be provided to all clients and must include:

(a) Periodic, at least annual, oral prophylaxis, by a dentist or dental hygienist; and,

(b) At least annually, a complete extra and intra-oral examination utilizing diagnostic aides necessary to properly evaluate each client’s oral condition.

(2) Comprehensive dental treatment services must be provided to all clients and must include:

(a) Daily oral care, as prescribed by a dentist or dental hygienist;

(b) Emergency treatment on a 24-hour, seven days-a-week basis, by a dentist; and,

History

Rulemaking Authority 400.967 FS. Law Implemented 400.967(2)(f) FS. History–New 12-21-15.

Fla. Admin. Code R. 59A-26.011 Psychological Services

Psychologists providing services to the clients of the facility must be licensed pursuant to Sections 490.005 and 490.006, F.S., and have a minimum of one year of experience or training in the field of intellectual or developmental disabilities.

History

Rulemaking Authority 400.967(2) FS. Law Implemented 400.967(2)(f) FS. History–New 12-21-15.

Fla. Admin. Code R. 59A-26.012 Drugs and Pharmaceutical Services

(1) An ICF/DD must have a Class I Institutional Pharmacy Permit as required by the Department of Health in Section 465.019, F.S. All prescription medications must be compounded and dispensed by a pharmacy registered in Florida. A consultant pharmacist must be responsible for implementation of the pharmacy program as defined by each licensee even when the consultant pharmacist is not the vendoring pharmacist.

(2) Labeling of prescription medications must be done as required by the Department of Health in Sections 465.0235, 465.186 and 499.0054, F.S., and rule Chapter 64B16-27, F.A.C., as required by the Department of Health. Stock bottles of nonprescription drugs which are properly labeled according to the regulations related to the Drug and Cosmetic Act, Section 499.0054, F.S., are permitted.

(3) All drugs, including nonprescription stock drugs, must be stored in a locked room or cabinet, or in a locked drug cart. External medications must be stored separately from internal and ophthalmic preparations.

(4) Biologicals and other drugs must be stored to maintain its integrity of packaging, quality and potency. If refrigeration is required then these drugs must be in a locked container.

(5) All drugs listed in Schedules II through V must be handled, used, administered and dispensed as required by the Florida Comprehensive Drug Abuse Prevention and Control Act in Section 893.06, F.S.

(6) A count of controlled drugs listed in Schedules II-V of Section 893.03, F.S., must be made jointly between shifts by the licensed nurse beginning duty and the licensed nurse leaving duty. For facilities licensed for six beds or less, the count must be done by the supervising registered nurse on a weekly basis. For facilities licensed for more than six beds, a medication count of controlled substances must be made at every change of shift by the licensed nurse or an unlicensed medication assistant (UMA) as defined in Rule 59A-26.002, F.A.C. The count at shift change must be witnessed by another licensed nurse or another staff member trained in medication administration.

(7) A record must be maintained for all drugs listed in Section 893.03, F.S., of the Florida Comprehensive Drug Abuse Prevention and Control Act as Schedules II, III, IV, and V for continuous reconciliation.

(8) Medicinal substances classified as controlled substances by the Drug Enforcement Administration (DEA), as provided in the Drug Abuse Prevention and Control Act of 1970 and related regulations, and Section 893.03, F.S., as required by the Florida Comprehensive Drug Abuse Prevention and Control Act and must be disposed of as required by Rule 64B16-28.303, F.A.C., as required by the Department of Health.

(9) Disposal of other drugs not covered above must be made in accordance with a system of drug administration.

(10) All prescribed drugs dispensed for the client while in the facility may be given to the client or client’s representative upon discharge with the physician’s written orders.

(11) An inventory of drugs released must be prepared and signed by the licensed nurse releasing the drugs and the person receiving the drugs. This inventory must be filed in the client’s medical record.

(a) All medications of deceased clients must be accounted for on an inventory list prepared by a licensed nurse and filed in the client’s record. These medications must be returned for credit or destroyed in accordance with subsections (8) and (9), above.

(b) All controlled drugs not administered to a client due to wastage, loss, or returned to the pharmacy must be documented in each client’s medical record and accounted for by licensed nurse as required by the Florida Comprehensive Drug Abuse Prevention and Control Act in Section 893.07, F.S.

(12) All verbal orders must be written on the physician’s order sheet by the licensed nurse receiving the order and countersigned by the physician within 72 hours. Verbal orders for Schedule II drugs are permitted in emergency situations but are limited to a 72-hour supply. In an emergency situation, the physician must directly contact the pharmacist and the pharmacist must receive a copy of the original or direct copy of the physician’s order within 72 hours as required by the Florida Comprehensive Drug Abuse Prevention and Control Act in Section 893.04, F.S.

(13) Telephoned physician orders for medication may only be accepted by a licensed nurse, a physician’s assistant or a licensed pharmacist. Telephoned orders will be immediately recorded in the client’s medical record. Faxed physician orders are acceptable with a physician’s signature. A physician’s signature on the original physician’s order must occur within 72 hours of receipt of the faxed order.

History

Rulemaking Authority 400.967 FS. Law Implemented 400.967(2)(f) FS. History–New 12-21-15.

Fla. Admin. Code R. 59A-26.013 Administration of Medications to ICF/DD Clients by Unlicensed Medication Assistants

(1) It is the responsibility of the licensee to ensure that individual unlicensed medication assistants (UMA or UMAs) who will be administering medication to clients meet all requirements of this rule.

(2) Unlicensed medication assistants may administer only prescribed, prepackaged, premeasured oral, topical nasal, and ophthalmic medications.

(3) UMAs may administer over the counter (OTC) medications as currently prescribed by the client’s health care professional.

(4) UMAs may not:

(a) Administer medications by injection including intra-muscular, intravenous or subcutaneous;

(b) Administer medication vaginally or rectally; or

(5) UMAs may administer medications to a client only after the following requirements are met for that client:

(a) A current informed consent has been signed by the client or client’s representative. The consent must acknowledge and permit UMAs to administer specifically listed medications prescribed by a licensed health care professional to the client. The informed consent must be updated and signed annually;

(b) A written report for the client that indicates the client’s behavior and any past medication reactions must be documented on the Medication Administration Record (MAR). The written report and MAR must be updated if the client’s behavior or medication reactions change. Information included in the written report can be provided by the client or client’s representative, or another UMA or direct care staff person who is familiar with the client. The person administering medications must be familiar with the information included in the written report and MAR prior to administering medications to clients; and,

(6) Administration of medication by UMAs must be under the supervision of a registered nurse or APRN.

(a) Supervision includes weekly monitoring of medication and 24-hour availability of a registered nurse or APRN via telephone or paging device;

(b) Prior to assigning tasks to an UMA, the supervisory nurse must verify the training and validation of the unlicensed medication assistant as required by this rule chapter;

(d) Monitoring and supervision of the completion of the assignment must be documented by the supervising nurse;

(e) The supervising nurse must participate in performance evaluations of the UMA relative to performance of medication administration.

(7) Requirements governing acquiring, receiving, dispensing, administering, disposing, labeling, and storage of medication by UMAs include:

(a) Outdated medication must be properly destroyed by the supervising nurse. The disposal must be witnessed by one other staff of the facility and a record of the medication disposal must be maintained by the facility and signed by the supervising nurse and witness;

(b) Torn, damaged, illegible or mislabeled prescription labels must be reported immediately to the dispensing pharmacy or pharmacist;

(d) No client shall be administered a prescription or OTC medication or treatment, except upon the written order of the client’s prescribing health care professional.

(8) When administering medications to clients, the UMA must:

(b) Prepare medications for one individual client at a time in a quiet location that is free from distraction;

(d) Administer medications to each client, at the time, with the dosage, and by the route prescribed by the client’s health care professional. Each time medication is administered:

Conduct a triple-check of the dosage and time of administration against the original medication container label and the MAR before administering or supervising the self-administration of the medication;
Confirm the client to whom the medication is to be administered is the same client for whom the medication has been prescribed or ordered;
Administer as prescribed and via the route instructed by the client’s prescribing health care professional;
Do not crush, dilute or mix medications without written directions or instructions from the client’s prescribing health care professional;
Check the expiration date before administering each medication. Medications with an expiration date preceding the current date must not be administered;
Facilitate the correct positioning and use any adaptive equipment or techniques required for that client for the proper administration of medications.

(e) Ensure the oral medication administered or supervised during self-administration has been completely ingested before leaving the client. Directly observe the client for a period of at least twenty minutes following the administration of a new medication ordered by the client’s prescribing health care professional. This observation period is to immediately detect and react to possible side effects of the medication or to document the effectiveness of the medication. UMAs must review the MAR for special instructions regarding required observation of medications and the UMA must monitor for side effects and effectiveness of all administered drugs.

(f) Immediately record the administration of the medication in the MAR.

History

Rulemaking Authority 400.9685, 400.967 FS. Law Implemented 400.9685, 400.967 FS. History–New 12-21-15.

Fla. Admin. Code R. 59A-26.014 Training and Validation Required for Unlicensed Medication Assistant

(1) Required medication administration training must include criteria to ensure that competency is demonstrated through validation and revalidation of the qualification of the UMA and all requirements of UMAs specified in this rule chapter.

(2) Medication administration training must be conducted by a registered nurse, APRN or physician for UMAs and will be provided by the ICF/DD licensee. Any person providing medication administration training sessions or conducting skills validation or revalidation tests must first complete a trainer orientation session, which includes requirements of this rule and information to be covered during medication administration training sessions. Documentation of the trainer’s completed orientation must be provided to each UMA that he or she trains or validates.

(3) Medication administration training must include the following topics:

(a) Basic knowledge and skills necessary for medication administration charting on the Medication Administration Record (MAR);

(b) Roles of the physician, nurse, pharmacist and direct care staff in medication supervision;

(d) Interpretation of common abbreviations used in the administration and charting of medications;

(e) Knowledge of facility medication systems;

(f) Safety precautions used in medication administration;

(g) Methods and techniques of medication administration;

(h) Problems and interventions in the administration of medications;

(i) Observation and reporting of anticipated side effects, adverse effects and desired positive outcome; and,

(j) Each duty of UMAs as required in this rule chapter.

(4) Validation or revalidation of the effective completion of the training is required for each UMA to assess that competency has been achieved after completion of required training. To become validated or revalidated, the UMA must be able to successfully demonstrate, in a practical setting, his or her ability to correctly administer or supervise the self-administration of medications to clients in a safe and sanitary manner and to correctly and accurately document actions related to the administration of medications, in accordance with the requirements of this chapter. At completion of the training, an UMA must attain an overall score of 100% on knowledge tests that cover the training and facility specific questions. The UMA will have three attempts to achieve a 100% score. If after the third attempt a score of 100% is not achieved, the UMA must repeat the training and may not administer medication to clients until such time as a score of 100% is achieved. Additionally, an UMA must be able to state the purpose, common side effects, and signs and symptoms of adverse reactions for a list of commonly used medications from memory or demonstrate how they obtain that information and maintain it for easy access.

(5) Validation or revalidation of competency will be conducted by an RN, physician, or APRN. The ICF/DD licensee will maintain documentation containing the following information:

(a) The name and address of the validator;

(b) Validation or revalidation date, with expiration date of 365 days from the validation;

(d) Validating health care professional’s license number, with license expiration date.

(7) The following must be validated or revalidated for each UMA:

(a) Demonstration of the ability to read and follow medication instructions on a prescription label, physician’s order or MAR;

(b) Demonstration of the ability to write legibly, complete required documentation, and convey accurate and discernible information; and,

(8) UMAs and the ICF/DD licensee must maintain a copy of the UMA’s current skills validation document, and documentation of orientation for their medication administration trainer and validator. UMAs are responsible for maintaining a copy of these documents and providing copies to the ICF/DD licensee, if requested.

(9) If requested, an UMA will have available a copy of their signed skills validation documentation to provide to the client or client’s representative. UMAs will also have available, if requested, a copy of their annual skills revalidation documentation, within five working days of the revalidation date.

(10) UMAs who have not successfully renewed their validation prior to the expiration date will not be eligible to administer medications to clients until medication administration retraining and revalidation of skills have been successfully completed.

History

Rulemaking Authority 400.9685, 400.967 FS. Law Implemented 400.9685, 400.967 FS. History–New 12-21-15.

Fla. Admin. Code R. 59A-26.015 Plant Maintenance and Housekeeping

(1) The facility must maintain the interior and exterior of buildings accessible to clients and all equipment, furniture, and furnishings in a clean manner and in such condition such that client safety and well-being are not jeopardized.

(2) Each licensee must establish written policies designed to maintain the physical plant and overall ICF/DD environment in such a manner that the safety and well-being of clients are ensured. The building and mechanical maintenance program must be under the supervision of a qualified person, as determined by the facility. All mechanical and electrical equipment must be maintained in working order, and must be accessible for cleaning and inspecting. All mechanical systems must be tested, balanced and operated prior to being placed into service and maintained in good working order. The facility must have a written plan for maintenance, including record keeping, sufficient staffing, equipment, and supplies. The licensee must:

(a) Maintain the building in good repair, safe and free of the following: cracks in the floors, walls, or ceilings; peeling wallpaper or paint; warped or loose boards; warped, broken, loose, or cracked floor covering, such as tile, linoleum or vinyl; loose handrails or railings; loose or broken window panes and screens; and other similar hazards;

(b) Maintain all electrical, lighting (interior and exterior), signal, mechanical, potable water supply, hot water heaters, heating, air conditioning, fire protection and sewage disposal systems in safe, clean and functioning condition;

(d) Maintain the interior and exterior finishes of the buildings as needed to keep them clean and safe, to include painting, washing, and routine maintenance;

(e) Maintain all furniture and furnishings in a clean and safe condition;

(f) Maintain the grounds free from refuse, litter, insect, vermin, and vermin breeding areas; and,

(g) Maintain screens on windows and doors in good repair, free of breaks in construction.

(3) The facility must have a plan for housekeeping including staff, equipment and supplies. As part of the licensee’s housekeeping plan, the licensee must:

(a) Keep the buildings in a clean, safe and orderly condition. This includes all rooms, corridors, attics, basements and storage areas;

(b) Keep floors clean and non-slip to ensure client safety;

(c) Control odors within the housekeeping staff’s areas of responsibility by effective cleaning procedures and by the proper use of ventilation. Deodorants must not be used to cover up odors caused by unsanitary conditions or poor housekeeping practices;

(d) Keep attics, basements, stairways and similar areas free of accumulations of refuse, discarded furniture, discarded equipment, newspapers, magazines, boxes and other similar items;

(e) Not use bathrooms, shower stalls and lavatories for laundering, janitorial or storage purposes; and,

(f) Store all cleaning compounds, insecticides and all other potentially hazardous compounds or agents in locked cabinets or rooms.

(4) The licensee must have a written plan and must supply clean linens to a client based on the weather and climate. Linens must be in good condition to provide proper care and comfort to each client, either through onsite laundry service or a contract with an outside service.

(a) The on-site laundry room must be maintained and operated in a clean, safe and sanitary manner.

(b) Written operating procedures must be developed and implemented to provide for the handling and storage of clean and soiled linens. These operating procedures must be available to all facility staff or Agency representatives upon request.

(c) Laundry personnel must thoroughly wash their hands and exposed portions of their arms with soap and water before starting work, after smoking, eating, using the toilet or handling soiled linens.

(d) Clean linen must be protected from contamination during handling and storage.

(e) Soiled linen must be handled and stored in a manner that protects facility clients and personnel.

(f) If an outside laundry service is used, the facility must ensure that clean linens are protected during transport back to the facility to avoid contamination.

(g) Clients’ personal clothing must be handled and clothing stored in a manner that will not allow contamination of clean clothing by soiled clothing. The licensee must ensure that the personal clothing or linens of each client are returned to that individual client after laundering.

History

Rulemaking Authority 400.967 FS. Law Implemented 400.967(2)(a), (c) FS. History–New 12-21-15.

Fla. Admin. Code R. 59A-26.016 Fire Protection, Life Safety, Systems Failure, and External Emergency Communications

(1) Standards for fire prevention for the facility are those adopted pursuant to Rule 69A-3.012, F.A.C., as required by the Division of State Fire Marshal at Department of Financial Services, and Chapter 69A-38, F.A.C., Uniform Fire Safety Standards for Residential Facilities for Individuals with Developmental Disabilities, as required by the Agency for Persons with Disabilities, as applicable to the classifications of occupancy therein.

(2) The Agency shall conduct an annual fire safety survey. Based upon the survey, a report of deficiencies will be provided to the facility with a time frame for correction.

(3) ICF/DD’s providing personal care, as defined in the Life Safety Code NFPA 101 as adopted pursuant to Rule 69A-3.012, F.A.C., as required by the Division of State Fire Marshal at the Department of Financial Services, and rule Chapter 69A-38, F.A.C., as required by the Agency for Persons with Disabilities, will be reviewed as a Residential Board and Care occupancy under the Florida Specific Edition of NFPA 101 Life Safety Code, as adopted pursuant to Rule 69A-3.012, F.A.C., as required by the Division of State Fire Marshal at the Department of Financial Services, and rule Chapter 69A-38, F.A.C. as required by the Agency for Persons with Disabilities. ICF/DD’s providing services to clients that receive chronic, skilled/acute nursing or medical care or designated as a Level of Care 9 will be reviewed as a Health Care occupancy status under the Florida Specific Edition of NFPA 101 Life Safety Code, as adopted pursuant to Rule 69A-3.012, F.A.C., as required by the Division of State Fire Marshal at Department of Financial Services and rule Chapter 69A-38, F.A.C., as required by the Agency for Persons with Disabilities. To ensure the life safety code requirements are appropriate for all clients served in an ICF/DD, each licensure survey shall establish or confirm the occupancy status. Beginning December 1, 2015, upon renewal of each ICF/DD license, the license shall display the occupancy status. The ICF/DD licensee must receive written approval from the Agency, including the Office of Plans and Construction, prior to a change in the occupancy status. A client requiring chronic, skilled/acute nursing or medical care, or designated as a Level of Care 9 client, may not reside in an ICF/DD with a Residential Board and Care occupancy status.

(4) Each licensee must provide fire protection through the elimination of fire hazards as evidenced by compliance with the fire codes referenced in subsection 59A-26.016(1), F.A.C.

(5) All fires or explosions must be reported by the licensee within 24 hours by phone to the Agency for Health Care Administration’s field office and the Office of Plans and Construction. Upon notification the Agency field office shall coordinate with the local fire investigation authority to determine the cause, origin, and circumstances of the fire or explosion. The licensee shall complete the form “Fire Incident Report”, AHCA #3500-0031, revised July 2014, incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06199 or from the Office of Plans and Construction, Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop 24, Tallahassee, Florida 32308 or from the website at http://ahca.myflorida.com/MCHQ/Plans/pdfs/Fire.pdf. The form must be completed by the licensee and submitted to the Agency’s Office of Plans and Construction within 10 calendar days of the incident.

(6) In the event of a system failure of the fire alarm system, smoke detection system, or sprinkler system, the following actions must be taken immediately by the licensee:

(a) Notify the local fire authority and document any instructions received by the licensee;

(b) Notify the Agency for Health Care Administration Office of Plans and Construction, and the Agency’s local field office; and,

(c) Assess the extent of the condition, and implement corrective action with a documented period for compliance. If the corrective action will take more than four hours to complete, the following items must be completed:

Implement a contingency plan containing a description of the problem, a specific description of the system failure, and the projected correction period. All staff on shifts involved must have documented in-service training for the emergency contingency.
Begin a documented fire watch until the system is restored. Persons used for fire watch must receive training specific to their duty including what to look for, what to do, and how to expeditiously contact the fire department. To maintain a fire watch, the facility must utilize only certified public fire safety personnel, a guard service, or facility staff. If facility staff is utilized for this function, they must meet the following requirements:

a. Be off duty from their regular facility position or assigned only to fire watch duty and be excluded from counting toward the required staffing pattern;

b. Be trained and competent as determined by the licensee in the duties and responsibilities of a fire watch; and,

c. Have immediate access to electronic communication.

If the projected correction period changes or when the system is restored to normal operation, the licensee must notify the Agency’s Office of Plans and Construction, the Agency’s local field office and local fire authorities.

(7) Each new facility must provide for external electronic communication not dependent on terrestrial telephone lines, cellular, radio or microwave towers, such as an on-site radio transmitter, satellite communication systems or a written agreement with an amateur radio operator volunteer group(s). If the latter, this agreement must provide for a volunteer operator and communication equipment to be relocated into the facility in the event of a disaster until communications are restored. Other methods, which can be shown to maintain uninterrupted electronic communications not dependent on land-based transmission, must be pre-approved by the Agency’s Office of Plans and Construction.

History

Rulemaking Authority 400.967 FS. Law Implemented 400.967(2)(a) FS. History–New 12-21-15.

Fla. Admin. Code R. 59A-26.017 Plans Submission and Fee Requirements

(a) Preliminary Stage II approval letter from the Agency’s Office of Plans and Construction;

(b) Construction documents and specifications for all work to be undertaken;

(c) A letter from the licensee holding the Agency harmless for any changes that may occur to the project as a result of the final construction document review; and,

(d) A life safety plan indicating temporary egress and detailed phasing plans indicating how the area(s) to be demolished or constructed is to be separated from all occupied areas must be submitted for review and approval when demolition or construction in and around occupied buildings is planned.

(3) Projects that have been submitted for the Agency’s Office of Plans and Construction review will be considered abandoned if:

(a) Construction has not begun within one year after written approval of the construction documents from the Agency’s Office of Plans and Construction;

(b) No further plans have been submitted for Agency review within one year after a project has been initiated with the Office of Plans and Construction, or

(c) Construction has been halted for more than one year. After this termination, resubmission as a new project will be required.

(5) The initial submission of plans to the Agency’s Office of Plans and Construction for any new project must include a completed Application for Plan Review, AHCA Form 3500-0011, June 2014, incorporated by reference and obtainable at http://www.flrules.org/Gateway/reference.asp?No=Ref-05456 or from the Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop 24, Tallahassee, Florida 32308, or from the Agency’s website at http://ahca.myflorida.com/plansandconstruction, and a valid certificate of need, if required pursuant to Chapter 408, F.S. This information must accompany the initial submission. Approval will not be granted for any project without a Certificate of Need as required by Rule 59C-1.004, F.A.C.

(6) Plans and specifications submitted for review shall be subject to a plan review fee pursuant to Section 400.967(5), F.S. A non-refundable initial fee of $2,000 will be charged for all projects. The Agency will also collect a fee, not to exceed one percent of the estimated construction cost or the actual cost of review, whichever is less, for the portion of the review which encompasses initial review through the initial revised construction document review. Additionally, the Agency will collect its actual costs on all subsequent portions of the review and construction inspections. All fees must be paid to the Agency for Health Care Administration, with notation of the Office of Plans and Construction facility log number, and identified that it is for the Agency’s Health Care Trust Fund. Plan review fees must be included with the application.

(7) Plans and specifications shall be submitted in three stages of development described in this rule. Approval of a Stage III submission is required to begin construction (except as permitted by subsection 59A-26.017(2), F.A.C.). These stages are as follows:

(a) Stage I, schematic plans.

(b) Stage II, preliminary plans or design development drawings.

(8) For each stage of submission a functional program or project narrative must be submitted. It must consist of a detailed word description of all contemplated work and any required phasing to be provided in the proposed construction.

(9) For projects involving only equipment changes or system renovations, construction documents must be submitted. These documents must include the following:

(a) Life safety plans showing the fire/smoke compartments in the area of renovation;

(b) Detailed phasing plans indicating how the new work will be separated from all occupied areas; and,

(10) Stage I, schematic plans must include:

(a) Single-line drawings of each floor showing the relationship of the various activities or services to each other and the room arrangement in each, which shall include:

The function of each room or space must be noted in or near the room or space;
The proposed roads and walkways, service and entrance courts, parking, and orientation must be shown on either a small plot plan or on the first floor plan;
A simple cross-section diagram showing the anticipated construction;
A schematic life safety plan showing smoke and fire compartments, exits, exit passageways, and gross areas of smoke and fire compartments; and,
Information as to which areas are sprinklered, both new and existing.

(b) The facility and general arrangement of other buildings, if the proposed construction is an addition or is otherwise related to existing buildings on the site.

(11) Stage II preliminary plans will be approved by the Agency upon successful demonstration that the construction will comply with applicable life safety code requirements, flood requirements and that the layout will accommodate all required functional space as evidenced by a thorough examination of documents submitted as required by this subsection. Stage II, preliminary plans must include:

(a) A vicinity map. For new facility construction a vicinity map shall include the major local highway intersections.

(b) Site development plans that include:

Existing grades and proposed improvements as required by the schematic submission;
Building locating dimensions;
Site elevations for both the 100-year flood elevations and hurricane Category 3 surge inundation elevations if the project involves the construction of a new facility or is a new addition of a wing or floor to a facility; and,
The location of the fire protection services water source to the building.

Floor plans, 1/8-inch scale minimum, showing door swings, windows, casework and millwork, fixed equipment and plumbing fixtures. Floor plans shall indicate the function of each space;
A large-scale plan of typical new bedrooms with a tabulation of gross and net square footage of each bedroom including a tabulation of the size of the bedroom window glass;
Typical large-scale interior and exterior wall sections to include typical rated fire and fire/smoke partitions and a typical corridor partition;
All exterior building elevations;
Equipment which is not included in the construction contract that requires mechanical or electrical service connections or construction modifications shall be identified to ensure coordination with the architectural, mechanical and electrical phases of construction; and,
Preliminary phasing plans indicating how the project is to be separated from all occupied areas must be provided if the project is located in an occupied facility.

(d) Life safety plans that include:

Single-sheet floor plans showing fire and smoke compartmentation, all means of egress and all exit signs. Additionally, depict and provide the longest path of travel in each smoke compartment to the door(s) to the adjoining compartment, calculate the total area of the smoke compartment in square feet, and tabulate exit inches;
All sprinklered areas, fire extinguishers, fire alarm devices and pull station locations;
Fully developed life safety plans if the project is an addition to or the conversion of an existing building;
Life safety plans of the floor being renovated and the required exit egress floor(s) if the project is a renovation in an existing building; and,
A life safety plan indicating temporary egress and detailed phasing plans indicating how the area(s) to be demolished or constructed are to be separated from all occupied areas when demolition or construction in and around occupied buildings is to be undertaken.

(e) Mechanical engineering plans that include:

Single-sheet floor plans with a one-line diagram of the ventilating system with relative pressures of each space;
A written description and drawings of the anticipated smoke control system, passive or active, and a sequence of operation correlated with the life safety plans;
The general location of all fire and smoke dampers, all duct smoke detectors and firestats;
If the building is equipped with fire sprinklers, the location of the sprinkler system risers and the point of connection for the fire sprinkler system. State the method of design for the existing and new fire sprinkler systems;
Locations of all plumbing fixtures and other items of equipment requiring plumbing services and/or gas services;
Locations of all medical gas outlets, piping distribution risers, terminals, alarm panel(s), low pressure emergency oxygen connection, isolation/zone valve(s), and gas source location(s);
Locations and relative sizes of major items of mechanical equipment such as chillers, air handling units, fire pumps, medical gas storage, boilers, vacuum pumps, air compressors, and fuel storage vessels;
Locations of hazardous areas and the volume of products to be contained therein; and,
Location of fire pump, stand pipes, and sprinkler riser(s).

(f) Electrical engineering drawings that include:

A one-line diagram of normal and essential electrical power systems showing service transformers and entrances, switchboards, transfer switches, distribution feeders and over-current devices, panel boards and step-down transformers. The diagram must include a preliminary listing and description of new and existing, normal and emergency loads, preliminary estimates of available short-circuit current at all new equipment and existing equipment serving any new equipment, short-circuit and withstand ratings of existing equipment serving new loads and any new or revised grounding requirements; and,
Fire alarm zones correlated with the life safety plan.

(g) Outline specifications that include a general description of the construction, including construction classification and ratings of components, interior finishes, general types and locations of acoustical material, floor coverings, electrical equipment, ventilating equipment and plumbing fixtures, fire protection equipment, and medical gas equipment.

(h) The general layout of spaces of the existing structure with the preliminary plans for the proposed facility whenever an existing structure is to be converted to an ICF/DD facility.

(i) The general layout of spaces of the facility whenever additions, modifications, alterations, renovations, and refurbishing to a facility are proposed.

(12) Stage III, construction documents. Stage III construction documents will be approved by the Agency upon successful demonstration that the construction will comply with all applicable codes and standards as evidenced by a thorough examination of documents submitted as required by this subsection.

(a) The Stage III, construction documents must be an extension of the Stage II, preliminary plan submission and must provide a complete description of the contemplated construction. Construction documents must be signed, sealed, dated and submitted for written approval to the Agency’s Office of Plans and Construction by a Florida-registered architect and Florida-registered professional engineer. These documents must consist of work related to civil, structural, mechanical, and electrical engineering, fire protection, lightning protection, landscape architecture and all architectural work. In addition to the requirements for Stage II submission, the following must be incorporated into the construction documents:

Site and civil engineering plans that indicate building and site elevations, site utilities, paving plans, grading and drainage plans and details, locations of the two fire hydrants utilized to perform the water supply flow test, and landscaping plans;
Life safety plans for the entire project;
Architectural plans that include:

a. Typical large-scale details of all typical interior and exterior walls and smoke walls, horizontal exits and exit passageways;

c. Floor/ceiling and roof/ceiling assembly descriptions for all conditions; and,

d. Details and other instructions to the contractor on the construction documents describing the techniques to be used to seal floor construction penetrations to the extent necessary to prevent smoke migration from floor to floor during a fire.

Structural engineering plans, schedules and details;
Mechanical engineering plans to include fire and smoke control plans that include:

a. All items of owner furnished equipment requiring mechanical services;

b. A clear and concise narrative control sequence of operations for each item of mechanical equipment, air conditioning, heating, ventilation, medical gas, plumbing, and fire protection and any interconnection of the equipment of the systems;

c. Mechanical engineering drawings that depict completely the systems to be utilized, whether new or existing, from the point of system origination to its termination;

d. A tabular schedule giving the required air flow (as computed from the information contained on the ventilation rate table) in cubic feet per minute (cfm) for supply, return, exhaust, outdoor, and ventilation air for each space listed or referenced by note on the ventilation rate table as shown on the architectural documents. The schedule must also contain the Heating Ventilation and Air Conditioning (HVAC) system design air flow rates and the resulting space relative pressures; and,

e. The schedule or portion of the schedule, as applicable, which must be placed in the specifications or in the drawing set containing the spaces depicted.

Fire protection plans, where applicable, that must include the existing system as necessary to define the new work;
Electrical engineering plans that must describe complete power, lighting, alarm, communications and lightning protection systems and power system study;
A power study that must include a fault study complete with calculations to demonstrate that over-current devices, transfer switches, switchboards, panel boards, motor controls, transformers and feeders are adequately sized to safely withstand available phase-to-phase and phase-to-ground faults. The study must also include an analysis of generator performance under fault conditions and a coordination study resulting in the tabulation of settings for all over-current device adjustable trips, time delays, relays and ground fault coordination. This must be provided for all new equipment and existing equipment serving any new equipment. Power studies for renovations of existing distribution systems must include only new equipment and existing equipment upstream to the normal and emergency sources of the new equipment. Renovations involving only branch circuit panel boards without modifications to the feeder must not require a full power study; instead, the power study must be limited to the calculation of new and existing loads of the branch circuit panel; and,
A complete set of specifications for all work to be undertaken.

a. All project required contractor supplied testing and/or certification reports shall be submitted in writing reviewed, and accepted by the engineer of record prior to presenting to the Agency for Health Care Administration for review.

b. The specifications shall require a performance verification test and balance air quantity values report with the specified air filters installed for each air handling unit system operating in the minimum pressure drop condition (clean filter state) and at the maximum pressure drop condition (dirty filter state). The air quantities reported are acceptable if they are within 10 percent of the design value and the space relative pressures are maintained. This requirement must apply to any air-handling unit affected by the construction to be performed.

(b) All construction documents must be coordinated to provide consistency of design intent throughout the documents. It is specifically required that in the case of additions to facilities, the mechanical and electrical, especially existing essential electrical systems and all other pertinent conditions, must be a part of this submission.

(c) Signed, sealed and dated subsequent addenda, change orders, field orders and other documents altering the above must be submitted for review to the Agency’s Office of Plans and Construction. The Agency will either approve or disapprove the submission based on compliance with all applicable codes and standards and shall provide a listing of deficiencies in writing.

(13) The initial submission will be acted upon by the Agency’s Office of Plans and Construction within 60 days of the receipt of the initial payment of the plan review fee. The Agency will either approve or disapprove the submission and shall provide a listing of deficiencies in writing. Each subsequent resubmission of documents for review on the project will initiate another 60-day response period. All deficiencies noted by the Agency must be satisfactorily corrected before final approval may be obtained for the project.

(14) Additions that increase the scope of the project by greater than fifty percent or revisions that change greater than fifty percent of the original scope of a project will be required to be submitted as a new project.

History

Rulemaking Authority 400.967 FS. Law Implemented 400.967(2), (5) FS. History–New 1-25-17.

Fla. Admin. Code R. 59A-26.018 Physical Plant Codes and Standards for ICF/DD

(1) All construction of new facilities or conversions and all additions, modifications, alterations, renovations, and refurbishing to the site, facility, equipment or systems of a facility must be in compliance with all applicable codes and standards. In addition to the standards in this rule, the following codes apply to design and construction of ICF/DD facilities:

(a) The Florida Building Code as adopted pursuant to Rule 61G20-1.001, F.A.C., by the Florida Building Code Commission at the Department of Business and Professional Regulation.

(b) The fire codes adopted by the State Fire Marshal pursuant to rule Chapter 69A-38, F.A.C., by the Division of State Fire Marshal at the Department of Financial Services.

(c) For the purpose of determining life safety occupancy classification, facilities providing services to clients that receive chronic, skilled/acute nursing or medical care or designated as a Level of Care 9 will be classified as a health care occupancy.

(d) For the purpose of determining life safety occupancy classification, facilities providing personal care services will be classified as a residential board and care occupancy.

(2) The Fire Safety Evaluation System (FSES) NFPA-101 adopted pursuant to rule Chapter 69A-38, F.A.C., as required by the Division of State Fire Marshall at the Department of Financial Services, shall not be used to meet the required codes and standards for new construction, renovations, or for conversion of an existing building to a new licensed ICF/DD.

(3) Where additions, modifications, alterations, refurbishing, renovations or reconstruction are undertaken within a facility, all such additions, modifications, alterations, refurbishing, renovations or reconstruction must comply with sections of the applicable codes for new facilities.

History

Rulemaking Authority 400.967 FS. Law Implemented 400.967(2)(a) FS. History–New 12-21-15.

Fla. Admin. Code R. 59A-26.019 Construction and Physical Environment Standards for Facilities Providing Services to Clients that Receive Chronic, Skilled/Acute Nursing or Medical Care or Designated as a Level of Care 9

All new facilities and all additions, renovations and alterations of existing facilities must be in compliance with the following physical plant standards:

(1) Site requirements.

(a) Utilities must be commensurate with the facility’s regular operational needs and emergencies. The site must be remote from uncontrolled or uncontrollable sources of insect and rodent harborage and air and water pollution.

(b) A site may include structures other than the ICF/DD facility such as storage sheds and greenhouses. Ancillary spaces may be available within the living units or in a separate on-site structure to provide services that cannot be purchased in the community or when clients are physically unable to attend community or therapy services.

(2) Living unit requirements.

(a) There must be sufficient equipment and appliances to meet the programmatic needs of all clients.

(b) Each living unit must have a kitchen that is adequate for preparing all meals, cleaning and storing of food and equipment. The kitchen design, appliances, equipment, materials and finishes must convey the image of a home like kitchen.

(d) Provisions must be made to ensure meals are eaten at the dining table with appropriate positioning devices, chairs or wheelchairs for each client, as needed.

(e) Sufficient space must be provided to accommodate client needs for indoor gross motor, fine motor and special teaching activities within the facility.

(f) Each client living unit must have three or more bedrooms.

Each client must have accessible personal space within the bedroom to accommodate an individual bed and personal furnishings, and to decorate and arrange without disturbing others. This space must also be utilized to store personal possessions.
The dimensions and arrangement of the client bedrooms must provide a minimum of three feet wide (0.91 m) clear access space to each bed along at least 75 percent of the length of one side of the bed and must be designed to allow the use of a wheelchair and other portable equipment. In multiple-bed rooms, a clearance of 3 feet 8 inches (1.11 meters) to any fixed obstruction must be available at the foot of each bed to permit the passage of equipment and beds. For beds equipped with a piped in medical gas headwall unit, there must be minimum clearance of 3 feet (0.91m) along the entire length of the bed between both sides of the bed and any other bed, wall or any other fixed obstruction. The maximum number of clients sharing a bedroom shall be two.

(g) Each living unit must provide adequate space for all clients to carry out normal bathroom functions, or for assistance in carrying out these functions, including bathing, toileting, washing and grooming. Facilities must be as comparable to normal home like standards as is appropriate to the functional level of clients. The standard range of bathroom fixtures must be provided in adequate numbers and in standard arrangements providing privacy for clients in performing each function. Each client must have access to a toilet room without having to enter the general corridor area. One toilet room shall serve no more than four beds and no more than two client rooms. The toilet room door must be side-hinged, swing out from the toilet room, and unless otherwise required by code, be at least 32 inches (81.28 centimeters) wide.

(h) Each living unit must provide a minimum of one multi-purpose staff workroom of not less than 120 square feet.

(i) Each living unit must be equipped to wash and dry the personal clothing of all clients residing in the living unit.

(j) Each living unit must include outdoor activity spaces that provide a variety of activities accessible to clients and that provide cover and protection from the elements.

(3) Details and finishes.

(a) Potential hazards such as sharp corners or loose laid rugs or carpets shall not be permitted.

(b) Doors to all rooms containing bathtubs, showers, and water closets for client use must be equipped with privacy hardware that permits emergency access without keys. When such rooms have only one entrance or are small, the doors must open outward and, if on the corridor, must open into an alcove.

(c) All interior doors, except those that automatically close upon smoke detection, must be side-hinged swinging type doors. Interior corridor doors, except those to small closets not subject to occupancy, shall not swing into the corridor.

(d) Operable windows must be equipped with insect screens.

(e) Threshold covers must be designed to facilitate use of wheelchairs and carts and to prevent tripping and shall provide a smooth and level transition from surface to surface.

(f) Grab bars, 1-1/2 inches (3.8 centimeters) in diameter, must be installed in all client showers, tubs, and baths and on both sides of all client-use toilets. Wall-mounted grab bars shall provide a 1-1/2 inch (3.8 centimeters) clearance from walls and shall sustain a concentrated load of 250 pounds (113.4 kilograms).

(g) Handrails with a maximum diameter of 1-1/2 inches (3.8 centimeters) must be provided on both sides of all corridors used by clients. Mounting height shall be between 36 inches (91.4 centimeters) and 42 inches (106.7 centimeters). A clearance of 1-1/2 inches (3.8 centimeters) must be provided between the handrail and the wall. Rail ends shall return to the wall.

(h) Each client hand washing facility must have a mirror for the client unless prohibited by the IDT. Mirror placement must allow for convenient use by both wheelchair occupants and ambulatory persons. Tops and bottoms may be at levels usable by clients either sitting or standing. Additional mirrors may be provided for wheelchair clients, or one separate full-length mirror located in the client room may be provided to meet the needs of wheelchair clients. All mirrors must provide a distortion free image.

(i) Provisions for soap dispensing and hand drying must be included at all hand washing facilities. Hand drying provisions in client use areas shall be paper or cloth towels enclosed to protect against dust or soil and shall be single-unit dispensing.

(j) Towel bars must be provided at each bathing area.

(k) Floor material must be readily cleanable and appropriate for the location. If composition floor tiles are used, the interstices must be tight. In residential care and sleeping areas, a base must be provided at the floor line. Floors in areas used for food preparation and assembly must be water-resistant. Floor surfaces, including tile joints, must be resistant to food acids. In all areas subject to frequent wet-cleaning methods, floor materials must not be physically affected by germicidal cleaning solutions. Floors subject to traffic while wet, such as shower and bath areas, kitchens, and similar work areas, must have a slip resistant surface and floor-to-base intersections must be watertight. Carpet and padding in client areas must be stretched tight, in good repair and free of loose edges or wrinkles that might create hazards or interfere with the operation of wheelchairs, walkers, or wheeled carts.

(l) Wall finishes must be washable and, if near plumbing fixtures, must be smooth and have a moisture-resistant finish. Finish, trim, walls, and floor constructions in dietary and food storage areas must be free from rodent and insect harboring spaces.

(m) Basic wall construction in areas not subject to conditioned air must be constructed of masonry, cement, plaster or moisture resistant gypsum wallboard.

(n) The finishes of all exposed ceilings and ceiling structures in the dietary facilities area must be readily cleanable with routine housekeeping equipment.

(o) Where it is not possible to inspect smoke barriers because of the fire-tested membrane, fire-rated access panels must be installed adjacent to each side of the smoke barriers at intervals not exceeding 30 feet (9.14 meters) and in such locations as necessary to view all surfaces of the barriers.

(p) There must be a minimum clearance of six inches (15.24 centimeters) between all conduits, piping, and ductwork at corridor walls to facilitate the inspection of these walls.

(4) Mechanical system requirements.

(a) Mechanical equipment must be installed in a designated equipment room(s), or in a space(s) located in an attic(s). If the unit serves only one room it may be located above the ceiling and must be accessible through an access opening as required by the Florida Building Code. Access panels are not required for lay-in ceiling installations provided the service functions are not obstructed by other above-ceiling construction such as electrical conduits, piping, audio-visual cabling and like equipment components or supports.

(b) Ventilation must be provided by mechanical means in all rooms in new facilities and in all renovated or remodeled rooms of a facility.

(c) For spaces listed in the Minimum Ventilation Rate Table, central station type air handling equipment must be used. Package terminal air conditioning units or fan coils may be used to serve client rooms and shall be provided with 20 percent filters minimum (Minimum Efficiency Reporting Value 5 or MERV 5).

(d) System designs utilizing fan coil or package terminal air conditioning units must have the outdoor air ventilation damper permanently closed. The ventilation requirement must be satisfied by a central station type air handling unit provided with a 30 percent filter minimum (MERV 5) or as required by the listed space served. Spaces designated for the exclusive use of physical plant personnel need not comply with this requirement.

(e) Administrative and other staff-only areas must be provided with outside air at the minimum rate of 20 cubic feet per minute (9.43 liters/second) per person, and the central system must have a minimum of 30 percent American Society of Heating Refrigerating and Air Conditioning Engineers, Inc. (ASHRAE), dust spot efficiency filter (MERV 5).

(f) All filters in systems in excess of 1,000 cubic feet per minute (28.32 cubic meters/minute) capacity must be installed with differential pressure gauges. The filter gauge must have the range of acceptable filter operation clearly and permanently indicated.

(g) The transfer of air quantities through one space to an adjacent space is not permitted except that the transfer of air to maintain space relative pressure by the undercutting of doors is permitted. The maximum allowable air quantity for door undercuts shall be 75 cubic feet per minute (35.34 liters per second) for single door widths up to 44 inches (111.7 centimeters).

(h) All supply, return and exhaust ventilation fans must operate continuously. Dietary hood, laundry area, administrative areas that are separated from all client areas and support areas, and maintenance area supply and exhaust fans shall be exempted from continuous operation.

(i) Cooling coil condensate must be piped to a roof drain, floor drain or other approved location.

(j) Exhaust fans and other fans operating in conjunction with a negative duct system pressure must be located at the discharge end of the system. Fans located immediately within the building located at the end of all exhaust ducts shall be permitted. Existing nonconforming systems need not be brought into compliance when equipment is replaced due to equipment failure.

(k) All new facility construction must have totally ducted supply, return, exhaust and outside air systems including areas of all occupancy classifications.

(l) During a fire alarm, fan systems and fan equipment serving more than one room must be stopped to prevent the movement of smoke by mechanical means from the zone in alarm to adjacent smoke zones.

(m) Air handling and fan coil units serving exit access corridors for the zone in alarm must shut down upon fire alarm.

(n) Smoke or fire/smoke dampers must close upon fire alarm and upon manual shutdown of the associated supply, return or exhaust fan.

(o) Mixing valves used in shower applications must be of the balanced-pressure type design.

(p) The temperature of hot water supplied to client use lavatories, showers and bath must be between 105ºF (40.6ºC) and 110ºF (43.3ºC) at the discharge end of the fixture.

(q) Wall mounted water closets, lavatories, drinking fountains and hand-washing facilities must be attached to floor mounted carriers and shall withstand an applied vertical load of a minimum of 250 pounds (113.39 kilograms) to the front of the fixture and provide deep seal traps for floor drains in client showers.

(r) Ice machines, rinse sinks, dishwashers, and beverage dispenser drip receptacles must be indirectly wasted.

(s) Each water service main, branch main, riser and branch to a group of fixtures must have valves. Stop valves must be provided for each fixture. Panels for valve access must be provided at all valves.

(t) Backflow preventers (vacuum breakers) must be installed on bedpan-rinsing attachments, hose bibs and supply nozzles used for connection of hoses or tubing in housekeeping sinks and similar applications.

(u) A backflow preventer must be installed on the facility main water source(s).

(5) Electrical requirements.

(a) All material, including equipment, conductors, controls, and signaling devices, must be installed to provide a complete electrical system with the necessary characteristics and capacity to supply the electrical facility requirements as shown in the specifications and as indicated on the plans submitted to the Agency. All materials and equipment must be listed as complying with applicable standards of Underwriter’s Laboratories, Inc., or other nationally recognized testing facilities. Field labeling of equipment and materials will be permitted only when provided by a Nationally Recognized Testing Laboratory (NRTL) that has been certified by the Occupational Safety & Health Administration (OSHA) for that referenced standard.

(b) For purposes of this section, a client room, a client therapy area or an examination room shall be considered a “patient care area” as described in NFPA 99 “Health Care Facilities,” and Chapter 27, “Electrical Systems” of the Florida Building Code.

(c) Panels located in spaces subject to storage must have the clear working space as required by Chapter 27, “Electrical Systems” of the Florida Building Code, permanently marked “Electrical Access – Not For Storage” with a line outlining the required clear working space on the floor and wall.

(d) Panels and electrical equipment, other than branch circuit devices serving the corridor, must not be located in egress corridors in new construction.

(e) Lighting.

All spaces occupied by people, machinery and equipment within buildings, approaches to buildings and parking lots must have electric lighting.
Client bedrooms must have general lighting and separate fixed night lighting. The night-light must have a switch at the entrance to each client’s room. A reading light must be provided for each client. Client reading lights, and other fixed lights not switched at the door, must have switch controls convenient for use at the luminary. Wall-mounted switches for control of lighting in client area must be of a quiet operating type.

(f) Receptacles.

The facility must provide one general purpose receptacle on a wall to serve each client and one additional receptacle at the head of the bed if a motorized bed is provided.
Duplex receptacles for general use must be installed in all general purpose corridors, approximately 50 feet (15.24 meters) apart and within 25 feet (7.62 meters) of corridor ends.

(g) Fire alarm systems. A fire alarm annunciator panel must be provided at a single, designated, location that is monitored 24-hour per day. The panel must indicate, audibly and visually, the zone of actuation of the alarm and system trouble. Devices located in each smoke compartment must be interconnected as a separate fire alarm zone. Annunciator wiring must be supervised. Annunciators must clearly indicate the zone location of the alarm. An adjacent zone location map to quickly locate alarm condition must be provided.

(h) Nurse call systems. Each facility must have a nurse call system that meets the following requirements:

A nurse call system must be provided that will register a call from each client bed to the related staff work area(s) by activating a visual signal at the client room door and activating a visual and audible signal in the clean utility, soiled utility, nourishment station, medication prep and the master station of the nursing unit or sub-nursing unit. Audible signals may be temporarily silenced provided subsequent calls automatically reactivate the audible signal. In rooms containing two or more calling stations, indicating lights must be provided for each calling station. In the corridor zone of multi-corridor nursing units, lights must be installed at corridor intersections in the vicinity of staff work areas;
An emergency calling station of the pull cord type must be provided and must be conveniently located for client use at each client toilet, bath or shower room, but not inside the shower unless the nurse call device is listed for wet locations. The call signal must be the highest priority and shall be cancelled only at the emergency calling station. The emergency station must activate distinctive audible and visual signals immediately at the client room door or wireless page, and activate a visual and audible signal in the staff work areas or mobile nurse station receiver and the master station of the client unit. If a mobile nurse station receiver is utilized to receive the client call it will be worn by all staff who are assigned to the client unit and must identify the specific client and or room from which the call was placed;
The nurse call master station must not block incoming client calls. The master station control settings must not prevent the activation of the incoming audible and visual signals. In wireless systems, all orphaned calls to mobile nurse station receivers will register at the nurse call master station;
In multi-client rooms, activation of an emergency call shall not cancel a normal call from the same room; and,
A corridor dome light must be located directly outside of any client care area that is equipped with a wired nurse call station.

(i) Emergency electrical system.

A Type 1 essential electrical system must be provided in all ICF/DD facilities as described in NFPA 99, “Health Care Facilities.”
In new construction, the normal main service equipment must be separated from the emergency distribution equipment by locating it in a separate room. Transfer switches must be considered emergency distribution equipment for this purpose.
Switches for critical branch lighting must be completely separate from normal switching. The devices or cover plates must be of a distinctive color. Critical branch switches may be adjacent to normal switches. Switches for life safety lighting are not permitted except as required for dusk-to-dawn automatic control of exterior lighting fixtures.
There must be selected life safety lighting provided at a minimum of one footcandle and designed for automatic dusk-to-dawn operation along the travel paths from the exits to the public way or to safe areas located a minimum of 30 feet (9.14 meters) from the building.
If a day tank is provided, then it must be equipped with a dedicated low level fuel alarm and a manual pump. The alarm must be located at the generator derangement panel.
Transfer switch contacts must be of the open type and must be accessible for inspection and replacement.
If required by the facility’s emergency food plan, then there must be power connected to the equipment branch of the essential electrical system for kitchen refrigerators, freezers and range hood exhaust fans. Selected lighting within the kitchen and dry storage areas must be connected to the critical branch of the essential electrical system.

(6) Other general requirements.

(a) There must be at least one telephone accessible to the clients.

(b) An accessible, potable supply of water must be provided in all facilities.

(c) An adequate and safe method of sewage collection, treatment and disposal must be provided in each facility. Whenever a municipal or public sewer system is available to the property such system must be used.

(d) In all facilities vermin must be controlled in all areas of the facility.

(7) Physical Plant Requirements for Disaster Resistance of ICF/DD Construction.

(a) Definitions. The following definitions apply specifically to this subsection:

Existing Facility means a facility that prior to December 1, 2015:

a. Is licensed and certified; or

b. Has received a Stage II preliminary plan approval from the Agency for a new facility.

New Facility means:

a. An ICF/DD licensed after December 1, 2015; or

b. A facility that receives a Stage II Preliminary Plan approval after December 1, 2015; or

c. An addition of a wing or floor to an existing ICF/DD, which has not received a Stage II Preliminary Plan approval pursuant to this section.

Net Square Footage means the clear floor space of an area excluding cabinetry and other fixed furniture or equipment.
During and Immediately Following means a period of 72 hours following the loss of normal support utilities to the facility.
Occupied Client Area(s) means the location of clients inside the new facility or in the addition of a wing or floor to an existing facility during and immediately following a disaster. If clients are to be relocated into an area of the existing facility during and immediately following a disaster, then for these purposes that location will be defined as the “occupied client area.”
Client Support Area(s) means the area(s) required to ensure the health, safety and well-being of clients during and immediately following a disaster, such as a staff work area, clean and soiled utility areas, food preparation area and other areas as determined by the licensee to be kept operational during and immediately following a disaster.
On-site means either in, immediately adjacent to, or on the campus of the facility, or addition of a wing or floor to an existing facility.
Client(s) Served means the number of clients as determined by the licensee that will be served in the occupied client area(s) during and immediately following a disaster, including clients from other facilities, if applicable.

(b) New Facility Construction Standards. The following construction standards are in addition to the physical plant requirements described in this rule. These minimum standards are intended to increase the ability of the new facility to be structurally capable of serving as a shelter for clients, staff and the family of clients and staff and equipped to be self-supporting during and immediately following a disaster.

Space standards.

a. Each new facility must provide a minimum of 30 net square feet (2.79 square meters) per client served in the occupied client area(s). The number of clients served is to be determined by the facility.

b. Each licensee must have space for administrative and support activities and space for use by facility staff to allow for care of clients in the occupied client area(s).

c. Each licensee must have space for all staff and family members of clients and staff.

Site standards.

a. The lowest floor of all new facilities shall be elevated to the "Base flood elevation" plus 2 feet (61 cm), or to the height of hurricane Category 3 (Saffir-Simpson scale) surge inundation elevation, as described by the Sea, Lake, and Overland Surge (SLOSH) from Hurricanes model developed by the Federal Emergency Management Agency (FEMA), United States Army Corps of Engineers (USACE), and the National Weather Service (NWS), whichever elevation requirement is more stringent. The Base flood elevation shall be defined as the elevation of an area having a 1 percent chance of being equaled or exceeded by flood waters in any given year.

b. For all existing facilities, the lowest floor elevations of all additions, and all resident support areas including food service, and all resident support utilities, including mechanical, and electrical (except fuel storage as noted in sub-subparagraph 59A-26.019(7)(b)9.e., F.A.C.) for the additions shall be at or above the elevation of the existing building, if the existing building was designed and constructed to comply with either the site standards of this rule or local flood resistant requirements in effect at the time of construction, whichever requires the higher elevation. If the existing building was constructed prior to the adoption of either the site standards of this rule or local flood resistant requirements, then substantial improvements as described in this section shall either be designed and constructed to meet the requirements of this rule or be designed and constructed to meet the dry flood proofing requirements of Florida Building Code.

c. Substantial improvement shall include any repairs, reconstruction(s), rehabilitation(s), additions(s) or improvement(s) to the building over a five year period, the cost of which cumulatively exceeds the market value of the building prior to the start of work.

d. Where an off-site public access route is available to the new facility at or above the 100-year flood plain, a minimum of one on-site emergency access route must be provided that is located at the same elevation as the public access route.

Roofing standards.

a. Loose-laid ballasted roofs are not permitted.

b. All new roof appendages such as ducts, tanks, ventilators, receivers, condensing units and decorative mansard roofs and their attachment systems must be structurally engineered to meet the wind load requirements of the FBC. All of these attachment systems must be connected directly to the underlying roof structure or roof support structure.

Exterior unit standards.

a. All exterior window units, skylights, exterior louvers and exterior door units, including vision panels and their anchoring systems shall be impact resistant or protected with an impact resistant covering meeting the requirements of the Testing Application Standards (TAS) 201, 202, and 203 of Florida Building Code – Test Protocols for High-Velocity Hurricane Zones and in accordance with the requirements of Sections 1626.2 through 1626.4 of the Florida Building Code. The impact resistant coverings may be either permanently attached or may be removable if stored on site of the facility.

b. The location or application of exterior impact protective systems shall not prevent required exit egress from the building.

c. When not being utilized to protect the windows, the protective system shall not restrict the operability (if provided) of the windows to the occupied client bedrooms.

d. When not being utilized to protect the windows, the protective system shall not reduce the percentage of the clear window opening below that which is required by the FBC for client bedrooms.

e. The glazed openings inside or outside of the protective systems must meet the cyclical loading requirements as required by Sections 1626.2-1626.4 of the FBC.

f. All of the exterior impact protective systems must be designed and installed so that they do not come in contact with the glazing under uniform, impact or cyclic pressure loading. The location or application of exterior impact protective systems must not prevent required exit/egress from the building.

Heating, Ventilation and Air Conditioning (HVAC) Standards.

a. All new air moving-equipment, dx condensing units, through-wall units and other HVAC equipment located outside of, partially outside of, or on the roof of the facility and providing services to the new facility shall be permitted only when either of the following are met:

I. They are located inside a penthouse designed to meet the wind load requirements of the Florida Building Code, Building; or

II. Their fastening systems are designed to meet the wind load requirements of the Florida Building Code, Building and they and all associated equipment are protected as required by TAS 201, 202, and 203 in accordance with the requirements of Sections 1626.2 through 1626.4 of the Florida Building Code from damage by horizontal impact by a separate and independent structure that allows access to all parts of the equipment at all times; or

III. They are completely protected by the equipment shrouding that meets the requirements of TAS 201, 202, and 203 in accordance with the requirements of Sections 1626.2 through 1626.4 of the Florida Building Code.

b. All occupied client areas and client support areas must be supplied with sufficient HVAC as determined by the facility to ensure the health, safety and well-being of all clients and staff during and immediately following a disaster.

c. As determined by the licensee, these selected HVAC systems and their associated support equipment, such as a control air compressor essential to the maintenance of the occupied client and client support area(s), must receive their power from the emergency power supply system(s).

d. Ventilation air change rates in occupied client areas must be maintained as specified in this section during and immediately following a disaster.

e. Auxiliary equipment and specialties such as hydronic supply piping and pneumatic control piping must be located, routed and protected in such a manner as determined by the licensee to ensure the equipment receiving the services will not be interrupted.

Plumbing standards.

a. There must be an independent on-site supply such as a water well, or on-site storage capability such as empty water storage containers or bladders, of potable water at a minimum quantity of three gallons per client served per day during and immediately following a disaster. Hot water in boilers or tanks must not be counted to meet this requirement.

b. There must be an independent on-site supply or storage capability of potable water at a minimum quantity of one gallon per facility staff, and other personnel in the facility per day during and immediately following a disaster. For planning purposes, the number of these personnel must be estimated by the licensee.

c. The licensee must determine what amount of water will be sufficient to provide for client services, and must maintain an on-site supply or on-site storage of the determined amount.

d. When used to meet the minimum requirements of this rule, selected system appurtenances such as water pressure maintenance house pumps and emergency water supply well pumps must take power from the emergency power supply system.

Medical gas systems standards. The storage, distribution piping system and appurtenances serving the occupied client area(s) and client support area(s) shall be contained within a protected area(s) designed and constructed to meet the structural requirements of the building code and debris impact requirements as required by Sections 1626.2 through 1626.4 of the Florida Building Code.
Emergency electrical generator and essential electrical system standards. There must be an on-site emergency electrical generator system designed to support occupied client areas and client support areas with the following support services:

a. Ice making equipment to produce ice for the clients or freezer storage equipment for the storage of ice for the clients.

b. Refrigerator units and food service equipment as required by the emergency food plan.

c. There must be one clothes washer and one clothes dryer for laundry service.

d. An emergency generator system must be fueled by a fuel supply stored on-site sized to fuel the generator for 100 percent load for 64 hours, or 72 hours for actual demand load of the occupied client areas and client support areas and client support utilities, during and immediately following a disaster, whichever is greater.

e. The fuel supply shall either be located below ground or contained within a protected area that is designed and constructed to meet the structural requirements as required by the Florida Building Code and debris impact requirements as specified by Sections 1626.2 through 1626.4 of the Florida Building Code. If an underground system is utilized, it shall be designed so as to exclude the entrance of any foreign solids or liquids.

f. All fuel lines supporting the generator system(s) for the occupied client area(s) and client support area(s) shall be protected also with a method designed and constructed to meet the structural requirements as required by the Florida Building Code and debris impact requirements as specified by Sections 1626.2 through 1626.4 of the Florida Building Code.

g. All panel boards, transfer switches, disconnect switches, enclosed circuit breakers or emergency system raceway systems required to support the occupied client area(s), client support area(s) or support utilities shall be contained within a protected area(s) designed and constructed to meet the structural requirements as required by the Florida Building Code and debris impact requirements as specified by Sections 1626.2 through 1626.4 of the Florida Building Code, and shall not rely on systems or devices outside of this protected area(s) for their reliability or continuation of service.

h. The emergency generator(s) shall be air or self-contained liquid cooled and it and other essential electrical equipment shall be installed in a protected area(s) designed and constructed to meet the structural requirements as required by the Florida Building Code and debris impact requirements as specified by Sections 1626.2 through 1626.4 of the Florida Building Code.

i. If the facility does not have a permanent on-site optional standby generator to operate the normal branch electrical system, then there shall be a permanently installed pre-designed electrical service entry for the normal branch electrical system that will allow a quick connection to a temporary electrical generator. This quick connection shall be installed inside of a permanent metal enclosure rated for this purpose and may be located on the exterior of the building.

Fire protection standards. If the facility requires fire sprinklers as part of its fire protection, one of the following must be met:

a. On-site water storage capacity to continue sprinkler coverage in accordance with the fire codes adopted by the state fire marshal or a fire watch must be conducted.

b. If the facility provides a fire watch in lieu of water storage to continue sprinkler coverage, then one 4-A type fire extinguisher or equivalent must be provided for every three or less 2-A fire extinguishers. These additional extinguishers must be equally distributed throughout the area they are protecting.

External Emergency Communication. Each new facility must provide for an external electronic communication not dependent on terrestrial telephone lines, cellular, radio or microwave towers, such as onsite radio transmitter, satellite communication systems or a written agreement with an amateur radio operator volunteer group(s). This agreement must provide for a facility volunteer operator and communication equipment to be re-located into the facility in the event of a disaster until communications are restored. Other methods that can be shown to maintain uninterrupted electronic communications not dependent on land-based transmission must be pre-approved by the Agency’s Office of Plans and Construction.

History

Rulemaking Authority 400.967 FS. Law Implemented 400.967(2)(a) FS. History–New 12-21-15.

Fla. Admin. Code R. 59A-26.020 Disaster Preparedness

(1) Each licensee must have a written plan with procedures to be followed in the event of an internally or externally caused disaster or emergency event. The initiation, development, and maintenance of this plan must be the responsibility of the facility administrator, and must be reviewed and approved by the County Emergency Management Agency. The plan must be reviewed and approved annually and include the following:

(a) Criteria as shown in Section 400.967(2)(g), F.S.; and,

(b) The Emergency Management Planning Criteria for Intermediate Care Facilities, AHCA Form 3110-6008, April 2025, which is incorporated herein by reference and available at http://flrules.org/Gateway/reference.asp?No=Ref-18493 and on the website at https://ahca.myflorida.com/emergency-resources.

(2) The facility must review and submit its emergency management plan on an annual basis and in accordance with section 408.821(1), F.S.

(3) A significant modification to a previously approved plan must be submitted within 30 days after the change. For the purposes of this rule, “significant modification” means a change to the information provided in support of the minimum required plan criteria, procedures, memorandums of understanding, contracts, or agreements identified in the plan, or appendices that alters the execution of the plan and the required arrangements made therein. Changes in spelling or grammar are not considered significant modifications for the purposes of this rule.

(a) Changes in the name, address, phone number, email address or position of staff identified in the plan are not considered significant modifications for the purposes of this rule. Changes to that information must be submitted to the county emergency management agency as part of the emergency management plan submitted annually.

(b) If a change to the emergency management plan is required to be submitted due to a significant modification, the change must be identified and described.

(c) A change to the emergency management plan due to a significant modification does not alter the annual review date unless the change is due to a change of ownership of the facility.

(4) If the licensee evacuates, the licensee must immediately, but within no more than 24 hours upon completion of evacuation, report the location and number of clients evacuated, and contact information for continued communication for the duration of the evacuation through an online database approved by the Agency.

History

Rulemaking Authority 400.967, 408.821(4) FS. Law Implemented 400.967(2)(g), 408.821(4) FS. History–New 12-21-15, Amended 1-19-26, Technical Change 5-18-26.

Chapter 59A-27 HEALTH CARE SERVICES POOLS

Fla. Admin. Code R. 59A-27.001 Definitions

As used in this rule chapter, the term:

(1) “Temporary employment” means employment whereby a pool hires its own employees or independent contractors and assigns them to health care facilities to support or supplement the facilities’ work force in special work situations such as employee absences, temporary skill shortages, seasonal workloads, and special assignments and projects.

(2) “Claims made coverage” refers to coverage of damage or injury for which the claim is first made during a policy period.

(3) “Nose coverage” refers to a provision attached to a claims made policy, extending the time prior to the policy inception date during which the damage or injury may have occurred and still be covered.

(4) “Tail coverage” refers to a provision attached to a claims made policy which extends the time during which a claim can be made and still be covered for a period of time after the expiration date of the policy.

(5) “Referral” shall mean the act of sending or directing a health care worker to a health care facility to work at the request of the facility.

(6) “Business location” refers to a physical location where a Pool conducts its day to day operations and maintains its records.

(7) “AHCA” refers to the Agency for Health Care Administration.

History

Rulemaking Authority 400.980 FS. Law Implemented 400.980 FS. History–New 10-17-94, Formerly 61E6-1.002, 64B22-1.001, Amended 6-27-02.

Fla. Admin. Code R. 59A-27.002 Registration and Change in Registration Information

(1) All health care services pools must register with AHCA using the Health Care Licensing Application, Health Care Services Pool, AHCA form 3110-1010, July 2014, https://www.flrules.org/gateway/reference.asp?No=Ref-04487, incorporated herein by reference, before providing health care personnel as temporary employees to any health care facility. The applicant must also submit the Health Care Licensing Application Addendum required in subsection 59A-35.060(1), F.A.C. The application form and addendum can be obtained at http://www/ahca.myflorida.com/HQAlicensureforms. The application form and addendum must be submitted with the registration fee of $616. Applications are reviewed in accordance with the process set forth in Section 408.806, F.S.

(a) When a change of ownership, as defined in Section 408.803(5), F.S., is planned, the buyer or transferee must submit an application for a new registration according to the time frame in Section 408.806(2)(b), F.S. The application form, addendum and fee required in subsection (1) must be submitted with the registration fee of $616 and a certificate of registration must be issued before the pool provides health care personnel as temporary employees to any health care facility.

(b) Screening for the managing employee and the financial officer shall be in accordance with level 2 standards for screening set forth in Section 408.809, F.S. and Rule 59A-35.090, F.A.C.

(2) Each health care services pool must renew its registration biennially as required in Section 408.806(2), F.S., by submitting the application form, addendum and fee in subsection (1).

(3) Registrants will receive a certificate acknowledging their registration and each renewal of registration. The current certificate of registration or renewal of registration must be conspicuously displayed on the premises and must be readily visible from the entrance.

(4) Change in Registration Information. A registered health care services pool shall notify the AHCA Long Term Care Services Unit of any change in business name; location; or mailing address as required in Rule 59A-35.040, F.A.C. Telephone, email and fax number changes shall be reported by email, mail or fax to AHCA Long Term Care Services Unit at LTCStaff@ahca.myflorida.com, 2727 Mahan Drive, Mail Stop #33, Tallahassee, Florida 32308, or fax (850)922-6059. Any request that results in the agency issuing a new registration certificate other than at initial application, renewal, or change of ownership must be accompanied with the fee required in subsections 59A-35.050(3) and (5), F.A.C.

History

Rulemaking Authority 400.980, 408.819 FS. Law Implemented 400.980, 408.805, 408.806, 408.810 FS. History–New 1-7-90, Amended 8-12-91, Formerly 7G-1.007, Amended 10-17-94, 2-27-97, Formerly 61E6-1.007, 64B22-1.002, Amended 6-27-02, 8-28-14.

Fla. Admin. Code R. 59A-27.003 Inspections

History

Rulemaking Authority 400.980 FS. Law Implemented 400.980 FS. History–New 8-2-90, Amended 8-12-91, Formerly 7G-1.011, 61E6-1.011, 64B22-1.003, Amended 6-27-02, Repealed 5-14-12.

Fla. Admin. Code R. 59A-27.004 Penalties and Enforcement Procedures

(1) Any person or entity operating a health care services pool without a registration, with an expired registration, or with a revoked registration, shall immediately cease operations until a proper registration can be acquired. Failure to cease operations after agency notification may result in a fine as stated in Section 408.812, F.S.

(2)(a) If the Health Care Services Pool fails to screen all employees or contractors, or employs persons who are disqualified from employment based on a criminal record check, a fine, as permitted in Section 408.813(3), F.S. shall be assessed for each employee or contractor.

(b) If AHCA determines the fine to be insufficient to the violation, it may deny, suspend or revoke the registration as permitted in Section 408.815, F.S.

(3) The failure to file a timely application for a renewal certificate of registration shall result in an administrative fine, pursuant to Section 408.806(2)(d), F.S.

(4) Any other violations of provisions of law or rule can result in a fine pursuant to Section 400.980, F.S.

(5) In determining whether to revoke or suspend a registration or to impose a fine, or in determining the amount of any such fine, AHCA shall consider the following information:

(a) The number of violations and remedial actions taken to correct the violations;

(b) The harm or potential for harm resulting from the violations;

(d) The existence of prior similar violations; and,

(e) The financial benefit or potential for financial benefit as a result of committing the violations.

History

Rulemaking Authority 400.980, 408.819 FS. Law Implemented 400.980, 408.806, 408.812, 408.813, 408.815 FS. History–New 8-2-90, Formerly 7G-1.013, Amended 10-17-94, Formerly 61E6-1.013, 64B22-1.004, Amended 6-27-02, 8-28-14.

Fla. Admin. Code R. 59A-27.005 Pool Administration

Health care services pools shall meet the following minimum standards of operation:

(1) Each pool, at the time of initial registration and at each registration renewal, shall identify a managing employee who will be responsible for the day-to-day supervision and administration of the pool and shall designate this individual, on the biennial registration application form required in subsection 59A-27.002(1), F.A.C., as the pool’s representative for purposes of any communications with AHCA Long Term Care Services Unit. The managing employee must be familiar with the work requirements and the prerequisites for licensure or certification in each of the health care disciplines and specialties for which the pool is providing referrals. Any time there is a change in this position, the pool shall give written notice to AHCA Long Term Care Services Unit of such change. Such notice shall be filed with AHCA Long Term Care Services Unit with the name of the replacement managing employee as required in paragraph 59A-35.110(1)(c), F.A.C.

(2) Each pool shall establish written procedures for the selection, documentation, screening and verification of credentials for each licensed health care practitioner referred or employed by the pool. At a minimum, these procedures shall require that:

(a) New personnel produce, for inspection by the pool, their current professional license or certification or a certified duplicate of the above, provided by the issuing department;

(b) Prior to the initial referral of each worker to a health care facility, each pool shall confirm the new worker’s licensure or certification with the issuing board or department. This confirmation shall be based upon either on-line verification through consulting the appropriate department web sites, or specific written requests or oral communications with the issuing authority. The worker’s personnel file shall reflect when and how this confirmation was obtained. If obtained from the internet, a printout of the page with the licensure or certification information will suffice. If confirmation was obtained through letter or direct contact, the file shall identify the individual with the issuing authority who provided the confirmation and shall identify who made the inquiry on behalf of the pool; and,

(c) Prior to the initial referral of each worker to a health care facility, the pool must confirm the identity of the worker, using the worker’s current drivers license or other photo identification and his or her professional license or certificate. Each worker shall produce such records for review by the health care facility upon request.

(3) Each pool shall establish written procedures for conducting periodic written performance evaluations of all health care workers. Evaluations shall be conducted at least annually and the pools shall make reasonable attempts to obtain information from health care facilities where the worker has provided services during the last evaluation period. For example, in obtaining this information, it is sufficient for the pool to ask the health care facility’s staff to complete a brief check-off sheet evaluating the worker or for the pool to contact one or more individuals at the health care facility who have been involved with supervising the worker and to obtain their evaluation of the worker’s performance. Each worker’s personnel file shall contain copies of all performance evaluations made by the pool regarding that worker.

(4) Each pool shall establish and maintain a system for the recording and follow-up of all complaints involving the individuals they refer to health care facilities and all such records must be kept in the worker’s personnel file.

(5) Prior to the initial referral of each worker to a health care facility, each pool shall obtain at least two current professional references. Notwithstanding the above, if the pool makes documented efforts to obtain such references but is unable to do so, it may substitute a personal reference in place of one of the required professional references.

(6) Each pool shall prepare a written orientation program which defines the responsibilities of the persons employed or engaged by the pool and shall require all new health care personnel to participate in the program. The orientation program shall, at a minimum, include any information provided by the health care facilities where the workers will be referred and shall include dress codes, safety and emergency procedures, and infection control procedures.

(7) Each pool shall maintain personnel files for each worker and such files shall be available during normal working hours for inspection by the department.

(8) A health care services pool must remain knowledgeable on the current regulations of each of the facility types and entities to which they send personnel to ensure compliance with Section 400.980(6), F.S., and only place personnel that meet all the needs and requirements of the facility or entity to which they are being sent. Each pool shall maintain health records on all health care workers who have direct contact with patients and shall require evidence of a physical examination. The pool employee or independent contractor must submit a statement from a health care professional licensed under Chapter 458 or 459, F.S., a physician’s assistant, or an advanced practice registered nurse or a registered nurse licensed under Chapter 464, F.S., under the supervision of a licensed physician, or acting pursuant to an established protocol signed by a licensed physician, based upon an examination within the last six months, that the employee or contractor is in good health sufficient to provide services to individuals with compromised health. It is the responsibility of the health care services pool to ensure that patients are not placed at risk by pool employees or contractors. Medical information is confidential and must not be disclosed without the specific consent of the person to whom it pertains. The written request to release the physical examination must be kept on file. If a person is found to have a communicable disease that could be casually transmitted, that person shall be removed from contact with patients until a physician’s statement, indicating that the person no longer has a communicable disease that can be casually transmitted.

(9) Each pool shall refer workers only for services to which they are qualified by their licensure and experience. Failure to exercise due care in the placement of a health care professional or knowingly referring a worker to an assignment to which he or she is not qualified, shall be grounds for revocation of registration or civil penalties, or both.

(10) Each pool shall, upon receiving such information, inform the health care facility if the licensed or certified professional worker being referred to the facility is on probation with their professional licensing board or commission. The pool shall also advise the licensed or certified professional that their probationary status has been given to the health care facility.

(11) The failure to comply with the financial responsibility law, Section 400.980(7), F.S., and these rules, the furnishing of false or misleading information, the failure to timely notify the AHCA of a change in status, or the failure to document compliance with the financial responsibility law upon request by the AHCA shall be grounds for disciplinary action, including fines or registration revocation, or both.

History

Rulemaking Authority 400.980, 408.819 FS. Law Implemented 400.980 FS. History–New 8-2-90, Formerly 7G-1.015, Amended 10-17-94, Formerly 61E6-1.015, 64B22-1.005, Amended 6-27-02, 8-28-14.

Fla. Admin. Code R. 59A-27.006 Procedures and Records

(1) Each health care services pool shall maintain the following business records and shall make these records available for inspection by the department upon request:

(a) Copies of corporate articles of incorporation and bylaws, if applicable;

(b) Records documenting the work performed by personnel referred by the pool including: the date of initial referral of a worker by the pool, dates and location of each placement and the names and addresses of client health care facilities. Copies of personnel time records or invoices identifying the services provided are acceptable records for meeting this requirement; and,

(c) Copies of any written employment contracts or other agreements entered into between the pool and each health care worker. Such contracts shall specifically and clearly advise the worker as to whether he or she is an employee of the pool or is an independent contractor referred by the pool. Also, where the worker is retained as an independent contractor, the contract or agreement shall specifically state that the independent contractor is responsible for paying federal income taxes. Prior to placement at a health care facility, the pool shall provide a document to each temporary health care worker, for his or her signature, which states that the worker understands his or her relationship with the pool, either as employee or independent contractor. This signed document shall be filed in the worker’s personnel file.

(2) Each health care services pool shall maintain a personnel file for each worker and such file shall be available for inspection by AHCA. Such file shall contain all information with respect to the skills and experience levels of personnel who are referred for work at health care facilities. In particular, the personnel file shall include the following:

(a) Evidence of the worker’s skills, qualifications and previous training. This shall include a skills inventory checklist, copies of current professional licenses and certificates, proof of education and training in specialized areas, copies of examinations given by the pool and individual examination scores, evidence of CPR or other certification and evidence of training and education regarding the treatment and prevention of human immunodeficiency virus and acquired immune deficiency syndrome;

(b) Documentation of submission for background screening and background screening results;

(d) Documentation of any complaints known to the pool involving any of its workers and any follow-up action taken with respect to such complaints;

(e) Evidence that the pool has provided information pertaining to occupational exposure to bloodborne pathogens;

(f) Copies of contracts, if any, between the pool and any client health care facility setting forth the terms and conditions under which the pool will provide medical staff to the health care facility. Such contracts shall specifically identify whether the workers to be provided by the pool are referred as employees of the pool or are referred as independent contractors;

(g) Copies of all records required by the United States Internal Revenue Service to be prepared by the pools for their employees or independent contractors;

(h) The employment, health and medical history records of the worker as specified in Rule 59A-27.005, F.A.C.; and

(i) Documentation to verify the worker’s employment eligibility in compliance with the immigration laws of the United States.

(3) Background Screening is required as stated in Section 408.809, F.S. and Rule 59A-35.090, F.A.C. Proof of required background screening shall be maintained by the health care services pool for all persons that are required to be screened.

History

Rulemaking Authority 400.980, 408.809, 408.819 FS. Law Implemented 400.980, 408.809 FS. History–New 8-2-90, Formerly 7G-1.017, Amended 10-17-94, Formerly 61E6-1.017, 64B22-1.006, Amended 6-27-02, 8-28-14.

Fla. Admin. Code R. 59A-27.009 Financial Responsibility Coverage Amounts

Proof of financial responsibility must be demonstrated through one of the following methods in the following coverage amounts:

(1) Establishing and maintaining an escrow account consisting of cash or assets eligible for deposit in accordance with Section 625.52, F.S. The cash or assets deposited shall be in an amount not less than $1,000,000 per claim, with a minimum aggregate deposit of not less than $3,000,000.

(2) Obtaining and maintaining an unexpired irrevocable letter of credit established pursuant to Chapter 675, F.S., in an amount not less than $1,000,000 per claim, with a minimum aggregate amount of credit of not less than $3,000,000. Such letters of credit shall be issued by any bank or savings association organized and existing under the laws of this state or any bank or savings association organized under the laws of the United States that has its principal place of business in this state or has a branch office which is authorized under the laws of this state or of the United States to receive deposits in this state.

(3) Obtaining and maintaining professional liability coverage in an amount not less than $1,000,000 per claim, with a minimum annual aggregate of not less than $3,000,000 from one of the following:

(a) An authorized insurer as defined under Section 624.09, F.S.;

(b) An eligible surplus lines insurer as defined under Section 626.918(2), F.S.;

(d) A plan of self-insurance as provided in Section 627.357, F.S.

History

Rulemaking Authority 400.980 FS. Law Implemented 400.980 FS. History–New 8-12-91, Formerly 7G-1.025, 61E6-1.025, 64B22-1.009, Amended 6-27-02.

Chapter 59A-29 HEALTH CARE PROVIDER CERTIFICATION

Fla. Admin. Code R. 59A-29.001 Definitions

History

Rulemaking Authority 440.13(3)(a), 440.591 FS. Law Implemented 440.13(3), (13) FS. History–New 3-14-95, Formerly 38F-53.001, Transferred to 69L-29.001.

Fla. Admin. Code R. 59A-29.002 Requirements for Certification

History

Rulemaking Authority 440.13(3)(a), 440.591 FS. Law Implemented 440.13(3), (13) FS. History–New 3-14-95, Formerly 38F-53.002, Transferred to 69L-29.002.

Fla. Admin. Code R. 59A-29.003 Certification Time Frames

History

Rulemaking Authority 440.13(3)(a), 440.591 FS. Law Implemented 440.13(3), (13) FS. History–New 3-14-95, Formerly 38F-53.002, Transferred to 69L-29.003.

Fla. Admin. Code R. 59A-29.004 Occasional Health Care Providers

History

Rulemaking Authority 440.13(3)(a), 440.591 FS. Law Implemented 440.13(3), (13) FS. History–New 3-14-95, Formerly 38F-53.004, Transferred to 69L-29.004.

Fla. Admin. Code R. 59A-29.005 Decertification of a Health Care Provider

History

Rulemaking Authority 440.13(3)(a), 440.591 FS. Law Implemented 440.13(3), (13) FS. History–New 3-14-95, Formerly 38F-53.005, Transferred to 69L-29.005.

Fla. Admin. Code R. 59A-29.006 Decertification Process

History

Rulemaking Authority 440.13(3)(a), 440.591 FS. Law Implemented 440.13(3), (8), (13) FS. History–New 3-14-95, Formerly 38F-53.006, Transferred to 69L-29.006.

Fla. Admin. Code R. 59A-29.007 Recertification Process

History

Rulemaking Authority 440.13(3)(a), 440.591 FS. Law Implemented 440.13(3), (13) FS. History–New 3-14-95, Formerly 38F-53.007, Transferred to 69L-29.007.

Fla. Admin. Code R. 59A-29.008 Determining Certification Status

History

Rulemaking Authority 440.13(3)(a), 440.591 FS. Law Implemented 440.13(3), (13) FS. History–New 3-14-95, Formerly 38F-53.008, Transferred to 69L-29.008.

Fla. Admin. Code R. 59A-29.009 Carrier Responsibilities

History

Rulemaking Authority 440.13(3)(a), 440.591 FS. Law Implemented 440.13(3), (13) FS. History–New 3-14-95, Formerly 38F-53.009, Transferred to 69L-29.009.

Fla. Admin. Code R. 59A-29.010 Health Care Provider Responsibilities

History

Rulemaking Authority 440.13(3)(a), 440.591 FS. Law Implemented 440.13(3), (13) FS. History–New 3-14-95, Formerly 38F-53.010, Transferred to 69L-29.010.

Fla. Admin. Code R. 59A-29.011 Workers' Compensation Certification Training Courses

History

Rulemaking Authority 440.13(3)(a), 440.591 FS. Law Implemented 440.13(3), (13) FS. History–New 3-14-95, Formerly 38F-53.011, Transferred to 69L-29.011.

Chapter 59A-30 EXPERT MEDICAL ADVISORS

Fla. Admin. Code R. 59A-30.002 Definitions

History

Rulemaking Authority 440.13(9), 440.591 FS. Law Implemented 440.13(9) FS. History–New 1-23-95, Formerly 38F-54.002, Amended 10-11-06, Transferred to 69L-30.002.

Fla. Admin. Code R. 59A-30.003 Procedure for Certification

History

Rulemaking Authority 440.13(9), 440.591 FS. Law Implemented 440.13(9) FS. History–New 1-23-95, Amended 6-8-95, Formerly 38F-54.003, Amended 10-11-06, Transferred to 69L-30.003.

Fla. Admin. Code R. 59A-30.004 Application for Expert Medical Advisor Certification

History

Rulemaking Authority 440.13(9), 440.591 FS. Law Implemented 440.13(9) FS. History–New 1-23-95, Formerly 38F-54.004, Amended 10-11-06, Transferred to 69L-30.004.

Fla. Admin. Code R. 59A-30.005 Assignment of Expert Medical Advisors

History

Rulemaking Authority 440.13(9), 440.591 FS. Law Implemented 440.13(9) FS. History–New 1-23-95, Formerly 38F-54.005, Amended 10-11-06, Transferred to 69L-30.005.

Fla. Admin. Code R. 59A-30.006 Temporary Expert Medical Advisors

History

Rulemaking Authority 440.13(9), 440.591 FS. Law Implemented 440.13(9) FS. History–New 1-23-95, Formerly 38F-54.006, Amended 10-11-06, Transferred to 69L-30.006.

Fla. Admin. Code R. 59A-30.007 Expert Medical Advisor Responsibilities

History

Rulemaking Authority 440.13(9), 440.591 FS. Law Implemented 440.13(9) FS. History–New 1-23-95, Formerly 38F-54.007, Amended 10-11-06, Transferred to 69L-30.007.

Fla. Admin. Code R. 59A-30.008 Carrier Responsibilities

History

Rulemaking Authority 440.13(9), 440.591 FS. Law Implemented 440.13(9) FS. History-New 1-23-95, Formerly 38F-54.008, Amended 10-11-06, Transferred to 69L-30.008.

Fla. Admin. Code R. 59A-30.009 Recertification of Expert Medical Advisors

History

Rulemaking Authority 440.13(9), 440.591 FS. Law Implemented 440.13(9) FS. History–New 1-23-95, Formerly 38F-54.009, Repealed 10-11-06.

Fla. Admin. Code R. 59A-30.010 Decertification

History

Rulemaking Authority 440.13(9), 440.591 FS. Law Implemented 440.13(9) FS. History-New 1-23-95, Formerly 38F-54.010, Amended 10-11-06, Transferred to 69L-30.010.

Chapter 59A-31 DISPUTED REIMBURSEMENT

Fla. Admin. Code R. 59A-31.002 Disputed Reimbursement Resolution

History

Rulemaking Authority 440.13(7), 440.591 FS. Law Implemented 440.13(7) FS. History–New 5-15-91, Amended 12-28-97, Formerly 38F-7.518, 38F-7.605, 4L-7.605, Amended 4-2-06, Repealed 11-28-06.

Fla. Admin. Code R. 59A-31.003 Petition Form

History

Rulemaking Authority 440.13(7)(e) FS. Law Implemented 440.13(7)(a) FS. History–New 11-28-06, Transferred to 69L-31.003.

Fla. Admin. Code R. 59A-31.004 Carrier Response Form

History

Rulemaking Authority 440.13(7)(e) FS. Law Implemented 440.13(7)(b) FS. History–New 11-28-06, Transferred to 69L-31.004.

Fla. Admin. Code R. 59A-31.005 Petition Requirements

History

Rulemaking Authority 440.13(7)(e), 440.591 FS. Law Implemented 440.13(7) FS. History–New 11-28-06, Transferred to 69L-31.005.

Fla. Admin. Code R. 59A-31.006 Consolidation of Petitions

History

Rulemaking Authority 440.13(7)(e), 440.591 FS. Law Implemented 440.13(7)(e) FS. History–New 11-28-06, Transferred to 69L-31.006.

Fla. Admin. Code R. 59A-31.007 Service of Petition on Carrier and Affected Parties

History

Rulemaking Authority 440.13(7)(e), 440.591 FS. Law Implemented 440.13(7)(a) FS. History–New 11-28-06, Transferred to 69L-31.007.

Fla. Admin. Code R. 59A-31.008 Computation of Time

History

Rulemaking Authority 440.13(7)(e), 440.591 FS. Law Implemented 440.13(7)(a), (b) FS. History–New 11-28-06, Transferred to 69L-31.008.

Fla. Admin. Code R. 59A-31.009 Carrier Response Requirements

History

Rulemaking Authority 440.13(7)(e), 440.591 FS. Law Implemented 440.13(7)(b) FS. History–New 11-28-06, Transferred to 69L-31.009.

Fla. Admin. Code R. 59A-31.010 Effect of Non-Response by Carrier

History

Rulemaking Authority 440.13(7), 440.591 FS. Law Implemented 440.13(7)(b) FS. History–New 11-28-06, Transferred to 69L-31.010.

Fla. Admin. Code R. 59A-31.011 Complete Record

History

Rulemaking Authority 440.13(7)(e), 440.591 FS. Law Implemented 440.13(7)(c) FS. History–New 11-28-06, Transferred to 69L-31.011.

Fla. Admin. Code R. 59A-31.012 Joint Stipulation of the Parties

History

Rulemaking Authority 440.13(7)(e), 440.591 FS. Law Implemented 440.13(7) FS. History–New 11-28-06, Transferred to 69L-31.012.

Fla. Admin. Code R. 59A-31.013 Petition Withdrawal

History

Rulemaking Authority 440.13(7)(e), 440.591 FS. Law Implemented 440.13(7)(a), (c) FS. History–New 11-28-06, Transferred to 69L-31.013.

Fla. Admin. Code R. 59A-31.014 Overutilization Issues Raised in Reimbursement Dispute Resolution

History

Rulemaking Authority 440.13(7)(e), 440.591 FS. Law Implemented 440.13(7)(b), 440.13(7)(c) FS. History–New 11-28-06, Transferred to 69L-31.014.

Fla. Admin. Code R. 59A-31.015 Managed Care Arrangements

History

Rulemaking Authority 440.13(7)(e), 440.134(25)(e), 440.591 FS. Law Implemented 440.13(7) FS. History–New 11-28-06, Transferred to 69L-31.015.

Chapter 59A-33 HEALTH CARE CLINIC LICENSURE

Fla. Admin. Code R. 59A-33.001 Definitions

In addition to definitions contained in chapter 400, part X, F.S., the following definitions shall apply specifically to health care clinics.

(1) “Licensee” means an individual, general partner of a limited partnership, general partnership, joint venture, limited liability company, limited liability partnership, unincorporated association, corporation or any other business relationship or entity that owns or controls a health care clinic or is the lessee of the health care clinic having the right of possession of the health care clinic location or mobile unit.

(2) “Physician” means a person currently licensed to practice medicine, osteopathy, chiropractic, or podiatry pursuant to chapters 458, 459, 460 or 461, F.S., respectively.

(3) “Unencumbered license” means a license issued by the respective health practitioner board of the Department of Health that permits a physician to perform all duties authorized under a license without restriction.

(4) “The Health Care Clinic Act” or “Act” means chapter 400, part X, F.S.

(5) “F.S.” means Florida Statutes.

(6) “F.A.C.” means Florida Administrative Code.

(7) “Licensed medical provider” means a licensed health care practitioner.

History

Rulemaking Authority 400.9925 FS. Law Implemented 400.991 (1), 400.9925, 400.9905(4)(g), (5) FS. History–New 8-28-06.

Fla. Admin. Code R. 59A-33.002 Licensure, Application Process, General Requirements

(1) The applicant or licensee shall make application for an initial, change of ownership, or renewal license to operate a health care clinic and shall provide all of the information required by this rule and chapter 400, part X, F.S., on the Health Care Licensing Application, Health Care Clinics, AHCA Form 3110-0013, July 2014, incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-04945, and available from the Agency for Health Care Administration website at: http://ahca.myflorida.com/HQAlicensureforms.

(2) The following shall be included with the application:

(a) License Fee. A nonrefundable $2,000 application fee payable to AHCA;

(b) Fictitious Name. When an applicant intends to operate under a fictitious name, a copy of an Affidavit of Compliance with Fictitious Name pursuant to section 865.09, F.S., or a copy of a registration form from the Division of Corporations, Secretary of State, showing registration of the applicant’s fictitious name;

(c) Evidence of Incorporation. When an applicant is a corporation or other entity, a copy of the registration of the applicant entity on file with the Division of Corporations, Secretary of State, State of Florida;

(d) Proof of financial ability to operate. Proof of financial ability to operate must be demonstrated for initial licensure and change of ownership applications as required in section 408.810(8), F.S. and rule 59A-35.062, F.A.C.;

(e) Accreditation. Each clinic engaged in magnetic resonance imaging (“MRI”) services shall provide documentation that it is accredited by a national accrediting organization that is approved by the Centers for Medicare and Medicaid Services for magnetic resonance imaging and advanced diagnostic imaging services within 1 year after licensure or one year after beginning MRI services to patients or placing a new magnet for an existing MRI. This period may be extended in accordance with section 400.9935(7)(a), F.S.;

(f) Background Screening. Applicants must submit evidence of compliance with level 2 background screening requirements as required in sections 400.991 and 408.809, F.S.; and,

(g) Medical/Clinic Director Attestation, AHCA Form 3110-1028 (Sept 2014), incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-04947, and available from the Agency for Health Care Administration website at: http://ahca.myflorida.com/HQAlicensureforms.

History

Rulemaking Authority 400.991(1), 400.9925, 408.809, 408.810(8), 408.819 FS. Law Implemented 400.9925, 400.991(1), 408.806, 408.809, 408.810(8) FS. History–New 8-28-06, Amended 2-12-15.

Fla. Admin. Code R. 59A-33.003 Initial License Applications Applicability

History

Rulemaking Authority 400.9925 FS. Law Implemented 400.991, 400.992, 400.9935(9) FS. History–New 8-28-06, Repealed 5-16-12.

Fla. Admin. Code R. 59A-33.004 Renewal License Applications

History

Rulemaking Authority 400.9925 FS. Law Implemented 400.991(4), (8), (9), 400.991(1) 400.9935(5), (11)(a), 400.995(1), (5) FS. History–New 8-28-06, Repealed 5-16-12.

Fla. Admin. Code R. 59A-33.005 Change of Ownership License Applications

History

Rulemaking Authority 400.9925 FS. Law Implemented 400.991(7)(d), 400.992(4)-(5), 400.9925(1)-(5), 400.993(2), 400.995(1), (6), (7) FS. History– New 8-28-06, Repealed 5-16-12.

Fla. Admin. Code R. 59A-33.006 Certificates of Exemption and Exempt Status

(1) Persons, facilities and entities, hereafter referred to as entities, exempt from health care clinic license requirements are set forth in section 400.9905(4), F.S. An entity is not required to have, but may voluntarily apply for, a certificate of exemption.

(2) Entities that claim an exemption, either by filing an application for a certificate of exemption with the Agency and receiving a certificate of exemption, or self-determining, must maintain an exempt status at all times of operation.

(3) Entities requesting a certificate of exemption from the health care clinic license requirements shall make application to the Agency on the Application for Certificate of Exemption from Licensure as a Health Care Clinic, AHCA Form 3110-0014, July 2018, which is incorporated by reference, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-10284. The application form is also available at http://www.ahca.myflorida.com/HQAlicensureforms.

(4) The applicant for a certificate of exemption must affirm:

(a) The specific exemption sought pursuant to section 400.9905(4), F.S.;

(b) The qualifying requirements for obtaining and maintaining an exempt status;

(c) The current existence of applicable exemption-qualifying health care practitioner licenses, qualified ownership, qualified certifications or registration of the entity or owners;

(d) The federal employer identification number;

(e) Proof of legal existence and fictitious name, when the entity and name are required to be filed with the Division of Corporations, Department of State; and

(f) Other satisfactory proof required by the form adopted by this rule.

(5) The fee for issuance of a certificate of exemption is required to be submitted to the Agency with the application.

(a) Applications received without the requisite fee shall be returned to the applicant unprocessed.

(b) When the payment of a certificate fee has been dishonored, the applicant has 10 days from the date of notification to remit to the Agency the certificate fee plus any applicable fees as provided by law in the form of a money order or cashier’s check. If the certificate fee is not paid, the application will be withdrawn or the certificate will be revoked.

(6) Upon receipt of an application for a certificate of exemption, the Agency shall examine the application and, within 30 days after receipt, notify the applicant in writing of any apparent errors or omissions and request any additional information required.

(7) Requested information omitted from an application for a certificate of exemption must be filed with the Agency within 21 days after the Agency’s request for omitted information or the application shall be deemed incomplete and shall be withdrawn from further consideration and the fees shall be forfeited.

(8) An application for a certificate of exemption from health care clinic licensure shall be granted or denied by the Agency within 60 days of receipt of a completed application.

(9) A certificate of exemption, unless sooner surrendered or revoked, shall automatically expire two years from the date of issuance, and shall be renewable biennially, provided that the applicant and facility continues to meet the requirements established under chapter 400, part X, F.S., and rule 59A-33.006, F.A.C.

(10) An application for renewal of the certificate of exemption must be submitted to the Agency 60 to 120 days prior to the date of expiration of the certificate of exemption.

(11) An application to change the name or address of the certificate of exemption must be submitted to the Agency 21 to 120 days in advance of the requested effective date.

(12) Whenever an entity discontinues operation, the entity shall notify the Agency in writing, prior to the discontinuance of operation, by submitting a letter to the Hospital and Outpatient Services Unit, 2727 Mahan Drive, Mail Stop #53, Tallahassee, Florida 32308 or via email at Hospitals@ahca.myflorida.com, including the effective date of closure. The entity shall remain responsible for retaining and appropriately distributing all medical records.

(13) If the applicant is required to register or file with the Florida Secretary of State, Division of Corporations, the principal, fictitious name and mailing addresses submitted with the licensure application for the applicant must be the same as the information registered with the Division of Corporations.

(14) An entity becomes a “clinic” as defined in section 400.9905(4), F.S., when it does not qualify for an exemption, provides health care services to individuals, and bills third-party payers for those services. A facility or entity’s exempt status expires when a change occurs that negates a facility or entity’s qualification for the exemption. In such a case, the health care clinic must file with the Agency a license application under sections 400.900-400.995, F.S. and shall be subject to all provisions applicable to unlicensed health care clinics. Failure to timely file an application for licensure of becoming a health care clinic will render the health care clinic unlicensed and subject the owners, medical or clinic directors and the health care clinic to sanctions under sections 400.900-400.995, F.S.

(15) The Agency will deny or revoke a certificate of exemption for the following actions by the applicant or owner:

(a) False representation of a material fact in the application for a certificate of exemption or omission of any material fact from the application.

(b) Failure to meet exemption criteria in section 400.9905, F.S.

(16) Certificates of exemption are not transferable, directly or indirectly. They are valid only for the entity, qualifying owners, licenses, registrations, certifications and services provided under specific statutory exemptions and are valid only for the specific exemption claimed and granted. In order for a certificate of exemption to be valid, the entity must apply for and receive an amended certificate of exemption for changes of name or location.

History

Rulemaking Authority 400.9925 FS. Law Implemented 400.9905(4), 400.9925, 400.9935 FS. History–New 8-28-06, Amended 2-12-15, 5-9-19.

Fla. Admin. Code R. 59A-33.007 AHCA Forms Availability, Information and Website

History

Rulemaking Authority 400.9925 FS. Law Implemented 120.54 FS. History–New 8-28-06, Repealed 4-5-15.

Fla. Admin. Code R. 59A-33.008 Medical or Clinic Director

(1) A licensed health care clinic may not operate or be maintained without the day-to-day supervision of a single medical or clinic director as defined in section 400.9905(5), F.S. The health care clinic responsibilities under sections 400.9935(1)(a)-(i), F.S., cannot be met without an active, appointed medical or clinic director. Failure of an appointed medical or clinic director to substantially comply with health care clinic responsibilities under rule 59A-33.012, F.A.C. and sections 400.9935(1)(a)-(i), F.S., shall be grounds for the revocation or suspension of the license and assessment of a fine pursuant to section 400.995(1), F.S.

(2) By statutory definition in section 400.9905(5), F.S., a medical director is a health care practitioner that holds an active and unencumbered Florida physician’s license in accordance with chapters 458 (medical physician), 459 (osteopathic physician), 460 (chiropractic physician) or 461 (podiatric physician), F.S. A suspended or non-renewed license is considered an encumbered license, as is a license that restricts the license holder from performing health care services in a manner or under supervision different from a license holder without board or Department of Health restrictions.

(3) The Agency shall issue an emergency order suspending the license of any health care clinic operated or maintained without a medical or clinic director as required by sections 400.990-400.995, F.S., and this rule for such period of time as the health care clinic is without a medical or clinic director. The Agency shall assess a civil fine of up to $5,000 for operating or maintaining a health care clinic without a medical or clinic director. Each day of operation following receipt of Agency notice is considered a separate offense. Operation and maintenance of a health care clinic without a medical or clinic director shall be grounds for revocation of the license in addition to the assessment of fines pursuant to section 400.995(1), F.S.

History

Rulemaking Authority 400.9925(1), (2) FS. Law Implemented 400.9905(5), 400.9915(3), 400.993, 400.9935(1)(a)-(g), 400.9935(3), 400.995(1) FS. History–New 8-28-06, Amended 2-12-15.

Fla. Admin. Code R. 59A-33.009 Financial Instability

When evidence of financial instability of a health care clinic is substantiated, the Agency will notify the health care clinic in writing that satisfactory proof of financial ability to comply with chapter 400, part X, F.S., must be provided.

(1) Evidence of financial instability of a health care clinic shall, without limitation, include issuance of checks and drafts for which there are insufficient funds, delinquent bills for such items as personnel salaries, drugs, lease, mortgage, utilities or other operational costs, appointment of a receiver, a voluntary or involuntary petition for bankruptcy, a voluntary arrangement with creditors, health care clinic closure, discontinuance of health care clinic business for more than 60 consecutive days or insolvency.

(2) The licensee shall submit to the Agency a written plan of correction to resolve specific financial problems that the Agency has identified as evidence of financial instability. Should the financial instability not be resolved within 90 days of the original notice, the licensee shall be subject to disciplinary action, fine, suspension or revocation of the license.

History

Rulemaking Authority 400.9925 FS. Law Implemented 400.992(3) FS. History–New 8-28-06.

Fla. Admin. Code R. 59A-33.010 Cessation of Business, Billing and Medical Records Retention, Suspended and Revoked Licenses

History

Rulemaking Authority 400.9925 FS. Law Implemented 400.991, 400.993, 400.994, 400.995 FS. History–New 8-28-06, Repealed 5-16-12.

Fla. Admin. Code R. 59A-33.011 Magnetic Resonance Imaging Exemption for Chief Financial Officer

History

Rulemaking Authority 400.9925 FS. Law Implemented 400.9905(3), 400.9935(11)(a), (g) FS. History–New 8-28-06, Repealed 5-16-12.

Fla. Admin. Code R. 59A-33.012 Inspection Requirements and Process

(1) An applicant for health care clinic licensure must demonstrate compliance with the requirements in chapter 400, part X, Florida Statutes (F.S.), chapter 408, part II, F.S., chapters 59A-35 and 59A-33, Florida Administrative Code (F.A.C.) during an inspection as required in sections 408.806 and 408.811, F.S. Inspections will be conducted for initial, renewal, change of ownership and complaint investigations.

(2) The medical or clinic director must attend the survey entrance conference and be available when the survey is conducted for the surveyor to determine compliance with minimum standards and requirements for licensure. Other key personnel required include the financial director, a representative of management or ownership and persons responsible for patient records and billing.

(3) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the time of the survey:

(a) The professional license or facsimile of the license for the medical or clinic director;

(b) Copy of medical or clinic director’s written agreement with the health care clinic assuming the responsibilities for the statutory activities in sections 400.9935(1)(a)-(i), F.S. If the medical or clinic director signs the Medical/Clinic Director Attestation, AHCA Form 3110-1028, incorporated by reference in rule 59A-33.002, F.A.C., acknowledging these responsibilities as specified in section 400.9935, F.S., this requirement is met;

(c) Written policies, protocols, guidelines and procedures used or to be used by the facility staff in day-to-day operations. This includes protocols for physician assistants and advanced practice registered nurse plus a copy of the supervision form submitted to the Department of Health by the physician supervisor;

(d) Any policies, procedures, guidelines, checklists and/or means that are used in the systematic creation and maintenance of the health care clinic’s medical record system;

(e) Any policies, procedures, guidelines, checklists that demonstrate compliance with the medical records retention, disposition, reproduction, and disclosure requirements of the medical or clinic director’s practice act;

(f) Any policies, procedures, guidelines, checklists that demonstrate compliance with the office surgery requirements of the practice acts for services performed at the facility;

(g) Any policies, procedures, guidelines, checklists that demonstrate compliance with adverse incident reporting requirements and injury disclosure;

(h) Personnel files;

(i) Logs, charts or notes demonstrating day-to-day oversight of health care clinic activities by the medical or clinic director;

(j) Copies of professional licenses issued by the respective boards and the Department of Health under the several practice acts;

(k) Any patient referral contracts or agreements of the health care clinic that are in writing and a disclosure to the surveyor of any such agreements that are not in writing including the names of the parties to the agreement, the date and the essential terms of agreement;

(l) For health care clinics that are in operation at the time of the survey, the surveyor will select a sample of at least five (5) patient medical records from the previous 6 months of operation with at least one Medicaid file, if certified as a Medicaid provider, plus the five (5) billing records that correspond with the five patient records;

(m) Description of means by which the health care clinic conducts a systematic review of billings that ensures billings are not fraudulent or unlawful. A sample must be reviewed by the medical director or clinic director at least once every 30 days and a record maintained by the health care clinic for at least three years identifying the records reviewed and when and what action was taken to correct fraudulent or unlawful billings. A log of systematic reviews shall be kept and maintained in a discrete file at the health care clinic for review on request of the Agency during the retention period;

(n) List of services provided or a general descriptor of scope, level and complexity of care for services provided;

(o) Current diagnostic and treatment equipment records showing equipment certification when such equipment must have regulatory certification. This requirement is met with presentation of a current maintenance agreement;

(p) An organizational flow chart with lines of authority and names of key individuals and positions;

(q) An all-inclusive and up to date listing of original signatures and initials of all persons entering information on billing and patient records, the printed name and medical designation, if any, such as PA, RN, MD, etc. The log shall be kept and concurrently maintained at the health care clinic. Information required by this rule shall be stored and maintained by the health care clinic for a period of 5 years.

(r) Log of all natural persons required and who have been screened under Level 2 criteria of Chapter 435 and Section 400.991, F.S.; and,

(s) Documentation for the past two years or from the date of licensure, whichever is earlier, demonstrating in writing compliance, when, and what action was taken by the medical or clinic director to perform the functions, duties and clinic responsibilities under Sections 400.9935(1)(a)-(i), F.S. Such documentation shall be made available to authorized agency personnel upon request.

History

Rulemaking Authority 400.9925, 408.806, 408.811, 408.819 FS. Law Implemented 400.9905(5), 400.9935(1)(a)-(i), 408.806, 408.811 FS. History–New 8-28-06, Amended 2-12-15.

Fla. Admin. Code R. 59A-33.013 Medical and Clinic Directorships Maximum Number of Clinics

A medical or clinic director may not serve in that capacity for more than a maximum of five health care clinics with a cumulative total of more than 200 employees and persons under contract with the health care clinic at any given time. A medical or clinic director may not supervise a health care clinic more than 200 miles from any other health care clinic supervised by the same medical or clinic director.

History

Rulemaking Authority 400.9925(2) FS. Law Implemented 400.9925(2) FS. History–New 8-28-06.

Chapter 59A-35 HEALTH CARE LICENSING PROCEDURES

Fla. Admin. Code R. 59A-35.020 Applicability

History

Rulemaking Authority 408.819 FS. Law Implemented 408.802 FS. History–New 7-14-10, Repealed 1-4-16.

Fla. Admin. Code R. 59A-35.030 Definitions

(1) “Address of record” means the location that is printed on the license and is the address at which the provider is licensed to operate. In the event a license displays multiple locations including branch offices, satellite offices, or off-site locations, the address of record is the main or principle office address.

(2) “Agency notification” or “Agency request” means the Agency sends notification by:

(a) Mail or personal delivery to the address of record for a licensee or applicant;

(b) Mail to an alternative mailing address if requested by the licensee or applicant, or

(3) “Days” means calendar days.

(4) “Management company” means an entity retained by a licensee to administer or direct the operation of a provider. This does not include an entity that serves solely as a lender or lien holder.

History

Rulemaking Authority 408.819 FS. Law Implemented 408.803 FS. History–New 7-14-10.

Fla. Admin. Code R. 59A-35.040 License Required; Display

(1) A license is valid only for the licensee, provider, and location for which the license is issued as it appears on the license.

(2) Any request to amend a license must be received by the Agency in advance of the requested effective date as detailed below. Requests to amend a license are not authorized until the license is issued.

(a) Requests to change the address of record must be received by the Agency 60 to 120 days in advance of the requested effective date for the following provider types:

Birth Centers, as provided under Chapter 383, F.S.,
Abortion Clinics, as provided under Chapter 390, F.S.,
Crisis Stabilization Units, as provided under Chapter 394, Parts I and IV, F.S.,
Short Term Residential Treatment Units, as provided under Chapter 394, Parts I and IV, F.S.,
Residential Treatment Facilities, as provided under Chapter 394, Part IV, F.S.,
Residential Treatment Centers for Children and Adolescents, as provided under Chapter 394, Part IV, F.S.,
Hospitals, as provided under Chapter 395, Part I, F.S.,
Ambulatory Surgical Centers, as provided under Chapter 395, Part I, F.S.,
Nursing Homes, as provided under Chapter 400, Part II, F.S.,
Hospices, as provided under Chapter 400, Part IV, F.S.,
Homes for Special Services as provided under Chapter 400, Part V, F.S.,
Transitional Living Facilities, as provided under Chapter 400, Part XI, F.S.,
Prescribed Pediatric Extended Care Centers, as provided under Chapter 400, Part VI, F.S.,
Intermediate Care Facilities for the Developmentally Disabled, as provided under Chapter 400, Part VIII, F.S.,
Assisted Living Facilities, as provided under Chapter 429, Part I, F.S.,
Adult Family-Care Homes, as provided under Chapter 429, Part II, F.S.; and,
Adult Day Care Centers, as provided under Chapter 429, Part III, F.S.

(b) Requests to change the address of record must be received by the Agency 21 to 120 days in advance of the requested effective date for the following provider types:

Drug Free Workplace Laboratories as provided under Sections 112.0455 and 440.102, F.S.,
Home Health Agencies, as provided under Chapter 400, Part III, F.S.,
Nurse Registries, as provided under Chapter 400, Part III, F.S.,
Companion Services or Homemaker Services Providers, as provided under Chapter 400, Part III, F.S.,
Home Medical Equipment Providers, as provided under Chapter 400, Part VII, F.S.,
Health Care Services Pools, as provided under Chapter 400, Part IX, F.S.,
Health Care Clinics, as provided under Chapter 400, Part X, F.S., including certificate of exemption,
Organ and Tissue Procurement Agencies, as provided under Chapter 381, F.S.

(c) All other requests to amend a license including but not limited to services, licensed capacity, and other specifications which are required to be displayed on the license by authorizing statutes or applicable rules must be received by the Agency 60 to 120 days in advance of the requested effective date. This deadline does not apply to a request to amend hospital emergency services defined in Section 395.1041(2), F.S.

(3) Failure to submit a timely request shall result in a $500 fine.

(4) A licensee is not authorized to operate in a new location until a license is obtained which specifies the new location. Failure to amend a license prior to a change of the address of record constitutes unlicensed activity.

History

Rulemaking Authority 408.819 FS. Law Implemented 408.804, 408.810, 408.813 FS. History–New 7-14-10, Amended 1-15-20, 11-1-21, Joint Administrative Procedures Committee Objection Filed–See FAR Vol. 51, No. 53, March 18, 2025, Amended 12-7-25, Amendment resolved Joint Administrative Procedures Committee objection 12-7-25, Florida Administrative Register Vol. 52, No. 21, February 2, 2026.

Fla. Admin. Code R. 59A-35.050 Fees Required; Adjustments

(1) Licensure fees, as defined by authorizing statute or rule, are non-refundable once submitted to the Agency. An applicant may submit a request for refund if monies in excess of required fees are submitted to the Agency. Such requests must be made using State of Florida Department of Financial Services, Application for Refund form number DFS-AA-4, Rev. 0207, incorporated herein by reference, available online at: http://myfloridacfo.com/aadir/refund_application.htm and submitted to the appropriate licensing unit. The following are examples of excess fee payments that are eligible for refund:

(a) Fees in excess of the required fee amount;

(b) A renewal reminder letter indicates an error in the required fee amount;

(d) An excess fee is submitted as an accredited provider when the licensee or applicant is not accredited, or

(e) An application is returned due to early submission.

(2) When payment for licensure fees has been dishonored, the licensee has 10 days from the date of notification to remit to the Agency the licensure fee plus any applicable fees as provided by law in the form of a money order or cashier’s check. In the event that the licensure fee is not paid, the license may be subject to revocation or suspension.

(3) A request for a replacement license must be accompanied by a $25.00 fee.

(4) In addition to required application, per-bed, and inspection fees, a request to amend a license must be accompanied by a $25.00 fee.

History

Rulemaking Authority 408.819 FS. Law Implemented 408.805 FS. History–New 7-14-10.

Fla. Admin. Code R. 59A-35.060 Licensure Application Process

(1) Applicants must apply for licensure or exemption using the program specific forms incorporated below and the Health Care Licensing Application Addendum, AHCA Form 3110-1024, August 2023, available at http://www.flrules.org/Gateway/reference.asp?No=Ref-16384. All forms are incorporated by reference and available at: https://ahca.myflorida.com/health-care-policy-and-oversight/hcpo-applications-for-licensure and online through the Agency’s Online Portal at: http://apps.ahca.myflorida.com/SingleSignOnPortal. For online submissions, the information required on the Health Care Licensing Application Addendum is incorporated into the program specific online licensure application forms.

(2) Renewal applicants must apply online by submitting the online licensure application form, fees, and supporting documents electronically through the Agency’s Online Portal. Hard copy application forms are not accepted for the purpose of licensure renewal. Renewal applications submitted on hard copy forms will be returned to the applicant unprocessed.

(3) Application forms to be used for licensure.

(a) Abortion Clinic, as provided under Chapter 390, F.S.

Health Care Licensing Application Abortion Clinic, AHCA Form 3130-1000, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16385; or
Health Care Licensing Online Application Abortion Clinic, AHCA Form 3130-1000OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16386.

(b) Adult Day Care Center, as provided under Chapter 429, Part III, F.S.

Health Care Licensing Application Adult Day Care Center, AHCA Form 3180-1004, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16387; or
Health Care Licensing Online Application Adult Day Care Center, AHCA Form 3180-1004OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16388.

Health Care Licensing Application Adult Family-Care Home, AHCA Form 3180-1022, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16389; or
Health Care Licensing Online Application Adult Family-Care Home, AHCA Form 3180-1022OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16390.

(d) Ambulatory Surgical Center, as provided in 395 Part I, F.S.

Health Care Licensing Application Ambulatory Surgical Center, AHCA Form 3130-2001, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16391; or
Health Care Licensing Online Application Ambulatory Surgical Center, AHCA Form 3130-2001OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16392.

(e) Assisted Living Facility, as provided in 429 Part I, F.S.

Health Care Licensing Application Assisted Living Facilities, AHCA Form 3110-1008, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16393; or
Health Care Licensing Online Application Assisted Living Facilities, AHCA Form 3110-1008OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16394.

(f) Birth Center, as provided under Chapters 383.30 – 383.335, F.S.

Health Care Licensing Application Birth Center, AHCA Form 3130-3001, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16395; or
Health Care Licensing Online Application Birth Center, AHCA Form 3130-3001OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16396.

(g) Crisis Stabilization Unit or Short-Term Residential Treatment Facility, as provided under Parts I and IV of Chapter 394, F.S.

Health Care Licensing Application Crisis Stabilization Unit or Short-Term Residential Treatment Facility, AHCA Form 3180-5003, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16397; or
Health Care Licensing Online Application Crisis Stabilization Unit or Short-Term Residential Treatment Facility, AHCA Form 3180-5003OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16398.

(h) Forensic Toxicology Laboratory (also known as Drug Free Workplace Laboratory), as provided under Chapter 112, Part I and 440.102, F.S.

Health Care Licensing Application Forensic Toxicology Laboratory, AHCA Form 3170-5001, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16399; or
Health Care Licensing Online Application Forensic Toxicology Laboratory, AHCA Form 3170-5001OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16400.

(i) Health Care Clinic, as provided under Chapter 400, Part X, F.S.

Health Care Licensing Application Health Care Clinic, AHCA Form 3110-0013, August 2023 incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16401; or
Health Care Licensing Online Application Form Health Care Clinic, AHCA Form 3110-0013OL, August 2023 incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16402.

(j) Health Care Services Pool, as provided under Chapter 400, Part IX, F.S.

Health Care Licensing Application Health Care Services Pool, AHCA Form 3110-1010, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16403; or
Health Care Licensing Online Application Health Care Services Pool, AHCA Form 3110-1010OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16404.

(k) Home Health Agency, as provided under Chapter 400 Part III, F.S.

Health Care Licensing Application Home Health Agencies, AHCA Form 3110-1011, July 2024, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-17848; or
Health Care Licensing Online Application Home Health Agencies, AHCA Form 3110-1011OL, July 2024, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-17847.

(l) Home Medical Equipment Provider, as provided under Chapter 400, Part VII, F.S.

Health Care Licensing Application Home Medical Equipment Provider AHCA Form 3110-1005, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16407; or
Health Care Licensing Online Application Home Medical Equipment Provider AHCA Form 3110-1005OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16408.

(m) Homemaker and Companion Services Provider, as provided under Chapter 400, Part III, F.S.

Health Care Licensing Application Homemaker and Companion Services Provider, AHCA Form 3110-1003, July 2024, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-17849; or
Health Care Licensing Online Application Homemaker and Companion Services Provider, AHCA Form 3110-1003OL, August 2023, incorporated by reference incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16410.

(n) Hospice, as provided under Chapter 400, Part IV, F.S.

Health Care Licensing Application Hospice, AHCA Form 3110-4001, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16411; or
Health Care Licensing Online Application Hospice, AHCA Form 3110-4001OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16412.

(o) Hospital, as provided under Chapter 395, Part I, F.S.

Health Care Licensing Application Hospitals, AHCA Form 3130-8001, July 2024, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-17813; or
Health Care Licensing Online Application Hospitals AHCA Form 3130-8001OL, July 2024, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-17815.

(p) Intermediate Care Facilities for the Developmentally Disabled, as provided under Chapter 400, Part VIII and Chapter 393, F.S.

Health Care Licensing Application Intermediate Care Facilities for the Developmentally Disabled, AHCA Form 3110-5003, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16415; or
Health Care Licensing Online Application Intermediate Care Facilities for the Developmentally Disabled, AHCA Form 3110-5003OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16416.

(q) Nurse Registry, as provided under 400.506, F.S.

Health Care Licensing Application Nurse Registry, AHCA Form 3110-7004, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16417; or
Health Care Licensing Online Application Nurse Registry, AHCA Form 3110-7004OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16418.

(r) Nursing Home, as provided under Chapter 400, Part II, F.S.

Health Care Licensing Application Nursing Home, AHCA Form 3110-6001, August 2023 incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16419; or
Health Care Licensing Online Application Nursing Home, AHCA Form 3110-6001OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16420.

(s) Organ Procurement Organization, Tissue Bank, or Eye Bank, as provided under Chapter 765, Part V, F.S.

Health Care Licensing Application Organ Procurement Organization, Tissue Bank, Eye Bank, AHCA Form 3140-2001, August 2023 incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16421; or
Health Care Licensing Online Application Organ Procurement Organization, Tissue Bank, Eye Bank, AHCA Form 3140-2001OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16422.

(t) Prescribed Pediatric Extended Care Center, as provided under Chapter 400, Part VI, F.S.

Health Care Licensing Application Prescribed Pediatric Extended Care Centers, AHCA Form 3110-8002, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16423; or
Health Care Licensing Online Application Prescribed Pediatric Extended Care Centers, AHCA Form 3110-8002OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16424.

(u) Residential Treatment Center for Children and Adolescents, as provided under Chapter 394, Part IV, F.S.

Health Care Licensing Application Residential Treatment Center for Children and Adolescents, AHCA Form 3180-5004, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16425; or
Health Care Licensing Online Application Residential Treatment Center for Children and Adolescents, AHCA Form 3180-5004OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16426.

(v) Residential Treatment Facility, as provided under Chapter 394, Part IV, F.S.

Health Care Licensing Application Residential Treatment Facility, AHCA Form 3180-5005, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16427; or
Health Care Licensing Online Application Residential Treatment Facility, AHCA Form 3180-5005OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16428.

(w) Transitional Living Facility, as provided under Chapter 400, Part XI

Health Care Licensing Application Transitional Living Facility, AHCA Form 3110-9001, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16429; or
Health Care Licensing Online Application Transitional Living Facility, AHCA Form 3110-9001OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16430.

(4) Application forms to be used to apply for certificates of exemption from licensure.

(a) Health Care Clinic Exemption from Licensure, as provided under Chapter 400, Part X, F.S.

Application for Certificate of Exemption from Licensure as a Health Care Clinic, AHCA From 3110-0014, August 2023 incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16431; or
Online Application for Certificate of Exemption from Licensure as a Health Care Clinic, AHCA Form 3110-0014OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16432.

(b) Home Health Agency Exemption from Licensure, as provided under Chapter 400 Part III, F.S.

Application for Certificate of Exemption from Licensure as a Home Health Agency, AHCA Form 3110-1009, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16433; or
Online Application for Certificate of Exemption from Licensure as a Home Health Agency, AHCA Form 3110-1009OL, August 2023, incorporated by reference at http://www.flrules.org/Gateway/reference.asp?No=Ref-16434.

(5) All required fees must be included with the application. Applications will be returned to the applicant unprocessed if required fees are not submitted with the application. Applications from state agencies must include a copy of the posted journal transactions by State Wide Document Number (SWDN) within benefiting Operating Level Organization (OLO) and site.

(6) Applications received more than 120 days prior to the date of license expiration or the effective date will be returned to the applicant unprocessed.

(7) If an applicant, licensee, or controlling interest is required to register or file with the Florida Secretary of State, Division of Corporations, the principal, fictitious name and mailing addresses submitted with the licensure application for the applicant, licensee and controlling interests must be the same as the information registered with the Division of Corporations.

(8) Unresponsive applicant. If certified mail sent to the provider’s address of record, or mailing address if applicable, is returned as unclaimed or undeliverable, the Agency will send a copy of the letter by regular mail to the provider’s address of record, or mailing address if applicable, with a copy to the applicant’s address if different from the provider. The applicant must respond to the request within 21 days of the date of the letter sent by regular mail. If timely response is not received, the application will be subject to withdrawal or denial.

(9) An application is considered complete upon receipt of:

(a) All required documents, information and required fees;

(b) All required background screening results; and,

(c) Completion of a satisfactory inspection if required by authorizing statutes or rules. Satisfactory inspection means no regulatory violations exist, or all prior violations found have been determined by the Agency to be corrected.

(10) A licensure inspection will not be authorized until sections (9)(a) and (b) of this rule have been satisfied.

(11) An application for license renewal may only be filed online by the licensee.

History

Rulemaking Authority 112.0455, 383.305, 390.0111, 390.012, 394.877, 395.004, 395.1055, 400.23, 400.497, 400.509, 400.605, 400.801, 400.914, 400.935, 400.967, 400.980, 400.9925, 400.9982, 408.819, 408.822, 429.41, 429.67, 429.73, 429.929, 765.541, FS. Law Implemented 112.0455, 383.305, 390.014, 390.015, 394.876, 394.877, 395.004, 395.0161, 400.062, 400.071, 400.464, 400.471, 400.506, 400.509, 400.606, 400.801, 400.905, 400.906, 400.931, 400.962, 400.980, 400.991, 400.9925, 400.9935, 400.9972, 400.801, 408.805, 408.806, 408.809, 408.810, 408.811, 408.822, 429.07, 429.11, 429.17, 429.67, 429.909, 765.544, FS. History–New 7-14-10, Amended 5-4-15, 3-5-24, 6-5-25.

Fla. Admin. Code R. 59A-35.062 Proof of Financial Ability to Operate

(1) Proof of financial ability to operate must be demonstrated for initial licensure and change of ownership applications, by submitting AHCA Form 3100-0009, July 2009, Proof of Financial Ability to Operate, incorporated herein by reference, and available online at: http://ahca.myflorida.com/HQAlicensureforms, as provided under Section 408.810(8), F.S., for the following provider types:

(a) Nursing Home Facilities, as specified in Chapter 400, Part II, F.S.;

(b) Assisted Living Facilities, as specified in Chapter 429, Part I, F.S.;

(d) Hospices, as specified in Chapter 400, Part IV, F.S.;

(e) Adult Day Care Centers, as specified in Chapter 429, Part III, F.S.;

(f) Prescribed Pediatric Extended Care Centers, as specified in Chapter 400, Part VI, F.S.;

(g) Home Medical Equipment Providers, as specified in Chapter 400, Part VII, F.S.;

(h) Intermediate Care Facilities for the Developmentally Disabled, as specified in Chapter 400, Part VIII, F.S.;

(i) Health Care Clinics, as specified in Chapter 400, Part X, F.S.; and,

(2) Proof of financial ability must be demonstrated for initial licensure and change of ownership applications for Nurse Registries, as specified in Chapter 400, Part III, F.S., by submitting AHCA Form 3110-7004A, September 2009, Nurse Registry Proof of Financial Ability to Operate, incorporated herein by reference, and available online at: http://ahca.myflorida.com/HQAlicensureforms.

(3) Definitions. The following definitions apply to this section for proof of financial ability to operate.

(a) “Assumptions” means the basis and rationale used in the financial projections to estimate the number and type of patients, the method of acquiring patients, the amount of resources needed to serve patients, the method by which these resources will be acquired, the method of recruiting and maintaining staff, the method of collecting revenue and paying expenses, and the basis for anticipated salaries and employee benefits.

(b) “Charity care” means the term as defined in Section 409.911, F.S.

(c) “Contingency funding” means a source of funding available to the licensee or applicant to cover the cost of events not considered in the financial projections, including, but not limited to, a drop in patient volume, a delay in Medicare and/or Medicaid certification, major repairs, purchase of capital equipment. The contingency fund will be a minimum of one month’s average operating expense over the first year of operations.

(d) “Contractual adjustments” means the difference in the established charges or rates of the provider and the rates negotiated by Medicare, Medicaid, HMO/PPOs, and Insurers.

(e) “Financial instability” means the provider cannot meet its financial obligations. Evidence such as the issuance of bad checks, an accumulation of delinquent bills, or inability to meet current payroll needs shall constitute prima facie evidence that the ownership of the provider lacks the financial ability to operate. Evidence shall also include the Medicare or Medicaid program’s indications or determination of financial instability or fraudulent handling of government funds by the provider.

(f) “Financial projections” means the expected operating results of the applicant as presented on AHCA Form 3100-0009, July 2009.

(g) “Full time equivalent” or “FTE” means a measure of full-time employment of 40 hours per week (1FTE = 40 hours per week or 2,080 hours annually).

(h) “Generally Accepted Accounting Principles” or “GAAP” means the term as defined in Rule 61H1-20.007, F.A.C., Department of Business and Professional Regulation, Board of Accountancy.

(i) “Liquid assets” means assets of the licensee or applicant that can easily and quickly be converted to cash such as publicly traded stocks, bonds, certificates of deposit, and money market accounts.

(j) “Net patient service revenue” means patient service revenue minus deductions from revenue. Deductions from revenue include contractual adjustments and charity care.

(k) “Operating expense” means total expenses incurred through the normal course of business.

(l) “Operating margin” means a measure of profitability and is calculated as follows: ([Net Patient Service Revenue - Operating Expenses] ÷ Net Patient Service Revenue) = Operating Margin.

(m) “Patient service revenue” means the total charge for a service provided.

(n) “Pre-opening costs” means the costs necessary to begin operations including advertising, equipment purchases, legal fees, accounting fees, consulting fees, pre-paid insurance, pre-paid rent, licensure fees, deposits (rent, utilities), requirement, staffing, and training.

(o) “Working capital” means the cash needed to sustain operations until a positive cash flow is achieved. (Largest cumulative cash need from Schedule 7 Line 21 of AHCA Form 3100-0009, July 2009).

(4) All documents required under this section must be prepared in accordance with generally accepted accounting principles. All documents required under this section for Home Health Agencies, Home Medical Equipment Providers and Health Care Clinics must be compiled and signed by a certified public accountant.

(5) A pro forma balance sheet, a pro forma cash flow statement and a pro forma income and expense statement for the first 2 years of operation which provide evidence of having sufficient assets, credit, and projected revenues to cover liabilities and expenses must be included. An application for change of ownership may elect not to complete the 2nd year of operations on AHCA Form 3100-0009, July 2009, if all of the following apply:

(a) As of the date of the application, the entity subject to the change of ownership has been licensed for at least 5 consecutive years;

(b) The applicant’s assets, credit, and projected revenues meet or exceed projected liabilities and expenses by the end of the first year;

(6) The applicant shall have demonstrated financial ability to operate if the applicant’s assets, credit, and projected revenues meet or exceed projected liabilities and expenses.

(7) An applicant for renewal of a license shall not be required to provide proof of financial ability to operate, unless the licensee or applicant has demonstrated financial instability. If an applicant or licensee has shown signs of financial instability, as provided in Section 408.810(9), F.S., at any time, the Agency may require the applicant or licensee to provide proof of financial ability to operate by submission of:

(a) AHCA Form 3100-0009, July 2009, Proof of Financial Ability Form, that includes a balance sheet and income and expense statement for the next 2 years of operation which provide evidence of having sufficient assets, credit, and projected revenues to cover liabilities and expenses; and,

(b) Documentation of correction of the financial instability, including but not limited to, evidence of the payment of any bad checks, delinquent bills or liens. If complete payment cannot be made, evidence must be submitted of partial payment along with a plan for payment of any liens or delinquent bills. If the lien is with a government agency or repayment is ordered by a federal or state court, an accepted plan of repayment must be provided.

History

Rulemaking Authority 408.819 FS. Law Implemented 408.806, 408.810 FS. History–New 7-14-10.

Fla. Admin. Code R. 59A-35.070 Change of Ownership

(1) Effective dates of change of ownership.

(a) A change of ownership application must include the effective date of the change of ownership.

(b) The change of ownership effective date cannot be prior to the date the application is received by the Agency. Failure to submit an application for licensure prior to the effective date of a change of ownership to a different legal entity constitutes unlicensed activity.

(c) The effective date of the change of ownership shall not be extended more than 60 days from the effective date reported on the application; written notification of a change in the effective date must be received by the Agency prior to the originally reported effective date. The Agency will deem the application withdrawn if the change of ownership does not occur within 60 days of the reported effective date.

(2) All required application documents and information must be received with the application or within 21 days of the request by the Agency with the exception of the transferee’s proof of right to occupy if required, which must be received by the Agency within 10 days after the effective date.

(3) When a change of ownership application is submitted during the review of a renewal licensure application, the pending renewal will be administratively withdrawn from review if the change of ownership application is approved with an effective date prior to the expiration of the license.

(4) Expiration of a license prior to the approval of the change of ownership application, when no renewal application has been submitted, will result in the denial of a change of ownership application.

(5) If the applicant has not been issued the license on the effective date of the change of ownership, documentation must be submitted that provides for continuation of operation of the licensee for those days between the date of the change of ownership and the date the applicant is licensed by the Agency.

History

Rulemaking Authority 408.819 FS. Law Implemented 408.803(3), 408.803(5), 408.806, 408.807, 408.810, 408.813 FS. History–New 7-14-10.

Fla. Admin. Code R. 59A-35.080 License Categories

(1) Provisional License. If a license expires while an action to deny or revoke the license is pending and renewal applications are filed, the Agency may issue a provisional license. The provisional license shall identify the pending action. The provisional license will expire when the Agency action is final or one year after issuance, whichever occurs first. The provisional license does not affect the revocation or denial action or constitute a defense on behalf of the licensee or applicant.

(2) Inactive License. An inactive license may be issued, as provided in Section 408.808(3), F.S.

(a) Requests for an inactive license must be submitted to the Agency as a written request that includes:

The reason that the provider will become inactive;
The proposed plan for transferring or discharging clients;
A plan for resuming services;
The date by which services are expected to resume; and,
Evidence of a State of Emergency or disaster if applicable.

(b) The inactive license will not be issued until all clients have been properly transferred or discharged. The expiration date of the inactive license will be issued for a period not to exceed 12 months. An application to extend the inactive period for an additional 12 months must be submitted 30 days prior to the expiration of the inactive license.

(c) Notification to reactivate the license and a complete licensure renewal application must be submitted to the Agency at least 90 days prior to the requested reactivation date. An onsite inspection may be required prior to reactivation. Licensure fees will be prorated based on the provider’s standard fee divided by the number of months remaining in the licensure cycle.

History

Rulemaking Authority 408.819 FS. Law Implemented 408.808(2), (3) FS. History–New 7-14-10.

Fla. Admin. Code R. 59A-35.090 Background Screening

(1) Definitions:

(a) “Arrest Report” means the detailed narrative written by the arresting law enforcement officer explaining the circumstances of the arrest.

(b) “Disposition” means the sentencing or other final settlement of a criminal case which shall include, regardless of adjudication, a plea of nolo contendere or guilty, or a conviction by a judge or jury.

(d) “Exemption from Disqualification” means an exemption granted by the Agency following a review of the Background Screening Application for Exemption, AHCA Form 3110-0019, July 2024, hereby incorporated by reference, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-17726, in which the individual must present clear and convincing evidence to support a reasonable belief that he or she has been rehabilitated and does not present a danger to the health, safety, and welfare of the patient or individual as described in Section 435.07, F.S.

(e) “FBI” means the Federal Bureau of Investigation.

(f) “FDLE” means the Florida Department of Law Enforcement.

(g) “Level 2 Screening” means an assessment of the criminal history record obtained through a fingerprint search through the FDLE and FBI to determine whether screened individuals have any disqualifying offenses pursuant to Section 435.04 or 408.809(4), F.S. An analysis and review of court dispositions and arrest reports may be required to make a final determination.

(h) “Livescan Service Provider” means an entity that scans fingerprints electronically and submits them to FDLE.

(2) Processing Screening Requests, Required Documents and Fees.

(a) Providers subject to the screening standards outlined in Section 408.809, F.S., must follow the requirements specified in Section 435.12, F.S. Care Provider Background Screening Clearinghouse and must register and initiate all criminal history checks through the Care Provider Background Screening Clearinghouse before referring an employee or potential employee for electronic fingerprint submission to the Department of Law Enforcement. Providers can access the Care Provider Background Screening Clearinghouse at: https://ahca.myflorida.com/backgroundscreening.

(b) Persons required to undergo Level 2 background screening must submit fingerprints electronically through a Livescan Service Provider contracted through the Agency or approved through the Florida Department of Law Enforcement. Payment for screening services must be made to the Livescan Service Provider at the time of services or through a payment arrangement with the Livescan Service Provider.

(c) If the individual’s fingerprints are rejected by the FBI due to illegible prints, the requesting provider will be notified through the Agency’s secure website. The individual must return to the same Livescan Service Provider and submit a second set of fingerprints in accordance with the guidelines established by the FBI.

(d) Attestation of Compliance with Background Screening Requirements, AHCA Form 3100-0008, July 2024, herein incorporated by reference, must be completed by the individual and retained by the provider upon hire to attest that they meet the requirements for qualifying for employment, they have not been unemployed for more than 90 days from a position that requires Level 2 screening, and they agree to inform the employer immediately if arrested for any disqualifying offense. The Attestation of Compliance is available at https://flrules.org/Gateway/reference.asp?No=Ref-17724, and available from the Agency for Health Care Administration’s website at: https://ahca.myflorida.com/health-quality-assurance/bureau-of-central-services/background-screening/additional-information/regulations.

(e) An administrator or chief financial officer must be screened and qualified prior to appointment to the position.

(3) Results of Screening and Notification.

(a) Final results of background screening requests will be provided through the Agency’s secure website that may be accessed by all health care providers applying for or actively licensed through the Agency that are registered with the Care Provider Background Screening Clearinghouse. The secure website is located at: apps.ahca.myflorida.com/SingleSignOnPortal.

(b) If a Level 2 criminal history is incomplete, correspondence will be sent to the individual being screened requesting the arrest report and court disposition information. Pursuant to Section 435.05(1)(d), F.S., the missing information must be filed with the Agency within 30 days of the Agency’s request or the individual is subject to disqualification in accordance with Section 435.06(3), F.S.

(c) The eligibility results of employee screening and the signed Attestation referenced in subsection 59A-35.090(2), F.A.C., must be in the employee’s personnel file, maintained by the provider.

(4) Exemption from Disqualification.

(a) Requests for an exemption from disqualification shall be submitted in writing to the Agency using the Background Screening Application for Exemption, AHCA Form 3110-0019, July 2024.

(b) Individuals that are licensed or certified in a profession under the jurisdiction of the Department of Health must apply for an exemption to the appropriate licensing or certifying board at the Department of Health unless the individual will be working in a position other than for which they are licensed or certified.

(c) The individual shall bear the burden of setting forth clear and convincing evidence of rehabilitation which includes any information indicating the individual presents no danger to the safety or well being of others. The individual must present such evidence as arrest reports, court dispositions, parole/probation information, and reference letters from employers, and/or personal references. Other documents that may be included are records of successful participation in a rehabilitation program, further education or training, community or church involvement, special awards or recognition or testimony by self or others.

(d) An “Application for Exemption” will not be considered until all required documents are obtained. If the application is deemed incomplete after 30 days of receipt by the Agency, the application will be closed. An Application for Exemption will not be considered if the applicant has not had a Level 2 Screening as defined in paragraph 59A-35.090(1)(g), F.A.C., within 6 months from their application date.

(e) In deciding whether to grant or deny an exemption request, the Agency shall consider factors such as the facts and circumstances surrounding the disqualifying offense(s), the nature of the harm to the victim, whether the individual is on probation or parole, whether restitution has been made, other offenses on the criminal history record and the length of time since the last offense, the history of the person since the disqualifying offense(s), work experience, personal references, performance evaluations, probation or parole violations, education, other evidence of rehabilitation, and the honesty and candor of the disqualified individual.

(f) Any exemption granted by the Agency is limited to the information provided at the time of application and the disqualifying offense or offenses committed prior to the date of the request for exemption.

(g) The Agency shall void any exemption granted to an individual when there is evidence that information which would adversely affect the decision was not made available at the time of the determination or there is an arrest or disposition of a new disqualifying offense since the date the exemption was granted.

(5) Unless otherwise specified, information requested pursuant to this section must be filed with the Agency within 21 days of the Agency’s request.

History

Rulemaking Authority 408.809, 408.819, 435.01 FS. Law Implemented 408.809, 408.810, 435.07 FS. History–New 7-14-10, Amended 12-16-13, 6-15-15, 2-13-18, 5-13-25, Technical Change 3-26-26.

Fla. Admin. Code R. 59A-35.100 Minimum Licensure Requirements

Provider location. A licensee must maintain proper authority for operation of the provider at the address of record. If such authority is denied, revoked or otherwise terminated by the local zoning or code enforcement authority, the Agency may deny or revoke an application or license, or impose sanctions.

History

Rulemaking Authority 408.819 FS. Law Implemented 408.810 FS. History–New 7-14-10, Amended 3-12-12.

Fla. Admin. Code R. 59A-35.110 Reporting Requirements; Electronic Submission

(1) During the two year licensure period, any change or expiration of any information that is required to be reported under Chapter 408, Part II, F.S., or authorizing statutes for the provider type as specified in Section 408.803(3), F.S., during the license application process must be reported to the Agency within 21 days of occurrence of the change, including:

(a) Insurance coverage renewal;

(b) Bond renewal;

(c) Change of administrator or the similarly titled person who is responsible for the day-to-day operation of the provider;

(d) Annual sanitation inspections;

(e) Fire inspections.

(2) Electronic submission of information.

(a) The following required information must be submitted electronically through the Agency’s Single Sign On Portal located at https://apps.ahca.myflorida.com/SingleSignOnPortal:

Nursing homes:

Adverse incident reports must be submitted electronically to the Agency within 15 calendar days after the occurrence of the incident as required in Section 400.147, F.S. on Nursing Home Adverse Incident, AHCA Form 3110-0010 OL, April 2017, which is hereby incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-08777, and through the Agency’s adverse incident reporting system which can only be accessed through the Agency’s Single Sign On Portal located at: https://apps.ahca.myflorida.com/SingleSignOnPortal.

Assisted living facilities:

Adverse incident reports must be submitted electronically to the Agency within 1 business day after the occurrence of the incident, and within 15 calendar days after the occurrence of the incident as required in Section 429.23, F.S., on Assisted Living Facility Adverse Incident, AHCA Form 3180-1025 OL, April 2017, which is hereby incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-08778, and through the Agency’s adverse incident reporting system which can only be accessed through the Agency’s Single Sign On Portal located at: https://apps.ahca.myflorida.com/SingleSignOnPortal.

Hospitals:

Adverse incident reports must be submitted electronically to the Agency within 15 calendar days after the occurrence of the incident as required in Section 395.0197, F.S., on Hospital Adverse Incident, AHCA Form 3140-5001 OL, April 2017, which is hereby incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-08779, and through the Agency’s adverse incident reporting system which can only be accessed through the Agency’s Single Sign On Portal located at: https://apps.ahca.myflorida.com/SingleSignOnPortal.

Ambulatory Surgical Centers:

Adverse incident reports must be submitted electronically to the Agency within 15 calendar days after the occurrence of the incident as required in Section 395.0197, F.S., on Ambulatory Surgical Center Adverse Incident, AHCA Form 3140-5004 OL, April 2017, which is hereby incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-08780, and through the Agency’s adverse incident reporting system which can only be accessed through the Agency’s Single Sign On Portal located at: https://apps.ahca.myflorida.com/SingleSignOnPortal.

Residential Mental Health Providers:

Crisis stabilization units, short-term residential treatment facilities, residential treatment facilities, and residential treatment centers for children and adolescents shall submit incidents as required by Section 394.907, F.S., and rules promulgated thereunder to the Agency within 1 business day of occurrence on Residential Mental Health Provider Incident Report, AHCA Form 3180-5008OL, October 2024, which is hereby incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-18470, and through the Agency’s adverse incident reporting system which can only be accessed through the Agency’s Single Sign On Portal located at: https://apps.ahca.myflorida.com/SingleSignOnPortal.

Hospitals and ambulatory surgical centers must submit annual reports pursuant to Section 395.0197 F.S., electronically to the Agency on Annual Report, AHCA Form 3140-5005 OL, May 2018, which is hereby incorporated by reference and available at: http://www.flrules.org/Gateway/reference.asp?No=Ref-12123, and through the Agency’s Single Sign On Portal located at: https://apps.ahca.myflorida.com/SingleSignOnPortal.
For the purposes of this rule, the following applies for submitting adverse incident reports:

a. A business day means any day other than a Saturday, Sunday, or legal holiday as designated in Section 110.117, F.S.

b. A preliminary (1-Day) report is deemed late when submitted more than 1 business day after the day of the incident.

c. Nursing Homes, Hospitals, and Ambulatory Surgical Centers: A full report (15- Day) is deemed late when submitted more than 15 calendar days after the day of the incident.

d. Assisted Living Facilities: A full report (15-Day) is deemed late when submitted more than 15 calendar days after the day of the incident or more than 3 business days after the Agency issues the reminder pursuant to Section 429.23(5), F.S., whichever is later.

e. Assisted Living Facilities and Nursing Homes that submit reports deemed late may be fined up to $50 per day late not to exceed $500.

(b) The licensee must retain a copy of all documentation generated at time of reporting as confirmation of successful electronic submission.

(c) If the Agency’s Single Sign On Portal or the online adverse incident reporting system is temporarily out of service the licensee may contact the Agency directly at 1(888)419-3456 for assistance. Reporting will resume as soon as online access is restored.

History

Rulemaking Authority 394.907, 395.0197, 408.806, 408.813, 408.819 FS. Law Implemented 394.907, 408.806, 408.813, 408.810 FS. History–New 7-14-10, Amended 11-13-17, 2-2-21, 10-4-21, 6-11-25, 11-27-25.

Fla. Admin. Code R. 59A-35.115 Patient Safety Surveys

(1) Each hospital, nursing home and ambulatory surgical center (ASC) must conduct or contract to conduct the Agency for Health Care Administration’s (Agency) Patient Safety Culture Survey (PSCS) pursuant to Section 395.1012(4), F.S. and Section 400.141 (F.S.). The initial submission period for hospitals and ASCs was in 2025, and the initial submission period for nursing homes is 2027. Submission periods are on a biennial basis.

(2) Reporting Period. Each facility must submit the PSCS data to the Agency between June 1st and August 31st every two years.

(3) Administering the survey.

(a) Each facility must administer the anonymous surveys to all the facility’s staff members. For the purposes of this rule, all persons who work in the facility are considered staff members.

For hospitals, staff respondents will complete the Hospital Patient Safety Culture Survey, AHCA Form 3130-8015, October, 2022, incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-15002 and at: https://ahca.myflorida.com/schs/commiteescouncils/indexpscs.shtml.
For ASCs, staff respondents will complete the Ambulatory Surgical Centers Patient Safety Culture Survey, AHCA Form 3130-8017, October, 2022, incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-14999 and at: https://ahca.myflorida.com/schs/commiteescouncils/indexpscs.shtml.
For nursing homes, staff respondents will complete the Nursing Home Patient Safety Culture Survey, AHCA Form 3130-8021, October 2025, incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-18906 and at: https://ahca.myflorida.com/schs/commiteescouncils/indexpscs.shtml.

(b) Guidance and requirements for administering the PSCS can be found in the PSCS data entry guide and data file specifications:

For hospitals, the Hospital Patient Safety Culture Survey Data Entry Guide and Data File Specifications, AHCA Form 3130-8014, October 2025, is incorporated by reference and available at: https://flrules.org/Gateway/reference.asp?No=Ref-18904 and at: https://ahca.myflorida.com/schs/commiteescouncils/indexpscs.shtml.
For ASCs, the PSCS Data Entry Guide and Data File Specifications, AHCA Form 3130-8016, October 2022, is incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-15001 and at: https://ahca.myflorida.com/schs/commiteescouncils/indexpscs.shtml.
For nursing homes, the Nursing Home Patient Safety Culture Survey Data Entry Guide and Data File Specifications, AHCA Form 3130-8022, October 2025, is incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-18905 and at: https://ahca.myflorida.com/schs/commiteescouncils/indexpscs.shtml.

(4) Data Submission.

(a) Upon the respondent’s completion of the survey, the contracted vendor or the facility personnel designated by the Chief Executive Officer (CEO), or the Nursing Home / ASC Administrator, as applicable, will collect, compile and submit the survey data using the facility specific data file specifications referenced in paragraph (3)(b) and the applicable data entry tool:

For hospitals, the PSCS Data Entry Tool, AHCA Form 3130-8015A October 2022, is incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-15003 and at: https://ahca.myflorida.com/schs/commiteescouncils/indexpscs.shtml.
For ASCs, the PSCS Data Entry Tool, AHCA Form 3130-8017A, October 2022, is incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-15000 and at: https://ahca.myflorida.com/schs/commiteescouncils/indexpscs.shtml.
For nursing homes, the Nursing Home Patient Safety Culture Survey Data Entry Tool, AHCA Form 3130-8021A, October 2025, is incorporated by reference and available at: https://www.flrules.org/Gateway/reference.asp?No=Ref-18907 and at: https://ahca.myflorida.com/schs/commiteescouncils/indexpscs.shtml.

(b) Once the contracted vendor or the designated facility personnel has compiled the survey data using the applicable data entry tool, the tool will export the survey data into a file. That file will be submitted to the Agency’s PSCS System, located at: https://ahca.myflorida.com/schs/commiteescouncils/indexpscs.shtml. The designated facility personnel or contracted vendor must complete registration into the PSCS System to confirm that they are authorized to submit on behalf of the facility.

(c) Upon successful registration into the PSCS System, and subsequent submission of the survey data file, a confirmation email of successful submission will be emailed to the contracted vendor or the designated facility personnel.

(d) The survey data findings will be published as available in accordance with Section 408.05(3)(d)3., F.S., at: https://ahca.myflorida.com/schs/commiteescouncils/indexpscs.shtml.

History

Rulemaking Authority 400.141, 408.05, 395.1012 FS. Law Implemented 400.141, 408.05, 395.1012 FS. History–New 1-26-23, Amended 5-31-26.

Fla. Admin. Code R. 59A-35.120 Inspections

(1) When regulatory violations are identified by the Agency:

(a) Deficiencies must be corrected within 30 days of the date the Agency sends the deficiency notice to the provider, unless an alternative timeframe is required or approved by the Agency.

(b) The Agency may conduct an unannounced follow-up inspection or off-site review to verify correction of deficiencies at any time.

(2) If an inspection is completed through off-site record review, any records requested by the Agency in conjunction with the review, must be received within 7 days of request and provided at no cost to the Agency. Each licensee shall maintain the records including medical and treatment records of a client and provide access to the Agency.

(3) Providers that are exempt from Agency inspections due to accreditation oversight as prescribed in authorizing statutes must provide:

(a) Documentation from the accrediting agency including the name of the accrediting agency, the beginning and expiration dates of the provider’s accreditation, accreditation status and type must be submitted at the time of license application, or within 21 days of accreditation.

(b) Documentation of each accreditation inspection including the accreditation organization’s report of findings, the provider’s response and the final determination must be submitted within 21 days of final determination or the provider is no longer exempt from Agency inspection.

(4) Providers may be exempt from routine Agency licensure inspections as a ‘low-risk provider’ defined in Section 408.803(10), F.S., if they meet the following criteria during the prior 30 months:

(a) Applicants for initial, renewal, change of ownership, or other license that do not share any common controlling interests with a provider that had a Class I, a Class II, or 3 or more uncorrected Class III deficiencies, license denial or revocation issued by the Agency, or an emergency action issued by the Agency pursuant to Section 120.60, F.S., including moratoria, license restriction, or suspension.

(b) Renewal applicants may be exempt from a biennial inspection if they have no:

Class I, Class II, or 3 or more uncorrected Class III deficiencies,
Substantiated complaints resulting in a Class I, a Class II, or 3 or more uncorrected Class III deficiencies.
Emergency actions issued by the Agency pursuant to Section 120.60, F.S., including moratoria, license restriction, or suspension.
Renewal applicants cannot be exempt from two consecutive biennial licensure inspections.

History

Rulemaking Authority 408.819, 408.811 FS. Law Implemented 408.811, 408.806 FS. History–New 7-14-10, Amended 5-17-21, Joint Administrative Procedures Committee Objection Filed–See FAR Vol. 51, No. 53, March 18, 2025, Amended 12-7-25, Amendment resolved Joint Administrative Procedures Committee objection 12-7-25, Florida Administrative Register Vol. 52, No. 21, February 2, 2026.

Fla. Admin. Code R. 59A-35.125 Standards for the Appropriate Use of Facial Coverings for Infection Control

(1) Definitions:

(a) “Common area” refers to areas in a health care setting where patients are not treated, diagnosed, or examined.

(b) “Employee” refers to any person under employment or contract of a health care setting, including health care practitioners, administrative staff, maintenance staff, aides, contractors, students, and volunteers.

(c) “Health care setting” refers to any place where health care practitioners and/or health care providers practice their profession or provide services.

(d) “Patient” refers to a person receiving services from a health care practitioner or health care provider.

(e) “Sterile areas” refers to locations where surgery is conducted or where procedures that require aseptic techniques are performed.

(f) “Sterile procedure" refers to aseptic procedures with the goal of minimizing the risk of microbial contamination to reduce the rate of invasive or surgical site infection.

(g) “Visitor” refers to any person in a health care setting who is not an employee or patient of the health care setting.

(2) Health care practitioners and health care providers may choose to require a patient to wear a facial covering only when the patient is in a common area of the health care setting and is exhibiting signs or symptoms of or has a diagnosed infectious disease that can be spread through droplet or airborne transmission.

(3) Health care practitioners and health care providers may choose to require a visitor to wear a facial covering only when the visitor is:

(a) Exhibiting signs or symptoms of or has a diagnosed infectious disease that can be spread through droplet or airborne transmission,

(b) In sterile areas of the health care setting or an area where sterile procedures are being performed,

(c) In an in-patient or clinical room with a patient who is exhibiting signs or symptoms of or has a diagnosed infectious disease that can be spread through droplet or airborne transmission, or

(d) Visiting a patient whose treating health care practitioner has diagnosed the patient with or confirmed a condition affecting the immune system in a manner which is known to increase risk of transmission of an infection from visitors without signs or symptoms of infection to a patient and whose treating practitioner has determined that the use of facial coverings is necessary for the patient’s safety.

(4) Opt-Out Requirements are as follows:

(a) Health care practitioners and health care providers who choose to require a facial covering for any patient must include in the policy a provision for the opting-out of wearing a facial covering. Such policy must be in accordance with the Florida Patient Bill of Rights and Responsibilities, section 381.026, F.S.

(b) Health care practitioners and health care providers who choose to require a facial covering for any visitor must include in the policy a provision for the opting-out of wearing a facial covering if an alternative method of infection control or infectious disease prevention is available.

(5) Health care practitioners and health care providers must allow an employee to opt out of facial covering requirements unless an employee is:

(a) Conducting sterile procedures,

(b) Working in a sterile area,

(c) Working with a patient whose treating health care practitioner has diagnosed the patient with or confirmed a condition affecting the immune system in a manner which is known to increase risk of transmission of an infection from employees without signs or symptoms of infection to a patient and whose treating practitioner has determined that the use of facial coverings is necessary for the patient’s safety,

(d) With a patient on droplet or airborne isolation, or

(e) Engaging in non-clinical potentially hazardous activities that require facial coverings to prevent physical injury or harm in accordance with industry standards.

History

Rulemaking Authority 408.824 FS. Law Implemented 408.824 FS. History – New 7-22-24, Amended 9-14-25.

Fla. Admin. Code R. 59A-35.150 Moratorium; Emergency Suspension

In addition to other remedies permitted by law, violation of a moratorium issued by the Agency is considered a Class I violation and subject to a fine of $500 per day until the violation is corrected.

History

Rulemaking Authority 408.819 FS. Law Implemented 408.813, 408.814 FS. History–New 7-14-10.

Chapter 59A-36 ASSISTED LIVING FACILITY

Fla. Admin. Code R. 59A-36.001 Standards and Criteria for Determining Compliance with Facility Standards and Resident Rights

History

Rulemaking Authority 429.28(3)(a) FS. Law Implemented 429.28 FS. History–New 11-28-16, Repealed 7-12-21.

Fla. Admin. Code R. 59A-36.002 Definitions

In addition to the terms defined in Section 429.02, F.S., the following definitions are applicable in this rule chapter:

(1) “Advertise” means any written, printed, oral, visual, or electronic promotion, statement of availability, qualifications, services offered, or other similar communication appearing in or on television, radio, the Internet, billboards, newspapers, magazines, business cards, flyers, brochures or other medium for the purpose of attracting potential residents to an assisted living facility. A complimentary listing of a licensed facility’s name, address, and telephone number in the telephone directory is not considered advertising.

(2) “Agency Central Office” means the Agency for Health Care Administration Assisted Living Unit (ALU), located at 2727 Mahan Drive, Mail Stop 30, Tallahassee, FL 32308-5403. The ALU telephone number and website address are (850)412-4304, and https://ahca.myflorida.com/health-quality-assurance/bureau-of-health-facility-regulation/assisted-living-unit/assisted-living-facility.

(3) “Agency Field Office” means the Agency for Health Care Administration’s Office in a particular geographic area. Information regarding local offices is available online at: http://ahca.myflorida.com/mchq/index.shtml#six.

(4) “Apartment” means a self-contained dwelling unit with a bathroom, kitchen area, and living and sleeping space that is contracted for use as a residence by one or more persons who maintain a common household.

(5) “Anti-Embolism Stockings and Hosiery” means prescribed close-fitting elastic-type coverings for therapeutic treatment of the legs. They may be knee high or thigh high length and have transparent, open-toe, or similar foot design.

(6) “Assistance with Activities of Daily Living” means individual assistance with the following:

(a) Ambulation – Providing physical support to enable the resident to move about within or outside the facility. Physical support includes supporting or holding the resident’s hand, elbow, or arm; holding on to a support belt worn by the resident to assist in providing stability or direction while the resident ambulates; or pushing the resident’s wheelchair. The term does not include assistance with transfer.

(b) Bathing – Assembling towels, soaps, or other necessary supplies; helping the resident in and out of the bathtub or shower; turning the water on and off; adjusting water temperatures; washing and drying portions of the body that are difficult for the resident to reach; or being available while the resident is bathing.

(d) Eating – Helping residents with or by cutting food, pouring beverages, or feeding residents who are unable to feed themselves.

(e) Grooming – Helping residents with shaving, oral care, care of the hair, or nail care.

(f) Toileting – Assisting the resident to the bathroom, helping the resident to undress, positioning the resident on the commode, and helping the resident with related personal hygiene including assistance with changing an adult brief and assistance with the routine emptying of a catheter or ostomy bag.

(7) “Assistance With Transfer” means providing verbal and physical cuing or physical assistance or both while the resident moves between bed and a standing position or between bed and chair or wheelchair. The term does not include total physical assistance with transfer provided by staff to residents.

(8) “Capacity” means the number of residents for which a facility has been licensed to provide residential care.

(9) “Case Manager” means an individual employed by or under contract with any agency or organization, public or private, who has the responsibility for assessing resident needs; planning services for the resident; coordinating and assisting residents with gaining access to needed medical, mental health, social, housing, educational or other services; monitoring service delivery; and evaluating the effects of service delivery.

(10) “Certified Nursing Assistant (CNA)” means an individual certified under Chapter 464, Part II, F.S.

(11) “Day Care Participant” means an individual who receives services at a facility for less than 24 hours per day.

(12) “Deficiency” means an instance of non-compliance with the requirements of Part II of Chapter 408, F.S., Part I of Chapter 429, F.S., rule Chapter 59A-35, F.A.C., and this rule chapter.

(13) “Direct Care Staff” means Staff in Regular Contact or Staff in Direct Contact with residents who provide personal or nursing services to residents, including administrators and managers providing such services.

(14) “Distinct Part” means designated bedrooms or apartments, bathrooms and a living area; or a separately identified wing, floor, or building that includes bedrooms or apartments, bathrooms and a living area. The distinct part may include a separate dining area, or meals may be served in another part of the facility.

(15) “Elopement” means an occurrence in which a resident leaves a facility without following facility policy and procedures.

(16) “Food Service” means the storage, preparation, service, and clean up of food intended for consumption in a facility either by facility staff or through a formal agreement that meals will be regularly catered by a third party.

(17) “Glucose Meter” or “glucometer” means a medical device that determines the approximate concentration of glucose in the blood.

(18) “Health Care Provider” means a health care practitioner licensed under Chapter 458, 459, or 464, F.S., as a physician, physician assistant, or advanced practice registered nurse; or an individual, entity, or organization licensed by the state to provide health care services.

(19) “Licensed Dietitian or Nutritionist” means a dietitian or nutritionist licensed under Chapter 468, Part X, F.S.

(20) “Local fire safety authority” means the authority having jurisdiction as defined in rule Chapter 69A-40, F.A.C.

(21) “Long-term Care Ombudsman Program (LTCOP)” means the long-term care ombudsman program established under Chapter 400, Part I, F.S.

(22) “Manager” means an individual who is authorized to perform the same functions as a facility administrator, and is responsible for the operation and maintenance of an assisted living facility while under the supervision of the administrator of that facility. A manager does not include staff authorized to perform limited administrative functions during an administrator’s temporary absence.

(23) “Mental Disorder” for the purposes of identifying a mental health resident, means schizophrenia and other psychotic disorders; affective disorders; anxiety related disorders; and personality and dissociative disorders. However, mental disorder does not include residents with a primary diagnosis of Alzheimer’s disease, other dementias, or mental retardation.

(24) “Mental Health Care Provider” means an individual, agency, or organization providing mental health services to clients of the Department of Children and Families; an individual licensed by the state to provide mental health services; or an entity employing or contracting with individuals licensed by the state to provide mental health services.

(25) “Mental Health Case Manager” means a case manager employed by or under contract to a mental health care provider to assist mental health residents residing in a facility holding a limited mental health license.

(26) “Nurse” means a licensed practical nurse (LPN), registered nurse (RN), or advanced practice registered nurse (APRN) licensed under Chapter 464, F.S.

(27) “Nursing Assessment” means a written review of information collected from observation and interaction with a resident, including the resident’s record and any other relevant sources of information, the analysis of the information, and recommendations for modification of the resident’s care, if warranted. The assessment must contain the signature and credential initials of the advanced practice registered nurse or registered nurse who conducted the assessment.

(28) “Nursing Progress Notes” or “Progress Report” means a written record of nursing services, other than medication administration or the taking of vital signs, provided to each resident who receives such services in a facility with a limited nursing or extended congregate care license. The progress notes must be completed by the nurse who delivered the service; must describe the date, type, scope, amount, duration, and outcome of services that are rendered; must describe the general status of the resident’s health; must describe any deviations in the residents health; must describe any contact with the resident’s physician; and must contain the signature and credential initials of the person rendering the service.

(29) “Optional State Supplementation (OSS)” means the state program providing monthly payments to eligible residents pursuant to Section 409.212, F.S., and rule Chapter 65A-2, F.A.C.

(30) “Owner” means a person, partnership, association, limited liability company, or corporation, that owns or leases the facility that is licensed by the agency. The term does not include a person, partnership, association, limited liability company, or corporation that contracts only to manage or operate the facility.

(31) “Physician” means an individual licensed under Chapter 458 or 459, F.S.

(32) “Pill organizer” means a container that is designed to hold solid doses of medication and is divided according to day or time increments.

(33) “Registered Dietitian” means an individual registered with the Commission on Dietetic Registration, the accrediting body of the Academy of Nutrition and Dietetics.

(34) “Respite Care” means facility-based supervision of an impaired adult for the purpose of relieving the primary caregiver.

(35) “Significant Change” means either a sudden or major shift in the behavior or mood of a resident that is inconsistent with the resident’s diagnosis, or a deterioration in the resident’s health status such as unplanned weight change, stroke, heart condition, enrollment in hospice, or stage 2, 3 or 4 pressure sore. Ordinary day-to-day fluctuations in a resident’s functioning and behavior, short-term illnesses such as colds, or the gradual deterioration in the resident’s ability to carry out the activities of daily living that accompanies the aging process are not considered significant changes.

(36) “Staff” means any individual employed by a facility, contracting with a facility to provide direct or indirect services to residents, or employed by a firm under contract with a facility to provide direct or indirect services to residents when present in the facility. The term includes volunteers performing any service that counts toward meeting any staffing requirement of this rule chapter.

(37) “Staff in Regular Contact” or “Staff in Direct Contact” mean all staff whose duties may require them to interact with residents on a daily basis.

(38) “Third Party” means any individual or business entity providing services to residents in a facility that is not staff of the facility.

(39) “Universal Precautions” are a set of precautions designed to prevent transmission of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and other bloodborne pathogens when providing first aid or health care. Universal precautions require that the blood and certain body fluids of all residents be considered potentially infectious for HIV, HBV, and other bloodborne pathogens.

(40) “Unscheduled Service Need” means a need for a personal service, nursing service, or mental health intervention that cannot be predicted in advance and that must be met promptly to ensure that the health, safety, and welfare of residents is preserved.

History

Rulemaking Authority 429.41, 429.929 FS. Law Implemented 429.07, 429.075, 429.11, 429.14, 429.19, 429.41, 429.47, 429.52, 429.905 FS. History–New 9-30-92, Formerly 10A-5.0131, Amended 10-30-95, 6-2-96, 4-20-98, 11-2-98, 10-17-99, 1-9-02, 7-30-06, 4-15-10, 4-17-14, 5-10-18, Formerly 58A-5.0131, Amended 10-7-21, 6-11-25, Technical Change 3-26-26.

Fla. Admin. Code R. 59A-36.003 Licensing and Change of Ownership

(1) LICENSE APPLICATION. An applicant for a standard assisted living facility license, a limited mental health license, an extended congregate care license, or a limited nursing services license may apply for licensure pursuant to the requirements of Chapters 408, Part II, 429, Part I, F.S., and rule Chapter 59A-35, F.A.C.

(2) CHANGE OF OWNERSHIP. In addition to the requirements for a change of ownership contained in Chapter 408, Part II, F.S., Section 429.12, F.S., and rule Chapter 59A-35, F.A.C., the following provisions relating to resident funds apply pursuant to Section 429.27, F.S.:

(a) At the time of transfer of ownership, all resident funds on deposit, advance payments of resident rents, resident security deposits, and resident trust funds held by the current licensee must be transferred to the applicant. Proof of such transfer must be provided to the agency at the time of the agency survey and before the issuance of a standard license. This provision does not apply to entrance fees paid to a continuing care facility subject to the acquisition provisions in Section 651.024, F.S.

(b) The transferor must provide to each resident a statement detailing the amount and type of funds held by the facility and credited to the resident.

(c) The transferee must notify each resident in writing of the manner in which the transferee is holding the resident’s funds and state the name and address of the depository where the funds are being held, the amount held, and type of funds credited.

(3) CONDITIONAL LICENSE. Except as provided in Section 429.14, F.S., the agency may issue a conditional license to a facility if, at the time of license renewal the facility is found to have uncorrected violations that the facility has had an opportunity to correct. The issuance of a conditional license does not change the biennial license expiration date.

(4) OSS RESIDENT DETERMINATION. With respect to the fee per bed required for a standard license, the number of OSS recipients claimed shall be the average number per month residing in the facility during the previous license period. An additional per bed charge shall be added to the bed fee for facilities whose average number of OSS residents per month was less than the number of beds designated for OSS recipients during the previous license period.

History

Rulemaking Authority 429.17, 429.27, 429.41 FS. Law Implemented 429.04, 429.07, 429.075, 429.11, 429.12, 429.17, 429.27, 429.41 FS. History–New 5-14-81, Amended 1-6-82, 5-19-83, 9-17-84, Formerly 10A-5.14, Amended 10-20-86, 6-21-88, 8-15-90, 9-30-92, Formerly 10A-5.014, Amended 10-30-95, 4-20-98, 10-17-99, 7-30-06, 4-17-14, 5-10-18, Formerly 58A-5.014.

Fla. Admin. Code R. 59A-36.004 License Requirements

(1) SERVICE PROHIBITION. An assisted living facility may not represent that it provides any service other than a service for which it is licensed to provide.

(2) CHANGE IN USE OF SPACE REQUIRING AGENCY CENTRAL OFFICE APPROVAL. A change in the use of space that increases or decreases a facility’s capacity must not be made without prior approval from the Agency Central Office. Approval must be based on the compliance with the physical plant standards provided in Rule 59A-36.014, F.A.C., as well as documentation of compliance with applicable fire safety and sanitation inspection requirements referenced in Rule 59A-36.005, F.A.C.

(3) CHANGE IN USE OF SPACE REQUIRING AGENCY FIELD OFFICE APPROVAL. A change in the use of space that involves converting an area to resident use, which has not previously been inspected for such use, must not be made without prior approval from the Agency Field Office. Approval must be based on compliance with the physical plant standards provided in Rule 59A-36.014, F.A.C., as well as documentation of compliance with applicable fire safety and sanitation inspection standards referenced in Rule 59A-36.005, F.A.C.

(4) CONTIGUOUS PROPERTY. If a facility consists of more than one building, all buildings included under a single license must be on contiguous property. “Contiguous property” means property under the same ownership separated by no more than a two-lane street that traverses the property. A licensed location may be expanded to include additional contiguous property with the approval of the agency to ensure continued compliance with the requirements and standards of Chapters 408, Part II, 429, Part I, F.S. and rule Chapter 59A-35, F.A.C., and this rule chapter.

(5) PROOF OF INSPECTIONS. A copy of the annual fire safety and sanitation inspections described in Rule 59A-36.005, F.A.C., must be submitted annually to the Agency Central Office. The annual inspections must be submitted no later than 30 calendar days after the inspections. Failure to comply with this requirement may result in administrative action pursuant to Chapter 408, Part II, and Section 429.14, F.S., and rule Chapter 59A-35, F.A.C.

(6) RESIDENTS RECEIVING STATE-FUNDED SERVICES. Upon request, the facility administrator or designee must identify residents receiving state-funded services to the agency and the department for monitoring purposes authorized by state and federal laws.

History

Rulemaking Authority 429.41 FS. Law Implemented 429.41, 429.44 FS. History–New 5-15-81, Amended 1-6-82, 9-17-84, Formerly 10A-5.16, Amended 6-21-88, 9-30-92, Formerly 10A-5.016, Amended 10-30-95, 10-17-99, 7-30-06, 4-15-10, 4-17-14, Formerly 58A-5.016.

Fla. Admin. Code R. 59A-36.005 Inspection Responsibilities

(1) County health departments are responsible for inspecting all license applicants and licensed facilities in matters regulated by:

(a) Rule 64E-12.004, F.A.C., and rule Chapter 64E-11, F.A.C., relating to food hygiene.

(b) Chapter 64E-12, F.A.C., relating to sanitary practices in community-based residential facilities.

(2) The local authority having jurisdiction over fire safety or State Fire Marshal is responsible for inspecting all license applicants and licensed facilities in matters regulated by Section 429.41, F.S., relating to uniform fire safety standards and Chapter 69A-40, F.A.C., Uniform Fire Safety Standards for Assisted Living Facilities.

(3) The agency is responsible for inspecting all license applicants and licensed facilities in all other matters regulated by this rule chapter.

History

Rulemaking Authority 429.41 FS. Law Implemented 429.41 FS. History–New 8-15-90, Formerly 10A-5.0161, Amended 10-30-95, 10-17-99, 3-13-14, Formerly 58A-5.0161.

Fla. Admin. Code R. 59A-36.006 Admission Procedures, Appropriateness of Placement and Continued Residency Criteria

(1) ADMISSION CRITERIA.

(a) An individual must meet the following minimum criteria in order to be admitted to a facility holding a standard, limited nursing services, or limited mental health license:

Be at least 18 years of age.
Be free from signs and symptoms of any communicable disease that may be transmitted to other residents or staff. However, an individual who has human immunodeficiency virus (HIV) infection may be admitted to a facility, provided that the individual would otherwise be eligible for admission according to this rule. In addition, an individual that exhibits signs or symptoms of or has been diagnosed with a respiratory illness that can be spread through droplet transmission, may be admitted, at the administrator’s discretion, if appropriate droplet precautions are implemented by facility staff. Appropriate droplet precautions include recommendations from nationally accepted standards, recommendations from the local county health department, and the facility’s infection prevention and control policies and procedures at the time of the individual’s admission. The individual must otherwise be eligible for admission according to this rule.
Be able to perform the activities of daily living, with supervision or assistance if necessary.
Be able to transfer, with assistance if necessary. The assistance of more than one person is permitted.
Be capable of taking medication, by either self-administration, assistance with self-administration, or administration of medication.

a. If the resident needs assistance with self-administration of medication, the facility must inform the resident of the professional qualifications of facility staff who will be providing this assistance. If unlicensed staff will be providing assistance with self-administration of medication, the facility must obtain written informed consent from the resident or the resident’s surrogate, guardian, or attorney-in-fact.

b. The facility may accept a resident who requires the administration of medication if the facility employs a nurse who will provide this service or the resident, or the resident’s legal representative, designee, surrogate, guardian, or attorney-in-fact, contracts with a third party licensed to provide this service to the resident.

Not have any special dietary needs that cannot be met by the facility.
Not be a danger to self or others as determined by a health care practitioner, or a mental health practitioner licensed under Chapter 490 or 491, F.S.
Not require 24-hour licensed professional mental health treatment.
Not be bedridden, unless the resident is receiving licensed hospice services pursuant to Section 429.26(1)(c), F.S.;
Not have any stage 3 or 4 pressure sores. A resident requiring care of a stage 2 pressure sore may be admitted provided that:

a. The resident either:

(I) Resides in a standard or limited nursing services licensed facility and contracts directly with a licensed home health agency or a nurse to provide care; or

(II) Resides in a limited nursing services licensed facility and care is provided by the facility pursuant to a plan of care issued by a health care practitioner;

b. The condition is documented in the resident’s record and admission and discharge logs; and,

c. If the resident’s condition fails to improve within 30 days as documented by a health care practitioner, the resident must be discharged from the facility.

Residents admitted to standard, limited nursing services, or limited mental health licensed facilities may not require any of the following nursing services:

a. Artificial airway management of any kind, except that of continuous positive airway pressure may be provided through the use of a CPAP or bipap machine;

b. Assistance with tube feeding,

c. Monitoring of blood gases,

d. Management of post-surgical drainage tubes and wound vacuum devices;

e. The administration of blood products in the facility; or

f. Treatment of surgical incisions or wounds, unless the surgical incision or wound and the underlying condition have been stabilized and a plan of care has been developed. The plan of care must be maintained in the resident’s record.

In addition to the nursing services listed above, residents admitted to facilities holding only standard and/or limited mental health licenses may not require any of the following nursing services:

a. Hemodialysis and peritoneal dialysis performed in the facility;

b. Intravenous therapy performed in the facility.

Not require 24-hour nursing supervision, unless the resident is receiving licensed hospice services pursuant to Section 429.26(1)(c), F.S.;
Not require skilled rehabilitative services as described in Rule 59G-4.290, F.A.C.
Be appropriate for admission to the facility as determined by the facility administrator. The administrator must base the determination on:

a. An assessment of the strengths, needs, and preferences of the individual;

b. The medical examination report required by Section 429.26, F.S.;

c. The facility’s admission policy and the services the facility is prepared to provide or arrange in order to meet resident needs. Such services may not exceed the scope of the facility’s license unless specified elsewhere in this rule; and,

d. The ability of the facility to meet the uniform fire safety standards for assisted living facilities established in rule Chapter 69A-40, F.A.C.

(b) A resident who otherwise meets the admission criteria for residency in a standard licensed facility, but who requires assistance with the administration and regulation of portable oxygen or assistance with routine colostomy care of stoma site flange placement, may be admitted to a facility with a standard license as long as the facility has a nurse on staff or under contract to provide the assistance or to provide training to the resident on how to perform these functions themselves.

(c) Nursing staff may not provide training to unlicensed persons, as defined in Section 429.256(1)(b), F.S., to perform skilled nursing services, and may not delegate the nursing services described in this section to certified nursing assistants or unlicensed persons. This provision does not restrict a resident or a resident’s representative from contracting with a licensed third party to provide the assistance if the facility is agreeable to such an arrangement and the resident otherwise meets the criteria for admission and continued residency in a facility with a standard license.

(d) Not withstanding any other provisions of this rule, an individual enrolled in and receiving licensed hospice services may be admitted to an assisted living facility pursuant to Section 429.26(1)(d), F.S.

(e) Resident admission criteria for facilities holding an extended congregate care license are described in Rule 59A-36.021, F.A.C.

(2) HEALTH ASSESSMENT. As part of the admission criteria, an individual must undergo a face-to-face medical examination completed by a health care practitioner as specified in either paragraph (a) or (b) of this subsection.

(a) A medical examination completed within 60 days before or within 30 days after the individual’s admission to a facility pursuant to Section 429.26(5), F.S. The examination must address the following:

The physical and mental status of the resident, including the identification of any health-related problems and functional limitations,
An evaluation of whether the individual will require supervision or assistance with the activities of daily living,
Any nursing or therapy services required by the individual,
Any special diet required by the individual,
A list of current medications prescribed, and whether the individual will require any assistance with the administration of medication,
Whether the individual has signs or symptoms of Tuberculosis, Methicillin Resistant Staphylococcus Aureus, Scabies or any other communicable disease, which are likely to be transmitted to other residents or staff,
A statement on the day of the examination that, in the opinion of the examining health care practitioner, the individual’s needs can be met in an assisted living facility; and,
The date of the examination, and the name, signature, address, telephone number, and license number of the examining health care practitioner.

(b) When a health care practitioner conducts a medical examination, the examination must be recorded on the practitioner’s form or on AHCA Form 1823, Resident Health Assessment for Assisted Living Facilities, April 2021, which is incorporated by reference and available online at: https://flrules.org/Gateway/reference.asp?No=Ref-13531. Faxed or electronic copies of the completed form are acceptable. If AHCA Form 1823 is used, the form must be completed as instructed.

If the health care practitioner’s form does not include all the examination items on AHCA Form 1823 or if AHCA Form 1823 is not completed fully, then the omitted items may be obtained by the administrator or designee either orally or in writing from the health care practitioner. The missing or omitted information must be obtained and documented in the resident’s record within 30 days after the resident’s admission to the facility.
Omitted or missing information received orally must include the name of the health care practitioner, the name and signature of the administrator or designee recording the information, and the date the information was provided.

(c) Medical examinations of residents placed by the department, by the Department of Children and Families, or by an agency under contract with either department must be conducted within 30 days before placement in the facility and recorded on AHCA Form 1823 described in paragraph (b).

(d) An assessment that has been conducted through the Comprehensive, Assessment, Review and Evaluation for Long-Term Care Services (CARES) program may be substituted for the medical examination requirements of Section 429.26, F.S. and this rule.

(e) Any orders issued by the health care practitioner conducting the medical examination for medications, nursing services, treatments, therapy, or therapeutic diets, may be attached to the health assessment. A health care practitioner may attach a DH Form 1896, Florida Do Not Resuscitate Order Form, for residents who do not wish cardiopulmonary resuscitation to be administered in the case of cardiac or respiratory arrest.

(f) A resident placed in a facility on a temporary emergency basis by the Department of Children and Families pursuant to Section 415.105 or 415.1051, F.S., is exempt from the examination requirements of this subsection for up to 30 days. However, a resident accepted for temporary emergency placement must be entered on the facility’s admission and discharge log and counted in the facility census. A facility may not exceed its licensed capacity in order to accept such a resident. A medical examination must be conducted on any temporary emergency placement resident accepted for regular admission.

(3) ADMISSION PACKAGE.

(a) The facility must make available to potential residents a written statement(s) that includes the following information listed below. Providing a copy of the facility resident contract or facility brochure containing all the required information meets this requirement.

The facility’s admission and continued residency criteria;
The daily, weekly or monthly charge to reside in the facility and the services, supplies, and accommodations provided by the facility for that rate;
Personal care services that the facility is prepared to provide to residents and additional costs to the resident, if any;
Nursing services that the facility is prepared to provide to residents and additional costs to the resident, if any;
Food service and the ability of the facility to accommodate special diets;
The availability of transportation and additional costs to the resident, if any;
Any other special services that are provided by the facility and additional cost if any;
Social and leisure activities generally offered by the facility;
Any services that the facility does not provide but will arrange for the resident and additional cost, if any;
The facility rules and regulations that residents must follow as described in Rule 59A-36.007, F.A.C.;
The facility policy concerning Do Not Resuscitate Orders pursuant to Section 429.255, F.S., and Rule 59A-36.009, F.A.C., and Advance Directives pursuant to Chapter 765, F.S.;
If the facility is licensed to provide extended congregate care, the facility’s residency criteria for residents receiving extended congregate care services. The facility must also provide a description of the additional personal, supportive, and nursing services provided by the facility including additional costs and any limitations on where extended congregate care residents may reside based on the policies and procedures described in Rule 59A-36.021, F.A.C.;
If the facility advertises that it provides special care for individuals with Alzheimer’s disease and related disorders, a written description of those special services as required in Section 429.177, F.S.; and,
The facility’s resident elopement response policies and procedures.

(b) Before or at the time of admission, the resident, or the resident’s responsible party, guardian, or attorney-in-fact, if applicable, must be provided with the following:

A copy of the resident’s contract that meets the requirements of Rule 59A-36.018, F.A.C.,
A copy of the facility statement described in paragraph (a) of this subsection, if one has not already been provided,
A copy of the resident’s bill of rights as required by Rule 59A-36.007, F.A.C.; and,
A Long-Term Care Ombudsman Program brochure that includes the telephone number and address of the district office.

(c) Documents required by this subsection must be in English. If the resident is not able to read, or does not understand English and translated documents are not available, the facility must explain its policies to a family member or friend of the resident or another individual who can communicate the information to the resident.

(4) CONTINUED RESIDENCY. Except as follows in paragraphs (a) through (c) of this subsection, criteria for continued residency in any licensed facility must be the same as the criteria for admission. As part of the continued residency criteria, a resident must have a face-to-face medical examination by a health care practitioner at least every 3 years after the initial assessment, or after a significant change, whichever comes first. A significant change is defined in Rule 59A-36.002, F.A.C. The results of the examination must be recorded on the practitioner’s form or on AHCA Form 1823, which is incorporated by reference in paragraph (2)(b) of this rule and must be completed in accordance with that paragraph. Exceptions to the requirement to meet the criteria for continued residency are:

(a) The resident may be bedridden for no more than 7 consecutive days, unless the resident is receiving licensed hospice services pursuant to Section 429.26(1)(c), F.S.

(b) A resident requiring care of a stage 2 pressure sore may be retained provided that:

The resident contracts directly with a licensed home health agency or a nurse to provide care, or the facility has a limited nursing services license and services are provided pursuant to a plan of care issued by a health care practitioner,
The condition is documented in the resident’s record; and,
If the resident’s condition fails to improve within 30 days, as documented by a health care practitioner, the resident must be discharged from the facility.

(c) A terminally ill resident who no longer meets the criteria for continued residency may continue to reside in the facility if the following conditions are met:

The resident qualifies for, is admitted to, and consents to receive services from a licensed hospice that coordinates and ensures the provision of any additional care and services that the resident may need;
Both the resident, or the resident’s legal representative if applicable, and the facility agree to continued residency;
A licensed hospice, in consultation with the facility, develops and implements an interdisciplinary care plan that specifies the services being provided by hospice and those being provided by the facility; and,
Documentation of the requirements of this paragraph is maintained in the resident’s file.

(d) The facility administrator is responsible for monitoring the continued appropriateness of placement of a resident in the facility at all times.

(e) A hospice resident that meets the qualifications of continued residency pursuant to this subsection may only receive services from the assisted living facility’s staff which are within the scope of the facility’s license.

(f) Assisted living facility staff may provide any nursing service permitted under the facility’s license and total help with the activities of daily living for residents admitted to hospice; however, staff may not exceed the scope of their professional licensure or training.

(g) Continued residency criteria for facilities holding an extended congregate care license are described in Rule 59A-36.021, F.A.C.

(5) DISCHARGE. If the resident no longer meets the criteria for continued residency, or the facility is unable to meet the resident’s needs, as determined by the facility administrator or health care practitioner, the resident must be discharged in accordance with Section 429.28, F.S.

History

Rulemaking Authority 429.07, 429.41 FS. Law Implemented 381.00316, 429.07, 429.26, 429.28, 429.41 FS. History–New 9-17-84, Formerly 10A-5.181, Amended 10-20-86, 6-21-88, 8-15-90, 9-30-92, Formerly 10A-5.0181, Amended 10-30-95, 6-2-96, 10-17-99, 7-30-06, 10-9-06, 4-15-10, 10-14-10, 4-17-14, 5-10-18, Formerly 58A-5.0181, 7-1-19, Amended 10-7-21, 6-11-25, 11-27-25, Technical Change 3-26-26.

Fla. Admin. Code R. 59A-36.007 Resident Care Standards

An assisted living facility must provide care and services appropriate to the needs of residents accepted for admission to the facility.

(1) SUPERVISION. Facilities must offer personal supervision as appropriate for each resident, including the following:

(a) Monitoring of the quantity and quality of resident diets in accordance with Rule 59A-36.012, F.A.C.

(b) Daily observation by designated staff of the activities of the resident while on the premises, and awareness of the general health, safety, and physical and emotional well-being of the resident.

(c) Maintaining a general awareness of the resident’s whereabouts. The resident may travel independently in the community.

(d) Contacting the resident’s health care provider and other appropriate party such as the resident’s family, guardian, health care surrogate, or case manager if the resident exhibits a significant change.

(e) Contacting the resident’s family, guardian, health care surrogate, or case manager if the resident is discharged or moves out.

(f) Maintaining a written record, updated as needed, of any significant changes, any illnesses that resulted in medical attention, changes in the method of medication administration, or other changes that resulted in the provision of additional services.

(2) SOCIAL AND LEISURE ACTIVITIES. Residents shall be encouraged to participate in social, recreational, educational and other activities within the facility and the community.

(a) The facility must provide an ongoing activities program. The program must provide diversified individual and group activities in keeping with each resident’s needs, abilities, and interests.

(b) The facility must consult with the residents in selecting, planning, and scheduling activities. The facility must demonstrate residents’ participation through one or more of the following methods: resident meetings, committees, a resident council, a monitored suggestion box, group discussions, questionnaires, or any other form of communication appropriate to the size of the facility.

(c) Scheduled activities must be available at least 6 days a week for a total of not less than 12 hours per week. Watching television is not an activity for the purpose of meeting the 12 hours per week of scheduled activities unless the television program is a special one-time event of special interest to residents of the facility. A facility whose residents choose to attend day programs conducted at adult day care centers, senior centers, mental health centers, or other day programs may count those attendance hours towards the required 12 hours per week of scheduled activities. An activities calendar must be posted in common areas where residents normally congregate.

(d) If residents assist in planning a special activity such as an outing, seasonal festivity, or an excursion, up to 3 hours may be counted toward the required activity time.

(3) ARRANGEMENT FOR HEALTH CARE. In order to facilitate resident access to health care as needed, the facility must:

(a) Assist residents in making appointments and remind residents about scheduled appointments for medical, dental, nursing, or mental health services.

(b) Provide transportation to needed medical, dental, nursing or mental health services, or arrange for transportation through family and friends, volunteers, taxi cabs, public buses, and agencies providing transportation.

(4) ACTIVITIES OF DAILY LIVING. Facilities must offer supervision of or assistance with activities of daily living as needed by each resident. Residents should be encouraged to be as independent as possible in performing activities of daily living.

(5) RESIDENT RIGHTS AND FACILITY PROCEDURES.

(a) A copy of the Resident Bill of Rights as described in Section 429.28, F.S., or a summary provided by the Long-Term Care Ombudsman Program must be posted in full view in a freely accessible resident area, and included in the admission package provided pursuant to Rule 59A-36.006, F.A.C.

(b) In accordance with Section 429.28, F.S., the facility must have a written grievance procedure for receiving and responding to resident complaints and a written procedure to allow residents to recommend changes to facility policies and procedures. The facility must be able to demonstrate that such procedure is implemented upon receipt of a complaint.

(c) The telephone number for lodging complaints against a facility or facility staff must be posted in full view in a common area accessible to all residents. The telephone numbers are: the Long-Term Care Ombudsman Program, 1(888)831-0404; Disability Rights Florida, 1(800)342-0823; the Agency Consumer Hotline 1(888)419-3456, and the statewide toll-free telephone number of the Florida Abuse Hotline, 1(800)96-ABUSE or 1(800)962-2873. The telephone numbers must be posted in close proximity to a telephone accessible by residents and the text must be a minimum of 14-point font.

(d) The facility must have a written statement of its house rules and procedures that must be included in the admission package provided pursuant to Rule 59A-36.006, F.A.C. The rules and procedures must at a minimum address the facility’s policies regarding:

Resident responsibilities;
Alcohol and tobacco use;
Medication storage;
Resident elopement;
Reporting resident abuse, neglect, and exploitation;
Administrative and housekeeping schedules and requirements;
Infection control, sanitation, and standard precautions;
The requirements for coordinating the delivery of services to residents by third party providers;
Assistive devices; and
Physical restraints.

(e) Residents may not be required to perform any work in the facility without compensation. Residents may be required to clean their own sleeping areas or apartments if the facility rules or the facility contract includes such a requirement. If a resident is employed by the facility, the resident must be compensated in compliance with state and federal wage laws.

(f) The facility must provide residents with convenient access to a telephone to facilitate the resident’s right to unrestricted and private communication, pursuant to Section 429.28(1)(d), F.S. The facility must allow unidentified telephone calls to residents. For facilities with a licensed capacity of 17 or more residents in which residents do not have private telephones, there must be, at a minimum, a readily accessible telephone on each floor of each building where residents reside.

(6) THIRD PARTY SERVICES.

(a) Nothing in this rule chapter is intended to prohibit a resident or the resident’s representative from independently arranging, contracting, and paying for services provided by a third party of the resident’s choice, including a licensed home health agency or private nurse, or receiving services through an out-patient clinic, provided the resident meets the criteria for admission and continued residency and the resident complies with the facility’s policy relating to the delivery of services in the facility by third parties. The facility’s policies must require the third party to coordinate with the facility regarding the resident’s condition and the services being provided.

(b) When residents require or arrange for services from a third party provider, the facility administrator or designee must allow for the receipt of those services, provided that the resident meets the criteria for admission and continued residency. The facility, when requested by residents or representatives, must coordinate with the provider to facilitate the receipt of care and services provided to meet the particular resident’s needs.

Care coordination includes documented communications about the resident’s condition and response to treatment or services ordered by the physician which may impact the resident’s appropriateness for continued residency in the facility;
Communications occur at least once every 30 days and whenever there is a significant change in the resident’s condition; and
If physician ordered treatments or services occur less often than once a month, communications must be conducted according to the ordered treatment or service schedule and whenever there is a significant change in the resident’s condition.
When communication with the third party provider is unsuccessful, at least two attempts at communication on two separate days must be documented. Documentation must include the name of the person from the third party provider with whom contact was attempted, the method of communication, and the date and time of the attempts. This documentation must be included in the resident’s record in accordance with the timeframes in subparagraphs 59A-36.007(6)(c)2. and 3.

(d) If residents accept assistance from the facility in arranging and coordinating third party services, the facility’s assistance does not represent a guarantee that third party services will be received. If the facility’s efforts to make arrangements for third party services are unsuccessful or declined by residents, the facility must include documentation in the residents’ record explaining why its efforts were unsuccessful. This documentation will serve to demonstrate its compliance with this subsection.

(7) ELOPEMENT STANDARDS.

(a) Residents Assessed at Risk for Elopement. All residents assessed at risk for elopement or with any history of elopement must be identified so staff can be alerted to their needs for support and supervision. All residents must be assessed for risk of elopement by a health care provider or a mental health care provider within 30 calendar days of being admitted to a facility. If the resident has had a health assessment performed prior to admission pursuant to paragraph 59A-36.006(2)(a), F.A.C., this requirement is satisfied. A resident placed in a facility on a temporary emergency basis by the Department of Children and Families pursuant to Section 415.105 or 415.1051, F.S., is exempt from this requirement for up to 30 days.

As part of its resident elopement response policies and procedures, the facility must make, at a minimum, a daily effort to determine that at risk residents have identification on their persons that includes their name and the facility’s name, address, and telephone number. Staff trained pursuant to paragraph 59A-36.011(10)(a) or (c), F.A.C., must be generally aware of the location of all residents assessed at high risk for elopement at all times.
The facility must have a photo identification of at risk residents on file that is accessible to all facility staff and law enforcement as necessary. The facility’s file must contain the resident’s photo identification upon admission or upon being assessed at risk for elopement subsequent to admission. The photo identification may be provided by the facility, the resident, or the resident’s representative.

(b) Facility Resident Elopement Response Policies and Procedures. The facility must develop detailed written policies and procedures for responding to a resident elopement. At a minimum, the policies and procedures must provide for:

An immediate search of the facility and premises,
The identification of staff responsible for implementing each part of the elopement response policies and procedures, including specific duties and responsibilities,
The identification of staff responsible for contacting law enforcement, the resident’s family, guardian, health care surrogate, and case manager if the resident is not located pursuant to subparagraph (8)(b)1.; and,
The continued care of all residents within the facility in the event of an elopement.

(c) Facility Resident Elopement Drills. The facility must conduct and document resident elopement drills pursuant to Section 429.41(1)(k), F.S.

(8) PHYSICAL RESTRAINTS. Residents for whom a physician has prescribed a physical restraint must have a written care plan for the use of the physical restraint. The care plan must be developed within 14 days of the device being prescribed, and prior to use on the resident.

(a) The care plan must specify:

The device prescribed for use;
The maximum amount of time the resident is to have the restraint applied each day; and,
In what manner and frequency staff will monitor, observe, and report to the physician any injuries, increase in agitation, signs and symptoms of depression, or decline in mobility or function related to the use of the prescribed restraint.

(b) Facility staff must ensure that the device is applied appropriately and safely.

(c) The resident’s physician must review the appropriateness of the continued use of the physical restraint annually, and documentation of this review must be maintained in the resident’s record. If the resident’s ability to independently remove or avoid the device fluctuates, the device must be considered a physical restraint and all requirements of this subsection apply.

(9) ASSISTIVE DEVICES. Facilities are responsible for ensuring the safe usage of a resident’s assistive devices.

(a) The facility must have policies and procedures that include the requirements and methods for assessing the physical condition of assistive devices that may injure the resident and procedures for recommending repair or replacement for the continuing safety of a resident’s assistive device.

(b) Documentation of each assistive device a resident uses must be included in the resident’s record.

(c) Direct care staff using assistive devices while rendering personal services to residents must know how to operate and utilize the equipment.

(d) All assistive devices must be clean, in good repair, and free of hazards.

(e) The facility must encourage and allow the resident to function with independence when using the assistive device.

(10) INFECTION CONTROL PROCEDURES. Facilities must provide services in a manner that reduces the risk of transmission of infectious diseases.

(a) The facility must implement a hand hygiene program before and after the provision of personal services to residents whenever there is an expectation of possible exposure to infectious materials or bodily fluids. Hand hygiene may include the use of alcohol-based rubs, antiseptic handwash, or handwashing with soap and water.

(b) Standard precautions must be used when there is an anticipated exposure to transmissible infectious agents in blood, body fluids, secretions, excretions, nonintact skin, and mucuous membranes during the provision of personal services. Standard precautions include: hand hygiene, and dependent upon the exposure, use of gloves, gown, mask, eye protection, or a face shield.

(c) The facility must clean and disinfect reusable medical equipment and communal assistive devices that have been designed for use by multiple residents before and after each use according to the manufacturer’s recommendations.

(11) OTHER STANDARDS. Additional care standards for residents residing in a facility holding a limited mental health, extended congregate care or limited nursing services license are provided in Rules 59A-36.020, 59A-36.021 and 59A-36.022, F.A.C., respectively.

History

Rulemaking Authority 429.41 FS. Law Implemented 429.255, 429.26, 429.28, 429.41 FS. History–New 9-17-84, Formerly 10A-5.182, Amended 10-20-86, 6-21-88, 8-15-90, 9-30-92, Formerly 10A-5.0182, Amended 10-30-95, 4-20-98, 11-2-98, 10-17-99, 7-30-06, 10-9-06, 4-15-10, 4-17-14, 5-10-18, Formerly 58A-5.0182, Amended 8-16-21, 6-11-25.

Fla. Admin. Code R. 59A-36.008 Medication Practices

Pursuant to Sections 429.255 and 429.256, F.S., and this rule, licensed facilities may assist with the self-administration or administration of medications to residents in a facility. A resident may not be compelled to take medications but may be counseled in accordance with this rule.

(1) SELF ADMINISTERED MEDICATIONS.

(a) Residents who are capable of self-administering their medications without assistance must be encouraged and allowed to do so.

(b) If facility staff observes health changes that could reasonably be attributed to the improper self-administration of medication, staff must consult with the resident concerning any problems the resident may be experiencing in self-administering the medications. The consultation should describe the services offered by the facility that aid the resident with medication administration through the use of a pill organizer, through providing assistance with self-administration of medications, or through administering medications. The facility must contact the resident’s health care provider when observable health changes occur that may be attributed to the resident’s medications. The facility must document such contacts in the resident’s records.

(2) PILL ORGANIZERS.

(a) Only a resident who self-administers medications may maintain a pill organizer.

(b) Unlicensed staff may not provide assistance with the contents of pill organizers.

(c) A nurse may manage a pill organizer to be used only by residents who self-administer medications. The nurse is responsible for instructing the resident in the proper use of the pill organizer. The nurse must manage the pill organizer in the following manner:

Obtain the labeled medication container from the storage area or the resident,
Transfer the medication from the original container into a pill organizer, labeled with the resident’s name, according to the day and time increments as prescribed,
Return the medication container to the storage area or resident; and,
Document the date and time the pill organizer was filled in the resident’s record.

(d) If there is a determination that the resident is not taking medications as prescribed after the medicinal benefits are explained, it must be noted in the resident’s record and the facility must consult with the resident concerning providing assistance with self-administration or the administration of medications if such services are offered by the facility. The facility must contact the resident’s health care provider regarding questions, concerns, or observations relating to the resident’s medications. Such communication must be documented in the resident’s record.

(3) ASSISTANCE WITH SELF-ADMINISTRATION.

(a) Any unlicensed person providing assistance with self-administration of medication must be 18 years of age or older, trained to assist with self administered medication pursuant to the training requirements of Rule 59A-36.011, F.A.C., and must be available to assist residents with self-administered medications in accordance with procedures described in Section 429.256, F.S. and this rule.

(b) In addition to the specifications of Section 429.256(3), F.S., assistance with self-administration of medication includes, orally advising the resident of the name and dosage of the medication and verbally prompting a resident to take medications as prescribed.

(c) In order to facilitate assistance with self-administration, trained staff may prepare and make available such items as water, juice, cups, and spoons. Trained staff may also return unused doses to the medication container. Medication, which appears to have been contaminated, must not be returned to the container.

(d) Trained staff must observe the resident take the medication. Any concerns about the resident’s reaction to the medication or suspected noncompliance must be reported to the resident’s health care provider and documented in the resident’s record.

(e) When a resident who receives assistance with medication is away from the facility and from facility staff, the following options are available to enable the resident to take medication as prescribed:

The health care provider may prescribe a medication schedule that coincides with the resident’s presence in the facility,
The medication container may be given to the resident, a friend, or family member upon leaving the facility, with this fact noted in the resident’s medication record,
The medication may be transferred to a pill organizer pursuant to the requirements of subsection (2), and given to the resident, a friend, or family member upon leaving the facility, with this fact noted in the resident’s medication record, or
Medications may be separately prescribed and dispensed in an easier to use form, such as unit dose packaging.

(f) Assistance with self-administration of medication does not include the activities detailed in Section 429.256(4), F.S.

(g) As used in Section 429.256(4)(h), F.S., the terms “judgment” and “discretion” mean interpreting vital signs and evaluating or assessing a resident’s condition.

(h) All trained staff must adhere to the facility’s infection control policy and procedures when assisting with the self-administration of medication.

(4) MEDICATION ADMINISTRATION.

(a) For facilities that provide medication administration, a staff member licensed to administer medications must be available to administer medications in accordance with a health care provider’s order or prescription label.

(b) Unusual reactions to the medication or a significant change in the resident’s health or behavior that may be caused by the medication must be documented in the resident’s record and reported immediately to the resident’s health care provider. The contact with the health care provider must also be documented in the resident’s record.

(c) Medication administration includes conducting any examination or other procedure necessary for the proper administration of medication that the resident cannot conduct personally and that can be performed by licensed staff.

(d) A facility that performs clinical laboratory tests for residents, including blood glucose testing, must be in compliance with the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) and Chapter 483, Part I, F.S. A valid copy of the federal CLIA Certificate must be maintained in the facility. A federal CLIA certificate is not required if residents perform the test themselves or if a third party assists residents in performing the test. The facility is not required to maintain a federal CLIA Certificate if facility staff assist residents in performing clinical laboratory testing with the residents’ equipment. Information about the federal CLIA Certificate is available from the Laboratory and In-Home Services Unit, Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop 32, Tallahassee, FL 32308; telephone (850)412-4500.

(5) MEDICATION RECORDS.

(a) For residents who use a pill organizer managed in subsection (2), the facility must keep either the original labeled medication container; or a medication listing with the prescription number, the name and address of the issuing pharmacy, the health care provider’s name, the resident’s name, the date dispensed, the name and strength of the drug, and the directions for use.

(b) The facility must maintain a daily medication observation record for each resident who receives assistance with self-administration of medications or medication administration. A medication observation record must be immediately updated each time the medication is offered or administered and include:

The name of the resident and any known allergies the resident may have;
The name of the resident’s health care provider and the health care provider’s telephone number;
The name, strength, and directions for use of each medication; and,
A chart for recording each time the medication is taken, any missed dosages, refusals to take medication as prescribed, or medication errors.

(c) For medications that serve as chemical restraints, the facility must, pursuant to Section 429.41, F.S., maintain a record of the prescribing physician’s annual evaluation of the use of the medication.

(6) MEDICATION STORAGE AND DISPOSAL.

(a) In order to accommodate the needs and preferences of residents and to encourage residents to remain as independent as possible, residents may keep their medications, both prescription and over-the-counter, in their possession both on or off the facility premises. Residents may also store their medication in their rooms or apartments if either the room is kept locked when residents are absent or the medication is stored in a secure place that is out of sight of other residents.

(b) Both prescription and over-the-counter medications for residents must be centrally stored if:

The facility administers the medication;
The resident requests central storage. The facility must maintain a list of all medications being stored pursuant to such a request;
The medication is determined and documented by the health care provider to be hazardous if kept in the personal possession of the person for whom it is prescribed;
The resident fails to maintain the medication in a safe manner as described in this paragraph;
The facility determines that, because of physical arrangements and the conditions or habits of residents, the personal possession of medication by a resident poses a safety hazard to other residents, or
The facility’s rules and regulations require central storage of medication and that policy has been provided to the resident before admission as required in Rule 59A-36.006, F.A.C.

Kept in a locked cabinet; locked cart; or other locked storage receptacle, room, or area at all times;
Located in an area free of dampness and abnormal temperature, except that a medication requiring refrigeration must be kept refrigerated. Refrigerated medications must be secured by being kept in a locked container within the refrigerator, by keeping the refrigerator locked, or by keeping the area in which the refrigerator is located locked;
Accessible to staff responsible for filling pill-organizers, assisting with self-administration of medication, or administering medication. Such staff must have ready access to keys or codes to the medication storage areas at all times; and,
Kept separately from the medications of other residents and properly closed or sealed.

(d) Medication that has been discontinued but has not expired must be returned to the resident or the resident’s representative, as appropriate, or may be centrally stored by the facility for future use by the resident at the resident’s request. If centrally stored by the facility, the discontinued medication must be stored separately from medication in current use, and the area in which it is stored must be marked “discontinued medication.” Such medication may be reused if prescribed by the resident’s health care provider.

(e) When a resident’s stay in the facility has ended, the administrator must return all medications to the resident, the resident’s family, or the resident’s guardian unless otherwise prohibited by law. If, after notification and waiting at least 15 days, the resident’s medications are still at the facility, the medications are considered abandoned and may disposed of in accordance with paragraph (f).

(f) Medications that have been abandoned or have expired must be disposed of within 30 days of being determined abandoned or expired and the disposal must be documented in the resident’s record. The medication may be taken to a pharmacist for disposal or may be destroyed by the administrator or designee with one witness.

(g) Facilities that hold a Special-ALF permit issued by the Board of Pharmacy may return dispensed medicinal drugs to the dispensing pharmacy pursuant to Rule 64B16-28.870, F.A.C.

(7) MEDICATION LABELING AND ORDERS.

(a) The facility may not store prescription drugs for self-administration, assistance with self-administration, or administration unless they are properly labeled and dispensed in accordance with Chapters 465 and 499, F.S., and Rule 64B16-28.108, F.A.C. If a customized patient medication package is prepared for a resident, and separated into individual medicinal drug containers, then the following information must be recorded on each individual container:

The resident’s name; and,
The identification of each medicinal drug in the container.

(b) Except with respect to the use of pill organizers as described in subsection (2), no individual other than a pharmacist may transfer medications from one storage container to another.

(c) If the directions for use are “as needed” or “as directed,” the health care provider must be contacted and requested to provide revised instructions. For an “as needed” prescription, the circumstances under which it would be appropriate for the resident to request the medication and any limitations must be specified; for example, “as needed for pain, not to exceed 4 tablets per day.” The revised instructions, including the date they were obtained from the health care provider and the signature of the staff who obtained them, must be noted in the medication record, or a revised label must be obtained from the pharmacist.

(d) Any change in directions for use of a medication that the facility is administering or providing assistance with self-administration must be accompanied by a written, faxes, or electronic copy of a medication order issued and signed by the resident’s health care provider. The new directions must promptly be recorded in the resident’s medication observation record. The facility may then obtain a revised label from the pharmacist or place an “alert” label on the medication container that directs staff to examine the revised directions for use in the medication observation record.

(e) A nurse may take a medication order by telephone. Such order must be promptly documented in the resident’s medication observation record. The facility must obtain a written medication order from the health care provider within 10 working days. A faxed or electronic copy of a signed order is acceptable.

(f) The facility must make every reasonable effort to ensure that prescriptions for residents who receive assistance with self-administration of medication or medication administration are filled or refilled in a timely manner.

(g) Pursuant to Section 465.0276(5), F.S., and Rule 61N-1.006, F.A.C., sample or complimentary prescription drugs that are dispensed by a health care provider, must be kept in their original manufacturer’s packaging, which must include the practitioner’s name, the resident’s name for whom they were dispensed, and the date they were dispensed. If the sample or complimentary prescription drugs are not dispensed in the manufacturer’s labeled package, they must be kept in a container that bears a label containing the following:

Practitioner’s name,
Resident’s name,
Date dispensed,
Name and strength of the drug,
Directions for use; and,
Expiration date.

(h) Pursuant to Section 465.0276(2)(c), F.S., before dispensing any sample or complimentary prescription drug, the resident’s health care provider must provide the resident with a written prescription, or a faxed or electronic copy of such order.

(8) OVER THE COUNTER (OTC) PRODUCTS. For purposes of this subsection, the term over the counter includes, but is not limited to, over the counter medications, vitamins, nutritional supplements and nutraceuticals, hereafter referred to as OTC products, that can be sold without a prescription.

(a) A facility may keep a stock supply of OTC products for multiple resident use. When providing any OTC product that is kept by the facility as a stock supply to a resident, the staff member providing the medication must record the name and amount of the OTC product provided in the resident’s medication observation record. All OTC products kept as a stock supply must be stored in a locked container or secure room in a central location within the facility and must be labeled with the medication’s name, the date of purchase, and with a notice that the medication is part of the facility’s stock supply.

(b) OTC products, including those prescribed by a health care provider but excluding those kept as a stock supply by the facility, must be labeled with the resident’s name and the manufacturer’s label with directions for use, or the health care provider’s directions for use. No other labeling requirements are required.

(d) A health care provider’s order is required when a nurse provides assistance with self-administration or administration of OTC products. When an order for an OTC product exists, the order must meet the requirements of paragraphs (b) and (c) of this subsection. A health care provider’s order for OTC products is not required when a resident self-administers his or her medications, or when unlicensed staff provides assistance with self-administration of medications.

History

Rulemaking Authority 429.256, 429.41 FS. Law Implemented 429.255, 429.256, 429.41 FS. History–New 10-17-99, Amended 7-30-06, 4-15-10, 10-14-10, 3-13-14, 5-10-18, Formerly 58A-5.0185, Amended 8-16-21, 6-11-25.

Fla. Admin. Code R. 59A-36.009 Do Not Resuscitate Orders (DNROs) and Advance Directives

(1) POLICIES AND PROCEDURES.

(a) Each assisted living facility must establish written policies and procedures regarding a resident’s rights concerning advance directives and Do Not Resuscitate Orders (DNROs). An assisted living facility may not require execution of a DNRO as a condition of admission or treatment. The assisted living facility must provide the following to each resident, or resident’s representative, at the time of admission:

A written or electronic copy of health care advance directive information pursuant to Chapter 765, F.S. This requirement may be met by providing information and sample forms for advance directives, which can be found on the Agency’s website at https://quality.healthfinder.fl.gov/report-guides/
DH Form 1896, Do Not Resuscitate Order, 02/2024, which is hereby incorporated by reference. This form may be obtained online at https://www.floridahealth.gov/about-us/resources/do-not-resuscitate-order/ or at: https://flrules.org/Gateway/reference.asp?No=Ref-19567.

(b) There must be documentation in the resident’s record indicating whether a DH Form 1896 has been executed. If a DH Form 1896 has been executed, a yellow copy of that document must be made a part of the resident’s record. If the assisted living facility does not receive a copy of a resident’s executed DH Form 1896, the assisted living facility must document in the resident’s record that it has requested a copy.

(2) LICENSE REVOCATION. An assisted living facility’s license is subject to revocation pursuant to Section 408.815, F.S., if, as a condition of treatment or admission, the facility requires an individual to execute or waive DH Form 1896.

(3) DNRO PROCEDURES. Pursuant to Section 429.255, F.S., an assisted living facility must honor a properly executed DH Form 1896 as follows:

(a) In the event a resident experiences cardiac or pulmonary arrest, staff trained in cardiopulmonary resuscitation (CPR) or a health care provider present in the facility, may withhold cardiopulmonary resuscitation (artificial ventilation, cardiac compression, endotracheal intubation and defibrillation).

(b) In the event a resident is receiving hospice services and experiences cardiac or pulmonary arrest, facility staff must immediately contact hospice staff. The hospice procedures take precedence over those of the assisted living facility.

History

Rulemaking Authority 429.255 FS. Law Implemented 429.255 FS. History–New 4-15-10, Amended 4-17-14, Formerly 58A-5.0186, 7-1-19, Amended 9-17-26.

Fla. Admin. Code R. 59A-36.010 Staffing Standards

(1) ADMINISTRATORS. Every facility must be under the supervision of an administrator who is responsible for the operation and maintenance of the facility including the management of all staff and the provision of appropriate care to all residents as required by Chapters 408, Part II, 429, Part I, F.S., and rule Chapter 59A-35, F.A.C., and this rule chapter.

(a) An administrator must:

Be at least 21 years of age;
If employed on or after October 30, 1995, have, at a minimum, a high school diploma or G.E.D.;
Be in compliance with Level 2 background screening requirements pursuant to Sections 408.809 and 429.174, F.S.;
Complete the core training and core competency test requirements pursuant to Rule 59A-36.011, F.A.C., no later than 90 days after becoming employed as a facility administrator. Administrators who attended core training prior to July 1, 1997, are not required to take the competency test unless specified elsewhere in this rule; and,
Satisfy the continuing education requirements pursuant to Rule 59A-36.011, F.A.C. Administrators who are not in compliance with these requirements must retake the core training and core competency test requirements in effect on the date the non-compliance is discovered by the agency or the department.

(b) In the event of extenuating circumstances, such as the death of a facility administrator, the agency may permit an individual who otherwise has not satisfied the training requirements of subparagraph (1)(a)4. of this rule, to temporarily serve as the facility administrator for a period not to exceed 90 days. During the 90 day period, the individual temporarily serving as facility administrator must:

Complete the core training and core competency test requirements pursuant to Rule 59A-36.011, F.A.C.; and,
Complete all additional training requirements if the facility maintains licensure as an extended congregate care or limited mental health facility.

(c) Administrators may supervise a maximum of either three assisted living facilities or a group of facilities on a single campus providing housing and health care Administrators who supervise more than one facility must appoint in writing a separate manager for each facility. However, an administrator supervising a maximum of three assisted living facilities, each licensed for 16 or fewer beds and all within a 15 mile radius of each other, is only required to appoint two managers to assist in the operation and maintenance of those facilities.

(d) An individual serving as a manager must satisfy the same qualifications, background screening, core training and competency test requirements, and continuing education requirements as an administrator pursuant to paragraph (1)(a) of this rule. Managers who attended the core training program prior to April 20, 1998, are not required to take the competency test unless specified elsewhere in this rule. In addition, a manager may not serve as a manager of more than a single facility, except as provided in paragraph (1)(c) of this rule, and may not simultaneously serve as an administrator of any other facility.

(e) Pursuant to Section 429.176, F.S., facility owners must notify the Agency Central Office within 10 days of a change in facility administrator on the Notification of Change of Administrator form, AHCA Form 3180-1006, June 2016, which is incorporated by reference and available online at: http://www.flrules.org/Gateway/reference.asp?No=Ref-09393.

(2) STAFF.

(a) Within 30 days after beginning employment, newly hired staff must submit a written statement from a health care provider documenting that the individual does not have any signs or symptoms of communicable disease. The examination performed by the health care provider must have been conducted no earlier than 6 months before submission of the statement. Newly hired staff does not include an employee transferring without a break in service from one facility to another when the facility is under the same management or ownership.

Evidence of a negative tuberculosis examination must be documented on an annual basis. Documentation provided by the Florida Department of Health or a licensed health care provider certifying that there is a shortage of tuberculosis testing materials satisfies the annual tuberculosis examination requirement. An individual with a positive tuberculosis test must submit a health care provider’s statement that the individual does not constitute a risk of communicating tuberculosis.
If any staff member has, or is suspected of having, a communicable disease, such individual must be immediately removed from duties until a written statement is submitted from a health care provider indicating that the individual does not constitute a risk of transmitting a communicable disease.

(b) Staff must be qualified to perform their assigned duties consistent with their level of education, training, preparation, and experience. Staff providing services requiring licensing or certification must be appropriately licensed or certified. All staff must exercise their responsibilities, consistent with their qualifications, to observe residents, to document observations on the appropriate resident’s record, and to report the observations to the resident’s health care provider in accordance with this rule chapter.

(d) An assisted living facility contracting to provide services to residents must ensure that individuals providing services are qualified to perform their assigned duties in accordance with this rule chapter. The contract between the facility and the staffing agency or contractor must specifically describe the services the staffing agency or contractor will provide to residents.

(e) For facilities with a licensed capacity of 17 or more residents, the facility must:

Develop a written job description for each staff position and provide a copy of the job description to each staff member; and,
Maintain time sheets for all staff.

(f) Level 2 background screening must be conducted for staff, including staff contracted by the facility to provide services to residents, pursuant to Sections 408.809 and 429.174, F.S.

(3) STAFFING STANDARDS.

(a) Minimum staffing:

Facilities must maintain the following minimum staff hours per week:

Number of Residents, Day Care Participants, and Respite Care Residents

Staff Hours/Week

0-5

168

6-15

212

16- 25

253

26-35

294

36-45

335

46-55

375

56- 65

416

66-75

457

76-85

498

86-95

539

For every 20 total combined residents, day care participants, and respite care residents over 95 add 42 staff hours per week.

Independent living residents, as referenced in subsection 59A-36.015(3), F.A.C., who occupy beds included within the licensed capacity of an assisted living facility but do not receive personal, limited nursing, or extended congregate care services, are not counted as residents for purposes of computing minimum staff hours.
At least one staff member who has access to facility and resident records in case of an emergency must be in the facility at all times when residents are in the facility. Residents serving as paid or volunteer staff may not be left solely in charge of other residents while the facility administrator, manager or other staff are absent from the facility.
In facilities with 17 or more residents, there must be at least one staff member awake at all hours of the day and night.
A staff member who has completed courses in First Aid and Cardiopulmonary Resuscitation (CPR) and holds a currently valid card documenting completion of such courses must be in the facility at all times.

a. Documentation of attendance at First Aid or CPR courses pursuant to subsection 59A-36.011(5), F.A.C., satisfies this requirement.

b. A nurse is considered as having met the course requirements for First Aid. An emergency medical technician or paramedic currently certified under Chapter 401, Part III, F.S., is considered as having met the course requirements for both First Aid and CPR.

During periods of temporary absence of the administrator or manager of more than 48 hours when residents are on the premises, a staff member who is at least 21 years of age must be physically present and designated in writing to be in charge of the facility. No staff member shall be in charge of a facility for a consecutive period of 21 days or more, or for a total of 60 days within a calendar year, without being an administrator or manager.
Staff whose duties are exclusively building or grounds maintenance, clerical, or food preparation do not count towards meeting the minimum staffing hours requirement.
The administrator or manager’s time may be counted for the purpose of meeting the required staffing hours, provided the administrator or manager is actively involved in the day-to-day operation of the facility, including making decisions and providing supervision for all aspects of resident care, and is listed on the facility’s staffing schedule.
Only on-the-job staff may be counted in meeting the minimum staffing hours. Vacant positions or absent staff may not be counted.

(b) Notwithstanding the minimum staffing requirements specified in paragraph (a), all facilities, including those composed of apartments, must have enough qualified staff to provide resident supervision, and to provide or arrange for resident services in accordance with the residents’ scheduled and unscheduled service needs, resident contracts, and resident care standards as described in Rule 59A-36.007, F.A.C.

(c) The facility must maintain a written work schedule that reflects its 24-hour staffing pattern for a given time period. Upon request, the facility must make the daily work schedules of direct care staff available to residents or their representatives.

(d) The facility must provide staff immediately when the agency determines that the requirements of paragraph (a) are not met. The facility must immediately increase staff above the minimum levels established in paragraph (a), if the agency determines that adequate supervision and care are not being provided to residents, resident care standards described in Rule 59A-36.007, F.A.C., are not being met, or that the facility is failing to meet the terms of residents’ contracts. The agency will consult with the facility administrator and residents regarding any determination that additional staff is required. Based on the recommendations of the local fire safety authority, the agency may require additional staff when the facility fails to meet the fire safety standards described in rule Chapter 69A-40, F.A.C., until such time as the local fire safety authority informs the agency that fire safety requirements are being met.

When additional staff is required above the minimum, the agency will require the submission of a corrective action plan within the time specified in the notification indicating how the increased staffing is to be achieved to meet resident service needs. The plan will be reviewed by the agency to determine if it sufficiently increases the staffing levels to meet resident needs.
When the facility can demonstrate to the agency that resident needs are being met, or that resident needs can be met without increased staffing, the agency may modify staffing requirements for the facility and the facility will no longer be required to maintain a plan with the agency.

(e) Facilities that are co-located with a nursing home may use shared staffing provided that staff hours are only counted once for the purpose of meeting either assisted living facility or nursing home minimum staffing ratios.

(f) Facilities holding a limited mental health, extended congregate care, or limited nursing services license must also comply with the staffing requirements of Rules 59A-36.020, 59A-36.021 or 59A-36.022, F.A.C., respectively.

History

Rulemaking Authority 429.41, 429.52, 429.929 FS. Law Implemented 429.174, 429.176, 429.41, 429.52, 429.905 FS. History–New 5-14-81, Amended 1-6-82, 9-17-84, Formerly 10A-5.19, Amended 10-20-86, 6-21-88, 8-15-90, 9-30-92, Formerly 10A-5.019, Amended 10-30-95, 4-20-98, 11-2-98, 10-17-99, 7-30-06, 4-15-10, 4-17-14, 5-10-18, Formerly 58A-5.019.

Fla. Admin. Code R. 59A-36.011 Staff Training Requirements and Competency Test

(1) ASSISTED LIVING FACILITY CORE TRAINING REQUIREMENTS AND COMPETENCY TEST.

(a) The assisted living facility core training requirements established by the department pursuant to Section 429.52, F.S., shall consist of a minimum of 26 hours of training plus a competency test.

(b) Administrators and managers must successfully complete the assisted living facility core training requirements within 3 months from the date of becoming a facility administrator or manager. Successful completion of the core training requirements includes passing the competency test. The minimum passing score for the competency test is 75%. Administrators who have attended core training prior to July 1, 1997, and managers who attended the core training program prior to April 20, 1998, shall not be required to take the competency test. Administrators licensed as nursing home administrators in accordance with Chapter 468, Part II, F.S., are exempt from this requirement.

(c) Administrators and managers shall participate in 12 hours of continuing education in topics related to assisted living every 2 years.

(d) A newly hired administrator or manager who has successfully completed the assisted living facility core training and continuing education requirements, shall not be required to retake the core training. An administrator or manager who has successfully completed the core training but has not maintained the continuing education requirements will be considered a new administrator or manager for the purposes of the core training requirements and must:

Retake the assisted living facility core training; and,
Retake and pass the competency test.

(e) The fees for the competency test shall not exceed $200.00. The payment for the competency test fee shall be remitted to the entity administering the test. A new fee is due each time the test is taken.

(2) STAFF PRESERVICE ORIENTATION.

(a) Facilities must provide a preservice orientation of at least 2 hours to all new assisted living facility employees who have not previously completed core training as detailed in subsection (1).

(b) New staff must complete the preservice orientation prior to interacting with residents.

(c) Once complete, the employee and the facility administrator must sign a statement that the employee completed the preservice orientation which must be kept in the employee’s personnel record.

(d) In addition to topics that may be chosen by the facility administrator, the preservice orientation must cover:

Resident’s rights; and,
The facility’s license type and services offered by the facility.

(3) STAFF IN-SERVICE TRAINING. Facility administrators or managers shall provide or arrange for the following in-service training to facility staff:

(a) Staff who provide direct care to residents, other than nurses, certified nursing assistants, or home health aides trained in accordance with Rule 59A-8.0095, F.A.C., must receive a minimum of 1 hour in-service training in infection control, including universal precautions and facility sanitation procedures, before providing personal care to residents. The facility must use its infection control policies and procedures when offering this training. Documentation of compliance with the staff training requirements of 29 CFR 1910.1030, relating to blood borne pathogens, may be used to meet this requirement.

(b) Staff who provide direct care to residents must receive a minimum of 1 hour in-service training within 30 days of employment that covers the following subjects:

Reporting adverse incidents.
Facility emergency procedures including chain-of-command and staff roles relating to emergency evacuation.

(c) Staff who provide direct care to residents, who have not taken the core training program, shall receive a minimum of 1 hour in-service training within 30 days of employment that covers the following subjects:

Resident rights in an assisted living facility.
Recognizing and reporting resident abuse, neglect, and exploitation. The facility must use its abuse prevention policies and procedures when offering this training.

(d) Staff who provide direct care to residents, other than nurses, CNAs, or home health aides trained in accordance with Rule 59A-8.0095, F.A.C., must receive 3 hours of in-service training within 30 days of employment that covers the following subjects:

Resident behavior and needs.
Providing assistance with the activities of daily living.

(e) Staff who prepare or serve food, who have not taken the assisted living facility core training must receive a minimum of 1-hour-in-service training within 30 days of employment in safe food handling practices.

(f) All facility staff shall receive in-service training regarding the facility’s resident elopement response policies and procedures within thirty (30) days of employment.

All facility staff shall be provided with a copy of the facility’s resident elopement response policies and procedures.
All facility staff shall demonstrate an understanding and competency in the implementation of the elopement response policies and procedures.

(4) HUMAN IMMUNODEFICIENCY VIRUS/ACQUIRED IMMUNE DEFICIENCY SYNDROME (HIV/AIDS). Pursuant to Section 381.0035, F.S., all facility employees, with the exception of employees subject to the requirements of Section 456.033, F.S., must complete a one-time education course on HIV and AIDS, including the topics prescribed in the Section 381.0035, F.S. New facility staff must obtain the training within 30 days of employment. Documentation of compliance must be maintained in accordance with subsection (12) of this rule.

(5) FIRST AID AND CARDIOPULMONARY RESUSCITATION (CPR). A staff member who has completed courses in First Aid and CPR and holds a currently valid card documenting completion of such courses must be in the facility at all times.

(a) Documentation that the staff member possess current CPR certification that requires the student to demonstrate, in person, that he or she is able to perform CPR and which is issued by an instructor or training provider that is approved to provide CPR training by the American Red Cross, the American Heart Association, the National Safety Council, or an organization whose training is accredited by the Commission on Accreditation for Pre-Hospital Continuing Education satisfies this requirement.

(b) A nurse shall be considered as having met the training requirement for First Aid. An emergency medical technician or paramedic currently certified under Chapter 401, Part III, F.S., shall be considered as having met the training requirements for both First Aid and C.P.R.

(6) ASSISTANCE WITH THE SELF-ADMINISTRATION OF MEDICATION AND MEDICATION MANAGEMENT. Unlicensed persons who will be providing assistance with the self-administration of medications as described in Rule 59A-36.008, F.A.C., must meet the training requirements pursuant to Section 429.52(6), F.S., prior to assuming this responsibility. Courses provided in fulfilment of this requirement must meet the following criteria:

(a) Training must cover state law and rule requirements with respect to the supervision, assistance, administration, and management of medications in assisted living facilities; procedures and techniques for assisting the resident with self-administration of medication including how to read a prescription label; providing the right medications to the right resident; common medications; the importance of taking medications as prescribed; recognition of side effects and adverse reactions and procedures to follow when residents appear to be experiencing side effects and adverse reactions; documentation and record keeping; and medication storage and disposal. Training shall include demonstrations of proper techniques, including techniques for infection control, and ensure unlicensed staff have adequately demonstrated that they have acquired the skills necessary to provide such assistance.

(b) The training must be provided by a registered nurse or licensed pharmacist who shall issue a training certificate to a trainee who demonstrates, in person and both physically and verbally, the ability to:

Read and understand a prescription label;
Provide assistance with self-administration in accordance with Section 429.256, F.S., and Rule 59A-36.008, F.A.C., including:

a. Assist with oral dosage forms, topical dosage forms, and topical ophthalmic, otic and nasal dosage forms;

b. Measure liquid medications, break scored tablets, and crush tablets in accordance with prescription directions;

c. Recognize the need to obtain clarification of an “as needed” prescription order;

d. Recognize a medication order which requires judgment or discretion, and to advise the resident, resident’s health care provider or facility employer of inability to assist in the administration of such orders;

e. Complete a medication observation record;

f. Retrieve and store medication;

g. Recognize the general signs of adverse reactions to medications and report such reactions;

h. Assist residents with insulin syringes that are prefilled with the proper dosage by a pharmacist and insulin pens that are prefilled by the manufacturer by taking the medication, in its previously dispensed, properly labeled container, from where it is stored, and bringing it to the resident for self-injection;

i. Assist with nebulizers;

j. Use a glucometer to perform blood glucose testing;

k. Assist residents with oxygen nasal cannulas and continuous positive airway pressure (CPAP) devices, excluding the titration of the oxygen levels;

l. Apply and remove anti-embolism stockings and hosiery;

m. Placement and removal of colostomy bags, excluding the removal of the flange or manipulation of the stoma site; and,

n. Measurement of blood pressure, heart rate, temperature, and respiratory rate.

(c) Unlicensed persons, as defined in Section 429.256(1)(b), F.S., who provide assistance with self-administered medications and have successfully completed the initial 6 hour training, must obtain, annually, a minimum of 2 hours of continuing education training on providing assistance with self-administered medications and safe medication practices in an assisted living facility. The 2 hours of continuing education training may be provided online.

(d) Trained unlicensed staff who, prior to the effective date of this rule, assist with the self-administration of medication and have successfully completed 4 hours of assistance with self-administration of medication training must complete an additional 2 hours of training that focuses on the topics listed in sub-subparagraphs (6)(b)2.h.-n. of this section, before assisting with the self-administration of medication procedures listed in sub-subparagraphs (6)(b)2.h.-n.

(7) NUTRITION AND FOOD SERVICE. The administrator or person designated by the administrator as responsible for the facility’s food service and the day-to-day supervision of food service staff must obtain, annually, a minimum of 2 hours continuing education in topics pertinent to nutrition and food service in an assisted living facility. This requirement does not apply to administrators and designees who are exempt from training requirements under paragraph 59A-36.012(1)(b), F.A.C. A certified food manager, licensed dietician, registered dietary technician or health department sanitarian is qualified to train assisted living facility staff in nutrition and food service.

(8) EXTENDED CONGREGATE CARE (ECC) TRAINING.

(a) The administrator and ECC supervisor, if different from the administrator, must complete core training and 4 hours of initial training in extended congregate care prior to the facility receiving its ECC license or within 3 months of beginning employment in a currently licensed ECC facility as an administrator or ECC supervisor. Successful completion of the assisted living facility core training shall be a prerequisite for this training. ECC supervisors who attended the assisted living facility core training prior to April 20, 1998, shall not be required to take the assisted living facility core training competency test.

(b) The administrator and the ECC supervisor, if different from the administrator, must complete a minimum of 4 hours of continuing education every two years in topics relating to the physical, psychological, or social needs of frail elderly and disabled persons, or persons with Alzheimer’s disease or related disorders.

(c) All direct care staff providing care to residents in an ECC program must complete at least 2 hours of in-service training, provided by the facility administrator or ECC supervisor, within 6 months of beginning employment in the facility. The training must address ECC concepts and requirements, including statutory and rule requirements, and the delivery of personal care and supportive services in an ECC facility.

(9) LIMITED MENTAL HEALTH TRAINING.

(a) Pursuant to Section 429.075, F.S., the administrator, managers and staff, who have direct contact with mental health residents in a licensed limited mental health facility, must receive the following training:

A minimum of 6 hours of specialized training in working with individuals with mental health diagnoses.

a. The training must be provided or approved by the Department of Children and Families and must be taken within 6 months of the facility’s receiving a limited mental health license or within 6 months of employment in a limited mental health facility.

b. Training received under this subparagraph may count once for 6 of the 12 hours of continuing education required for administrators and managers pursuant to Section 429.52(5), F.S., and subsection (1) of this rule.

A minimum of 3 hours of continuing education, which may be provided by the ALF administrator, online, or through distance learning, biennially thereafter in subjects dealing with one or more of the following topics:

a. Mental health diagnoses; and,

b. Mental health treatment such as:

(I) Mental health needs, services, behaviors and appropriate interventions;

(II) Resident progress in achieving treatment goals;

(III) How to recognize changes in the resident’s status or condition that may affect other services received or may require intervention; and,

(IV) Crisis services and the Baker Act procedures.

For administrators and managers, the continuing education requirement under this subsection will satisfy 3 of the 12 hours of continuing education required biennially pursuant to Section 429.52(5), F.S., and subsection (1) of this rule.
Administrators, managers and direct contact staff affected by the continuing education requirement under this subsection shall have up to 6 months after the effective date of this rule to meet the training requirement.

(b) Administrators, managers and staff do not have to repeat the initial training should they change employers provided they present a copy of their training certificate to the current employer for retention in the facility’s personnel files. They must also ensure that copies of the continuing education training certificates, pursuant to subparagraph (9)(a)2. of this subsection, are retained in their personnel files.

(10) ALZHEIMER’S DISEASE AND RELATED DISORDERS (“ADRD”) TRAINING REQUIREMENTS. Facilities which advertise that they provide special care for persons with ADRD, or who maintain secured areas as described in Chapter 4, Section 464.4.6 of the Florida Building Code, as adopted in Rule 61G20-1.001, F.A.C., Florida Building Code Adopted, must ensure that facility staff receive training in accordance with Section 430.5025, Florida Statutes.

(11) DO NOT RESUSCITATE ORDERS TRAINING.

(a) Currently employed facility administrators, managers, direct care staff and staff involved in resident admissions must receive at least one hour of training in the facility’s policies and procedures regarding Do Not Resuscitate Orders.

(b) Newly hired facility administrators, managers, direct care staff and staff involved in resident admissions must receive at least one hour of training in the facility’s policy and procedures regarding DNROs within 30 days after employment.

(12) TRAINING DOCUMENTATION AND MONITORING.

(a) Except as otherwise noted, certificates, or copies of certificates, of any training required by this rule must be documented in the facility’s personnel files. The documentation must include the following:

The title of the training program,
The subject matter of the training program,
The training program agenda,
The number of hours of the training program,
The trainee’s name, dates of participation, and location of the training program,
The training provider’s name, dated signature and credentials, and professional license number, if applicable.

(b) Upon successful completion of training pursuant to this rule, the training provider must issue a certificate to the trainee as specified in this rule.

(c) The facility must provide the Department of Elder Affairs and the Agency for Health Care Administration with training documentation and training certificates for review, as requested. The department and agency reserve the right to attend and monitor all facility in-service training, which is intended to meet regulatory requirements.

History

Rulemaking Authority 429.178, 429.41, 429.52 FS. Law Implemented 429.07, 429.075, 429.178, 429.41, 429.52 FS. History–New 9-30-92, Formerly 10A-5.0191, Amended 10-30-95, 6-2-96, 4-20-98, 11-2-98, 10-17-99, 7-5-05, 7-30-06, 10-9-06, 7-1-08, 4-15-10, 5-10-18, Formerly 58A-5.0191, Amended 6-5-24.

Fla. Admin. Code R. 59A-36.012 Food Service Standards

(1) GENERAL RESPONSIBILITIES. When food service is provided by the facility, the administrator, or an individual designated in writing by the administrator, must be responsible for total food services and the day-to-day supervision of food services staff. In addition, the following requirements apply:

(a) If the designee is an individual who has not completed an approved assisted living facility core training course, such individual must complete the food and nutrition services module of the core training course before assuming responsibility for the facility’s food service. The designee is not subject to the 1 hour in-service training in safe food handling practices.

(b) If the designee is a certified food manager, certified dietary manager, registered or licensed dietitian, dietetic registered technician, or health department sanitarian, the designee is exempt from the requirement to complete the food and nutrition services module of the core training course before assuming responsibility for the facility’s food service as required in paragraph (1)(a) of this rule.

(d) An administrator or designee must provide regular meals that meet the nutritional needs of residents, and therapeutic diets as ordered by the resident’s health care provider for residents who require special diets.

(e) An administrator or designee must comply with the food service continuing education requirements specified in Rule 59A-36.011, F.A.C.

(2) DIETARY STANDARDS.

(a) The meals provided by the assisted living facility must be planned based on the current USDA Dietary Guidelines for Americans, 2020-2025, which are incorporated by reference and available for review at: http://www.flrules.org/Gateway/reference.asp?No=Ref-04003, and the current table of Dietary Reference Intakes established by the Food and Nutrition Board of the Institute of Medicine of the National Academies, 2019, which are incorporated by reference and available for review at: https://ods.od.nih.gov/HealthInformation/Dietary_Reference_Intakes.aspx. Therapeutic diets must meet these nutritional standards to the extent possible.

(b) The residents’ nutritional needs must be met by offering a variety of meals adapted to the food habits, preferences, and physical abilities of the residents, and must be prepared through the use of standardized recipes. For facilities with a licensed capacity of 16 or fewer residents, standardized recipes are not required. Unless a resident chooses to eat less, the facility must serve the standard minimum portions of food according to the Dietary Reference Intakes.

(c) All regular and therapeutic menus to be used by the facility must be reviewed annually by a licensed or registered dietitian, a licensed nutritionist, or a registered dietetic technician supervised by a licensed or registered dietitian, or a licensed nutritionist to ensure the meals meet the nutritional standards established in this rule. The annual review must be documented in the facility files and include the original signature of the reviewer, registration or license number, and date reviewed. Portion sizes must be indicated on the menus or on a separate sheet.

Daily food servings may be divided among three or more meals per day, including snacks, as necessary to accommodate resident needs and preferences.
Menu items may be substituted with items of comparable nutritional value based on the seasonal availability of fresh produce or the preferences of the residents.

(d) Menus must be dated and planned at least 1 week in advance for both regular and therapeutic diets. Residents must be encouraged to participate in menu planning. Planned menus must be conspicuously posted or easily available to residents. Regular and therapeutic menus as served, with substitutions noted before or when the meal is served, must be kept on file in the facility for 6 months.

(e) Therapeutic diets must be prepared and served as ordered by the health care provider.

Facilities that offer residents a variety of food choices through a select menu, buffet style dining, or family style dining are not required to document what is eaten unless a health care provider’s order indicates that such monitoring is necessary. However, the food items that enable residents to comply with the therapeutic diet must be identified on the menus developed for use in the facility.
The facility must document a resident’s refusal to comply with a therapeutic diet and provide notification to the resident’s health care provider of such refusal.

(f) For facilities serving three or more meals a day, no more than 14 hours must elapse between the end of an evening meal containing a protein food and the beginning of a morning meal. Intervals between meals must be evenly distributed throughout the day with not less than 2 hours nor more than 6 hours between the end of one meal and the beginning of the next. For residents without access to kitchen facilities, snacks must be offered at least once per day. Snacks are not considered to be meals for the purposes of calculating the time between meals.

(g) Food must be served attractively at safe and palatable temperatures. All residents must be encouraged to eat at tables in the dining areas. A supply of eating ware sufficient for all residents, including adaptive equipment if needed by any resident, must be on hand.

(h) A 3-day supply of nonperishable food, based on the number of weekly meals the facility has contracted with residents to serve, must be on hand at all times. The quantity must be based on the resident census and not on licensed capacity. The supply must consist of foods that can be stored safely without refrigeration. Water sufficient for drinking and food preparation must also be stored, or the facility must have a plan for obtaining water in an emergency, with the plan coordinated with and reviewed by the local disaster preparedness authority.

(3) FOOD HYGIENE. Copies of inspection reports issued by the county health department for the last 2 years pursuant to Rule 64E-12.004, or Chapter 64E-11, F.A.C., as applicable, depending on the licensed capacity of the assisted living facility, must be on file in the facility.

(4) CONTRACTED FOOD SERVICE. When food service is contracted by the facility, the facility must ensure that the contracted food service meets all dietary standards imposed by this rule and is adequately protected upon delivery to the facility pursuant to subsection 64E-12.004(4), F.A.C. The facility must maintain:

(a) A copy of the current contract between the facility and the food service contractor.

History

Rulemaking Authority 429.41 FS. Law Implemented 429.41, 429.52 FS. History–New 5-14-81, Amended 1-6-82, 5-19-83, 9-17-84, Formerly 10A-5.20, Amended 10-20-86, 6-21-88, 8-15-90, 9-30-92, Formerly 10A-5.020, Amended 10-30-95, 6-2-96, 10-17-99, 4-17-14, Formerly 58A-5.020, Amended 10-4-22.

Fla. Admin. Code R. 59A-36.013 Fiscal Standards

(1) FINANCIAL STABILITY. The facility must be administered on a sound financial basis in order to ensure adequate resources to meet resident needs pursuant to the requirements of Chapter 408, Part II, Part I, F.S., and rule Chapter 59A-35, F.A.C., and this rule chapter.

(2) RESIDENT TRUST FUNDS. Funds or other property received by the facility belonging to or due a resident, including personal funds, must be held as trust funds and expended only for the resident’s account. Resident funds or property may be held in one bank account if a separate written accounting for each resident is maintained. A separate bank account is required for facility funds; co-mingling resident funds with facility funds is prohibited. Written accounting procedures for resident trust funds must include income and expense records of the trust fund, including the source and disposition of the funds.

(3) SURETY BONDS. Pursuant to the requirements of Section 429.27(2), F.S.:

(a) For entities that own more than one facility in the state, one surety bond may be purchased to cover the needs of all residents served by the entities.

(b) The following additional bonding requirements apply to facilities serving residents receiving OSS:

If serving as representative payee for a resident receiving OSS, the minimum bond proceeds must equal twice the value of the resident’s monthly aggregate income, which must include any supplemental security income or social security disability income plus the OSS payments, including the personal needs allowance.
If holding a power of attorney for a resident receiving OSS, the minimum bond proceeds must equal twice the value of the resident’s monthly aggregate income, which must include any supplemental security income or social security disability income; the OSS payments, including the personal allowance; plus the value of any property belonging to a resident held at the facility.

(c) Upon the annual issuance of a new bond or continuation bond, the facility must file a copy of the bond with the Agency Central Office.

(4) LIABILITY INSURANCE. Pursuant to Section 429.275, F.S., facilities must maintain liability insurance coverage, as defined in Section 624.605, F.S., that remains in force at all times. On the renewal date of the facility’s policy or whenever a facility changes policies, the facility must file documentation of continued coverage with the Agency Central Office. Such documentation must be issued by the insurance company and must include the name and street address of the facility, a reference that the facility is an assisted living facility, the facility’s licensed capacity, and the dates of coverage.

History

Rulemaking Authority 429.24, 429.27, 429.275, 429.41 FS. Law Implemented 429.27, 429.275 FS. History–New 5-14-81, Amended 1-6-82, 9-17-84, Formerly 10A-5.21, Amended 6-21-88, 8-15-90, 9-30-92, Formerly 10A-5.021, Amended 10-30-95, 6-2-96, 10-17-99, 4-17-14, Formerly 58A-5.021.

Fla. Admin. Code R. 59A-36.014 Physical Plant Standards

(1) NEW FACILITIES. Newly constructed facilities to be licensed as assisted living facilities, and existing structures, not previously licensed as assisted living facilities, to be converted to assisted living facilities, as well as any subsequent additions, modifications, alterations, renovations or refurbishing of such facilities, are required by governmental entities other than the Department of Elder Affairs to adhere to certain building code and fire safety standards. Such standards may be found in:

(a) Chapter 4, Section 464, of the Florida Building Code as adopted in Rule 61G20-1.001, F.A.C.;

(b) Section 633.022, F.S., Uniform Firesafety Standards and rule Chapter 69A-40, F.A.C. The Uniform Fire Safety Standards for Assisted Living Facilities; and,

(2) EXISTING FACILITIES.

(a) An assisted living facility must comply with the rule or building code in effect at the time of initial licensure, as well as the rule or building code in effect at the time of any additions, modifications, alterations, refurbishment, renovations or reconstruction. Determination of the installation of a fire sprinkler system in an existing facility must comply with the requirements described in Section 429.41, F.S.

(b) A facility undergoing change of ownership is considered an existing facility for purposes of this rule.

(3) OTHER REQUIREMENTS.

(a) All facilities must:

Provide a safe living environment pursuant to Section 429.28(1)(a), F.S.;
Be maintained free of hazards; and,
Ensure that all existing architectural, mechanical, electrical and structural systems, and appurtenances are maintained in good working order.

(b) Pursuant to Section 429.27, F.S., residents must be given the option of using their own belongings as space permits. When the facility supplies the furnishings, each resident bedroom or sleeping area must have at least the following furnishings:

A clean, comfortable bed with a mattress no less than 36 inches wide and 72 inches long, with the top surface of the mattress at a comfortable height to ensure easy access by the resident,
A closet or wardrobe space for hanging clothes,
A dresser, chest or other furniture designed for storage of clothing or personal effects,
A table or nightstand, bedside lamp or floor lamp, and waste basket; and,
A comfortable chair, if requested.

(d) Residents who use portable bedside commodes must be provided with privacy during use.

(e) Facilities must make available linens and personal laundry services for residents who require such services. Linens provided by a facility must be free of tears, stains and must not be threadbare.

History

Rulemaking Authority 429.41 FS. Law Implemented 429.27, 429.28, 429.41 FS. History–New 5-14-81, Amended 1-6-82, 5-19-83, 9-17-84, Formerly 10A-5.23, Amended 10-20-86, 6-21-88, 8-15-90, 9-30-92, Formerly 10A-5.023, Amended 10-30-95, 6-2-96, 10-17-99, 7-30-06, 4-15-10, 4-17-14, Formerly 58A-5.023.

Fla. Admin. Code R. 59A-36.015 Records

The facility must maintain required records in a manner that makes such records readily available at the licensee’s physical address for review by a legally authorized entity. If records are maintained in an electronic format, facility staff must be readily available to access the data and produce the requested information. For purposes of this section, “readily available” means the ability to immediately produce documents, records, or other such data, either in electronic or paper format, upon request.

(1) FACILITY RECORDS. Facility records must include:

(a) The facility’s license displayed in a conspicuous and public place within the facility.

(b) An up-to-date admission and discharge log listing the names of all residents and each resident’s:

Date of admission, the facility or place from which the resident was admitted, and if applicable, a notation indicating that the resident was admitted with a stage 2 pressure sore; and,
Date of discharge, reason for discharge, and identification of the facility or home address to which the resident was discharged. Readmission of a resident to the facility after discharge requires a new entry in the log. Discharge of a resident is not required if the facility is holding a bed for a resident who is out of the facility but intending to return pursuant to Rule 59A-36.018, F.A.C. If the resident dies while in the care of the facility, the log must indicate the date of death.

(c) A log listing the names of all temporary emergency placement and respite care residents if not included on the log described in paragraph (b).

(d) The facility’s emergency management plan, with documentation of review and approval by the county emergency management agency, as described in Rule 59A-36.019, F.A.C., that must be readily available by facility staff.

(e) The facility’s liability insurance policy required in Rule 59A-36.013, F.A.C.

(f) For facilities that have a surety bond, a copy of the surety bond currently in effect as required by Rule 59A-36.013, F.A.C.

(g) The admission package presented to new or prospective residents (less the resident’s contract) described in Rule 59A-36.006, F.A.C.

(h) If the facility advertises that it provides special care for persons with Alzheimer’s disease or related disorders, a copy of all such facility advertisements as required by Section 429.177, F.S.

(i) A grievance procedure for receiving and responding to resident complaints and recommendations as described in Rule 59A-36.007, F.A.C.

(j) All food service records required in Rule 59A-36.012, F.A.C., including menus planned and served and county health department inspection reports. Facilities that contract for food services, must include a copy of the contract for food services and the food service contractor’s license or certificate to operate.

(k) All fire safety inspection reports issued by the local authority or the State Fire Marshal pursuant to Section 429.435, F.S., and rule Chapter 69A-40, F.A.C., issued within the last 2 years.

(l) All sanitation inspection reports issued by the county health department pursuant to Section 381.031, F.S., and Chapter 64E-12, F.A.C., issued within the last 2 years.

(m) Pursuant to Section 429.35, F.S., all completed survey, inspection and complaint investigation reports, and notices of sanctions and moratoriums issued by the agency within the last 5 years.

(n) The facility’s resident elopement response policies and procedures.

(o) The facility’s documented resident elopement response drills.

(p) The facility’s policies and procedures pursuant to subsection 59A-36.007(10), F.A.C.;

(q) The facility’s abuse prevention policies and procedures;

(r) The facility’s medication practices;

(s) The facility’s policy on physical restraints;

(t) The facility’s policy on assistive devices;

(u) The facility’s policy on third-party providers;

(v) The facility’s policy on visitation pursuant to Section 408.823(2)(a), F.S.;

(w) For facilities licensed as limited mental health, extended congregate care, or limited nursing services, records required as stated in Rules 59A-36.020, 59A-36.021 and 59A-36.022, F.A.C., respectively.

(2) STAFF RECORDS.

(a) Personnel records for each staff member must contain, at a minimum, a copy of the employment application, with references furnished, and documentation verifying freedom from signs or symptoms of communicable disease. In addition, records must contain the following, as applicable:

Documentation of compliance with all staff training and continuing education required by Rule 59A-36.011, F.A.C.,
Copies of all licenses or certifications for all staff providing services that require licensing or certification,
Documentation of compliance with level 2 background screening for all staff subject to screening requirements as specified in Section 429.174, F.S., and Rule 59A-36.010, F.A.C.,
For facilities with a licensed capacity of 17 or more residents, a copy of the job description given to each staff member pursuant to Rule 59A-36.010, F.A.C.,
Documentation verifying direct care staff and administrator participation in resident elopement drills pursuant to paragraph 59A-36.007(8)(c), F.A.C.

(b) The facility is not required to maintain personnel records for staff provided by a licensed staffing agency or staff employed by an entity contracting to provide direct or indirect services to residents and the facility. However, the facility must maintain a copy of the contract between the facility and the staffing agency or contractor as described in Rule 59A-36.010, F.A.C.

(c) The facility must maintain the written work schedules and staff time sheets for the most current 6 months as required by Rule 59A-36.010, F.A.C.

(3) RESIDENT RECORDS. Resident records must be maintained on the premises and include:

(a) Resident demographic data as follows:

Name,
Sex,
Race,
Date of birth,
Place of birth, if known,
Social security number,
Medicaid and/or Medicare number, or name of other health insurance carrier,
Name, address, and telephone number of next of kin, legal representative, or individual designated by the resident for notification in case of an emergency; and,
Name, address, and telephone number of the resident’s health care practioner and case manager, if applicable.

(b) A copy of the Resident Health Assessment form, AHCA Form 1823 or the health care practitioner’s medical examination form described in Rule 59A-36.006, F.A.C.

(c) Any orders for medications, nursing services, therapeutic diets, do not resuscitate orders, or other services to be provided, supervised, or implemented by the facility that require a health care provider’s order.

(d) Documentation of a resident’s refusal of a therapeutic diet pursuant to Rule 59A-36.012, F.A.C., if applicable.

(e) The resident care record described in paragraph 59A-36.007(1)(f), F.A.C.

(f) A weight record that is initiated on admission. Information may be taken from AHCA Form 1823 or the resident’s health assessment. Residents receiving assistance with the activities of daily living must have their weight recorded semi-annually. This subsection does not apply to residents who are receiving licensed hospice services when such residents, their representatives, or their physicians request in writing that weights not be taken.

(g) For facilities that will have unlicensed staff assisting the resident with the self-administration of medication, a copy of the written informed consent described in Rule 59A-36.006, F.A.C., if such consent is not included in the resident’s contract.

(h) For facilities that manage a pill organizer, assist with self-administration of medications or administer medications for a resident, copies of the required medication records maintained pursuant to Rule 59A-36.008, F.A.C.

(i) A copy of the resident’s contract with the facility, including any addendums to the contract as described in Rule 59A-36.018, F.A.C.

(j) For a facility whose owner, administrator, staff, or representative thereof, serves as an attorney in fact for a resident, a copy of the monthly written statement of any transaction made on behalf of the resident as required in Section 429.27, F.S.

(k) For any facility that maintains a separate trust fund to receive funds or other property belonging to or due a resident, a copy of the quarterly written statement of funds or other property disbursed as required in Section 429.27, F.S.

(l) If the resident is an OSS recipient, a copy of the Department of Children and Families form Alternate Care Certification for Optional State Supplementation (OSS), CF-ES 1006, October 2005, which is hereby incorporated by reference and available for review at: http://www.flrules.org/Gateway/reference.asp?No=Ref-04004. The absence of this form will not be the basis for administrative action against a facility if the facility can demonstrate that it has made a good faith effort to obtain the required documentation from the Department of Children and Families.

(m) Documentation of the appointment of a health care surrogate, health care proxy, guardian, or the existence of a power of attorney, where applicable.

(n) For hospice patients, the interdisciplinary care plan and other documentation that the resident is a hospice patient as required in Rule 59A-36.006, F.A.C.

(o) The resident’s Do Not Resuscitate Order, DH Form 1896, if applicable.

(p) For independent living residents who receive meals and occupy beds included within the licensed capacity of an assisted living facility, but who are not receiving any personal, limited nursing, or extended congregate care services, record keeping may be limited to a log listing the names of residents participating in this arrangement.

(q) Except for resident contracts, which must be retained for 5 years, all resident records must be retained for 2 years following the departure of a resident from the facility unless it is required by contract to retain the records for a longer period of time. Upon request, residents must be provided with a copy of their records upon departure from the facility.

(r) Additional resident records requirements for facilities holding a limited mental health, extended congregate care, or limited nursing services license are provided in Rules 59A-36.020, 59A-36.021 and 59A-36.022, F.A.C., respectively.

(4) RECORD INSPECTION.

(a) The resident’s records must be available to the resident; the resident’s legal representative, designee, surrogate, guardian, attorney in fact, or case manager; or the resident’s estate, and such additional parties as authorized in writing or by law.

(b) Pursuant to Section 429.35, F.S., agency reports that pertain to any agency survey, inspection, or monitoring visit must be available to the residents and the public. In facilities that are co-located with a licensed nursing home, the inspection of record for all common areas is the nursing home inspection report.

History

Rulemaking Authority 429.41, 429.275 FS. Law Implemented 429.24, 429.255, 429.256, 429.26, 429.27, 429.275, 429.35, 429.41, 429.52 FS. History–New 5-14-81, Amended 1-6-82, 5-19-83, 9-17-84, Formerly 10A-5.24, Amended 10-20-86, 6-21-88, 8-15-90, 9-30-92, Formerly 10A-5.024, Amended 10-30-95, 4-20-98, 11-2-98, 10-17-99, 7-30-06, 10-9-06, 4-17-14, Formerly 58A-5.024, Amended 3-23-23.

Fla. Admin. Code R. 59A-36.016 Adverse Incident Report

History

Rulemaking Authority 429.23 FS. Law Implemented 429.23 FS. History–New 1-9-02, Amended 7-30-06, 4-17-14, Formerly 58A-5.0241, 7-1-19, Repealed 7-12-21.

Fla. Admin. Code R. 59A-36.017 Liability Claim Report

History

Rulemaking Authority 429.23 FS. Law Implemented 429.23 FS. History–New 1-9-02, Amended 3-13-14, Formerly 58A-5.0242, 7-1-19, Repealed 7-12-21.

Fla. Admin. Code R. 59A-36.018 Resident Contracts

(1) Pursuant to Section 429.24, F.S., the facility must offer a contract for execution by the resident or the resident’s legal representative before or at the time of admission. The contract must contain the following provisions:

(a) A list of the specific services, supplies and accommodations to be provided by the facility to the resident, including limited nursing and extended congregate care services that the resident elects to receive;

(b) The daily, weekly, or monthly rate;

(c) A list of any additional services and charges to be provided that are not included in the daily, weekly, or monthly rates, or a reference to a separate fee schedule that must be attached to the contract;

(d) A provision stating that at least 30 days written notice will be given before any rate increase;

(e) Any rights, duties, or obligations of residents, other than those specified in Section 429.28, F.S.;

(f) The purpose of any advance payments or deposit payments, and the refund policy for such advance or deposit payments;

(g) A refund policy that must conform to Section 429.24(3), F.S.;

(h) A written bed hold policy and provisions for terminating a bed hold agreement if a facility agrees in writing to reserve a bed for a resident who is admitted to a nursing home, health care facility, or psychiatric facility. The resident or responsible party must notify the facility in writing of any change in status that would prevent the resident from returning to the facility. Until such written notice is received, the agreed upon daily, weekly, or monthly rate may be charged by the facility unless the resident’s medical condition prevents the resident from giving written notification, such as when a resident is comatose, and the resident does not have a responsible party to act on the resident’s behalf;

(i) A provision stating whether the facility is affiliated with any religious organization and, if so, which organization and its relationship to the facility;

(j) A provision that, upon determination by the administrator or health care provider that the resident needs services beyond those that the facility is licensed to provide, the resident or the resident’s representative, or agency acting on the resident’s behalf, must be notified in writing that the resident must make arrangements for transfer to a care setting that is able to provide services needed by the resident. In the event the resident has no one to represent him or her, the facility must refer the resident to the social service agency for placement. If there is disagreement regarding the appropriateness of placement, provisions outlined in Section 429.26(8), F.S., will take effect;

(k) A provision that residents must be assessed upon admission pursuant to subsection 59A-36.006(2), F.A.C., and every 3 years thereafter, or after a significant change, pursuant to subsection (4), of that rule;

(l) The facility’s policies and procedures for self-administration, assistance with self-administration, and administration of medications, if applicable, pursuant to Rule 59A-36.008, F.A.C. This also includes provisions regarding over-the-counter (OTC) products pursuant to subsection (8) of that rule; and,

(m) The facility’s policies and procedures related to a properly executed DH Form 1896, Do Not Resuscitate Order.

(2) The resident, or the resident’s representative, must be provided with a copy of the executed contract.

(3) The facility may not levy an additional charge for any supplies, services, or accommodations that the facility has agreed by contract to provide as part of the standard daily, weekly, or monthly rate. The resident or resident’s representative must be furnished in advance with an itemized written statement setting forth additional charges for any services, supplies, or accommodations available to residents not covered under the contract. An addendum must be added to the resident contract to reflect the additional services, supplies, or accommodations not provided under the original agreement. Such addendum must be dated and signed by the facility and the resident or resident’s legal representative and a copy given to the resident or resident’s representative.

History

Rulemaking Authority 429.24, 429.41 FS. Law Implemented 429.24, 429.41 FS. History–New 10-17-99, Amended 7-30-06, 4-15-10, 3-13-14, Formerly 58A-5.025.

Fla. Admin. Code R. 59A-36.019 Emergency Management

(1) EMERGENCY PLAN COMPONENTS. Pursuant to Section 429.41, F.S., each facility must prepare a written comprehensive emergency management plan using “Minimum Emergency Management Planning Criteria for Assisted Living Facilities,” AHCA Form 3180-5006, September 2023, incorporated by reference and available at https://flrules.org/Gateway/reference.asp?No=Ref-15964. The form is also available at: https://ahca.myflorida.com/MCHQ/Emergency_Activities/index.shtml. The emergency management plan must, at a minimum, address the following:

(a) Provision for all hazards;

(b) Provision for the care of residents remaining in the facility during an emergency, including pre-disaster or emergency preparation; protecting the facility; supplies; emergency power; food and water; staffing; and emergency equipment;

(c) Provision for the care of residents who must be evacuated from the facility during an emergency including identification of such residents and transfer of resident records; evacuation transportation; sheltering arrangements; supplies; staffing; emergency equipment; and medications;

(d) Provision for the care of additional residents who may be evacuated to the facility during an emergency including the identification of such residents, staffing, and supplies;

(e) Identification of residents with Alzheimer’s disease or related disorders, and residents with mobility limitations who may need specialized assistance either at the facility or in case of evacuation;

(f) Identification of and coordination with the county emergency management agency;

(g) Arrangement for post-disaster activities including responding to family inquiries, obtaining medical intervention for residents, transportation, and reporting to the county emergency management agency the number of residents who have been relocated, and the place of relocation; and,

(h) The identification of staff responsible for implementing each part of the plan.

(2) EMERGENCY PLAN APPROVAL.

(a) The facility must review and submit its emergency management plan on an annual basis in accordance with section 408.821(1), F.S.

A significant modification to a previously approved plan must be submitted within 30 days after the change. For the purposes of this rule, “significant modification” means a change to the information provided in support of the minimum required plan criteria, procedures, memorandums of understanding, contracts, or agreements identified in the plan, or appendices that alters the execution of the plan and the required arrangements made therein. Changes in spelling or grammar are not considered significant modifications for the purposes of this rule.
Changes in the name, address, phone number, email address or position of staff identified in the plan are not considered significant modifications for the purposes of this rule. Changes to that information must be submitted to the county emergency management agency as part of the emergency management plan submitted annually.
If a change to the emergency management plan is required to be submitted due to a significant modification, the change must be identified and described.
A change to the emergency management plan due to a significant modification does not alter the annual review date unless the change is due to a change of ownership of the facility.

(b) The county emergency management agency is the final administrative authority for emergency management plans prepared by assisted living facilities.

(c) Any plan approved by the county emergency management agency is considered to have met all the criteria and conditions established in this rule.

(3) PLAN IMPLEMENTATION.

(a) All staff must be trained in their duties and are responsible for implementing the emergency management plan. New staff must be trained on the plan within 30 days of employment.

(b) If telephone service is not available during an emergency, the facility must request assistance from local law enforcement or emergency management personnel in maintaining communication.

(4) FACILITY EVACUATION. The facility must evacuate the premises during or after an emergency if so directed by the county emergency management agency.

(a) The facility must report the evacuation to the county emergency management agency or designee and to the agency within 6 hours of the evacuation order. If the evacuation takes more than 6 hours, the facility must report when the evacuation is completed.

(b) The facility must not be re-occupied until the area is cleared for reentry by the county emergency management agency or its designee and the facility can meet the immediate needs of the residents.

(d) The facility is responsible for knowing the location of all residents until the residents have been relocated to another facility.

(e) The facility must provide the agency with the name of a contact person who must be available by telephone 24 hours a day, seven days a week, until the facility is re-occupied.

(f) The facility must assist in the relocation of residents, and must cooperate with outreach teams established by the Department of Health or emergency management agency to assist in relocation efforts. Resident needs and preferences must be considered to the extent possible in any relocation decision.

(5) EMERGENCY SHELTER. In the event a state of emergency has been declared and the facility is not required to evacuate the premises, the facility may provide emergency shelter above the facility’s licensed capacity provided the following conditions are met:

(a) Life safety will not be jeopardized for any individual;

(b) The immediate needs of residents and other individuals sheltered at the facility can be met by the facility;

(c) The facility reports the number of individuals over its licensed capacity and the conditions causing it to the Agency Field Office within 48 hours or as soon as practical. As an alternative, the facility may report to the Agency Central Office at (850)412-4304. If the facility will continue to be over capacity after the declared emergency ends, the agency will review requests for excess capacity on a case-by-case basis; and,

(d) The facility maintains a log of the additional individuals being housed in the facility. The log must include the individual’s name, usual address, and the dates of arrival and departure. The log must be available for review by representatives of the agency, the department, the local emergency management agency or its designee. The admissions and discharge log maintained by the facility may be used for this purpose provided the information is maintained in a manner that is easily accessible.

History

Rulemaking Authority 429.41, 408.821, FS. Law Implemented 429.41, 408.821, FS. History–New 10-17-99, Amended 7-30-06, 4-17-14, Formerly 58A-5.026, Amended 7-1-19, 11-23-23, Technical Change 3-26-26.

Fla. Admin. Code R. 59A-36.020 Limited Mental Health

(1) LICENSE APPLICATION.

(a) Any facility intending to admit one or more mental health residents must obtain a limited mental health license from the agency before accepting the mental health resident.

(b) Facilities applying for a limited mental health license that have uncorrected deficiencies or violations found during the facility’s last survey, complaint investigation, or monitoring visit will be surveyed before the issuance of a limited mental health license to determine if such deficiencies or violations have been corrected.

(2) RECORDS.

(a) A facility with a limited mental health license must maintain an up-to-date admission and discharge log containing the names and dates of admission and discharge for all mental health residents. The admission and discharge log required in Rule 59A-36.015, F.A.C., satisfies this condition provided that all mental health residents are clearly identified.

(b) Staff records must contain documentation that designated staff have completed limited mental health training as required by Rule 59A-36.011, F.A.C.

Documentation, provided by a mental health care provider within 30 days of the resident’s admission to the facility, that the resident is a mental health resident as defined in Section 394.4574, F.S., and that the resident is receiving social security disability or supplemental security income and optional state supplementation as follows:

a. An affirmative statement on the Alternate Care Certification for Optional State Supplementation (OSS) form, CF-ES 1006, October 2005, which is hereby incorporated by reference and available for review at: http://www.flrules.org/Gateway/reference.asp?No=Ref-03988, that the resident is receiving SSI or SSDI due to a mental disorder,

b. Written verification provided by the Social Security Administration that the resident is receiving SSI or SSDI for a mental disorder. Such verification may be acquired from the Social Security Administration upon obtaining a release from the resident permitting the Social Security Administration to provide such information, or

c. A written statement from the resident’s case manager or other mental health care provider that the resident is an adult with severe and persistent mental disorder. The case manager or other mental health care provider must consider the following minimum criteria in making that determination:

(I) The resident is eligible for, is receiving, or has received mental health services within the last 5 years, or

(II) The resident has been diagnosed as having a severe or persistent mental disorder.

An appropriate placement assessment provided by the resident’s mental health care provider within 30 days of admission to the facility that the resident has been assessed and found appropriate for residence in an assisted living facility. Such assessment must be conducted by a psychiatrist, clinical psychologist, clinical social worker, psychiatric nurse, or an individual supervised by one of these professionals.

a. Any of the following documentation that contains the name of the resident and the name, signature, date, and license number, if applicable, of the person making the assessment, meets this requirement:

(I) Completed Alternate Care Certification for Optional State Supplementation (OSS) form, CF-ES Form 1006,

(II) Discharge Statement from a state mental hospital completed no more than 90 days before admission to the assisted living facility provided it contains a statement that the individual is appropriate to live in an assisted living facility, or

(III) Other signed statement that the resident has been assessed and found appropriate for residency in an assisted living facility.

b. A mental health resident returning to a facility from treatment in a hopsital or crisis stabilization unit will not be considered a new admission and will not require a new assessment. However, a break in a resident’s residency that requires the facility to execute a new resident contract or admission agreement will be considered a new admission and the resident’s mental health care provider must provide a new assessment.

A Community Living Support Plan. Each mental health resident and the resident’s mental health case manager must, in consultation with the facility administrator, prepare a plan within 30 days of the resident’s admission to the facility or within 30 days after receiving the appropriate placement assessment in paragraph (2)(c), whichever is later, that:

a. Includes the specific needs of the resident that must be met in order to enable the resident to live in the assisted living facility and the community,

b. Includes the clinical mental health services to be provided by the mental health care provider to help meet the resident’s needs, and the frequency and duration of such services,

c. Includes any other services and activities to be provided by or arranged for by the mental health care provider or mental health case manager to meet the resident’s needs, and the frequency and duration of such services and activities,

d. Includes the obligations of the facility to facilitate and assist the resident in attending appointments and arranging transportation to appointments for the services and activities identified in the plan that have been provided or arranged for by the resident’s mental health care provider or case manager,

e. Includes a description of other services to be provided or arranged by the facility,

f. Includes a list of factors pertinent to the care, safety, and welfare of the mental health resident and a description of the signs and symptoms particular to the resident that indicate the immediate need for professional mental health services,

g. Is in writing and signed by the mental health resident, the resident’s mental health case manager, and the assisted living facility administrator or manager and a copy placed in the resident’s file. If the resident refuses to sign the plan, the resident’s mental health case manager must add a statement that the resident was asked but refused to sign the plan,

h. Is updated at least annually or if there is a significant change in the resident’s behavioral health,

i. May include the Cooperative Agreement described in subparagraph (2)(c)4. If included, the mental health care provider must also sign the plan; and,

j. Must be available for inspection to those who have legal authority to review the document.

Cooperative Agreement. The mental health care provider for each mental health resident and the facility administrator or designee must prepare a written statement, within 30 days of the resident’s admission to the facility or receipt of the resident’s appropriate placement assessment, whichever is later. The statement:

a. Provides procedures and directions for accessing emergency and after-hours care for the mental health resident. The provider must furnish the resident and the facility with the provider’s 24-hour emergency crisis telephone number;

b. Must be signed by the administrator or designee and the mental health care provider, or by a designated representative of a Medicaid prepaid health plan if the resident is on a plan and the plan provides behavioral health services in Section 409.912, F.S.;

c. May cover all mental health residents of the facility who are clients of the same provider; and,

d. May be included in the Community Living Support Plan described in subparagraph (2)(c)3.

Missing documentation will not be the basis for administrative action against a facility if the facility can demonstrate that it has made a good faith effort to obtain the required documentation from the appropriate party. A documented request for such missing documentation made by the facility administrator within 72 hours of the resident’s admission will be considered a good faith effort. The documented request must include the name, title, and phone number of the person to whom the request was made and must be kept in the resident’s file.

(3) RESPONSIBILITIES OF FACILITY. In addition to the staffing and care standards of this rule chapter to provide for the welfare of residents in an assisted living facility, a facility holding a limited mental health license must:

(a) Meet the facility’s obligation to assist the resident in carrying out the activities identified in the Community Living Support Plan;

(b) Provide an opportunity for private face-to-face contact between the mental health resident and the resident’s mental health case manager or other treatment personnel of the resident’s mental health care provider;

(c) Observe resident behavior and functioning in the facility, and record and communicate observations to the resident’s mental health case manager or mental health care provider regarding any significant behavioral or situational changes that may signify the need for a change in the resident’s professional mental health services, supports, and services described in the community living support plan, or that the resident is no longer appropriate for residency in the facility;

(d) If the facility initiates an involuntary mental health examination pursuant to Section 394.463, F.S., the facility must document the circumstances leading to the initiation of the examination;

(e) Ensure that designated staff have completed limited mental health training as required by Rule 59A-36.011, F.A.C.; and,

(f) Maintain facility, staff, and resident records in accordance with the requirements of this rule chapter.

History

Rulemaking Authority 429.41 FS. Law Implemented 429.075, 429.26, 429.41 FS. History–New 8-15-90, Amended 9-30-92, Formerly 10A-5.029, Repromulgated 10-30-95, Amended 6-2-96, 11-2-98, 7-30-06, Amended 4-17-14, 5-10-18, Formerly 58A-5.029.

Fla. Admin. Code R. 59A-36.021 Extended Congregate Care Services

(1) LICENSING.

(a) Any facility intending to establish extended congregate care services must obtain a license from the agency before accepting residents needing extended congregate care services.

(b) Only the portion of a facility that meets the physical requirements for extended congregate care in Chapter 4, Section 464 of the Florida Building Code as adopted in Rule 61G20-1.001, F.A.C., and is staffed in accordance with subsection (3), is considered licensed to provide extended congregate care services to residents who meet the admission and continued residency requirements of this rule.

(2) EXTENDED CONGREGATE CARE POLICIES. Policies and procedures established through extended congregate care services must promote resident independence, dignity, choice, and decision-making. The facility must develop and implement specific written policies and procedures that address:

(a) Aging in place;

(b) The facility’s residency criteria developed in accordance with the admission and discharge requirements described in subsection (4), and extended congregate care services listed in subsection (7);

(c) The personal and supportive services the facility intends to provide, how the services will be provided, and the identification of staff positions to provide the services including their relationship to the facility;

(d) The nursing services the facility intends to provide, identification of staff positions to provide nursing services, and the license status, duties, general working hours, and supervision of such staff;

(e) Identifying potential unscheduled resident service needs and mechanisms for meeting those needs including the identification of resources to meet those needs;

(f) A process for mediating conflicts among residents regarding choice of room or apartment and roommate; and,

(g) How to involve residents in decisions concerning the resident. The services must provide opportunities and encouragement for the resident to make personal choices and decisions. If a resident needs assistance to make choices or decisions, a family member or other resident representative must be consulted. Choices must include at a minimum whether:

To participate in the process of developing, implementing, reviewing, and revising the resident’s service plan,
To remain in the same room in the facility, except that a current resident transferring into an extended congregate care services may be required to move to the part of the facility licensed for extended congregate care, if only part of the facility is so licensed,
To select among social and leisure activities,
To participate in activities in the community. At a minimum the facility must arrange transportation to such activities if requested by the resident; and,
To provide input with respect to the adoption and amendment of facility policies and procedures.

(3) STAFFING REQUIREMENTS. The following staffing requirements apply for extended congregate care services:

(a) Supervision by an administrator who has a minimum of two years of managerial, nursing, social work, therapeutic recreation, or counseling experience in a residential, long-term care, or acute care setting or agency serving elderly or disabled persons. If an administrator appoints a manager as the supervisor of an extended congregate care facility, both the administrator and manager must satisfy the requirements of subsection 59A-36.010(1), F.A.C.

A baccalaureate degree may be substituted for one year of the required experience.
A nursing home administrator licensed under Chapter 468, F.S., is qualified under this paragraph.

(b) Provide staff or contract the services of a nurse who must be available to provide nursing services, participate in the development of resident service plans, and perform monthly nursing assessments for extended congregate care residents.

(c) Provide enough qualified staff to meet the needs of extended congregate care residents in accordance with Rule 59A-36.010, F.A.C., and to provide the services established in each resident’s service plan.

(d) Ensure that adequate staff is awake during all hours to meet the scheduled and unscheduled needs of residents.

(e) Immediately provide additional or appropriately qualified staff, when the agency determines that service plans are not being followed or that residents’ needs are not being met because insufficient staffing, in accordance with the staffing standards established in Rule 59A-36.010, F.A.C.

(f) Ensure and document that staff receive extended congregate care training as required in Rule 59A-36.011, F.A.C.

(4) ADMISSION AND CONTINUED RESIDENCY.

(a) An individual must meet the following minimum criteria in order to receive extended congregate care services:

Be at least 18 years of age;
Be free from signs and symptoms of any communicable disease that may be transmitted to other residents or staff. However, an individual who has human immunodeficiency virus (HIV) infection may be admitted to a facility, provided that the individual would otherwise be eligible for admission according to this rule. In addition, an individual that exhibits signs or symptoms of or has been diagnosed with a respiratory illness that can be spread through droplet transmission, may be admitted, at the administrator’s discretion, if appropriate droplet precautions are implemented by facility staff. Appropriate droplet precautions include recommendations from nationally accepted standards, recommendations from the local county health department, and the facility’s infection prevention and control policies and procedures at the time of the individual’s admission. The individual must otherwise be eligible for admission according to this rule.
Be able to transfer, with assistance if necessary. The assistance of more than one individual is permitted;
Not be a danger to self or others as determined by a health care practitioner or mental health practitioner licensed under Chapter 490 or 491, F.S.;
Not be bedridden, unless the resident is receiving licensed hospice services pursuant to Section 429.26(1)(c), F.S.;
Not have any stage 3 or 4 pressure sores;
Not require any of the following nursing services:

a. Artificial airway management of any kind except that of continuous positive airway pressure may be provided through the use of a CPAP or bipap machine,

b. Nasogastric tube feeding,

c. Monitoring of blood gases,

d. Management of post-surgical drainage tubes or wound vacuums,

e. Skilled rehabilitative services as described in Rule 59G-4.290, F.A.C., or

f. Treatment of a surgical incision, unless the surgical incision and the condition that caused it have been stabilized and a plan of care developed. The plan of care must be maintained in the resident’s record at the facility.

Not require 24-hour nursing supervision, unless the resident is receiving licensed hospice services pursuant to Section 429.26(1)(c), F.S.; and,
Have been determined to be appropriate for admission to the facility by the facility administrator or manager. The administrator or manager must base his or her decision on:

a. An assessment of the strengths, needs, and preferences of the individual, the health assessment required by subsection (6) of this rule, and the preliminary service plan developed in subsection (7),

b. The facility’s residency criteria, and services offered or arranged for by the facility to meet resident needs; and,

c. The ability of the facility to meet the uniform fire safety standards for assisted living facilities established in rule Chapter 69A-40, F.A.C.

Notwithstanding any other provision of this rule, as individual enrolled and receiving licensed hospice services pursuant to Section 429.26(1)(c), F.S. may be admitted and receive extended congregate care services.

(b) Criteria for continued residency in an extended congregate care services must be the same as the criteria for admission, except as specified below.

A resident may be bedridden for up to 14 consecutive days.
A terminally ill resident who no longer meets the criteria for continued residency may continue to reside in the facility if the following conditions are met:

a. The resident qualifies for, is admitted to, and consents to the services of a licensed hospice that coordinates and ensures the provision of any additional care and services that may be needed,

b. Continued residency is agreeable to the resident and the facility,

c. An interdisciplinary care plan, which specifies the services being provided by hospice and those being provided by the facility, is developed and implemented by a licensed hospice in consultation with the facility; and,

d. Documentation of the requirements of subparagraph (5)(b)2., is maintained in the resident’s file.

The extended congregate care administrator or manager is responsible for monitoring the appropriateness of continued residency of a resident in extended congregate care services at all times.
A hospice resident that meets the qualifications of continued residency pursuant to this rule may only receive services from the assisted living facility’s staff within the scope of the facility’s license.
Staff may provide any nursing service permitted under the facility’s license and total help with the activities of daily living for residents admitted to hospice. Staff may not exceed the scope of their professional licensure or training in any licensed assisted living facility.

(5) HEALTH ASSESSMENT. Before receiving extended congregate care services, all persons. including residents transferring within the same facility to that portion of the facility licensed to provide extended congregate care services, must be examined by a health care practitioner pursuant to Rule 59A-36.006, F.A.C. A health assessment conducted no more than 60 days before receiving extended congregate care services meets this requirement. Once receiving services, a new health assessment must be obtained at least annually.

(6) SERVICE PLANS.

(a) Before receiving services, the extended congregate care administrator or manager must develop a preliminary service plan that includes an assessment of whether the resident meets the facility’s residency criteria, an appraisal of the resident’s unique physical, psychological and social needs and preferences, and an evaluation of the facility’s ability to meet the resident’s needs.

(b) Within 14 days of receiving services, the extended congregate care administrator or manager must coordinate the development of a written service plan that takes into account the resident’s health assessment obtained pursuant to subsection (5); the resident’s unique physical, psychological and social needs and preferences; and how the facility will meet the resident’s needs including the following if required:

Health monitoring,
Assistance with personal care services,
Nursing services,
Supervision,
Special diets,
Ancillary services,
The provision of other services such as transportation and supportive services; and,
The manner of service provision, and identification of service providers, including family and friends, in keeping with resident preferences.

(c) Pursuant to the definitions of “shared responsibility” and “managed risk” as provided in Section 429.02, F.S., the service plan must be developed and agreed upon by the resident or the resident’s representative or designee, surrogate, guardian, or attorney-in-fact, and must reflect the responsibility and right of the resident to consider options and assume risks when making choices pertaining to the resident’s service needs and preferences.

(d) The service plan must be reviewed and updated quarterly to reflect any changes in the manner of service provision, accommodate any changes in the resident’s physical or mental status, or pursuant to recommendations for modifications in the resident’s care as documented in the nursing assessment.

(7) EXTENDED CONGREGATE CARE SERVICES. All services must be provided in the least restrictive environment, and in a manner that respects the resident’s independence, privacy, and dignity.

(a) A facility providing extended congregate care services may provide supportive services including social service needs, counseling, emotional support, networking, assistance with securing social and leisure services, shopping service, escort service, companionship, family support, information and referral, assistance in developing and implementing self-directed activities, and volunteer services. Family or friends must be encouraged to provide supportive services for residents. The facility must provide training for family or friends to enable them to provide supportive services in accordance with the resident’s service plan.

(b) A facility providing extended congregate care services must make available the following additional services if required by the resident’s service plan:

Total help with bathing, dressing, grooming and toileting,
Nursing assessments conducted more frequently than monthly,
Measurement and recording of basic vital functions and weight,
Dietary management including provision of special diets, monitoring nutrition, and observing the resident’s food and fluid intake and output,
Assistance with self-administered medications, or the administration of medications and treatments pursuant to a health care practitioner’s order. If the individual needs assistance with self-administration the facility must inform the resident of the qualifications of staff who will be providing this assistance, and if unlicensed persons will be providing such assistance, obtain the resident’s or the resident’s surrogate, guardian, or attorney-in-fact’s informed written consent to provide such assistance as required in Section 429.256, F.S.,
Supervision of residents with dementia and cognitive impairments,
Health education and counseling and the implementation of health-promoting programs and preventive regimes,
Provision or arrangement for rehabilitative services; and,
Provision of escort services to health-related appointments.

(c) Nursing staff providing extended congregate care services may provide any nursing service permitted within the scope of their license consistent with the residency requirements of this rule and the facility’s written policies and procedures, provided the nursing services are:

Authorized by a health care practitioner’s order and pursuant to a plan of care,
Medically necessary and appropriate for treatment of the resident’s condition,
In accordance with the prevailing standard of practice in the nursing community,
A service that can be safely, effectively, and efficiently provided in the facility,
Recorded in nursing progress notes; and,
In accordance with the resident’s service plan.

(d) At least monthly, or more frequently if required by the resident’s service plan, a nursing assessment of the resident must be conducted.

(8) RECORDS. In addition to the records required in Rule 59A-36.015, F.A.C., a facility providing extended congregate care services must maintain the following:

(a) The service plans for each resident receiving extended congregate care services;

(b) The nursing progress notes for each resident receiving nursing services from the facility’s staff;

(d) The facility’s extended congregate care policies and procedures.

(9) DISCHARGE. If the facility and the resident are unable to agree on a service plan, the facility is unable to meet the resident’s needs as identified in the service plan, or the resident no longer meets the criteria for continued residency, the resident must be discharged or relocated in accordance with Sections 429.26 and 429.28, F.S.

History

Rulemaking Authority 429.07, 429.41 FS. Law Implemented 429.07, 429.255, 429.26, 429.28, 429.41 FS. History–New 9-30-92, Formerly 10A-5.030, Amended 10-30-95, 6-2-96, 4-20-98, 11-2-98, 10-17-99, 7-30-06, 4-17-14, 5-10-18, Formerly 58A-5.030, Amended 9-9-21, 9-28-22, 11-27-25.

Fla. Admin. Code R. 59A-36.022 Limited Nursing Services

Any facility intending to provide limited nursing services must obtain a license from the agency.

(1) NURSING SERVICES. In addition to any nursing service permitted under a standard license pursuant to Section 429.255, F.S., a facility with a limited nursing services license may provide nursing care to residents who do not require 24-hour nursing supervision and to residents who do require 24-hour nursing care and are enrolled in hospice.

(2) RESIDENT CARE STANDARDS.

(a) A resident receiving limited nursing services in a facility holding only a standard and limited nursing services license must meet the admission and continued residency criteria specified in Rule 59A-36.006, F.A.C.

(b) In accordance with Rule 59A-36.010, F.A.C., the facility must employ sufficient and qualified staff to meet the needs of residents requiring limited nursing services based on the number of such residents and the type of nursing service to be provided.

(c) Limited nursing services may only be provided as authorized by a health care practitioner’s order, a copy of which must be maintained in the resident’s file.

(d) Facilities licensed to provide limited nursing services must employ or contract with a nurse(s) who must be available to provide such services as needed by residents. The facility’s employed or contracted nurse must coordinate with third party nursing services providers to ensure resident care is provided in a safe and consistent manner. The facility must maintain documentation of the qualifications of nurses providing limited nursing services in the facility’s personnel files.

(e) The facility must ensure that nursing services are conducted and supervised in accordance with Chapter 464, F.S., and the prevailing standard of practice in the nursing community.

(3) RECORDS.

(a) A record of all residents receiving limited nursing services and the type of services provided must be maintained at the facility.

(b) Nursing progress notes must be maintained for each resident who receives limited nursing services from facility staff.

(c) A nursing assessment conducted at least monthly must be maintained on each resident who receives a limited nursing service.

History

Rulemaking Authority 429.41 FS. Law Implemented 429.07, 429.255, 429.26, 429.41 FS. History–New 9-30-92, Formerly 10A-5.031, Amended 10-30-95, 10-17-99, 7-30-06, 3-13-14, 5-10-18, Formerly 58A-5.031, Amended 10-7-21, 6-11-25.

Fla. Admin. Code R. 59A-36.023 Administrative Enforcement

Facility staff must cooperate with agency personnel during surveys, complaint investigations, monitoring visits, license application and renewal procedures and other activities necessary to ensure compliance with Part II, Chapter 408, F.S., Part I, Chapter 429, F.S., rule Chapter 59A-35, F.A.C., and this rule chapter.

(1) Abbreviated Survey.

(a) An applicant for license renewal who does not have any class I or class II violations or uncorrected class III violations, confirmed long-term care ombudsman program complaints, or confirmed licensing complaints within the two licensing periods immediately preceding the current renewal date, is eligible for an abbreviated biennial survey by the agency. For the purpose of this rule, a confirmed long-term care ombudsman program complaint is a complaint that is verified and referred to a regulatory agency for further action. Facilities that do not have two survey reports on file with the agency under current ownership are not eligible for an abbreviated inspection. Upon arrival at the facility, the agency must inform the facility that it is eligible for an abbreviated survey, and that an abbreviated survey will be conducted.

(b) Compliance with key quality of care standards described in the following statutes and rules will be used by the agency during its abbreviated survey of eligible facilities:

Section 429.26, F.S., and Rule 59A-36.006, F.A.C., relating to residency criteria;
Section 429.27, F.S., and Rule 59A-36.013, F.A.C., relating to proper management of resident funds and property;
Section 429.28, F.S., and Rule 59A-36.007, F.A.C., relating to respect for resident rights;
Section 429.41, F.S., and Rule 59A-36.007, F.A.C., relating to the provision of supervision, assistance with the activities of daily living, and arrangement for appointments and transportation to appointments;
Section 429.256, F.S., and Rule 59A-36.008, F.A.C., relating to assistance with or administration of medications;
Section 429.41, F.S., and Rule 59A-36.010, F.A.C., relating to the provision of sufficient staffing to meet resident needs;
Section 429.41, F.S., and Rule 59A-36.012, F.A.C., relating to minimum dietary requirements and proper food hygiene;
Section 429.075, F.S., and Rule 59A-36.020, F.A.C., relating to mental health residents’ community support living plan;
Section 429.07, F.S., and Rule 59A-36.021, F.A.C., relating to meeting the environmental standards and residency criteria in a facility with an extended congregate care license; and
Section 429.07, F.S., and Rule 59A-36.022, F.A.C., relating to the provision of care and staffing in a facility with a limited nursing services license.

(c) The agency will expand the abbreviated survey or conduct a full survey if violations which threaten or potentially threaten the health, safety, or welfare of residents are identified during the abbreviated survey. The facility must be informed when a full survey will be conducted. If one or more of the following serious problems are identified during an abbreviated survey, a full biennial survey will be immediately conducted:

Violations of rule Chapter 69A-40, F.A.C., relating to firesafety, that threaten the life or safety of a resident;
Violations relating to staffing standards or resident care standards that adversely affect the health, safety, or welfare of a resident;
Violations relating to facility staff rendering services for which the facility is not licensed; or
Violations relating to facility medication practices that are a threat to the health, safety, or welfare of a resident.

(2) Survey Deficiency.

(a) Before or in conjunction with a notice of violation issued pursuant to Part II, Chapter 408, F.S., and Section 429.19, F.S., the agency shall issue a statement of deficiency for class I, II, III, and IV violations which are observed by agency personnel during any inspection of the facility. The deficiency statement must be issued within 10 working days of the agency’s inspection and must include:

A description of the deficiency;
A citation to the statute or rule violated; and
A time frame for the correction of the deficiency.

(b) Additional time may be granted to correct specific deficiencies if a written request is received by the agency before the expiration of the time frame included in the agency’s statement.

(3) Employment of A Consultant.

(a) Medication Deficiencies.

If a class I, class II, or uncorrected class III deficiency directly relating to facility medication practices as established in Rule 59A-36.008, F.A.C., is documented by agency personnel pursuant to an inspection of the facility, the agency must notify the facility in writing that the facility must employ or contract the services of a pharmacist licensed pursuant to Section 465.0125, F.S., or registered nurse as determined by the agency.
After developing and imprementing a corrective action plan in compliance with Section 429.42(2), F.S., the initial on-site consultant visit must take place within 7 working days of the notice of a class I or class II deficiency and within 14 working days of the notice of an uncorrected Class III deficiency. The facility must have available for review by the agency a copy of the license of the consultant pharmacist or registered nurse and the consultant’s signed and dated review of the corrective action plan no later than 10 working days subsequent to the initial on-site consultant visit.
The facility must provide the agency with, at a minimum, quarterly on-site corrective action plan updates until the agency determines after written notification by the consultant and facility administrator that deficiencies are corrected and staff has been trained to ensure that proper medication standards are followed and that such consultant services are no longer required. The agency must provide the facility with written notification of such determination.

(b) Dietary Deficiencies.

If a Class I, Class II, or uncorrected Class III deficiency directly related to dietary standards as established in Rule 59A-36.012, F.A.C., is documented by agency pursuant to an inspection of the facility, the agency must notify the facility in writing that the facility must employ or contract the services of a registered or licensed dietitian, or a licensed nutritionist.
The initial on-site consultant visit must take place within seven working days of the notice of a Class I or II deficiency or within 14 working days of the notice of an uncorrected Class III deficiency. The facility must have available for review by the agency a copy of the license or registration of the consultant dietitian or nutritionist and the consultant’s signed and dated review of the facility’s corrective action plan, if a plan is required by the agency, no later than 10 working days after the initial onsite consultant visit.
If a corrective action plan is required, the facility must provide the agency with, at a minimum, quarterly onsite corrective action plan updates until the agency determines after written notification by the dietary consultant and facility administrator, that deficiencies are corrected and staff has been trained to ensure that proper dietary standards are followed and consultant services are no longer required. The agency must provide the facility with written notification of such determination.

History

Rulemaking Authority 429.41, 429.42 FS. Law Implemented 429.19, 429.34, 429.41, 429.42 FS. History–New 9-30-92, Formerly 10A-5.033, Amended 10-30-95, 10-17-99, 1-9-02, 7-30-06, 4-15-10, 3-13-14, Formerly 58A-5.033.

Fla. Admin. Code R. 59A-36.024 Waivers

The agency, in consultation with the department, may waive rules promulgated pursuant to Part I, Chapter 429, F.S., if the waiver request meets the conditions set forth in Section 429.41(4), F.S., and demonstrates and evaluates innovative or cost-effective congregate care alternatives which will enable individuals to age in place.

(1) Application Process.

(a) Licensed assisted living facilities proposing a waiver under this statute must submit the request in writing. All requests must include the facility name and address, license number, administrator’s name and contact information for the requestor, or its attorney. Petitions for waiver of rules other than for the objectives detailed in Section 429.41(4), F.S., including emergency waivers, will not be considered under this section but should follow the petition for waiver provisions of Section 120.542, F.S., and rule Chapter 28-104, Variance or Waiver, F.A.C.

(b) The written request must address the elements required in Section 429.41(4), F.S. In addition, the following information must be included in order to demonstrate how a waiver of the stated rule will permit development of a concept that will achieve the purpose of the underlying statute:

The rule or rules for which the waiver is requested.
The licensee’s anticipated date or dates for implementation of the concept.
If applying based on cost-effectiveness or cost-savings, a cost-benefit analysis of the proposed alternative to both residents or potential residents as well as facility operations.
An analysis of the impact the alternative will have on the relevant local community, including any barriers such as zoning or use issues, which may need resolution prior to implementation.
Specific performance measures with an annual projection of objectives and goals to be achieved broken into quarterly increments or an annual projection of outcome measures, if the concept will be implemented in less than 90 days.
If applying based on cost-effectiveness or cost-savings, an annual budget projection for the proposed alternative broken into quarterly increments.

(c) A waiver can be requested at the time of the initial license application, relicensure, or any time during the licensure period.

(d) Waiver requests must be submitted to the Agency for Health Care Administration, Assisted Living Unit, 2727 Mahan Drive, Mail Stop 30, Tallahassee, Florida 32308-5403.

(2) In accordance with Section 120.542(6), F.S., the agency shall post notice of the request within fifteen (15) days of receipt of the request. The agency shall make any requests for additional information within 30 days of receipt of the request. If additional information is provided, the agency may request clarification of only that information no later than 30 days following receipt of the information. The agency shall process the waiver request pursuant to the time frame referenced in Section 120.542(8), F.S.

(3) The agency, in consultation with the department, will evaluate all requests in light of the likelihood the concept, as described in detail, will achieve the underlying statutory objectives of innovative or cost effective congregate care alternatives to enable individuals to age in place, as provided in Section 429.41(4), F.S. Waivers may be granted only so long as there is reasonable assurance that the health, safety or welfare of residents will not be endangered by the waiver.

(4) The agency shall grant or deny the request for waiver and enter an order summarizing the facts it relied on and reasons supporting its decision. The agency must provide notice of its order as described in Section 120.542(8), F.S. The requestor shall be advised that a denial of the request may be reviewed as provided in subsection (5) of this rule.

(5) Report of Findings. A facility that has been granted a waiver must submit an annual report within 12 months of the order granting the waiver as specified in Section 429.41(4), F.S. If the report is not submitted as required, the agency may revoke the waiver.

(a) The agency will review the report of findings to determine whether the waiver shall be renewed or revoked. The agency shall make the determination based on whether the facility has met the requirements outlined in subparagraph (1)(b) of this rule. The agency shall enter an order providing the general basis for making its decision and notify the licensee of its opportunity to seek review of a revocation in accordance with Sections 120.569 and 120.57, F.S., and Rule 28-106.111, F.A.C.

(b) The agency may also consider other material which is available relative to this review.

(d) In reviewing the report of findings, the agency, in consultation with the department, shall assess whether statutory or regulatory changes should be pursued to enable other facilities to adopt the same practices.

History

Rulemaking Authority 429.41 FS. Law Implemented 120.542, 429.41 FS. History–New 9-30-92, Formerly 10A-5.035, Amended 10-30-95, 7-1-08, 4-17-14, Formerly 58A-5.035.

Fla. Admin. Code R. 59A-36.025 Emergency Environmental Control for Assisted Living Facilities

(1) DETAILED EMERGENCY ENVIRONMENTAL CONTROL PLAN. Each assisted living facility shall prepare a detailed plan (“plan”) to serve as a supplement to its Comprehensive Emergency Management Plan, to address emergency environmental control in the event of the loss of primary electrical power in that assisted living facility which includes the following information:

(a) The acquisition of a sufficient alternate power source such as a generator(s), maintained at the assisted living facility, to ensure that current licensees of assisted living facilities will be equipped to ensure ambient air temperatures will be maintained at or below 81 degrees Fahrenheit for a minimum of ninety-six (96) hours in the event of the loss of primary electrical power.

The required temperature must be maintained in an area or areas, determined by the assisted living facility, of sufficient size to maintain residents safely at all times and that is appropriate for resident care needs and life safety requirements. For planning purposes, no less than twenty (20) net square feet per resident must be provided. The assisted living facility may use eighty percent (80%) of its licensed bed capacity as the number of residents to be used in the calculation to determine the required square footage. This may include areas that are less than the entire assisted living facility if the assisted living facility’s comprehensive emergency management plan includes allowing a resident to congregate when he or she desires in portions of the building where temperatures will be maintained and includes procedures for monitoring residents for signs of heat related injury as required by this rule. This rule does not prohibit a facility from acting as a receiving provider for evacuees when the conditions stated in Section 408.821, F.S. and subsection 59A-36.019(5), F.A.C., are met. The plan shall include information regarding the area(s) within the assisted living facility where the required temperature will be maintained.
The alternate power source and fuel supply shall be located in an area(s) in accordance with local zoning and the Florida Building Code.
Each assisted living facility is unique in size; the types of care provided; the physical and mental capabilities and needs of residents; the type, frequency, and amount of services and care offered; and staffing characteristics. Accordingly, this rule does not limit the types of systems or equipment that may be used to achieve ambient temperatures at or below 81 degrees Fahrenheit for a minimum of ninety-six (96) hours in the event of the loss of primary electrical power. The plan shall include information regarding the systems and equipment that will be used by the assisted living facility and the fuel required to operate the systems and equipment.

a. An assisted living facility in an evacuation zone pursuant to Chapter 252, F, S. must maintain an alternative power source and fuel as required by this subsection at all times when the assisted living facility is occupied but is permitted to utilize a mobile generator(s) to enable portability if evacuation is necessary.

b. Assisted living facilities located on a single campus with other facilities under common ownership, may share fuel, alternative power resources, and resident space available on the campus if such resources are sufficient to support the requirements of each facility’s residents, as specified in this rule. Details regarding how resources will be shared and any necessary movement of residents must be clearly described in the emergency power plan.

(b) The acquisition of sufficient fuel, and safe maintenance of that fuel at the facility, to ensure that in the event of the loss of primary electrical power there is sufficient fuel available for the alternate power source to maintain ambient temperatures at or below 81 degrees Fahrenheit for a minimum of ninety-six (96) hours after the loss of primary electrical power during a declared state of emergency. The plan must include information regarding fuel source and fuel storage.

Facilities must store minimum amounts of fuel onsite as follows:

a. A facility with a licensed capacity of 16 beds or less must store 48 hours of fuel onsite.

b. A facility with a licensed capacity of 17 or more beds must store 72 hours of fuel onsite.

An assisted living facility located in an area in a declared state of emergency area pursuant to Section 252.36, F.S. that may impact primary power delivery must secure ninety-six (96) hours of fuel. The assisted living facility may utilize portable fuel storage containers for the remaining fuel necessary for ninety-six (96) hours during the period of a declared state of emergency.
Piped natural gas is an allowable fuel source and meets the onsite fuel supply requirements under this rule.
If local ordinances or other regulations limit the amount of onsite fuel storage for the assisted living facility’s location, then the assisted living facility must develop a plan that includes maximum onsite fuel storage allowable by the ordinance or regulation and a reliable method to obtain the maximum additional fuel at least 24 hours prior to depletion of onsite fuel.

(c) The acquisition of services necessary to maintain, and test the equipment and its functions to ensure the safe and sufficient operation of the alternate power source maintained at the assisted living facility.

(d) The acquisition and maintenance of a carbon monoxide alarm.

(2) SUBMISSION OF THE PLAN.

(a) Each new assisted living facility shall submit the plan required under this rule prior to obtaining a license.

(b) Each existing assisted living facility that undergoes any additions, modifications, alterations, refurbishment, renovations or reconstruction that require modification of its systems or equipment affecting the facility’s compliance with this rule shall amend its plan and submit it to the county emergency management agency for review and approval.

(3) APPROVED PLANS.

(a) Each assisted living facility must maintain a copy of its approved plan in a manner that makes the plan readily available at the licensee’s physical address for review by a legally authorized entity. If the plan is maintained in an electronic format, assisted living facility staff must be readily available to access and produce the plan. For purposes of this section, “readily available” means the ability to immediately produce the plan, either in electronic or paper format, upon request.

(b) Within 30 days of the approval of the plan from the county emergency management agency, the assisted living facility shall submit in writing proof of the approval to the Agency for Health Care Administration to assistedliving@ahca.myflorida.com.

(c) The assisted living facility shall submit a consumer-friendly summary of the emergency power plan to the Agency. The Agency shall post the summary and notice of the approval and implementation of the assisted living facility emergency power plans on its website within ten (10) business days of the plan's approval by the county emergency management agency and update within ten (10) business days of implementation.

(4) IMPLEMENTATION OF THE PLAN.

(a) Each assisted living facility licensed prior to the effective date of this rule shall, no later than June 1, 2018, have implemented the plan required under this rule.

(b) Each new assisted living facility shall implement the plan required under this rule prior to obtaining a license.

(c) Existing assisted living facilities that undergo any additions, modifications, alterations, refurbishment, renovations or reconstruction that require modification of the systems or equipment affecting the assisted living facility’s compliance with this rule shall implement its amended plan concurrent with any such additions, modifications, alterations, refurbishment, renovations or reconstruction.

(5) POLICIES AND PROCEDURES.

(a) Each assisted living facility shall develop and implement written policies and procedures to ensure that the assisted living facility can effectively and immediately activate, operate and maintain the alternate power source and any fuel required for the operation of the alternate power source. The procedures shall ensure that residents do not experience complications from fluctuations in ambient air temperatures inside the facility. Procedures must address the care of residents occupying the facility during a declared state of emergency, specifically, a description of the methods to be used to mitigate the potential for heat related injury including:

The use of cooling devices and equipment;
The use of refrigeration and freezers to produce ice and appropriate temperatures for the maintenance of medicines requiring refrigeration;
Wellness checks by assisted living facility staff to monitor for signs of dehydration and heat injury; and
A provision for obtaining medical intervention from emergency services for residents whose life safety is in jeopardy.

(b) Each assisted living facility shall maintain the written policies and procedures in a manner that makes them readily available at the licensee’s physical address for review by a legally authorized entity. If the policies and procedures are maintained in an electronic format, assisted living facility staff must be readily available to access the policies and procedures and produce the requested information. For purposes of this section, “readily available” means the ability to immediately produce the policies and procedures, either in electronic or paper format, upon request.

(6) REVOCATION OF LICENSE, FINES OR SANCTIONS. For a violation of any part of this rule, the Agency for Health Care Administration may seek any remedy authorized by Chapter 429, Part I, or Chapter 408, Part II, F.S., including, but not limited to, license revocation, license suspension, and the imposition of administrative fines.

(7) COMPREHENSIVE EMERGENCY MANAGEMENT PLAN.

(a) Assisted living facilities whose comprehensive emergency management plan is to evacuate must comply with this rule.

(b) Each facility whose plan has been approved shall submit the plan as an addendum with any future submissions for approval of its comprehensive emergency management plan.

(8) NOTIFICATION.

(a) Within five (5) business days, each assisted living facility must notify in writing, unless permission for electronic communication has been granted, each resident and the resident’s legal representative:

Upon the initial submission of the plan to the county emergency management agency that the plan has been submitted for review and approval;
Upon final implementation of the plan by the assisted living facility.
Annual submissions and approvals of the plan do not require notification to residents or their legal representatives unless a significant modification as defined in Rule 59A-36.019, F.A.C., has been made to the plan.

(b) Each assisted living facility must maintain a copy of each notification set forth in paragraph (a) above in a manner that makes each notification readily available at the licensee’s physical address for review by a legally authorized entity. If the notifications are maintained in an electronic format, facility staff must be readily available to access and produce the notifications. For purposes of this section, “readily available” means the ability to immediately produce the notifications, either in electronic or paper format, upon request.

History

Rulemaking Authority 429.41, FS. Law Implemented 429.19, 429.41, FS. History–New 3-26-18, Formerly 58A-5.036, Amended 7-1-19, 11-23-23.

Fla. Admin. Code R. 59A-36.027 ALF Core Training Provider Qualifications

(1) PRIMARY REQUIREMENTS. In order to register as an assisted living facility core training provider (hereafter referred to as “core training provider,” “training provider,” or “provider”), all applicants must meet the requirements outlined in Section 429.52(10), F.S. The requirements are as follows:

(a) Completion of the minimum core training requirements developed by the Agency pursuant to Section 429.52(9), F.S., and Rule 59A-36.028, F.A.C.;

(b) Successful passage of the competency test, which requires a minimum score of 75%; and,

(c) Compliance with the minimum of 12 contact hours of continuing education in topics related to assisted living every 2 years pursuant to Section 429.52(5), F.S., and paragraph 59A-36.011(1)(c), F.A.C.

(2) ADDITIONAL REQUIREMENTS. In addition to meeting the 3 primary requirements set forth in subsection (1), of this rule, applicants must meet one of the requirements outlined in Section 429.52(11), F.S., or one of the requirements established in this subsection. The requirements are as follows:

(a) A minimum of 5 years of employment with the Agency for Health Care Administration (AHCA), or formerly the Department of Health and Rehabilitative Services, as a surveyor of assisted living facilities; or

(b) A minimum of 5 years of employment in a professional position in the AHCA Assisted Living Unit; or

(c) A minimum of 5 years of employment as an educator or staff trainer for persons working in an ALF or other long-term care (LTC) settings; or

(d) A minimum of 5 years of employment as an assisted living facility core trainer, which was not directly associated with the department; or

(e) A minimum of a 4-year degree from an accredited college or university in areas of healthcare, gerontology, social work, education or human services; and a minimum of 3 years experience as an educator or staff trainer for persons working in an ALF or other LTC settings after core certification.

History

Rulemaking Authority 429.52 FS. Law Implemented 429.52 FS. History–New 6-15-09, Formerly 58T-1.203.

Fla. Admin. Code R. 59A-36.028 ALF Minimum Core Training Curriculum Requirements

(1) CURRICULUM REQUIREMENTS. An approved core training provider must conduct core training using the curriculum outlined in AHCA Form 3180-1038, September 2019, which is incorporated by reference in this rule. The curriculum is available from the Agency for Health Care Administration, Assisted Living Unit, 2727 Mahan Drive, Tallahassee, FL 32308-5403 or the Agency’s website at: http://acha.myflorida.com/MCHQ/Health_Facility_Regulation/Assisted_Living/alf.shtml.

(2) MONITORING. The Agency reserves the right to do the following:

(a) Require submission of the core training schedule from a core trainer;

(b) Attend and monitor core training courses;

(d) Conduct on-site or virtual monitoring, follow-up monitoring, and require implementation of a corrective action plan if the provider does not adhere to the approved curriculum.

(3) CANCELLATION OF CORE REGISTRATION. The Agency may cancel the core registration and remove any ALF core training provider from the approved list who fails to:

(a) Submit a core training schedule within 10 business days after the request;

(b) Comply with a corrective action plan issued by the Agency within 45 calendar days after the notification;

(c) Have a student passage rate at or above 55% as determined by the Agency’s contracted vendor in the preceding calendar year;

(d) Conduct an ALF core training session in the preceding calendar year; or

(e) Submit at least 10 examinees’ names to the Agency’s contracted ALF core training testing vendor in the preceding calendar year.

History

Rulemaking Authority 429.52 FS. Law Implemented 429.52 FS. History–New 6-15-09, Formerly 58T-1.205, Amended 8-16-21, 6-11-25.

Fla. Admin. Code R. 59A-36.029 ALF Core Training Provider Initial Registration Process

(1) REGISTRATION PROCESS.

(a) Before core training can be conducted, an applicant must meet the training provider qualifications outlined in Section 429.52(10), F.S., and Rule 59A-36.027, F.A.C. Additionally, an applicant must register with, and obtain from, the Agency a unique provider registration number as set forth in this subsection.

(b) An applicant must complete ACHA Form 3180-1039, Application for Assisting Living Facility (ALF) Core Training Provider Registration, September, 2019. The form is hereby incorporated by reference and may be obtained from the Agency for Health Care Administration, Assisted Living Unit, 2727 Mahan Drive, Tallahassee, FL 32308-5403 or the Agency’s website at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Assisted_Living/alf.shtml.

(2) APPROVAL PROCESS. Within 30 calendar days after receiving a core training provider application, the Agency must submit written notification approving or denying the application, or requesting supplemental information or clarification.

(a) If the application is approved, the Agency must include a unique provider registration number in the notice.

(b) If the application is denied, the Agency must provide the reason or reasons for denial in the notice.

(c) If the application is determined to require supplemental information or clarification, the Agency must state the supplemental information or clarification that is being requested.

If the Agency does not receive the requested information within 30 calendar days of the request, the application will be deemed incomplete and closed.
If the Agency receives the requested information within 30 calendar days of the request, the Agency must process the training provider application within 30 calendar days after all required information is received.

History

Rulemaking Authority 429.52 FS. Law Implemented 429.52 FS. History–New 6-15-09, Formerly 58T-1.207.

Fla. Admin. Code R. 59A-36.030 Process for Maintaining ALF Core Training Provider Registration

(1) MAINTAINING ALF CORE TRAINING PROVIDER REGISTRATION.

(a) After receiving the initial core training provider registration, the approved provider must re-register with the Agency every 2 years by submitting documentation of his or her compliance with the continuing education requirement as specified in Section 429.52(5), F.S. and this rule.

(b) The provider must submit the documentation to the address referenced on AHCA Form 3180-1038. It must be submitted no later than 30 calendar days after each two-year continuing education cycle. The 2-year cycle begins on the date of the initial training provider registration. Documentation must include the following:

Title of the training program;
Subject matter of the training program;
The training program agenda including topics discussed;
The core training provider’s name and registration number;
Date(s) of participation;
Number of hours of the training program; and
The continuing education training provider’s name, signature, credentials, and professional license number, if applicable.

(2) APPROVAL PROCESS.

(a) Within 30 calendar days after receiving the required continuing education documentation, the Agency must notify the provider in writing that the continuing education requirement:

Has been met; or
Has not been met and the reasons why; or
Has omissions or additional information is requested.

a. If the Agency does not receive the omitted or additional information within 30 calendar days of the request, the provider’s registration shall be cancelled. The Agency must provide written notification of its decision, including the reason for the cancellation, no later than 30 calendar days after the deadline for the request for the omitted or additional information.

b. If the Agency receives the omitted or additional information as requested within the 30 calendar day time period, the Agency must process the core training provider’s registration within 30 calendar days after all required information is received. The Agency must provide written notification to the provider of its decision.

(b) Failure to submit proof of the continuing education requirement as specified in this rule shall result in cancellation of the core training provider’s registration. The Agency must provide written notification of such action no later than 30 calendar days after the information was due.

(c) If the provider’s registration is cancelled under paragraphs (a) and (b) of this subsection, and the provider subsequently meets the continuing education requirement, he or she may re-apply for registration as specified in Rule 59A-36.029, F.A.C., and include documentation that the continuing education requirement has been met pursuant to this rule.

History

Rulemaking Authority 429.52 FS. Law Implemented 429.52 FS. History–New 6-15-09, Formerly 58T-1.209.

Fla. Admin. Code R. 59A-36.031 Registered ALF Core Training Provider Responsibilities

The following are the responsibilities of a registered core training provider:

(1) USE OF MINIMUM CORE TRAINING CURRICULUM. A registered core training provider is responsible for the following:

(a) Conducting core training using the minimum core training curriculum required by Rule 59A-36.028, F.A.C.; and

(b) Ensuring that all changes in ALF statutes and rules are immediately incorporated into the contents of his or her core training curriculum.

(2) CERTIFICATES. After a trainee successfully completes core training, the approved training provider must issue a certificate to him or her. In addition to the provider’s unique registration number, the certificate must include the information referenced in paragraph 59A-36.011(12)(a), F.A.C. The provider’s signature and registration number shall serve as documentation that the trainee has completed the required training.

(3) RECORDS. Approved providers must maintain records of each course taught for a minimum of 5 years. Course records must include the following information:

(a) The title of the training program;

(b) The agenda;

(d) The training provider’s name and registration number;

(e) The trainees’ names, dates of participation and training location; and

(f) Training evaluations and roster signed by trainees.

(4) COMPETENCY EXAM.

(a) Approved training providers must submit the names of trainees completing core training to the testing authority within 10 calendar days after completion of the course. Names must be submitted to the following address: ALF at The MacDonald Research Institute, 28953 SR 54, Wesley Chapel, FL 33543. Names may be alternately submitted via email to alftest.tmri@gmail.com.

(b) The testing authority shall not process any requests for the competency exam, nor sit any individual for the exam, unless proper notice is submitted by an approved training provider pursuant to paragraph (4)(a) of this subsection.

(5) GUEST SPEAKERS. If a core training provider uses guest trainers to teach or participate in specific training modules covered in the minimum core training curriculum referenced in Rule 59A-36.028, F.A.C., the core trainer is responsible to ensure that the guest speaker meets the following minimum conditions:

(a) Has expertise in the specific subject matter; and

(b) Covers all components of the subject matter if he or she provides the module or portion of the module instruction.

History

Rulemaking Authority 429.52 FS. Law Implemented 429.52 FS. History–New 6-15-09, Formerly 58T-1.211.

Chapter 59A-37 ADULT FAMILY CARE HOMES

Fla. Admin. Code R. 59A-37.001 Definitions

The following terms or phrases are defined in Section 429.65, F.S., and are applicable to this rule chapter: activities of daily living (ADLs), adult family-care home (AFCH), agency (AHCA), aging in place, appropriate placement, chemical restraint, department, disabled adult, frail elder, personal services or personal care, provider, relative, relief person, and resident. Additional definitions applicable to this rule chapter are as follows:

(1) “Adult household member” means the provider and any person, 18 years of age or older, who is permanently or regularly present in the home for more than a few hours at a time. A person shall be considered a household member even though the person has another residence if the person is in a position of familial authority or perceived familial authority.

(2) “Advertise” means any written, printed, oral, visual, or electronic promotion, statement of availability, qualifications, services offered, or other similar communication appearing in or on television, radio, the Internet, billboards, newspapers, newsletters, magazines, business cards, flyers, brochures or other medium used for the purpose of attracting potential residents to an adult family-care home. A complimentary listing of the licensed AFCH’s name, address, and telephone number in the telephone directory shall not be considered advertising.

(3) “Applicant” means an individual applying for an adult family-care home license.

(4) “Assistance with activities of daily living” means individual assistance with the following:

(a) Ambulating – Providing physical support to enable the resident to move about and maintain balance and providing necessary assistance with walking, stair climbing, or pushing a wheelchair.

(b) Bathing – Assembling towels, soaps, and other necessary supplies, helping the resident in and out of the bathtub or shower, turning water on and off, adjusting water temperatures, washing and drying portions of the resident’s body which are difficult to reach, or being available while the resident is bathing.

(d) Eating – Helping with cutting food, pouring beverages, and hand feeding residents who are unable to feed themselves.

(e) Grooming – Helping the resident with shaving, oral care, care of the hair, and nail care.

(f) Toileting – Reminding the resident about using the toilet, assisting the resident to the bathroom, helping to undress, positioning on the commode, and helping with related personal hygiene, including changing adult briefs.

(5) “Bedridden” means confined to bed because of inability to ambulate or transfer to a wheelchair even with assistance, or to sit safely in a chair or wheelchair without personal assistance or physical restraint.

(6) “Capacity” means the number of residents for which an adult family-care home has been licensed to provide room, board and personal care.

(7) “Case manager” means an individual employed by or under contract with any agency or organization, public or private, who has responsibility for assessing resident needs, planning services, coordinating and assisting residents to gain access to needed medical, mental health, social, housing, educational or other services, and monitoring and evaluating service delivery.

(8) “Deficiency” means an instance of non-compliance with the requirements of Chapter 429, Part II, F.S., and this rule chapter.

(9) “Health care provider” means a physician or physician’s assistant licensed under Chapter 458 or 459, F.S., or advanced registered nurse practitioner licensed under Chapter 464, F.S.

(10) “Long-Term Care Ombudsman Council” (LTCOC) means the State Long-Term Care Ombudsman Council or the district long-term care ombudsman councils established under Chapter 400, Part I, F.S.

(11) “Moratorium” means that an AFCH may not admit a new resident from the date the moratorium is imposed by AHCA until the date the moratorium is lifted by AHCA.

(12) “Nurse” means a licensed practical nurse (LPN), registered nurse (RN), or advanced registered nurse practitioner (ARNP) under Chapter 464, F.S.

(13) “Nursing progress notes” or “nursing notes” means a written record of nursing services, other than medication administration or the taking of vital signs, provided to each resident who receives such services. The notes shall be completed by the nurse who delivered the service and shall describe the date, type, scope, amount, duration, and outcome of services that are rendered; the general status of the resident’s health; any deviations; any contact with the resident’s health care provider; and contains the signature and credential initials of the person rendering the service.

(14) “Optional state supplementation (OSS)” means the state program providing monthly payments to eligible residents pursuant to Section 409.212, F.S., and rule Chapter 65A-2, F.A.C.

(15) “Physical restraint” means a device or item which physically limits, restricts, or deprives an individual of movement or mobility. The term also includes any device which was not specifically manufactured as a restraint but which has been altered, arranged or otherwise used for this purpose or otherwise modified to be used as a physical restraint. The term does not include an item or device which the individual can remove or avoid without assistance.

(16) “Pressure sore” means a breakdown in skin integrity caused by immobility and prolonged pressure. The 4 stages of pressure sores can be identified as follows: stage 1 – a nonblanching macule that may appear red or violet; stage 2 – a skin breakdown as far as the dermis; stage 3 – a skin breakdown into the subcutaneous tissue; stage 4 – penetrate bone, muscle or the joint.

(17) “Reside” or “resides” means the licensee or applicant lives in the AFCH as a primary residence. For purposes of this rule chapter, any two of the following documents, which include the name of the licensee or applicant and the AFCH address, are accepted by the agency as proof that the licensee or applicant physically lives in the AFCH:

(a) Homestead exemption documentation, or

(b) Lease or rental agreement accompanied by a corresponding utility bill and telephone bill, or

(18) “Resident’s representative” means a guardian, attorney-in-fact, next-of-kin, health care surrogate or proxy, or other responsible party with authority to make decisions on behalf of a resident.

(19) “Staff” means any person employed by or under contract to the provider, who directly or indirectly provides services to residents. Staff does not include persons contracting directly with a resident.

(20) “Twenty-four-hour nursing supervision” means nursing services that are ordered by a physician for a person whose condition requires physician supervision and continued monitoring of vital signs and physical status. Such services must be medically complex enough to require the constant supervision, assessment, planning, or intervention by a nurse; be performed by or under the direct supervision of a nurse; required on a daily basis; and consistent with the nature and severity of the resident’s condition or the disease state or stage.

History

Rulemaking Authority 429.67, 429.73 FS. Law Implemented 429.65, 429.67, 429.71, 429.73 FS. History–New 5-14-86, Amended 2-2-95, Formerly 10A-14.002, Amended 9-19-96, 6-6-99, 4-15-10, Formerly 58A-14.002, 7-1-19.

Fla. Admin. Code R. 59A-37.002 License Application, Renewal and Conditional Licenses

(1) LICENSE APPLICATION.

(a) An applicant for an adult family care home license may apply for licensure pursuant to the requirements of Chapters 408, Part II, and 429, Part II, F.S., Chapter 59A-35, F.A.C., and this rule chapter. In addition to those requirements, the application must be accompanied by the following:

Evidence of a Level 2 background screening conducted pursuant to Chapter 435, F.S., for the applicant, each relief person, all adult household members, and all staff.
If located in an area zoned single-family or multi-family, a community residential home certification form signed by the Department of Children and Family Services’ district community residential home coordinator. If not located in an area zoned single-family or multi-family, Local Zoning Form, AHCA Form 3180-1021, August 2021, which is incorporated by reference, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-14001, or a letter from the local zoning authority, signed by the county zoning official, which states that the applicant is in compliance with local zoning ordinances. The form is available online at http://www.ahca.myflorida.com/HQAlicensureforms.
Documentation of a satisfactory sanitation inspection as required under Rule 59A-37.009, F.A.C.
Documentation of a satisfactory fire safety inspection as required under Rule 59A-37.010, F.A.C.
Income and Expense Statement, AHCA Form 3180-1017, August 2021, which is incorporated by reference, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-14000. The form is available online at http://www/ahca.myflorida.com/HQAlicensureforms.
Written assurance affirming that the applicant is aware of and will complete the training requirements as described in Rule 59A-37.007, F.A.C.
Documentation that the provider resides in the adult family-care home pursuant to Section 429.67(2), F.S., and subsection 59A-37.001(17), F.A.C.

(b) If, at the time of applying for an initial license, an applicant is already providing room, board, and one or more personal services to persons who will be considered residents, the provider must be in compliance with all admission and care standards applicable to residents under this rule chapter upon licensing.

(2) LICENSE RENEWAL. In addition to the requirements of Chapters 408, Part II, and 429, Part II, F.S., and Chapter 59A-35, F.A.C., and this rule chapter, all applicants for license renewal shall provide the following:

(a) Documentation of a satisfactory sanitation inspection as required under Rule 59A-37.009, F.A.C.

(b) Documentation of a satisfactory fire safety inspection as required under Rule 59A-37.010, F.A.C.

(c) Documentation that the provider resides in the adult family care home pursuant to Section 429.67(2), F.S., and subsection 59A-37.001(17), F.A.C.

(d) Upon application for license renewal the Agency may request documentation of adequate financial resources to operate the adult family-care home in compliance with health and safety standards if the financial stability of the AFCH is in question. Indicators of financial instability are: filing of bankruptcy; issuance of checks returned for insufficient funds; non-payment of rent, mortgage, utilities, staff wages or salaries, or taxes; confirmed complaints to the Agency or ombudsman council regarding withholding of funds or refunds due to residents; and any other information which indicates the inability of the home to meet its financial responsibilities in a full and timely manner.

(3) Lease or rental agreements submitted pursuant to Section 429.67(2), F.S., must be accompanied by documentation demonstrating that the property owner permits the operation of an adult family care home provider by the tenant on the premises described in the lease or rental agreement.

(4) CONDITIONAL LICENSE. The Agency may issue a conditional license to an AFCH if, at the time of license renewal the provider is found to have uncorrected deficiencies.

(a) The issuance of a conditional license shall be contingent upon Agency approval of a written plan of correction which includes corrective steps that will be taken to eliminate the deficiencies and a timetable for correction of the deficiencies by the expiration date of the conditional license.

(b) A conditional license shall be issued by the Agency only for that time period necessary to comply with applicable licensing standards and complete license renewal procedures, but not to exceed 6 months.

(c) A conditional license shall be revoked and license denied if subsequent follow-up surveys by the Agency indicate that necessary progress has not been made toward compliance with applicable licensing standards.

(d) The issuance of a conditional license does not change the biennial license expiration date.

History

Rulemaking Authority 429.67, 429.69, 429.71, 429.73 FS. Law Implemented 429.67, 429.69, 429.71, 429.73 FS. History–New 5-14-86, Amended 2-2-95, Formerly 10A-14.003, Amended 9-19-96, 3-25-98, 6-6-99, 1-1-04, 7-30-06, 4-15-10, Formerly 58A-14.003, Amended 7-1-19, 2-27-22, 6-11-25.

Fla. Admin. Code R. 59A-37.003 License Requirements

(1) LICENSE TIMEFRAME. Except for conditional licenses, all AFCH licenses shall be effective for 2 years from the date of issuance.

(2) LICENSE CONDITIONS. A license to operate an AFCH is not transferable and is valid only for the provider named, the capacity stated, and the premises described on the license. A change of ownership is prohibited.

(3) VOLUNTARY CLOSURE. The licensed provider shall give at least 60 days written notice of any intent to voluntarily close a currently licensed AFCH to the AHCA Assisted Living Unit, each residents or resident’s representative, and case managers of OSS recipients.

(4) LICENSED CAPACITY.

(a) There shall be no more than 5 residents in any AFCH. The number of residents permitted in a particular adult family-care home will be determined by the agency based upon the fire safety standards provided under Rule 59A-37.010, F.A.C., and compliance with physical site standards established in Rule 59A-37.009, F.A.C. An increase in capacity may not be made without the prior approval of the agency.

(b) Adult relatives of the provider who require personal care and supervision and reside in the home for more than 30 days shall be considered residents only for the purposes of determining capacity.

(c) Except homes licensed as adult foster homes or adult congregate living facilities prior to January 1, 1994, each AFCH must designate at least one licensed space for a resident receiving optional state supplementation.

(5) ADVERTISING. A licensed adult family-care home may advertise accommodations and services consistent with its license.

(a) The AFCH may not be listed in the yellow pages of the telephone directory under the heading of “nursing home” or “assisted living facility.”

(b) An advertisement for an adult family-care home must include the term “adult family-care home” and the home’s license number.

(c) Pursuant to Section 429.83, F.S., an AFCH claiming to provide special care for persons with Alzheimer’s disease or other related dementias must disclose those special care services in any advertisement or in a separate document, which shall be distributed to the public upon request.

(6) POSTING OF INFORMATION. For the purpose of a resident’s ability to lodge complaints, the AFCH licensee or designee must post the addresses and toll-free telephone numbers for the following entities in full view in a common area accessible to all residents:

(a) District Long-Term Care Ombudsman Council;

(b) Advocacy Center for Persons with Disabilities;

(d) Agency Consumer Hotline; and,

(e) Florida Abuse Hotline.

History

Rulemaking Authority 429.67, 429.73 FS. Law Implemented 429.67, 429.73, 429.83 FS. History–New 5-14-86, Amended 2-2-95, Formerly 10A-14.004, Amended 9-19-96, 6-6-99, 4-15-10, Formerly 58A-14.004, 7-1-19.

Fla. Admin. Code R. 59A-37.004 Admission Criteria and Procedures, Appropriateness of Placement, and Continued Residency Requirements

(1) ADMISSION. In order to be admitted as a resident to an AFCH, an individual must:

(a) Be at least 18 years of age.

(b) Be free from apparent signs and symptoms of any communicable disease, including tuberculosis which is likely to be transmitted to others as documented in the Health Assessment Form described in subsection (2). A person who has HIV infection may be admitted provided the person would otherwise be eligible for admission according to this rule.

(c) Be capable of self-preservation in an emergency situation involving the immediate evacuation of the AFCH, with assistance with ambulation, if needed.

(d) Be able to perform, with supervision or assistance, activities of daily living.

(e) Not be a danger to self or others as determined by a health care provider or licensed mental health professional.

(f) Not require licensed professional mental health treatment on a 24-hour a day basis.

(g) Not have special dietary needs which cannot be met by the provider.

(h) Not be bedridden.

(i) Not have stage 3 or 4 pressure sores. An individual with a stage 2 pressure sore may be admitted only if the individual is under the care of a licensed nurse pursuant to a plan of care issued by a licensed health care provider. Such nursing service must be provided in accordance with Rule 59A-37.006, F.A.C.

(j) Not require the use of chemical or physical restraints.

(k) Not require 24-hour nursing supervision.

(l) Not have personal care and nursing needs which exceed the capability of the provider to meet or arrange for such needs. The provider is responsible for determining the appropriate placement of the individual in the AFCH.

(2) HEALTH ASSESSMENT.

(a) Prior to admission to an AFCH, an individual must have a face-to-face medical examination conducted by a licensed health care provider using AHCA Form 3110-1023, Resident Health Assessment for Adult Family-Care Homes (AFCH), January 2008, which is incorporated by reference. It is available by writing to the Agency for Health Care Administration, Assisted Living Unit, 2727 Mahan Drive, Mail Stop 30, Tallahassee, FL 32308-5403 or calling (850)412-4304. It also may be obtained from the Agency’s website at http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Assisted_Living/docs/afch/AFCH_Res_Health_Assmnt.pdf.

Items on the form that may have been omitted by the licensed health care provider during the examination do not necessarily require an additional face-to-face examination for completion.
The AFCH provider, or relief person, may obtain the omitted information either verbally or in writing from the licensed health care provider.
Omitted information received verbally must be documented in the resident’s record, including the name of the licensed health care provider giving the information, the name of the AFCH provider or relief person recording the information, and the date the information was obtained.

(b) Every year thereafter, or after a significant change as defined in subsection (4) of Rule 59A-37.006, F.A.C., whichever comes first, the resident must have a face-to-face medical examination conducted by a licensed health care provider using the form referenced in paragraph (a) of this subsection. After the effective date of this rule, providers shall have up to 12 months to comply with this requirement for residents currently living in the AFCH.

(3) HOUSE RULES AND COMPLAINT PROCEDURES.

(a) Prior to, or at the time of admission, the AFCH must provide the resident, or representative, with the following:

A copy of the AFCH house rules,
The Resident’s Bill of Rights established under Section 429.85, F.S.,
Written information referenced in subsection (6) of Rule 59A-37.003, F.A.C., and the procedure for making complaints to these entities.

(b) Additionally, the provider, or relief person, must make the resident, or representative, aware of the location of the documents posted pursuant to subsection (6) of Rule 59A-37.003, F.A.C.

(4) DO NOT RESUSCITATE ORDERS and ADVANCE DIRECTIVES:

(a) Each adult family-care home (AFCH) must establish written policies and procedures addressing residents’ rights regarding advance directives and do not resuscitate orders (DNROs). The policies shall not require treatment or admission decisions to depend on whether an individual has executed or waived a DNRO.

(b) The AFCH’s policy must include:

At the time of admission, providing each resident, or the resident’s representative, with written information on health care advance directives pursuant to Chapter 765, F.S. Information and sample forms for advance directives can be found on the Agency’s website at https://quality.healthfinder.fl.gov/report-guides/advance-directives.
At the time of admission, providing each resident, or the resident’s representative, with written information about the AFCH’s DNRO policies, including details specified in DH Form 1896, Do Not Resuscitate Order 02/2024, incorporated by reference in Rule 64J-2.018, F.A.C. This form may be obtained online at https://www.floridahealth.gov/about-us/resources/do-not-resuscitate-order/.
Documentation requirements regarding whether the resident has executed a DNRO must be maintained in the resident’s record. If a DNRO has been executed, a copy must be included in the resident’s record. If the AFCH does not receive a copy, the AFCH must document in the resident’s record that it has requested a copy.

(c) An AFCH shall be subject to revocation of its license pursuant to Section 408.815, F.S., if the AFCH, as a condition of treatment or admission, requires an individual to execute or waive a DNRO, pursuant to Section 765.110, F.S.

(d) Pursuant to Section 429.73, F.S., in the event a resident experiences cardiopulmonary arrest, an AFCH must honor a properly executed DNRO as follows:

The AFCH provider, or relief person, who is trained in cardiopulmonary resuscitation (CPR), may withhold cardiopulmonary resuscitation, or
The AFCH provider, or relief person, shall immediately contact “911.” Cardiopulmonary resuscitation may be withheld or withdrawn from a resident by an individual pursuant to Section 401.45, F.S.
Adult family-care home providers shall not be subject to criminal prosecution or civil liability, nor be considered to have engaged in negligent or unprofessional conduct for withholding or withdrawing cardiopulmonary resuscitation pursuant to such a Do Not Resuscitate Order and rules adopted by the department, pursuant to Section 429.73, F.S. Any AFCH provider, who, in good faith, obeys the directives of an existing DNRO, executed pursuant to Section 401.45, F.S., will not be subject to prosecution or civil liability for his or her performance regarding patient care.

(5) TEMPORARY EMERGENCY SERVICES. Residents placed on an emergency basis by the Department of Children and Family Services pursuant to Section 415.105 or 415.1051, F.S., must meet the admission requirements of this rule. However, only residents whose stay in the home exceeds 30 days must be examined by a licensed health care provider under subsection (2) of this rule, and covered by a residency agreement under Rule 59A-37.005, F.A.C. A temporary emergency placement may not be made if the placement causes the home to exceed licensed capacity.

(6) CONTINUED RESIDENCY.

(a) The criteria for continued residency shall be the same as the criteria for admission, including a face-to-face medical examination conducted by a licensed health care provider pursuant to subsection (2) of this rule, with the following exceptions:

A resident may be bedridden for up to 7 days for a temporary illness.
A resident with a stage 2 pressure sore must be discharged if the pressure sore has not healed within 30 days or has not been reduced to stage 1.
A terminally ill resident who no longer meets the criteria for continued residency may continue to reside in the AFCH if:

a. The resident qualifies for, is admitted to, and consents to the services of a licensed hospice which coordinates the additional care that may be needed,

b. Continued residency is agreeable to the resident and the provider; and,

c. An interdisciplinary care plan is developed and implemented by the hospice in consultation with the provider.

(b) If the resident no longer qualifies for continued residency, the provider shall assist the resident to obtain another placement.

(7) DISCHARGE.

(a) Except as provided in paragraph (b), a resident shall not be discharged without 30 days’ written notice stating reasons for the move or transfer. The notice shall be delivered to the resident or the resident’s representative.

(b) Residents shall only be moved or transferrred without the required 30 day notice for the following reasons:

The resident’s health requires an immediate relocation to a facility which provides a more skilled level of care as certified by a licensed health care provider,
The resident’s behavior poses an imminent danger to self or others, significantly interferes with the orderly operation of the home, or is continually offensive to other residents, or
The AFCH has had its license denied, revoked, or has voluntarily surrendered its license.

History

Rulemaking Authority 429.73 FS. Law Implemented 429.65, 429.73, 429.85 FS. History–New 2-2-95, Formerly 10A-14.0061, Amended 9-19-96, 6-6-99, 1-1-04, 4-29-08, 9-16-10, Formerly 58A-14.0061, Amended 7-1-19, 8-17-26.

Fla. Admin. Code R. 59A-37.005 Residency Agreement

(1) Pursuant to Section 429.81, F.S., before or at the time of admission to an AFCH, the provider and the resident or the resident’s representative must sign a residency agreement, a copy of which must be given to the provider and kept on file for 5 years after the expiration of the agreement, and a copy of which must be provided to the resident or resident’s representative.

(2) The residency agreement must include the following:

(a) A list specifically setting forth the services and accommodations to be provided by the adult family-care home.

(b) The daily, weekly or monthly rates and charges and a statement that the provider will provide at least 30 days’ notice before implementing a rate increase.

(c) A bed hold policy for residents who request the provider to reserve a bed for the resident if the resident’s health requires the resident to be admitted to a nursing home or hospital. The bed hold policy shall permit the provider to continue to charge the agreed upon daily rate until the provider receives notification in writing from the resident or the resident’s representative that the resident will not be returning to the home. However, the provider may not continue to charge the agreed upon daily rate if the resident’s physical or mental condition prevents the resident from giving notification and the resident does not have a representative to act on the resident’s behalf.

(d) The AFCH’s discharge policy.

(e) A refund policy to apply when a resident is discharged or dies. The refund policy shall state that:

The resident or resident’s representative is entitled to a prorated refund for any unused portion of payment beyond the discharge or termination date. The refund will be less the cost of documented damages to the AFCH caused by the resident before the discharge or termination date that results from circumstances other than normal use. Claims against the refund must be in writing and must include a list of all documented damages and costs.
The refund must occur within 45 days of receipt of a written notice of discharge, or 15 days after the resident has moved or dies, whichever occurs later.

(f) A statement regarding the level of supervision to be provided.

(3) An addendum shall be added to the residency agreement to reflect any additional services and charges not covered by the original agreement. Such addendum must be dated and signed by the provider and the resident or resident’s representative and a copy given to the provider and the resident or the resident’s representative.

History

Rulemaking Authority 429.81 FS. Law Implemented 429.81, 429.85 FS. History–New 6-6-99, Amended 4-29-08, Formerly 58A-14.0062, 7-1-19.

Fla. Admin. Code R. 59A-37.006 Standards and Practices for Care and Services

The adult family-care home provider shall ensure the provision of the following in accordance with Chapter 429, Part II, F.S., this rule chapter, and the residency agreement:

(1) PERSONAL SERVICES.

(a) Assistance with or supervision of the activities of daily living as required by the resident. For a diabetic resident or a resident who has documented circulatory problems, cutting toenails shall only be permitted with written approval of the health care provider.

(b) Assistance with or supervision of the self-administration of medication, or medication administration.

Residents who are capable of self-administering their medications shall be encouraged and allowed to do so.
For residents who require supervision or assistance with self-administration, the provider or staff shall, as needed:

a. Remind residents when to take medications,

b. Prepare and make available such items as water, juice, cups, spoons, or other items necessary for administering the medication,

c. Obtain the medication and provide it to the resident,

d. Observe the resident take the medication and verify that the resident is taking the dosage as prescribed; and,

e. Provide any other assistance at the express direction of the resident or the resident’s representative, except for administering the medication as defined in Section 465.003, F.S.

Medication administration in an AFCH is a nursing service and may only be provided as described in subsection (5) of this rule, except that instead of nursing progress notes, a record of medication administration shall be maintained which includes the name of the resident and any known allergies the resident may have; the name of the resident’s health care provider and the health care provider’s telephone number; the name of each medication prescribed, its strength, and directions for use; and a chart for recording each time the medication is taken, any missed dosages, refusals to take medication as prescribed, or medication errors. The chart must be updated each time the medication is administered.
A list of currently prescribed medications shall be maintained for all residents who self-administer or who require supervision or assistance with medications which includes the name of each medication prescribed, its strength and directions for use, and common side effects.
Nurses may manage weekly pill organizers for residents who self-administer or who require supervision or assistance with self-administration.
Prescription medications which are centrally stored by the provider shall be appropriately stored in their legally dispensed, labeled, original containers. Appropriately stored means that the medication be kept in an area free of dampness and abnormal temperatures, except that a medication requiring refrigeration shall be refrigerated.

(2) SUPERVISION.

The AFCH provider shall provide general supervision 24 hours per day, except as provided in paragraph (a), of this subsection. General supervision means the provider or designee is aware of the resident’s whereabouts and well-being while the resident is on the premises of the AFCH. The provider is responsible for determining the level of supervision necessary to ensure the resident’s safety and security as well as to remind the resident of any important tasks or activities, including appointments.

(a) A resident may be left without supervision in an AFCH for up to 2 hours in a 24-hour period if his or her licensed health care provider submits written certification that doing so will not compromise the resident’s health, safety, security or well-being. This certification is included on AHCA Form 3110-1023, Resident Health Assessment for Adult Family-Care Homes (AFCH), as referenced in Rule 59A-37.004, F.A.C.

(b) The health care provider’s certification must be completed annually from the date of the original assessment, or sooner, if a significant change occurs pursuant to subsection (4) of this rule, or when there is a compelling reason why the resident should not be left without supervision in the AFCH.

(c) The provider must be accessible by telephone or pager or other appropriate means so that the resident is able to communicate with him or her during the period that the resident is left without supervision in the AFCH.

(3) INCIDENT REPORTING.

Any major incident and the action taken in response to that incident must be documented in the resident’s record. A major incident includes:

(a) An injury to a resident which requires assessment and treatment by a health care provider. The resident’s record must include a description of the circumstances under which the injury occurred.

(b) A resident is missing. Whenever a resident is determined to be missing, the provider, relief person, or staff-in-charge shall notify the local law enforcement agency within 1 hour. The resident’s representative, next-of-kin, and case manager shall be notified within 4 hours or within a time frame previously agreed upon in writing between the provider and the resident’s representative, next-of-kin, or case manager.

(c) Any event, such as a fire, natural disaster, or other occurrence, which results in the disruption of the AFCH’s normal activities.

(d) The death of a resident. The resident’s representative, next-of-kin, case manager, and law enforcement must be notified immediately upon discovery of the death.

(4) HEALTH MONITORING. The AFCH provider shall be responsible for observing, recording and reporting any significant changes in the resident’s normal appearance, behavior or state of health to the resident’s health care provider, representative, and case manager. Significant changes include a sudden or major shift in behavior or mood; or a deterioration in health status, such as unplanned weight change, stroke, heart condition, a stage 2 pressure sore. Ordinary day-to-day fluctuations in functioning and behavior, short-term illness such as a cold, or the gradual deterioration in the ability to carry out the activities of daily living that accompanies the aging process are not considered significant changes. As part of health monitoring, residents must be weighed monthly.

(5) FOOD SERVICE.

(a) For residents not routinely absent from the home for a day program or other purpose, at least 3 meals shall be prepared and served in the home where the resident lives during each 24 hour period. Beverages and nutritious snacks shall be made available between meals.

(b) If residents are routinely absent from the AFCH during a regular meal time, they must be provided with take-out meals if other provisions have not been made by the resident or the day program.

(c) Payment for meals eaten away from home for the convenience of the provider (i.e., restaurants or senior meal sites) is the responsibility of the provider. However, meals and snacks as part of an individually arranged recreational outing are the responsibility of the resident.

(d) In order to ensure adequate nutrition and variety, meals shall be planned based on the recommendations of the U.S. Department of Agriculture’s Food Guide Pyramid – A Guide to Daily Food Choices, dated August 1992, which is incorporated by reference; prepared by methods which conserve nutritional value; and served in a form easy for the residents to manage. A copy of the Food Guide Pyramid may be obtained from the Assisted Living Program, Department of Elderly Affairs, 4040 Esplanade Way, Tallahassee, Florida 32399-7000, telephone number (850)414-2309.

(e) Special diets are to be provided as prescribed in written orders by the resident’s health care provider.

(f) Consideration shall be given to the resident’s cultural and ethnic background and individual preferences in food selection and preparation.

(g) Dining and serving arrangements shall provide an opportunity for residents to make food selections.

(h) All residents shall be given the opportunity to eat with the AFCH provider, other residents, and other members of the household.

(6) NURSING SERVICES. In order to permit the resident to age in place, any nursing service needed by the resident can be provided or arranged for by the provider, or the resident or the resident’s representative may directly contract with a licensed home health agency or nurse to provide these services, provided that:

(a) The resident does not exceed the admission and continued residency standards provided under Rule 59A-37.004, F.A.C.; and,

(b) If provided or arranged for by the AFCH provider, the nursing service must be:

Authorized by a health care provider’s order,
Medically necessary and reasonable for treatment of the resident’s condition,
Properly provided pursuant to Chapter 464, F.S., and the prevailing standard of practice in the nursing community,
A service that can be safely, effectively, and efficiently provided in the home,
Recorded in nursing progress notes; and,
Provided in accordance with the residency agreement.

(7) ADDITIONAL SERVICES. The adult family-care home provider shall also ensure the provision of the following:

(a) The arrangement of, transportation to, and for someone to accompany the resident to medical, dental, nursing, or mental health appointments, to the extent needed by the resident.

(b) Clothing that is in good repair, consistent with general standards of dress in the community, and appropriate for the season.

(c) Linens and laundry services shall be furnished as needed by the provider. Residents who wish to use their own linens, or who are willing and able to do their own laundry shall be permitted to do so.

(d) Securing social and leisure services for the resident.

(e) Arranging for participation in religious activities, if requested by the resident.

(f) A congenial and homelike atmosphere within the residence.

History

Rulemaking Authority 429.73 FS. Law Implemented 429.73, 429.85 FS. History–New 5-14-86, Amended 2-2-95, Formerly 10A-14.007, Amended 9-19-96, 6-6-99, 4-29-08, 9-16-10, Formerly 58A-14.007, 7-1-19.

Fla. Admin. Code R. 59A-37.007 Staff Qualifications, Responsibilities and Training

(1) MINIMUM STAFF REQUIREMENTS.

The provider, all staff, each relief person, and all adult household members must submit a statement from a licensed health care provider that he or she is free from apparent signs and symptoms of communicable diseases, including tuberculosis. The statement must be based on an examination conducted within the six months prior to employment. Annually thereafter, the individual must submit documentation from a licensed health care provider that he or she is free from tuberculosis. An exception is that an individual with a positive tuberculosis test must submit a statement from a licensed health care provider that he or she does not constitute a risk of communicating tuberculosis.

(2) PROVIDER.

(a) An adult family-care home provider must:

Be at least 21 years of age.
Live in the home.
Be able to read, write and complete written materials involved in applying for an AFCH license and maintaining an AFCH.

(b) An adult family-care home provider is responsible for:

The operation and maintenance of the AFCH in accordance with Chapters 408, Part II, 429, Part II, F.S., Chapter 59A-35, F.A.C., and this rule chapter.
Ensuring that residents are appropriate for placement and continued residency in the home as provided under Rule 59A-37.004, F.A.C., and that care and services are provided for residents in accordance with Rule 59A-37.006, F.A.C.

(c) In the event of severe illness, incapacity, or death of the provider, the relief person or staff in charge shall notify each resident’s representative or case manager, and the Agency Field Office within 24 hours.

(3) RELIEF PERSONS.

(a) The adult family care home provider must designate one or more relief persons to assume responsibility for the care of residents if the provider is not available to perform that duty.

(b) The relief person must be:

At least 21 years of age; and,
Knowledgeable about and able to provide for all care needs of the residents.

(c) The provider must notify the agency in writing within 30 days of a change in relief persons and ensure that the relief person is appropriately background screened and trained as described in this rule.

(4) TRAINING.

(a) All AFCH providers must attend a 12-hour basic adult family-care home training program which covers the minimum requirements of Section 429.75, F.S., prior to accepting any residents, or for providers who already have persons residing in the home that will be considered residents, prior to licensing.

(b) The AFCH provider shall annually obtain 3 hours of continuing education in topics related to the care and treatment of frail elders or disabled adults, or the management and administration of an adult family-care home.

(c) The AFCH provider, each relief person, and any person left in sole charge of residents, which may include staff, household members or volunteers, must hold a currently valid card documenting completion of courses in First Aid and CPR. A nurse shall be considered as having met the training requirement for First Aid.

(d) Prior to assuming responsibility for the care of residents or within 30 days of employment, the AFCH provider shall ensure that each relief person and all staff receive training in areas that are relevant to the person’s job duties, including emergency and evacuation procedures, universal precautions, food safety, reporting abuse and neglect, and resident rights.

(e) Except as otherwise noted, certificates of any training required by this rule shall be documented in the facility’s personnel files.

History

Rulemaking Authority 429.67, 429.73, 429.75 FS. Law Implemented 429.67, 429.73, 429.75 FS. History–New 2-2-95, Formerly 10A-14.008, Amended 9-19-96, 6-6-99, 1-1-04, 7-30-06, 4-15-10, Formerly 58A-14.008, Amended 7-1-19, 2-27-22, 6-11-25.

Fla. Admin. Code R. 59A-37.008 Records

(1) RESIDENT RECORDS. The AFCH provider shall maintain a separate record for each resident on the premises and available for inspection by the agency.

(a) The record shall contain:

AHCA Form 3110-1023 (AFCH-1110) 01/08, Resident Health Assessment for Adult Family-Care Homes (AFCH), required by Rule 59A-37.004, F.A.C. A completed and signed form faxed by the health care provider shall be acceptable. The resident’s health care provider’s certification whether he or she may be left without supervision in the AFCH for up to 2 hours in a 24-hour period (Section H of the form) must be completed and included pursuant to paragraphs (a) and (b), of subsection 59A-37.006(2), F.A.C.
A copy of the residency agreement which meets the requirements of Rule 59A-37.005, F.A.C., including a copy of any notices of rate increases sent to the resident or the residents representative and any addendums.
For residents who are OSS recipients, a copy of the Alternate Care Certification for Optional State Supplementation (OSS) Form, CF-ES 1006, February 2005, provided by the Department of Children and Family Services.
Resident information which includes:

a. The name, address and telephone number of the resident’s guardian, attorney-in-fact, health care surrogate, next-of-kin, and any other responsible party with authority to make decisions on behalf of the resident.

b. The name, address and telephone number of the resident’s health care provider, health maintenance organization, dentist and case manager as applicable.

A complete accounting of any resident funds being received or distributed by the provider as required by Section 429.85, F.S.
For residents who self-administer, with or without supervision or assistance, a list of the resident’s current medications; or for resident’s receiving administration, the record of medications administered, as required under Rule 59A-37.006, F.A.C.
For residents receiving nursing services provided or arranged for by the provider, the nursing progress notes required under Rule 59A-37.006, F.A.C., and the health care provider’s order authorizing the nursing service.
A copy of any special diet order prescribed by the resident’s health care provider as required under Rule 59A-37.006, F.A.C.
A record of any major incidents or significant health changes and action taken in response to such incidents or changes as required under Rule 59A-37.006, F.A.C.
The resident’s monthly weight record as required by Rule 59A-37.006, F.A.C.
Documentation that the resident’s bill of rights and the procedure for lodging complaints has been discussed with the resident or the resident’s representative, as required by Rule 59A-37.004, F.A.C.
Documentation that the house rules have been discussed with the resident or the resident’s representative as required by Rule 59A-37.004, F.A.C.
A copy of any notice of discharge sent to the resident or the resident’s representative pursuant to Rule 59A-37.004, F.A.C.

(b) Closed resident records shall be retained for a period of 5 years after the resident leaves the AFCH. The provider shall be permitted 1 working day to produce closed records.

(2) STAFF RECORDS.

(a) An AFCH provider shall, at a minimum, maintain the following personnel records on the premises and available for inspection by the agency:

For the AFCH provider, each relief person, each adult household member, and each staff person verification of freedom from communicable disease as required under Rule 59A-37.007, F.A.C.
For the AFCH provider, each relief person, and each staff person:

a. Written documentation of all training required by Rule 59A-37.007, F.A.C.

b. A copy of any professional license.

For each staff member employed by the provider, a copy of the employment application which shall include the date of beginning employment.
For any person left in sole charge of residents written documentation of First Aid and CPR training as required by Rule 59A-37.007, F.A.C.

(b) If the AFCH provider contracts with a staffing agency to provide services to residents, the contract between the AFCH provider and the staffing agency must specifically describe the services the agency will be providing to residents. The AFCH provider is not required to maintain personnel records for staff provided by a staffing agency.

(3) FACILITY RECORDS. The AFCH provider shall maintain the following records on the premises and ensure the records are available for inspection by the agency:

(a) The AFCH license issued by the agency, which shall also be available to the public upon request.

(b) A copy of the most recent county health department inspection required by Rule 59A-37.009, F.A.C.

(d) Documentation of radon testing.

(e) The emergency plan required by Rule 59A-37.010, F.A.C.

(f) An up-to-date log listing all residents, and each resident’s:

Date of admission, the place admitted from and the reason for moving into the home, if known; and,
Date of discharge, the reason for discharge, and the location to which the person has been discharged, or if the person is deceased, the date of death.

(g) All completed survey and complaint investigation reports, and notices of sanctions and moratoriums issued to the AFCH by the agency within the last 3 years, which shall also be available to the public upon request.

(h) For AFCHs which claim to provide special care for persons with Alzheimer’s disease or related disorders, a copy of all advertisements or documents distributed to the public as described in Rule 59A-37.003, F.A.C.

(i) The facility shall maintain a record of each fire exit drill on Form DI4-1437, revised 1/2001, Fire Exit Drill Records for Adult Family Care Homes as set forth in subsections 59A-37.006(6) and (7), F.A.C.

History

Rulemaking Authority 429.67, 429.73, 429.75, 429.81 FS. Law Implemented 429.67, 429.73, 429.75, 429.81, 429.85 FS. History–New 6-6-99, Amended 7-30-06, 4-29-08, Formerly 58A-14.0085, 7-1-19.

Fla. Admin. Code R. 59A-37.009 Physical Site Standards

(1) GENERAL REQUIREMENTS.

(a) The AFCH shall be located, designed, equipped, and maintained to ensure a home-like environment, and to provide safe care and supervision for all residents. Residents shall be allowed free use of all space within the home except when such use interferes with the safety, privacy, and personal possessions of household members and other residents.

(b) The AFCH shall be structurally sound and in good repair. Windows, doors, plumbing, and appliances shall be functional and in good working order. All furniture and furnishings shall be clean and functional.

(c) In order to ensure a safe and sanitary environment, the AFCH must be inspected by the county health department, pursuant to Chapter 64E-12, F.A.C., at the time of license application and prior to license renewal.

(2) COMMON AREAS.

(a) At a minimum, there must be 40 square feet of common space per each resident and household occupant, or a total of 150 square feet of common area, whichever is greater. Common space includes the living room, family room, and dining room. The basement and garage shall not be included in the total common area unless such space was constructed or renovated to be used as a common area pursuant to a lawfully issued permit. Household occupants include residents and household members, 2 years of age and older, who reside in the AFCH.

(b) The furnishings in common areas shall be adequate to accommodate all residents and household members, including allowing the residents and household members to eat together in the dining area. The provider shall assist the resident to use any adaptive equipment for eating if such equipment has been ordered by the resident’s health care provider.

(c) The AFCH shall, at a minimum, maintain a telephone in the home which is available and accessible for the residents’ use at all times and, to the extent practicable, situated so as to facilitate private communication.

(d) Pursuant to Section 400.0071, F.S., the procedures for lodging complaints with the long-term care ombudsman council must be posted in full-view in a common area accessible to all residents.

(3) BEDROOMS.

(a) Single bedrooms for residents shall provide at least 80 square feet of floor space for each resident. Multi-occupancy bedrooms shall provide at least 60 square feet of floor space per resident. Any area where a sloped ceiling does not allow a person to stand upright shall not be counted as part of the required floor space. Homes licensed for the first time after February 2, 1995, or already licensed homes who increase their maximum capacity after February 2, 1995, may not have more than two residents per room.

(b) Bedrooms for all residents shall be finished with walls or partitions which go from floor to ceilings and which have a door which opens directly to a hallway or common area without passage through another bedroom or common bathroom. Bedroom doors shall not have vision panels. Window drapes or shades shall be provided to ensure resident privacy.

(c) There shall be a separate bed at least 36 inches wide and 72 inches in length for each resident consisting of a mattress and frame at a comfortable height to assure easy access by the resident. Cots, rollaways, bunks, trundles, couches, and folding beds may not be used for residents.

(d) A household member may not sleep in areas designated as common areas, nor share a bedroom with a resident. Married residents shall be provided the option of sharing bedroom accommodations, but non-related residents of different genders shall not be required to share bedroom accommodations.

(e) In addition to closet space, each bedroom shall have separate and private storage space for each resident’s clothing and personal effects. Residents shall be allowed to keep and use reasonable amounts of personal belongings, and shall be allowed to decorate their private quarters in an individual style provided such decor does not damage the provider’s property.

(f) Bedrooms shall be on a ground level for residents who are non-ambulatory or have impaired mobility.

(4) BATHROOMS.

(a) A toilet and sink shall be provided on each floor with resident bedrooms. There shall be at least one toilet and sink for each 4 household occupants, and at least one tub or shower for each 6 household occupants. Household occupants include residents and household members, 2 years of age and older, who reside in the AFCH.

(b) Bathrooms shall have a finished interior, a mirror, and a door which insures privacy and opens to a hall or common area. Access to a bathroom may not be through another person’s bedroom.

(c) Glass shower doors shall be tempered safety glass; shower curtains shall provide privacy. Non-slip floor surfaces shall be provided in tubs and showers. Residents shall have racks or hooks for drying bath linens and be provided a separate place for tooth brushes and towels.

(d) Bathrooms used by physically handicapped residents shall have grab bars for toilets, tubs, and showers. Hot water temperature shall be supervised for persons unable to self-regulate water temperature.

(e) If the home has a hot tub or spa, it shall have a safety cover when not in use.

(5) OUTDOOR AREAS. The AFCH shall have a yard available and accessible for use by residents.

History

Rulemaking Authority 429.67, 429.73 FS. Law Implemented 429.67, 429.73 FS. History–New 2-2-95, Formerly 10A-14.009, Amended 9-19-96, 3-25-98, 6-6-99, Formerly 58A-14.009, 7-1-19.

Fla. Admin. Code R. 59A-37.010 Fire Safety Standards and Emergency Procedures

(1) FIRE SAFETY STANDARDS.

(a) Each adult family-care home shall be subject to the requirements of rule Chapter 69A-57, F.A.C., Uniform Fire Safety Standards for Adult Family Care Homes.

(b) At the time of license application, prior to license renewal, and prior to an increase in capacity, the provider shall request the local authority having jurisdiction over fire safety to inspect the home for compliance with local codes and ordinances and the minimum standards of this rule. The inspection may be made by an employee of the agency who has a certification in fire safety, if the local fire authority indicates in writing that there is no inspector available to conduct an inspection. However, only the local fire authority shall give approval for multi-storied frame buildings.

(2) EMERGENCY PROCEDURES.

(a) The AFCH shall have a written plan which specifies emergency and evacuation procedures for fires and such natural disasters as hurricanes, floods, and tornadoes. The provider shall review the plan’s emergency and evacuation procedures with the residents, the relief person, all staff, and all household members.

(b) The provider shall at all times maintain first aid and emergency supplies including a 3-day supply of non-perishable food based on the number of residents and household members currently residing in the home, and 2 gallons of drinking water per current resident and household member.

The emergency number 911,
Police,
Fire department,
Ambulance,
The Florida Poison Information Center 1(800)282-3171,
Abuse Hotline 1(800)962-2873,
District Long-Term Care Ombudsman Council,
AHCA’s Field Office,
The Relief Person; and,
Providers of essential medical services.

(d) In the event of a declared disaster or emergency, the AFCH provider shall make available all necessary information regarding a resident’s location to essential medical services providers, both during and after the disaster or emergency.

History

Rulemaking Authority 429.67, 429.73 FS. Law Implemented 429.67, 429.73 FS. History–New 9-19-96, Amended 6-6-99, 7-30-06, Formerly 58A-14.0091, 7-1-19.

Fla. Admin. Code R. 59A-37.011 Administrative Enforcement

(1) GENERAL REQUIREMENTS.

(a) The provider shall cooperate with agency personnel during surveys or inspections, complaint investigations, implementation of correction plans, license application and renewal procedures, and other activities necessary to ensure compliance with Chapter 429, Part II, F.S., and this rule chapter.

(b) In addition to agency personnel, reasonable access to enter and inspect a licensed AFCH must be provided to any designated agent of the department, the Department of Health, the local authority with jurisdiction over fire safety, the Department of Children and Family Services, and the Human Rights Advocacy Committee. Representatives of the district long-term care ombudsman council shall be provided reasonable access pursuant to the provisions of Section 400.0073, F.S.

(2) INSPECTIONS.

(a) The agency shall conduct a survey or inspection of an adult family-care home:

Prior to issuance of a license,
Prior to annual renewal of a license,
Upon receipt of an oral or written complaint of practices that threaten the health, safety, or welfare of residents,
At any time if the agency has reason to believe an AFCH has violated a provision of Chapter 429, Part II, F.S., or this rule chapter,
To determine if cited deficiencies or noticed violations have been corrected; and
To determine if an adult family care home is operating without a license.

(b) The inspection shall consist of full access to and examination of the home’s physical premises, including the buildings, grounds, and equipment, and facility and resident records.

(c) Agency personnel may interview the provider, relief person, staff and residents. Interviews shall be conducted privately.

(d) Agency personnel shall respect the private possessions of residents, providers, household members, and staff while conducting the inspection.

(e) At the time of the inspection, the provider will be orally advised of any deficiencies found by agency personnel and a time frame established for correction of the violations. The time frame for the correction of violations starts from the date of the inspection. Cited deficiencies must be observed or otherwise substantiated by agency personnel. A written statement listing the deficiencies found, the rules or statutes violated, any corrections required, and time frames for correction shall be mailed to the AFCH by the agency within 10 working days after the date of inspection.

(f) For Class I violations that present an imminent danger to the health, safety or welfare of residents, the provider must correct the violation and abate the conditions no later than 24 hours and after agency inspection, unless a different time frame has been fixed by the agency as required by Section 429.71, F.S. The agency shall inspect the AFCH after the 24 hour period to determine if the violations have been corrected.

(g) For deficiencies found following an initial license or license renewal survey, a follow-up survey will be conducted to determine if the deficiencies have been corrected within the required time frame.

(3) COMPLAINT INVESTIGATIONS.

(a) The agency shall investigate any complaints regarding alleged practices in an AFCH that threaten the health, safety, or welfare of residents and shall notify the provider of the nature of the complaint, the results of the investigation, and any proposed action or sanction.

(b) If a complaint pertaining to the health, safety or welfare of residents is substantiated, the license of the provider shall be subject to agency actions or sanctions as provided in Chapter 429, Part II, F.S., and this rule.

The provider may not retaliate against any resident by increasing charges; decreasing services, rights or privileges; threatening to increase charges or decrease services, rights or privileges; by taking or threatening to take any action to coerce or compel the resident to leave the home or by harassing, abusing or threatening to harass or abuse a resident in any manner after the resident has filed a complaint with the agency or with the long-term care ombudsman council.
Any complainant, witness or staff shall not be subject to any retaliation, including restriction of access to the home or a resident, staff dismissal or harassment by a provider for filing a complaint or being interviewed about a complaint or being a witness.

(4) PLAN OF CORRECTION. For deficiencies found following a complaint investigation or other monitoring visit, the provider must provide a written plan of correction for each deficiency cited and a time frame for the correction of the deficiencies within the time frame discussed at the time of the complaint investigation or monitoring visit. The plan of correction must be returned no later than 10 working days after receipt of written notice.

(5) INFORMAL CONFERENCE. At any time after receipt of an oral or written notice of deficiencies, but prior to the expiration of the time frame for making corrections, the licensee or the agency may request a conference. The purpose of the conference is to discuss the deficiency and to provide information to the licensee or to the agency to assist the licensee in complying with the requirements of Chapter 429, Part II, F.S., and these rules. The request by a licensee or the agency for a conference does not extend any previously established time limit for correction.

(6) ADMINISTRATIVE SANCTIONS.

(a) If, after inspection the deficiencies have not been corrected within the time frame specified, or if the agency has not otherwise received sufficient evidence of compliance by the provider, the agency shall serve notice of administrative complaint upon the licensee in the manner provided under Chapter 120, F.S., and impose one or more administrative sanctions as provided under Sections 429.69 and 429.71, F.S.

(b) Notice of a license suspension or revocation shall be posted in the AFCH and visible to the public entering the home and residents.

(7) MORATORIUMS.

(a) Pursuant to Section 429.71, F.S., an immediate moratorium on admissions to an AFCH shall be placed on the home by the agency when it has determined that any condition or practice in the home presents a serious threat to the health, safety, or welfare of the residents.

(b) Following the imposition of the moratorium, the provider shall be provided with written confirmation of the placing of a moratorium by the agency, which notice shall be posted in the AFCH such that it is visible to the public entering the home, and shall:

Explain the reasons the moratorium was imposed,
Advise the provider how to arrange for an appraisal inspection by agency personnel to verify that corrections have been made,
Advise the provider of his/her right to request an administrative hearing pursuant to Section 120.57, F.S.

(c) While the moratorium is in effect, residents who have been temporarily discharged from the AFCH to a nursing home or hospital at the time the moratorium is imposed may not be re-admitted without agency approval.

(d) Moratoriums shall not be lifted until the violations have been corrected and the agency has been assured by an appraisal inspection that there is no longer any threat to the residents’ health, safety, or welfare. The lifting of a moratorium will be confirmed by written notification.

History

Rulemaking Authority 429.67, 429.71, 429.73 FS. Law Implemented 429.67, 429.71, 429.85 FS. History–New 2-2-95, Formerly 10A-14.010, Amended 9-19-96, 6-6-99, Formerly 58A-14.010, 7-1-19.

Chapter 59A-38 HOSPICE PROCEDURES

Fla. Admin. Code R. 59A-38.001 Definitions

In addition to definitions contained in Chapter 400, Part IV, F.S., the following terms shall apply:

(1) Advertising: The delivery, distribution, publication or display of an item, document, or medium initiated by the hospice that is intended to offer, describe, or advertise hospice or hospice-like services to the general public. A type of listing, which is formatted to only include a licensed hospice provider’s name, address, and telephone number in the telephone directory, shall not be considered advertising.

(2) Agency: Agency for Health Care Administration.

(3) AHCA: Agency for Health Care Administration.

(4) Autonomous: A separate and distinct operational entity, which functions under its own administration and bylaws, either within or independently of a parent organization.

(5) Department: Department of Elder Affairs.

(6) Employ: To engage the services of an individual, on either a salary or volunteer basis.

(7) Home: The patient’s current primary place of residence, including a private residence, assisted living facility, nursing home, hospice residential unit, or other place of permanent or temporary residence.

(8) Home Health Aide: An individual who provides personal health care services for a patient in the patient’s home or place of residence under the supervision of a registered nurse.

(9) Licensed Practical Nurse: An individual licensed pursuant to Chapter 464, F.S., to practice practical nursing.

(10) Patient Care Staff: Persons involved in direct care of the patient, including registered nurses, practical nurses and home health aides, social workers and other mental health professionals, and clergy or pastoral counselors.

(11) Patient’s Family: The person or those persons designated by the patient as having primary responsibility for care, or persons who are closely linked with the patient and are involved in the health and supportive care of the patient.

(12) Patient and Family Unit: The patient and the patient’s family.

(13) Registered Nurse: An individual who is licensed pursuant to Chapter 464, F.S., to practice professional nursing.

(14) Satellite Office: An office or other physical location serving as a contact point for patients, which is remote from the provider’s principal office, but is not separately licensed, and shares administration with the principal office.

History

Rulemaking Authority 400.605 FS. Law Implemented 400.602, 400.605 FS. History–New 5-6-82, Formerly 10A-12.02, 10A-12.002, Amended 4-27-94, Formerly 59A-2.002, Amended 6-5-97, 8-11-08, Formerly 58A-2.002.

Fla. Admin. Code R. 59A-38.002 License Requirements

(1) In addition to the requirement specified in Section 400.602(1)(b), F.S., the face of the license must contain the following information:

(a) The name and address of the provider, including the principal office and all satellite offices;

(b) All freestanding hospice inpatient facilities and residential units;

(d) The name of the owner; and,

(e) The effective and expiration dates of the license.

(2) The hospice must notify the department and the agency in writing at least sixty (60) days before making a change in name or address of the provider’s principal or satellite offices.

(3) If a change of ownership as defined in Section 408.803(5), F.S., is contemplated, the new owner must submit a license application and must receive a license prior to commencement of operation of the hospice. The following materials must accompany the license application:

(a) A signed agreement to correct any existing licensure deficiencies;

(b) Documented evidence that the change of ownership has taken place or will take place upon approval of the license; and,

(c) A statement that records pertaining to the administrative operation of the provider must be retained and made available for official inspection by the agency.

(4) If a merger of two or more hospice providers is contemplated, the legal and incorporated entity that will be responsible for the operational function of the hospice after the merger must notify the agency prior to the merger. Notification must include the anticipated date for the merger and the reason for the merger. The agency shall require the legal entity to submit a license application, including a revised plan for the delivery of hospice care to terminally ill patients and their families.

History

Rulemaking Authority 400.605 FS. Law Implemented 400.602, 400.605 FS. History–New 5-6-82, Formerly 10A-12.03, 10A-12.003, Amended 4-27-94, Formerly 59A-2.003, Amended 6-5-97, 8-11-08, Formerly 58A-2.003.

Fla. Admin. Code R. 59A-38.003 Licensure Procedure

(1) Licenses issued by the AHCA to operate a hospice shall be based upon the results of a survey conducted by the AHCA to determine compliance with the requirements of Chapter 400, Part IV, F.S., and with these rules. A license shall be issued to any not-for-profit public or private agency who meets all federal, state and local requirements.

(2) Application for license shall be made to the AHCA on forms prescribed by the AHCA. The application shall be accompanied by a license fee of six hundred dollars ($600.00) as provided under Section 400.606, F.S., in check or money order, payable to the Agency for Health Care Administration.

(3) In addition to the information required in Section 400.606(1), F.S., the following information is required for the licensure application:

(a) The name of the hospice’s administrator and the administrator’s license number if the administrator is a licensed professional; the name and license number of the hospice’s medical director; the number and types of licensed professionals, including clergy, employed or to be employed by the hospice; the number of home health aides employed or to be employed by the hospice; the number and types of other personnel employed or to be employed by the hospice and assigned to a hospice care team or teams.

(b) For initial licensure only, the Certificate of Need and certificates of occupancy signed by local authorized zoning, building and electrical officials shall be attached to the application. For initial licensure, where there are no municipal, county or electrical building codes, the applicant shall provide a written statement of compliance with these regulations from a registered architect or professional engineer who shall substitute for the authorities specified above. A separate survey for fire safety and physical plant requirements of residential and freestanding inpatient facilities operated by the hospice shall be made by the AHCA prior to the opening of the facilities and on a periodic basis.

(c) As a condition of licensure, each successful applicant shall submit the names and professions for all hospice care team staff, and license numbers held by hospice care team staff who are licensed, no later than three (3) months after the license is issued.

History

Rulemaking Authority 400.605 FS. Law Implemented 400605(1)(a) FS. History–New 5-6-82, Formerly 10A-12.04, Amended 10-6-91, Formerly 10A-12.004, Amended 4-27-94, Formerly 59A-2.004, Amended 6-5-97, 8-10-03, Formerly 58A-2.004.

Fla. Admin. Code R. 59A-38.004 Administration of the Hospice

(1) Governing Body. The hospice provider must establish written bylaws for a governing body with autonomous authority for the conduct of the hospice program. The governing body must satisfy the following requirements:

(a) Members must reside or work in the hospice provider’s service area as defined in paragraph 59C-1.0355(2)(k), F.A.C.

(b) No person shall be denied membership on the governing body by reason of race, creed, color, age or sex.

Adoption in writing of the following documents which must be in compliance with provisions of Chapter 400, Part IV, F.S., and these rules, with updates as necessary:

a. Criteria defining eligibility for hospice services;

b. A program for building and coordinating relationships with other community organizations in order to provide hospice patients assistance with meals, utility payments, legal services, home repair and equipment, and other needs as identified on an individual basis;

c. Standards of hospice care which will ensure compliance with these rules and Chapter 400, Part IV, F.S., and which will promote and maintain a quality of life for each patient and family that reflects the patient’s needs and values;

d. A comprehensive emergency management plan for all administrative, residential, free-standing inpatient facilities, and hospice services designed to protect the safety of patients and their families and hospice staff; and,

e. An annual operating and strategic plan and budget.

Promulgation of rules and bylaws which include at least the following:

a. The purpose of the hospice;

b. Annual review of the rules and bylaws which shall be dated and signed by the chairman of the governing body;

c. The powers and duties of the officers and committees of the governing body;

d. The qualifications, method of selection and terms of office of members and chairpersons of the governing body and committees; and,

e. A mechanism for the administrator’s appointment of the medical director and other professional and ancillary personnel.

(2) Administrative Officer. The hospice provider must employ an administrator whose duties must be outlined in a written job description, including job qualifications. The administrator must be approved by the governing body. The job description must be kept in an administrative file.

(a) The administrator shall be responsible for day-to-day operations and the quality of services delivered by the hospice provider.

(b) The administrator must be responsible for maintaining an administrative office for the purpose of the operations of the hospice provider.

(3) Administrative Policies and Practices.

(a) The administrator must be responsible for developing, documenting and implementing administrative policies and practices which are consistent with these rules, the bylaws, and the plans and decisions adopted by the governing body. These policies and practices must ensure the most efficient operation of the hospice program and the safe and adequate care of the patient and family units. These policies and practices must include:

Policies governing admission to the hospice program and discontinuation of care.
Personnel policies applicable to all full-time and part-time paid employees and volunteers, including job descriptions, job qualifications and duties, which shall be kept in an administrative file.
A plan for orientation and training of all staff, including volunteers, which must ensure that staff receive training prior to the delivery of services. This plan must describe the method of assessing training needs and designing training to meet those needs, and must include a curriculum outline with specific objectives.
Financial policies and practices that include:

a. An annual budget for approval by the governing body;

b. An annual audited financial statement for approval by the governing body;

c. An ongoing bookkeeping and financial management system that is developed and implemented according to sound business practice;

d. An ongoing payroll system that is developed and implemented according to sound business practice;

e. Procedures for accepting and accounting for gifts and donations; and,

f. A fee schedule for hospice care.

Policies for administering drugs and biologicals in the home which must include:

a. All orders for medications shall be dated and signed by a physician licensed in the State of Florida pursuant to Chapter 458 or 459, F.S.

b. All orders for medications shall contain the name of the drug, dosage, frequency and route.

c. All verbal orders for medication or treatments, or changes in medication or treatment must be taken by a licensed health professional and recorded in the patient’s record. Verbal orders must be signed by the physician within thirty (30) calendar days from the date of the order.

d. Experimental drugs shall not be administered without the written consent of the patient or the patient’s legal representative, surrogate or proxy. The program administering such drugs must fully inform the patient or the patient’s legal representative, surrogate or proxy of any risks, and be prepared to invoke remedial action should an adverse reaction occur. A copy of the signed consent must be kept in the patient’s record.

Policies and procedures for the administration and provision of pharmaceutical services in inpatient and residential settings that are consistent with the drug therapy needs of the patient as determined by the medical director or the patient’s attending physician(s). The pharmaceutical services shall be directed by a pharmacist registered in the State of Florida.
Policies and procedures approved by the medical director and governing body pertaining to the hospice provider’s drug control system including specific policies and procedures for disposal of Class II drugs upon the death of a patient.
Procedures which ensure the hospice provider can provide patients with medications on a twenty-four (24) hours a day, seven (7) days a week basis.
Policies and procedures for maintenance, confidentiality, and retention of clinical records for a minimum five-year period following the patient’s death.
Procedures for inpatient visitation by family and friends.
Procedures for maintaining a record of requests for services. The record shall indicate the action taken regarding each request for hospice services and whether or not the patient has the ability to pay for the services. In no case shall a hospice provider refuse or discontinue hospice services based on the inability of the patient to pay for such services.
Notice to the public that the hospice provider renders services regardless of ability to pay.
Notice to the public of all services provided by the hospice program, the geographic area in which the services are available, and admission criteria.
Policies for educating the community to enhance public awareness of hospice services.
Policies and procedures for completion, retention, and submission of reports and records as required by the department, agency, and other authorized agencies.
Policies and procedures for implementing universal precautions as established by the Centers for Disease Control and Prevention.

(b) Equipment and personnel, under medical supervision, must be provided for diagnostic procedures to meet the needs of the hospice inpatient, residential and home-care programs. This must include the services of a clinical laboratory and radiological services, which must meet all standards of the State of Florida. There must be written agreements or contracts for such services unless provided on the premises of the hospice. The hospice program must ensure that services are available twenty-four (24) hours a day, seven (7) days a week, either through contractual agreement, written agreement, or direct service provision by the hospice provider.

(c) Each hospice provider shall develop an infection control program which specifies procedures and responsibilities for inpatient, residential care and home-care programs. Procedures regulating the structure and function of this program shall be approved by the medical director and the governing body, and shall comply with federal and state laws regarding blood-borne pathogens, infection control and biohazardous waste.

(4) Each hospice provider must comply with the national hospice outcome measures as adopted by the Centers for Medicare and Medicaid Services (CMS) pursuant to 42 Code of Federal Regulations (CFR) Part 418, as a tool to set benchmarks for measuring quality of hospice care in the state.

(5) National Initiatives.

(a) In accordance with Section 400.60501, F.S., and as referenced in subsection (4) of this rule, the Agency adopts the national initiative of utilizing patient/family surveys as a tool to set benchmarks for measuring quality of hospice care in the State of Florida.

(b) Hospice providers must maintain documentary evidence of their compliance with these national initiatives and demonstrate their operations to the Agency during the survey process.

History

Rulemaking Authority 400.605, 400.60501 FS. Law Implemented 400.605(1)(c), 400.60501, 400.610 FS. History–New 5-6-82, Formerly 10A-12.05, 10A-12.005, Amended 4-27-94, Formerly 59A-2.005, Amended 6-5-97, 8-6-02, 8-10-03, 8-11-08, Formerly 58A-2.005, Amended 8-9-21, 2-26-26.

Fla. Admin. Code R. 59A-38.005 Coordinated Care Program

(1) The administrator shall be responsible for ensuring the development, documentation and implementation of a staffing pattern for all components of a hospice program (inpatient, residential and home-care), which shall be kept in an administrative file.

(a) A general staffing plan shall include the rationale for determining staffing requirements, which shall be based on the needs of the patients and their families and shall ensure appropriate care to meet those needs.

(b) The staffing patterns for contracted inpatient components shall meet or exceed the minimum staffing requirements under which the contracted facility is currently licensed.

(c) Minimum service provided for routine home care, consistent with the patient’s status and the family’s well-being, shall be a weekly telephone contact and a biweekly visit by a registered nurse.

(2) The administrator shall be responsible for ensuring the development, documentation and implementation of a current plan that delineates cooperative planning, decision-making and documentation by the disciplines represented in the members of the hospice care team and which provides the staff with methods of meeting collective and individual responsibilities as outlined and assigned in the plan of care for each patient and family unit. Such policies and procedures shall, at a minimum, include the following:

(a) Identification of the patient and the patient's family as the unit of care;

(b) Identification of the hospice care team as the unit that provides care to the patient and family unit and that is responsible for admission, assessment and the individual plan of care for the patient and the patient's family in accordance with the requirements of Section 400.6095, F.S.;

(c) Methods of controlling the symptoms of terminal illness together with methods of evaluating and studying such methods;

(d) Methods of teaching the patient and the patient’s family those skills necessary to promote the patient and family relationship and enhance the independence of the patient and family unit; and,

(e) Methods to ensure that the patient and the patient’s family shall, insofar as practical, define the needs to be addressed in the plan of care, provide significant information and assistance in developing and implementing an effective plan of care, and have access to the written plan of care upon request.

(3) The administrator shall be responsible for ensuring that the hospice care team:

(a) Provides a mechanism whereby the patient and the patient’s family shall be able to communicate directly with a member of the hospice care team on a twenty-four (24) hours a day, seven (7) days a week basis.

(b) Documents all such communication including requests for hospice care and the disposition of such requests.

(c) Is staffed in such a manner as to be able to receive and respond to such requests and provide interdisciplinary hospice services on a twenty-four (24) hours a day, seven (7) days a week basis.

(d) Provides continuity of services without interruption through all modes of care delivery in the hospice program. Admission to a hospice program means accessibility to all its hospice core services as described in Section 400.609(1), F.S.

(e) Documents all services provided by the hospice care team in the interdisciplinary care record.

History

Rulemaking Authority 400.605 FS. Law Implemented 400.605 FS. History–New 5-6-82, Formerly 10A-12.09, 10A-12.009, Amended 4-27-94, Formerly 59A-2.009, Amended 6-5-97, Formerly 58A-2.009.

Fla. Admin. Code R. 59A-38.006 Quality Assurance and Utilization Review (QAUR)/Quality Assessment and Performance Improvement (QAPI) Committee and Plan

Pursuant to Section 400.610(2), F.S., each hospice must appoint a committee which must develop, document and implement a comprehensive quality assurance and utilization review plan, also referred to as a quality assessment and performance improvement plan. The QAUR/QAPI plan must be in accordance with quality assessment and performance improvement (QAPI) standards incorporated within the Medicare Conditions for Participation, 42 C.F.R., Part 418, and must include goals and objectives, provisions for identifying and resolving problems, methods for evaluating the quality and appropriateness of care, and the effectiveness of actions taken to resolve identified problems. The QAUR/QAPI plan must establish a process for revising policies, procedures and practices when reviews have identified problems. The QAUR/QAPI committee must review the QAUR/QAPI plan and report findings and recommendations to the governing body annually. Dated and signed minutes of those meetings of the governing body at which QAUR/QAPI findings and recommendations are presented must be kept in an administrative file.

(1) The QAUR/QAPI committee must be composed of individuals who are trained, qualified, supervised and supported by review procedures and written criteria related to treatment outcomes. These review procedures and written criteria must be established with involvement from physicians, and shall be evaluated and updated annually by the QAUR/QAPI committee.

(2) An incident or accident report shall be required in every instance of error in treatment, adverse reaction to treatment or medication, or injury to the patient. All of these incident or accident reports shall be reviewed by the QAUR/QAPI committee.

(3) The QAUR/QAPI committee must audit patient records, including interdisciplinary care records, on a regular and periodic basis. All records must be stored in secured areas to protect patient confidentiality.

(a) Active patient records shall be kept at the main office, a satellite office, a hospice residential facility or a hospice inpatient facility.

(b) The master record may be moved to storage in a secure and accessible location after termination of bereavement services or a minimum of one year after the patient’s death.

(4) The QAUR/QAPI committee shall assist the administrator in developing, documenting and implementing a formal training and orientation program for individuals conducting utilization review activities.

(5) Activities undertaken by the QAUR/QAPI committee must demonstrate a systematic collection, review, and evaluation of information and must result in proposed actions to correct any identified problems. The information used by the QAUR/QAPI committee must include:

(a) Care provided in alternate settings and by contracted entities;

(b) Services provided by professional and volunteer staff;

(d) Incident reports;

(e) Complaints received from patients and their families;

(f) High-risk, high-volume and problem-prone activities that would have a significant impact on patients, staff or the organization, even if adverse incidents occur infrequently. For example, high-risk activities may include review and evaluation of protocols for containment of communicable diseases, emergency evacuations and continuity of operations; high-volume activities might include collection of information regarding administration of medications; lastly, identifying problem-prone activities might include deterioration or malfunction of equipment, including security of information systems, disposal of contaminated materials or other bio-medical waste; and,

(g) Appropriateness of team services and levels of care measured by whether:

The plan of care was directly related to the identified physical and psychosocial needs of the patient and the patient’s family;
Services, medications and treatments prescribed were in accordance with the current hospice plan of care; and,
The hospice care was primarily a home-care program that utilized inpatient hospice care on a short-term or respite basis only.

(6) The QAUR/QAPI committee shall periodically review the accessibility of hospice services and the quality of those services.

(7) The QAUR/QAPI committee shall make recommendations to the administrator and the governing body for resolving identified problems and for improving patient and family care.

History

Rulemaking Authority 400.605 FS. Law Implemented 400.605, 400.610 FS. History–New 5-6-82, Formerly 10A-12.10, 10A-12.010, Amended 4-27-94, Formerly 59A-2.010, Amended 6-5-97, 8-11-08, Formerly 58A-2.010.

Fla. Admin. Code R. 59A-38.007 Demographic and Provision of Care Data Reporting

(1) Each hospice shall submit demographic and provision of care data to the Agency annually for the calendar year period January 1 through December 31 no later than March 31 of the following year. Data must be submitted through the link included in the e-blast sent to each provider one month prior to the due date for the submission period.

(2) Data submitted must detail the following information in aggregate numbers for the submission period:

(a) Inpatient Care and Residential Units operated by the hospice, including freestanding units and contracted locations of care to include:

Name and address of facility.
County where facility is located.
Number of beds within the facility.
Number of facility admissions.
Total facility patient days.

(b) Primary diagnosis of patients at time of admission to include:

Cancer.
Illness due to Acquired Immune Deficiency Syndrome (AIDS).
Heart, Circulatory, or Cardiovascular Disease.
End-Stage Pulmonary Disease.
End-Stage Renal Disease (ESRD).
Stroke.
Dementia or Alzheimer’s Disease.
Other diagnoses.

0-18 years of age.
19-44 years of age.
45-64 years of age.
65-84 years of age.
85 years of age and older.

(d) Race of patients admitted during the reporting period in aggregate number:

Asian/Pacific Islander.
Native Hawaiian or Other Pacific Islander.
Black/African American.
White/Caucasian.
Two or more races or not known.
American Indian or Alaskan Native.
Other.

(e) Ethnicity of persons admitted during reporting period irrespective of reported race:

Hispanic.
Non-Hispanic.

(f) Gender of persons admitted during the reporting period:

Male.
Female.
Not known or not reported.

(g) Percent of reimbursement for patient care by payor source:

Medicare.
Medicaid.
Third party.
Self-pay.
Uncompensated.
Other.

(h) Total number of patient days by location during the reporting period:

Private residence.
Adult Family Care Home.
Assisted Living Facility.
Nursing Home – Contracted Non-Inpatient Bed.
Nursing Home – Contracted Inpatient Bed.
Hospital – Dedicated Hospice Unit.
Hospital – Other Than Dedicated Hospice Unit.
Hospice Residential Facility.
Freestanding Hospice Inpatient Facility.
Other.

(i) Total number of patient discharges by disposition during the reporting period:

Deaths.
Non-Deaths.

(3) Demographic and provision of care data will be available through the following link as a summary of the data reported: https://quality.healthfinder.fl.gov/Hospice/Hospice.aspx

(4) A licensee that fails to submit the required information by the due date may be fined up to $50 per day late not to exceed $500 in accordance with section 408.813, F.S.

History

Rulemaking Authority 400.605 FS. Law Implemented 400.605 FS. History–New 5-6-82, Formerly 10A-12.12, 10A-12.012, Amended 4-27-94, Formerly 59A-2.012, Amended 6-5-97, 8-11-08, Formerly 58A-2.012, Amended 10-31-23.

Fla. Admin. Code R. 59A-38.008 Medical Direction

(1) The hospice shall employ a medical director who shall be a hospice physician licensed in the State of Florida pursuant to Chapter 458 or 459, F.S., who has admission privileges at one or more hospitals commonly serving patients in that hospice’s service area as defined in Rule 59C-1.0355, F.A.C. Duties shall be enumerated in a job description, including job qualifications, which shall be kept in an administrative file.

(2)(a) The medical director or his or her designee, a physician licensed under Chapter 458 or 459, F.S., must be a member of the hospice care team and must be responsible for the direction and quality of the medical component of the care rendered to the patient by the hospice care team. The patient’s attending physician(s) may remain the primary physician(s) to the patient, depending upon the preferences of the patient and the patient’s family. The patient and the patient’s family may elect to have the hospice medical director assume all or part of the primary medical care functions, or act as a consultant to the patient’s attending physician(s). In either case, the hospice care team must maintain a reporting relationship with the patient’s attending physician(s).

(b) Duties of the medical director shall include:

Reviewing clinical material of the patient’s attending physician(s) to document basic disease process, prescribed medicines, assessment of patient’s health at time of entry and the drug regimen, or performing an admission history and physical for each patient.
Validating the attending physician(s)’ prognosis and life expectancy for the patient.
Assisting in developing and medically validating the plan of care for each patient and family unit with the coordination of the patient’s attending physician(s).
Attending and actively participating in patient and family care conferences.
Rendering or actively supervising medical care for hospice patients and maintaining a record of such care.
Maintaining a regular schedule of participation in all components of the hospice care program and maintaining twenty-four (24) hours a day, seven (7) days a week coverage of and ready availability to the hospice program through him or herself or his or her licensed hospice physician designee.
Acting as a consultant to attending, including personal, physicians and other members of the hospice care team; helping to develop and review policies and procedures for delivering care and services to the patient and family unit; serving on appropriate committees; and reporting regularly to the hospice administrator regarding medical care delivered to the hospice patients.
Maintaining liaison with the patient’s attending physician(s), who is encouraged to provide primary care to his or her patient even though the patient also receives hospice care. The hospice physician will provide palliative care to his or her patient.
Establishing written protocols for symptom control, i.e., pain, nausea, vomiting, or other symptoms.
Assisting 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 physician(s) who shall perform duties prescribed herein. Any appointed physician shall be subject to the same licensing qualifications as the hospice medical director.

(4) The medical director shall assist the administrator in developing, documenting and implementing policies and procedures for regulating the delivery of physicians’ services, for orientation of new hospice physicians, and for continuing training and support of hospice physicians. These policies and procedures shall:

(a) Ensure that a hospice physician is on-call twenty-four (24) hours a day, seven (7) days a week; and

(b) Provide for the review and evaluation of clinical practices within hospice inpatient, residential and home-care programs in coordination with the QAUR/QAPI committee.

History

Rulemaking Authority 400.605 FS. Law Implemented 400.605, 400.610, 400.6105 FS. History–New 5-6-82, Formerly 10A-12.14, 10A-12.014, Amended 4-27-94, Formerly 59A-2.014, Amended 6-5-97, 8-11-08, Formerly 58A-2.014.

Fla. Admin. Code R. 59A-38.009 Nursing Services

(1) The hospice shall employ a registered nurse who shall monitor all services provided by hospice nurses and home health aides. The supervising registered nurse shall be qualified by supervisory or hospice experience and shall have completed a hospice training program sponsored by the employing hospice. Duties shall be enumerated in a job description, including job qualifications, which shall be kept in an administrative file.

(2) The supervising registered nurse shall assist the administrator in developing, documenting and implementing policies and procedures for the delivery of clinical nursing services throughout the hospice program, including home-care, residential and inpatient programs; the orientation and training of newly employed or contractual hospice nurses and home health aides; and ongoing training and education of the hospice nurses and home health aides.

(3) The hospice shall ensure, by employment or contractual arrangements, that there are sufficient nurses and home health aides to meet the health care needs of the patient population of the hospice.

History

Rulemaking Authority 400.605 FS. Law Implemented 400.605, 400.609, 400.6105 FS. History–New 6-5-97, Formerly 58A-2.0141.

Fla. Admin. Code R. 59A-38.010 Spiritual Counseling Services

(1) The hospice shall employ a clergy-person or pastoral counselor to provide spiritual counseling. The clergy-person or pastoral counselor shall have a degree in ministry from a college, university or divinity school; or shall have completed a clinical pastoral education program with an emphasis in health care ministry; or shall have completed formal training and is recognized as qualified to perform pastoral services in his or her religion or belief system. The clergy-person or pastoral counselor shall also have completed a hospice training program sponsored by the employing hospice. Duties shall be enumerated in a job description, including job qualifications, which shall be kept in an administrative file.

(2) The clergy-person or pastoral counselor shall assist the administrator in developing, documenting and implementing policies and procedures regulating the delivery of such services.

(3) The hospice shall ensure, by employment or contractual arrangement, that there are sufficient clergy-persons or pastoral counselors to provide spiritual support to the patient population of the hospice and the patients’ families.

(4) The hospice and its agents shall not impose the dictates of any value or belief system on its patients and their families.

History

Rulemaking Authority 400.605 FS. Law Implemented 400.605, 400.609, 400.6105 FS. History–New 5-6-82, Formerly 10A-12.15, 10A-12.015, Amended 4-27-94, Formerly 59A-2.015, Amended 6-5-97, Formerly 58A-2.015.

Fla. Admin. Code R. 59A-38.011 Counseling and Social Services

(1) The hospice shall employ a social worker who has a degree in social work or a degree in a related field with experience in social work, and who has completed a hospice training program sponsored by the employing hospice. Duties shall be enumerated in a job description, including job qualifications, which shall be kept in an administrative file.

(2) Therapeutic counseling services, if provided, must be provided by a social worker, marriage and family therapist, mental health counselor, or other mental health professional who is licensed by or authorized under the laws of the state of Florida to provide such services.

(3) The social worker shall assist the administrator in developing, documenting and implementing policies and procedures regulating the delivery of such services.

(4) The hospice shall ensure, by employment or contractual arrangement, that there are sufficient social workers and other mental health professionals to meet the social, emotional and mental health needs of the patients and families being served by the hospice.

History

Rulemaking Authority 400.605 FS. Law Implemented 400.605, 400.609, 400.6105 FS. History–New 5-6-82, Formerly 10A-12.16, 10A-12.016, Amended 4-27-94, Formerly 59A-2.016, Amended 6-5-97, Formerly 58A-2.016.

Fla. Admin. Code R. 59A-38.012 Volunteer Services

(1) The hospice shall employ a coordinator of volunteer services who shall assist the administrator in developing, documenting and implementing a volunteer services program which meets the operational needs of the program and provides services to the patient and family units in accordance with the individual plans of care. Duties shall be enumerated in a job description, including job qualifications, which shall be kept in an administrative file.

(2) The volunteer coordinator shall assist the administrator in developing, documenting and implementing policies and procedures regulating the delivery of such services, volunteer orientation, and ongoing training and support for volunteers.

(3) The hospice shall make effort to recruit volunteers to provide support for the needs and comfort of the patient population of the hospice and the patients’ families.

History

Rulemaking Authority 400.605 FS. Law Implemented 400.605, 400.609, 400.6105 FS. History–New 5-6-82, Formerly 10A-12.17, 10A-12.017, Amended 4-27-94, Formerly 59A-2.017, Amended 6-5-97, Formerly 58A-2.017.

Fla. Admin. Code R. 59A-38.013 Bereavement Services

The hospice shall provide bereavement counseling and services to the families of hospice patients for a minimum of one (1) year following the patient’s death. The formal and informal supportive services which comprise bereavement counseling shall be supervised or provided by professional staff as described in Rules 59A-38.010 and 59A-38.011, F.A.C.

(1) The administrator shall ensure the development, documentation and implementation of policies and procedures regulating the delivery of bereavement counseling and services.

(2) The bereavement program shall provide educational and spiritual materials and individual and group support services for the patient’s family after the patient’s death.

History

Rulemaking Authority 400.605 FS. Law Implemented 400.605, 400.609 FS. History–New 5-6-82, Formerly 10A-12.18, 10A-12.018, Amended 4-27-94, Formerly 59A-2.018, Amended 6-5-97, Formerly 58A-2.018.

Fla. Admin. Code R. 59A-38.014 Nutritional Services

The administrator shall ensure that dietary services and nutritional counseling services are available to all patient and family units in all components of hospice care on an as-needed basis.

(1) The administrator shall ensure the development, documentation and implementation of written policies and procedures for dietary services including nutritional counseling services.

(2) In hospice residential care and hospice inpatient care settings, the hospice shall provide consultation by a licensed dietitian on practical freedom-of-choice diets for hospice patients and shall ensure that patients’ favorite foods are included in their diets whenever possible.

History

Rulemaking Authority 400.605 FS. Law Implemented 400.605, 400.609 FS. History–New 5-6-82, Formerly 10A-12.19, 10A-12.019, Amended 4-27-94, Formerly 59A-2.019, Amended 6-5-97, Formerly 58A-2.019.

Fla. Admin. Code R. 59A-38.015 Advance Directives and Do Not Resuscitate Orders (DNRO)

(1) The administrator must ensure the development, documentation and implementation of policies and procedures which delineate the hospice’s compliance with the state law and rules relative to advance directives. The hospice must not base or condition treatment or admission upon whether or not the patient has executed or waived an advance directive. In the event of a conflict between the hospice’s policies and procedures and the patient’s advance directive, resolution must be made in accordance with Chapter 765, F.S.

(2) The hospice’s policies and procedures must include:

(a) At the time of admission, providing each patient, or the patient’s surrogate, proxy or other legal reprensentative, with a copy of Form SCHS-4-2006, “Health Care Advance Directives – The Patient’s Right to Decide,” effective April 2006, or with a copy of some other substantially similar document which incorporates information regarding advance directives included in Chapter 765, F.S. The form is hereby incorporated by reference and is available from the Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop 34, Tallahassee, FL 32308, or the agency’s website at: http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/HC_Advance_Directives /docs/adv_dir.pdf.

(b) At the time of admission, providing each patient, or the patient’s surrogate, proxy or other legal representative, with written information concerning the hospice’s policies regarding resuscitation and advance directives, including information concerning DH Form 1896, Florida Do Not Resuscitate Order Form, incorporated by reference in Rule 64J-2.018, F.A.C.

(c) Requiring documentation of the existence of an advance directive in the patient’s medical record. A hospice which is provided with a patient’s advance directive shall make the advance directive or a copy thereof a part of the patient’s interdisciplinary care record and the patient’s medical record.

(3) Pursuant to Section 400.6095(8), F.S., a hospice may withhold or withdraw cardiopulmonary resuscitation from a patient if a valid Do Not Resuscitate Order (DNRO) is presented and executed pursuant to Section 401.45, F.S.

(a) An absence of an order not to resuscitate, executed pursuant to Section 401.45, F.S., does not preclude a physician from withholding or withdrawing cardiopulmonary resuscitation as otherwise permitted by law.

(b) Hospice personnel shall not be subject to criminal prosecution or civil liability, nor be considered to have engaged in negligent or unprofessional conduct for withholding or withdrawing cardiopulmonary resuscitation pursuant to such a DNRO and rules adopted by the department, pursuant to Section 400.6095(8), F.S. Any licensed professional hospice personnel, who, in good faith, obeys the directives of an existing DNRO, executed pursuant to Section 401.45, F.S., will not be subject to prosecution or civil liability for his or her performance regarding patient care.

(4) Pursuant to Section 765.110, F.S., a hospice health care provider or facility shall be subject to discipline if the healthcare provider or facility requires an individual to execute or waive an advance directive as a condition of treatment or admission.

History

Rulemaking Authority 765.110, 400.605, 400.6095(8) FS. Law Implemented 400.605, 400.6095(8), 765.109, 765.110 FS. History–New 1-11-93, Formerly 59A-2.025, Amended 4-27-94, Formerly 59A-2.0232, Amended 6-5-97, 8-11-08, Formerly 58A-2.0232.

Fla. Admin. Code R. 59A-38.016 Residential Units

(1) Residential units which are established by a licensed hospice provider will not be required to be separately licensed. Residential units shall comply with local codes and ordinances governing zoning, fire, safety, and health standards.

(2) Residential units shall be maintained in a manner which provides for managing personal hygiene needs of the patients and implementation of infection control procedures.

(3) Equipment and furnishings in residential units will provide for the health care needs of the resident while providing a home-like or non-institutional type of atmosphere.

(4) The hospice provider shall insure that:

(a) Each patient residing in a residential unit has an identified individual who will serve as that patient’s principal advocate and contact person.

(b) The residential unit is staffed at sufficient skill level and number to meet the needs of the patients and their families.

At all times the residential unit shall be staffed with a minimum of two (2) employees, one (1) of which shall be a licensed nurse.
Units for more than eight (8) patients shall be a staff-to-patient ratio of one to four (1:4) calculated on a twenty-four (24) hour period. At no time shall the unit have a staff-to-patient ratio of less than one to six (1:6).
All staff on duty shall assist with evacuation of patients in the event of an emergency.

(5) Services provided in the residential unit are consistent with the plan of care prepared for that patient and are consistent with services provided by the hospice program in other settings.

(6) Residential units shall be equipped to prepare meals that meet the dietary requirements of the patient.

(7) Upon adoption of this rule, newly constructed or renovated residential units shall comply with the requirements of Section 400.6051, F.S.

History

Rulemaking Authority 400.605 FS. Law Implemented 400.605, 400.6051 FS. History–New 4-27-94, Formerly 59A-2.0236, Amended 6-5-97, 8-10-03, 4-24-07, Formerly 58A-2.0236.

Fla. Admin. Code R. 59A-38.017 Physical Plant Requirements (Inpatient Facility and Unit)

(1) As used in this rule, “inpatient facility and unit” means the location where inpatient services are provided to hospice patients.

(2) All new inpatient facilities and units, and additions or renovations to existing facilities and units shall be in compliance with the requirements of Section 400.6051, F.S.

History

Rulemaking Authority 400.605, 400.6051 FS. Law Implemented 400.6051 FS. History–New 8-10-03, Amended 4-24-07, Formerly 58A-2.025.

Fla. Admin. Code R. 59A-38.018 Comprehensive Emergency Management Plan

(1) Pursuant to Section 400.610(1)(b), F.S., each hospice shall prepare and maintain a comprehensive emergency management plan, hereinafter referred to as “the plan,” in accordance with the “Comprehensive Emergency Management Plan (CEMP) Format for Hospices,” DOEA Form H-001, March 2007, which is incorporated by reference. This document is available from the Agency for Health Care Administration, Licensed Home Health Programs Unit, 2727 Mahan Drive, Mail Stop 34, Tallahassee, Florida 32308 or the agency website at http://elderaffairs.state.fl.us/doea/ruleforms/DOEA-Form-H-001.pdf, and shall be included as part of the hospice’s comprehensive emergency management plan.

(2) The plan shall be submitted electronically for review to the local county health department in each county that the hospice is licensed to serve. Any method other than electronic submission of the form shall be expressly approved by the local county health department.

(3) The hospice shall report changes in the after-hours emergency telephone number and address of those staff who are coordinating the hospice’s emergency response to the local emergency management agency and county health department. The telephone numbers must include all numbers where the coordinating staff can be contacted outside the hospice’s regular office hours. All hospices must report these changes, whether the plan has been previously reviewed or not, as defined in subsection (2) above.

(4) Upon a change of ownership, the new owner shall submit a new plan identifying any substantive changes, including facility renovations and changes noted in subsection (3) above. Those hospices which previously have had the plan reviewed by the local county health department as defined in subsection (2) above, shall report any substantive changes to the reviewing entity.

(5) The plan shall describe:

(a) Procedures to ensure preparation of hospice patients for potential or imminent emergencies and disasters.

(b) Procedures for annual review of the plan and for the governing body to incorporate substantive changes to the plan.

(6) In the event of an emergency or disaster, the hospice shall implement the hospice’s plan in accordance with Section 400.610, F.S.

(7) On admission, each hospice patient and, where applicable, home caregiver shall be informed of the hospice plan and of the special-needs registry maintained by the local emergency management agency, pursuant to Section 252.355, F.S. The hospice shall document in the patient’s file if:

(a) The patient plans to evacuate the home or the hospice facility;

(b) The caregiver can take responsibility for services normally provided by the hospice during the emergency or disaster; or

(8) Upon imminent threat of an emergency or disaster, the hospice shall confirm each patient’s plan during and immediately following an emergency or disaster.

(9) When the hospice is unable to provide services during an emergency or disaster, the hospice shall make all reasonable efforts to inform, where applicable, those facility and home patients whose services will be interrupted during the emergency or disaster, including patients sheltering in place, and shall inform when services are anticipated to be restored.

(10) Each hospice shall contact each local emergency management agency in counties served by that hospice to determine procedures for registration of special-needs registrants as referenced in Section 252.355, F.S.

(11) Upon admission of a patient, each hospice shall collect registration information for special-needs registrants who will require continuing care or services during a disaster or emergency, consistent with Section 252.355, F.S. This registration information shall be submitted, when collected, to the local emergency management agency, or on a periodic basis as determined by the local emergency management agency.

(12) The hospice shall educate patients registered with the special-needs registry that services provided by the hospice in special-needs shelters shall meet the requirements in Section 400.610(1)(b), F.S.

(13) The hospice shall maintain a current list of patients who are special-needs registrants, and shall forward this list to the local emergency management agency upon imminent threat of disaster or emergency and in accordance with the local emergency management agency procedures.

(14) Each hospice record for patients who are listed in the special-needs registry established pursuant to Section 252.355, F.S., shall include a description of how care or services will be continued in the event of an emergency or disaster pursuant to Section 400.610(1)(b), F.S. The hospice shall discuss the emergency provisions with the patient and the patient’s caregiver, including where and how the patient is to evacuate, procedures for notifying the hospice in the event that the patient evacuates to a location other than the shelter identified in the patient record, and advance directives.

(15) The hospice shall maintain for each special-needs patient a list of client-specific medications, supplies, and equipment required for continuing care and service, should the patient be evacuated. If the hospice provides services to home patients, the hospice shall make arrangements to make the list of medications, supplies, and equipment available to each special-needs registrant in the event of an evacuation. The hospice shall notify the patient that he or she is responsible for maintaining a supply of medications in the home. The list shall include the names of all medications, dose, frequency, times, any other special considerations for administration, any allergies, names of physicians and telephone numbers, and name and telephone number of the patient’s pharmacy. If the patient gives consent, the list may also include the patient’s diagnosis.

History

Rulemaking Authority 400.605, 400.610(1)(b) FS. Law Implemented 400.605, 400.610 FS. History–New 8-6-02, Amended 4-24-07, Formerly 58A-2.026.

Fla. Admin. Code R. 59A-38.019 Hospice Employee Training Requirements

(1) Each hospice licensed under Chapter 400, Part IV, F.S., shall provide that hospice employees receive the following training:

(a) Completion of the required initial one hour of training after June 30, 2003, shall satisfy the requirement referenced in Section 400.6045(1)(b), F.S. Initial one-hour training shall address the following subject areas:

Understanding Alzheimer’s Disease and Related Disorders;
Characteristics of Alzheimer’s Disease and Related Disorders; and,
Communicating with patients with Alzheimer's Disease or Related Disorders.

(b) Completion of the required three hours of training after June 30, 2003, shall satisfy the requirement referenced in Section 400.6045(1)(c), F.S. The three hours of training must address the following subject areas as they apply to Alzheimer’s Disease and Related Disorders:

Behavior management;
Assistance with activities of daily life to promote the patient’s independence;
Activities for patients;
Stress management for the care giver;
Family issues;
Patient environment; and,
Ethical issues.

(c) A detailed description of the subject areas that shall be included in a curriculum which meets the requirements of paragraphs (a) and (b) of this subsection, can be found in the document Training Guidelines for the Special Care of Hospice Patients with Alzheimer’s Disease or Related Disorders, September 2003, incorporated by reference, available from the Department of Elder Affairs, 4040 Esplanade Way, Tallahassee, Florida 32399-7000.

(d) Persons who seek to provide Alzheimer’s Disease or Related Disorders training in accordance with this subsection shall provide the Department of Elder Affairs or its designee documentation that they hold a Bachelor’s degree in a health-care, human service, or gerontology related field from an accredited college or university or hold a license as a registered nurse, and:

Possess teaching or training experience as an educator of care givers for persons with Alzheimer’s Disease or Related Disorders, or
Have one year of practical experience in a program providing care to persons with Alzheimer’s Disease or Related Disorders, or
Have completed a specialized training program in Alzheimer’s Disease or Related Disorders from a university or an accredited health care or human service or gerontology continuing education provider.

(e) With reference to requirements in paragraph (d), years of teaching experience or training as an educator of care givers for persons with Alzheimer’s Disease or Related Disorders may substitute on a year-by-year basis for the required Bachelor’s degree. A Master’s degree from an accredited college or university in a subject related to health-care, human service, or gerontology can substitute for the teaching or training experience referenced in paragraph (d).

(2) A hospice employee who has successfully completed training and continuing education consistent with the requirements of Section 429.178, F.S., or completed training consistent with the requirements of Section 400.1755 or 429.917, F.S., shall be considered as having met the training requirements of this rule.

(3) All training required by this rule and Section 400.6045, F.S., must be completed only once for each applicable employee.

History

Rulemaking Authority 400.6045(1) FS. Law Implemented 400.6045(1) FS. History–New 1-1-04, Formerly 58A-2.027, 7-1-19.

Fla. Admin. Code R. 59A-38.020 Hospice Training Provider and Curriculum Approval

(1) Persons seeking approval as an Alzheimer’s Disease or Related Disorders training provider shall complete DOEA form Hospice/ADRD-001, Application for Alzheimer’s Disease or Related Disorders Training Provider Certification, dated September 2003, which is incorporated by reference and available at the Department of Elder Affairs, 4040 Esplanade Way, Tallahassee, Florida 32399-7000. Persons seeking to obtain approval of the Alzheimer’s Disease or Related Disorder curriculum shall complete DOEA form Hospice/ADRD-002, Application for Alzheimer’s Disease or Related Disorders Training Three-Year Curriculum Certification, dated September 2003, which is incorporated by reference and available at the Department of Elder Affairs, 4040 Esplanade Way, Tallahassee, Florida 32399-7000. Approval must be obtained from the Department or its designee for the training provider and the training curriculum prior to commencing training activities. Approval of the training curriculum shall be granted for 3 years, whereupon the training curriculum must be re-submitted to the Department or its designee for re-approval.

(2) Upon receipt of the training provider’s or the training curriculum application, the Department or its designee shall respond in writing within 30 calendar days in one of the following three ways:

(a) Notify the applicant that the application is approved or not approved. If an application is not approved, the Department or its designee shall respond in writing indicating the reasons for not approving the application and information or documentation needed for approval;

(b) Request additional information from the applicant in order to make a determination. Requested information omitted from an application shall be filed with the Department or its designee within 90 days of the Department’s or its designee’s request for omitted information, or the application shall be deemed incomplete, and shall be withdrawn from further consideration. Once the additional information has been received by the Department or its designee the Department or its designee will have 30 calendar days to make a determination; or

(c) Notify the applicant that an additional 30 calendar days is needed to review the application and make a determination. Upon notice of approval from the Department or its designee, the applicant may be identified as an approved training provider or as having an approved training curriculum as indicated by the Department or its designee. The Department or its designee shall maintain a list of approved training providers and training curriculum and provide a list of approved training providers to all interested parties upon request.

(3) Upon successful completion of training, the trainee shall be issued a certificate by the approved training provider. The certificate shall include the title of the training and the Department of Elder Affairs curriculum approval number, the number of hours of training, the participant’s name, dates of attendance, location, the training provider’s name and the Department of Elder Affairs training provider’s approval number, and dated signature. The training provider’s signature on the certificate shall serve as documentation that the training provider has verified that the trainee has completed the required training pursuant to Section 400.6045, F.S., and Rule 59A-38.019, F.A.C.

(4) The Department reserves the right to attend and monitor training courses, review records and course materials approved pursuant to this rule, and revoke approved training provider status on the basis of non-adherence to approved curricula, the provider’s failure to maintain required training credentials, or circumstances in which the provider is found to knowingly disseminate any false or misleading information.

(5) Training providers and training curricula which are approved consistent with the provisions of Sections 400.1755, 429.178 and 429.917, F.S., shall be considered as having met the requirements of this rule.

(6) Certificates or copies of certificates of any training required by this rule shall be documented in the hospice’s personnel files.

History

Rulemaking Authority 400.6045(1) FS. Law Implemented 400.6045(1) FS. History–New 1-1-04, Formerly 58A-2.028.

Division 59E Hospital and Nursing Home Reporting Systems and Other Provisions Relating to Hospitals

Chapter 59E-2 ORGANIZATION AND PROCEDURE AND RULES OF GENERAL APPLICABILITY

Fla. Admin. Code R. 59E-2.001 Mission and Goals

History

Rulemaking Authority 407.03 FS. Law Implemented 120.53, 407.03 FS. History–New 7-7-80, Amended 3-15-83, Formerly 4D-2.01, 27J-2.001, Amended 4-4-90, 6-1-92, Formerly 10N-2.001, Repealed 10-18-95.

Fla. Admin. Code R. 59E-2.002 The Agency Head

History

Rulemaking Authority 407.03 FS. Law Implemented 120.53, 407.03 FS. History–New 7-7-80, Amended 3-15-83, 12-29-83, Formerly 4D-2.02, 27J-2.002, Amended 4-4-90, 6-1-92, Formerly 10N-2.002, Repealed 10-18-95.

Fla. Admin. Code R. 59E-2.0021 Board Officers; Election and Duties

History

Rulemaking Authority 407.01, 407.03 FS. Law Implemented 120.53, 407.03 FS. History–New 6-1-92, Formerly 10N-2.0021, Repealed 5-10-12.

Fla. Admin. Code R. 59E-2.003 Agency Organization and Committee Structure

History

Rulemaking Authority 407.03 FS. Law Implemented 120.53, 407.01, 407.03 FS. History–New 7-7-80, Amended 3-15-83, 11-5-84, Formerly 4D-2.03, 27J-2.003, Amended 4-4-90, 6-1-92, Formerly 10N-2.003, Repealed 10-18-95.

Fla. Admin. Code R. 59E-2.004 Board’s Official Headquarters

History

Rulemaking Authority 407.03 FS. Law Implemented 120.53 FS. History–New 7-7-80, Amended 12-29-83, Formerly 4D-2.04, 27J-2.004, Amended 4-4-90, 6-1-92, Formerly 10N-2.004, Repealed 10-18-95.

Fla. Admin. Code R. 59E-2.005 Meeting Attendance; Notice of Meetings

History

Rulemaking Authority 120.53(1), 407.01, 407.03 FS. Law Implemented 120.53(1) FS. History–New 7-7-80, Amended 12-29-83, 11-5-84, Formerly 4D-2.05, 27J-2.005, Amended 6-1-92, Formerly 10N-2.005, Repealed 2-29-96.

Fla. Admin. Code R. 59E-2.0051 Meeting Attendance; Notice of Meetings

History

Rulemaking Authority 407.01, 407.03 FS. Law Implemented 120.53 FS. History–New 6-1-92, Formerly 4D-2.0051, Repealed 2-29-96.

Fla. Admin. Code R. 59E-2.0053 Meetings Conducted by Communications Media Technology

History

Rulemaking Authority 120.53, 407.03 FS. Law Implemented 120.52, 120.53 FS. History–New 6-1-92, Formerly 10N-2.0053, Repealed 5-10-12.

Fla. Admin. Code R. 59E-2.0055 Consideration of Board Policy

History

Rulemaking Authority 120.53, 120.54, 407.03 FS. Law Implemented 407.01 FS. History–New 6-1-92, Formerly 10N-2.0055, Repealed 10-18-95.

Fla. Admin. Code R. 59E-2.006 Workshops

History

Rulemaking Authority 120.53(1), 395.505(1) FS. Law Implemented 120.53(1) FS. History–New 7-7-80, Formerly 4D-2.06, 27J-2.006, 10N-2.006, Repealed 2-29-96.

Fla. Admin. Code R. 59E-2.007 Declaratory Statements

History

Rulemaking Authority 120.565 FS. Law Implemented 120.565 FS. History–New 7-7-80, Formerly 4D-2.07, 27J-2.007, Amended 6-1-92, Formerly 10N-2.007, Repealed 10-18-95.

Fla. Admin. Code R. 59E-2.010 Official Reporter

History

Rulemaking Authority 120.53(1), 395.505(1) FS. Law Implemented 120.53(4) FS. History–New 7-7-80, Amended 12-29-83, Formerly 4D-2.10, 27J-2.010, 10N-2.010, Repealed 10-18-95.

Fla. Admin. Code R. 59E-2.012 Agency Clerk

History

Rulemaking Authority 120.53(1), 395.505(1) FS. Law Implemented 120.53(1) FS. History–New 7-7-80, Amended 10-20-80, 11-5-84, Formerly 4D-2.12, 27J-2.012, 10N-2.012, Repealed 10-18-95.

Fla. Admin. Code R. 59E-2.013 Model Rules of Procedure

History

Rulemaking Authority 120.53(1) FS. Law Implemented 120.53(1)(c) FS. History–New 7-7-80, Formerly 4D-2.13, 27J-2.013, Amended 6-1-92, Formerly 10N-2.013, Repealed 10-18-95.

Fla. Admin. Code R. 59E-2.014 Model Rules of Procedure

History

Rulemaking Authority 408.15 FS. Law Implemented 120.53 FS. History–New 2-29-96, Repealed 5-10-12.

Fla. Admin. Code R. 59E-2.015 Filing Requirements; Facsimile Transmission

History

Rulemaking Authority 408.15 FS. Law Implemented 408.061, 408.062, 408.072, 408.08 FS. History–New 6-1-92, Formerly 10N-2.015, Amended 6-7-94, Repealed 5-10-12.

Fla. Admin. Code R. 59E-2.017 Extensions for Filing

History

Rulemaking Authority 408.15 FS. Law Implemented 408.061, 408.072, 408.08 FS. History–New 6-1-92, Formerly 10N-2.017, Amended 6-7-94, Repealed 2-25-19.

Fla. Admin. Code R. 59E-2.021 Public Inspection and Copying of Board Records

History

Rulemaking Authority 120.53, 408.062, 408.15 FS. Law Implemented 119.07, 408.062 FS. History–New 6-1-92, Formerly 10N-2.021, Repealed 2-29-96.

Fla. Admin. Code R. 59E-2.022 Patient Records

History

Rulemaking Authority 408.15 FS. Law Implemented 119.07, 120.53, 408.15 FS. History–New 7-7-80, Amended 11-5-84, Formerly 4D-2.09, Amended 12-15-86, Formerly 27J-2.009, Amended 3-20-88, 4-4-90, Formerly 10N-2.009, Amended 6-1-92, Formerly 10N-2.022, Repealed 2-29-96.

Fla. Admin. Code R. 59E-2.024 Violation of Chapter 408 F.S. or Agency Rules

(1) Failure to comply with the requirements of Chapter 408, F.S., or the requirements of Agency rules is punishable by a fine not to exceed $1,000 per day. Each day that a report, document or assessment payment is late or each day of such other violation is considered a separate offense for which an administrative fine will be assessed.

(2) Entities subject to the Agency’s jurisdiction are responsible for knowledge of and compliance with applicable rules and statutes.

(3) Violations which may occur include:

(a) Failure to file a report or document on or before the due date. This violation includes submission of a report or document which does not contain all required information or does not meet format requirements;

(b) Failure to correct a report or document which has been filed but contains errors or deficiencies;

(c) Failure to file a report or document. This violation occurs when the report or document is not submitted within one year of its original due date or when a report or document is submitted but it does not contain all required information or does not meet format requirements;

(d) Knowingly submitting a false report or document;

(e) Failure to pay an assessment due pursuant to Section 408.08, F.S.

(4) Prior to seeking to impose an administrative fine against an entity for the violations described in paragraphs (3)(a) and (b) above, the Agency will send a notice of violation to the entity by certified mail, return receipt requested. If the entity corrects the violation within 10 working days of receipt of the notice, no violation will be deemed to have occurred and no administrative fine will be sought or imposed. If the entity does not correct the violation within that time, it shall be subject to imposition of an administrative fine which will be calculated from the original due date of the report or document.

(5) Prior to seeking to impose an administrative fine against an entity for the violation described in paragraph (3)(c) above, the agency will send a notice of violation to the entity by certified mail, return receipt requested. If the entity corrects the violation within 10 working days of receipt of the notice, no violation will be deemed to have occurred and no administrative fine will be sought or imposed. If the entity does not correct the violation within that time, it shall be subject to imposition of an administrative fine which will be calculated from the date of the entity’s receipt of the notice of violation.

History

Rulemaking Authority 408.15 FS. Law Implemented 408.08 FS. History–New 6-1-92, Formerly 10N-2.024, Amended 7-18-19.

Fla. Admin. Code R. 59E-2.025 Guidelines for Calculation of Administrative Fines

(1) In order to provide consistency and predictability in the imposition of administrative fines, the Agency will follow these guidelines in imposing fines for the following offenses.

(a) Failure to file a report or document on or before the due date; failure to correct a report or document which has been filed but contained errors or deficiencies; failure to pay an assessment due pursuant to Sections 408.08, and 408.20, F.S.:

Fine

per bed

per day

Minimum

Fine

per day

Maximum

Fine

per day

First Occurrence

$.10

$20

$150

Second Occurrence

$.20

$40

$300

Third Occurrence

$.50

$100

$500

(b) Failure to file a report or document on or before the due date or failure to correct a report or document which has been filed but contained errors or deficiencies when such violation results in the information being unavailable for inclusion in the Agency’s scheduled publication or scheduled public release of the information:

Fine

per bed

per day

Minimum

Fine

per day

Maximum

Fine

per day

First Occurrence

$3.50

$750

$1,000

Second Occurrence

N/A

$750

$1,000

(2) No fine may be assessed which exceeds $1,000 per day for each day in violation.

History

Rulemaking Authority 408.15 FS. Law Implemented 408.08 FS. History–New 6-1-92, Formerly 10N-2.025, Amended 10-7-21, 2-26-26.

Chapter 59E-4 NURSING HOME REPORTING SYSTEM

Fla. Admin. Code R. 59E-4.001 Purpose

History

Rulemaking Authority 407.03 FS. Law Implemented 407.30-.34 FS. History–New 9-24-86, Formerly 27J-4.001, Amended 6-1-92, Formerly 10N-4.001, Repealed 5-10-12.

Fla. Admin. Code R. 59E-4.002 Definitions

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.07(41) FS. History–New 9-24-86, Formerly 27J-4.002, Amended 6-1-92, Formerly 10N-4.002, Amended 11-22-93, Repealed 5-10-12.

Fla. Admin. Code R. 59E-4.004 Financial Reporting Requirements

History

Rulemaking Authority 408.15 FS. Law Implemented 408.061, 408.062 FS. History–New 2-4-87, Formerly 27J-4.004, Amended 6-1-92, Formerly 10N-4.004, Repealed 5-10-12.

Fla. Admin. Code R. 59E-4.005 Special Information Requests

History

Rulemaking Authority 408.061 FS. Law Implemented 408.061, 408.062, 408.08 FS. History–New 9-24-86, Formerly 27J-4.005, 10N-4.005, Repealed 5-10-12.

Fla. Admin. Code R. 59E-4.009 Change of Ownership

History

Rulemaking Authority 408.15 FS. Law Implemented 408.061 FS. History–New 9-24-86, Amended 2-4-87, Formerly 27J-4.009, Amended 6-1-92, Formerly 10N-4.009, Repealed 5-10-12.

Fla. Admin. Code R. 59E-4.011 Collection of Data on Nursing Home Charges

History

Rulemaking Authority 408.15 FS. Law Implemented 408.062 FS. History–New 6-8-89, Amended 6-1-92, Formerly 10N-4.011, Repealed 5-10-12.

Fla. Admin. Code R. 59E-4.101 Definitions

(1) “Actual report” is the report of a nursing home and/or a nursing home’s home office’s actual financial and statistical data as outlined in the FNHURS Manual.

(2) “Change of ownership” means a change of ownership as defined in section 408.803 F.S.

(3) “Chart of accounts” means the list of accounts, code numbers, definitions, standard units of measure and principles, and concepts included in the FNHURS Manual.

(4) “Fiscal Year” means the 12-month fiscal period set by the nursing home and nursing home’s home office for financial reporting and budgeting.

(5) “FNHURS Manual,” hereafter referred to as “the manual,” means the State of Florida Nursing Home Uniform Reporting System Manual, which outlines requirements for using the FNHURS Online System.

(6) “FNHURS Online System,” hereafter referred to as “the system,” is the State of Florida Nursing Home Uniform Reporting System described in the FNHURS Manual for electronic filing of nursing homes’ and their home offices’ prior year reports.

(7) “Financial statements” means financial statements as defined in Rule 61H1-20.005, F.A.C., prepared in accordance with US GAAP.

(8) “Home Office” means an affiliated entity or group of entities that allocate costs to providers participating in the Florida Medicaid Program, as defined by the Provider Reimbursement Manual (CMS Pub. 15-1). A management company related to the provider as defined in Chapter 10, CMS Pub. 15-1 is considered a home office for the purposes of this rule.

(9) “Nursing Home,” hereafter referred to as “licensee,” means a provider licensed under Chapter 400, Part II, and 408 Part II, F.S. Providers that are part of a continuing care retirement community are not required to report financial data pursuant to section 408.061(6), F.S., under this rule chapter.

(10) “Prior year report” means, the actual report and corresponding financial statements with an audit report of an independent certified public accountant for the same reporting period that also includes an opinion on the audited financial statements.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.032, 408.061(2), FS. History–New 11-1-23.

Fla. Admin. Code R. 59E-4.102 Florida Nursing Home Uniform Reporting System

(1) The Agency hereby establishes a uniform system for electronic filing of nursing homes’ and their home offices’ prior year reports by adopting the Florida Nursing Home Uniform Reporting System (FNHURS) Manual, June 2023, which is incorporated by reference and available at: http://www.flrules.org/Gateway/reference.asp?No=Ref-15957. The manual is also available at: https://ahca.myflorida.com/health-care-policy-and-oversight/bureau-of-central-services/financial-analysis/fnhurs.

(2) Each licensee and their home office must submit their actual report, required attachments and audited financial statements using the FNHURS Online System in accordance with the requirements outlined in the manual. The system is available through the Agency’s Single Sign On Portal located at https://apps.ahca.myflorida.com/crs.

(3) Prior Year Report Submission.

(a) Each licensee and their home office must submit their prior year report to the Agency not more than 120 days after the end of their set fiscal year. Separate prior year reports must be submitted for each licensee, regardless of ownership or operation.

(b) The licensee or their home office may request an automatic extension through the system to the Agency for up to 30 days to submit the report if the request is received at least one week prior to the due date of the report as required by paragraph (3)(a).

(c) The actual report must be prepared for each licensee and their home office from audited financial statements for submission of the prior year report in the system. If the actual report does not correspond with the audited financial statements, the licensee and/or their home office must provide a reconciliation of the amounts presented in the audited financial statements to amounts reported in the actual report.

If the licensee and/or their home office is unable to obtain audited financial statements for the first year of submission within the required timeframe, the licensee and/or their home office must submit a copy of unaudited financial statements for the initial report along with its actual report in lieu of audited financial statements for that first year of submission.
Licensees and/or their home offices that are unable to obtain audited financial statements for the first year of submission must include an audited financial statement for the first year submission with their next fiscal year submission. The audit of the first fiscal year report may be contained in the audit of the next fiscal year submission as a separate column on the income statement, balance sheet and statement of cash flows.
Any changes between the initial report’s unaudited and audited financial statements submitted for the actual report must be revised pursuant to Rule 59E-4.103, F.A.C.

(d) The licensee’s home office and all affiliated licensees must share the same fiscal year for the purposes of this rule.

(e) A report is considered submitted when it contains:

All schedules, reports, attachments and data required in this rule chapter and outlined in the manual;
The appropriate signatures by the Administrator/Chief Executive Officer and/or Chief Financial Officer of the licensee and their home office; and
Signed copies of audited financial statements unless an exception is noted pursuant to section (b)1. for the initial report.

(4) Review, Notification and Extension.

(a) The licensee or their home office will be notified of whether a submitted report is “Accepted” or “Not Accepted.” A report is considered “Accepted” if the data are mathematically accurate, reasonable and verifiable, and the report timely meets the minimum requirements of Chapter 408, F.S. and this rule chapter.

(b) After a report is “Accepted,” the Agency may request additional information about, or a revision to, the report after reviewing the aggregate data of all nursing homes in the State.

(c) The Agency may request additional information from any licensee or their home office via email or through notification in the system. The licensee or their home office must respond within 21 days of a request for information made by the Agency.

(d) Deemed Not Filed.

If a licensee or the home office fails to submit an actual report or its audited financial statements by the due date, it will be considered to be in a Deemed Not Filed status and subject to a $10,000 fine pursuant to section 408.061(7)(a), F.S.
Mitigation - the licensee may request and the Agency shall approve a waiver of this fine due to delays caused by the following circumstances:

a. Impact from a natural disaster;

b. Impact from a Pandemic;

c. Damage to the facility from something other than a natural disaster;

d. Records/Systems impacted by a cyber attack;

e. Declared Bankruptcy; and,

f. Audited Financial Statements not completed. This means that the audit opinion will not or is likely not to be signed prior to the due date of the report.

In order to qualify for the waiver of the fine in (4)(d)2. above, the Agency must receive the request through the system via the comments section and/or in writing in the attachment section before the actual report due date as described in (3)(a) and (b) above. The request shall include the nursing home/home office name, license number, fiscal year impacted by the request, and the specific mitigation reason enumerated in (4)(d)2. above. Agency staff will review and respond to the request through the system in the comments section.
In no case shall the $10,000 fine be automatically waived in (4)(d)2. above if either the actual report or the audit is submitted more than 3 months after the due date as described in (3)(a) and (b) above. If the actual report and/or audit is filed 3 months after the due date and one of the mitigation items enumerated above is cited, the Agency will consider a reduction in the fine based on additional mitigating factors and the time taken for the nursing home to file. If the licensee failed to request mitigation or did not request mitigation timely as described in this rule, the Agency will impose a $10,000 fine and increase the fine by $10,000 for every additional 10 days period after the due date that the licensee remains in a Deemed Not Filed status pursuant to section 408.061(7)(a), F.S.

(e) Notice of Violation

If a licensee or the home office of a licensee submits a report that does not conform to the requirements of this rule chapter, the report will be deemed “Not Accepted” and a Notice of Violation will be sent to the licensee and/or their home office via email and/or by notification through the system. Failure of a licensee or home office to submit audited financial statements purusant to subparagraph (3)(c)2. will result in the first year submission being deemed “Not Accepted” and a Notice of Violation will be sent to the licensee and/or their home office via email and/or by notification through the system.
The notice shall indicate the deficiencies found, the corrections or modifications necessary to make its data complete and verifiable, and the time by which a corrected or modified report must be received by the Agency.
The licensee or their home office shall have no fewer than 10 business days following receipt of a notice of violation to submit or resubmit the report to the Agency with any corrections or modifications detailed in the notice.
Failure to timely respond to a Notice of Violation may result in a fine of $1,000 per day per violation pursuant to Section 408.08(2), F.S.

(5) Modifications or corrections to a report can be made by resubmitting the report through the system.

(6) In the event a consolidated audit exists for a corporate entity, the signed copy of the consolidated audit can be substituted for individual audits of the licensee and their home office if:

(a) The consolidated audit includes consolidating schedules listing the home office and each licensee as a separate column on the consolidating schedules.

(b) The consolidating schedules include a balance sheet and income statement.

(c) The consolidating schedules include an opinion from the certified public accountant that the schedules are presented fairly in all material respects, in relation to the financial statements as a whole.

(7) In the event a licensee’s or their home office’s audited actual data is restated, the licensee or their home office must report the restatement to the Agency within 30 days of the issuance of the restatement. The restated audit must include a letter explaining the reason for the restatement and an updated opinion on the audited financial statements taken as a whole.

History

Rulemaking Authority 408.061(2),408.061(7)(b), 408.15 FS. Law Implemented 408.061(2), 408.061(7) FS. History–New 11-1-23, Amended 2-24-26.

Fla. Admin. Code R. 59E-4.103 Prior Year Report Revisions, Ownership Change and Fiscal Year End (FYE) Change

(1) A licensee or their home office may submit revisions to a prior year report. Revisions to financial data must be supported by audited financial statements. Revisions to data not included in audited financial statements must be accompanied by documentation to support the accuracy of the revised data. Revised data must be submitted in accordance with Rule 59E-4.102, F.A.C., and will not be made available for internal or other governmental agency use until all revisions have been accepted.

(2) Change of Ownership. A prior year report shall be filed for the period from the effective date of the change of ownership to the end of the new owner’s fiscal year. The Agency may waive the reporting requirements as the result of a change of ownership in the following circumstances:

(a) The new owner does not change the fiscal year end of the licensee and is able to provide a prior year report for the entire fiscal year.

(b) The prior year report period required by this section covers less than nine months.

(3) Fiscal Year End Change. A licensee or their home office which changes its fiscal year end shall file its prior year report for the fiscal period ending on the date prior to the beginning of the new fiscal year within 120 days after such date.

(4) The Agency will not accept any prior year revisions of a previously accepted FNHURS report that is more than three fiscal years past the current fiscal year that is due to the Agency.

History

Rulemaking Authority 408.061(2), 408.15 FS. Law Implemented 408.061(2) FS. History–New 11-1-23.

Chapter 59E-5 HOSPITAL UNIFORM REPORTING SYSTEM AND OTHER PROVISIONS RELATING TO HOSPITALS

Fla. Admin. Code R. 59E-5.101 Definitions

The definitions set forth in section 408.032, F.S., and the following definitions shall apply to this chapter, and to the Florida Hospital Uniform Reporting System (FHURS) Manual, unless otherwise specified:

(1) “Actual report” is the report of a hospital’s actual financial and statistical data as required by the reporting forms contained in the FHURS Manual.

(2) “Change in hospital ownership” means that a majority of the ownership or the controlling interest of the hospital is transferred or assigned. A change in ownership includes, but is not limited to, the acquisition of the hospital by any person or other legal entity by any means; the leasing of the hospital when the lessee agrees to undertake or provide services at the hospital to the extent that legal liability for operation of the hospital rests with the lessee; conversion of the hospital’s type or kind of business organization; the sale, acquisition, assignment or other voluntary or involuntary transfer of a majority of the ownership or the controlling interest of the hospital; merger of the hospital corporation into a new corporation; or consolidation of the hospital corporation with one or more corporations resulting in the creation of a new corporation.

(3) “Charity care patient” means a medically indigent patient whose charges are, in whole or in part, classified as “Charity/Uncompensated Care – Other” who meets the requirements of Account 5960, Chapter III, FHURS Manual and/or “Charity/Uncompensated Care – Hill Burton” who meets the requirements of Account 5950, Chapter III, FHURS Manual.

(4) “Chart of accounts” means the list of accounts, code numbers, definitions, standard units of measure and principles and concepts included in the FHURS Manual.

(5) “Day of admission” means the day on which a person is admitted to a hospital or sub-acute facility for bed occupancy for purposes of receiving inpatient hospital or sub-acute services and counts as one inpatient day. If admission and discharge or death occur the same day, the day is considered a day of admission and counts as one inpatient day.

(6) “Executive staff members” means the Secretary, and such other staff members as designated by the Secretary.

(7) “FHURS Manual” means the State of Florida Hospital Uniform Reporting System Manual as adopted by the Agency and incorporated by reference in rule 59E-5.102, F.A.C.

(8) “Financial statements” means a presentation of financial data, including accompanying notes, derived from accounting records and intended to communicate a hospital’s economic resources or obligations at a point in time, or the changes therein for a period of time, and the results of operations for a period of time in accordance with generally accepted accounting principles.

(9) “Generally accepted accounting principles” (GAAP) means the term as defined in rule 61H1-20.007, F.A.C., Department of Business and Professional Regulation, Board of Accountancy.

(10) “Generally accepted auditing standards” (GAAS) means the term as defined in rule 61H1-20.008, F.A.C., Department of Business and Professional Regulation, Board of Accountancy.

(11) “Gross patient services revenue,” means the sum of daily hospital service charges, ambulatory service charges, ancillary service charges; including all charges for sub-acute services.

(12) “Gross operating revenue” means “Gross revenue” as that term is defined in section 408.07(22), F.S.

(13) “Inpatient admission” means a person who has been admitted to a hospital for bed occupancy for purposes of receiving inpatient hospital services. An inpatient is a patient as defined in subsection 59E-7.011(4), F.A.C.

(14) “Inpatient revenue” or “Gross Inpatient Revenue” means gross charges generated from the provision of hospital services to any patient admitted to the hospital as an inpatient.

(15) “Net inpatient revenue” means inpatient revenue minus deductions from inpatient revenue.

(16) “Net operating revenue” means “Net revenue” as that term is defined in section 408.07(34), F.S.

(17) “Net outpatient revenue” means outpatient revenue minus deductions from outpatient revenue.

(18) “Non-operating revenue” means revenue not directly related to the entity’s ongoing or principle operations. Non-operating revenue may include unrestricted gifts, unrestricted income from endowment funds, gain on sale of hospital properties, and income and gains from investments of general funds.

(19) “Other operating revenue” means a class of revenues which are defined in section 408.07(38), F.S.

(20) “Outpatient” means a person who receives a pre-admission assessment, a diagnostic procedure, or a therapeutic procedure at a hospital licensed under chapter 395, F.S., who is not an inpatient admission.

(21) “Outpatient revenue” or “Gross Outpatient Revenue” means total charges for hospital services rendered to outpatients.

(22) “Patient day” means a day which begins at midnight and ends 24 hours later. The midnight-to-midnight method must be used even if the provider uses a different definition of a patient day for its statistical or other purposes. Whenever a patient occupies a bed in more than one patient care area in one day, the inpatient day should be counted only in the patient care area in which the patient was located at the census-taking hour. The day of admission will be counted as a full day; however, the day of discharge is not counted. A full day must be counted when a patient is admitted as an inpatient with the expectation of the patient remaining overnight and occupying a bed, but is discharged on the same day.

(23) “Prior year report” means, collectively, the actual report and the corresponding financial statements with an audit report of an independent Florida-licensed certified public accountant or a certified public accountant that meets the requirements of rule 61H1-29.002, F.A.C., for the same reporting period and including an opinion on the audited financial statements.

(24) “Total deductions from inpatient revenue” means that portion of total deductions from gross revenue, as defined in section 395.701(1), F.S., directly attributable to inpatient revenue.

(25) “Total deductions from outpatient revenue” means that portion of total deductions from gross revenue, as defined in section 395.701(1), F.S., directly attributable to outpatient revenue.

(26) “Total net revenue” means the sum of net patient services revenue, other operating revenue, and non-operating revenue.

(27) “Total net patient services revenue” means gross patient service revenue minus deductions from revenue as defined in section 408.07(17), F.S.

(28) “Total revenue” means the sum of gross patient services revenue, other operating revenue and non-operating revenue.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.032, 408.061(2), (3), 408.07 FS. History–New 6-11-92, Formerly 10N-5.101, Amended 3-16-03, 6-28-18.

Fla. Admin. Code R. 59E-5.102 Florida Hospital Uniform Reporting System

(1) The Agency for Health Care Administration (Agency) hereby adopts and establishes a uniform system for electronic filing of hospital prior your actual reports by adopting the State of Florida Hospital Uniform Reporting System (FHURS) Manual, Version 2017-1, June 2017, which is incorporated herein by reference and available at http://ahca.myflorida.com/MCHQ/Central_Services/Financial_Ana_Unit/fa_data/index.shtml. A copy of the manual can also be found at: http://www.flrules.org/Gateway/reference.asp?No=Ref-09522.

(2) All hospital prior year actual reports and required attachments including audited financial statements shall be filed using the FHURS Online system as described in the FHURS Online AHCA Portal Registration Guide, FHURS Online User Manual, and FHURS Manual. The FHURS Online AHCA Portal Registration Guide and FHURS Online User Manual are available at http://ahca.myflorida.com/MCHQ/Central_Services/Financial_Ana_Unit/fa_data/index.shtml.

History

Rulemaking Authority 408.061(2), 408.15(8) FS. Law Implemented 408.061(2), (19) FS. History–New 6-11-92, Formerly 10N-5.102, Amended 2-24-94, 3-16-03, 6-8-03, 9-12-05, 3-28-10, 6-28-18.

Fla. Admin. Code R. 59E-5.103 Reporting Requirements

History

Rulemaking Authority 408.061(2), (3), (4)(a), (7), 408.15(8) FS. Law Implemented 395.701, 408.061(2), (3), (4)(a), (7) FS. History–New 6-11-92, Formerly 10N-5.103, Amended 3-16-03, Repealed 2-25-19.

Fla. Admin. Code R. 59E-5.201 Prior Year Report Requirements

(1) Each hospital shall submit to the Agency, not more than 120 days subsequent to the end of its fiscal year, its prior year report for the fiscal year then ended.

(2) Separate reports are required for each licensed hospital, regardless of ownership or operation. Hospitals that have multiple premises on a single license may file a single report for all premises on that license.

(3) The prior year report shall consist of the following:

(a) FHURS Online report. The prior year actual report shall be submitted to the Agency using FHURS Online, AHCA Form 3120-0001OL, March 2018, which is hereby incorporated by reference. This form is only accepted electronically and can be accessed through the Agency’s Single Sign On Portal located at https://apps.ahca.myflorida.com/SingleSignOnPortal. A copy of the form can also be found at http://www.flrules.org/Gateway/reference.asp?No=Ref-09510. FHURS Online has been developed by the Agency for the purpose of electronically filing the prior year actual report. FHURS Online is a web-based application that reproduces the FHURS worksheets pursuant to rules 59E-5.102 and 59E-5.205, F.A.C., of this chapter.

(b) The FHURS report shall be sent to the Agency on or before the due date of the report in accordance with the FHURS Online AHCA Portal Registration Guide and the FHURS Online User Manual and shall contain the following information:

FHURS “Worksheet A” that contains the appropriate signatures by the Chief Executive Officer and Chief Financial Officer of the hospital.
A signed copy of the audited financial statements.

(4) The actual report shall be prepared for each hospital from the audited financial statements. Whenever an actual report is not in agreement with the corresponding audited financial statements, the hospital shall provide a reconciliation of the amounts presented in the audited financial statements to amounts reported in the actual report.

(5) In the event a hospital’s audited actual data is restated in accordance with generally accepted accounting principles, the hospital shall report the restatement to the Agency within 30 days of the issuance of the restatement.

(6) The hospital can request and shall be granted a one time 30 day extension of time for compliance with the filing requirements found in chapter 59E-5, F.A.C. if:

a. The extension request is made in writing no later than 30 calendar days prior to the due date and is received at the following location:

Financial Analysis Unit

Agency for Health Care Administration

2727 Mahan Drive Mail Stop# 60

Tallahassee, Florida 32308-5403

b. The request for an extension includes the following information:

(I) The hospital name.

(II) The Hospital File Number – for example, 10-0000 or 2396-0000.

(III) A description, including the fiscal period, of the report or document for which an extension of time is requested for compliance with the filing requirements in section 408.072, F.S., or chapter 59E-5, F.A.C. – for example, “prior year report for the period 1/1/2015 to 12/31/2015.”

(IV) Authorization of the designated representative of the hospital.

History

Rulemaking Authority 408.061(2), 408.15(8) FS. Law Implemented 408.061 FS. History–New 6-11-92, Formerly 10N-5.201, Amended 3-28-99, 9-12-05, 3-28-10, 6-28-18.

Fla. Admin. Code R. 59E-5.202 Prior Year Report Revisions, Ownership Change and Fiscal Year End (FYE) Change

(1) A hospital may file revisions, amendments, restatements, corrections or other changes (hereinafter “revisions”) to a prior year report. Revisions to financial data must be supported by audited financial statements. Revisions to data not included in audited financial statements must be accompanied by documentation to support the accuracy of the revised data. Revised data must be submitted in accordance with rule 59E-5.102, F.A.C., and will not be made available for internal or other governmental agency use until all revisions have been accepted.

(2) Ownership Change. Within 120 days of the last date of ownership of a facility by the previous owner, a prior year report shall be filed for the period from the beginning of the facility’s fiscal year to the effective date of the change of ownership. The new owner shall be responsible for ensuring that such filing is accomplished. The Agency may waive the separate reporting requirement in the following circumstances:

(a) If a new owner does not change the fiscal year end of the facility and provides the Agency with a written statement within 60 days of the change in ownership that such period of prior ownership will be included in the audited financial statements and actual report to be filed by the new owner within 120 days of the facility’s fiscal year end and that the new owner agrees to be responsible for all Agency-related obligations, fines, assessments, and other filing and reporting responsibilities for the entire fiscal year.

(b) If the new owner changes the fiscal year end, and the period of prior ownership is a period of one month or less and the hospital has provided a written request within 60 days of the change in ownership.

(3) Fiscal Year End Change. A hospital which changes its fiscal year end shall file its prior year report for the fiscal period ending on the date prior to the beginning of the new fiscal year within 120 days after such date.

History

Rulemaking Authority 408.061, 408.15 FS. Law Implemented 408.072, 408.08, 408.15 FS. History–New 6-11-92, Formerly 10N-5.202, Amended 6-28-18.

Fla. Admin. Code R. 59E-5.203 Prior Year Report Revisions

History

Rulemaking Authority 408.061, 408.15 FS., Chapter 88-394, Laws of Florida. Law Implemented 408.061 FS. History–New 6-11-92, Formerly 10N-5.203, Repealed 2-25-19.

Fla. Admin. Code R. 59E-5.204 Prior Year Report Review

(1) A report shall be considered filed when it contains all schedules and data required by the Agency and has been prepared in the form and manner specified by the Agency.

(2) In the event the Agency requires additional budget, financial, statistical, or other information to fully understand a report provided by a hospital, a written request, which details the additional information to be provided and which establishes a deadline for response, shall be mailed to the hospital. Upon agreement by the Agency staff and the hospital, the additional information may be requested and provided informally if expedited review is required.

(3) Within 90 days after receipt of a prior year report, the Agency staff shall determine and notify the hospital whether the report is “Accepted”, or “Not Accepted”.

History

Rulemaking Authority 408.061, 408.15 FS. Law Implemented 408.061, 408.062 FS. History–New 6-11-92, Formerly 10N-5.204, Amended 3-28-99.

Fla. Admin. Code R. 59E-5.205 Notice of Violation or Deemed Not Filed and Response

(1) Once a report has been filed in accordance with rule 59E-5.201, F.A.C., the Agency will review the report and determine if:

(a) It meets all requirements of chapter 59E-5, F.A.C., and chapter 408, Florida Statutes.

(b) The data are mathematically accurate, reasonable and verifiable.

(2) If the report does not conform to the above requirements, the report will be deemed “not accepted” and a notice of violation will be sent via email and/or through notification through the FHURS Online system.

(3) The notice shall clearly indicate the deficiencies found, the corrections or modifications necessary to make it complete or conforming or its data verifiable, as well as the time by which a corrected or modified report must be received by the Agency.

(4) A hospital shall have no fewer than 10 working days following receipt of the notice of violation or notice of deemed not filed to return the requested corrected or modified report to the Agency.

(5) Modifications or corrections to various accounts and worksheet cells shall be made by resubmitting the entire report via the FHURS Online system in accordance with rule 59E-5.102, F.A.C.

History

Rulemaking Authority 408.061(2), 408.15(8) FS. Law Implemented 408.061(2), 408.08 FS. History–New 6-11-92, Formerly 10N-5.205, Amended 3-28-99, 3-16-03, 9-12-05, 6-28-18.

Fla. Admin. Code R. 59E-5.206 Instructions and Specifications for Using COMPASS to Prepare and Transmit Hospital Prior Year Reports in Accordance with the Florida Hospital Uniform Reporting System

History

Rulemaking Authority 408.061(2), 408.15(8) FS. Law Implemented 408.061, 408.08 FS. History–New 3-28-99, Amended 9-12-05, Repealed 2-25-19.

Fla. Admin. Code R. 59E-5.601 AHCA Program Assessment

(1) Every year, each hospital shall pay to the Board an assessment equal to .04 percent of its gross operating costs for its last fiscal year. The assessment shall be paid in quarterly payments of .01 percent, with the first quarter beginning on July 1 of each state fiscal year.

(2) Each quarterly assessment payment shall be received in the Board office no later than 30 days from the first day of the quarter.

(3) The Board shall provide an invoice to each hospital for each quarterly payment. However, failure to provide this notice or failure of a hospital to receive this notice does not relieve a hospital of its responsibility to pay the assessment in a timely fashion.

(4) If the Board has not received a hospital’s assessment payment by the due date, a second notice and a copy of the original invoice will be sent. If the assessment is paid within 10 days of the hospital’s receipt of the second notice, the payment will be considered to have been timely paid. If the assessment is not paid within this 10 day period, the assessment is late from the original due date. Paragraph 59E-2.025(1)(a), F.A.C., provides guidelines for imposition of fines from failure to pay an assessment.

(5) Initial assessments against new hospitals shall be paid at the time a hospital is licensed. The assessment will be based on the hospital’s projected gross operating costs during its first year of operation and until its first Prior Year Report is accepted by the Board. Upon approval of the first Prior Year Report, the assessment will be based upon actual gross operating costs as reflected in that report.

(6) In the event a hospital fails to file its Prior Year Report or the report is not accepted by the Board, the quarterly assessment will be based on the most recently filed Prior Year Report accepted by the Board.

(7) If the data contained in the Prior Year Report is based upon a fiscal period of less than one calendar year, the data provided will be annualized and the quarterly assessment will be calculated on an annualized basis.

(8) Assessments are made against facilities, accordingly all assessments accrued shall be paid by the facility regardless of any change of ownership.

History

Rulemaking Authority 408.15 FS. Law Implemented 408.061 FS. History–New 6-11-92, Formerly 10N-5.601.

Fla. Admin. Code R. 59E-5.603 Medical Education Tertiary Care Disbursement

History

Rulemaking Authority 408.15 FS., Chapter 88-394, Laws of Florida. Law Implemented 408.072 FS. History–New 6-11-92, Formerly 10N-5.603, Repealed 12-31-15.

Fla. Admin. Code R. 59E-5.605 Public Medical Assistance Trust Fund Assessments

(1) Within six months after the end of each hospital’s fiscal year, the Agency’s Division of Health Quality Assurance will certify to the Bureau of Finance and Accounting the amount of each hospital’s public medical assistance trust fund assessment. The amount certified shall be equal to the sum of 1.5 percent of the annual net inpatient revenue of each hospital and 1.0 percent of the annual net outpatient revenue of each hospital, based upon the actual data filed with the Agency for the reporting period.

(2) Each hospital shall be notified of the assessment amount being certified to the Bureau of Finance and Accounting.

(3) Within 21 days of receipt of notification of the assessment amount, a hospital may request a hearing pursuant to section 120.57, F.S.

(4) If a hearing is timely requested, the Agency shall certify to the Bureau of Finance and Accounting an interim assessment amount which shall equal the assessment amount last certified to the Bureau of Finance and Accounting. Upon resolution of the issues regarding certification, the proper assessment amount shall be certified. The assessment amount for the year shall not be affected by the issuance of an interim assessment.

(5) The certified assessment amount is the total amount due to the Agency and shall be payable to and collected by the Agency in equal quarterly amounts, beginning the first full calendar quarter occurring six months after the end of the hospital’s fiscal year.

(6) In the event a hospital fails to file its Prior Year Report or the report is not accepted by the Agency, the quarterly assessment shall be based on the most recently filed Prior Year Report accepted by the Agency.

(7) Following the first quarterly assessment of the certified assessment amount, the Agency shall perform a reconciliation of the hospital’s total assessment amounts with the quarterly assessment amount due.

(a) If the sum of the amounts collected is less than the sum of the certified assessments, then the Agency shall issue an invoice for and collect the difference. The invoice for the assessment reconciliation shall be due and payable within 30 days of being issued. Assessments not paid within thirty days of the due date shall be subject to an administrative fine pursuant to section 395.701(3), F.S.

(b) If the sum of the amounts collected is greater than the sum of the certified assessments, then the hospital may request a refund from the Agency.

(8) Initial assessments of new hospitals will be certified upon approval of the first Prior Year Report.

(9) Hospitals that file a Prior Year Report of less than 12-months (Short Report) due to a change of fiscal year end or change of ownership shall be issued a quarterly invoice(s) for the certified assessment on the Short Report only after all four quarters of the previous 12-month period have been invoiced, and prior to the first quarterly invoice issued for the new full fiscal year. Any difference between the certified assessment amounts and Agency collections will be reconciled as described in subsection (7), above.

(10) Assessments are made against facilities, accordingly the amount of the assessment and liability for the assessment remains with the facility regardless of any change in ownership.

History

Rulemaking Authority 395.7017, 408.15(8) FS. Law Implemented 395.701, 408.061 FS. History–New 6-11-92, Formerly 10N-5.606, Amended 5-26-03, 11-1-13.

Chapter 59E-7 INPATIENT DATA COLLECTION

Fla. Admin. Code R. 59E-7.001 Submission of Hospital Patient Discharge Data

History

Rulemaking Authority 88-394, Laws of Florida, 408.07, 408.08, 408.61 FS. Law Implemented 408.072, 408.08, 408.61 FS. History–New 1-23-92, Formerly 10D-7.001, Repealed 12-15-96.

Fla. Admin. Code R. 59E-7.002 Schedule for Submission of Patient Discharge Data and Extensions

History

Rulemaking Authority 88-394, Laws of Florida, 408.061, 408.072, 408.08, 408.15 FS. Law Implemented 408.061, 408.072, 408.08 FS. History–New 1-23-92, Formerly 10D-7.002, Repealed 12-15-96.

Fla. Admin. Code R. 59E-7.003 Reporting Instructions

History

Rulemaking Authority 88-394, Laws of Florida, 408.061, 408.072, 408.08, 408.15 FS. Law Implemented 408.061, 408.072, 408.08 FS. History–New 1-23-92, Formerly 10D-7.003, Repealed 12-15-96.

Fla. Admin. Code R. 59E-7.004 Certification Procedures

History

Rulemaking Authority 88-394, Laws of Florida, 408.061, 408.072, 408.08, 408.15 FS. Law Implemented 408.061, 408.072, 408.08 FS. History–New 1-23-92, Formerly 10D-7.004, Repealed 12-15-96.

Fla. Admin. Code R. 59E-7.005 Discharge Data Tape/Diskette Format – Data Elements and Codes

History

Rulemaking Authority 88-394, Laws of Florida, 408.061, 408.072, 408.08, 408.15 FS. Law Implemented 408.061, 408.072, 408.08 FS. History–New 1-23-92, Formerly 10D-7.005, Repealed 12-15-96.

Fla. Admin. Code R. 59E-7.006 Discharge Data Tape/Diskette Format – Record Layout

History

Rulemaking Authority 88-394, Laws of Florida, 408.061, 408.072, 408.08, 408.15 FS. Law Implemented 408.061, 408.072, 408.08 FS. History–New 1-23-92, Formerly 10D-7.006, Repealed 12-15-96.

Fla. Admin. Code R. 59E-7.007 Data Standards

History

Rulemaking Authority 88-394, Laws of Florida, 408.061, 408.072, 408.08, 408.15 FS. Law Implemented 408.061, 408.072, 408.08 FS. History–New 1-23-92, Formerly 10D-7.007, Repealed 12-15-96.

Fla. Admin. Code R. 59E-7.008 Hospital Patient Data Release

History

Rulemaking Authority 88-394, Laws of Florida, 408.15 FS. Law Implemented 120.33, 408.15 FS. History–New 9-28-92, Formerly 10D-7.008, Repealed 12-15-96.

Fla. Admin. Code R. 59E-7.011 Definitions

History

Rulemaking Authority 408.061(1)(e), 408.15(8) FS. Law Implemented 408.061 FS. History–New 12-15-96, Amended 7-11-01, Repealed 1-1-10.

Fla. Admin. Code R. 59E-7.012 Inpatient Data Reporting Instructions

A facility must register through the FDDC portal to submit its data file according to the specifications in subsections (1) through (2).

(1) The Internet address for submitting inpatient data files is https://apps.ahca.myflorida.com/Fddc/.

(2) Beginning with the fourth quarter 2022 data reporting period as defined in paragraph 59E-7.023(1)(d), F.A.C., inpatient patient data must be submitted using the Inpatient Data XML PD10-5 Schema available at: http://ahca.myflorida.com/xmlschemas/PD10-5.xsd. The Inpatient Data XML PD10-5 Schema (effective January 2023) is incorporated by reference at https://www.flrules.org/Gateway/reference.asp?No=Ref-15080.

(3) The data in the XML file shall contain the data elements, codes and standards required in Rules 59E-7.027, 59E-7.028 and 59E-7.030, F.A.C.

History

Rulemaking Authority 408.061(1)(e), 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063 FS. History–New 12-15-96, Amended 1-4-00, 7-11-01, 7-12-05, 5-22-07, 1-1-10, 10-1-15, 1-1-18, 2-16-23.

Fla. Admin. Code R. 59E-7.013 Penalties for Hospital Inpatient Discharge Data Reporting Discrepancies

History

Rulemaking Authority 408.061(1)(e), 408.15(8) FS. Law Implemented 408.061(13), (16) FS. History–New 12-15-96, Repealed 1-1-10.

Fla. Admin. Code R. 59E-7.014 Inpatient Data Format - Data Elements, Codes and Standards

History

Rulemaking Authority 408.061(1)(e), 408.15(8) FS. Law Implemented 408.061 FS. History–New 12-15-96, Amended 7-11-01. 7-12-05, 5-22-07, Repealed 1-1-10.

Fla. Admin. Code R. 59E-7.015 Public Records

History

Rulemaking Authority 408.061(1)(e), 408.15(8) FS. Law Implemented 119.07(1)(a), (2)(a), 408.061(8) FS. History–New 12-15-96, Amended 7-12-05, Repealed 1-1-10.

Fla. Admin. Code R. 59E-7.016 General Provisions

History

Rulemaking Authority 408.061(1)(e), 408.15(8) FS. Law Implemented 408.061 FS. History–New 12-15-96, Amended 7-11-01, 7-12-05, Repealed 1-1-10.

Fla. Admin. Code R. 59E-7.020 Purpose of Inpatient Data Reporting

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063, 408.05, 408.07, 408.08 FS. History–New 1-1-10, Repealed 5-3-12.

Fla. Admin. Code R. 59E-7.021 Definitions

(1) “Acute Care” means inpatient general routine care provided to patients who are in an acute phase of illness, which includes the concentrated and continuous observation and care provided in the intensive care units of an institution.

(2) “Comprehensive Rehabilitation” means services provided in a Specialty Rehabilitation Hospital licensed under Chapter 395, F.S., or services provided in a hospital rehabilitation distinct part unit.

(3) “Distinct Part Unit” means a unique unit or level of care at a hospital requiring the issuance of a separate claim to a payer.

(4) “ECMORB” means a Supplementary Classification of External Causes of Morbidity and Poisoning, ICD-10-CM, where environmental events, circumstances, and conditions are the cause of injury, poisoning, and other adverse effects as specified in the ICD-10-CM manual and the conventions of coding.

(5) “Executive Officer” means a reporting facility’s chief executive officer, chief financial officer, chief operating officer, president, or any vice president of the hospital in charge of a principal business unit, division or function (administration or finance).

(6) “Inpatient” means a patient who has an admission order given by a licensed physician or other individual who has been granted admitting privileges by the hospital. Observation patients are excluded.

(7) “Newborn” means a baby born within the hospital or the initial admission of an infant to any hospital within 24 hours of birth. Excludes babies born in a different hospital and transferred to the reporting hospital.

(8) “NPI” means National Provider Identification. An NPI is a unique identification number assigned to a provider by the Centers for Medicare & Medicaid Services.

(9) “NUBC” means National Uniform Billing Committee. A national body that defines the data elements that are reported on the Uniform Bill UB-04 and annually publishes an Official UB-04 Data Specifications Manual.

(10) ISO 3166 – The International Standard for Organization is a standardized list of country names and codes first published in 1974 and updated 2008. ISO 3166 is available at: http://www.iso.org/iso/english_country_names_and_code_elements.

(11) “FDDC” means Florida Discharge Data Collection system. An online portal for all data collection applications including, but not limited to, quarterly data file submissions, facility contact information, exemption requests, resubmission requests, and certification.

History

Rulemaking Authority 408.061(1)(e), 408.15(8) FS. Law Implemented 408.061 FS. History–New 1-1-10, Amended 12-5-10, Formerly 59E-7.011, Amended 10-1-15, 1-1-18, 2-16-23.

Fla. Admin. Code R. 59E-7.022 Inpatient Data Reporting and Audit Procedures

(1) Hospitals licensed under Chapter 395, F.S., except state-operated hospitals, in operation for all or any of the reporting periods described in subsection 59E-7.023(1), F.A.C., below, shall submit hospital inpatient discharge data to the Agency according to the provisions in Rules 59E-7.012 and 59E-7.021 through 59E-7.030, F.A.C.

(2) Each hospital shall submit a separate report for each location per Section 408.061(3), F.S.

(3) All acute, intensive care, long term acute care, short term and long term psychiatric, substance abuse and comprehensive rehabilitation live discharges and deaths, including newborn live discharges and deaths, shall be reported. Submit one record per inpatient discharge, to include all newborn admissions, transfers and deaths. Patients receiving rehabilitation services while in the acute care setting (not discharged or transferred to a distinct part unit) are included in the inpatient reporting for service type 1. Report all rehabilitation services provided in either a rehabilitation hospital or in a non-acute distinct part unit in the inpatient reporting for service type 2.

(4) Upon notification by the Agency staff, all hospitals shall provide access to all required information from the medical records and billing documents underlying and documenting the hospital inpatient discharge reports submitted, as well as other inpatient related documentation deemed necessary to conduct complete inpatient data audits of hospital data, subject to the limitations as set forth in Section 408.061(1)(d), F.S. No inpatient discharge records that support inpatient discharge data are exempt from disclosure to the Agency for audit purposes.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063, 408.05, 408.08(1) FS. History–New 1-1-10, Formerly 59E-7.012, Amended 1-1-18.

Fla. Admin. Code R. 59E-7.023 Schedule for Submission of Inpatient Data and Extensions

(1) All hospitals reporting their inpatient discharge data shall report according to the following schedule:

(a) Each data file submitted for the 1st quarter covering inpatient discharges occurring between January 1 and March 31 inclusive, of each year, may be submitted no later than June 1 of the calendar year during in which the discharge occurred. This is considered to be the first quarter, regardless of the hospital’s fiscal year. First quarter data must be certified by August 31 of the same calendar year.

(b) Each data file submitted for the 2nd quarter covering inpatient discharges occurring between April 1 and June 30 inclusive, of each year, may be submitted no later than September 1 of the calendar year during in which the discharge occurred. This is considered to be the second quarter, regardless of the hospital’s fiscal year. Second quarter data must be certified by November 30 of the same calendar year.

(c) Each data file submitted for the 3rd quarter covering inpatient discharges occurring between July 1 and September 30 inclusive, of each year, may be submitted no later than December 1 of the calendar year during in which the discharge occurred. This is considered to be the third quarter, regardless of the hospital’s fiscal year. Third quarter data must be certified by February 28 of the following calendar year.

(d) Each data file submitted for the 4th quarter covering inpatient discharges occurring between October 1 and December 31 inclusive, of each year, may be submitted no later than March 1 of the calendar year following the year in which the discharge occurred. This is considered to be the fourth quarter, regardless of the hospital’s fiscal year. Fourth quarter data must be certified by May 31 of the next calendar year.

(2) Failure to certify the data on or before the certification due date as specified in paragraphs 59E-7.023(1)(a)-(d), F.A.C., or failure to correct a data file which has been submitted but contains errors or deficiencies, by the certification deadline is punishable by fine pursuant to Rule 59E-7.026, F.A.C. FDDC will send notification to the facility of pending errors or deficiencies. Rejected data files must be corrected, resubmitted and certified by the certification due date.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063, 408.05, 408.07(2), 408.15(11) FS. History–New 1-1-10, Formerly 59E-7.012, Amended 1-1-18, 2-16-23.

Fla. Admin. Code R. 59E-7.025 Certification, Audits and Resubmission Procedures

(1) Submission of data files for all hospitals must be in compliance with Rules 59E-7.012 and 59E-7.021 through 59E-7.030, F.A.C. The executive officer, administrator, or authorized designee shall certify the data quarterly as accurate, complete and verifiable by completing the electronic certification in FDDC. The electronic certification attests the inpatient patient data report has been examined and, to the best of the submitter’s knowledge and belief, the information contained in this data file is true, accurate, and complete, and has been prepared from the books and records of this facility. The data is considered “certified” for the reporting quarter upon completion of the facility’s electronic certification.

(2) A facility whose data file is not certified within five (5) calendar months following the last day of the reporting quarter shall be subject to penalties pursuant to Rule 59E-7.026, F.A.C. A facility will not be penalized for delays caused by the Agency that are documented by the reporting facility to include online reporting system downtime.

(3) Changes or corrections to certified data may be accepted from a facility for a period of twelve (12) months following the first date of the affected quarter. The Agency may grant approval if it determines that resubmission will significantly impact data quality. The facility must submit an electronic resubmission request in FDDC. The electronic request must explain the cause contributing to the inaccurate reporting, and include the reason for the corrections or changes, the total number of records affected by quarters and years, the data type and the date that the replacement file will be submitted to the Agency. Any changes to a hospital’s data after this twelve (12) month period shall be subject to penalties pursuant to Rule 59E-7.026, F.A.C. Resubmission of previously certified data must be certified within thirty (30) days following receipt of the data file from the facility.

(4) A facility must electronically update their facility contact information in FDDC when a change of the facility contact responsible for handling the data file submission or the facility CEO or Administrator occurs. Information must include full names, title, applicable phone and fax numbers, and email address.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063, 408.15(11), 408.08(1)(2) FS. History–New 1-1-10, Formerly 59E-7.012, Amended 1-1-18, 2-16-23.

Fla. Admin. Code R. 59E-7.026 Penalties for Hospital Inpatient Discharge Data Reporting Discrepancies

(1) For purposes of this rule chapter, a report or other information is “incomplete” when it does not contain all data required by the Agency in this rule and in forms incorporated by reference or when it contains inaccurate data. The Agency shall to the extent practical, apply the same audit standards and use the same audit procedures for all hospitals or audit a random sample of hospitals. The Agency will notify each hospital of any possible errors discovered by audit and request that the hospital either correct the data or verify that the data is complete and correct. A report or other information is “false” if done or made with the knowledge of the preparer or an administrator that it contains information or data which is not true or accurate.

(2) A hospital which refuses to file, fails to timely file, or files false or incomplete reports or other information required to be filed under the provisions of Section 408.08(2), F.S., other Florida Law, or a rule adopted thereunder, shall be subject to administrative fines pursuant to Section 408.813, F.S. Failure to comply with reporting requirements will also result in the referral of a hospital to the Agency’s Bureau of Health Facility Regulation.

(3) Notifications will be sent to reporting facilities who do not submit their data file by the initial due date as specified in Rule 59E-7.023, F.A.C.

(4) The penalty period will begin on the first calendar day following the certification due date for purposes of penalty assessments.

(5) Any hospital which is delinquent for a certification deadline as specified in Rule 59E-7.023, F.A.C., shall be subject to a fine of $100.00 per day of violation for the first violation, $350.00 per day of violation for the second violation, and $1,000.00 per day of violation for the third and all subsequent violations. Following four consecutive non-delinquent quarters, the fine violation matrix will reset to the first violation rate. Violations will be considered those activities which necessitate the issuance of an administrative complaint by the Agency unless the administrative complaint is withdrawn or final order dismissing the administrative complaint is entered. Any hospital which files false information to the Agency shall be subject to a fine not exceeding $1,000.00 per day per violation, in addition to any other fine imposed hereunder.

History

Rulemaking Authority 408.061(1)(e), 408.15(8), 408.813 FS. Law Implemented 408.08(2), (3), (5), 408.813 FS. History–New 1-10-10, Formerly 59E-7.013, Amended 1-1-18.

Fla. Admin. Code R. 59E-7.027 Header Record

The first record in the data file shall be a header record containing the information described below.

(1) Report Year. Enter the year of the data in the format YYYY where YYYY represents the year in four (4) digits. A required field.

(3) Data Type. Enter PD10-5 for Inpatient Data. A required field.

(4) Submission Type. Enter I or R where I indicates an initial submission of a data file or resubmission of a data file prior to certification, R indicates a replacement submission of previously certified inpatient data where resubmission has been requested or authorized by the Agency. A required field.

(5) Processing Date. Enter the date that the data file was created in the format YYYY-MM-DD where MM represents numbered months of the year from 01 to 12, DD represents numbered days of the month from 01 to 31, and YYYY represents the year in four (4) digits. A required field.

(6) AHCA Facility Number. Enter the identification number of the facility as assigned by the Agency for reporting purposes. A valid identification number must be between one (1) digit and eight (8) digits. A required field.

(8) Organization Name. Enter the name of the hospital from which the patient was discharged, and which is responsible for reporting the data. All questions regarding data accuracy and integrity will be referred to this entity. Up to a forty (40) character field. A required field.

History

Rulemaking Authority 408.061(1)(e), 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063 FS. History–New 1-1-10, Formerly 59E-7.014, Amended 10-1-15, 1-1-18, 2-16-23.

Fla. Admin. Code R. 59E-7.028 Inpatient Data Elements, Codes and Standards

All hospitals submitting data in compliance with Rules 59E-7.012 and 59E-7.021 through 59E-7.030, F.A.C., shall report the required data elements and data element codes listed below as stipulated by the Agency.

(1) AHCA Facility Number. Enter the identification number of the hospital as assigned by the Agency for reporting purposes. A valid identification number must be between one (1) digit and eight (8) digits. A required field.

(2) Patient Control Number. An alpha-numeric code containing standard letters or numbers assigned by the facility as a unique identifier for each record submitted in the reporting period to facilitate retrieval of the individual’s account of services (accounts receivable) containing the financial billing records and any postings of payment. The ‘Patient Control Number’ is defined as ‘Record id’ in the schema. Up to twenty four (24) characters. Duplicate patient control numbers are not permitted. A required field. The hospital must maintain a key list to locate actual records upon request by the Agency.

(3) Medical or Health Record Number. An alpha-numeric code assigned to the patient’s medical or health record by the facility. The medical or health record number references a file that contains the history of treatment. It should not be substituted for the Patient Control Number. Up to twenty four (24) characters. A required field.

(4) Patient Social Security Number. The social security number (SSN) of the patient. The SSN is a nine (9) digit number issued by the Social Security Administration used to facilitate retrieval of individual case records, track multiple patient discharges and for medical research. Reporting 777777777 is acceptable for those patients where efforts to obtain the SSN have been unsuccessful or the patient is under two (2) years of age and does not have a SSN or for patients who are non-U.S. citizens who have not been issued SSNs. If only the last four digits of a patients SSN are known, report 77777XXXX where XXXX represent the last known four digits of the patient SSN. The last four digit SSN format must be used only when the full SSN is unknown and not as a substitute for all nine digit SSN’s. A required entry.

(5) Patient Ethnicity. Self-designated by the patient or patient’s parent or guardian. Use “Unknown” where efforts to obtain the information from the patient or from the patient’s parent or guardian have been unsuccessful. The patient’s ethnic background shall be reported as one choice from the following list of alternatives. A required entry. Must be a two (2) digit code as follows:

(a) E1 = Hispanic or Latino. A person of Mexican, Puerto Rican, Cuban, Central or South American or other Spanish culture or origin, regardless of race.

(b) E2 = Non-Hispanic or Latino. A person not of any Spanish culture or origin.

(a) 1 – American Indian or Alaska Native. A person having origins in any of the original peoples of North and South America (including Central America), and who maintains cultural identification through tribal affiliation or community recognition.

(b) 2 – Asian. A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent. This area includes, for example, Cambodia, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand and Vietnam.

(d) 4 – Native Hawaiian or other Pacific Islander. A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.

(e) 5 – White. A person having origins in any of the original peoples of Europe, North Africa, or the Middle East.

(f) 6 – Other. Any other possible options not covered in the above categories, including a patient who has more than one race.

(g) 7 – Unknown. Use if the patient refuses or fails to disclose.

(7) Patient Birth Date. The date of birth of the patient. A ten (10) character field in the format YYYY-MM-DD where MM represents the numbered months of the year from 01 to 12, DD represents numbered days of the month from 01 to 31, and YYYY represents the year in four (4) digits. Unknown birthdates should use the default of 1880-01-01. A birth date after the discharge date is not permitted. A required entry.

(8) Patient Sex. The patient sex at the time of admission. A required entry. Must be a one (1) alpha character in upper case as follows:

(a) M – Male;

(b) F – Female; and,

(c) U – Unknown – Use where efforts to obtain the information have been unsuccessful or where the patient’s sex cannot be determined due to a medical condition.

(9) Patient Zip Code. The numeric five (5) digit United States Postal Service ZIP Code of the patient’s address. Use 00009 for foreign residences. Use 00007 for homeless patients. Use 00000 where efforts to obtain the information have been unsuccessful. A required entry.

(10) Patient Country Code. The country code of residence. A two (2) digit upper case alpha code from the International Standard for Organization country code list, ISO 3166 or latest release. A required entry. Use 99 where the country of residence is unknown or where efforts to obtain the information have been unsuccessful.

(11) Type of Service Code. A code designating the type of discharges as either acute inpatient, long term care, short term and long term psychiatric, or comprehensive rehabilitation. A required entry. Must be a one digit code as follows:

(a) 1 – Inpatient, as described in subsection 59E-7.021(6), F.A.C.; and,

(b) 2 – Comprehensive Rehabilitation, as described in subsection 59E-7.021(2), F.A.C.

(12) Priority of Admission. The scheduling priority of the initial admission. A required entry. Must be a one (1) digit code as follows:

(a) 1 – Emergency. The patient requires immediate medical intervention as a result of severe, life-threatening or potentially disabling conditions;

(b) 2 – Urgent. The patient requires attention for the care and treatment of a physical or mental disorder;

(d) 4 – Newborn. A baby born within the facility or the initial admission of an extramural birth infant to an acute care facility within 24 hours of birth, as described in subsection 59E-7.021(7), F.A.C. Use of this code requires the use of a special Point of Origin for Admission code; and,

(e) 5 – Trauma. A patient treated as a trauma patient with or without trauma activation at a State of Florida designated trauma center.

(13) Source or Point of Origin for Admission. Must be a one (1) character alpha code or two (2) digit numeric code indicating the direct source of patient origin for the admission or visit. Codes 10 or 13 are to be used only for newborn admissions. A required entry. Alpha characters must use upper case.

(a) 01 – Non-health care facility point of origin. The patient was admitted to this facility. Includes a patient coming from home or workplace.

(b) 02 – Clinic or Physician’s Office. The patient was admitted to this facility from a clinic or physician’s office.

(c) 04 – Transfer from a hospital. The patient was admitted to this facility as a transfer from an acute care facility where the patient was an inpatient. Transfer must be from a different hospital. Excludes transfers from hospital inpatients in the same facility.

(d) 05 – Transfer from a Skilled Nursing Facility (SNF) or Intermediate Care Facility (ICF). The patient was admitted to this facility from a SNF or ICF where the patient was a resident.

(e) 06 – Transfer from another health care facility. The patient was admitted to this facility as a transfer from another type of health care facility not defined elsewhere in this code list.

(f) 08 – Court/Law Enforcement. The patient was admitted upon the direction of a court of law, or upon the request of a law enforcement Agency representative. Includes transfers from incarceration facilities.

(g) 09 – Information Not Available. The means by which the patient was admitted to this hospital is not known.

(h) D – Transfer from one distinct unit of the hospital to another distinct unit of the same hospital resulting in a separate claim. The patient was admitted to this facility as a transfer from hospital inpatient within this hospital resulting in a separate claim to the payer. For purposes of this code, “Distinct Unit” is defined as a unique unit or level of care at the hospital requiring the issuance of a separate claim to the payer.

(i) E – Transfer from an Ambulatory Surgery Center.

(j) F – Transfer from a hospice facility and under a hospice plan of care or enrolled in a hospice program.

Codes required for newborn admissions (Priority of Admission=4):

(k) 10 – Born inside this hospital; and,

(l) 13 – Born outside this hospital.

(14) Admission Date. The date the patient was admitted to the initial reporting facility. A ten (10) character field in the format YYYY-MM-DD where MM represents the numbered months of the year from 01 to 12, DD represents numbered days of the month from 01 to 31, and YYYY represents the year in four (4) digits. Admission date must equal or precede the discharge date. A required entry.

(15) Inpatient Admission Time. The hour on a 24-hour clock during which the patient’s initial inpatient admission to the hospital occurred. A required entry. Use 99 where efforts to obtain the information have been unsuccessful. Must be two digits as follows:

A.M. HOURS

(a) 00 – 12:00 midnight to 12:59:59

(b) 01 – 01:00 to 01:59:59

(d) 03 – 03:00 to 03:59:59

(e) 04 – 04:00 to 04:59:59

(f) 05 – 05:00 to 05:59:59

(g) 06 – 06:00 to 06:59:59

(h) 07 – 07:00 to 07:59:59

(i) 08 – 08:00 to 08:59:59

(j) 09 – 09:00 to 09:59:59

(k) 10 – 10:00 to 10:59:59

(l) 11 – 11:00 to 11:59:59

P.M. HOURS

(m) 12 – 12:00 noon to 12:59:59

(n) 13 – 01:00 to 01:59:59

(o) 14 – 02:00 to 02:59:59

(p) 15 – 03:00 to 03:59:59

(q) 16 – 04:00 to 04:59:59

(r) 17 – 05:00 to 05:59:59

(s) 18 – 06:00 to 06:59:59

(t) 19 – 07:00 to 07:59:59

(u) 20 – 08:00 to 08:59:59

(v) 21 – 09:00 to 09:59:59

(w) 22 – 10:00 to 10:59:59

(x) 23 – 11:00 to 11:59:59

(y) 99 – Unknown

(16) Discharge Date. The date the patient was discharged from the reporting facility. A ten (10) character field in the format YYYY-MM-DD where MM represents the numbered months of the year from 01 to 12, DD represents numbered days of the month from 01 to 31, and YYYY represents the year in four (4) digits. Discharge date must equal or follow the admission date, and discharge date must occur within the reporting period as shown on the header record. A required entry.

(17) Discharge Time. The hour on a 24-hour clock in which the patient was discharged from the discharging hospital. A required entry. Use 99 where efforts to obtain the information have been unsuccessful. Must be two digits as follows:

A.M. HOURS

(a) 00 – 12:00 midnight to 12:59:59

(b) 01 – 01:00 to 01:59:59

(d) 03 – 03:00 to 03:59:59

(e) 04 – 04:00 to 04:59:59

(f) 05 – 05:00 to 05:59:59

(g) 06 – 06:00 to 06:59:59

(h) 07 – 07:00 to 07:59:59

(i) 08 – 08:00 to 08:59:59

(j) 09 – 09:00 to 09:59:59

(k) 10 – 10:00 to 10:59:59

(l) 11 – 11:00 to 11:59:59

P.M. HOURS

(m) 12 – 12:00 noon to 12:59:59

(n) 13 – 01:00 to 01:59:59

(o) 14 – 02:00 to 02:59:59

(p) 15 – 03:00 to 03:59:59

(q) 16 – 04:00 to 04:59:59

(r) 17 – 05:00 to 05:59:59

(s) 18 – 06:00 to 06:59:59

(t) 19 – 07:00 to 07:59:59

(u) 20 – 08:00 to 08:59:59

(v) 21 – 09:00 to 09:59:59

(w) 22 – 10:00 to 10:59:59

(x) 23 – 11:00 to 11:59:59

(y) 99 – Unknown

(18) Patient Discharge Status. Patient disposition at discharge. A required entry. Must be a two (2) digit code as follows:

(a) 01 – Discharged to home or self-care (routine discharge).

(b) 02 – Discharged or transferred to a short-term general hospital for inpatient care.

(c) 03 – Discharged or transferred to a skilled nursing facility with Medicare certification in anticipation of skilled care.

(d) 04 – Discharged or transferred to an intermediate care facility.

(e) 05 – Discharged or transferred to a designated cancer center or Children’s Hospital.

(f) 06 – Discharged or transferred to home under care of home health care organization service in anticipation of skilled care.

(g) 07 – Left the hospital against medical advice (AMA) or discontinued care.

(h) 20 – Expired.

(i) 21 – Discharged or transferred to court/law enforcement.

(j) 50 – Hospice-Home.

(k) 51 – Hospice Medical Facility (Certified) providing hospice level of care.

(l) 62 – Discharged or transferred to an Inpatient Rehabilitation Facility (IRF) including rehabilitation distinct part units of a hospital.

(m) 63 – Discharged or transferred to a Medicare certified long term care hospital.

(n) 64 – Discharged or transferred to a Nursing Facility certified under Medicaid but not certified under Medicare.

(o) 65 – Discharged or transferred to a psychiatric hospital including psychiatric distinct part units of a hospital.

(p) 66 – Discharged or transferred to a Critical Access hospital.

(q) 70 – Discharged or transferred to another type of health care institution not defined elsewhere in this code list.

(19) Principal Payer Code. Describes the expected primary source of reimbursement for services rendered based on the patient’s status at the time of reporting. A required entry. Must be a one (1) character alpha field using upper case as follows:

(a) A – Medicare. Patients covered by Medicare where Centers for Medicare and Medicaid Services is the direct payer.

(c) C – Medicaid. Patients covered by state administered Florida Medicaid where the payment is directly from the State of Florida Medicaid program.

(d) D – Medicaid Managed Care. Patients covered by Medicaid funded capitated plans. This would include any program where the patient is enrolled in the Medicaid program but the payment is not directly from the state of Florida Medicaid program. This designation is to be used regardless of whether the hospital has a contract with that plan.

(e) E – Commercial Health Insurance. Patients covered by any type of private coverage, including HMO, PPO, self-insured plans.

(f) H – Workers’ Compensation. Patients covered by any type of workers compensation plan, including self insured plans, managed care plans or the State of Florida sponsored workers compensation plan.

(g) I – TriCare or Other Federal Government. Patients covered by any federal government program for active and retired military and their families, Black Lung, Section 1011, the Federal Prison System, or any other federal program.

(h) J – VA. Patients covered by the Veteran’s Administration (VA).

(j) L – Self Pay. Patients with no insurance coverage.

(k) M – Other. This would include patients covered by any other type of payer not meeting the descriptions in paragraphs (a)-(j), above, or paragraphs (l)-(o), below.

(m) O – KidCare. Includes Healthy Kids, MediKids and Children’s Medical Services.

(n) Q – Commercial Liability Coverage. Patients whose health care is covered under a liability policy, such as automobile, homeowners or general business.

(20) Principal Diagnosis Code. The code representing the diagnosis established, after study, to be chiefly responsible for occasioning the admission. Principal diagnosis code must contain a valid ICD-10-CM code for the reporting period. A diagnosis code cannot be used more than once as a principal or other diagnosis for each hospitalization reported. The code must be entered with a decimal point that is included in the valid code. A required entry. Alpha characters must be in upper case.

(21) Other Diagnosis Code (1), Other Diagnosis Code (2), Other Diagnosis Code (3), Other Diagnosis Code (4), Other Diagnosis Code (5), Other Diagnosis Code (6), Other Diagnosis Code (7), Other Diagnosis Code (8), Other Diagnosis Code (9), Other Diagnosis Code (10), Other Diagnosis Code (11), Other Diagnosis Code (12), Other Diagnosis Code (13), Other Diagnosis Code (14), Other Diagnosis Code (15), Other Diagnosis Code (16), Other Diagnosis Code (17), Other Diagnosis Code (18), Other Diagnosis Code (19), Other Diagnosis Code (20), Other Diagnosis Code (21), Other Diagnosis Code (22), Other Diagnosis Code (23), Other Diagnosis Code (24), Other Diagnosis Code (25), Other Diagnosis Code (26), Other Diagnosis Code (27), Other Diagnosis Code (28), Other Diagnosis Code (29), and Other Diagnosis Code (30). A code representing a condition that is related to the services provided during the hospitalization excluding external cause of morbidity codes. Report external cause of morbidity codes as described in subsection (61), below. No more than thirty (30) other diagnosis codes may be reported. Less than thirty (30) entries is permitted. If an Other Diagnosis Code is reported, a valid Principal Diagnosis code must be reported. Must contain a valid ICD-10-CM code for the reporting period. An Other Diagnosis Code cannot be used more than once as a principal or other diagnosis for each hospitalization reported. The code must be entered with use of a decimal point that is included in the valid code. Alpha characters must be in upper case.

(22) Present on Admission Indicator for Principal Diagnosis Code, Present on Admission for Other Diagnosis Code (1), Present on Admission Indicator for Other Diagnosis Code (2), Present on Admission Indicator for Other Diagnosis Code (3), Present on Admission Indicator for Other Diagnosis Code (4), Present on Admission Indicator for Other Diagnosis Code (5), Present on Admission Indicator for Other Diagnosis Code (6), Present on Admission Indicator for Other Diagnosis Code (7), Present on Admission Indicator for Other Diagnosis Code (8), Present on Admission Indicator for Other Diagnosis Code (9), Present on Admission Indicator for Other Diagnosis Code (10), Present on Admission Indicator for Other Diagnosis Code (11), Present on Admission Indicator for Other Diagnosis Code (12), Present on Admission Indicator for Other Diagnosis Code (13), Present on Admission Indicator for Other Diagnosis Code (14), Present on Admission Indicator for Other Diagnosis Code (15), Present on Admission Indicator for Other Diagnosis Code (16), Present on Admission Indicator for Other Diagnosis Code (17), Present on Admission Indicator for Other Diagnosis Code (18), Present on Admission Indicator for Other Diagnosis Code (19), Present on Admission Indicator for Other Diagnosis Code (20), Present on Admission Indicator for Other Diagnosis Code (21), Present on Admission Indicator for Other Diagnosis Code (22), Present on Admission Indicator for Other Diagnosis Code (23), Present on Admission Indicator for Other Diagnosis Code (24), Present on Admission Indicator for Other Diagnosis Code (25), Present on Admission Indicator for Other Diagnosis Code (26), Present on Admission Indicator for Other Diagnosis Code (27), Present on Admission Indicator for Other Diagnosis Code (28), Present on Admission Indicator for Other Diagnosis Code (29), Present on Admission Indicator for Other Diagnosis Code (30), Present on Admission Indicator for External Cause of Morbidity Code (1), Present on Admission Indicator for External Cause of Morbidity Code (2), and Present on Admission Indicator for External Cause of Morbidity Code (3). A code differentiating whether the condition represented by the corresponding Principal Diagnosis Code (20), Other Diagnosis Code (21), (1) through (30), and External Cause of Morbidity Code (61), (1) through (3), was present on admission or whether the condition developed after admission as determined by the physician, medical record or nature of the condition. A required entry.

(a) Y – Yes. Present at the time that the order for inpatient admission occurs.

(b) N – No. Not present at the time that the order for inpatient admission occurs.

(d) W – Clinically Undetermined. Provider is unable to clinically determine whether condition was present on admission or not.

(e) 1 – Exempt. A condition that is included on the current Centers for Medicare & Medicaid Services ICD-CM “Exempt from Reporting” list.

(23) Principal Procedure Code. The code representing the procedure most related to the principal diagnosis. No entry is permitted consistent with the records of the reporting entity. Must contain a valid ICD-10-PCS procedure code for the reporting period. If a principal procedure date is reported, a valid principal procedure code must be reported. Alpha characters must be in upper case.

(24) Principal Procedure Date. The date when the principal procedure was performed. If a principal procedure is reported, a principal procedure date must be reported. No entry is permitted if no principal procedure is reported. A ten (10)-character field in the format YYYY-MM-DD where MM represents the numbered months of the year from 01 to 12, DD represents numbered days of the month from 01 to 31, and YYYY represents the year in four (4) digits. The principal procedure date must be less than seven (7) days prior to the admission date and not later than the discharge date.

(25) Other Procedure Code (1), Other Procedure Code (2), Other Procedure Code (3), Other Procedure Code (4), Other Procedure Code (5), Other Procedure Code (6), Other Procedure Code (7), Other Procedure Code (8), Other Procedure Code (9), Other Procedure Code (10), Other Procedure Code (11), Other Procedure Code (12), Other Procedure Code (13), Other Procedure Code (14), Other Procedure Code (15), Other Procedure Code (16), Other Procedure Code (17), Other Procedure Code (18), Other Procedure Code (19), Other Procedure Code (20), Other Procedure Code (21), Other Procedure Code (22), Other Procedure Code (23), Other Procedure Code (24), Other Procedure Code (25), Other Procedure Code (26), Other Procedure Code (27), Other Procedure Code (28), Other Procedure Code (29) and Other Procedure Code (30). A code representing a procedure provided during the hospitalization. If a principal procedure is not reported, an Other Procedure Code must not be reported. No more than thirty (30) other procedure codes may be reported. Less than thirty (30) or no entry is permitted. Must be a valid ICD-10-PCS procedure code for the reporting period. Alpha characters must be in upper case.

(26) Other Procedure Code Date (1), Other Procedure Code Date (2), Other Procedure Code Date (3), Other Procedure Code Date (4), Other Procedure Code Date (5), Other Procedure Code Date (6), Other Procedure Code Date (7), Other Procedure Code Date (8), Other Procedure Code Date (9), Other Procedure Code Date (10), Other Procedure Code Date (11), Other Procedure Code Date (12), Other Procedure Code Date (13), Other Procedure Code Date (14), Other Procedure Code Date (15), Other Procedure Code Date (16), Other Procedure Code Date (17), Other Procedure Code Date (18), Other Procedure Code Date (19), Other Procedure Code Date (20), Other Procedure Code Date (21), Other Procedure Code Date (22), Other Procedure Code Date (23), Other Procedure Code Date (24), Other Procedure Code Date (25), Other Procedure Code Date (26), Other Procedure Code Date (27), Other Procedure Code Date (28), Other Procedure Code Date (29) and Other Procedure Code Date (30). The date when the procedure was performed. A required entry if a corresponding procedure code (26), (1) through (30) is reported. A ten (10) character field in the format YYYY-MM-DD where MM represents the numbered months of the year from 01 to 12, DD represents numbered days of the month from 01 to 31, and YYYY represents the year in four (4) digits. The procedure date must be less than seven (7) days prior to the admission date and not later than the discharge date.

(27) Attending Practitioner Identification Number. The Florida license number of the medical doctor, osteopathic physician, dentist, podiatrist, chiropractor or advanced practice registered nurse who had primary responsibility for the patient’s medical care and treatment or who certified as to the medical necessity of the services rendered. For military physicians not licensed in Florida, use US999999999. An alpha-numeric field of up to fifteen (15) characters. A required entry. Alpha characters must be in upper case.

(28) Attending Practitioner National Provider Identification (NPI). A unique ten (10) character identification number assigned to a provider. A required entry for providers in the US or its territories and providers not in the US or its territories upon mandated HIPAA NPI implementation date. For military physicians, medical residents, or individuals not required to obtain a NPI number, use 9999999999.

(29) Operating or Performing Practitioner Identification Number. The Florida license number of the medical doctor, osteopathic physician, dentist, podiatrist, chiropractor or advanced practice registered nurse who had primary responsibility for the principal procedure performed. The operating or performing practitioner may be the attending practitioner. For military physicians not licensed in Florida, use US999999999. No entry is permitted if no principal procedure is reported. An alpha-numeric field of up to fifteen (15) characters. Alpha characters must be in upper case.

(30) Operating or Performing Practitioner National Provider Identification (NPI). A unique ten (10) character identification number assigned to a provider who had primary responsibility for the Principal Procedure performed. A required identification number for providers in the U.S. or its territories and providers not in U.S. or its territories upon mandated HIPAA NPI implementation date. For military physicians, medical residents, or individuals not required to obtain a NPI number, use 9999999999. No entry is permitted if no principal procedure is reported.

(31) Other Operating or Performing Practitioner Identification Number. The Florida license number of a medical doctor, osteopathic physician, dentist, podiatrist, chiropractor or advanced practice registered nurse who assisted the operating or performing practitioner or performed a secondary procedure. The other operating or performing practitioner must not be reported as the operating or performing practitioner. The other operating or performing practitioner may be the attending practitioner. For military physicians not licensed in Florida, use US999999999. No entry is permitted consistent with the records of the reporting entity. An alpha-numeric field of up to fifteen (15) characters. Alpha characters must be in upper case.

(32) Other Operating or Performing Practitioner National Provider Identification (NPI). A unique ten (10) character identification number assigned to a provider who assisted the operating or performing practitioner or performed a secondary procedure. A required identification number for providers in the U.S. or its territories and providers not in U.S. or its territories upon mandated HIPAA NPI implementation date. For military physicians, medical residents, or individuals not required to obtain a NPI number, use 9999999999. No entry is permitted if no principal procedure is reported.

(33) Room and Board Charges. Routine service charges incurred for accommodations. Report charges for revenue codes 11X through 16X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no Room and Board Charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(34) Nursery Level I Charges. Accommodation charges for well-baby care services which include sub-ventilation care, intravenous feedings and gavage to neonates. Report charges for revenue code 170 and 171, or 179 if applicable, as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no Nursery Charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(35) Nursery Level II Charges. Accommodation charges for services which include provision of ventilator services. Report charges for revenue code 172, or 179 if applicable, as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no Level II Nursery Charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(36) Nursery Level III Charges. Accommodation charges for services which include continuous cardiopulmonary support services, complex pediatric surgery, neonatal cardiovascular surgery, pediatric neurology and neurosurgery, and pediatric cardiac catheterization. Report charges for revenue code 173, 174, or 179 if applicable, as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no Level III Nursery Charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(37) Intensive Care Charges. Routine service charges for medical or surgical care provided to patients who require a more intensive level of care than is rendered in the general medical or surgical unit. Exclude neonatal intensive care charges reported as a Level III Nursery Charge. Report charges for revenue code 20X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no intensive care charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(38) Coronary Care Charges. Routine service charges for medical care provided to patients with coronary illness who require a more intensive level of care than is rendered in the general medical unit. Report charges for revenue code 21X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no coronary care charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(39) Pharmacy Charges. Charges for medication. Report charges for revenue codes 25X and 63X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no pharmacy charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(40) Medical and Surgical Supply Charges. Charges for supply items required for patient care. Report charges for revenue codes 27X and 62X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no medical and surgical supply charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(41) Laboratory Charges. Charges for the performance of diagnostic and routine clinical laboratory tests and for diagnostic and routine tests in tissues and culture. Report charges for revenue codes 30X and 31X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no laboratory charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(42) Radiology or Other Imaging Charges. Charges for the performance of diagnostic and therapeutic radiology services including computed tomography, mammography, magnetic resonance imaging, nuclear medicine, and chemotherapy administration of radioactive substances. Report charges for revenue codes 32X through 35X, 40X and 61X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no radiology or other imaging charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(43) Cardiology Charges. Facility charges for cardiac procedures rendered such as, but not limited to, heart catheterization or coronary angiography. Report charges for revenue code 48X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no cardiology charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(44) Respiratory Services or Pulmonary Function Charges. Charges for administration of oxygen, other inhalation services, and tests that evaluate the patient’s respiratory capacities. Report charges for revenue codes 41X and 46X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no respiratory service or pulmonary function charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(45) Operating Room Charges. Charges for the use of the operating room. Report charges for revenue code 36X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no operating room charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(46) Anesthesia Charges. Charges for anesthesia services by the facility. Report charges for revenue code 37X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no anesthesia charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(47) Recovery Room Charges. Charges for the use of the recovery room. Report charges for revenue code 71X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no recovery room charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(48) Labor Room Charges. Charges for labor and delivery room services. Report charges for revenue code 72X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no labor room charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(49) Emergency Room Charges. Charges for medical examinations and emergency treatment. Report charges for revenue code 45X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no emergency room charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(50) Trauma Response Charges. Charges for a trauma team activation at a State of Florida licensed trauma center. Report charges for revenue code 68X used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no trauma response charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(51) Treatment or Observation Room Charges. Charges for use of a treatment room or for the room charge associated with observation services. Report charges for revenue code 76X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no treatment or observation room charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(52) Behavioral Health Charges. Charges for behavioral health treatment and services. Report charges for revenue codes 90X though 91X and 100X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(53) Oncology. Charges for treatment of tumors and related diseases. Excludes therapeutic radiology services reported in radiology and other imaging services in subsection (42). Report charges for revenue code 28X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no oncology charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(54) Physical Therapy Charges. Charges for physical therapy in revenue code 42X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(55) Occupational Therapy Charges. Charges for occupational therapy for revenue code 43X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(56) Speech Therapy or Language Pathology Charges. Charges for speech therapy or language pathology therapy for revenue code 44X as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(57) Comp Rehab Room Charges. Charges for comprehensive rehabilitation room charges for revenue codes 0118, 0128, 0138, 0148, 0158 as used in the UB-04. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(58) Other Charges. Other facility charges not included in subsections (33) to (56), above. Include charges that are not reflected in any of the preceding specific revenue accounts in the UB-04. Do not include charges from revenue codes 96X, 97X, 98X, or 99X in the UB-04 for professional fees and personal convenience items. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Report zero (0) if there are no other charges. Negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(59) Total Gross Charges. The total of undiscounted charges for services rendered by the hospital. Include charges for services rendered by the hospital excluding professional fees. The sum of all charges reported above in subsections (33) through (57), must equal total charges, plus or minus thirteen ($13.00) dollars. Report in dollars rounded to the nearest whole dollar, without dollar signs or commas, excluding cents. Zero (0) or negative amounts are not permitted unless verified separately by the reporting entity. A required entry.

(60) Infant Linkage Identifier. The social security number of the patient’s birth mother where the patient is less than two (2) years of age. A nine (9) digit field to facilitate retrieval of individual case records, to be used to link infant and mother records, and for medical research. Reporting 777777777 for the mother’s SSN is acceptable for those patients where efforts to obtain the mother’s SSN have been unsuccessful or the mother is known to be from a country other than the United States. Infants in the custody of the State of Florida or adoptions, use 333333333 if the birth mother’s SSN is not available. A required field for patients whose age is less than two (2) years of age at admission. Zero fill if the patient is two (2) years of age or older. A required entry.

(61) Admitting Diagnosis. The diagnosis provided by the admitting physician at the time of admission which describes the patient’s condition upon admission or purpose of admission. Must contain a valid ICD-10-CM code for the reporting period. The code must be entered with use of a decimal point that is included in the valid code. A required entry. Alpha characters must be in upper case.

(62) External Cause of Morbidity Code (1), External Cause of Morbidity Code (2) and External Cause of Morbidity Code (3). A code representing circumstances or conditions as the cause of the injury, poisoning, or other adverse effects recorded as a diagnosis. External Cause of Morbidity Code (1), should indicate the nature of the adverse effect. External Cause of Morbidity Codes (2) and (3), are used for secondary to the primary code. No more than three (3) external cause of morbidity codes may be reported. Must be a valid ICD-10-CM cause of morbidity code for the reporting period. An external cause of morbidity code cannot be used more than once for each hospitalization reported. The code must be entered with use of a decimal point that is included in the valid code. Alpha characters must be in upper case.

(63) Emergency Department (ED) Date of Arrival. The date the patient registered in the Emergency Department if the visit results in an inpatient admission to the reporting facility. A ten (10) character field in the format YYYY-MM-DD where MM represents the numbered months of the year from 01 to 12, DD represents numbered days of the month from 01 to 31, and YYYY represents the year in four (4) digits. Admission date must equal or precede the discharge date. Use 0000-00-00 for patients not admitted through the Emergency Department. A required entry.

(64) Emergency Department (ED) Hour of Arrival. The hour on a 24-hour clock during which the patient’s registration in the emergency department occurred. A required entry. Use 99 where the patient was not admitted through the emergency department or where efforts to obtain the information have been unsuccessful. Must be two (2) digits as follows:

A.M. HOURS

(a) 00 – 12:00 midnight to 12:59:59

(b) 01 – 01:00 to 01:59:59

(d) 03 – 03:00 to 03:59:59

(e) 04 – 04:00 to 04:59:59

(f) 05 – 05:00 to 05:59:59

(g) 06 – 06:00 to 06:59:59

(h) 07 – 07:00 to 07:59:59

(i) 08 – 08:00 to 08:59:59

(j) 09 – 09:00 to 09:59:59

(k) 10 – 10:00 to 10:59:59

(l) 11 – 11:00 to 11:59:59

P.M. HOURS

(m) 12 – 12:00 noon to 12:59:59

(n) 13 – 01:00 to 01:59:59

(o) 14 – 02:00 to 02:59:59

(p) 15 – 03:00 to 03:59:59

(q) 16 – 04:00 to 04:59:59

(r) 17 – 05:00 to 05:59:59

(s) 18 – 06:00 to 06:59:59

(t) 19 – 07:00 to 07:59:59

(u) 20 – 08:00 to 08:59:59

(v) 21 – 09:00 to 09:59:59

(w) 22 – 10:00 to 10:59:59

(x) 23 – 11:00 to 11:59:59

(y) 99 – Unknown.

(65) Condition Code. A two-character code that describes patients admitted to the inpatient facility after receiving treatment in the facility’s emergency department. Do not use this code for patients admitted to the hospital through the ED when the registration department is closed. Report using the two-character indicator code ‘P7’. Otherwise zero fill using “00.” A required field.

(66) Trailer record. The last record in the data file shall be a trailer record and must accompany each data set. Report only the total number of patient data records contained in the file, excluding header and trailer records. The number entered must equal the number of records processed. Do not include leading zeros.

History

Rulemaking Authority 408.061(1)(e), 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063 FS. History–New 1-1-10, Amended 12-5-10, Formerly 59E-7.014, Amended 10-1-15, 1-1-18, 2-16-23.

Fla. Admin. Code R. 59E-7.029 Patient Date Release

(1) Agency records, public records under Chapter 119, F.S. (Florida’s Public Records Law), are available for public inspection during normal business hours. Copies of such records may be obtained upon request and upon payment of the cost of copying.

(2) Patient-specific records collected by the Agency pursuant to Rules 59E-7.021-.030, F.A.C., are exempt from disclosure pursuant to Section 408.061(7), F.S., and shall not be released unless modified to protect patient confidentiality as described in paragraph (2)(a), below, and released in the manner described in paragraphs (2)(c) and (2)(d).

(a) The patient-specific record shall be modified to protect patient confidentiality as follows:

Patient Control Number as assigned by the facility. Delete.
Patient Social Security Number. Delete.
Patient Birth Date. Substitute age in years and an indicator of Age < 29 Days except for persons 100 and older, substitute age > 100 years.
Admission Date. Delete. (admit month cannot be substituted)
Discharge Date. Substitute quarters 1-4. (discharge month cannot be substituted)
Principal Procedure Date. Days from admission to Principal Procedure will be substituted.
Other Procedure Date. Days from admission to Other Procedure will be substituted.
Infant Linkage ID. Delete.
Medical or Health Record Number. Delete.
ED Date of Arrival. Visit Time Hours (VTH) will be substituted. The VTH will calculate the number of hours spent at the ED from registration to discharge.

(b) A record linkage number shall be assigned which does not identify an individual patient and cannot reasonably be used to identify an individual patient through use of data available through the Agency for Health Care Administration, but which can be used for confidential data output for bona fide research purposes.

(c) The modified data records described in paragraph (2)(a), shall be released as a set of all records occurring in one calendar quarter based on date of discharge.

(d) The modified data described in paragraph (2)(a), shall be released in accordance with the Limited Data Set requirements of the federal Health Insurance Portability and Accountability Act and shall be made available on or after quarterly data has been certified as accurate by the hospitals as required by Section 408.061(1)(a), F.S.

(3) Aggregate reports derived from patient-specific hospital records collected pursuant to Rules 59E-7.021 through 59E-7.030, F.A.C., are public records and shall be released as described in this rule, provided that the aggregate reports do not include the patient control number as assigned by the facility, patient social security number, record linkage number, patient birth date, admission date, discharge date, principal procedure date, other procedure date, ED date of arrival, infant linkage identifier or medical or health record number and provided the aggregate reports contain the combination of five or more records for any data disclosed.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.061 FS. History–New 1-1-10, Formerly 59E-7.015, Amended 1-1-18.

Fla. Admin. Code R. 59E-7.030 General Provisions

Hospitals submitting inpatient discharge data pursuant to the provisions contained in these rules shall be directed by the following specific general provisions for inpatient data reporting:

(1) Any inpatient who is transferred or discharged from the acute care setting into a rehabilitative care distinct part unit or free standing hospital, must be reported as a separate record from the patients acute care record. The acute care discharge record is assigned data type one (1), and the comprenhensive rehabilitative therapy discharge record is assigned data type two (2).

(2) If inpatients are administratively transferred or formally discharged from the acute care setting into a distinct-part Medicare certified skilled nursing unit or to hospice care, reporting accountability ceases at the time of discharge or transfer. Patient’s receiving sub-acute care in these setting are excluded from inpatient reporting requirements.

(3) Observation patients are not included in the inpatient reported unless admitted to the hospital as an inpatient.

History

Rulemaking Authority 408.061(1)(e), 408.15(8) FS. Law Implemented 408.061, 408.062, 408.063 FS. History–New 1-1-10, Formerly 59E-7.016, Amended 1-1-18.

Fla. Admin. Code R. 59E-7.101 Reports of Information by Health Insurers Required

History

Rulemaking Authority 408.15 FS. Law Implemented 408.006, 408.061 FS. History–New 3-9-89, Formerly 10N-1.035, Amended 2-17-92, Formerly 10N-7.101, Repealed 9-20-94.

Fla. Admin. Code R. 59E-7.201 Submission of Comprehensive Inpatient Rehabilitation Hospital Patient Data

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.005(2), 408.05(2)(f)-(g), 408.05(6), 408.061(1)(a) -(b), 408.061(2)-(3), 408.061(8)-(9), 408.062(1)(f), 408.063(2), 408.07, 408.072, 408.085 FS. History–New 3-31-94, Repealed 1-1-10.

Fla. Admin. Code R. 59E-7.202 Schedule for Submission of Patient Data and Extensions

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.005(2), 408.05(2)(f)-(g), 408.05(6), 408.061(1)(a)-(b), 408.061(2)-(3), 408.061(8)-(9), 408.062(1)(f), 408.063(2), 408.07, 408.072, 408.08(9), 408.085 FS. History–New 3-31-94, Repealed 1-1-10.

Fla. Admin. Code R. 59E-7.203 Reporting Instructions

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.005(2), 408.05(2)(f)-(g), 408.05(6), 408.061(1)(a)-(b), 408.061(2)-(3), 408.061(8)-(9), 408.062(1)(f), 408.063(2), 408.07, 408.072, 408.085 FS. History–New 3-31-94, Repealed 1-1-10.

Fla. Admin. Code R. 59E-7.204 Certification Procedures

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.005(2), 408.05(2)(f)-(g), 408.05(6), 408.061(1)(a)-(b), 408.061(2)-(3), 408.061(8)-(9), 408.062(1)(f), 408.063(2), 408.07, 408.072, 408.08(9), 408.085 FS. History–New 3-31-94, Repealed 1-1-10.

Fla. Admin. Code R. 59E-7.205 Patient Data Format – Data Elements and Codes

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.005(2), 408.05(2)(f)-(g), 408.05(6), 408.061(1)(a)-(b), 408.061(2)-(3), 408.061(8)-(9), 408.062(1)(f), 408.063(2), 408.07, 408.072, 408.085 FS. History–New 3-31-94, Repealed 1-1-10.

Fla. Admin. Code R. 59E-7.206 Patient Data Format – Record Layout

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.005(2), 408.05(2)(f)-(g), 408.05(6), 408.061(1)(a)-(b), 408.061(2)-(3), 408.061(8)-(9), 408.062(1)(f), 408.063(2), 408.07, 408.072, 408.085 FS. History–New 3-31-94, Repealed 1-1-10.

Fla. Admin. Code R. 59E-7.207 Data Standards

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.005(2), 408.05(2)(f)-(g), 408.05(6), 408.061(1)(a)-(b), 408.061(2)-(3), 408.061(8)-(9), 408.062(1)(f), 408.063(2), 408.07, 408.072, 408.085 FS. History–New 3-31-94, Repealed 1-1-10.

Fla. Admin. Code R. 59E-7.208 Notice of Potential Future Additional Data Requirements

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.005(2), 408.05(2)(f)-(g), 408.05(6), 408.061(1)(a)-(b), 408.061(2)-(3), 408.061(8)-(9), 408.062(1)(f), 408.063(2), 408.07, 408.072, 408.085 FS. History–New 3-31-94, Repealed 1-1-10.

Chapter 59E-8 Fees for Information Services

Fla. Admin. Code R. 59E-8.001 Determination of Fees

(1) The Florida Center for Health Information and Transparency will periodically, but no less frequently than biannually, calculate the average time required to access, merge, validate, and prepare standard information sets for delivery to the requester. These average times will be used to establish the fees for information services described in the Price List.

(2) Requests for information not addressed in the Price List, ad hoc custom requests, will be priced based on the time required to analyze the request and write the query, and the time required to access, merge, validate and prepare the information for delivery to the requester.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.05(5)(b) FS. History–New 1-3-08.

Fla. Admin. Code R. 59E-8.002 Price List

(1) The Price List of the Florida Center for Health Information and Transparency is posted at http://www.floridahealthfinder.gov/Researchers/OrderData/order-data.aspx.

(2) The Price List dated 8-1-07 is incorporated by reference as AHCA Form FC4200-003.

History

Rulemaking Authority 408.15(8) FS. Law Implemented 408.05(5)(b) FS. History–New 1-3-08.

Chapter 59E-9 Claims Data Collection

Fla. Admin. Code R. 59E-9.010 Claims Data Collection

(1) Definitions.

(a) “Affiliate” means an entity that exercises control over or is directly or indirectly controlled by the insurer through equity ownership of voting securities; common managerial control; or collusive participation by the management of the insurer and affiliate in the management of the insurer or the affiliate as defined in Section 624.10(1), F.S.

(b) “Agency” means the Florida Agency for Health Care Administration (AHCA) as defined in Section 408.032(1), F.S.

(c) “Claims Data” means complete and accurate eligibility data, medical claims data, and pharmacy claims data of Covered Lives held by Payers as specified in the Submission Guide.

(d) “Covered Lives” means individuals for whom Florida Claims Data is held by the Payer inclusive of insureds, individual policyholders, group certificate-holders, subscribers, members and dependents.

(e) “Facility” means Florida licensed facility pursuant to Chapter 395, F.S.

(f) “HIPAA” means the federal Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 and its implementing regulations (45 C.F.R. Parts 160-164), and any requirements of the Health Information Technology for Economic and Clinical Health Act, as incorporated in the American Recovery and Reinvestment Act of 2009 and its implementing regulations.

(g) “Payer” means health insurers as defined in Chapter 624, F.S., or Health Maintenance Organizations as defined in Chapter 641, F.S., including their Affiliates, that participate in the Florida state group health insurance plan created under Section 110.123, F.S., or Medicaid managed care pursuant to Part IV of Chapter 409, F.S.

(h) “Service or Care Bundle” means a typical treatment plan for a medical condition that consists of one or more procedures, tests and services. Bundles are broken down into treatment steps and those steps may include one or more procedures, tests or services.

(i) “Submission Guide” means the document entitled “Florida Claims Data Submission Guide,” November 2017, that sets forth the required schedules, data file format, record specifications, data elements, definitions, code tables and edit specifications for Payers’ submission of Claims Data to the Agency through its Vendor, hereby incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-09235.

(j) “Vendor” means the organization that is under contract with the Agency pursuant to Section 408.05(3)(c), F.S.

(2) Claims Data Collected.

(a) The Vendor shall collect Claims Data from all Payers as specified in Rule 59E-9.010, F.A.C.

(b) Payers shall be exempt from providing Claims Data from health plans covered by the Employee Retirement Income Security Act (ERISA) of 1974 when such employer(s) affirmatively elects not to share these Claims Data.

(c) The Vendor shall not collect Claims Data that reflects the types of coverage referenced in Sections 627.6385(3)(a) through (3)(l) and 641.54 (7)(a) through (7)(l), F.S.

(d) Before delivering Claims Data to the Vendor, each Payer shall remove all information subject to restrictions on use or restrictions of disclosure set forth in 42 C.F.R. Part 2, if applicable.

(3) Claims Data Submission.

(a) Payers shall submit Claims Data for all Covered Lives held by the Payer and its Affiliates to the Agency, through its Vendor, as defined in the Submission Guide.

(b) All Payers submitting their Claims Data shall submit according to the schedule defined in the Submission Guide.

(c) The submission of Claims Data by Payers will be pursuant to a Data Contribution Agreement hereby incorporated by reference as Exhibit B, AHCA Form 4200-0008, November 2017, in the Submission Guide and specified by the Agency and subject to federal and state law and regulation. Payers cannot condition submission on any additional terms, conditions, or restrictions.

(4) Claims Data Audit, Resubmission, and Certification Procedures.

(a) The Submission Guide specifies Claims Data audits, and resubmission policies and procedures.

(b) All Payers submitting data in compliance with this rule shall certify that the data submitted is accurate, complete and verifiable using the Certification of Claims Form hereby incorporated by reference in Exhibit A, AHCA Form 4200-0007, November 2017, in the Submission Guide.

(5) Requirements for Claims Data Publication.

(a) The Agency, as specified in Section 408.05(3)(c), F.S. through its Vendor, shall publish and make available to the public estimated pricing data (de-identified in accordance with HIPAA) based on the Claims Data, on a consumer-friendly website. The website shall allow users to search for the price of health care services by condition or Service Bundles as defined by the Vendor and the Agency.

(b) The Vendor shall calculate an estimated average payment and range of payments for a condition or service bundle to be displayed on the website.

(c) Florida specific state, county and facility-level price estimates will be calculated from the claims dataset based on the location of the provider in the Claims Data.

(d) Price estimates will be reported on the website at the facility or geographic level as directed by the Agency. Price estimates will be derived from historic Claims Data trended forward, and reported using a data suppression methodology such that calculated prices for Service or Care Bundles at a facility or geographic level are based on a designated minimum number of Payers per facility and/or geographic level and a minimum number of claims per Payer needed to disconnect specific prices from any particular Payer.

History

Rulemaking Authority 408.05(3)(e) FS. Law Implemented 408.05(3) FS. History–New 4-2-18.

Division 59G Medicaid

Chapter 59G-1 GENERAL MEDICAID

Fla. Admin. Code R. 59G-1.001 Purpose

The agency adopts these rules to comply with the requirements of Chapter 409, F.S. All rules in Title 59G, F.A.C., must be read in conjunction with the statutes, federal regulations, and all other rules and regulations pertaining to the Medicaid program.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.901-409.9205, 409.961-409.985 FS. History–New 4-29-93, Formerly 10P-1.001.

Fla. Admin. Code R. 59G-1.002 General Medicaid Provisions

History

Rulemaking Authority 409.026(1) FS. Law Implemented 409.267 FS. History–New 1-1-77, Amended 5-7-79, 6-4-82, 7-17-83, 5-1-84, Formerly 10C-7.030, Repealed 10-30-96.

Fla. Admin. Code R. 59G-1.010 Definitions

(1) This rule applies to all providers rendering Florida Medicaid services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Definitions Policy, May 2024, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-16590.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.901-.920, 409.973 FS. History–New 4-29-93, Formerly 10P-1.010, Amended 6-24-98, 4-16-06, 9-18-17, 6-17-24, 4-30-25.

Fla. Admin. Code R. 59G-1.020 Definition of County of Residence

For the purpose of county financial participation in the Medicaid Program, the county of residence for inpatient hospital care and nursing home care is determined by the recipient’s address information contained in the federally approved Medicaid eligibility system.

(1) For hospital claims, whether through fee-for-service or managed care, the address is based on the current living or residential address, with the exception of when the resident lives in a nursing home. When a recipient lives in a nursing home, the address is based on the prior address.

(2) For nursing home claims, whether through fee-for-service or managed care, the address is based on the prior address, except when a recipient is admitted to a nursing home directly from a place of residence outside of the State of Florida. If the recipient is admitted to a nursing home from another state, the nursing home address will be used for county billing purposes.

(3) Since address information for children in custody of the Department of Children and Families is unavailable, counties are not responsible for these payments.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.915 FS. History–New 1-1-77, Formerly 10C-7.31, 10C-7.031, Amended 10-23-12.

Fla. Admin. Code R. 59G-1.025 Medicaid County Billing

History

Rulemaking Authority 409.919 FS. Law Implemented 409.915 FS. History–New 10-23-12, Repealed 2-23-16.

Fla. Admin. Code R. 59G-1.030 Administrative Proceedings

History

Rulemaking Authority 20.05, 120.53(1)(b), (c), 409.026(8), 409.285, 409.910(21), 409.919-.920 FS. Law Implemented 120.53(1)(b), (c), 120.57, 120.58, 409.285, 409.901-.920 FS. History–New 1-1-77, Amended 3-30-78, Formerly 10C-7.035, Amended 11-13-91, Formerly 10C-7.035, Repealed 10-30-96.

Fla. Admin. Code R. 59G-1.035 Determining Generally Accepted Professional Medical Standards

(1) Definitions.

(a) Generally accepted professional medical standards – Standards based on reliable scientific evidence published in peer-reviewed scientific literature generally recognized by the relevant medical community or practitioner specialty associations’ recommendations.

(b) Health service(s) – Diagnostic tests, therapeutic procedures, or medical devices or technologies.

(2) Pursuant to the criteria set forth in subparagraph 59G-1.010(166)(a)3., Florida Administrative Code (F.A.C.), the Agency for Health Care Administration (hereafter referred to as Agency) will determine when health services are consistent with generally accepted professional medical standards and are not experimental or investigational.

(3) Health services that are covered under the Florida Medicaid program are described in the respective coverage and limitations handbooks, policies, and fee schedules, which are incorporated by reference in the F.A.C. The public may request a health service be considered for coverage under the Florida Medicaid program by submitting a written request via email to HealthServiceResearch@ahca.myflorida.com. The request must include the name, a brief description, and any additional information that supports coverage of the health service, including sources of reliable evidence as defined in paragraph 59G-1.010(84)(b), F.A.C.

(4) To determine whether the health service is consistent with generally accepted medical standards, the Agency shall consider the following factors:

(a) Evidence-based clinical practice guidelines.

(b) Published reports and articles in the authoritative medical and scientific literature related to the health service (published in peer-reviewed scientific literature generally recognized by the relevant medical community or practitioner specialty associations).

(d) Utilization trends.

(e) Coverage policies by other creditable insurance payor sources.

(f) Recommendations or assessments by clinical or technical experts on the subject or field.

(5) Based upon the information collected, a report with recommendations will be submitted to the Deputy Secretary for Medicaid (or designee) for review. The Deputy Secretary for Medicaid (or designee) will make a final determination as to whether the health service is consistent with generally accepted professional medical standards and not experimental or investigational.

(6) In order for the health service to be covered under the Florida Medicaid program, it must also meet all other medical necessity criteria as defined in subsection 59G-1.010(166), F.A.C., and funded through the General Appropriations Act or Chapter 216, F.S.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.912, 409.913 FS. History–New 2-26-14, Amended 9-28-15.

Fla. Admin. Code R. 59G-1.036 Clinical Trials

(1) This rule applies to any person or entity prescribing or reviewing a request for Florida Medicaid covered services and to all providers of Florida Medicaid covered services who are enrolled in or registered with the Florida Medicaid program.

(2) Definitions. Clinical Trials ‒ Biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison.

(3) Coverage. Florida Medicaid reimburses for services as a result of a recipient participating in a clinical trial in accordance with the service-specific coverage policy when the services:

(a) Are covered under the Florida Medicaid program.

(b) Would otherwise be provided to a recipient who is not participating in a clinical trial.

(d) Are not expected or unique to the experimental or investigational treatment.

(e) Are not covered by the clinical trial sponsor.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.905, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History‒New 4-4-16.

Fla. Admin. Code R. 59G-1.040 Preadmission Screening and Resident Review

(1) Purpose. This rule applies to all Florida Medicaid-certified nursing facilities (NF), regardless of payer source; all providers rendering NF services to Florida Medicaid recipients; and all entities that perform a function in the Preadmission Screening and Resident Review (PASRR) process as specified in this rule.

(2) Definitions.

(a) Hospital Discharge Exemption – Exception to the Level II evaluation and determination requirement prior to admission to an NF in accordance with Title 42, Code of Federal Regulations (CFR), section 483.106(b)(2)(i)(A)-(C).

(b) Intellectual Disability (ID) – As defined in 42 CFR 483.102(b)(3). The diagnosis of ID includes related conditions, i.e., individuals who have a severe, chronic disability that meets all of the following conditions:

Is attributable to one of the following:

a. Cerebral palsy or epilepsy.

b. Any other condition, (other than mental illness), found to be closely related to ID because the condition results in impairment of general intellectual functioning or adaptive behavior similar to that of persons diagnosed with ID, and requires treatment or services similar to those required for these persons.

Is manifested before the person reaches the age of 22 years.
Is likely to continue indefinitely.
Results in substantial functional limitations in three or more of the following areas of major life activity:

a. Self-care.

b. Understanding and use of language.

c. Learning.

d. Mobility.

e. Self-direction.

f. Capacity for independent living.

(d) Level I PASRR Screen – Process to identify diagnosed or suspected ID, serious mental illness (SMI), or both, based on information gathered by the screener.

(e) Level II Evaluation and Determination – An in-depth, individualized, assessment of the individual to confirm whether the applicant to an NF has SMI, ID, or both; to assess the need for NF services; and evaluate what specialized services, if any, are needed.

(f) New Admission – An individual admitted to any NF for the first time, who was not readmitted or admitted as an inter-facility transfer.

(g) Preadmission Screening and Resident Review – Federal requirement mandated by 42 CFR 483.100-483.138.

(h) Readmission – When an NF resident is transferred to a hospital and returns to any NF within 90 calendar days.

(i) Resident Review (RR) – An evaluation and determination conducted by state-designated authorities when an NF resident experiences a significant change in his or her physical or mental status.

(j) Serious Mental Illness (SMI) – As defined in 42 CFR 483.102(b)(1).

(k) Significant Change – A decline or improvement in an NF resident’s physical or mental status that is anticipated to require intervention.

(l) Specialized Services – Services specified by the state, or its designee, that are not covered in the NF per diem, and are required for appropriate placement in the NF setting for individuals with ID, SMI, or both.

(3) Level I PASRR Screen.

(a) The Agency for Health Care Administration (AHCA), or its designee, performs the Level I PASRR screens for all individuals seeking admission to an NF.

(b) The Agency for Health Care Administration delegates the following entities to perform Level I PASRR screens (collectively referred to as the Level I PASRR screeners):

Florida Department of Health (DOH) for individuals under the age of 21 years. The Department of Health may not further delegate Level I screening responsibilities.
Florida Department of Elder Affairs’ (DOEA) Comprehensive Assessment and Review for Long-Term Care Services (CARES) program for individuals age 21 years and older. The CARES program may only delegate the Level I PASRR screen responsibility to hospital and NF staff who are licensed clinical social workers, physicians, physician assistants, registered nurses, mental health counselors, psychologists, or persons who hold a Master’s Degree in Social Work.

(c) The Level I PASRR screen must be completed by the Level I PASRR screener prior to all new admissions to an NF, and within two business days of the request.

(4) Level II PASRR Evaluation Request.

Upon completion of the Level I PASRR screen, if the individual has a diagnosis of or suspicion of having an SMI, ID, or both:

(a) The Level I PASRR screener must send the individual or their legal representative, as applicable, written notice stating the individual has a diagnosis of, or is suspected of having, an SMI, ID, or both, and is being referred for a Level II PASRR evaluation.

(b) The AHCA-designated Level I PASRR screener must send all of the following documentation for a Level II PASRR evaluation to the Agency for Persons with Disabilities (APD), or the state’s contracted vendor, for individuals diagnosed with, or suspected of having, an ID; or, to the state’s contracted Level II PASRR evaluator for individuals diagnosed with, or suspected of having, an SMI:

Completed Preadmission Screening and Resident Review (PASRR) Level I Screen For Serious Mental Illness (SMI) and/or Intellectual Disability or Related Conditions (ID) (Level I PASRR Screen), AHCA MedServ Form 004 Part A, March 2017, incorporated by reference and available on AHCA’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at https://www.flrules.org/Gateway/reference.asp?No=Ref-07931.
Informed consent, as documented on the Level I PASRR Screen, AHCA MedServ Form 004 Part A, March 2017, or the Preadmission Screening and Resident Review (PASRR) Resident Review (RR) – Evaluation Request For a Significant Change for Serious Mental Illness (SMI) and/or Intellectual Disability or Related Conditions (ID) (Resident Review-Evaluation Request), AHCA MedServ Form 004 Part A1, March 2017, incorporated by reference and available on AHCA’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at https://www.flrules.org/Gateway/reference.asp?No=Ref-07932.
AHCA 5000-3008 Form, incorporated by reference in Rule 59G-1.045, F.A.C.
Other medical documentation including history, most recent physical, relevant case notes or records of treatment and medication administration records, as applicable.
Psychiatric or psychological evaluation, if available.
An assessment conducted by CARES or the minimum data set (MDS), if applicable, if the individual is age 21 years and older.
An assessment conducted by DOH or the MDS, if applicable, if the individual is under the age of 21 years.

(5) The Level I PASRR screener must document the type of provisional admission an individual is seeking, if applicable, and ensure the individual is referred for a Level II evaluation and determination in accordance with subsection (6), as appropriate.

(6) Level II Evaluation Time Frames.

(a) A Level II evaluation must be finalized within seven business days of a completed Level II request if the Level I PASRR screen indicates a diagnosis, or suspicion of, SMI, ID, or both.

(b) Exceptions to the timeframe specified in paragraph (6)(a) are as follows:

Within seven calendar days after the delirium clears, in cases of delirium.
Within seven calendar days of admission for emergency admissions requiring protective services.
In advance of the expiration of the 14 days, when an individual is admitted to an NF for an in-home caregiver’s respite in accordance with Section 400.172, Florida Statutes (F.S.), and is expected to remain in the facility for longer than a 14 calendar day stay, no more than twice in a calendar year.
By calendar day 40, when an individual is admitted to an NF under the hospital discharge exemption, and is expected to stay in the NF longer than 30 calendar days. In this instance, the NF must notify the AHCA-designated Level I screener on the 25th day of the individual’s stay if the stay is expected to extend past 30 calendar days.
Prior to returning to the NF, when an individual with SMI, ID, or both, is transferred to the hospital from the NF, and the hospital stay is longer than 90 consecutive days.

(7) If the individual is not admitted to an NF within 30 calendar days of the Level II evaluation, another Level II evaluation must be completed.

(8) Level II Evaluation Entities and Components.

(a) The following entities are responsible for completing the Level II evaluation for applicants to an NF or residents referred for an RR (collectively known as the Level II evaluator):

State-contracted vendor for individuals diagnosed with, or suspected of having, an SMI.
Agency for Persons with Disabilities, or the state’s contracted vendor, for individuals diagnosed with, or suspected of having, an ID.

(b) All Level II evaluations must involve the following:

Individual being evaluated and the legal representative, if appropriate.
Individual’s family if the individual or the legal representative agrees to family participation.

(c) The Level II evaluation may be terminated if the evaluator determines at any time during the evaluation that the individual:

Does not have an SMI or ID.
Has a primary diagnosis of dementia.
Has a non-primary diagnosis of dementia without a primary diagnosis of SMI or ID.

(9) Level II Evaluation for Individuals with Diagnosis of, or Suspicion of Having, an SMI.

(a) A Level II evaluation for individuals with a diagnosis, or suspicion of having, an SMI must:

Confirm or rule out the diagnosis, or suspicion of, an SMI. A qualified mental health professional must review accurate and recent data of a comprehensive history and a physical examination, or perform or ensure performance of the same, including:

a. Complete medical history.

b. Review of all body systems.

c. Specific evaluation of the individual’s neurological system in the areas of motor functioning, sensory functioning, gait, deep tendon reflexes, cranial nerves, and abnormal reflexes.

d. Additional evaluations conducted by appropriate specialists, where abnormal findings are the basis for an NF placement.

e. Comprehensive drug history including current or immediate past use of medications that could mask symptoms or mimic SMI.

f. Psychosocial evaluation of the person, including current living arrangements and medical and support systems.

g. Comprehensive psychiatric evaluation including a complete psychiatric history, evaluation of SMI functioning, memory functioning, and orientation; description of current attitudes and overt behaviors; affect, suicidal or homicidal ideation, paranoia; and degree of reality testing (presence and content of delusions) and hallucinations.

Include a functional assessment of the individual’s ability to engage in activities of daily living and the level of support that would be needed to assist the individual to perform these activities while living in the community. The assessment must determine whether this level of support can be provided to the individual in an alternative community setting or whether the level of support needed is such that an NF placement is required. The functional assessment must address the individual’s ability to:

a. Self-monitor health status.

b. Self-administer and schedule medical treatment (including medication compliance) or both.

c. Self-monitor nutritional status.

d. Handle money.

e. Dress appropriately.

f. Self-groom.

Confirm the need for NF services and recommend specialized services, if applicable.

(b) Specialized services for an SMI diagnosis are:

Services that are utilized to address an episode of SMI and that are rendered in an NF at levels required to avert or eliminate the need for inpatient psychiatric care.
Developed and supervised by a qualified mental health professional and include one or all of the following:

a. Psychiatric consultation and evaluation.

b. Psychotropic medication management.

c. Psychological evaluation.

d. Psychotherapy.

(10) Level II Evaluation for Individuals with Diagnosis, or Suspicion of Having, an ID.

(a) A Level II evaluation for individuals diagnosed with, or suspected of having, an ID must:

Confirm or rule out the diagnosis, or suspicion, of an ID. A licensed psychologist must identify the intellectual functioning measurement of individuals with an ID.
Confirm the need for NF services and recommend specialized services as necessary by assessing:

a. The individual’s medical problems.

b. The level of impact these problems have on the individual’s independent functioning.

c. All current medications used by the individual, and the current response of the individual to any prescribed medications in the following drug groups:

(I) Hypnotics.

(II) Antipsychotics (neuroleptics).

(III) Mood stabilizers and antidepressants.

(IV) Antianxiety-sedative agents.

(V) Anti-Parkinson agents.

d. Self-monitoring of health status.

e. Self-administering and scheduling of medical treatments, including medication compliance.

f. Self-monitoring of nutritional status.

g. Self-help development such as toileting, dressing, grooming, and eating.

h. Sensorimotor development such as ambulation, positioning, transfer skills, gross motor dexterity, visual motor perception, fine motor dexterity, hand-eye coordination, and extent to which prosthetic, orthotic, corrective, or mechanical supportive devices can improve the individual’s functional capacity.

i. Speech and language (communication) development such as expressive language (verbal and nonverbal), receptive language (verbal and nonverbal), extent to which non-oral communication systems can improve the individual’s functional capacity, auditory functioning, and extent to which amplification devices (e.g., hearing aid) or a program of amplification can improve the individual’s functional capacity.

j. Social development such as interpersonal skills, recreation-leisure skills, and relationships with others.

k. Academic or educational development, including functional learning skills.

l. Instrumental activities of daily living.

m. Vocational development, including present vocational skills.

n. Affective development such as ability to express emotions, make judgments and independent decisions.

o. The presence of identifiable maladaptive or inappropriate behaviors of the individual based on systematic observation such as the frequency and intensity of identified maladaptive or inappropriate behaviors.

(b) Specialized services for ID are directed toward the acquisition of the behaviors necessary for the individual to function with as much self-determination and independence as possible, and toward the prevention or deceleration of regression or loss of current optimal functional status. Specialized services for individuals with ID are:

Behavior analysis services, pursuant to Rule 65G-4.009, F.A.C.
Training services, to include:

a. Services intended to support the participation of recipients in daily, meaningful, valued routines of the community which may include work-like settings that do not meet the definition of supported employment.

b. Training in the activities of daily living, self-advocacy, and adaptive and social skills that are age and culturally appropriate. The service expectation is to achieve the goals defined by each individual or, if appropriate, the individual’s legal representative. The training, activities, and routine established by the adult day training program must be meaningful to the individual and provide an appropriate level of variation and interest in accordance with a formal implementation plan that is developed under the direction of the individual or, if appropriate, the individual’s legal representative.

(11) Level II Determination.

(a) The following entities are responsible for completing the Level II determination:

The Agency for Persons with Disabilities for individuals diagnosed with, or suspected of having, an ID.
The Department of Children and Families’ (DCF) for individuals diagnosed with, or suspected of having, an SMI.
The Department of Children and Families is the lead agency in coordinating a joint determination with APD when the individual has a diagnosis of, or suspicion of having, both an SMI and an ID.

(b) The Level II determination must be issued in the form of a written summary report that:

Confirms or rules out SMI or ID.
Identifies the name and professional title of each person who performed the evaluation(s) and the date on which each portion of the evaluation was administered.
Summarizes the medical and social history, including the positive traits, developmental strengths and weaknesses, and developmental or mental health needs of the individual.
Identifies whether NF services and specialized services are needed.
Identifies any specific SMI or ID services the individual requires, including those of a lesser intensity when specialized services are not recommended.
Identifies placement options that are available to the individual, including whether the individual’s needs could be met in a community setting, and what services would be needed for the individual to live in such a setting.
Documents the individual and legal representative, if appropriate, have been educated about all placement options (including information about the benefits of integrated settings), and that any concerns or objections raised by the individual or legal representative have been addressed.
Includes the basis for the summary report’s conclusions.
Notifies the individual and legal representative of the right to appeal the determination.
Interprets and explains the summary report to the individual and legal representative.

(c) If the Level II evaluator rules out SMI or ID, the determination does not have to include the items indicated in subparagraphs (11)(b)4.-7., of this section.

(d) The Department of Children and Families or APD must send the completed determination summary with the notice of the administrative fair hearing process and the individual’s rights to:

The evaluated individual and his or her legal representative, as appropriate.
The admitting or retaining NF.
The individual’s attending physician.
The discharging hospital, if applicable.
The Level I screener appropriate to individual’s age.

(12) Resident Review.

(a) The NF must notify CARES or DOH, as appropriate, when an NF resident who has, or is newly suspected of having, SMI, ID, or both, experiences a significant change that:

Will not normally resolve itself without intervention by staff or by implementing standard disease-related clinical interventions (for individuals experiencing a decline in condition).
Impacts more than one area of the resident’s health status.

(b) The NF must submit all of the following documentation:

Completed AHCA MedServ Form 004 Part A1, March 2017.
Documented informed consent.
Level I PASRR screen.
Level II evaluation and determination or most recent RR, as applicable.
Long Term Care MDS or the most recent physical assessment, or an assessment provided by CARES or DOH.
Case notes.
Record of treatment.
Medication administration record.
Psychiatric or psychological evaluation, if available.

(13) Medicaid-certified nursing facilities must comply with 42 United States Code section 1396r(e)(7)(C), when a resident no longer requires NF services, but still requires specialized services, or no longer requires either NF services or specialized services.

(14) Consent for Level II Evaluation.

(a) If a Level II evaluation is required as a result of the Level I screen, or a resident review is required, written notice must be issued in accordance with 42 CFR 483.128(a) to individuals who have, or are suspected of having, SMI or ID, and are being referred to the state authorities for SMI or ID to perform the Level II evaluation. The signature of the individual being assessed, or their legal representative, must be obtained on AHCA MedServ Form 004 Part A1, March 2017, when possible as acknowledgement and consent for the Level II evaluation. Signing does not mean that the signator agrees with any determination(s).

(b) The signature is an acknowledgement of the signator’s:

Opportunity to participate in decisions regarding the arrangements for continued care.
Acknowledgement of verbal and written information regarding the range of services in the assessed individual’s community.

(c) If an individual is unwilling, or unable, to sign and has no legal representative or health care agent to sign, information regarding the reason for the inability to obtain the signature must be indicated on the Level I PASRR Screen, AHCA MedServ Form 004 Part A, March 2017, or Resident Review-Evaluation Request, AHCA MedServ Form 004 Part A1, March 2017.

(15) Records. Nursing facilities must maintain copies of all PASRR screenings, evaluations, re-evaluations, and determinations in the individual’s file for the duration of his or her stay in the facility and for a period of five years after the individual has been discharged or transferred to another facility.

(16) Appeals. In accordance with state and federal law, an individual may request an appeal through the Medicaid fair hearing process if he or she believes the State has made an erroneous determination with regard to the preadmission and annual resident review processes.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.905(8), 409.912 FS. History‒New 12-31-13, Amended 3-29-17.

Fla. Admin. Code R. 59G-1.045 Medicaid Forms

The following forms are incorporated by reference and are used either by other state agencies or providers rendering Florida Medicaid services to recipients. The forms are available from the Agency for Health Care Administration’s Web site at http://ahca.myflorida.com/Medicaid/review/index.shtml.

(1) Acquired Immune Deficiency Syndrome (AIDS) Physician Referral for Individuals at Risk of Hospitalization, AHCA Form 5000-0607, January 2018, http://www.flrules.org/Gateway/reference.asp?No=Ref-09057.

(2) Adults with Cystic Fibrosis Physician Referral for Individuals at Risk of Hospitalization, AHCA Form 5000-0608, January 2018, http://www.flrules.org/Gateway/reference.asp?No=Ref-09058.

(3) Consent for Voluntary Suspension of Authorized Services for Florida Medicaid State Plan Recipients, AHCA Form 5000-0123, August 2017, http://www.flrules.org/Gateway/reference.asp?No=Ref-09059.

(4) Medical Certification for Medicaid Long-term Care Services and Patient Transfer Form, AHCA Form 5000-3008, June 2016, http://www.flrules.org/Gateway/reference.asp?No=Ref-07012.

(5) Model Waiver Physician Referral for Individuals at Risk of Hospitalization, AHCA Form 5000-0025, January 2018, http://www.flrules.org/Gateway/reference.asp?No=Ref-09060.

(6) State of Florida Abortion Certification Form, AHCA MedServ Form 011, June 2016, http://www.flrules.org/Gateway/reference.asp?No=Ref-07013.

(7) State of Florida Exception to Hysterectomy Acknowledgment Requirement, ETA-5001, June 2016, http://www.flrules.org/Gateway/reference.asp?No=Ref-07014.

(8) State of Florida Hysterectomy Acknowledgment Form, HAF-5000, June 2016, http://www.flrules.org/Gateway/reference.asp?No=Ref-07015.

(9) The United States Department of Health and Human Services’ Consent for Sterilization Form – HHS-687 (10/12), http://www.flrules.org/Gateway/reference.asp?No=Ref-07926.

(10) Unborn Activation Form, AHCA Form 5240-006, (February 2017), http://www.flrules.org/Gateway/reference.asp?No=Ref-07915.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.905, 409.912 FS. History–New 9-28-15, Amended 7-11-16, 4-5-17, 2-8-18.

Fla. Admin. Code R. 59G-1.050 General Medicaid Policy

(1) Purpose. This rule specifies requirements that apply to all providers rendering Florida Medicaid services to recipients.

(2) Billing the Recipient. Providers must inform a recipient of his or her responsibility to pay for services that are not covered by Florida Medicaid, and document in the recipient’s file that the recipient was informed of his or her liability, prior to rendering each service.

(a) Providers may seek reimbursement from a recipient under the following circumstances:

The recipient is not eligible for Florida Medicaid on the date of service.
The service rendered is not covered by Florida Medicaid, if the provider seeks reimbursement from all patients for the specific service.
The provider verifies that the recipient has exceeded the Florida Medicaid coverage.
The recipient is enrolled in a Florida Medicaid managed care plan (plan) and is informed that:

a. The plan denies authorization for the service.

b. The treating provider is not in the plan’s provider network (with the exception of emergency services).

(b) Providers may not seek reimbursement from recipients for missed appointments.

(c) Providers may not seek reimbursement from the recipient if the provider fails to bill Florida Medicaid correctly and in a timely manner. Providers who submit a claim to Florida Medicaid for reimbursement of a covered service whether the claim has been approved, partially approved, or denied, may not:

Seek reimbursement from the recipient, the recipient’s relatives, or any person, or persons, acting as the recipient’s designated representative.
File a lien against the recipient, the recipient’s parent, legal guardian, or estate.
Apply money received from any non-Florida Medicaid source to charges related to a claim paid by Florida Medicaid (also known as “balance billing”).
Turn a recipient’s overdue account over to a collection agency, except in circumstances as specified in paragraph (2)(a), above.

(3) Cost of Doing Business. Florida Medicaid does not reimburse for time spent completing and submitting Florida Medicaid claims or time spent responding to an audit.

(4) Emergency Medicaid For Aliens. Florida Medicaid covers emergency services provided to aliens who meet all Florida Medicaid eligibility requirements except for citizenship or alien status, as follows:

(a) Eligibility is only authorized for the duration of the emergency.

(b) Florida Medicaid does not cover continuous or episodic services after the emergency has been alleviated.

(c) Providers must submit documentation establishing the emergency nature of the service with the claim for reimbursement. Exceptions are labor, delivery, and dialysis services, which are considered emergencies and are payable without documentation when the emergency indicator is entered on the claim form.

(5) Free Choice of Providers. Recipients may obtain services from any qualified Florida Medicaid provider that agrees to provide the services in accordance with Title 42, Code of Federal Regulations (CFR), section 431.51, except:

(a) Allowable restrictions specified in section 1915(a) of the Social Security Act.

(b) When the recipient is enrolled in a Florida Medicaid managed care program. Managed care plans may not restrict enrollee choice for a family planning provider and must cover family planning services regardless of whether the provider is in the managed care plan’s provider network.

(6) Inmates of a Public Institution. Florida Medicaid does not cover services provided to individuals residing in public institutions as defined in 42 CFR 435.1009 and Section 409.9025, F.S. These individuals include those residing in correctional and holding facilities for prisoners who meet either of the following:

(a) Have been arrested or detained pending disposition of charges.

(b) Held under court order as material witnesses or juveniles.

(7) Gender Dysphoria.

(a) Florida Medicaid does not cover the following services for the treatment of gender dysphoria:

Puberty blockers;
Hormones and hormone antagonists;
Sex reassignment surgeries; and
Any other procedures that alter primary or secondary sexual characteristics.

(b) For the purpose of determining medical necessity, including Early and Periodic Screening, Diagnosis, and Treatment (EPSDT), the services listed in subparagraph (7)(a) do not meet the definition of medical necessity in accordance with Rule 59G-1.010, F.A.C.

(8) Out-of-State Services.

(a) Emergency. Florida Medicaid covers emergency services provided out-of-state without a referral, or authorization, when the recipient’s health will be endangered if the care and services are postponed until returning to Florida.

(b) Non-Emergency. Florida Medicaid covers services performed out-of-state, in accordance with the service-specific coverage policy, when both of the following are met:

The recipient’s primary care or specialist physician refers the recipient for services.
Services are prior authorized by the Florida Medicaid quality improvement organization in accordance with Florida Medicaid’s Authorization Requirements Policy, as incorporated by reference in Rule 59G-1.053, F.A.C.

(c) Florida Medicaid does not cover services for recipients living out-of-state who are enrolled under the Title-IV-E Florida foster or adoption subsidy.

(9) Payment in Full. Providers must accept payment from Florida Medicaid as payment in full, except for Florida Medicaid copayments and coinsurance. For information on copayment requirements and exemptions, refer to Florida Medicaid’s General Policies on copayment and coinsurance.

(10) Recipients or Providers that are Out of the Country. Florida Medicaid does not cover services provided to recipients when they are outside of the United States (U.S.), or for services rendered by providers who are not in the U.S.

(11) Refusal of Services.

(a) Providers may not refuse to provide a covered Florida Medicaid service to a recipient solely because the recipient’s eligibility does not display in the Florida Medicaid Management Information System, if the recipient has a valid temporary proof of eligibility from the Department of Children and Families, or proof of presumptive eligibility.

(b) Right to Refuse Services. Providers may limit the number of Florida Medicaid recipients the provider serves, and accept or reject recipients in accordance with the policies of the facility or practice, except as follows:

A hospital may not refuse to provide emergency services in accordance with the 1986 Emergency Medical Treatment and Active Labor Act.
Providers may not deny services to recipients based solely upon race, creed, color, national origin, disabling condition, or disability, in accordance with federal anti-discrimination laws.

(12) Solicitation (Patient Brokering). Providers may not knowingly solicit, offer, pay, or receive any payment, including any kickback, bribe, or rebate, directly or indirectly, overtly or covertly, in cash or in kind, in return for referring an individual to a person for furnishing, or arranging for the furnishing of, any item or service for which payment may be made, in whole or in part, under the Florida Medicaid program, or in return for obtaining, purchasing, leasing, ordering, or arranging for, or recommending, obtaining, purchasing, leasing, or ordering any goods, facility, item, or service, for which payment may be made, in whole or in part, under the Florida Medicaid program.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.9025, 409.973 FS. History–New 3-11-18, Amended 8-21-22.

Fla. Admin. Code R. 59G-1.052 Third-Party Liability Requirements

(1) This policy applies to all persons who are required to notify Florida Medicaid of any third-party benefits a recipient may have and to providers rendering Florida Medicaid services to recipients.

(2) Purpose. Third-party liability (TPL) refers to the legal obligation of third-parties to pay part, or all, of the expenditures for medical assistance furnished under the Florida Medicaid program. In accordance with Title 42, Code of Federal Regulations (CFR), section 433, Subpart D, all other available third-party resources must meet their legal obligation to pay claims before the Florida Medicaid program pays for a recipient’s health care services.

(3) Definitions.

(a) Dually Eligible Recipient. As defined in Rule 59G-1.010, Florida Administrative Code (F.A.C.).

(b) Rate. As defined in Rule 59G-1.010, F.A.C.

(4) Third-Party Liability Vendor. The Agency for Health Care Administration (AHCA) contracts with a TPL vendor to identify, manage, and recover funds and overpayments paid on behalf of recipients when a third-party is, or was, responsible. The TPL vendor also administers Florida Medicaid’s third-party liability recovery programs for casualty, estate, trust, and annuities on behalf of deceased Medicaid recipients.

Information regarding AHCA’s TPL vendor can be found on the AHCA Web site at http://www.ahca.myflorida.com/Admin/.

(5) Third-Party Liability Notices.

(a) Notices regarding any third-party benefit, including trust, annuity, or estate probate actions, must be submitted in accordance with Sections 409.910, 409.9101, Florida Statutes (F.S.), to the appropriate address located on the AHCA Web site at http://www.ahca.myflorida.com/Admin/.

(b) Notice provided to any other AHCA office, or delivered to any other address, is not effective to fulfill the notice requirements.

(6) Exhausting Third-Party Resources.

(a) Florida Medicaid is the payer of last resort. Providers must exhaust all TPL sources of payment, such as Medicare, TRICARE, private health insurance, AARP plans, or automobile coverage prior to submitting or resubmitting a claim for reimbursement to Florida Medicaid.

(b) The following programs are exceptions to Florida Medicaid being the payer of last resort:

Federal funds for the Individuals with Disabilities Education Act, Part B or C.
Indian Health Services, according to 42 CFR 136.61.
Programs funded through state and county funds, including:

a. Acquired Immune Deficiency Syndrome (AIDS) drug assistance programs.

b. County health departments.

c. Department of Health indigent drug programs.

d. Substance abuse, mental health, and developmental disabilities programs operated by the Department of Children and Families and the Agency for Persons with Disabilities.

e. Victim’s compensation funds.

f. Vocational rehabilitation programs.

(7) Refusal of Services. Providers may not refuse to furnish a covered Florida Medicaid service to a recipient solely because of the presence of other insurance, including Medicare, in accordance with 42 CFR 447.20(b).

(8) Reimbursement for Services Provided to Recipients with TPL.

(a) Florida Medicaid reimburses the difference between the Florida Medicaid rate and the third-party payment, minus any applicable Florida Medicaid copayment or coinsurance, unless otherwise specified in this rule.

(b) Florida Medicaid does not reimburse for services when:

The amount of any third-party payment(s) (including Medicare) is equal to, or exceeds, the Florida Medicaid rate for the service.
The provider’s TPL claim is denied for failing to obtain the appropriate authorization from the third-party. Services approved by Medicare do not require Florida Medicaid prior authorization.

(9) Third-Party Liability Resources.

(a) Providers must inquire if a recipient has third-party insurance coverage and if there have been any changes to existing third-party coverage.

(b) Third-party liability information for a recipient, when known to Florida Medicaid, is available for providers on the Florida Medicaid fiscal agent’s Web site at http://portal.flmmis.com/flpublic, or by phone using the Florida Medicaid Automated Voice Response System (AVRS) at 1(800)239-7560.

(c) Providers must determine if the insurance on the Florida Medicaid file is applicable to the services being provided. Florida Medicaid uses the following two-digit numeric codes for each associated insurance coverage type, when verifying recipient eligibility and for claims processing purposes:

CODE

INSURANCE COVERAGE TYPE

BASIC SURGICAL

BASIC HOSPITAL/MEDICAL/SURGICAL

PHARMACY ADMINISTRATOR (TPA)

MAJOR MEDICAL

ACCIDENT ONLY (NON AUTO)

VEHICLE ALL INCLUSIVE

MAJOR MEDICAL WITH TPA OR NO PHARMACY

CANCER

MEDICARE SPECIAL NEED PLAN

MEDICARE SUPPLEMENT

NURSING HOME SUPPLEMENT

HEALTH MAINTENANCE ORGANIZATION

DENTAL

TRICARE

HMO WITHOUT PHARMACY

CONTINUING CARE/LIFE CARE

MEDICARE ADVANTAGE PLAN

FULLY LIABLE MEDICARE ADVANTAGE PLAN

PHARMACY CARD SERVICE

HOSPITAL ROOM – BOARD/INDEMNITY

BASIC MEDICAL

(d) Discounted Contracts.

Florida Medicaid reimburses providers contracted with a third-party in which the provider agrees to accept as full payment an amount less than its customary charges. Florida Medicaid reimbursement is limited to any remaining recipient liability, such as a copayment or deductible.
If the discount contract’s allowable fee is less than Florida Medicaid’s maximum allowable rate and there remains a recipient liability, providers must:

a. Compute the amount of the recipient’s responsibility (deductible, coinsurance, etc.).

b. Deduct the result of sub-subparagraph a. from the Florida Medicaid rate.

c. Include the result of sub-subparagraph b. as the third-party payment on the claim.

Providers must prorate the discount contract’s allowable TPL payment and the recipient responsibility for each line item, if the explanation of benefits from the TPL is not itemized.

(e) Discounted Contracts for Diagnostic Related Groups (DRG) or Enhanced Ambulatory Patient Grouping (EAPG). Providers must ensure that the Florida Medicaid reimbursement is equal to, or less than, any contracted or negotiated TPL rate(s) for claims reimbursed through DRG or EAPG.

(f) Contributions to a Facility.

Providers must treat any contribution made to a facility on behalf of a specific recipient as a third-party payment and include it on the claim form.
Providers are not required to report a contribution made to a facility when the contribution is not for a specific recipient, but for the benefit of all residents.

(10) Florida Medicaid Payments for Dually Eligible Recipients.

(a) Medicare Part A Premium. Florida Medicaid will pay the Part A premium for dually eligible recipients with full Florida Medicaid, Qualified Medicare Beneficiaries (QMB), Supplemental Security Income (SSI), or Medically Needy with QMB.

(b) Medicare Part B Premium. Florida Medicaid will pay the Part B premium for dually eligible recipients with full Florida Medicaid, QMB, SSI, Specified Low-Income Medicare Beneficiary (SLMB), or Qualified Individual (QI1) benefits, or Medically Needy with QMB, SLMB, or QI1 benefits. Florida Medicaid does not reimburse expenditures that could have been paid for under Medicare Part B, but were not, because an individual was not enrolled in Part B in accordance with 42 CFR 431.625(d). This limit applies to all recipients who are eligible for enrollment under Part B, whether individually or through an agreement under section 1843(a) of the Social Security Act.

(d) Medicare Part D.

Florida Medicaid reimburses for drugs that are excluded by Medicare from Medicare Part D coverage for dually eligible recipients who are eligible to receive prescribed drug services in accordance with the Florida Medicaid prescribed drug services coverage policy.
Florida Medicaid does not pay for Medicare Part D premiums, or for any Medicare Part D copayments, coinsurance, or deductibles.
Florida Medicaid does not reimburse for drugs for dually eligible recipients who are eligible for Medicare Part D, but who are not enrolled.

(11) Florida Medicaid Claim Reimbursement for Dually Eligible Recipients.

(a) Florida Medicaid reimburses Medicare Parts A, B, and C, deductible(s), coinsurance, and copayments for dually eligible recipients in accordance with Section 409.908, F.S., based on the lesser of the amount billed or the Florida Medicaid rate.

(b) Florida Medicaid reimbursement for dually eligible recipients is as follows:

Subtract the Medicare paid amount, plus any other third-party payment, from the Medicaid rate.

If the calculated amount in paragraph (b) is zero or a negative amount, no payment is made.
If the calculated amount in paragraph (b) is a positive amount (rate calculation), compare the rate calculation to the sum of the coinsurance or copayment and deductible amounts; and, pay the lesser of these two amounts, except as otherwise specified in Section 409.908, F.S.

(c) For Medicare Part B services not covered by Florida Medicaid provided to dually eligible recipients with QMB benefits (with or without other Florida Medicaid benefits) or SSI recipients, the Florida Medicaid rate referenced in paragraph (11)(a), above, shall be 50% of the Medicare-allowed amount and paid in accordance with paragraphs (a) and (b) of this section.

(12) Inpatient Hospital Services for Dually Eligible Recipients.

(a) Dually eligible recipients with Medicare Part A or C benefits, age 21 years and older, simultaneously deplete both Medicare and Florida Medicaid covered hospital days.

(b) Once a dually eligible recipient has exhausted all Medicare Part A benefits, or if the recipient does not have Medicare Part A Coverage, the provider must:

Bill Medicare for Medicare-allowable Part B inpatient ancillary services.
Enter any available Medicare Part B reimbursement as TPL on the Florida Medicaid claim for inpatient services.

(13) Florida Medicaid Patient Responsibility for Dually Eligible Recipients. Florida Medicaid reimburses for services in accordance with section (11) above, minus any applicable service specific patient responsibility. Notwithstanding the requirements specified in Rule 59G-4.200, F.A.C., if a recipient has QMB benefits and is also eligible for full Florida Medicaid benefits, or is receiving SSI, providers may not charge the patient responsibility during the Medicare coinsurance days (day 21 up to day 100) for nursing facility services.

(14) Payment for Part B Nursing Facility Services for Dually Eligible Recipients. Florida Medicaid reimburses, in accordance with the methodology specified in paragraph (11)(a), above, for Medicare approved Part B services that are not included in the nursing facility’s cost report prepared pursuant to Rule 59G-6.010, F.A.C.

(15) Timely Filing of Claims for Reimbursement Secondary to Medicare. Providers may submit claims to Florida Medicaid within 12 months from the date of service, or within 6 months after AHCA or the provider receives notice of the disposition of the Medicare claim, whichever is greater.

(16) Fee-For-Service Exceptional Claims Process.

(a) Providers may submit claims for a Florida Medicaid covered service when all of the following are met:

When the claim was denied by the Florida Medicaid fiscal agent.
Any third-party payer, or Medicare denied the claim (unless Medicare determined the service is not medically necessary).

(b) Providers must submit fee-for-service exceptional claims to the appropriate address listed on the AHCA Web site at http://ahca.myflorida.com/Medicaid/Operations/assistance/providers.shtml.

History

Rulemaking Authority 409.910, 409.919 FS. Law Implemented 409.910, 409.9101 FS. History–New 8-14-18.

Fla. Admin. Code R. 59G-1.053 Authorization Requirements

(1) This rule applies to providers rendering Florida Medicaid services to recipients.

(2) All providers must comply with the provisions of the Florida Medicaid Authorization Requirements Policy, June 2016, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06927.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.908, 409.912, 409.9127, 409.913 FS. History‒New 7-11-16.

Fla. Admin. Code R. 59G-1.054 Recordkeeping and Documentation Requirements

(1) This rule applies to providers rendering Florida Medicaid services to recipients.

(2) Documentation Requirements.

(a) All Florida Medicaid providers must:

Ensure medical records establish the medical necessity for and the extent of services provided.
Sign and date each medical record within two business days from the date and time of service, or otherwise authenticate the record by signature, written initials, or computer entry. Electronic signatures are permissible as defined in Chapter 668, Part I, F.S.
Initial rubber stamped signatures.

(b) Unless otherwise specified in Florida Medicaid coverage policies, providers must document the following information for each service visit or encounter with a Florida Medicaid recipient:

Chief complaint of the visit.
Date(s) of service.
Description of services rendered (as applicable).
Diagnosis.
Diagnostic tests and results (as applicable).
History and physical assessment (as applicable).
Prescribed or provided medications and supplies (as applicable).
Progress reports.
Referrals to other services (as applicable).
Scheduling frequency for follow-up or other services (as applicable).
Treatment plan (as applicable).

(3) Electronic Records.

(a) Providers that create or maintain electronic records must develop and implement an electronic records policy to comply with the applicable state and federal laws, rules, and regulations to ensure the validity and security of electronic records. Electronic record policies must address the technical safeguards required by Title 45, Code of Federal Regulations, Section 164.312, where applicable.

(b) Providers that maintain electronic records must have the ability to produce electronic records in a paper format within a reasonable time, upon AHCA’s request.

(4) Recordkeeping Requirements. Providers must retain all business records, medical-related records, and medical records, as defined in Rule 59G-1.010, F.A.C., according to the requirements specified below, as applicable:

(a) Providers may maintain records on paper, magnetic material, film, or other media including electronic storage, except as otherwise required by law or Florida Medicaid requirements. All records must be accessible, legible, and comprehensible.

(b) Providers must retain all records related to services rendered to Florida Medicaid recipients for a period of at least five years from the date of service. Medicare crossover-only providers must retain health care service records for six years.

(5) Copying or Transferring Records.

(a) Providers may seek reimbursement from a recipient for copying medical records at the recipient’s request when the provider’s standard policy is to bill all patients for copying medical records and the recipient is notified of the copying charge before the records are copied.

(b) Providers may not seek reimbursement from the recipient or AHCA for copying records requested by AHCA or any other state or federal agency or their authorized representatives.

(6) Right to Review Records.

(a) Authorized state and federal agencies, and their authorized representatives, may audit or examine provider records. This examination includes all records these agencies find necessary to determine whether Florida Medicaid payment amounts were, or are, due. This requirement applies to the provider’s records and records for which the provider is the custodian. Providers must give authorized state and federal agencies, and their authorized representatives, access to all Florida Medicaid recipient records and any other information that cannot be separated from Florida Medicaid-related records.

(b) Providers must send, at their expense, legible copies of all Florida Medicaid-related information to the authorized state and federal agencies or their authorized representatives upon their request.

(c) All records must be provided regardless of the media format on which the original records are retained by the provider at the time of the request. All medical records may be reproduced electronically or onto paper copies as authorized by the requestor.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.907, 409.913 FS. History‒New 7-17-16, Amended 5-8-17.

Fla. Admin. Code R. 59G-1.056 Copayments and Coinsurance

(1) This rule applies to providers rendering Florida Medicaid services to recipients.

(2) Requirement. Recipients are responsible for paying all applicable copayment and coinsurance amounts directly to the provider who furnished Florida Medicaid covered services.

(3) Amounts. The copayment and coinsurance amounts, as specified in Section 409.9081, F.S., are as follows:

SERVICE

FEE

Chiropractor services, per provider or group provider, per day

$1.00

Community behavioral health services, per provider, per day

$2.00

Home health services, per provider, per day

$2.00

Hospital outpatient services, per visit

$3.00

Federally qualified health center visit, per clinic, per day

$3.00

Independent laboratory services, per provider, per day

$1.00

Non-emergency transportation services, per each one-way trip

$1.00

Nurse practitioner services, per provider or group provider, per day

$2.00

Optometrist services, per provider or group provider, per day

$2.00

Physician and physician assistant, per provider or group provider, per day

$2.00

Podiatrist services, per provider or group provider, per day

$2.00

Portable x-ray services, per provider, per day

$1.00

Rural health clinic visit, per clinic, per day

$3.00

Use of the hospital emergency department for non-emergency services

5% of the first $300.00 of the Florida Medicaid payment (maximum $15.00)

(4) Exemptions. The following categories of recipients are not required to pay a copayment or coinsurance:

(a) Individuals under the age of 21 years.

(b) Pregnant women – for pregnancy-related services, including services for medical conditions that may complicate the pregnancy. This exemption includes the six week period following the end of the pregnancy.

(c) Individuals receiving services in an inpatient hospital setting, long-term care facility, or other medical institution if, as a condition of receiving services in the institution, that individual is required to spend all of his or her income for medical care costs with the exception of the minimal amount required for personal needs.

(d) Individuals who require emergency services after the sudden onset of a medical condition which, if left untreated, would place their health in serious jeopardy.

(e) Individuals receiving services or supplies related to family planning.

(5) Recipients Unable to Pay. Providers may not deny services to a recipient based solely on the recipient’s inability to pay a Florida Medicaid copayment or coinsurance amount. Providers may bill the recipient for the unpaid copayment or coinsurance amount.

(6) Third-Party Coverage. Recipients who have third-party liability coverage (including recipients eligible for Medicare) are required to pay copayment or coinsurance amounts, unless:

(a) The recipient is otherwise exempt.

(b) The Medicare or third-party payment is equal to, or exceeds, the Florida Medicaid fee for the service. Providers must reimburse recipients who have paid a Florida Medicaid copayment when the Medicare or third-party liability payment is equal to or exceeds the Florida Medicaid fee for the service.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.9081 FS. History‒New 7-17-16.

Fla. Admin. Code R. 59G-1.057 Telemedicine

(1) This rule applies to any person or entity prescribing or reviewing a request for Florida Medicaid services and to all providers of Florida Medicaid services that are enrolled in or registered with the Florida Medicaid program.

(2) Definition. Telemedicine – The practice of health care delivery by a practitioner who is located at a site other than the site where a recipient is located for the purposes of evaluation, diagnosis, or treatment.

(3) Who Can Provide. Practitioners licensed within their scope of practice to perform the service.

(4) Coverage. Florida Medicaid reimburses for telemedicine services using interactive telecommunications equipment that includes, at a minimum audio and video equipment permitting two-way, real time, interactive communication between a recipient and a practitioner.

(5) Exclusion. Florida Medicaid does not reimburse for:

(a) Telephone conversations, chart review(s), electronic mail messages, or facsimile transmissions.

(b) Equipment required to provide telemedicine services.

(6) Reimbursement. The following applies to practitioners rendering services in the fee-for-service delivery system:

(a) Florida Medicaid reimburses the practitioner who is providing the evaluation, diagnosis, or treatment recommendation located at a site other than where the recipient is located.

(b) Providers must include modifier GT on the CMS-1500 claim form, incorporated by reference in Rule 59G-4.001, F.A.C.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.905 FS. History‒New 6-20-16.

Fla. Admin. Code R. 59G-1.058 Eligibility

(1) Purpose. This rule specifies recipient eligibility requirements for Florida Medicaid covered services and applies to all providers rendering Florida Medicaid covered services to recipients.

(2) Eligibility Determination. The Department of Children and Families (DCF) and the Social Security Administration (SSA) determine recipient eligibility for Florida Medicaid in accordance with Section 409.902, F.S., and rule Chapter 65A-1, Florida Administrative Code (F.A.C.).

(a) Eligibility Determined by Qualified Designated Providers. Qualified designated providers determine presumptive eligibility for pregnant women (PEPW) in accordance with rule Chapter 65A-1, F.A.C.

(b) Eligibility Determined by Qualified Hospitals.

Qualified hospitals enrolled in Florida Medicaid may make presumptive eligibility determinations for the following:

a. Pregnant women.

b. Infants and children under the age of 19 years.

c. Parents and other caretakers or relatives.

d. Former foster care children.

The presumptive period begins on the date the determination is made and ends on the earlier of the following:

a. The last day of the month following the month in which the determination of presumptive eligibility is made.

b. The date DCF makes a Florida Medicaid eligibility determination.

(3) Newborn Presumptive Eligibility. A newborn is deemed eligible for full Florida Medicaid covered services when the mother is eligible for Florida Medicaid on the date of the child’s birth, unless the mother is eligible under the PEPW category.

(a) A pregnant recipient may obtain a Florida Medicaid identification (ID) number and Florida Medicaid ID card for her unborn child. The cards are issued as “baby of” plus the mother’s name, and assigned a card control number that providers use to obtain the baby’s Medicaid ID number. The baby’s Florida Medicaid ID number will not be active until after the baby is born.

(b) Providers may request a Florida Medicaid ID number assignment for a newborn via a Medical Assistance Referral Form, CF-ES 2039, April 2003, incorporated by reference in Rule 65A-1.400, F.A.C., and available on the DCF Website at https://eds.myflfamilies.com/DCFFormsInternet/Search/DCFFormSearch.aspx.

(c) Providers may activate a newborn’s Florida Medicaid ID number by submitting a completed Unborn Activation Form, AHCA Form 5240-006, February 2017, incorporated by reference in Rule 59G-1.045, F.A.C., to the Florida Medicaid fiscal agent.

(4) Proof of Eligibility. Providers must verify recipient eligibility prior to rendering services.

(5) Recipient Does Not Have an ID Card. Providers may verify eligibility and render services if the recipient does not have an ID card.

(6) Card Not Proof of Eligibility. Possession of a Florida Medicaid ID card does not constitute proof of eligibility.

(7) Eligibility Program Codes (also known as Aid Categories). Florida Medicaid eligibility program codes indicate benefit coverage and limitations, as follows:

FLORIDA MEDICAID ELIGIBILITY CODES ON THE FLORIDA MEDICAID MANAGEMENT INFORMATION SYSTEM RECIPIENT SUBSYSTEM

Code

Description

Coverage

5007

Pharmaceutical Expense Program

Provides assistance with Medicare Part B coinsurance for persons not eligible for Florida Medicaid or Qualified Medicare Beneficiaries (QMB), who were diagnosed with cancer or received an organ transplant and were receiving drugs to treat these conditions in December 2005 under the Medically Needy program, who were and continue to be, eligible for Medicare.

This is not a Florida Medicaid service; it is funded in full by general revenue.

MA I

Former Foster Care Children Up to Age 26

Full Medicaid, except institutional care in skilled nursing facility or swing bed, intermediate care facility for individuals with intellectual disabilities (ICF/IID), state mental health hospital, or home and community-based (HCBS) waiver services.

Full Medicaid, except institutional care in skilled nursing facility or swing bed, ICF/IID, state mental health hospital, or HCBS waiver services.

MA R

Parents and Caretakers

MB C

Mary Brogan Breast and Cervical Cancer Program

MCFE

IV-E Foster Care and Adoption Subsidy Medicaid

MCFN

Non IV-E Foster Care, Adoption Subsidy and Emergency Shelter Medicaid

ME C

Extended Medicaid Due to Alimony or Spousal Support

ME I

Transitional Medicaid Due to Caretaker Income

MH H

Stand Alone Hospice Medicaid

MH M

Hospice Medicaid Supplemental to MEDS-AD (MM S)

MH S

Hospice Medicaid Supplemental to SSI Medicaid (MS)

MM C

MEDS for Children Born After 09-30-1983 (Through age 18)

MM I

MEDS for Infants Under 1 Year Old

MM P

MEDS for Pregnant Women

MM S

MEDS for Aged and Disabled

MM T

MEDS for Pregnant Women (Protected Eligibility)

Presumptively Eligible Newborn Medicaid

MO Y

Low Income Family Medicaid for Age 19-20

MREI

RAP/CHEP Extended Medicaid for Earned Income

MR R

RAP/CHEP Direct Assistance Medical Assistance

SSI Medicaid

MT A

Protected Medicaid for Widows 1 and Children

MT C

Regular Protected Medicaid (COLA)

MT D

Protected Medicaid for Disabled Adult Children

MT W

Protected Medicaid for Widows II

Continuous Coverage for SSI child who loses SSI eligibility

MK A

MediKids (Subsidized – $15)

Full Medicaid, except institutional care in a skilled nursing facility or swing bed, ICF/IID, state mental health hospital, or HCBS waiver services. Must be enrolled in managed care to be eligible.

MK B

MediKids (Subsidized – $20)

MK C

MediKids (Full pay – $187.96)

MI A

Institutional Care Medicaid Supplemental to LIF Medicaid

Full Medicaid, including institutional care in a skilled nursing facility or swing bed, ICF/IID, or state mental health hospital.

MI I

Stand Alone Institutional Care Medicaid

MI M

Institutional Care Medicaid Supplemental to MEDS-AD (MM S)

MI S

Institutional Care Medicaid Supplemental to SSI Medicaid (MS)

MI T

Institutional Care Medicaid Failed-Transfer of Assets

Full Medicaid, except institutional care in a skilled nursing facility or swing bed, ICF/IID, state mental health hospital, or HCBS waiver services.

MW A

Medicaid Waivers

Full Medicaid, including waiver services.

ML A

AFDC Related Emergency Medical Assistance for Noncitizens

Limited to emergency care (emergency inpatient, labor and delivery, kidney dialysis).

ML S

SSI Related Emergency Medical Assistance for Noncitizens

NA R

Medically Needy for Parents, Caretakers and Children

Must meet Share of Cost.

Eligibility is displayed in FMMIS on the date the recipient attains Florida Medicaid eligibility by meeting his or her share of cost, through the end of that month.

Eligible for all services except:

Assistive care services

Intermediate care facilities for individuals with intellectual disabilities

Home and community-based services waiver programs

Nursing facility services

Regional perinatal intensive care center services

State mental hospital services

Statewide inpatient psychiatric program services.

NCFN

Non IV-E Foster Care Medically Needy

NM P

MEDS for Pregnant Women Medically Needy

NO Y

Medically Needy for Children Ages 19 thru 20

NR R

RAP/CHEP Medically Needy

SSI-related Medically Needy

Covers aged, blind or disabled

NL A

Family-related Emergency Medical Assistance for Noncitizens Medically Needy

Limited to emergency care (emergency inpatient, labor and delivery, kidney dialysis) for non-qualified aliens; must meet Share of Cost.

NL S

SSI-related Emergency Medical Assistance for Noncitizens Medically Needy

Family Planning Medicaid

Limited to family planning services.

Presumptive Eligibility for Pregnant Women

Limited to outpatient, office, transportation, and emergency room services. Does not cover inpatient or delivery services.

QMB

Qualified Medicare Beneficiaries

Limited to Medicare premiums, deductibles, and coinsurance.

QMBR

Qualified Medicare Beneficiaries (Renal Disease)

QI1

Qualifying Individuals 1

Limited to Medicare Part B premium.

SLMB

Special Low Income Beneficiaries

Working Disabled

Limited to Medicare Part A premium.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.903 FS. History–New 3-25-18, Amended 8-19-21, 4-30-25.

Fla. Admin. Code R. 59G-1.060 Provider Enrollment Policy

(1) This rule applies to all individuals, groups, and entities that are seeking to enroll, renew, or maintain enrollment as an authorized provider for the Florida Medicaid program.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Provider Enrollment Policy, February 2026, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-19181.

(3) The following forms are incorporated by reference and available on the Florida Medicaid web portal at http://portal.flmmis.com/flpublic, and as follows:

(a) Agency Certification Adult Mental Health Targeted Case Management, AHCA MedServ Form 023, (APR 2024), http://www.flrules.org/Gateway/reference.asp?No=Ref-18560.

(b) Agency Certification Children’s Mental Health Targeted Case Management, AHCA MedServ Form 022, (APR 2024), http://www.flrules.org/Gateway/reference.asp?No=Ref-18561.

(c) Agency Certification Intensive Case Management Team Services Adult Mental Health Targeted Case Management, AHCA MedServ Form 024, (APR 2024), http://www.flrules.org/Gateway/reference.asp?No=Ref-18562.

(d) Comprehensive Behavioral Health Assessment Agency and Practitioner Self-Certification, AHCA Form 5000-3512, May 2014, http://www.flrules.org/Gateway/reference.asp?No=Ref-11334.

(e) County Health Department Agreement Provider Credentialing of Behavioral Health Providers and Social Workers, AHCA Form 5000-1066, June 2019, http://www.flrules.org/Gateway/reference.asp?No=Ref-11336.

(f) Electronic Data Interchange Agreement, AHCA Form 5000-1062, June 2019, http://www.flrules.org/Gateway/reference.asp?No=Ref-11350.

(g) Florida Medicaid Provider Enrollment Application Out-of-State Fee for Service, AHCA Form 5000-1260, (JAN 2021), http://www.flrules.org/Gateway/reference.asp?No=Ref-13975.

(h) Florida Medicaid Provider Enrollment Change of Ownership (CHOW) Disclosure Form-Hospital, Institutional Care (ICF) and Skilled Nursing Facility ONLY, AHCA Form 5000-1264, (JAN 2021), http://www.flrules.org/Gateway/reference.asp?No=Ref-13976.

(i) Group Membership Authorization, AHCA Form 5000-1061, June 2019, http://www.flrules.org/Gateway/reference.asp?No=Ref-13977.

(j) Non-profit Organization Certification – Fingerprinting Exemption, AHCA Form 5000-1261, (JAN 2021), http://www.flrules.org/Gateway/reference.asp?No=Ref-13978.

(k) Physician Group Certificate of Ownership, AHCA Form 5000-1068, June 2019, http://www.flrules.org/Gateway/reference.asp?No=Ref-11338.

(l) Practitioner Collaborative Agreement, AHCA Form 5000-1067, June 2019, http://www.flrules.org/Gateway/reference.asp?No=Ref-11339.

(m) School District Assurance Agreement Provider Credentialing of Behavior Analysts, AHCA Form 5000-1162, June 2019, http://www.flrules.org/Gateway/reference.asp?No=Ref-11341.

(n) School District Assurance Agreement Provider Credentialing of Behavioral Sciences Staff, AHCA Form 5000-1160, June 2019, http://www.flrules.org/Gateway/reference.asp?No=Ref-11342.

(o) School District Assurance Agreement Provider Credentialing of Mental Health Counselors and Family Therapists, AHCA Form 5000-1161, June 2019, http://www.flrules.org/Gateway/reference.asp?No=Ref-11343.

(p) School District Assurance Agreement Provider Credentialing of Psychologists, Behavior Analysts, and Social Workers, AHCA Form 5000-1163, June 2019, http://www.flrules.org/Gateway/reference.asp?No=Ref-11344.

(q) School District Assurance Agreement Provider Credentialing of Registered Nurses and Licensed Practical Nurses, AHCA Form 5000-1164, June 2019, http://www.flrules.org/Gateway/reference.asp?No=Ref-11345.

(r) School District Assurance Agreement Provider Credentialing of School Health Aides, AHCA Form 5000-1165, June 2019, http://www.flrules.org/Gateway/reference.asp?No=Ref-11346.

(s) School District Assurance Agreement Provider Credentialing of Therapists and Therapy Assistants, AHCA Form 5000-1166, June 2019, http://www.flrules.org/Gateway/reference.asp?No=Ref-11347.

(t) Special Exempt Entity Certification – Fingerprinting Exemption, AHCA Form 5000-1262, (JAN 2021), http://www.flrules.org/Gateway/reference.asp?No=Ref-13979.

(u) State of Florida Agency for Health Care Administration Florida Medicaid Provider Surety Bond, AHCA Form 5000-1064, June 2019, http://www.flrules.org/Gateway/reference.asp?No=Ref-11348.

(v) Therapeutic Foster Care Provider Agency Self-Certification, AHCA Form 5000-3513, March 2014, http://www.flrules.org/Gateway/reference.asp?No=Ref-11349.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.907, 409.973 FS. History–New 12-25-19, Amended 2-9-22, 4-30-25, 4-8-26.

Fla. Admin. Code R. 59G-1.100 Medicaid Fair Hearings

(1) Purpose.

This rule establishes procedures applicable to Fair Hearings conducted by the Agency for Health Care Administration (Agency) pursuant to Section 409.285(2), Florida Statutes (F.S.).

(2) Definitions.

The following definitions are applicable to this rule:

(a) Action – In the case of a recipient receiving services through the fee-for-service (FFS) delivery system, any of the following:

The reduction, suspension, or termination by the Agency of a previously authorized service, or
The denial, in whole or in part, of a requested service or supplies by the Agency.

(b) Adverse Benefit Determination – In the case of a managed care plan enrollee, any of the following:

The denial, in whole or in part, of a requested service or supplies by the plan,
The reduction, suspension, or termination by the plan of a previously authorized service,
The failure of the plan to provide services in a timely manner as specified in the Agency’s contract with the plan, or
The denial by the plan of an enrollee’s request to dispute a Florida Medicaid financial liability, including, copayments and coinsurance.

(c) Authorized Representative – A person designated to request or represent the interests of the recipient or enrollee in a fair hearing.

(d) Benefit(s) – Florida Medicaid-covered services and supplies, as set forth in the Florida Medicaid State Plan, coverage policies, handbooks, fee schedules, or applicable waiver for Florida Medicaid waiver benefits. For managed care plan enrollees, benefits include expanded benefits covered by a plan as set forth under the terms and conditions of the plan’s contract with the Agency.

(e) Business Day – Any day in which the Agency conducts business, excluding Saturdays, Sundays, and holidays as defined in Section 110.117, F.S.

(f) Corrective Action – Corrective payments, or if appropriate, admission or readmission of a recipient or enrollee to a facility, in accordance with Title 42, Code of Federal Regulation (CFR), section 431.246.

(g) Day – A calendar day.

(h) Disenrollment Denial – The Agency’s denial of an enrollee’s request for disenrollment from a plan pursuant to Section 409.969, F.S.

(i) Enrollee – Recipient who is a member of a managed care plan.

(j) Fair Hearing (Hearing) – Proceedings conducted by the Agency pursuant to Section 409.285(2), F.S.

(k) File(d) – Received by the Office of Fair Hearings or by the Hearing Officer during the course of a hearing.

(l) Final Order – A written order rendered by the Agency constituting final agency action in a fair hearing.

(m) Fee-For-Service Recipient (FFS recipient) – Florida Medicaid recipient receiving benefits under the FFS delivery system.

(n) Good Cause – An incident or occurrence which is beyond the control of the movant and which prevents compliance. The Fair Hearing Officer will determine good cause based on the facts and circumstances the movant presents in support of the application for the relief sought.

(o) Hearing Officer – The presiding officer appointed by the Agency to conduct a fair hearing.

(p) Hearing Request – A clear, written or oral expression to the Agency requesting review of:

An action,
A plan appeal of an adverse benefit determination,
A disenrollment denial, pertaining to the enrollee, or
A matter within the fair hearing jurisdiction of the Agency.

(q) Legal Holiday – As designated in Section 110.117, F.S.

(r) Medical Supplies (Supply or Supplies) – As defined in Rule 59G-4.070, F.A.C.

(s) Notice of Action (NOA) – Written notice from the Agency to a FFS recipient regarding an action.

(t) Notice of Adverse Benefit Determination (NABD) – Written notice from a plan to an enrollee regarding an adverse benefit determination.

(u) Notice of Plan Appeal Resolution (NPAR) – Written notice from a plan to an enrollee resolving the enrollee’s plan appeal.

(v) Office of Fair Hearings (Office) – The hearing authority within the Agency designated to conduct fair hearings.

(w) Plan – Managed medical assistance and long-term care plans as defined in Rule 59G-1.010, F.A.C.

(x) Plan Appeal – A review by the plan of an adverse benefit determination.

(y) Recipient – Individual determined to be eligible for Florida Medicaid-covered services by the Department of Children and Families or the Social Security Administration, and who is enrolled in the Florida Medicaid program.

(z) Send (Sent) – Delivery by U.S. mail, email, facsimile transmission, or hand delivery.

(aa) Service(s) – Any diagnostic or treatment procedure(s) or other medical or allied care claimed to have been furnished to a recipient and listed in an itemized claim for payment; or, in the case of a claim based on costs, any entry in the cost report, books of account, or other documents supporting such claim.

(3) Jurisdiction and Right to a Hearing.

The Agency has jurisdiction and must provide a fair hearing for:

(a) A FFS recipient who makes a hearing request regarding:

The reduction, suspension, or termination by the Agency of a previously authorized service,
The denial, in whole or in part, of a requested service or supply by the Agency, or
The failure of the Agency to provide a timely NOA subsequent to the Agency’s failure to provide all medically necessary services to the recipient with reasonable promptness.

(b) An enrollee who makes a hearing request regarding:

A notice of plan appeal resolution indicating that the plan appeal did not result in the reversal of a prior denial of a new service, or the reduction, suspension, or termination of a previously authorized service, if timely challenged by the enrollee in accordance with the plan appeal procedures following the timely issuance of the plan’s NABD to the enrollee,
The failure of the plan to adhere to notice and timing requirements applicable to plan appeals, or
The failure of the plan to timely notice the enrollee through a NABD, subsequent to the plan’s failure to provide medically necessary services requested by the enrollee to the enrollee with reasonable promptness.

(d) A recipient who receives notification from the Agency pursuant to Rule 59G-5.110, F.A.C., that a reimbursement request is denied in whole or in part.

(e) A recipient entitled to a fair hearing pursuant to Section 409.285(2), F.S.

(f) The Agency need not grant a fair hearing if the sole issue is a federal or state law requiring an automatic change adversely affecting some or all recipients.

(g) A recipient who makes a hearing request regarding a denial or reduction to a medically necessary Florida Medicaid service and seeks corrective action.

(4) Parties.

(a) The parties to a fair hearing regarding FFS benefits are the FFS recipient and the Agency.

(b) The parties to a fair hearing regarding managed care benefits are the enrollee and the plan. Upon request by the Agency, the Agency may be granted party status by the Hearing Officer.

(d) The parties to a fair hearing regarding a reimbursement request pursuant to Rule 59G-5.110, F.A.C., are the recipient and the Agency.

(e) The parties to any fair hearing pursuant to Section 409.285(2), F.S., not specified herein, are the recipient and the appropriate state agency or its designee.

(5) Pleadings, Papers, Addresses, and Service.

(a) Any pleading or paper received by the Office before 5:00 p.m. on a business day shall be filed as of that day. A pleading or paper received after 5:00 p.m. on a business day, or on a Saturday, Sunday, or legal holiday shall be filed as of 8:00 a.m. on the next business day.

(b) A recipient or their authorized representative, must provide and maintain a mailing address of record with the Office, or if they elect service via email, must provide and maintain a valid email address of record with the Office. A plan and legal counsel to a party must provide and maintain a valid mailing and email address on file with the Office and consent to service via email. Service at the mailing address, or email address, if applicable, of record is presumed to be valid service.

(c) Each plan, and legal counsel to a party, must maintain a designated email address with the Office. Recipients may designate an email address with the Office. The Office shall provide all fair hearing-related communications to a party with a designated email address at that email address. Service on a party’s, an authorized representative’s, or legal counsel’s designated email address is presumed to be valid service.

(d) Unless the Hearing Officer orders otherwise, every pleading and paper filed in a fair hearing, except applications for witness subpoenas, shall be served on each party at the mailing address of record or designated email address.

(e) Service on counsel of record or on an authorized representative at the mailing address of record or designated email address is presumed to be valid service on the party.

(6) Computation of Time.

(a) In computing any period of time under this rule, by order of a Hearing Officer, or by any applicable statute, the day of the act from which the period of time begins to run shall not be included. The last day of the period shall be included unless it is a Saturday, Sunday, or a legal holiday in which event the period shall run until the end of the next business day. When the period of time allowed is less than seven days, only business days shall be included in the computation.

(b) Five days shall be added to the time limits when service is made by U.S. mail. One business day shall be added when service is made by overnight courier. No additional time shall be added if service is made by email, facsimile transmission, or hand delivery.

(7) Appearances, Authorized Representatives, and Withdrawal.

(a) Recipients may represent themselves in a fair hearing, they may be represented by a non-attorney authorized representative, or, they may be represented by an attorney authorized to practice law in Florida retained by the recipient, or a person with authority to retain counsel for the recipient.

(b) Counsel representing a party in a fair hearing shall promptly file with the Office and serve on each other party a notice of appearance, which includes counsel’s mailing address of record and email address. Filing of a notice of appearance shall constitute acceptance of service at the email address provided by counsel.

(c) Any person, including counsel or a recipient’s provider, requesting a fair hearing on behalf of a recipient, or seeking to represent a recipient in a fair hearing, must provide and maintain with the Office:

A written authorization signed by the recipient or by a person with legal authority to act on behalf of the recipient, designating the person as the recipient’s authorized representative; and,
A mailing address of record, and may designate an email address with the Office. As set forth herein, counsel appearing on behalf of a recipient consents to service via email.

(d) Upon motion, the Hearing Officer shall grant counsel of record or an authorized representative leave to withdraw from representation of a party for good cause shown. The motion shall contain the mailing address, email address, if applicable, and telephone number of the party represented.

(8) Requests for Fair Hearing.

(a) A recipient may make a hearing request either orally or in writing.

(b) Any person, including counsel or a recipient’s provider, making a hearing request on behalf of a recipient, or seeking to represent a recipient in a fair hearing, must file with the Office a written authorization signed by the recipient or by a person with legal authority to act on behalf of the recipient, designating the person as the recipient’s authorized representative.

(d) The Agency may waive the 90 day time limit for making a hearing request when:

The Agency fails to send a timely NOA to the FFS recipient, or
The Agency fails to act on a FFS recipient’s specific request for benefits.

(e) An enrollee must initiate and complete a plan appeal before making a fair hearing request. The plan appeal is complete when:

The enrollee receives from the plan a NPAR indicating the plan appeal was not resolved wholly in the enrollee’s favor, or
The plan fails to adhere to notice and timing requirements applicable to plan appeals.

(f) An enrollee need not initiate and complete a plan appeal before making a fair hearing request if the request is based on a plan determination or NOA rendered before March 1, 2017.

(g) A fair hearing request by an enrollee must be received by the Agency within 120 days of the date the required NPAR is sent to the enrollee.

(h) In other instances where a recipient is entitled to a fair hearing, the hearing request must be received by the Agency within 90 days of the date of the required time to provide a NOA, or such other time specified by law.

(9) Acknowledgement, Denial, and Dismissal of Fair Hearing Requests.

(a) The Office shall provide each party with prompt, written acknowledgement of a fair hearing request. The parties shall comply with any instructions issued with the acknowledgement.

(b) A Hearing Officer is authorized to deny or dismiss a request for a fair hearing for reasons consistent with this rule, including the following:

The Office does not have jurisdiction over the subject matter of the fair hearing,
The enrollee has not completed the plan appeal,
A fair hearing request is untimely,
A person other than the recipient makes a hearing request without also filing a written designation signed by the recipient authorizing the representation,
The recipient:

a. Files a written withdrawal of the fair hearing request, or

b. Fails to appear at the scheduled fair hearing without good cause; examples of good cause include but are not limited to a disabling accident, illness, or declared emergency.

The fair hearing is moot, or
The sole issue is a federal or state law requiring an automatic change adversely affecting some or all recipients or enrollees.

(10) Notice of Fair Hearing.

(a) The Office shall provide each party with a written notice of fair hearing at least 14 days in advance of the fair hearing date.

(b) The recipient or enrollee may waive the 14 days advance notice requirement, upon written request.

(11) Consolidated Hearings.

The Hearing Officer may consolidate separate fair hearing requests involving the same recipient if it appears consolidation would promote the just, speedy, and inexpensive resolution of the proceedings, and would not prejudice the rights of the recipient, or unduly prejudice another party.

(12) Access to Case File Prior to Fair Hearing.

(a) The recipient or enrollee must be provided access to his or her entire case file, including all medical records and any other documents and records considered or relied upon by a plan regarding a plan appeal, or by the Agency, whichever is applicable. Access to documents specified herein must be provided within seven days of the recipient’s or enrollee’s request to the plan or Agency.

(b) For expedited fair hearings, the entire case file, or any requested portion, must be provided within 24 hours of the recipient’s or enrollee’s request.

(13) Discovery; Subpoenas.

(a) Each party may obtain discovery through the means and in the manner provided in Rules 1.280 through 1.410, Florida Rules of Civil Procedure. The Hearing Officer may issue orders to effect the purposes of discovery and to prevent delay, including the imposition of sanctions in accordance with the Florida Rules of Civil Procedure, except contempt.

(b) Upon the request of any party, the Hearing Officer may issue subpoenas for the attendance of witnesses for deposition or at the hearing. The requesting party shall indicate whether the witness is also requested to bring documents, and if so, specify the documents to be produced.

(c) A subpoena may be served by any person specified by law to serve process, or by any person who is not a party and who is 18 years of age or older. Service shall be made by delivering a copy to the person named in the subpoena. Proof of service shall be made by affidavit of the person making service, if not served by a person specified by law to serve process.

(d) Any motion to quash or limit a subpoena shall be filed with the Office or Hearing Officer and shall state the grounds relied upon.

(14) Continuances and Abandonment.

(a) The Hearing Officer may grant a continuance of a fair hearing for good cause shown, or upon stipulation of all parties of record. Except in cases of emergency, requests for continuance shall be made at least five days prior to the date noticed for the hearing. Examples of good cause include but are not limited to the recipient’s inability to attend the hearing through no fault of his or her own, or a party’s good faith need for more time to conduct discovery.

(b) The Hearing Officer may find that a fair hearing is abandoned if the recipient or enrollee fails to appear at a properly noticed fair hearing without good cause. Examples of good cause include but are not limited to a disabling accident, illness, or declared emergency.

(15) Motions.

(a) All motions shall be in writing and filed with the Office. The motion shall state the relief requested and the grounds relied upon in support of the motion. If the movant is represented by counsel, the motion shall be accompanied by a written memorandum of law in support of the motion, unless otherwise permitted by the Hearing Officer.

(b) All motions, other than a motion to dismiss, shall include a statement that the movant has conferred with all other parties of record and shall state whether each party has any objection to the motion. Any statement that the movant was unable to confer with another party or parties before filing the motion must provide information regarding the date(s) and method(s) by which contact was attempted.

(c) When time permits, the other parties to the fair hearing may, within seven days of service, file written memoranda in response to a motion. No reply to a response shall be permitted, unless leave is sought from and granted by the Hearing Officer.

(d) Motions shall be decided on the basis of the pleadings, the grounds set forth in the motion, and any supporting or opposing legal memoranda, unless the Hearing Officer orders a motion hearing to resolve the issues. The Hearing Officer shall conduct such proceedings and render such orders as necessary to dispose of the issues raised by a motion.

(e) Motions for extension of time, other than a motion for continuance of the fair hearing, shall be filed no later than two days prior to the expiration of the deadline sought to be extended and shall state good cause for the request. Examples of good cause include but are not limited to a disabling accident, illness, or declared emergency.

(f) Motions made orally on the record during the course of a fair hearing, except for motions for extension of time or for a continuance, are exempt from these requirements, unless otherwise ordered by the Hearing Officer.

(16) Hearing Officers.

(a) A Hearing Officer shall be appointed by the Agency to preside over each fair hearing and must:

Ensure that the fair hearing is conducted in a manner consistent with this rule and promotes the fair, just, and speedy resolution of the proceeding,
Be impartial and was not involved in the initial determination giving rise to the fair hearing; and,
Refrain from unilateral communications with a party or a party’s representative regarding the substance of the issues presented in the fair hearing; if any such communication occurs, the Hearing Officer shall document the communication in the record of the fair hearing.

(b) The Hearing Officer shall have the authority to issue any and all orders and render rulings consistent with this rule.

(17) Conduct of Hearing.

(a) Hearings conducted pursuant to this rule are only open to the parties and their witnesses, unless authorized by the Hearing Officer and with the consent of the recipient or enrollee.

(b) Each fair hearing shall be a de novo, evidentiary proceeding, and shall be conducted in a manner that meets the requirements of this rule.

(c) Each fair hearing shall be conducted by telephone or in such manner as prescribed by the Hearing Officer. The Hearing Officer has the authority to swear witnesses and take their testimony under oath. Testimony taken by telephone or other telecommunications media does not require that a notary be present with the witness to administer the oath; however, the Hearing Officer must be satisfied as to the identity of the party or witness testifying.

(d) Each fair hearing shall be recorded. A copy of the recording shall be provided to the recipient or enrollee, upon request and free of charge.

(e) The recipient must have access to his or her entire case file including all medical records and any other documents and records considered or relied upon by a plan regarding a plan appeal, or by the Agency, whichever is applicable, during the course of the hearing. These materials shall be provided upon the recipient’s request free of charge.

(f) When the plan is a party, it shall file with the Office or Hearing Officer all legal authorities, Florida Medicaid policies and regulations, and contractual provisions relied upon for its determination of any issues presented in the fair hearing. The enrollee must have access to this information during the course of the hearing.

(g) The burden of proof is on the party asserting the affirmative of an issue, except as otherwise required by statute. The burden of proof is on the Agency or plan, whichever is applicable, when the issue presented is the suspension, reduction, or termination of a previously authorized service. The burden of proof is on the recipient or enrollee, when the issue presented is the denial or a limited authorization of a service. The party with the burden of proof shall establish its position to the satisfaction of the Hearing Officer by a preponderance of the evidence.

(h) Opening and closing statements may be presented by each party.

(i) The recipient or enrollee shall be entitled to:

Introduce evidence relevant to the issues presented,
Examine and rebut any evidence presented by another party through the introduction of rebuttal evidence, and examination and cross-examination of any witness,
If documentary evidence is received in the form of a copy or excerpt, to compare the copy with the original, if available and to conduct cross-examination when such documents are made a part of the record,
Call witnesses at the hearing,
Cross-examine adverse witnesses; and,
Impeach any witness.

(j) Irrelevant, immaterial, or unduly repetitious evidence shall be excluded, but all other evidence of a type commonly relied upon by reasonably prudent persons in the conduct of their affairs shall be admissible, whether or not such evidence would be admissible in a trial in the courts of Florida. Any part of the evidence may be received in written form, and all testimony of parties and witnesses shall be taken only on oath or affirmation.

(k) Hearsay evidence may be used to supplement or explain evidence but is not sufficient in itself to support a finding, unless the evidence is within an exception to the Hearsay Rule under Sections 90.801-.805, F.S.

(l) When official recognition is requested, the parties shall be notified and given an opportunity to examine and contest the material(s). Official recognition may be requested by motion and shall be granted or denied, in whole or in part, at the discretion of the Hearing Officer and in accordance with the provisions governing judicial notice in Sections 90.201-.203, F.S.

(m) The rules of privilege apply to the same extent as in civil actions under Florida law.

(n) If the fair hearing involves medical issues, such as those concerning a diagnosis, an examining physician’s report or a medical review team’s decision, and if the Hearing Officer considers it necessary to have a medical assessment other than that performed by the individual involved in making the original decision, such a medical assessment must be obtained at expense of the Agency, in a hearing for a FFS recipient, or the plan, in a hearing for an enrollee, whichever is applicable, and made part of the record.

(o) Post-hearing submissions can be authorized by the Hearing Officer with the consent of the recipient or enrollee.

(p) If the fair hearing involves corrective action, the recipient must demand the corrective action and submit record evidence of the recipient’s liability or potential liability for payment of the already-provided service.

(18) Final Orders.

(a) A Hearing Officer shall render a Final Order in each fair hearing.

(b) The Final Order shall be rendered within 90 days of the date of the request for a fair hearing, unless the time period is waived by the recipient or extended by order of the Hearing Officer.

(c) The Final Order must be based exclusively on evidence introduced at the hearing and any post-hearing submission authorized by the Hearing Officer. Findings of fact shall be based upon a preponderance of the evidence, unless otherwise provided by statute, and shall be based exclusively on the evidence of record and on matters officially recognized.

(d) The Final Order shall be in writing and shall include: a caption, specify the time and place of the fair hearing, list the parties and witnesses who appeared at the fair hearing, a statement of the issues addressed, findings of fact, conclusions of law, and, the resolution of the issues.

(e) The Final Order shall be sent to each party on the date rendered.

(f) The Final Order may prescribe corrective action retroactively to the date the incorrect action was taken.

(g) The Final Order shall include notice to the recipient or enrollee of the right to seek judicial review, the procedure which must be followed, and the time limits which apply.

(h) Rehearing or reconsideration of a Final Order is prohibited under this rule.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.285 FS. History–New 3-1-17, Amended 12-18-17, 9-24-18.

Chapter 59G-4 MEDICAID POLICY

Fla. Admin. Code R. 59G-4.001 Medicaid Providers Who Bill on the CMS-1500

(1) All Medicaid providers and their billing agents who submit claims on behalf of an enrolled Medicaid provider who are required by their service specific coverage and limitations handbook or other notification by the Medicaid Program to bill the Florida Medicaid Program on a paper CMS-1500 claim form for reimbursement of services performed on a Medicaid eligible recipient, must be in compliance with the provisions of the Florida Medicaid Provider Reimbursement Handbook, CMS-1500, July 2008, which is incorporated by reference. The handbook is available from the Medicaid fiscal agent’s web portal at http://mymedicaid-florida.com. Click on Public Information for Providers, then on Provider Support, and then on Provider Handbooks. Paper copies of the handbook may be obtained by calling the Provider Contact Center at 1(800)289-7799 and selecting Option 7.

(2) The following forms that are included in the Florida Medicaid Provider Reimbursement Handbook, CMS-1500, are incorporated by reference: in Chapter 1, the CMS-1500 Claim Form, Approved OMB-0938-0999 Form CMS-1500 (08-05), one page double-sided; and in Chapter 3, the Florida’s Healthy Start Prenatal Risk Screening Instrument, DH 3134, 2/01, one page; State of Florida, Florida Medicaid Authorization Request, PA01 07/08, one page; Medically Needy Billing Authorization, DF-ES 2902, June 2003, one page; Consent For Sterilizatión, HHS-687 (11/2006), doublesided; Consentimiento Para La Esterilizacion, HHS-687-1 (11/2006), doublesided; State of Florida, Hysterectomy Acknowledgment Form, HAF 07/1999, one page; State of Florida, Exception to Hysterectomy Acknowledgment Requirement, ETA 07/2008, one page; State of Florida, Abortion Certification Form, AHCA-Med Serv Form 011, August 2001, one page. All the forms except for the Healthy Start Prenatal Risk Screening Instrument are available from the Medicaid fiscal agent by calling the Provider Contact Center at 1(800)289-7799 and selecting Option 7 or from its Web Portal at http://mymedicaid-florida.com. Click on Public Information for Providers, then on Provider Support, and then on Forms. The Healthy Start Prenatal Risk Screening Instrument is available from the local County Health Department.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.905, 409.906, 409.907, 409.908, 409.912 FS. History–New 10-1-03, Amended 7-2-06, Amended 3-7-07, 4-9-08, 12-3-08.

Fla. Admin. Code R. 59G-4.002 Provider Reimbursement Schedules and Billing Codes

(1) This rule applies to providers rendering Florida Medicaid services to recipients.

(2) Florida Medicaid reimburses for services rendered in the fee-for-service delivery system based on a fee schedule, cost report, or contract. The following fee schedules and billing codes are incorporated by reference and available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml.

(3) Florida Medicaid Fee Schedules Effective January 1, 2025:

(a) Assistive Care Services Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18271.

(b) Behavior Analysis Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18300.

https://www.flrules.org/Gateway/reference.asp?No=Ref-18352.

(d) Birth Center Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18302.

(e) Community-Based Substance Abuse County Match Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18304.

(f) Community Behavioral Health Services Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18364.

(g) County Health Department Certified Match Program Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18305.

(h) Dental General Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18306.

(i) Durable Medical Equipment and Medical Supply Services Provider Fee Schedule for All Medicaid Recipients

https://www.flrules.org/Gateway/reference.asp?No=Ref-18307.

(j) Early Intervention Services Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18308.

(k) Family Home Health Aide Services Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18309.

(l) Hearing Services Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18310.

(m) Home Health Visit Services Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18311.

(n) Licensed Midwife Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18313.

(o) Medicaid Certified School Match Program Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18314.

(p) Medical Foster Care Services Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18315.

(q) Occupational Therapy Services Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18354.

(r) Personal Care Services Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18317.

(s) Physical Therapy Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18365.

(t) Physician Pediatric Surgery Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18319.

(u) Prescribed Drugs Immunization Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18322.

(v) Private Duty Nursing Services Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18324.

(w) Radiology Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18325.

(x) Regional Perinatal Intensive Care Center (RPICC) Neonatal Services Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18326.

(y) Regional Perinatal Intensive Care Center (RPICC) Obstetrical Services Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18327.

(z) Respiratory Therapy Services Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18328.

(aa) Speech-Language Pathology Services Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18362.

(bb) Transportation Services Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18332.

(cc) Visual Services Fee Schedule

https://www.flrules.org/Gateway/reference.asp?No=Ref-18333.

(4) Florida Medicaid Fee Schedules Effective July 1, 2025:

(a) Independent Laboratory Fee Schedule

https://flrules.org/Gateway/reference.asp?No=Ref-18822.

(b) Practitioner Fee Schedule

https://flrules.org/Gateway/reference.asp?No=Ref-18628.

https://flrules.org/Gateway/reference.asp?No=Ref-18823.

(d) Prescribed Pediatric Extended Care Services Fee Schedule

https://flrules.org/Gateway/reference.asp?No=Ref-18630.

(5) Florida Medicaid Fee Schedule Effective July 8, 2025:

Specialized Therapeutic Services Fee Schedule

https://flrules.org/Gateway/reference.asp?No=Ref-18631.

(6) Florida Medicaid Fee Schedules Effective October 1, 2025:

(a) Independent Laboratory Fee Schedule

https://flrules.org/Gateway/reference.asp?No=Ref-18824.

(b) Practitioner Fee Schedule

https://flrules.org/Gateway/reference.asp?No=Ref-18935.

https://flrules.org/Gateway/reference.asp?No=Ref-18825.

(d) Targeted Case Management Services Fee Schedule

https://flrules.org/Gateway/reference.asp?No=Ref-18820.

(7) Florida Medicaid Billing Codes Effective January 1, 2025:

(a) County Health Department Billing Codes

https://www.flrules.org/Gateway/reference.asp?No=Ref-18334.

(b) Federally Qualified Health Center Billing Codes

https://www.flrules.org/Gateway/reference.asp?No=Ref-18335.

https://www.flrules.org/Gateway/reference.asp?No=Ref-18336.

(d) Hospital Outpatient Services Billing Codes

https://www.flrules.org/Gateway/reference.asp?No=Ref-18337.

(e) Intermediate Care Facility for Individuals with Intellectual Disabilities Services Billing Codes

https://www.flrules.org/Gateway/reference.asp?No=Ref-18338.

(f) Nursing Facility Services Billing Codes

https://www.flrules.org/Gateway/reference.asp?No=Ref-18358.

(g) Rural Health Clinic Billing Codes

https://www.flrules.org/Gateway/reference.asp?No=Ref-18341.

(h) Statewide Inpatient Psychiatric Program Services Billing Codes

https://www.flrules.org/Gateway/reference.asp?No=Ref-18359.

(8) Florida Medicaid Billing Codes Effective July 1, 2025:

Prescribed Drugs Physician Administered Billing Codes

https://flrules.org/Gateway/reference.asp?No=Ref-18629

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.905, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History–New 8-18-05, Amended 11-30-05, 4-16-06, 10-11-06, 3-27-07, 7-25-07, 9-29-08, 4-28-09, 2-11-10, 1-31-11, 7-16-13, 5-21-14, 6-20-16, 6-22-17, 2-8-18, 5-7-18, 1-7-19, 7-17-19, 12-15-20, 9-29-21, 8-2-22, 12-31-23, 10-21-24, 8-24-25, 1-18-26.

Fla. Admin. Code R. 59G-4.003 Medicaid Providers Who Bill on the UB-04

(1) All Medicaid providers and their billing agents who submit claims on behalf of an enrolled Medicaid provider, who are required by their service-specific coverage and limitations handbook or other notification by the Medicaid Program to bill the Florida Medicaid Program on a paper UB-04 claim form for reimbursement of services performed on a Medicaid eligible recipient, must be in compliance with the provisions of the Florida Medicaid Provider Reimbursement Handbook, UB-04, July 2008, which is incorporated by reference. The handbook is available from the Medicaid fiscal agent’s web portal at http://mymedicaid-florida.com. Click on Public Information for Providers, then on Provider Support, and then on Provider Handbooks. Paper copies of the handbook may be obtained by calling the Provider Contact Center at 1(800)289-7799 and selecting Option 7.

(2) The following form that is included in the Florida Medicaid Provider Reimbursement Handbook, UB-04, is incorporated by reference: in Chapter 1, the UB-04 CMS-1450, Approved OMB No. 0938-0997, May 2007, one page double-sided. The form is available from the Medicaid fiscal agent’s Provider Contact Center by calling 1(800)289-7799 and selecting Option 7.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.905, 409.906, 409.907, 409.908, 409.912 FS. History–New 10-2-07, Amended 2-25-09.

Fla. Admin. Code R. 59G-4.010 Advanced Registered Nurse Practitioner Services

History

Rulemaking Authority 409.919 FS. Law Implemented 409.905, 409.907, 409.908, 409.9081 FS. History–New 12-21-80, Formerly 10C-7.52, Amended 8-18-92, Formerly 10C-7.052, Amended 8-22-96, 3-11-98, 10-13-98, 6-8-99, 4-23-00, 8-5-01, 2-20-03, 8-5-03, 8-3-04, 8-18-05, Repealed 10-27-13.

Fla. Admin. Code R. 59G-4.013 Allergy Services

(1) This rule applies to any person or entity prescribing or reviewing a request for allergy services and to all providers of allergy services who are enrolled in or registered with the Florida Medicaid program.

(2) All persons or entities described in subsection (1), must be in compliance with the provisions of the Florida Medicaid Allergy Services Coverage Policy, June 2016, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06743.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 6-29-16.

Fla. Admin. Code R. 59G-4.015 Emergency Transportation Services

(1) This rule applies to all providers rendering Florida Medicaid emergency transportation services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Emergency Transportation Services Coverage Policy, October 2016, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-07441.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.901, 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 7-23-06, Amended 8-22-13, 10-27-16.

Fla. Admin. Code R. 59G-4.020 Ambulatory Surgical Center Services

(1) This rule applies to all providers rendering Florida Medicaid ambulatory surgical center services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Ambulatory Surgical Center Services Coverage Policy, January 2019, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-10151.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 10-25-84, Formerly 10C-7.531, Amended 5-13-92, 7-12-92, 7-27-93, Formerly 10C-7.0531, Amended 9-8-94, 7-3-95, 11-18-97, 10-27-98, 1-1-01, 7-26-01, 2-25-03, 2-17-04, 1-10-05, 10-2-05, 7-2-06, 1-20-13, 7-2-17, 2-11-19.

Fla. Admin. Code R. 59G-4.022 Anesthesia Services

(1) This rule applies to any person or entity prescribing or reviewing a request for anesthesia services and to all providers of anesthesia services who are enrolled in or registered with the Florida Medicaid program.

(2) All persons or entities described in subsection (1), must be in compliance with the provisions of the Florida Medicaid Anesthesia Services Coverage Policy, June 2016, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06764.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 7-5-16.

Fla. Admin. Code R. 59G-4.025 Assistive Care Services

(1) This rule applies to all providers rendering Florida Medicaid assistive care services to recipients.

(2) All providers must comply with the provisions of the Florida Medicaid Assistive Care Services Coverage Policy, July 2017, incorporated by reference, and available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-08262.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.906, 409.912, 409.973 FS. History–New 11-28-01, Amended 7-20-10, 7-10-17.

Fla. Admin. Code R. 59G-4.026 Gastrointestinal Services

(1) This rule applies to any person or entity prescribing or reviewing a request for gastrointestinal practitioner services and to all providers of gastrointestinal practitioner services who are enrolled in or registered with the Florida Medicaid program.

(2) All persons or entities described in subsection (1), must be in compliance with the provisions of the Florida Medicaid Gastrointestinal Services Coverage Policy, June 2016, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-06742.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 6-29-16.

Fla. Admin. Code R. 59G-4.027 Behavioral Health Overlay Services

(1) This rule applies to all providers of behavioral health overlay services who are enrolled in the Florida Medicaid program.

(2) All providers of behavioral health overlay services must be in compliance with the provisions of the Florida Medicaid Behavioral Health Overlay Services Coverage and Limitations Handbook, March 2014, available at http://www.flrules.org/Gateway/reference.asp?No=Ref-03748, incorporated by reference. The handbook is available on the Medicaid fiscal agent’s website at www.mymedicaid-florida.com. Select Public Information for Providers, then Provider Support, and then Provider Handbooks. Paper copies of the handbook may be obtained by calling the Provider Services Contact Center at 1(800)289-7799 and selecting Option 7.

(3) The following forms are included in the Florida Medicaid Behavioral Health Overlay Services Coverage and Limitations Handbook and are incorporated by reference: Certification of Eligibility, AHCA Form 5000-3522, Revised March 2014; Provider Agency Self-Certification, AHCA Form 5000-3523, Revised March 2014. These forms are available by photocopying them from the Florida Medicaid Behavioral Health Overlay Services Coverage and Limitations Handbook.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.9081, 409.912, 409.913 FS. History–New 3-13-14.

Fla. Admin. Code R. 59G-4.028 Behavioral Health Assessment Services

(1) This rule applies to all providers rendering Florida Medicaid behavioral health assessment services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Behavioral Health Assessment Services Coverage Policy, November 2019, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-11244

History

Rulemaking Authority 409.919,409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History‒New 11-28-19.

Fla. Admin. Code R. 59G-4.029 Behavioral Health Medication Management Services

(1) This rule applies to all providers rendering Florida Medicaid behavioral health medication management services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Behavioral Health Medication Management Services Coverage Policy, November 2019, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-11245.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 11-28-19.

Fla. Admin. Code R. 59G-4.030 Reproductive Services

(1) This rule applies to all providers rendering Florida Medicaid reproductive services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Reproductive Services Coverage Policy, July 2016, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06938.

(3) The United States Department of Health and Human Services’ Consent for Sterilization Form – HHS-687 (10/12), is incorporated by reference, http://www.flrules.org/Gateway/reference.asp?No=Ref-07025, and available at http://www.hhs.gov/opa/pdfs/consent-for-sterilization-english-updated.pdf.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.905, 409.906, 409.973 FS. History–New 4-18-85, Formerly 10C-7.532, Amended 8-18-92, Formerly 10C-7.0532, Amended 4-22-96, 3-11-98, 10-13-98, 5-24-99, 4-23-00, 8-5-01, 2-20-03, 8-5-0, 7-27-04, 8-18-05, 5-21-14, 7-11-16.

Fla. Admin. Code R. 59G-4.031 Behavioral Health Community Support Services

(1) This rule applies to all providers rendering Florida Medicaid behavioral health community support services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Behavioral Health Community Support Services Coverage Policy, November 2019, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-11246.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913, 409.973 History–New 11-28-19.

Fla. Admin. Code R. 59G-4.032 Integumentary Services

(1) This rule applies to any person or entity prescribing or reviewing a request for integumentary services and to all providers of integumentary services who are enrolled in or registered with the Florida Medicaid program.

(2) All persons or entities described in subsection (1), must be in compliance with the provisions of the Florida Medicaid Integumentary Services Coverage Policy, June 2016, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06758.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 6-29-16.

Fla. Admin. Code R. 59G-4.033 Cardiovascular Services

(1) This rule applies to any person or entity prescribing or reviewing a request for cardiovascular services and to all providers of cardiovascular services who are enrolled in or registered with the Florida Medicaid program.

(2) All persons or entities described in subsection (1), must be in compliance with the provisions of the Florida Medicaid Cardiovascular Services Coverage Policy, June 2016, incorporated by reference. The policy is available from the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-06772.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 6-29-16.

Fla. Admin. Code R. 59G-4.035 Medicaid Certified School Match Program

(1) This rule applies to all school districts enrolled in the Medicaid certified school match program, as described in Section 409.9071, F.S.

(2) All school district providers enrolled in Medicaid under the certified school match program must be in compliance with the Florida Medicaid Certified School Match Coverage and Limitations Handbook, January 2005, incorporated by reference, and the Florida Medicaid Provider Reimbursement Handbook, CMS-1500, which is incorporated by reference in Rule 59G-4.001, F.A.C. Both handbooks are available from the Medicaid fiscal agent.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.905, 409.906, 409.9071, 409.908, 409.9122, 409.9126, 1011.70 FS. History–New 4-9-98, Amended 11-23-99, 5-27-01, 10-31-02, 10-28-03, 1-10-06.

Fla. Admin. Code R. 59G-4.040 Chiropractic Services

(1) This rule applies to all providers rendering Florida Medical chiropractic services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Chiropractic Services Coverage Policy, January 2019, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at https://www.flrules.org/Gateway/reference.asp?No=Ref-10150.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906, 409.907, 409.908, 409.9081 FS. History–New 6-1-89, Amended 7-1-91, 12-31-91, 3-17-92, 4-21-92, 11-9-92, 7-5-93, 1-19-94, Formerly 10C-7.066, Amended 10-10-94, 5-25-95, 1-9-96, 10-21-97, 5-24-99, 4-23-00, 7-5-01, 2-20-03, 8-5-03, 8-3-04, 8-18-05, 5-31-10, 8-16-15, 2-11-19.

Fla. Admin. Code R. 59G-4.050 Community Behavioral Health Services

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.9081, 409.912, 409.913 FS. History–New 1-27-82, Amended 10-25-84, Formerly 10C-7.525, Amended 1-19-94, Formerly 10C-7.0525, Amended 9-21-98, 11-14-00, 1-19-05, 3-13-14, Repealed 12-22-19.

Fla. Admin. Code R. 59G-4.052 Behavioral Health Therapy Services

(1) This rule applies to all providers rendering Florida Medicaid behavioral health therapy services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Behavioral Health Therapy Services Coverage Policy, November 2019, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-11247.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913. 409.973 FS. History–New 11-28-19.

Fla. Admin. Code R. 59G-4.055 County Health Department Clinic

(1) This rule applies to all county health department clinic (CHD) providers that are in or registered with the Florida Medicaid program.

(2) All CHD providers must comply with Title 42, Code of Federal Regulations, Parts 440 and 491.

(3) Florida Medicaid reimburses CHD providers for services rendered through the fee-for-service delivery system at one encounter rate per day, per recipient, per provider. For rates, see http://ahca.myflorida.com/Medicaid/Finance/finance/institutional/index.shtml.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.905, 409.906, 409.908 FS. History–New 6-27-93, Formerly 10P-4.350, Amended 4-16-95, 6-4-96, 6-24-98, 7-18-01, 11-17-03, 2-19-07, 9-29-08, 6-29-16.

Fla. Admin. Code R. 59G-4.058 Medicaid County Health Department Certified Match Program

(1) This rule applies to providers rendering certified match services in county health departments to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid County Health Department Certified Match Program Coverage Policy, January 2019, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-10059.

(3) The following form is included in the Florida Medicaid County Health Department Certified Match Program Coverage Policy, January 2019, and is incorporated by reference: Quarterly Certification of State Expenditures By County Health Departments, AHCA Form 5000-4058, August 2018.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.9071, 409.908 FS. History–New 6-21-00, Amended 11-17-03, 12-25-18.

Fla. Admin. Code R. 59G-4.060 Dental Services

(1) This rule applies to all providers rendering Florida Medicaid Dental Services.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Dental Services Coverage Policy, August 2018, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-09633.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 7-10-80, Amended 2-19-81, 10-27-81, 7-21-83, Formerly 10C-7.523, Amended 9-11-90, 11-3-92, Formerly 10C-7.0523, Amended 6-29-93, Formerly 10P-4.060, Amended 7-19-94, 7-16-96, 3-11-98, 10-13-98, 12-28-98, 6-10-99, 4-23-00, 4-24-01, 7-5-01, 2-20-03, 8-5-03, 1-8-04, 10-12-04, 6-28-05, 7-2-06, 5-21-07, 2-23-09, 5-3-12, 5-3-16, 9-24-18.

Fla. Admin. Code R. 59G-4.070 Durable Medical Equipment and Medical Supplies

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History–New 8-26-92, Formerly 10C-7.070, Amended 5-23-94, 1-7-96, 3-4-99, 10-18-00, 4-30-01, 10-1-08, 9-28-10, Repealed 1-1-25.

Fla. Admin. Code R. 59G-4.071 Durable Medical Equipment and Medical Supply Services Provider Fee Schedules

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History–New 5-7-07, Amended 5-8-08, 9-21-11, 6-4-12, 2-26-13, 12-2-13, 7-2-14, Repealed 6-20-16.

Fla. Admin. Code R. 59G-4.072 Durable Medical Equipment and Medical Supply Services: Specialized

(1) This rule applies to all providers rendering Florida Medicaid durable medical equipment and medical supply services: specialized to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Durable Medical Equipment and Medical Supply Services Coverage Policy: Specialized, December 2023, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-16180.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 1-10-24, Amended 5-31-26.

Fla. Admin. Code R. 59G-4.073 Durable Medical Equipment and Medical Supply Services: Orthotic and Prosthetic

(1) This rule applies to all providers rendering Florida Medicaid durable medical equipment and medical supply services: orthotic and prosthetic to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Durable Medical Equipment and Medical Supply Services Coverage Policy: Orthotic and Prosthetic, December 2023, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-16182.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 1-10-24, Amended 5-31-26.

Fla. Admin. Code R. 59G-4.074 Durable Medical Equipment and Medical Supply Services: Respiratory

(1) This rule applies to all providers rendering Florida Medicaid durable medical equipment and medical supply services: respiratory to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Durable Medical Equipment and Medical Supply Services Coverage Policy: Respiratory, December 2023, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-16185.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 1-10-24, Amended 5-31-26.

Fla. Admin. Code R. 59G-4.075 Durable Medical Equipment and Medical Supply Services: Wheelchairs, Hospital Beds, and Ambulatory Aids

(1) This rule applies to all providers rendering Florida Medicaid durable medical equipment and medical supply services: wheelchairs, hospital beds, and ambulatory aids to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Durable Medical Equipment and Medical Supply Services Coverage Policy: Wheelchairs, Hospital Beds, and Ambulatory Aids, December 2023, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-16184.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 1-10-24, Amended 5-31-26.

Fla. Admin. Code R. 59G-4.076 Durable Medical Equipment and Medical Supply Services: Continence, Ostomy, and Wound Care

(1) This rule applies to all providers rendering Florida Medicaid durable medical equipment and medical supply services: continence, ostomy, and wound care to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Durable Medical Equipment and Medical Supply Services Coverage Policy: Continence, Ostomy, and Wound Care, December 2023, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-16183.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 1-10-24, Amended 5-31-26.

Fla. Admin. Code R. 59G-4.077 Durable Medical Equipment and Medical Supply Services: Enteral and Parenteral Nutrition

(1) This rule applies to all providers rendering Florida Medicaid durable medical equipment and medical supply services: enteral and parenteral nutrition to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Durable Medical Equipment and Medical Supply Services Coverage Policy: Enteral and Parenteral Nutrition, December 2023, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-16181.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 1-10-24, Amended 5-31-26.

Fla. Admin. Code R. 59G-4.080 Child Health Check-Up

History

Rulemaking Authority 409.919 FS., Chapter 92-129, Sec. 58, Laws of Florida. Law Implemented 409.905, 409.908 FS. History–New 1-1-77, Amended 2-6-78, 1-4-79, 2-18-80, 9-15-80, 9-30-81, Formerly 10C-7.47, Amended 7-17-91, 5-11-92, 5-27-93, Formerly 10C-7.047, Amended 12-26-95, 4-22-98, 9-26-00, 11-17-03, Repealed 7-11-16.

Fla. Admin. Code R. 59G-4.085 Early Intervention Services

(1) This rule applies to all providers rendering Florida Medicaid early intervention services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Early Intervention Services Coverage Policy, October 2023, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://acha.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-15977.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.906, 409.908, 409.973 FS. History–New 4-30-00, Amended 8-9-04, 5-22-06, 1-10-08, 8-13-17, 11-16-23, 5-31-26.

Fla. Admin. Code R. 59G-4.087 Evaluation and Management Services

(1) This rule applies to any person or entity prescribing or reviewing a request for evaluation and management services and to all providers of evaluation and management services who are enrolled in or registered with the Florida Medicaid program.

(2) All persons or entities described in subsection (1), must be in compliance with the provisions of the Florida Medicaid Evaluation and Management Services Coverage Policy, June 2016, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-06775.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 6-29-16.

Fla. Admin. Code R. 59G-4.090 Family Planning

History

Rulemaking Authority 409.919 FS. Law Implemented 409.905(3), 409.908, 409.913(5)(e), (8)(h) FS. History–New 1-1-77, Amended 5-10-79, 10-23-85, Formerly 10C-7.43, Amended 8-18-92, Formerly 10C-7.043, Repealed 10-17-95.

Fla. Admin. Code R. 59G-4.100 Federally Qualified Health Center

(1) This rule applies to all federally qualified health centers (FQHC) that are enrolled in or registered with the Florida Medicaid program.

(2) All FQHCs must comply with Title 42, Code of Federal Regulations, Parts 440 and 491.

(3) Florida Medicaid reimburses for services provided through the fee-for-service delivery system at an encounter rate. Providers may be reimbursed for up to one medical, one dental, and one behavioral health visit provided to a recipient on the same day. For rates, see http://ahca.myflorida.com/Medicaid/Finance/finance/institutional/index.shtml.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.905, 409.906, 409.908, 409.9081 FS. History–New 6-27-93, Formerly 10P-4.100, Amended 4-16-95, 5-28-96, 6-24-98, 12-31-01, 11-17-03, 2-19-07, 9-29-08, 6-29-16.

Fla. Admin. Code R. 59G-4.105 Dialysis Services

(1) This rule applies to all providers rendering Florida Medicaid dialysis services to recipients.

(2) All providers of dialysis services must be in compliance with the provisions of the Florida Medicaid Dialysis Services Coverage Policy, June 2025, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-18127.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.906, 409.908, 409.973 FS. History–New 8-24-99, Amended 7-29-09, 1-3-16, 8-18-25.

Fla. Admin. Code R. 59G-4.106 Freestanding Dialysis Center Fee Schedule

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906, 409.908 FS. History–New 7-29-09, Repealed 6-20-16.

Fla. Admin. Code R. 59G-4.108 Genitourinary Services

(1) This rule applies to any person or entity prescribing or reviewing a request for genitourinary services and to all providers of genitourinary practitioner services who are enrolled in or registered with the Florida Medicaid program.

(2) All persons or entities described in subsection (1), must be in compliance with the provisions of the Florida Medicaid Genitourinary Services Coverage Policy, June 2016, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-06780.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 6-29-16.

Fla. Admin. Code R. 59G-4.110 Hearing Services

(1) This rule applies to any person or entity prescribing or reviewing a request for hearing services and to all providers of hearing services who are enrolled in or registered with the Florida Medicaid program.

(2) All persons or entities described in subsection (1), must be in compliance with the provisions of the Florida Medicaid Hearing Services Coverage Policy, June 2016, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06744.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.012, 409.913, 409.973 FS. History–New 8-3-80, Amended 7-21-83, Formerly 10C-7.522, Amended 4-13-93, Formerly 10C-7.0522, Amended 12-21-97, 10-13-98, 5-7-00, 7-5-01, 2-20-03, 8-5-03, 7-27-04, 7-26-05, 8-18-05, 11-29-06, 6-29-16.

Fla. Admin. Code R. 59G-4.120 Statewide Inpatient Psychiatric Program

(1) This rule applies to all providers of the Statewide Inpatient Psychiatric Program who are enrolled in or registered with the Florida Medicaid program.

(2) All providers of the Statewide Inpatient Psychiatric Program must be in compliance with the provisions of the Florida Medicaid Statewide Inpatient Psychiatric Coverage Policy, December 2015, incorporated by reference. The policy is available on the Medicaid fiscal agent’s website at http://portal.flmmis.com/FLPublic, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06157.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.9081, 409.912, 409.913 FS. History–New 1-3-16.

Fla. Admin. Code R. 59G-4.125 Behavior Analysis Services

(1) This rule applies to all providers rendering Florida Medicaid behavior analysis services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Behavior Analysis Services Coverage Policy, December 2024, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at https://www.flrules.org/Gateway/reference.asp?No=Ref-17525.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.906, 409.973 FS. History–New 2-19-17, Amended 10-29-17, 10-9-23, 2-10-25.

Fla. Admin. Code R. 59G-4.127 Florida Assertive Community Treatment Services

(1) This rule applies to all providers rendering Florida Medicaid Florida Assertive Community Treatment Services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Florida Assertive Community Treatment Services Policy, December 2023, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-16146.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906 FS. History–New 11-22-21, Amended 1-4-24, 3-12-26.

Fla. Admin. Code R. 59G-4.128 Qualified Residential Treatment Program Services

(1) This rule applies to all providers rendering Florida Medicaid qualified residential treatment program services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Qualified Residential Treatment Program Services Coverage Policy, May 2025, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at https://www.flrules.org/Gateway/reference.asp?No=Ref-18081.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.175, 409.906, 409.973 FS. History–New 7-8-25.

Fla. Admin. Code R. 59G-4.130 Home Health Visit Services

(1) This rule applies to all providers rendering Florida Medicaid home health visit services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Home Health Visit Services Coverage Policy, September 2024, incorporated by reference. The policy is available on the Agency for Health Care Administration’s (AHCA) website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-16937.

(3) The following forms are incorporated by reference and are available on the AHCA website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and in the Florida Medicaid Home Health Visit Services Policy, September 2024.

(a) Parent or Legal Guardian Medical Limitations, AHCA Form 5000-3501, November 2016, http://www.flrules.org/Gateway/reference.asp?No=Ref-07496.

(b) Parent or Legal Guardian Work Schedule, AHCA Form 5000-3503, November 2016, http://www.flrules.org/Gateway/reference.asp?No=Ref-07497.

(c) Parent or Legal Guardian Statement of Work Schedule, AHCA Form 5000-3504, November 2016, http://www.flrules.org/Gateway/reference.asp?No=Ref-07498.

(d) Parent or Legal Guardian School Schedule, AHCA Form 5000-3505, November 2016, http://www.flrules.org/Gateway/reference.asp?No=Ref-07499.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 400.4765, 409.902, 409.905, 409.907, 409.908, 409.9081, 409.912, 409.913, 409.973 FS. History–New 1-1-77, Amended 4-1-78, 9-28-78, 1-24-79, 7-17-83, Formerly 10C-7.44, Amended 6-1-88, 4-9-89, 1-1-90, 5-26-93, Formerly 10C-7.044, Amended 3-14-95, 12-27-95, 5-7-96, 2-9-98, 5-30-00, 11-24-03, 10-30-07, 12-29-08, 6-25-12, 6-25-13, 10-14-14, 11-17-16, 10-1-24.

Fla. Admin. Code R. 59G-4.132 Home Health Electronic Visit Verification Program

(1) This rule applies to providers enrolled directly in the Florida Medicaid program that furnish home health services (home health visits, private duty nursing, and personal care services) to recipients through the fee-for-service delivery system as specified on the Agency for Health Care Administration’s (AHCA) website at http://ahca.myflorida.com/Medicaid/home_health/dmv.shtml in accordance with Section 409.9132, Florida Statutes (F.S.).

(2) Definition. Direct service provider – An individual who personally (face-to-face) provides services to recipients in accordance with Rule 59G-4.261, 59G-4.215 or 59G-4.130, Florida Administrative Code (F.A.C.).

(3) Home Health Electronic Visit Verification Program.

(a) All providers must comply with Section 409.9132, F.S.

(b) The Agency for Health Care Administration contracts with a vendor to electronically verify the delivery of home health services provided to recipients in their residence or other authorized setting.

Providers must document the home health service encounter for each recipient served (in accordance with the recipient’s approved plan of care) and verify the delivery of the services rendered using AHCA’s designated vendor’s electronic visit verification (EVV) system.
Direct service providers must verify delivery of the service using the vendor’s system at the beginning and end of each home health service encounter.
Providers must submit claims through AHCA’s designated vendor’s system to the Florida Medicaid fiscal agent for services rendered and verified in accordance with the prior authorization in the Florida Medicaid Management Information System.

(4) Providers that fail to comply with the Home Health Electronic Visit Verification Program are subject to potential denial or non-payment of claims, sanctions, fines, and suspension or termination from the Florida Medicaid program, in accordance with Rule 59G-9.070, F.A.C.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.9132 FS. History–New 2-22-17.

Fla. Admin. Code R. 59G-4.140 Hospice Services

(1) This rule applies to all providers rendering Florida Medicaid hospice services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Hospice Services Coverage Policy, December 2021, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-13873.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.906, 409.908, 409.973 FS. History–New 1-1-87, Amended 10-9-90, 5-13-92, 10-8-92 Formerly 10C-7.0533, Amended 2-14-95, 12-27-95, 9-21-99, 8-4-04, 10-2-05, 8-27-06, 12-24-07, 6-2-16, 12-5-21, 5-31-26.

Fla. Admin. Code R. 59G-4.150 Inpatient Hospital Services

(1) This rule applies to all providers rendering Florida Medicaid inpatient hospital services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Inpatient Hospital Services Coverage Policy, March 2025, incorporated by reference.The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-17935.

(3) The United States Department of Health and Human Services’ Consent for Sterilization Form – HHS-687 (07/25), is incorporated by reference, http://www.flrules.org/Gateway/reference.asp?No=Ref-16383, and available at https://opa.hhs.gov/grant-programs/title-x-service-grants/key-resources-title-x-grantees.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 1-1-77, Amended 3-30-78, 1-2-79, 2-3-81, 7-28-81, 7-1-83, 3-1-84, 10-31-85, Formerly 10C-7.39, Amended 10-2-86, 2-28-89, 10-17-89, 10-14-90, 5-21-91, 11-14-91, 3-25-92, 5-13-92, 7-12-92, 8-9-93, 12-21-93, Formerly 10C-7.039, Amended 6-13-94, 12-27-94, 2-21-95, 9-11-95, 11-12-95, 2-20-96, 6-9-96, 5-12-99, 1-1-01, 2-25-09, 7-11-16, 4-3-24, 5-25-25.

Fla. Admin. Code R. 59G-4.160 Outpatient Hospital Services

(1) This rule applies to all providers rendering Florida Medicaid outpatient hospital services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Outpatient Hospital Services Coverage Policy, August 2019, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-10811.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 1-1-77, Revised 12-7-78, 1-18-82, Amended 7-1-83, 7-16-84, 7-1-85, 10-31-85, Formerly 10C-7.40, Amended 9-16-86, 2-28-89, 5-21-91, 5-13-92, 7-12-92, 1-5-93, 6-30-93, 7-20-93, 12-21-93, Formerly 10C-7.040, Amended 6-13-94, 12-27-94, 2-21-95, 9-11-95, 11-12-95, 2-20-96, 10-27-98, 5-12-99, 10-18-99, 3-22-01, 8-12-01, 2-25-03, 8-14-03, 11-28-04, 8-18-05, 1-10-06, 4-16-06, 2-25-09, 6-25-12, 7-11-16, 9-8-19.

Fla. Admin. Code R. 59G-4.165 Inpatient Mental Health and Tuberculosis Hospital Services

History

Rulemaking Authority 409.919 FS. Law Implemented 409.905(5), 409.906(18), 409.908, 409.913(5)(e), (8)(h) FS. History–New 1-1-77, Amended 10-1-77, 3-10-83, Formerly 10C-7.46, Amended 5-26-93, Formerly 10C-7.046, Repealed 7-2-06.

Fla. Admin. Code R. 59G-4.170 Intermediate Care Facility for Individuals with Intellectual Disabilities Services

(1) This rule applies to all providers rendering Florida Medicaid intermediate care facility for individuals with intellectual disabilities services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Intermediate Care Facility for Individuals with Intellectual Disabilities Services Coverage Policy, January 2023, incorporated by reference. The policy is available on the Agency for Health Care Administration’s (AHCA) website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-14986.

(3) The Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID) Utilization Review (UR) Plan, AHCA Form 5000-3009, July 2016, is incorporated by reference. The plan is available on the AHCA website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-07011.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906, 409.908, 409.913 FS. History–New 8-31-76, Amended 1-1-77, 10-16-77, 7-7-81, 4-12-83, 1-12-84, 7-2-84, 7-1-85, Formerly 10C-7.49, Amended 7-19-88, 6-4-92, 5-11-93, Formerly 10C-7.049, Amended 11-27-95, 10-4-01, 1-23-05, 7-11-16, 1-11-23, 3-12-26.

Fla. Admin. Code R. 59G-4.171 Intermediate Care Facilities for the Mentally Retarded/Developmentally Disabled; Recipient Eligibility Criteria

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906(13), 409.908, 409.913(5)(e) FS. History–New 1-1-77, Amended 3-10-83, Formerly 10C-7.34, Amended 12-28-93, Formerly 10C-7.034, Repealed 7-11-16.

Fla. Admin. Code R. 59G-4.180 Intermediate Care Services

(1) Purpose. This rule establishes the level of care criteria that must be met in order for nursing and rehabilitation services to qualify as intermediate care services and clarifies the criteria that must be met in order for such services to qualify as an intermediate level I or intermediate level II service under Medicaid.

(2) Definitions as used in this section.

(a) Intermediate care nursing home resident. A Medicaid nursing home applicant or recipient who requires intermediate care services including 24-hour observation and care and the constant availability of medical and nursing treatment and care, but not to the degree of care and treatment provided in a hospital or that which meets the criteria for skilled nursing services.

(b) Rehabilitation services. Individualized activities or exercises prescribed by health care professionals that are designed to restore the recipient to self-sufficiency or to maintain the recipient at the highest attainable functional level.

(c) Routine. The administration of medications, treatments, or services in accordance with an established or predetermined schedule and performed for individuals whose medical needs are stabilized or chronic.

(3) Intermediate Services criteria.

(a) To be classified as requiring Intermediate Care Services, Level I or Level II in the community or in a nursing facility, the applicant or recipient must require the type of medical, nursing or rehabilitation services specified in this subsection.

(b) Intermediate Care Services. To be classified as intermediate care services, the nursing or rehabilitation service must be:

Ordered by and remain under the supervision of a physician;
Medically necessary and provided to an applicant or recipient whose health status and medical needs are of sufficient seriousness as to require nursing management, periodic assessment, planning or intervention by licensed nursing or other health professionals;
Required to be performed under the supervision of licensed nursing or other health professionals;
Necessary to achieve the medically desired results and to ensure the comfort and safety of the applicant or recipient;
Required on a daily or intermittent basis;
Reasonable and necessary to the treatment of a specific documented medical disorder, disease or impairment; and,
Consistent with the nature and severity of the individual’s condition or the disease state or stage.

(c) When determining whether intermediate care services are required, consideration shall be given to the nature of the services prescribed and to which level of nursing or other health care personnel meets the qualifications necessary to provide such services, the availability and accessibility of community or alternative resources, and how the recipient’s, applicant’s or resident’s needs can be most effectively and efficiently met.

(d) The amount of care required shall not be a primary factor in determining whether or not an applicant or resident requires intermediate care services.

(e) To qualify for placement in a nursing facility, the applicant or recipient must require intermediate care services including 24 hour observation and care and the constant availability of medical and nursing treatment and care, but not to the degree of care and services provided in a hospital or that meets the criteria for skilled services.

(4) Intermediate Care Services Level I.

(a) Intermediate Care Service Level I is extensive health related care and service required by an individual who is incapacitated mentally or physically.

(b) Examples of services that qualify as Intermediate Care Services Level I:

Administration of routine or stabilized dosages of oral medication, eye drops or ointments;
Routine administration of intramuscular or subcutaneous medication and observation of the individual’s response and side effects;
Administration and adjustment of medication for pain and the monitoring of results and side effects;
Routine administration of insulin to a diabetic resident whose condition is stable, but who is unable to self-administer due to physical, mental or medical reasons;
Routine oral suctioning;
Tracheostomy care when the individual’s condition is stable, but the individual is unable to care for the tracheostomy due to physical, mental or medical reasons;
Routine intermittent positive pressure breathing (IPPB) therapy after a regimen of therapy has been established or therapy is performed by the resident with nursing supervision;
Routine care of stoma and surrounding skin in the presence of colostomy, gastrostomy or ileostomy, excluding the initial period of training, teaching or intensive care, and special problems, for example, bleeding, severe diarrhea, or stricture;
Routine care of a supra-pubic catheter, excluding special care in cases of hemorrhage, frequent obstruction, frequent changes;
Routine services to maintain satisfactory functioning of indwelling bladder catheters, including routine insertion of catheter and, excluding special care in cases of infection, hemorrhage, frequent obstruction, frequent changes of the catheter, irrigations more than two times daily, or the use of special medications for irrigation and instillation;
Changes of dressings, sterile or aseptic, for noninfected postoperative or chronic conditions;
Prophylactic and palliative skin care, including bathing and application of creams, or treatment of minor and noninfected skin problems;
Routine care of the incontinent resident, including the use of diapers and protective sheets;
General maintenance care in connection with a plaster cast;
Routine care in connection with temporary casts, splints, braces or similar devices, excluding observing for circulatory or skin changes in unstable cases;
Decubitus care involving superficial, noninfected lesions and preventive measures when a resident is susceptible to decubitic formation;
Bowel and bladder control training and maintenance after a successful program has been established;
Care of a resident with an amputation or a fracture requiring routine care of a stabilized condition and reinforcement of an established rehabilitation plan;
Use of heat as a palliative and comfort measure, such as whirlpool and hydrocollator, including the use of special baths with whirl-type action when not required to be performed by a physical therapist or licensed nurse;
Routine administration of medical gases after a regimen of therapy has been established by a physician and is administered by the resident;
Assistance or supervision in dressing, eating and toileting;
Periodic positioning or repositioning;
General supervision of exercises which have been taught to the resident, including the carrying out of a maintenance program, for example, the performance of repetitive exercises required to maintain functions in paralyzed extremities, assisted walking, and similar procedures;
Administration of oxygen on an emergency or short-term basis;
Rehabilitative restorative care, passive range of motion (ROM) exercise;
Routine use of physical restraints or protective devices; and,
Routine dietary management.

(c) Intermediate Care Services Level II is limited health related care and services required by an individual who is mildly incapacitated or ill to a degree to require medical supervision. Individuals requiring this level of care shall:

Be ambulatory, with or without assistive devices,
Demonstrate independence in activities of daily living, and,
Not require the administration of psychotropic drugs on a daily or intermittent basis or exhibit periods of disruptive or disorganized behavior requiring 24-hour nursing supervision.

(d) Examples of services, in addition to medical supervision, that qualify as intermediate care Level II:

Administration of routine oral medication;
Assistance with mobilization, helping a resident maintain balance when transferring from bed to chair and providing necessary help when climbing steps or manipulating wheelchair in difficult places;
Assistance with bathing, that is, assembling towels, soap, and other necessary supplies, helping the recipient in and out of the bathtub or shower, turning the water on and off, adjusting water temperature, washing and drying portions of the body which are difficult for the recipient to reach and being available while the recipient is bathing himself;
Assistance with dressing, that is, helping the recipient to choose and to put on appropriate clean clothing, and fastening hooks, buttons, zippers and ties;
Assistance with meals, that is, helping with cutting up food and pouring beverages;
Assistance with grooming, that is, helping the recipient to shave, wash, comb and curl hair, and to clean and file fingernails and toenails. Fingernails or toenails should not be cut by the recipient unless approved by the physician;
Provision of social and leisure services which are arranged for and individually designed to reduce isolation and withdrawal and to enhance communication and social skills;
Self-administration of medical gases, oral medications, subcutaneous medication after a regimen of therapy has been established and self-administration approved by the physician;
Ongoing medical and social evaluations to determine the point when a recipient’s progress has reached the stage at which medical and related needs can be met appropriately outside of the nursing facility or through alternative placement or services;
Application of dressings and treatments prescribed by the physician for small or superficial areas requiring a dressing;
Application of elastic stockings, when prescribed, if the recipient cannot manage independently;
Administration of oxygen or intermittent positive pressure breathing when prescribed by the physician and performed by the recipient;
Assistance with colostomy care, that is, helping the recipient care for permanent colostomy which the recipient ordinarily cares for;
Routine measurement and recording of vital signs and weights, including being alert to symptoms and readings corresponding to abnormal conditions of the residents;
Routine restorative and rehabilitation procedures, that is, the encouragement and incorporation of range of motion exercises in the daily activities schedule.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.905(2), (4), (8), 409.906(14) FS. History–New 1-1-77, Formerly 10C-7.33, Amended 12-2-86, Formerly 10C-7.033, Amended 2-28-95.

Fla. Admin. Code R. 59G-4.190 Laboratory Services

(1) This rule applies to all providers rendering Florida Medicaid laboratory services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Laboratory Services Coverage Policy, June 2025, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-18126.

History

Rulemaking Authority 409.919, 409.961 F.S. Law Implemented 383.145, 409.905, 409.906, 409.907, 409.908, 409.912, 409.913, 409.973, 409.9745 F.S. History–New 1-1-77, Amended 10-11-81, Formerly 10C-7.41, Amended 6-30-92, Formerly 10C-7.041, Amended 9-28-94, 1-9-96, 10-20-96, 9-14-97, 3-22-00, 5-16-01, 2-14-02, 8-25-03, 9-3-03, 10-27-03, 8-18-05, 5-7-07, 6-29-16, 4-3-24, 8-18-25.

Fla. Admin. Code R. 59G-4.192 Statewide Medicaid Managed Care Long-term Care Program

(1) This rule applies to all providers rendering Florida Medicaid Statewide Medicaid Managed Care Long-term Care Program services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Statewide Medicaid Managed Care Long-term Care Program Coverage Policy, March 2017, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at https://www.flrules.org/Gateway/reference.asp?No=Ref-07927.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.978, 409.979 FS. History–New 4-23-17.

Fla. Admin. Code R. 59G-4.193 Statewide Medicaid Managed Care Long-term Care Waiver Program Prioritization and Enrollment

(1) This rule applies to individuals living in their home, or a community setting, who are seeking Florida Medicaid coverage for home and community-based services (HCBS) through the Florida Medicaid Statewide Medicaid Managed Care Long-term Care (LTC) program.

(2) Definitions. The following definitions are applicable to this policy.

(a) Aging Out – When an individual who is enrolled in the Department of Children and Families’ (DCF) Community Care for Disabled Adults or Home Care for Disabled Adults program reaches the maximum age for the program and is referred for screening and prioritization for the LTC program.

(b) Authorized Representative – As defined in Section 409.962, Florida Statutes (F.S.).

(c) Enrollment – When the Agency for Health Care Administration (AHCA) places a recipient in a Florida Medicaid managed care plan.

(d) High Priority Rank –Number indicating an individual’s assessed need for LTC services and placement on the wait list, based on priority ranks of 3 and above in accordance with paragraph (3)(b) of this rule.

(e) Imminent Risk – When individuals living in their home or a community setting meet all of the following:

Unable to perform self-care because of deteriorating mental or physical health condition(s).
There is no capable caregiver.
Placement in a nursing facility is likely within a month, or very likely within three months.

(f) Low Priority Rank – Number indicating an individual’s assessed need for LTC services, based on priority ranks of 1 or 2.

(g) Priority Rank – Automatically generated number indicating an individual’s assessed need for LTC services and to determine placement on the wait list, based on the priority score.

(h) Priority Score – Automatically generated number based on a Department of Elder Affairs’ (DOEA) screening completed in accordance with Rule 58A-1.010, Florida Administrative Code (F.A.C.).

(i) Rescreening – As defined in Section 409.962, F.S.

(j) Screening – As defined in Section 409.962, F.S.

(k) Significant Change – As defined in Section 409.962, F.S.

(l) Wait List – A list maintained by DOEA of individuals who have been screened and assigned a high priority rank by an Aging and Disability Resource Center (ADRC).

(3) Process.

(a) The Department of Elder Affairs will prioritize individuals determined eligible for the LTC program pursuant to Section 409.979, F.S., in accordance with the priority score determined using the DOEA Priority Score Calculation (November 2014) methodology, incorporated by reference and available at http://elderaffairs.state.fl.us/doea/SMMCLTC/2014_Priority_Score_Calculation.pdf and at http://www.flrules.org/Gateway/reference.asp?No=Ref-07525.

(b) Priority scores are grouped into low and high priority score ranges and frailty-based levels or categories (referred to as “ranks”) as follows:

Low Priority Score

a. Rank 1: 0-15.

b. Rank 2: 16-29.

High Priority Score

a. Rank 3: 30-39.

b. Rank 4: 40-45.

c. Rank 5: Greater than or equal to 46.

d. Rank 6: Aging Out Referral.

e. Rank 7: Imminent Risk.

f. Rank 8: Adult Protective Services High Risk Referral.

(d) When the screening process is complete, DOEA will provide the individual, or their authorized representative, written notification of all of the following:

The individual’s priority rank.
Contact information for the ADRCs.
Instructions for requesting an administrative fair hearing in accordance with Title 42, Code of Federal Regulations (CFR), Section 431, Subpart E, Section 409.285, F.S., and Rule 65-2.042, F.A.C.
Instructions for requesting a copy of the completed screening tool, which includes the priority score.
Instructions for requesting a rescreening. The individual, or their authorized representative, may request a rescreening due to a significant change.
For individuals with a high priority rank, notification of wait list placement.
For individuals with a low priority rank, notification of ineligibility for wait list placement and information on how to find community resources available to assist them.

(e) The ADRCs will administer rescreening as follows:

For individuals with a low priority rank, the ADRCs may administer rescreening upon request annually or will administer rescreening upon notification of a significant change in an individual’s circumstances.
For individuals with a high priority rank, the ADRCs will administer rescreening annually or upon notification of a significant change in an individual’s circumstances.

(f) If DOEA is unable to contact the individual, or their authorized representative, to schedule an initial screening or rescreening; or if the individual does not keep an appointment for a screening or rescreening, DOEA will send written correspondence to the individual’s, or to their authorized representative’s, last documented address:

Requesting the individual, or their authorized representative, contact DOEA within 30 calendar days of the date of the notice.
Notifying the individual, or their authorized representative, that the individual may be removed from the initial screening process or wait list if no contact is made.
Providing instructions for re-initiating the screening process, requesting a rescreening, and contacting the ADRCs.

(g) The Department of Elder Affairs will maintain the last documented contact information for each individual with a low priority rank for purposes of any future rescreening.

(h) For individuals released from the wait list, the Department of Elder Affairs will send written notice to the individual’s, or to their authorized representative’s, last documented address about submission requirements for a completed and signed Medical Certification for Medicaid Long-term Care Services and Patient Transfer Form, AHCA MedServ Form 5000-3008, June 2016, incorporated by reference in Rule 59G-1.045, F.A.C. The individual, or their authorized representative, must return the completed form to DOEA within 30 calendar days of the date of the notice.

(i) The Department of Elder Affairs will contact the individual, or their authorized representative, to determine clinical eligibility for the LTC program in accordance with Rule 58A-1.010, F.A.C.

(j) The Agency for Health Care Administration will enroll individuals who have been released from the waitlist and meet the eligibility criteria specified in Section 409.979, F.S., in the LTC program.

(4) Individuals may bypass the screening and wait list process to enroll in the LTC program in accordance with Section 409.979, F.S.

(5) Exclusion. This rule is not applicable to Institutional Care Program (ICP) applicants or ICP recipients residing in nursing facilities.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409. 978, 409.979 FS. History–New 12-8-16, Amended 7-20-21, 3-12-26.

Fla. Admin. Code R. 59G-4.195 Licensed Midwife Services

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906, 409.908, 409.9081 FS. History–New 6-29-93, Formerly 10C-7.0520, Amended 3-10-96, 3-11-98, 10-13-98, Repealed 8-28-14.

Fla. Admin. Code R. 59G-4.197 Medical Foster Care Services

(1) This rule applies to all providers rendering Florida Medicaid medical foster care services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Medical Foster Care Services Coverage Policy, December 2019, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-11402.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.903, 409.905, 409.908, 409.912, 409.913, 409.973 FS. History–New 2-22-00, Amended 3-6-01, 3-1-04, 8-15-07, 12-18-17, 1-16-20.

Fla. Admin. Code R. 59G-4.199 Mental Health Targeted Case Management Services

(1) This rule applies to all mental health targeted case management providers enrolled in the Medicaid Mental Health Targeted Case Management Program.

(2) All Medicaid-enrolled mental health targeted case management providers must be in compliance with the Florida Medicaid Mental Health Targeted Case Management Coverage and Limitations Handbook, July 2006, updated June 2007, incorporated by reference, and the Florida Medicaid Provider Reimbursement Handbook, Non-Institutional 081, which is incorporated by reference in Rule 59G-13.001, F.A.C. Both handbooks are available from the Medicaid fiscal agent’s website at http://floridamedicaid.acs-inc.com. Click on Provider Support, and then on Handbooks. Paper copies of the handbooks may be obtained by calling the Medicaid fiscal agent at 1(800)377-8216.

(3) The following forms that are included in the Florida Medicaid Mental Health Targeted Case Management Coverage and Limitations Handbook are incorporated by reference: Agency Certification, Children’s Mental Health Targeted Case Management, AHCA-Med Serv Form 022, June 2007, in Appendix B, one page; Agency Certification, Adult Mental Health Targeted Case Management, AHCA-Med Serv Form 023, June 2007, in Appendix C, one page; Agency Certification, Intensive Case Management Team Services, Adult Mental Health Targeted Case Management, AHCA-Med Serv Form 024, June 2007, in Appendix D, one page; Case Management Supervisor Certification, Children’s Mental Health Targeted Case Management, AHCA-Med Serv Form 025, July 2006, in Appendix E, one page; Case Management Supervisor Certification, Adult Mental Health Targeted Case Management, AHCA-Med Serv Form 026, July 2006, in Appendix F, one page; Case Manager Certification, Children’s Mental Health Targeted Case Management, AHCA-Med Serv Form 027, July 2006, in Appendix G, one page; Case Manager Certification, Adult Mental Health Targeted Case Management, AHCA-Med Serv Form 028, July 2006, in Appendix H, one page; Children’s Certification, Children’s Mental Health Targeted Case Management, AHCA-Med Serv Form 029, July 2006, in Appendix I, one page; Adult Certification, Adult Mental Health Targeted Case Management, AHCA-Med Serv Form 030, July 2006, in Appendix J, one page; Adult Certification, Intensive Case Management Team Services, Adult Mental Health Targeted Case Management, AHCA-Med Serv Form 031, July 2006, in Appendix K, two pages; Medicaid 30-Day Certification for Children’s or Adult Mental Health Targeted Case Management, AHCA-Med Serv Form 032, June 2007, in Appendix L, one page. The forms are available by photocopying them from the Florida Medicaid Mental Health Targeted Case Management Coverage and Limitations Handbook.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906, 409.907, 409.908 FS. History–New 6-21-06, Amended 1-2-08.

Fla. Admin. Code R. 59G-4.200 Nursing Facility Services

(1) This rule applies to any person or entity prescribing or reviewing a request for nursing facility services and to all providers of nursing facility services who are enrolled in or registered with the Florida Medicaid program.

(2) All providers of nursing facility services must be in compliance with the provisions of the Florida Medicaid Nursing Facility Services Coverage Policy, May 2016, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-06634.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.908, 409.912, 409.913, 409.973 FS. History–New 1-1-77, Amended 6-13-77, 10-1-77, 1-1-78, 2-1-78, 12-28-78, 2-14-80, 4-5-83, 1-1-84, 8-29-84, 9-1-84, 9-5-84, 7-1-85, Formerly 10C-7.48, Amended 8-19-86, 6-1-89, 7-2-90, 6-4-92, 8-5-92, 11-2-92, 7-20-93, Formerly 10C-7.048, Amended 11-28-95, 5-9-99, 10-15-00, 10-4-01, 2-10-04, 9-28-04, 8-31-05, 7-23-06, 5-3-16.

Fla. Admin. Code R. 59G-4.201 Neurology Services

(1) This rule applies to all providers rendering Florida Medicaid neurology services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Neurology Services Coverage Policy, October 2018, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-09873.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 6-29-16, Amended 10-15-18.

Fla. Admin. Code R. 59G-4.205 Practitioner Services

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.905, 409.906, 409.907, 409.908, 409.9081, 409.912, 409.913 FS. History–New 6-11-13, Amended 4-1-14, Repealed 7-11-16.

Fla. Admin. Code R. 59G-4.207 Oral and Maxillofacial Surgery Services

(1) This rule applies to any person or entity prescribing or reviewing a request for oral and maxillofacial surgery services and to all providers of oral and maxillofacial surgery services who are enrolled in or registered with the Florida Medicaid program.

(2) All providers of oral and maxillofacial surgery services must be in compliance with the provisions of the Florida Medicaid Oral and Maxillofacial Surgery Services Coverage Policy, May 2016, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-06594.

History

Rulemaking Authority 409.919, 490.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 5-3-16.

Fla. Admin. Code R. 59G-4.210 Visual Care Services

(1) This rule applies to any person or entity prescribing or reviewing a request for visual care services and to all providers of visual care services who are enrolled in or registered with the Florida Medicaid program.

(2) All persons or entities described in subsection (1), must be in compliance with the provisions of the Florida Medicaid Visual Care Services Coverage Policy, June 2016, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-06752.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.9081, 409.912, 409.913, 409.973 FS. History–New 4-13-93, Amended 7-1-93, Formerly 10C-7.069, Amended 12-21-97, 10-13-98, 5-24-99, 4-23-00, 7-5-01, 2-20-03, 8-5-03, 5-24-05, 8-18-05, 5-22-06, 4-4-07, 5-1-14, 6-29-16.

Fla. Admin. Code R. 59G-4.211 Orthopedic Services

(1) This rule applies to any person or entity prescribing or reviewing a request for orthopedic services and to all providers of orthopedic services who are enrolled in or registered with the Florida Medicaid program.

(2) All persons or entities described in subsection (1), must be in compliance with the provisions of the Florida Medicaid Orthopedic Services Coverage Policy, June 2016, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-06788.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 6-29-16.

Fla. Admin. Code R. 59G-4.215 Personal Care Services

(1) This rule applies to all providers rendering Florida Medicaid personal care services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Personal Care Services Coverage Policy, October 2024, incorporated by reference. The policy is available on the Agency for Health Care Administration’s (AHCA) website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-17129.

(a) Parent or Legal Guardian Medical Limitations, AHCA Form 5000-3501, November 2016, http://www.flrules.org/Gateway/reference.asp?No=Ref-07496.

(b) Parent or Legal Guardian Work Schedule, AHCA Form 5000-3503, November 2016, http://www.flrules.org/Gateway/reference.asp?No=Ref-07497.

(c) Parent or Legal Guardian Statement of Work Schedule, AHCA Form 5000-3504, November 2016, https://www.flrules.org/Gateway/reference.asp?No=Ref-07498.

(d) Parent or Legal Guardian School Schedule, AHCA Form 5000-3505, November 2016, http://www.flrules.org/Gateway/reference.asp?No=Ref-07499.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 400.4765, 409.902, 409.905, 409.907, 409.908, 409.9081, 409.912, 409.913, 409.973 FS. History–New 11-17-16, Amended 12-22-24.

Fla. Admin. Code R. 59G-4.220 Podiatry Services

(1) This rule applies to any person or entity prescribing or reviewing a request for podiatry services and to all providers of podiatry services who are enrolled in or registered with the Florida Medicaid program.

(2) All persons or entities described in subsection (1), must be in compliance with the provisions of the Florida Medicaid Podiatry Services Coverage Policy, June 2016, incorporated by reference. The policy is available from the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-06779.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 1-23-84, Amended 10-25-84, Formerly 10C-7.529, Amended 4-21-92, 11-9-92, 7-1-93, Formerly 10C-7.0529, 10P-4.220, Amended 1-7-96, 3-11-98, 10-13-98, 5-24-99, 4-23-00, 7-5-01, 2-20-03, 8-5-03, 8-18-05, 4-13-10, 6-29-16.

Fla. Admin. Code R. 59G-4.222 Pain Management Services

(1) This rule applies to any person or entity prescribing or reviewing a request for pain management services and to all providers of pain management services who are enrolled in or registered with the Florida Medicaid program.

(2) All persons or entities described in subsection (1), must be in compliance with the provisions of the Florida Medicaid Pain Management Services Coverage Policy, June 2016, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-06777.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 6-29-16.

Fla. Admin. Code R. 59G-4.230 Physician Services

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.9081, 409.912, 409.913 FS. History–New 1-1-77, Revised 2-1-78, 4-1-78, 1-2-79, 1-1-80, Amended 2-8-82, 3-11-84, Formerly 10C-7.38, Amended 1-10-91, 11-5-92, 1-7-93, Formerly 10C-7.038, Amended 6-29-93, 9-6-93, Formerly 10P-4.230, Amended 6-13-94, 2-9-95, 3-10-96, 5-28-96, 3-18-98, 9-22-98, 8-25-99, 4-23-00, 8-5-01, 2-20-03, 8-5-03, 8-3-04, 8-18-05, 8-31-05, 10-26-06, 2-11-07, 5-7-07, 7-2-07, 11-15-07, 10-21-10, Repealed 10-27-13.

Fla. Admin. Code R. 59G-4.231 Physician Assistant Services

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906, 409.907, 409.908, 409.9081 FS. History–New 8-21-95, Amended 5-28-96, 3-11-98, 10-13-98, 8-9-99, 4-23-00, 8-5-01, 2-20-03, 8-5-03, 8-3-04, 8-18-05, Repealed 10-27-13.

Fla. Admin. Code R. 59G-4.235 Respiratory System Services

(1) This rule applies to any person or entity prescribing or reviewing a request for respiratory system services and to all providers of respiratory system services who are enrolled in or registered with the Florida Medicaid program.

(2) All persons or entities described in subsection (1), must be in compliance with the provisions of the Florida Medicaid Respiratory System Services Coverage Policy, June 2016, incorporated by reference. The policy is available from the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-06792.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 6-29-16.

Fla. Admin. Code R. 59G-4.240 Radiology and Nuclear Medicine Services

(1) This rule applies to all providers rendering Florida Medicaid radiology and nuclear medicine services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Radiology and Nuclear Medicine Services Coverage Policy, May 2019, incorporated by reference. The policy is available on the Agency for Health Care Administration website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-10372.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.908, 409.912, 409.913, 409.973 FS. History–New 10-11-81, Formerly 10C-7.411, Amended 7-1-92, Formerly 10C-7.0411, Amended 5-16-94, 1-9-96, 10-20-96, 8-27-97, 3-22-00, 2-14-02, 6-1-03, 8-5-03, 3-15-04, 8-18-05, 6-29-16, 5-27-19.

Fla. Admin. Code R. 59G-4.250 Prescribed Drug Services

(1) This rule applies to all providers rendering Florida Medicaid prescribed drug services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Prescribed Drug Services Coverage Policy, December 2017, incorporated by reference. The policy available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at https://www.flrules.org/Gateway/reference.asp?No=Ref-08824.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 1-1-77, Amended 6-30-77, 10-1-77, 2-1-78, 4-1-78, 9-28-78, 6-1-79, 2-28-80, 11-11-81, 7-3-84, Formerly 10C-7.42, Amended 3-11-86, 12-5-88, 6-4-90, 10-29-90, 5-20-92, 4-11-93, Formerly 10C-7.042, Amended 12-28-95, 8-3-97, 2-11-98, 9-13-99, 7-20-00, 1-29-01, 4-24-01, 10-6-02, 12-7-06, 11-3-08, 6-19-12, 7-2-14, 12-24-17.

Fla. Admin. Code R. 59G-4.251 Prescribed Drugs Reimbursement Methodology

(1) This rule applies to all prescribed drug service providers enrolled in the Florida Medicaid program that provide services under the fee-for-service delivery system in accordance with Rule 59G-4.250, Florida Administrative Code (F.A.C.).

(2) Definitions.

(a) Actual Acquisition Cost for Prescribed Drugs – (AAC) – The National Average Drug Acquisition Cost (NADAC) will be used for the AAC, when available. If the NADAC is unavailable, the AAC will be equal to the wholesaler acquisition cost.

(b) Average Sales Price – (ASP) – The average sales price as reported by prescribed drug manufacturers to the Centers for Medicare and Medicaid Services (CMS).

(c) State Maximum Allowable Cost – (SMAC) – The maximum allowable unit cost established by the state; SMAC may be manually set.

(d) Usual and Customary Charge ‒ (U&C Charge) ‒ The average charge to all other customers in any quarter for the same drug, quantity, and strength.

(e) Wholesaler Acquisition Cost ‒ (WAC) – The cost wholesalers pay for a prescribed drug.

(3) Reimbursement Methodology.

(a) Florida Medicaid reimburses for drugs dispensed by an approved Florida Medicaid pharmacy provider, or a provider enrolled as a dispensing practitioner, in an amount not to exceed the lesser of:

The AAC plus a professional dispensing fee (PDF) of $10.24.
The WAC plus a PDF of $10.24.
The SMAC plus a PDF of $10.24.
The provider’s U&C Charge.

(b) The above reimbursement methodology applies to all of the following:

Covered outpatient drugs dispensed by a retail community pharmacy.
Specialty drugs dispensed primarily through the mail.
Drugs not purchased pursuant to the 340B program by a covered entity, as defined in section 340B(a)(4) of the federal Public Health Service Act.
Drugs dispensed in an institutional or long-term care pharmacy, when not included as part of the floor stock contained in the institution’s cost report.

(4) Florida Medicaid utilizes the actual purchased drug price plus a PDF in the reimbursement methodology for drugs acquired via the Federal Supply Schedule.

(5) Florida Medicaid utilizes the actual purchased drug price plus a PDF in the reimbursement methodology for drugs acquired via nominal price.

(6) Florida Medicaid reimburses for drugs purchased under the 340B program at the actual purchased drug price, which cannot exceed the 340B ceiling price, plus a dispensing fee of $10.24.

(7) Florida Medicaid reimburses for clotting factor to the vendor(s) awarded the state’s hemophilia contract(s) at the negotiated price.

(8) Florida Medicaid reimburses for prescribed drugs administered by a licensed practitioner in an office setting at 106 percent of ASP, as provided by CMS quarterly in the format of drug pricing files, available at https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files; or, when no ASP rate is available, at WAC.

(9) Florida Medicaid reimburses for prescribed drugs purchased under the 340B program administered in an outpatient facility at an amount not to exceed the 340B ceiling price.

(10) Florida Medicaid does not reimburse for investigational or experimental drugs.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906, 409.908, 409.912 FS. History–New 1-28-09, Amended 8-23-09, 5-20-12, 6-2-16, 3-29-18, 12-20-21, 7-15-26.

Fla. Admin. Code R. 59G-4.252 Diabetic Supply Services

(1) This rule applies to all providers rendering Florida Medicaid diabetic supply services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Diabetic Supply Services Coverage Policy, September 2024, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at https://www.flrules.org/Gateway/reference.asp?No=Ref-16935.

(3) This rule is in effect for five years from its effective date.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.906, 409.9063, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 10-1-24.

Fla. Admin. Code R. 59G-4.255 Prescription Drug Coverage Denials

(1) Medicaid-participating pharmacies shall provide the pamphlet, Important Information About Your Florida Medicaid Prescription Drug Benefits, 10/03/05, or Información Importante A cerca de sus beneficios de medicamentos con receta del Medicaid de la Florida, 11/01/05, which are incorporated by reference, to Medicaid recipients whose prescription drug claims are denied by Medicaid if the pharmacy cannot resolve the denial during that day’s pharmacy visit. The pharmacy must write on the pamphlet the date, the recipient’s name, the drug name, and the reason for the denial or write on the pamphlet the date and recipient’s name and attach a printout of the computer screen stating the drug name and the reason for the denial. The pamphlets are available from the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/Prescribed_Drug/multi_source.shtml.

(2) Medicaid-participating pharmacies shall post two signs, Important Notice to Medicaid Recipients, 5/14/2004, and Aviso Importante a Recipientes de Medicaid, 5/14/2004, which are incorporated by reference, in a conspicuous location that is visible to recipients. The signs inform recipients of a toll-free number that can be called if the prescription is denied and the pharmacy failed to provide the denial information and an Important Information About Your Florida Medicaid Prescription Drug Benefits or Información Importante A cerca de sus beneficios de medicamentos con receta del Medicaid de la Florida pamphlet to the recipient. The signs are available from the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/Prescribed_Drug/multi_source.shtml.

History

Rulemaking Authority 409.902, 409.919 FS. Law Implemented 409.902, 409.906, 409.919 FS. History–New 3-2-06.

Fla. Admin. Code R. 59G-4.260 Prescribed Pediatric Extended Care Services

(1) This rule applies to all providers rendering Florida Medicaid prescribed pediatric extended care (PPEC) services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Prescribed Pediatric Extended Care Services Coverage Policy, February 2018, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-08568.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913 FS. History–New 8-27-91, Amended 4-21-92, 3-9-93, Formerly 10C-7.0471, Amended 2-11-96, 2-22-00, 5-11-04, 4-24-07, 9-4-13, 2-8-18.

Fla. Admin. Code R. 59G-4.261 Private Duty Nursing and Family Home Health Aide Services

(1) This rule applies to all providers rendering Florida Medicaid private duty nursing and family home health aide services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Private Duty Nursing and Family Home Health Aide Services Coverage Policy, February 2026, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://flrules.org/Gateway/reference.asp?No=Ref-19351.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 400.4765, 409.902, 409.905, 409.907, 409.908, 409.9081, 409.912, 409.913, 409.973 FS. History–New 11-17-16, Amended 10-1-24, 7-2-26.

Fla. Admin. Code R. 59G-4.264 Regional Perinatal Intensive Care Center Services

(1) This rule applies to any person or entity prescribing or reviewing a request for obstetrical and neonatal services provided in a regional perinatal intensive care center (RPICC), and to all physicians providing services in a RPICC who are enrolled in the Florida Medicaid program and rendering services in the fee-for-service delivery system.

(2) Definitions.

(a) High-Risk Pregnancy ‒ A pregnancy in which the woman whose medical history and diagnosis indicates, without consideration of a previous cesarean section, that a normal uncomplicated pregnancy and delivery are unlikely to occur.

(b) Recipient ‒ For the purpose of this rule, the term used to describe an individual enrolled in Florida Medicaid.

(3) Who Can Provide.

Physicians who are participants in the Department of Health’s Children’s Medical Services RPICC program and render inpatient hospital obstetrical and neonatal services to recipients in a designated RPICC facility.

(4) Coverage. Florida Medicaid reimburses for the following services performed by a physician in a RPICC facility:

(a) Obstetrical services for recipients with high-risk pregnancies.

(b) Up to 365 days of neonatal services when the recipient meets all of the following:

Is more than 20 weeks gestation.
Requires more than 48 hours of services.
Requires Level III intensive care as specified in Rule 64C-6.003, Florida Administrative Code (F.A.C.).

(5) Documentation. Providers submitting an obstetrical antepartum or postpartum claim, or a neonatal transfer claim, must include a RPICC Entitlement Exception Report, June 2016, incorporated by reference, http://www.flrules.org/Gateway/reference.asp?No=Ref-07022, and completed using the University of Florida’s RPICC Data System at https://esteps.med.ufl.edu/, with each claim.

(6) Reimbursement.

(a) Florida Medicaid reimburses providers in accordance with the Florida Medicaid fee schedule(s) for RPICC services, incorporated by reference in Rule 59G-4.002, F.A.C.

(b) Florida Medicaid apportions reimbursement among providers when a recipient is transferred between RPICC facilities based on the number of days a recipient receives services in each location. Providers must submit claims after the recipient is discharged from the last facility and ensure dates of service on the claim form(s) do not overlap.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913 FS. History–New 7-11-16.

Fla. Admin. Code R. 59G-4.266 Qualified Evaluator Network

(1) Purpose. The Agency for Health Care Administration (AHCA), or its designee, will register qualified evaluators for the purpose of determining that a child in the legal custody of the Department of Children and Families (DCF) is suitable for residential treatment services (as defined in Section 39.407(6)(a), F.S.).

(2) Qualifications:

(a) A licensed psychiatrist or a psychologist meeting all of the following criteria may be registered as a qualified evaluator by AHCA, or its designee:

Be licensed in Florida in accordance with Chapter 458, 459, or 490, F.S.
Have three or more years of clinical experience in the diagnosis and treatment of serious emotional disturbances in children and adolescents.
Have no actual or perceived conflict of interest with any inpatient facility or residential treatment center or program.
Have successfully passed background screening requirements of the Florida Department of Law Enforcement and Federal Bureau of Investigations.

(b) The Agency for Health Care Administration will maintain a list of qualified evaluators who have been registered in each AHCA region on its Florida Medicaid Quality website at http://ahca.myflorida.com/medicaid/Policy_and_Quality/Quality/index.shtml.

(3) Selection Process. Interested applicants can submit a resume and proof of the qualification items in subsection (2) to AHCA, or its designee. Then, DCF can select a qualified evaluator from the list of evaluators maintained by AHCA, to perform a suitability assessment (as described in Section 39.407(6), F.S.). Selection of the qualified evaluator will be made based on the geographic proximity of the qualified evaluator to the child and the availability of the qualified evaluator to perform the assessment.

(4) Fees: The Department of Children and Families, or its designee, will reimburse the qualified evaluator for performance of a suitability assessment in accordance with the following fee schedule or may choose to negotiate a mutually agreed upon rate with the qualified evaluator:

Description:

Cost Per Assessment:

Initial Assessment

$400.00

90-Day Assessment

$560.00

Rescheduling Fee

$120.00

History

Rulemaking Authority 39.407(6)(i) FS. Law Implemented 39.407 FS. History‒New 9-28-15.

Fla. Admin. Code R. 59G-4.270 Registered Nurse First Assistant Services

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902 409.906, 409.908, 409.9081 FS. History–New 3-11-98, Amended 10-13-98, 5-24-99, 4-23-00, 7-5-01, 2-20-03, 8-5-03, 8-4-04, 8-18-05, Repealed 10-27-13.

Fla. Admin. Code R. 59G-4.280 Rural Health Clinic

(1) This rule applies to all rural health clinic (RHC) providers that are enrolled in or registered with the Florida Medicaid program.

(2) All RHC providers must comply with Title 42, Code of Federal Regulations, Parts 440 and 491.

(3) Florida Medicaid reimburses for services provided through the fee-for-service delivery system at one encounter rate per day, per recipient. For rates, see http://ahca.myflorida.com/Medicaid/Finance/finance/institutional/index.shtml.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.905, 409.908, 409.9081 FS. History–New 4-14-80, Amended 12-28-80, Formerly 10C-7.51, Amended 8-11-91, 1-19-93, Formerly 10C-7.051, Amended 6-29-94, 6-10-96, 6-24-98, 12-4-00, 5-31-04, 5-7-07, 6-29-16.

Fla. Admin. Code R. 59G-4.290 Skilled Services

(1) Purpose. This rule establishes the level of care criteria that must be met in order for nursing and rehabilitative services to qualify as skilled services under Medicaid.

(2) Definitions as used in this section.

(a) Continuous. The need for 24-hour care in a skilled nursing facility with professional nursing services available.

(b) Direct supervision. Performance of a procedure in the presence of professional personnel or their presence in the facility during the time in which the procedure is being performed.

(c) Licensed nursing personnel. Registered professional or licensed practical nurses, currently licensed by the State of Florida to practice as a registered nurse or licensed practical nurse respectively.

(d) Professional personnel. Florida licensed or certified physicians, registered nurses, respiratory care practitioners/therapists, audiologists, physical, occupational or speech therapists.

(e) Rehabilitative services. Individualized services prescribed by a health care professional that are designed to restore a recipient to self-sufficiency or to the highest attainable functional level in the shortest possible time following an illness or injury.

(f) Skilled care recipient. A Medicaid applicant or recipient who requires skilled nursing or skilled rehabilitative services.

(3) Skilled Services Criteria.

(a) To be classified as requiring skilled nursing or skilled rehabilitative services in the community or in a nursing facility, the recipient must require the type of medical, nursing or rehabilitative services specified in this subsection.

(b) Skilled Nursing. To be classified as skilled nursing service, the service must meet all of the following conditions:

Ordered by and remain under the supervision of a physician;
Sufficiently medically complex to require supervision, assessment, planning, or intervention by a registered nurse.
Required to be performed by, or under the direct supervision of, a registered nurse or other health care professionals for safe and effective performance;
Required on a daily basis;
Reasonable and necessary to the treatment of a specific documented illness or injury; and,
Consistent with the nature and severity of the individual’s condition or the disease state or stage.

Intravenous medication or fluids.
Intramuscular or subcutaneous injection and hypodermoclysis when:

a. Administered by licensed nursing personnel at least 5 times weekly, excluding daily insulin administration; and,

b. Observation is necessary to assess the recipient’s response to treatment or to identify adverse reactions.

Management and monitoring medication regime on a daily basis:

a. For drugs whose dosage requirements may rapidly change;

b. For drugs prone to cause adverse reactions, severe side effects or unfavorable reactions; and,

c. For residents with unstable conditions.

Levin tube and gastrostomy feedings; excluding feedings performed by residents, family members, or friends.
Administration of medical gases, aerosolized medication or oxygen which is started, monitored and regulated by professional staff.
Naso-pharyngeal and tracheotomy aspiration, excluding tracheotomy care in self-care residents.
Insertion, replacement, and sterile irrigation of catheters when:

a. Medically necessary or required for reasons other than to maintain satisfactory catheter functioning and dryness;

b. The medical need is documented by the physician;

c. Continuous irrigation, frequent insertion, special care or observation is required because of bleeding, infection, obstruction, or heavy sediment formations; and,

d. Care of a recently inserted supra-pubic catheter, inserted within 2-4 weeks, is required.

Colostomy and ileostomy care:

a. When medically necessary and required during early postoperative period;

b. During the period of initial self-care training, or

c. When complications are present and documented in the medical record.

Treatment of decubitus ulcers when:

a. Deep or wide without necrotic center;

b. Deep or wide with layers of necrotic tissue, or

c. Infected and draining.

Treatment of widespread infected or draining skin disorders.
Application of dressings involving prescription medication and aseptic techniques when documented as required on a daily basis. Excludes simple dressings involving non-infected cases, simple skin breaks, and healed postoperative incisions.
Heat treatments prescribed by a physician as daily treatment for a specific condition.
Rehabilitation nursing procedures required on a daily basis as necessary to restore functioning, including teaching and adaptive aspects of nursing.

(4) Skilled Rehabilitative Services. To be classified as skilled rehabilitative services, the services must meet all of the following conditions:

(a) Ordered by and remain under the supervision of a physician;

(b) Reasonable and necessary to the treatment of a recent or presently existing illness or injury;

(d) Required at least 5 days a week; and,

(e) Reviewed and reevaluated at least every 30 days by the physician and the physical, occupational therapist or respiratory care practitioner/therapist.

(5) Examples of services that qualify as skilled rehabilitation services:

(a) Daily services of a speech pathologist or audiologist when necessary for the restoration of function in speech or hearing.

(b) Ongoing assessment of rehabilitation potential and needs in accordance with Rule 59G-4.320, F.A.C.

Such services must be provided as an integral part of the management of the care plan; and,
Must include results of tests and measurements of range of motion, strength, balance, coordination, endurance, functional ability, physical capacities, perceptual deficits, speech and language or hearing disorders.

(c) Therapeutic exercise or activities that, because of the type of exercise employed or the condition of the recipient, must be performed by or under the supervision of a qualified physical therapist or occupational therapist to ensure the safety of the recipient and the effectiveness of the treatment.

(d) Gait evaluation and training when furnished in accordance with the treatment plan and designed to restore function to a recipient whose ability to walk has been impaired by neurological, muscular or skeletal abnormalities.

(e) Range of motion exercises that are part of the active treatment for a specific disease state which has resulted in a loss of, or restriction of, mobility as evidenced by a therapist’s notes showing the degree of motion lost and the degree to be restored.

(f) Maintenance therapy, when the specialized knowledge, skills, and judgment of a qualified therapist are required to design and implement a maintenance program based on an initial evaluation and periodic assessment of the recipient’s needs, and consistent with the recipient’s capacity and tolerance. For example, a recipient with Parkinson’s disease who has not been under a rehabilitative program may require the services of a qualified therapist to determine the type of exercise that will contribute the most to the maintenance of his present level of functioning.

(g) Ultrasound, short-wave and microwave therapy by a qualified physical therapist.

(h) Hot pack, hydrocollator, infrared treatments, paraffin baths, and whirlpool in cases in which the recipient’s condition is complicated by circulatory deficiency, areas of desensitization, or complications, and the skills, knowledge and judgment of a qualified physical therapist are required.

(i) Chest physiotherapy or augmentary airway clearance techniques, maintain airway patency and lung volume.

(6) Examples of services that qualify as either skilled nursing or skilled rehabilitative services:

(a) Ongoing involvement of registered nurses or other professional personnel in the evaluation of the total needs of a resident and management of the treatment plan.

(b) Continuous observation and monitoring for complications, adverse reactions, or changes in the status of a recipient’s condition when required to identify and evaluate the individual’s need for modification of the treatment plan or institution of a critical medical procedure.

(c) Ongoing teaching and training activities that are required to teach a recipient or caregiver how to manage the treatment regime or perform self care or treatment skills. This service must be ordered by the physician and evidenced by a recent change in the health status of the resident. Skilled teaching and training services must be documented on at least a daily basis in the progress notes.

(7) Medically fragile. To be classified as medically fragile, the applicant or recipient must be:

(a) Age birth through age 20 years old;

(b) Require skilled nursing in a nursing facility; and,

(c) Be technologically dependent on apparatus or procedures to sustain life, or require significantly more intense and continual professional nursing supervision and intervention to sustain life and who, without the provision of such continuous services and observation, is likely to expire.

(8) Services shall be considered skilled in cases in which medically complex condition(s) or medically fragile condition(s) are documented by a physician, or when the instability of the recipient’s condition requires frequent nursing intervention, observation and assessment of the recipient’s status and response to care.

(9) The restorative or recovery potential of the individual shall not be a factor when determining the need for skilled services.

(10) To qualify for placement in a nursing facility, the applicant or recipient must require 24 hour observation and care and the constant availability of medical and nursing treatment and care, but not to the degree of care and services provided in a hospital.

(11) When determining whether nursing facility services are required, consideration shall be given to the individual’s physical and mental condition, excluding individuals with functional psychoses, acute psychiatric illness or individuals requiring or receiving active psychiatric treatment, or who require 24-hour care for diagnostic evaluation and psychiatric treatment.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.905(2), (5), (8), 409.906(11) FS. History–New 1-1-77, Amended 8-29-77, Formerly 10C-7.32, Amended 6-22-86, Formerly 10C-7.032, Amended 2-21-95.

Fla. Admin. Code R. 59G-4.295 Therapeutic Group Care Services

(1) This rule applies to all providers rendering Florida Medicaid therapeutic group care services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Therapeutic Group Care Services Coverage Policy, July 2017, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-08487.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 3-13-14, Amended 8-6-17.

Fla. Admin. Code R. 59G-4.300 State Mental Health Hospital Services

(1) This rule applies to all providers rendering Florida Medicaid state mental health hospital services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid State Mental Health Hospital Services Coverage Policy, January 2018, incorporated by reference. The policy is available on the Agency for Health Care Administration’s Web site at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/refernce.asp?No=Ref-08934.

(3) The Physician Certification State Mental Health Hospital Services Form – AHCA Med Serv Form 034, January 2008, is incorporated by reference, and available at http://ahca.myflorida.com/Medicaid/review/index.shtml, and http://www.flrules.org/Gateway/reference.asp?No=Ref-08935.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906, 409.908 FS. History–New 5-29-06, Amended 6-30-10, 2-8-18.

Fla. Admin. Code R. 59G-4.310 Targeted Case Management for Children at Risk of Abuse and Neglect

(1) This rule applies to all providers of targeted case management for children at risk of abuse and neglect who are enrolled in the Florida Medicaid program.

(2) All providers of targeted case management for children at risk of abuse and neglect must be in compliance with the provisions of the Florida Medicaid Targeted Case Management Services for Children at Risk of Abuse and Neglect Coverage and Limitations Handbook, May 2014, available at http://www.flrules.org/Gateway/reference.asp?No=Ref-03963, incorporated by reference. The handbook is available from the Medicaid fiscal agent’s website at www.mymedicaid-florida.com. Select Public Information for Providers, then Provider Support, and then Provider Handbooks. Paper copies of the handbook may be obtained by calling the Provider Services Contact Center at 1(800)289-7799 and selecting Option 7.

(3) The following forms, included in the Florida Medicaid Targeted Case Management Services for Children at Risk of Abuse and Neglect Coverage and Limitations Handbook, are incorporated by reference: Contractor Certification for Children’s Services Council, AHCA Form 5000-3535, revised May 2014; Case Manager Supervisor Certification, AHCA Form 5000-3536, revised May 2014; Case Manager Certification, AHCA Form 5000-3537, revised May 2014; Child Certification, AHCA Form 5000-3538, revised May 2014; Provider Agency Certification for Children’s Services Council, AHCA Form 5000-3539, May 2014; Certification of Funds, AHCA Form 5000-3532, revised May 2014. These forms are available by photocopying them from the Florida Medicaid Targeted Case Management Services for Children at Risk of Abuse and Neglect Coverage and Limitations Handbook. The handbook is available from the Medicaid fiscal agent.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.9081, 409.912, 409.913 FS. History‒New 5-1-14.

Fla. Admin. Code R. 59G-4.318 Occupational Therapy Services

(1) This rule applies to all providers rendering Florida Medicaid occupational therapy services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Occupational Therapy Services Coverage Policy, October 2016, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at https://www.flrules.org/Gateway/reference.asp?No=Ref-07515.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 11-29-16.

Fla. Admin. Code R. 59G-4.320 Physical Therapy Services

(1) This rule applies to all all providers rendering Florida Medicaid physical therapy services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Physical Therapy Services Coverage Policy, October 2016, incorporated by reference. The policy is available from the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at https://www.flrules.org/Gateway/reference.asp?No=Ref-07516.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 5-24-92, Amended 4-12-93, Formerly 10C-7.068, Amended 5-4-94, 12-26-95, 3-9-99, 12-2-03, 12-3-08, 8-22-13, 11-29-16.

Fla. Admin. Code R. 59G-4.322 Respiratory Therapy Services

(1) This rule applies to all providers rendering Florida Medicaid respiratory therapy services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Respiratory Therapy Services Coverage Policy, August 2018, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-09634.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 11-29-16, 9-24-18.

Fla. Admin. Code R. 59G-4.324 Speech-Language Pathology Services

(1) This rule applies to all providers rendering Florida Medicaid speech-language pathology services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Speech-Language Pathology Services Coverage Policy, October 2016, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-07518.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History–New 11-29-16.

Fla. Admin. Code R. 59G-4.330 Non-Emergency Transportation Services

(1) This rule applies to all providers rendering Florida Medicaid non-emergency transportation services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Non-Emergency Transportation Services Coverage Policy, November 2019, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-11228.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.901, 409.902, 409.905, 409.907, 409.908, 409.9081, 409.912, 409.913, 409.973 FS. History–New 1-1-77, Amended 10-1-77, 1-27-81, 8-28-84, Formerly 10C-7.45, Amended 4-13-93, Formerly 10C-7.045, Amended 1-7-98, 12-18-05, 7-23-06, 10-27-16, 11-19-19.

Fla. Admin. Code R. 59G-4.340 Visual Aid Services

(1) This rule applies to all providers of visual aid services who are enrolled in or registered with the Florida Medicaid program.

(2) All providers of visual aid services must be in compliance with the provisions of the Florida Medicaid Visual Aid Services Coverage Policy, November 2015, incorporated by reference. The policy is available from the Medicaid fiscal agent’s website at http://portal.flmmis.com/flpublic, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-05963.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906, 409.908 FS. History–New 7-30-80, Formerly 10C-7.521, Amended 4-20-93, 8-25-93, Formerly 10C-7.0521, Amended 12-21-97, 10-13-98, 6-10-99, 4-23-00, 1-23-02, 2-20-03, 8-5-03, 10-12-04, 8-18-05, 5-22-06, 4-4-07, 5-31-10, 11-15-15.

Fla. Admin. Code R. 59G-4.360 Transplant Services

(1) This rule applies to all providers rendering Florida Medicaid transplant services.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Transplant Services Coverage Policy, May 2019, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-10371.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.905, 409.907, 409.908, 409.912, 409.913, 409.973 FS. History‒New 6-29-16, Amended 5-27-19.

Fla. Admin. Code R. 59G-4.370 Behavioral Health Intervention Services

(1) This rule applies to all providers rendering Florida Medicaid behavioral health intervention services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Behavioral Health Intervention Services Coverage Policy, November 2019, incorporated by reference. The policy is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-11248.

History

Rulemaking Authority 409.919, 409.961 FS. Law Implemented 409.902, 409.903, 409.905, 409.908, 409.912, 409.913, 409.973 FS. History–New 12-2-19.

Chapter 59G-5 PROVIDER ENROLLMENT AND PROVIDER REQUIREMENTS

Fla. Admin. Code R. 59G-5.010 Provider Enrollment

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.907, 409.9071, 409.908 FS. History–New 9-22-93, Formerly 10P-5.010, Amended 7-8-97, 9-8-98, 7-5-99, 7-10-00, 5-7-03, 7-7-05, 1-16-20.

Fla. Admin. Code R. 59G-5.020 Provider Requirements

(1) All Medicaid providers enrolled in the Medicaid program and billing agents who submit claims to Medicaid on behalf of an enrolled Medicaid provider must comply with the provisions of the Florida Medicaid Provider General Handbook, July 2012, which is incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-02671 and from the fiscal agent’s Web site at www.mymedcaid-florida.com. Select Public Information for Providers, then Provider Support, and then Provider Handbooks. A paper copy of the handbook may be obtained by calling the Provider Services Contact Center at 1(800) 289-7799 and selecting Option 7.

(2) The following forms that are included in the Florida Medicaid Provider General Handbook are incorporated by reference. In Chapter 3, Temporary Emergency Medicaid Identification Card, July 2008; CF-ES 2681, Notice and Proof of Presumptive Eligibility for Medicaid for Pregnant Women, Feb 2003; CF-ES Form 2014, Authorization for Medicaid/Medikids Eligibility, Feb 2003; AHCA Form 5240-006, Unborn Activation Form, January 2007; CF-ES 2039, Medical Assistance Referral, Sep 2002. In Chapter 4, AHCA-Med Serv 038, Crossover with TPL Claim and/or Adjustment Form, July 2008; AHCA Form 5000-3527, Medicare Part C-Medicaid CMS-1500 Crossover Invoice, June 2012; AHCA Form 5000-3528, Medicare Part C-Medicaid UB-04 Crossover Invoice, June 2012. Appendix D, AHCA Med Serv Form 2000-0016, Medicaid Out-of-State Prior-Authorization Request Form, January 2012. The CF-ES forms are available from the Department of Children and Family Services. The other forms are available from the Medicaid fiscal agent’s Web site at www.mymedicaid-florida.com. Select Public Information for Providers, then Provider Support, and then Forms. Paper copies of the forms may be obtained by calling the Provider Services Contact Center at 1(800) 289-7799 and selecting Option 7.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.905, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History–New 9-22-93, Formerly 10P-5.020, Amended 7-8-97, 1-9-00, 4-24-01, 8-6-01, 10-8-03, 1-19-05, 5-24-07, 2-25-09, 6-13-13.

Fla. Admin. Code R. 59G-5.110 Direct Reimbursement to Recipients

(1) Purpose. This rule describes the circumstances when the Agency for Health Care Administration (AHCA) may directly reimburse eligible Florida Medicaid recipients; how AHCA reimburses recipients; and documentation requirements for direct reimbursement.

(2) Determination Criteria. Florida Medicaid recipients may be eligible for direct reimbursement if:

(a) Medical goods and services were paid for by the recipient or a person legally responsible for their bills from the date of an erroneous denial or termination of Florida Medicaid eligibility to the date of a reversal of the unfavorable eligibility determination.

(b) The goods and services were medically necessary as defined in Rule 59G-1.010, Florida Administrative Code (F.A.C.); rendered by a provider that is qualified to perform the service including meeting any applicable certification or licensure requirements (the provider is not required to be enrolled or registered as a Florida Medicaid provider); and covered by Florida Medicaid for the recipient’s eligibility group on the date of service.

(c) Reimbursement for the medical goods or services is not available through any third-party payer on the date of service for which direct reimbursement is requested.

(3) Reimbursement Process. Recipients must submit direct reimbursement requests to AHCA within 12 months of the date of the reversal of the unfavorable eligibility determination described in paragraph (2)(a).

(a) The reimbursement request must include evidence of all out-of-pocket expenses paid to the provider, validated through receipts submitted by the recipient to: Agency for Health Care Administration, 2727 Mahan Drive, MS #58, Tallahassee, FL 32308.

(b) The Agency for Health Care Administration will send a Florida Medicaid Direct Reimbursement Recipient Information Request, AHCA Form 5240-0002, June 2016, incorporated by reference and available on the AHCA website at http://ahca.myflorida.com/Medicaid/review/index.shtml, or at http://www.flrules.org/Gateway/reference.asp?No=Ref-06750, to recipients if more information is required to determine their eligibility for direct reimbursement. Recipients must complete and return the signed form in accordance with the instructions provided on the form.

(c) The Agency for Health Care Administration will send a Florida Medicaid Direct Reimbursement Provider Information Request, AHCA Form 5240-0003, June 2016, incorporated by reference and available on the AHCA website at http://ahca.myflorida.com/Medicaid/review/index.shtml, or at http://www.flrules.org/Gateway/reference.asp?No=Ref-06750, if more information is needed from the provider to determine recipient eligibility for direct reimbursement. Providers must complete and return the signed form in accordance with the instructions provided on the form.

(4) Recipient Notification. The Agency for Health Care Administration will send reimbursement directly to the recipient in the amount the recipient paid to the provider. If AHCA determines that the expenses do not qualify for reimbursement, the recipient will be notified in writing after all information has been reviewed.

(5) Fair Hearing. The recipient has the right to request a Medicaid fair hearing if notified that reimbursement in full or in part is not approved. A request for a fair hearing must be made within 90 days from the date the notification is mailed to the recipient. The fair hearing may be requested by calling the Medicaid Helpline at 1(877)254-1055 or by contacting the Department of Children and Families Office of Appeal Hearings at appeal.hearings@myflfamilies.com.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902 FS. History–New 9-22-93, Formerly 10P-5.110, Amended 5-9-99, 6-2-16.

Chapter 59G-6 REIMBURSEMENT TO PROVIDERS

Fla. Admin. Code R. 59G-6.005 Reimbursement Methodology for Services Provided by Medical School Faculty

(1) This rule applies to all providers who are enrolled in Florida Medicaid who:

(a) Are defined as practitioners under the Centers for Medicare and Medicaid Services’ Merit-based Incentive Payment System (MIPS).

(b) Provide medical services, dental services, behavioral health services, hearing services, and vision services to Florida Medicaid recipients receiving services through the fee-for-service delivery system.

(c) Are employed by, or contracted with, a Florida public or private, non-profit, accredited medical, dental, or optometry school to provide supervision and teaching of medical, dental, or optometric students, residents, or fellows.

(2) Reimbursement.

(a) Florida Medicaid reimburses providers for covered medical, hearing, vision, dental, and behavioral health services listed on the applicable Florida Medicaid fee schedule, incorporated by reference in Rule 59G-4.002, F.A.C., at either:

Two hundred-three percent of the Medicare rate, based on Florida locality code 0910299, listed on the 2018 Medicare Part B physician fee schedule – Loc 03, 04, and 99, incorporated by reference, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-13315, https://ahca.myflorida.com/medicaid/review/Reimbursement/2018-01-01_Fee_Schedules/Practitioner_Fee_Schedule_2018.pdf, and at Physician Fee Schhttps://www.cms.gov/apps/physician-fee-schedule/search/search-criteria.aspxedule Search (cms.gov).
Two hundred-three percent of the Florida Medicaid rate if the service is not covered by Medicare.

(b) Florida Medicaid reimbursement to providers for clean claims submitted to the Florida Medicaid Management Information System specified in this rule shall not exceed the amount specified in the General Appropriations Act.

(c) Florida Medicaid will reconcile claims reimbursed in accordance with this rule on a quarterly basis. Any claims reimbursed after the maximum reimbursable amount is reached will be recouped, or adjusted to the standard Florida Medicaid rate, as appropriate.

(3) Exclusions. Florida Medicaid does not reimburse providers in accordance with this rule for the following:

(a) Services rendered to dually eligible Medicare and Medicaid recipients.

(b) Vaccine, laboratory, and radiology services.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.908 FS. History–New 6-13-17, Amended 12-25-18, 8-15-21, 4-30-25.

Fla. Admin. Code R. 59G-6.009 Training, Education, and Clinicals in Health Funding Program

(1) This rule applies to all federally qualified health centers (FQHC), community mental health centers (CMHC), rural health clinics (RHC), or certified community behavioral health clinics (CCBHC) participating in the Florida Medicaid program that establish, maintain, or expand a clinical training program in accordance with section 409.91256, Florida Statutes, (F.S.).

(2) Definitions.

(a) Accredited program. Training or educational program endorsed by the Accreditation Council for Graduate Medical Education (ACGME) or the Commission on Dental Accreditation (CODA), as applicable to the educational or residency program.

(a) Health care practitioners. Residents or students who are enrolled in a Florida-based, accredited educational or residency program as specified in section 409.91256, F.S.

(b) Preceptor. Licensed Florida health care practitioner who directs, trains, teaches, and evaluates students or residents participating in TEACH, pursuant to section 409.91256, F.S.

(d) Training, Education, and Clinicals in Health Funding Program (TEACH). Established in section 409.91256, F.S., the purpose of TEACH is to provide qualified facilities with funds to educate, train, and provide clinical experience to students and residents to become health care practitioners.

(3) TEACH Program Process.

(a) Application. Qualified facilities must apply for participation in TEACH by submitting the TEACH application portion of the Training, Education, and Clinicals in Health (TEACH) Funding Program Application and Quarterly Reporting Template, AHCA Form 5000-4061, JUN 2025, incorporated by reference and available at: https://ahca.myflorida.com/medicaid/medicaid-finance-and-analytics/medicaid-program-finance/lip-dsh-gme-operations/teach, and https://flrules.org/Gateway/reference.asp?No=Ref-18615 to the Agency for Health Care Administration (Agency) by the established deadline.

(b) Agreement. Upon approval of the application, qualified facilities must contract with the Agency via submission of the completed Training, Education, and Clinicals in Health (TEACH) Funding Program Agreement, AHCA Form 5000-4060, MAY 2025 (agreement), incorporated by reference and available at: https://flrules.org/Gateway/reference.asp?No=Ref-18616. The agreement will be provided electronically to the qualified facility, correspondingly returned to the Agency, and effective upon acceptance of the agreement by the Agency.

The agreement contains requirements for provider participation in the TEACH Funding Program, at a minimum to include:

Precepting residents and students.
Maintaining accreditation as appropriate to the training provided.
Ensuring that preceptors and teaching staff meet standards established by the Agency.
Collecting and reporting required data quarterly to the Agency.

(4) Reimbursement. Subject to annual appropriation, the Agency may reimburse qualified facilities participating in TEACH up to $75,000 per fiscal year; or, up to $100,000 per fiscal year, if the facility operates an accredited residency program in Florida.

In the case where the applications received for TEACH result in expenditures that will exceed the appropriation, a proportional reduction will be made to all reimbursements, by applying a uniform percentage decrease such that the appropriation is fully exhausted but not exceeded.

(5) Eligible Costs. The qualified facility must apply for reimbursement under the TEACH Funding Program using the Training, Education, and Clinicals in Health (TEACH) Funding Program Application and Quarterly Reporting Template, AHCA Form 5000-4061, JUN 2025 (template), incorporated by reference and available at: https://ahca.myflorida.com/medicaid/medicaid-finance-and-analytics/medicaid-program-finance/lip-dsh-gme-operations/teach and https://flrules.org/Gateway/reference.asp?No=Ref-18615.

The template records expeditures, reconciling eligible costs associated with training students or residents as health care practitioners, based upon the number of clinical training hours per student as specified in section 409.91256, F.S., administrative costs, and, if applicable, loss of revenue. Clinical supervision will be defined based on the facility’s accrediting body standards.

(6) Reporting Requirements. Reimbursement under TEACH requires provision of quarterly reports in an Agency-approved format from qualified facilities to the Agency. The reports must include student demographics and clinical evaluations by program participants, program enrollment and completion statistics, and post-training employment data, in accordance with section 409.91256, F.S.

(a) Data accuracy. Qualifying facilities must attest to the accuracy of the data submitted within each quarterly report by signing and submitting the Training, Education, and Clinicals in Health (TEACH) Funding Program Certification, AHCA Form 5000-4059, MAY 2025, incorporated by reference, and available at: https://ahca.myflorida.com/medicaid/medicaid-finance-and-analytics/medicaid-program-finance/lip-dsh-gme-operations/teach and https://flrules.org/Gateway/reference.asp?No=Ref-18613.

(b) Data submission. If a facility fails to submit the required quarterly reports by the statutory deadline, the Agency will withhold payments until the data has been received by the Agency.

(7) Program Term. The TEACH Funding Program ends on or before July 1, 2034, in accordance with section 409.91256, F.S.

History

Rulemaking Authority 409.91256, 409.919 FS. Law Implemented 409.905, 409.906, 409.908, 409.909, 409.91256 FS. History–New 10-26-25.

Fla. Admin. Code R. 59G-6.010 Payment Methodology for Nursing Home Services

(1) This rule applies to all nursing facility providers rendering Florida Medicaid nursing facility services in accordance with Rule 59G-4.200, F.A.C.

(2) Definitions.

(a) Adjusted Facility Sq Ft ‒ Component of the Fair Rental Value System (FRVS) Calculation, the Minimum, Maximum, or Actual Sq. Ft per bed, defined in Section 409.908(2)(b)1.g., Florida Statutes (F.S.).

(b) Allowable Medicaid Costs – Are defined in CMS Publication 15-1 chapter 21 under reasonable costs and costs related and not related to patient care.

(c) Budget Neutrality Factor ‒ Budget neutrality multipliers shall be incorporated into the Prospective Payment System (PPS) and exempt provider rate setting to ensure that total reimbursement is as required through the General Appropriations Act. Quality Incentive Payments, Direct Care Staffing and Ventilator add-ons, and the Nursing Facility Quality Assessment are excluded.

(d) Depreciation Factor ‒ Component of the FRVS Calculation, referred to as Obsolescence Factor, defined in Section 409.908(2)(b)1.g., F.S.

(e) Direct Care Cost Component ‒ The direct patient care component shall include the Medicaid allowable portion of salaries and benefits of direct care staff providing nursing services including registered nurses(RN), licensed practical nurses (LPN), certified nursing assistants (CNA), and personal care attendants (PCA) who deliver care directly to residents in the nursing facility, allowable therapy costs, and dietary costs adjusted for inflation. PCA should be reported under Direct Care with Nurse Aide expenses. Direct care staff does not include nursing administration, Minimum Data Set (MDS) and care plan coordinators, staff development, infection control preventionist, risk managers, and staffing coordinators. There shall be no costs directly or indirectly allocated to the direct care component from a home office or management company for staff who do not deliver care directly to residents in the nursing facility.

(f) Equipment Cost ‒ Component of the FRVS Calculation, referred to as moveable equipment allowance, defined in Section 409.908(2)(b)1.g., F.S.

(g) Exempt Providers – Pediatric, facilities operated by the Florida Department of Veterans Affairs, and government-operated facilities are exempt from reimbursement under the prospective payment methodology and shall be reimbursed on a cost-based prospective payment system, in accordance with Section 409.908(2)(b)8., Florida Statutes (F.S.). Reimbursement of direct care, indirect care, and operating costs are subject to reimbursement ceilings and targets.

(h) Fair Rental Rate ‒ Component of the FRVS Calculation defined in Section 409.908(2)(b)1.g., F.S.

(i) Floors – Floors are calculated for the direct care and indirect care cost components for each peer group and are equal to the price times the floor percentage as defined in Section 409.908(2)(b)1.c., F.S.

(j) Floor Reduction – The difference between the floor and the provider’s inflated per day cost component, if a provider’s cost is below the floor.

(k) Fair Rental Value System (FRVS) Rate – A FRVS is used to reimburse providers for their facility related capital costs. A provider must submit an FRVS survey to the Agency for Health Care Administration (AHCA) using the electronic form and instructions on the Florida Nursing Home: Fair Rental Value Survey web page. The survey information is used to compute an adjusted age for each provider, based on the most recent survey received by April 30 of each year for the subsequent rate period. The nursing facility provider’s FRVS survey will be used to calculate the rate for a future rate period

(l) High Medicaid Utilization and High Direct Patient Care Add-On ‒ Providers who meet the minimum Medicaid utilization and staffing criteria outlined in Section 409.908(2)(b)6., F.S. and have a prospective payment per diem rate that is lower than their per diem rate effective September 1, 2016, shall receive the lesser of a $20 per diem increase or a per diem increase sufficient to set their rate equal to their September 1, 2016 rate.

(m) Indirect Care Cost Component ‒ All other allowable Medicaid patient care costs, that are not listed in the operating or direct care components, are adjusted for inflation and shall be included in the indirect patient care component.

(n) Land Allocation Percentage ‒ Component of the FRVS Calculation, referred to as Land Valuation, defined in Section 409.908(2)(b)1.g., F.S.

(o) Medians ‒ The mid-points of the inflated per diems for direct care, indirect care, and operating cost components of all included providers in a peer group. Beginning October 1, 2018 separate medians shall be calculated for operating, direct, and indirect cost components based on the most recent cost reports received for the September 2016 rate setting by the rate setting acceptance cut-off date, per Section 409.908(2)(b)1.b., F.S. Beginning October 1, 2021 medians shall be calculated based on the most recently finalized, audited cost report, every 4th year.

(p) Medicaid Adjustment Rate (MAR) – An add-on to the direct care and indirect care cost components of exempt providers with greater than 50 percent Medicaid utilization.

(q) Medicaid Bad Debt – Amounts considered to be uncollectible from accounts and notes receivable which are created or acquired in providing services per CMS publication 15-1 chapter 3 section 302.1.

(r) Nursing Facility Quality Assessment (NFQA) – An assessment imposed on each nursing facility provider used to obtain Federal financial participation through the Medicaid program and partially fund the quality incentive payment program for nursing facilities that exceed quality benchmarks. The per diem Florida Medicaid share of the NFQA is calculated as follows:

Total patient days minus Medicare days (exclusive of Medicare Part A resident days) is equal to total non-Medicare days.
The product of total non-Medicare days, NFQA rate and Florida Medicaid days as a percentage of total days is equal to the total NFQA Florida Medicaid share.
Total NFQA Florida Medicaid share divided by Florida Medicaid days is equal to the per diem Florida Medicaid Share of the NFQA.

(s) Occupancy Percentage ‒ Component of the Fair Rental Value System (FRVS) Calculation, the Minimum Occupancy, defined in Section 409.908(2)(b)1.g., F.S.

(t) Offense ‒ Full Quality Assessment Payment not received by the 20th day of the next succeeding calendar month.

(u) Operating Cost Component ‒ The operating component shall include the costs for medical records, plant operation, housekeeping, administration, Medicaid bad debt and laundry and linen.

(v) Quality Assessment Payment – Timely submission of one month’s total number of resident days and rendering of Quality Assessment Fee Payment equal to the assessment rate times the reported number of days.

(w) Peer Group – Providers are divided into two peer groups defined in Section 409.908(2)(b)1.a., F.S.

(x) Price ‒ The standardized rate for each peer group that is calculated for the direct care, indirect care and operating cost components as the median times the price percentage as defined in Section 409.908(2)(b)1.b., F.S.

(y) Quality Incentive Payment – A provider is awarded points for process, outcome, structural and credentialing measures using most recently reported data on May 31 of the rate period year. To qualify for a quality incentive payment, a provider must meet the minimum threshold defined in Section 409.908(2)(b)1.f., F.S. The Quality Incentive budget is defined in Section 409.908(2)(b)1.e., F.S.

Process Measures ‒ Includes Flu Vaccine, Antipsychotic Medication, Antianxiety and Hypnotic, and Restraint quality metrics. For each rate period, data to calculate these quality metrics is from the Medicare Nursing Home Compare datasets using the most recent four quarter average available on May 31 of the rate period year. Providers are ranked based on the percentage of residents who have, or do not have, a particular condition. Providers whose fourth quarter measure score is at or above the 90th percentile for a particular measure will be awarded 3 points, those scoring from the 75th up to 90th percentiles will be awarded 2 points, and those scoring from the 50th up to 75th percentiles will receive 1 point. Providers who score below the 50th percentile and achieve a 20 percent improvement from the previous year will receive 0.5 points. The quality measure percentiles that are used to award the points will be recalculated during rebase years starting October 2021 and every subsequent 4th year. During non-rebase years the quality measure percentiles will be frozen.
Outcome Measures – Includes Urinary Tract Infections, Pressure Ulcers, Falls, Incontinence, Hospitalizations per 1000 long-stay resident days, Registered Nurse Turnover, and Decline in Activities of Daily Living quality metrics. Outcome Measures are scored and percentiles are calculated using the same methodology as Process Measures. Data to calculate these metrics is from the Medicare Nursing Home Compare datasets.
Structure Measures – Includes Direct Care Staffing from the Medicaid cost report received by the rate setting cutoff date and Social Work and Activity Staff as reported on CMS Facility Staffing Payroll-Based Journal data for the four most recent quarters as of May 31 of the year in which the rate period begins. Structure Measures are scored and percentiles are calculated using the same methodology as Process Measures and Outcome Measures. Structure Measure percentiles are recalculated annually.
Credentialing Measures – Includes CMS Overall 5-Star, Florida Gold Seal, Joint Commission Accreditation, and American Health Care Association National Quality Award. Facilities assigned a rating of 3, 4, or 5 stars in the CMS 5- Star program will receive 1, 3, or 5 points, respectively. For each rate period, the CMS 5-Star Rating Measure will be calculated using the most recent overall rating from the Star Ratings dataset from the Nursing Home Compare datasets provided by CMS as of May 31 of the year in which the rate period begins. Facilities that have either a Florida Gold Seal, Joint Commission Accreditation, or the silver or gold American Health Care Association National Quality Award on May 31 of the current year will be awarded 5 points. Recipients of the Florida Gold Seal Award can be viewed on Florida Health Finder website, recipients of the Joint Commission Accreditation can be viewed on the Joint Commission website, and recipients of the American Health Care Association National Quality Award can be viewed on the American Health Care Association website.

(z) Rate Period – October 1 ‒ September 30.

(aa) Rate Setting Acceptance Cost Report Cutoff Date – The cost report cutoff date is April 30, or the next business day if April 30 falls on a weekend or State of Florida observed holiday, of the year in which the rate period beings. A link to the Cost Report template Web site can be found at http://ahca.myflorida.com/Medicaid/cost_reim/ecr.shtml.

(bb) Rebase Rate Semester – Direct care, indirect care, and operating cost components will be rebased beginning October 1, 2021 and every subsequent fourth year by using the most recently finalized, audited cost report available by the rate setting acceptance cut-off date.

(cc) Reimbursement Ceiling ‒ The upper rate limits, calculated based on all Medicaid Nursing Facility providers, for operating, direct care, and indirect care components applicable to exempt nursing facility providers in a peer group.

(dd) Reimbursement Targets – Provider specific per diem limitations, for the operating and indirect care cost components for exempt providers.

(ee) RSMeans Data ‒ The industry-standard for materials, labor, and equipment cost information database used by contractors and other professionals to accurately estimate construction project costs.

(ff) Subsequent Offense ‒ any offense within a period of five years preceding the most recent quality assessment due date.

(gg) Ventilator Supplemental Payment ‒ Effective October 1, 2019, claims and encounter data with diagnosis code Z99.11, dependence on respirator (ventilator) status, with dates of service in the prior calendar year will be used to calculate the ventilator supplemental payment. The sum of claims and encounters with diagnosis code Z99.11 for the facility will be divided by annualized Medicaid days from the most recently submitted cost report received by the Rate Setting Acceptance Cost Report Cutoff Date, then multiplied by $200.00. The result will be added to the rate setting per diem.

(3) Reimbursement. Effective each October 1 the AHCA will reimburse for Florida Medicaid nursing facility services rendered by nursing facilities using the Prospective Payment System (PPS) methodology in accordance with Section 409.908(2)(b), F.S. Exempt providers will be reimbursed using a cost based methodology.

(4) Reimbursement Methodology.

(a) PPS Calculation. The calculation is as follows:

(Operating Price + Direct Care Price - Floor Reduction + Indirect Care Price - Floor Reduction + FRVS Rate + Pass Through Payments) * Budget Neutrality Factor + Quality Incentive Payment + Medicaid Share of NFQA + Ventilator Supplemental Payment + High Medicaid Utilization and High Direct Patient Care Add-On))

(b) Quality Incentive Payment Calculation. The calculation is as follows:

Facility Annualized Medicaid Days/Average Annualized Medicaid Days of All Facilities* Quality Points with Lower Limit/Sum of Total Points Awarded to All Facilities * Total Quality Budget/Facility Annualized Medicaid Days

Building = Current Year RSMeans Cost Per Sq Ft * Adjusted Facility Sq Ft * Zip Code Location Factor

Land = Building * Land Allocation Percentage

Undepreciated Value = Building + Land + Equipment

Depreciation = (Building + Equipment) * Depreciation Factor * Facility Adjusted Age

FRVS Rate = (Undepreciated Value – Depreciation) * Fair Rental Rate/(Occupancy Percentage * 365.25)

Current Year RSMeans Cost Per Sq Ft and Zip Code Location Factor are defined in the latest Gordian Building Construction Costs publication with RSMeans Data available on March 31 of the year in which the rate period begins.
Facility Adjusted Age is calculated using FRVS survey data.

(d) Exempt Calculation. The calculation is as follows:

(Operating Cost Component + Direct Care Cost Component + Indirect Care Cost Component + MAR + FRVS Rate + Pass Through Payments) * Budget Neutrality Factor + Medicaid Share of NFQA

(e) Exempt Providers rate components will be limited to Reimbursement Targets and Reimbursement Ceilings.

(5) NFQA

(a) Participating nursing facilities shall use the Nursing Facility Quality Assessment form (only accepted electronically), AHCA Form 5000-3549, Revised October 2013, incorporated by reference, for the submission of its monthly quality assessment. This form can be accessed at http://ahca.myflorida.com/QAF/index.shtml.

(b) Each facility shall report monthly to AHCA its Quality Assessment Payment. Facilities are required to submit their full Quality Assessment Payment no later than 20 days from the next succeeding calendar month.

(c) Providers are subject to the following monetary fines pursuant to Section 409.9082(7), F.S., for failure to timely submit the Quality Assessment Payment:

For a facility’s first offense, a fine of $500 per day shall be imposed until the total number of resident days is submitted and quality assessment is paid in full, but in no event shall the fine exceed the amount of the quality assessment.
For any offense subsequent to a first offense, a fine of $1,000 per day shall be imposed until the total number of resident days is submitted and Quality Assessment Payment is paid in full, but in no event shall the fine exceed the amount of the quality assessment.
In the event that a provider fails to report their total number of resident days as defined in Section 409.9082(1)(c), F.S., by the 20th day of the next succeeding calendar month, the fines in paragraphs (a)-(c), apply and the maximum amount of the fines shall be equal to their last submitted quality assessment amount but in no event shall the total fine exceed the amount of the quality assessment.

(d) In addition to the aforementioned fines, providers are also subject to the non-monetary remedies enumerated in Section 409.9082(7), F.S. Imposition of the non-monetary remedies by AHCA will be as follows:

For a third subsequent offense, AHCA will withhold any medical assistance reimbursement payments until the assessment is recovered.
For a fourth or greater subsequent offense, AHCA will seek suspension or revocation of the facility’s license.

(e) Sanctions for failure to timely submit a quality assessment are non-allowable costs for reimbursement purposes and shall not be included in the provider’s Medicaid per diem rate.

(f) The facility may amend any previously submitted quality assessment data, but in no event may an amendment occur more than twelve months after the due date of the assessment. The deadline for submitting an amended assessment shall not relieve the facility from their obligation to pay any amount previously underpaid and shall not waive AHCA’s right to recoup any underpaid assessments.

(6) The Florida Medicaid rate is equal to the Medicare allowed amount for Medicare approved Part B therapy services provided in nursing facilities. Medicare approved Part B therapy services must be excluded as an allowable cost from the Medicaid cost report.

History

Rulemaking Authority 409.919, 409.9082 FS. Law Implemented 409.908, 409.9082, 409.913 FS. History–New 7-1-85, Amended 10-1-85, Formerly 10C-7.482, Amended 7-1-86, 1-1-88, 3-26-90, 9-30-90, 12-17-90, 9-15-91, 3-26-92, 10-22-92, 4-13-93, 6-27-93, Formerly 10C-7.0482, Amended 4-10-94, 9-22-94, 5-22-95, 11-27-95, 11-6-97, 2-14-99, 10-17-99, 1-11-00, 4-24-00, 9-20-00, 11-20-01, 2-20-02, 7-14-02, 1-8-03, 6-11-03, 12-3-03, 2-16-04, 7-21-04, 10-12-04, 4-19-06, 7-1-06, 8-26-07, 2-12-08, 9-22-08, 3-3-10, 2-23-11, 5-3-12, 2-13-14, 1-19-15, 5-3-15, 7-17-16, 8-6-17, 3-25-18, 4-15-20, 9-14-21, 7-8-25.

Fla. Admin. Code R. 59G-6.020 Payment Methodology for Inpatient Hospital Services

(1) Reimbursement to participating inpatient hospitals for services provided shall be in accordance with the Florida Title XIX Inpatient Hospital Reimbursement Plan (the Plan), Version XLIV, effective July 1, 2017, http://www.flrules.org/Gateway/reference.asp?No=Ref-09420, incorporated by reference. The Plan is applicable to the fee-for-service delivery system.

(2) A copy of the Plan as revised may be obtained by writing to the Bureau of Medicaid Program Finance, Agency for Health Care Administration, 2727 Mahan Drive, Building 3, Mail Stop 8, Tallahassee, Florida 32308.

(3) The Provider Reimbursement Manual CMS PUB. 15-1, is incorporated by reference, http://www.flrules.org/Gateway/reference.asp?No=Ref-08256, and available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Paper-Based-Manuals-Items/CMS021929.html. The following cost reports are included in the Plan and are incorporated by reference: CMS-2552-96, June 2003, http://www.flrules.org/Gateway/reference.asp?No=Ref-07058; and CMS-2552-10, October 2012, http://www.flrules.org/Gateway/reference.asp?No=Ref-07059. These cost reports are available on the Centers for Medicare and Medicaid Services website at http://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/CostReports/Hospital-1996-form.html and http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3P240f.pdf, respectively.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.905, 409.908, 409.909, 409.913, 409.9113, 409.9115, 409.9116, 409.9118, 409.9119 FS. History–New 10-31-85, Formerly 10C-7.391, Amended 10-1-86, 1-10-89, 11-19-89, 3-26-90, 8-14-90, 9-30-90, 9-16-91, 4-6-92, 11-30-92, 6-30-93, Formerly 10C-7.0391, Amended 4-10-94, 8-15-94, 1-11-95, 5-13-96, 7-1-96, 12-2-96, 11-30-97, 9-16-98, 11-10-99, 9-20-00, 3-31-02, 1-8-03, 7-3-03, 2-1-04, 2-16-04, 2-17-04, 8-10-04, 10-12-04, 1-10-06, 4-19-06, 12-11-06, 3-4-08, 6-10-08, 1-11-09, 3-24-10, 7-5-10, 7-15-10, 2-23-11, 10-30-12, 4-23-14, 1-19-15, 6-15-15, 7-11-16, 7-10-17, 7-12-18.

Fla. Admin. Code R. 59G-6.025 Reimbursement Methodology for Cancer Hospitals

(1) This rule applies to Florida Medicaid providers that render inpatient and outpatient hospital services to recipients through the fee-for-service delivery system. The providers must be considered as a cancer hospital and:

(a) Be members of the Alliance of Dedicated Cancer Centers.

(b) Meet the criteria under Title 42, United States Code, section 1395ww(d)(1)(B)(v).

(2) Definitions.

(a) Upper Payment Limit (UPL) – The annual maximum amount Florida Medicaid may pay in the aggregate to inpatient hospitals for inpatient and outpatient services rendered under the Florida Medicaid fee-for-service delivery system.

(b) UPL Gap – The difference between the annual maximum amount Medicare would pay to a cancer hospital for inpatient and outpatient hospital services rendered to recipients and the actual amount paid by Florida Medicaid for those services.

(c) Valid Claim – A “clean claim” as defined in Rule 59G-1.010, F.A.C., for inpatient and outpatient hospital services that meet all of the following:

Provided by a cancer hospital under the fee-for-service delivery system.
Provided to Florida Medicaid recipients who are not also eligible for Medicare.

(3) Reimbursement.

(a) Effective October 26, 2017, Florida Medicaid reimburses cancer hospitals for inpatient and outpatient hospital services rendered to eligible Florida Medicaid recipients in an amount up to each hospital’s UPL, in accordance with Title 42, Code of Federal Regulations (CFR), section 447.272.

(b) Florida Medicaid calculates supplemental payments to cancer hospitals based upon the UPL gap.

(c) Florida Medicaid reimbursement to providers for state fiscal year (SFY) 2017-2018 will be prorated by using the ratio of effective dates within SFY 2017-2018 and multiplying the ratio by the UPL gap for hospital inpatient and outpatient services. The calculated ratio for SFY 2017-2018 is 0.6795.

(d) Florida Medicaid will calculate supplemental payments quarterly, based on valid claims that have a paid date within the previous three months.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.905, 409.908 FS. History–New 5-13-19.

Fla. Admin. Code R. 59G-6.030 Payment Methodology for Outpatient Hospital Services

Reimbursement to participating outpatient hospitals for services provided shall be in accordance with the Florida Title XIX Outpatient Hospital Reimbursement Plan (the Plan), Version XXVII, effective date July 1, 2016, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-08175. The Plan is applicable to the fee-for-service delivery system. A copy of the Plan as revised may be obtained by writing to the Bureau of Medicaid Program Finance, Agency for Health Care Administration, 2727 Mahan Drive, Building 3, Mail Stop #23, Tallahassee, Florida 32308.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.905, 409.908, 409.913 FS. History–New 10-31-85, Amended 12-31-85, Formerly 10C-7.401, Amended 10-1-86, 3-26-90, 9-30-90, 10-13-91, 7-1-93, Formerly 10C-7.0401, Amended 4-10-94, 9-18-96, 9-5-99, 9-20-00, 12-6-01, 11-10-02, 2-16-04, 10-12-04, 7-4-05, 4-19-06, 12-11-06, 3-4-08, 6-10-08, 1-11-09, 3-24-10, 6-24-10, 2-23-11, 10-30-12, 4-30-14, 9-30-14, 5-3-15, 6-15-16, 6-26-17.

Fla. Admin. Code R. 59G-6.031 Enhanced Ambulatory Patient Grouping Reimbursement Methodology for Hospital Outpatient Services and Ambulatory Surgical Centers

(1) This rule applies to all hospitals and ambulatory surgical centers (ASC) rendering Florida Medicaid outpatient hospital services to recipients, in accordance with Rules 59G-4.160 and 59G-4.020, Florida Administrative Code, (F.A.C.), respectively.

(2) Definitions.

(a) Annual Appropriation – The funding provided in the General Appropriations Act and the incorporated Medicaid Hospital Funding Programs document.

(b) Automatic Rate Enhancement – An additional fee applied to each payable claim line.

(d) Base Year – A period of historical claims extracted for a pricing simulation.

(e) Bundled EAPG Payment – A single payment applied to one claim line that includes reimbursement for services reported on multiple claim lines.

(f) Charge Cap – A limitation that ensures the Medicaid-allowed amount does not exceed the submitted charges on either individual service line(s), or overall for the entire outpatient claim.

(g) Crossover Claim – Provider claim for services provided to recipients who are eligible for Medicare and Medicaid services, or who have other third-party insurance.

(h) Discounting Claim Line – A service line on a claim where the payment is adjusted.

(i) Enhanced Ambulatory Patient Groups (EAPG) – A product of 3M Health Information Systems (HIS) that categorizes outpatient services and procedures into groups for payment based on clinical information present on an outpatient claim.

(j) EAPG Code – Proprietary number developed by 3M HIS to indicate a specific grouping of services.

(k) EAPG Methodology – Reimbursement system that provides an all-inclusive rate for all services and items furnished during an outpatient visit, unless otherwise specified. The methodology categorizes the amount and type of services provided during an outpatient visit and groups together procedures, medications, materials, and patient factors that share similar characteristics and resource utilization. Each category is assigned an EAPG code. Each EAPG code is assigned a relative weight (which may equal zero) that is used to calculate payment.

(l) Florida Medicaid Outpatient Charges – The billed charges for outpatient services covered by the Florida Medicaid program for a hospital or an ASC.

(m) General Hospital – As defined in Section 395.002(10), Florida Statutes (F.S.).

(n) High Medicaid Outpatient Utilization Hospital – A hospital that renders 55 percent or more of its total annual outpatient services to Florida Medicaid recipients.

(o) Payment Adjustment Factor – A multiplier used to package and consolidate payment for similar services; or, to discount services if the services are determined to be clinically similar to other services on the claim.

(p) Policy Adjustor – Numerical multipliers included in the EAPG claim service line payment calculation that increase or decrease payments to categories of services, categories of providers, or both.

(q) Provider Rate Worksheets – A list of the EAPG base rates and automatic rate enhancements for each hospital and ASC.

(r) Relative Weights – National average values calculated by 3M HIS which identify the relative amount of resources utilized to perform the services mapped to the EAPG code.

(s) Rural Hospital – As defined in Section 395.602(2), F.S.

(t) Service Line Payment – A calculation used to determine individual claim line reimbursement.

(u) Service Line Procedure Code – The assigned Common Procedure Terminology© (CPT) Code and Health Procedural Code System (HCPCS) included on a claim line.

(3) Reimbursement. Effective July 1, 2017, the Agency for Health Care Administration (AHCA) will reimburse for Florida Medicaid outpatient hospital services rendered by hospital and ASC providers using the EAPG payment methodology in accordance with Section 409.905, F.S.

(4) Reimbursement Methodology.

(a) EAPG Payment Calculation. The calculation is as follows:

[(Base Rate * EAPG Relative Weight * Policy Adjustor * Payment Adjustment Factor) (up to the $1,500 recipient annual benefit limit, when applicable)] + Automatic Rate Enhancement.

(b) Base Rate. AHCA will establish base rates. The base rates for dates of service beginning July 1, 2017 through March 31, 2018 are found on the Provider EAPG Rate Worksheet FY 2017-2018, incorporated by reference and available on the AHCA website at http://ahca.myflorida.com/medicaid/cost_reim/archive/hospital_rates_archive.shtml#rates and at http://www.flrules.org/Gateway/reference.asp?No=Ref-10093. The base rates for dates of service beginning April 1, 2018 through June 30, 2018 are found on the Provider EAPG Rate Worksheet Reconciliation, incorporated by reference and available on the AHCA website at http://ahca.myflorida.com/medicaid/cost_reim/hospital_rates.shtml and at http://www.flrules.org/Gateway/reference.asp?No=Ref-10094.

The base rates for dates of service beginning July 1, 2018 are found in Provider EAPG Rate Worksheet FY 2018-2019, incorporated by reference and available on the AHCA website at http://ahca.myflorida.com/medicaid/cost_reim/hospital_rates.shtml and at http://www.flrules.org/Gateway/reference.asp?No=Ref-10095.

(c) EAPG Relative Weight. AHCA will use 3M HIS relative weights as found on the EAPG Rate Worksheet FY 2018-19, incorporated by reference and available on the AHCA website at http://ahca.myflorida.com/medicaid/cost_reim/hospital_rates.shtml and at http://www.flrules.org/Gateway/reference.asp?No=Ref-10096.

AHCA will use the service line procedure code to determine the EAPG code and relative weight, except in claims for evaluation and management services without another significant procedure, wherein AHCA will use the recipient’s primary diagnosis to determine the EAPG code and relative weight.

(d) Policy Adjustor. AHCA will only include a provider policy adjustor in the EAPG payment for rural hospitals and high Florida Medicaid outpatient utilization hospitals.

(e) Payment Adjustment Factor. AHCA will establish the Payment Adjustment Factor(s) as follows:

The Payment Adjustment Factor will be 1.0 for claim service lines that pay in full.
The Payment Adjustment Factor will be zero for bundled lines.
The Payment Adjustment Factor will be 0.50 on discounting claim lines, except for bilateral procedures.
The Payment Adjustment Factor will be 1.50 for bilateral procedures.

(f) Automatic Rate Enhancements. AHCA will apply an automatic rate enhancement to payable claim lines for outpatient hospitals for dates of service beginning July 1, 2017 as found on the Provider EAPG Rate Worksheet FY 2017-2018, incorporated by reference and available on the AHCA website at: http://ahca.myflorida.com/medicaid/cost_reim/archive/hospital_rates_archive.shtml and at http://www.flrules.org/Gateway/reference.asp?No=Ref-10093. AHCA will apply an automatic rate enhancement to payable claim lines for outpatient hospitals for dates of service beginning July 1, 2018 as found on the Provider EAPG Rate Worksheet FY 2018-19, incorporated by reference and available on the AHCA website at: http://ahca.myflorida.com/medicaid/cost_reim/hospital_rates.shtml and at http://www.flrules.org/Gateway/reference.asp?No=Ref-10095.

For each hospital receiving automatic rate enhancements, AHCA will calculate a per-payable-service-line payment amount by dividing the annual appropriation by the number of Florida Medicaid outpatient payable service lines in the base year.
AHCA will apply an automatic rate enhancement payment as follows:

a. To claim service lines that receive a bundled EAPG payment.

b. When adjudicated after a recipient reaches his or her annual hospital outpatient benefit limit with claim service lines that are paid $0.00 and have a status of paid.

AHCA will apply an automatic rate enhancement payment of $0.00 to claim service lines when claim service lines are denied.

(g) Budget Neutrality. AHCA will reconcile the EAPG parameters to comply with budget neutrality requirements.

(h) Terminated Procedures. AHCA will reimburse providers for procedures that are terminated prior to the administration of anesthesia at 50% of the rate.

(i) Charge Cap. AHCA will not apply a charge cap to services reimbursed under the EAPG payment methodology.

(5) Exclusion. AHCA will not apply the EAPG reimbursement methodology to reimburse the following:

Services covered under the transplant global fee in accordance with Rule 59G-4.150, F.A.C.
Vagus nerve stimulator device payments.
Newborn hearing screening.

(6) Cost Settlement. AHCA will not subject hospitals and ASCs reimbursed using the EAPG payment methodology to retrospective cost settlement.

(7) Crossover Pricing. For hospital outpatient crossover claims, AHCA will determine the Medicaid-allowed amount using the EAPG pricing methodology.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.905, 409.908, 409.913 FS. History–New 12-25-18.

Fla. Admin. Code R. 59G-6.035 Certified Public Expenditures Program for Emergency Transportation Services

(1) This rule applies to all publicly owned or operated emergency transportation services providers rendering Florida Medicaid emergency transportation services to recipients under the fee-for-service delivery system.

(2) Providers must submit AHCA Form 5000-0035, May 2017, Emergency Medical Transportation Integrated Disclosure and Medicaid Cost Report General Information, incorporated by reference, and available at http://ahca.myflorida.com/Medicaid/Finance/finance/LIP-DSH/PEMT/index.shtml, and at https://www.flrules.org/Gateway/reference.asp?No=Ref-08173, to the Agency for Health Care Administration (AHCA) annually, to be eligible to use certified public expenditure funds as state match in order to receive federal financial participation in accordance with the state’s Supplemental Payment for Publicly Owned or Operated Emergency Medical Transportation Providers, SPA 2015-014, incorporated by reference, available at http://ahca.myflorida.com/Medicaid/Finance/finance/LIP-DSH/PEMT/index.shtml, and at https://www.flrules.org/Gateway/reference.asp?No=Ref-08178. The form must be completed in accordance with AHCA Form 5000-0035A, May 2017, Emergency Medical Transportation Services Cost Report Instructions, incorporated by reference, and available at http://ahca.myflorida.com/Medicaid/Finance/finance/PEMT/index.shtml, and at https://www.flrules.org/Gateway/reference.asp?No=Ref-08176.

(3) Funds are appropriated from the Medical Care Trust Fund for the Certified Public Expenditures Program for Emergency Transportation Services and are supplemental to the reimbursement rates on the Florida Medicaid Emergency Transportation Services Fee Schedule, incorporated by reference in Rule 59G-4.002, F.A.C.

(4) The Provider Reimbursement Manual CMS PUB. 15-1, April 5, 2012, is incorporated by reference, and available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Paper-Based-Manuals-Items/CMS021929.html, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-08256.

(5) Title 2, Code of Federal Regulations (CFR), Subtitle A, Chapter II Part 200, December 19, 2014, is incorporated by reference, and available at https://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title02/2cfr200_main_02.tpl, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-08177.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.908 FS. History–New 6-15-17.

Fla. Admin. Code R. 59G-6.040 Payment Methodology for ICF/MR-DD Services in Publicly Owned and Publicly Operated Facilities

Reimbursement to participating ICF/MR-DD facilities for services provided shall be in accord with the Florida Title XIX ICF/MR-DD Reimbursement Plan for Publicly Owned and Publicly Operated Facilities, Version VIII, Effective Date November 21, 2004, and incorporated herein by reference. A copy of the Plan as revised may be obtained by writing to Deputy Secretary for Medicaid, Agency for Health Care Administration, Mail Stop 8, Tallahassee, Florida 32308.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.908, 409.9131(6) FS. History–New 7-1-85, Amended 2-25-86, Formerly 10C-7.491, Amended 11-19-89, 8-14-90, 12-26-90, 9-17-91, 1-27-94, Formerly 10C-7.0491, Amended 11-15-94, 3-14-99, 11-21-04.

Fla. Admin. Code R. 59G-6.045 Payment Methodology for Services in Facilities Not Publicly Owned and Not Publicly Operated (Facilities Formerly Known as ICF-MR/DD Facilities)

(1) This rule applies to participating intermediate care facilities for individuals with intellectual disabilities (ICF/IID) not publicly owned and not publicly operated rendering Florida Medicaid services to recipients in accordance with Rule 59G 4.170, Florida Administrative Code (F.A.C.).

(2) Definitions.

(a) Acceptable cost report – A completed, accurate and legible cost report that contains all relevant schedules, worksheets and supporting documents in accordance with cost reporting instructions.

(b) AHCA – Agency for Health Care Administration.

(c) Eligibility Factor – The percentage of days that a provider is in compliance with all conditions of participation during the rate period in effect one year prior to the rate period being set.

(d) Filing due date (cost report) – No later than five calendar months after the close of the ICF/IID’s cost reporting year.

(e) Incentive – An amount paid to providers whose annual rates of cost increase for operating costs or resident care costs from one cost reporting period to the next are less than 1.4 times the average cost increase for the applicable period documented by the ICF/IID Cost Inflation Index.

(f) Interim cost per diem – A reimbursement rate or a portion of an overall reimbursement rate that is calculated from budgeted cost data divided by the total resident days.

(g) Medicaid Trend Adjustment (MTA) – The MTA is a percentage reduction that is uniformly applied to all Florida Medicaid providers each rate period when the rate setting unit cost is greater than the legislative unit cost and all quality assessment funds have been exhausted.

(h) Operating cost per diem – Those costs not directly related to resident care, property costs, or Return on Equity (ROE). Operating costs include administrative, plant operation, laundry, and housekeeping costs divided by the total resident days.

(i) Patient Responsibility – The amount a recipient is required to pay the ICF/IID, as determined by the Department of Children and Families (DCF), based upon the recipient’s monthly income.

(j) Property cost per diem – A calculation based upon those costs related to the ownership or leasing of an ICF/IID. Such costs may include property taxes, insurance, interest and depreciation, or rent divided by the total resident days.

(k) Quality Assessment – Pursuant to Section 409.9083, Florida Statutes (F.S.), a per-resident-day basis assessment is imposed upon each ICF/IID.

(l) Rate setting due date – February 1 of each year shall be the rate setting due date. All cost reports received by AHCA on or before February 1 shall be used to establish the reimbursement rates for the upcoming rate period. If February 1 falls on the weekend, the due date shall be the first business day following February 1.

(m) Reimbursement Class – Designated provider reimbursement level for the provision of services to recipients residing in an ICF/IID, as follows:

Developmental Residential and Developmental Institutional – A reimbursement level for recipients who are ambulatory or self-mobile using mechanical devices and who can transfer themselves without human assistance but may require assistance and oversight to ensure safe evacuation.
Developmental Non-ambulatory and Developmental Medical – A reimbursement level for recipients who are capable of mobility only with human assistance or require human assistance to transfer to or from a mobility device or require continuous medical and nursing supervision.

(n) Resident care cost per diem – Those costs directly attributed to nursing services, dietary costs, and other costs directly related to resident care such as activity costs, social services, and all medically-ordered therapies divided by the total resident days.

(o) Return on Equity (ROE) or use allowance cost per diem – Net Income or Profits or Shareholder’s Equity divided by the total resident days.

(p) Target Rate Factor – 1.4 times the simple average of the monthly Florida ICF/IID Cost Inflation Indices associated with the most recent cost reporting period divided by the simple average of the monthly indices associated with the prior cost reporting period.

(3) Reimbursement. Each July 1, AHCA will reimburse for Florida Medicaid services rendered by facilities not publicly owned and not publicly operated in accordance with Section 409.906, F.S.

(4) Reimbursement Methodology.

(a) Rate setting method.

Determine Inflated Prior Period Costs of Operating and Resident Care components

Prior Period Inflated Costs Per Diem = (Prior Period Base *Target Rate of Inflation)/Resident Days

Current Period Costs Per Diem = Total Allowable Cost of Component/Resident Days
Determine the Incentive Basis for Operating and Resident Care component per diems

If Prior Period Inflated Costs Per Diem > Current Period Costs Per Diem,

Incentive Basis = Prior Period Inflated Costs Per Diem ‒ Current Period Costs Per Diem

Final Incentive Per Diem

a. For Operating component = Eligibility Factor *Minimum of:

(I) Incentive Basis for Operating Component *50%

(II) Incentive Basis for Operating Component ‒ Current Period Costs Per Diem *10%

b. For Resident Care component = Eligibility Factor *Minimum of:

(I) Incentive Basis for Resident Care Component *50%

(II) Incentive Basis for Resident Care Component ‒ Current Period Costs Per Diem *3%

Current Period Base Per Diem = Current Period Costs Per Diem + Final Incentive Per Diem
Prospective Rate Per Diem = Current Period Base Per Diem *(Simple average of the monthly cost inflation indices for the prospective rate period/Simple average of the monthly cost inflation indices for the cost report period used to calculate current base per diems)
Total Prospective per diem = Prospective Rate of Operating per diem + Prospective Rate of Resident Care per diem + Property per diem + ROE or use allowance + Interim Components + MTA + Quality Assessment.

(b) Base Year ceilings for new providers in facilities with six beds or less.

Property costs per diems shall not be in excess of the established ceiling limitations.
Operating costs per diems shall not be in excess of the 90th percentile of per resident day costs of all currently participating ICF/IID providers that have prospective rates. This ceiling shall be recalculated for every rate period beginning July 1 of each year.
Resident care costs per diems shall not exceed the highest per resident day cost for the respective reimbursement class of any other currently participating provider having a prospective rate. The ceiling shall be recalculated for every rate period beginning July 1 of each year.
Total costs per diem ceilings (including ROE) shall not exceed the total costs per diem ceilings for interim cost per diems multiplied times 4% (l.04). When a provider is limited to the total ceiling in the base year, the total ceiling shall be allocated to each component to cost settle interim rates and to calculate prospective rates based on the percentage that each component's actual allowable cost is to the total actual allowable cost for all components, including ROE, in the base year.

(5) Intermediate Care Facility Quality Assessment Fee (QAF). In accordance with Section 409.9083, F.S., there is imposed upon each ICF/IID, a quality assessment. The aggregate amount of assessments for all ICF/IIDs in a given year shall be an amount not exceeding the maximum percentage allowed under federal law of the total aggregate net patient services revenue of assessed facilities.

(a) Participating ICF/IIDs shall use the Facility Quality Assessment form (only accepted electronically), AHCA Form 5000-3548, October 2013, incorporated by reference, for the submission of its monthly quality assessment. This form can be accessed at https://apps.ahca.myflorida.com/nfqa/, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-13532.

(b) Each facility shall report monthly to the Agency its total number of resident days and remit an amount equal to the assessment rate times the reported number of days. Facilities are required to submit their full quality assessment payment by the 15th day of the next succeeding calendar month.

(6) Sanctions. Providers are subject to the following monetary fines pursuant to Section 409.9083(6), F.S., for failure to timely pay a quality assessment:

(a) For a facility’s first offense, a fine of $500 per day shall be imposed until the quality assessment is paid in full, but in no event shall the fine exceed the amount of the quality assessment.

(b) For any offense subsequent to a first offense, a fine of $1,000 per day shall be imposed until the quality assessment is paid in full, but in no event shall the fine exceed the amount of the quality assessment. A subsequent offense is defined as any offense within a period of five years preceding the most recent quality assessment due date.

(c) An offense is defined as one month’s quality assessment payment not received by the 20th day of the next succeeding calendar month.

(d) In the event that a provider fails to report their total number of resident days as defined in Section 409.9083(1)(c), F.S., by the 20th day of the next succeeding calendar month, the fines in paragraphs (a)-(b) apply and the maximum amount of the fines shall be equal to their last submitted quality assessment amount, but no greater than $1000 per day, and in no event shall the total fine exceed the amount of the quality assessment.

(e) In addition to the aforementioned fines, providers are also subject to the non-monetary remedies enumerated in Section 409.9083(6), F.S. Imposition of the non-monetary remedies by the Agency will be as follows:

For a third subsequent offense, the Agency will withhold any medical assistance reimbursement payments until the assessment is recovered.
For a fourth or greater subsequent offense, the Agency will seek suspension or revocation of the facility’s license.

(7) Sanctions for failure to timely submit a quality assessment are non-allowable costs for reimbursement purposes and shall not be included in the provider’s Medicaid per diem rate.

(8) The facility may amend any previously submitted quality assessment data, but in no event may an amendment occur more than twelve months after the due date of the assessment. The deadline for submitting an amended assessment shall not relieve the facility from their obligation to pay any amount previously underpaid and shall not waive the Agency’s right to recoup any underpaid assessments.

History

Rulemaking Authority 409.919, 409.9083 FS. Law Implemented 409.908, 409.9083 FS. History–New 3-14-99, Amended 10-12-04, 2-22-06, 4-12-09, 3-3-10, 2-23-11, 7-16-12, 2-13-14, 2-4-15, 6-15-15, 7-11-16, 6-27-17, 3-11-18, 10-24-21, 4-30-25.

Fla. Admin. Code R. 59G-6.050 Payment Methodology for Medicaid Non-Institutional Provider Services

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.905(1), (6), (7), (9), (10), 409.906(4), (6), (7), (8), (15), (16), 409.908, 409.913(5)(e), (8)(h) FS. History–New 5-14-92, Amended 11-3-92, 2-10-93, 9-6-93, Formerly 10C-7.0382, Amended 6-23-94, 12-29-94, 5-16-95, Repealed 7-26-09.

Fla. Admin. Code R. 59G-6.080 Payment Methodology for Federally Qualified Health Center and Rural Health Center Services

Reimbursement to participating health centers for services provided shall be in accordance with the Florida Title XIX Federally Qualified Health Center and Rural Health Center Reimbursement Plan (the Plan), Version V, effective July 1, 2014, available at http://www.flrules.org/Gateway/reference.asp?No=Ref-05547, incorporated by reference. The Plan is applicable to the fee-for-service delivery system. A copy of the Plan as revised may be obtained by writing to the Office of the Deputy Secretary for Medicaid, 2727 Mahan Drive, Building 3, Mail Stop #8, Tallahassee, FL 32308.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.908 FS. History–New 6-3-93, Formerly 10P-6.080, Amended 4-10-94, 12-26-01, 2-1-04, 8-10-15, 5-23-16.

Fla. Admin. Code R. 59G-6.090 Payment Methodology for County Health Departments

(1) This rule applies to all county health departments (CHD)s rendering Florida Medicaid clinic services to recipients in accordance with Rule 59G-4.055, Florida Administrative Code (F.A.C.).

(2) Definitions.

(a) Allowable Cost – Cost(s) incurred for recipient-related health care services, except as outlined in subsection (5).

(b) Buy-back – A provision that allows a CHD to decrease the Medicaid Trend Adjustment from the established percent to zero percent.

(c) County Health Department (CHD) Clinic Services – Florida Medicaid primary and preventive health care services, related diagnostic services, and dental services.

(d) Encounter – A visit occurring on a specific day between a recipient and health care professional(s). Two Encounters occurring on the same day will not be reimbursed separately, even if the Encounters are for different types of services.

(e) Filing Due Date – Date that is no later than five calendar months after the close of a CHD’s cost reporting year; or, date that is within six months of a CHD’s cost reporting year, if a certified report is filed.

(f) Legislative Unit Cost – The weighted average per diem of the state anticipated expenditure after all rate reductions, but prior to any Buy-back.

(g) Medicaid Trend Adjustment – A proportional percentage rate reduction that is uniformly applied to all Florida Medicaid providers’ Rate Period, which equals all recurring and nonrecurring budget reductions on an annualized basis and is applied to all components of the prospective per diem.

(h) Rate Period – July 1 of a calendar year through June 30 of the next calendar year.

(i) Rate Setting Due Date – April 15: all cost reports received by Florida Medicaid on or before April 15 of each Rate Period will be used to establish the reimbursement rates for the subsequent Rate Period.

(j) Rate Setting Unit Cost – The weighted average per diem after all rate reductions but prior to any Buy-backs, which is based on submitted cost reports.

(3) Reimbursement. The Agency for Health Care Administration (AHCA) will reimburse for Florida Medicaid services rendered by Florida Medicaid-enrolled CHDs at a rate-per-Encounter, based upon the total Allowable Cost for each clinic in accordance with Section 409.908, Florida Statutes (F.S.).

(4) Reimbursement Methodology.

The Agency for Health Care Administration establishes reimbursement Encounter rates for each CHD that renders services in accordance with Title 42, Code of Federal Regulations (CFR), section 440.90. The rates become effective on July 1 of the applicable Rate Period and are calculated as follows:

(a) Setting Individual CHD Rates. To determine reimbursement Encounter rates, AHCA will perform the following:

Review and adjust each CHD’s cost report (available to AHCA as of the Rate Setting Due Date) to reflect the results of desk and field audits.
Determine each CHD’s Encounter rate by dividing total Allowable Cost by total allowable Encounters.
Adjust each CHD’s Encounter rate with an inflation factor based on the Consumer Price Index (CPI) at the midpoint of the CHD’s cost reporting period divided by the CPI projected for the midpoint of each Rate Period.

(b) Method of Establishing Historical Rate Reductions.

To establish historical rate reductions, AHCA will apply a recurring methodology that incorporates the reductions imposed in the following manner:

a. Divide the total amount of each recurring reduction imposed by the number of Encounters originally used in the rate calculation for each rate setting period, which will yield a rate reduction per diem for each Rate Period.

b. Multiply the resulting rate reduction per diem for each Rate Period by the projected number of Encounters used in establishing the current budget estimate, which will yield the total current reduction amount to be applied to current rates.

c. In the event that the total current reduction amount is greater than the historical reduction amount, AHCA will hold the rate reduction to the historical reduction amount.

The recurring methodology includes an efficiency calculation wherein the reduction amount is subtracted from the CHD prospective rate to calculate the final prospective rate, which cannot exceed the $180 ceiling rate nor be lower than the $100 floor rate. If the floor rate is higher than the CHD prospective rate, the CHD prospective rate (which cannot exceed cost) will be used.

Apply the first rate reduction based on the calculations outlined above and proportionately reduce the rates until the required savings is achieved.
Compare the unit cost for the current rate setting to the budgeted unit cost for state fiscal year (SFY) 2010-2011, which is ($163.10). If the unit cost for the current rate setting is less than the budgeted unit cost for SFY 2010-2011, no further rate reduction will be required.
Utilize the Buy-back CHD Clinic Services amount provided in the General Appropriations Act for the applicable Rate Period for rate reductions that were effective on or after July 1, 2008.
The total Buy-back amount must not exceed the total reductions.

(5) Exclusion. Costs related to the following services are excluded from each CHD’s reimbursement Encounter rate and will be reported in the cost report under non-allowable service(s):

(a) Ambulance services.

(b) Home health services.

(d) Any health care services rendered away from the clinic, at a hospital, or a nursing home, including off-site radiology and clinical laboratory services. However, services rendered away from the clinic may be reimbursable under a Florida Medicaid service-specific coverage policy, if the services were provided in accordance with the applicable coverage policy.

(e) Prescription drugs and immunization costs.

(6) Cost Settlement. Reimbursement rates may be adjusted under one of the following conditions:

(a) Submission of amended cost reports.

(b) The results of a desk or on-site audit.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.908, 409.913 FS. History–New 6-3-93, Formerly 10P-6.090, Amended 7-21-02, 3-10-94, 11-21-04, 1-11-09, 3-24-10, 2-23-11, 5-3-12, 4-3-13, 4-23-14, 5-3-15, 8-10-15, 6-15-16, 4-12-17, 3-11-18, 2-27-20.

Chapter 59G-7 THIRD-PARTY LIABILITY

Fla. Admin. Code R. 59G-7.003 Medicaid Third Party Liability Responsibility and Notices

History

Rulemaking Authority 409.026(8), 409.910(23), 409.919 FS. Law Implemented 409.910 FS. History–New 11-13-91, Formerly 10C-35.003, Amended 10-3-96, Repealed 8-14-18.

Fla. Admin. Code R. 59G-7.004 Forms

History

Rulemaking Authority 120.53(1)(b), (c), 409.026(1), (6), (8), 409.910(23), 409.919 FS. Law Implemented 120.52(16), 120.53(1), 409.910 FS. History–New 11-13-91, Formerly 10C-35.004, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.0211 Exchange of Medicaid Data with Health Insurers

History

Rulemaking Authority 409.026(8), 409.910(22), (23), 409.919 FS. Law Implemented 409.910(20), 624.424(9), 641.261, 641.411 FS. History–New 11-14-89, Formerly 10C-7.0302, Amended 11-13-91, Formerly 10C-35.0211, Amended 10-3-96, Repealed 9-24-18.

Fla. Admin. Code R. 59G-7.023 Probable Existence of Third-Party Liability Established

History

Rulemaking Authority 409.026(8), 409.910(23), 409.919 FS. Law Implemented 409.910(1), (3) FS. History–New 11-13-91, Formerly 10C-35.023, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.032 Recovery of Reimbursement - General

History

Rulemaking Authority 409.026(8), 409.910(23), 409.919 FS. Law Implemented 409.910 FS. History–New 11-13-91, Formerly 10C-35.032, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.0322 Conflicting Claims by Medicare and Medicaid

History

Rulemaking Authority 120.53(1)(b), (c), 409.026(8), 409.910(23), 409.919 FS. Law Implemented 120.53(1)(b), (c), 409.910 FS. History–New 11-13-91, Formerly 10C-35.0322, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.0331 Small Claim Exception under Paragraph (11)(f) of the MTPLA

History

Rulemaking Authority 120.53(1), 409.026(8), 409.910(23), 409.919 FS. Law Implemented 120.53(1), 409.910 FS. History–New 11-13-91, Formerly 10C-35.0331, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.0332 All Medical Assistance; Medicaid Program Repaid First

History

Rulemaking Authority 409.026(8), 409.910(23), 409.919 FS. Law Implemented 409.910 FS. History–New 11-13-91, Formerly 10C-35.0332, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.034 Settlement Agreements

History

Rulemaking Authority 20.05, 120.53(1)(b), (c), 409.026(8), 409.285, 409.910(23), 409.919 FS. Law Implemented 120.53(1)(b), (c), 120.57, 120.58, 409.285, 409.902, 409.910 FS. History–New 11-13-91, Formerly 10C-35.034, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.035 Fees of Recipient’s Attorney

History

Rulemaking Authority 409.026(8), 409.910(23), 409.919 FS. Law Implemented 409.910 FS. History–New 11-13-91, Formerly 10C-35.035, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.051 Required to Seek Reimbursement

History

Rulemaking Authority 409.026(8), 409.910(23), 409.919 FS. Law Implemented 409.902, 409.907, 409.908, 409.910, 409.912, 409.913, 409.920 FS. History–New 11-13-91, Formerly 10C-35.051, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.053 Hospital Third-Party Liability Plan

History

Rulemaking Authority 409.026(8), 409.910(23), 409.919 FS. Law Implemented 409.902, 409.907, 409.908, 409.910, 409.912, 409.913, 409.920 FS. History–New 11-13-91, Formerly 10C-35.053, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.054 Prompt Repayment

History

Rulemaking Authority 409.026(8), 409.910(23), 409.919 FS. Law Implemented 409.902, 409.907, 409.908, 409.910, 409.912, 409.913, 409.920 FS. History–New 11-13-91, Formerly 10C-35.054, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.056 Benefits under Certain Plans

History

Rulemaking Authority 409.026(8), 409.910(21), 409.919 FS. Law Implemented 409.902, 409.907, 409.908, 409.910, 409.912, 409.913, 409.920 FS.; 42 U.S.C. ss. 1396a(a)(25), (a)(27), (a)(45), 1396k (Social Security Act ss. 1902(a)(25), (a)(27), (a)(45), 1912); 42 C.F.R. ss. 433.135-433.140, 447.15, 447.20, 447.21. History–New 11-13-91, Formerly 10C-35.056, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.057 Provider Third-Party Liability Audits

History

Rulemaking Authority 409.026(8), 409.910(23), 409.919 FS. Law Implemented 409.902, 409.907, 409.908, 409.910, 409.912, 409.913, 409.920 FS. History–New 11-13-91, Formerly 10C-35.057, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.058 Billing Statement and Medical Records

History

Rulemaking Authority 409.026(8), 409.910(23), 409.919 FS. Law Implemented 409.902, 409.907, 409.908, 409.910, 409.912, 409.913, 409.920 FS. History–New 11-13-91, Formerly 10C-35.058, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.0581 Statements as Notice

History

Rulemaking Authority 409.026(8), 409.910(23), 409.919 FS. Law Implemented 409.902, 409.907, 409.908, 409.910, 409.912, 409.913, 409.920 FS. History–New 11-13-91, Formerly 10C-35.0581, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.060 Cooperation Required

History

Rulemaking Authority 120.53, 409.026(8), 409.910(23), 409.919 FS. Law Implemented 120.57, 120.58, 120.68, 409.901, 409.902, 409.910, 409.920(2)(a), (c) FS. History–New 11-13-91, Formerly 10C-35.060, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.0601 Non-cooperation

History

Rulemaking Authority 120.53, 409.026(8), 409.910(23), 409.919 FS. Law Implemented 120.57, 120.58, 120.68, 409.901, 409.902, 409.910, 409.920(2)(a), (c) FS. History–New 11-13-91, Formerly 10C-35.0601, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.061 Duty to Inform

History

Rulemaking Authority 409.026(8), 409.910(23), 409.919 FS. Law Implemented 409.901, 409.902, 409.910, 409.920(2)(a), (c) FS. History–New 11-13-91, Formerly 10C-35.061, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.062 Notice of Proceedings or Claim

History

Rulemaking Authority 409.026(8), 409.910(23), 409.919 FS. Law Implemented 409.901, 409.902, 409.910, 409.920(2)(a), (c) FS. History–New 11-13-91, Formerly 10C-35.062, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.063 Settlement and Notice

History

Rulemaking Authority 409.026(8), 409.910(23), 409.919 FS. Law Implemented 409.901, 409.902, 409.910, 409.920(2)(a), (c) FS. History–New 11-13-91, Formerly 10C-35.063, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.064 Appearance to Provide Information

History

Rulemaking Authority 409.026(8), 409.910(23), 409.919 FS. Law Implemented 120.58, 409.257, 409.901, 409.902, 409.910, 409.920(2)(a), (c) FS. History–New 11-13-91, Formerly 10C-35.064, Amended 10-3-96, Repealed 5-10-12.

Fla. Admin. Code R. 59G-7.007 Health Insurance Premium Payment Program

(1) Under the Health Insurance Premium Payment (HIPP) program, the Agency for Health Care Administration (AHCA) shall provide financial assistance to recipients in order to obtain or maintain Employer Sponsored Insurance (ESI) coverage pursuant to sections 409.9122(14) and 409.977(4), F.S. This includes the recipient’s share of the ESI premiums, copayments, deductibles, coinsurance and other cost sharing obligations for Medicaid services and items covered under the State Plan. The amount of financial assistance provided for each recipient may not exceed the amount of the Medicaid managed care premium that would have been paid for that recipient.

(a) The recipient’s health care services will be covered through their ESI primary coverage. Medicaid will cover the lesser of the ESI required copayments, deductibles, or coinsurance, up to the Medicaid fee when the recipient’s ESI provider is also a Medicaid enrolled provider. Medicaid will deduct any applicable Medicaid copay for covered state plan services. If a recipient chooses to utilize non-Medicaid providers, only the ESI coverage will apply and the recipient may be subject to ESI required copayments, deductibles, or coinsurance.

(b) Medicaid will cover any state plan services that are not provided by the recipient’s ESI when those services are provided by an enrolled Medicaid provider.

(2) Participation in the HIPP program.

(a) Recipients must enroll in or be enrolled in and maintain their ESI coverage during the period of participation. Recipients will be identified by AHCA, or its designee, and will be sent an enrollment package.

(b) Participation in the program shall be subject to a cost effectiveness determination as defined in subsection (3) of this rule, by AHCA and subsequent redeterminations, at least once every six months.

For non-pregnant adult Medicaid recipients with access to ESI for whom AHCA has made a determination of cost effectiveness, participation shall be mandatory.
For Medicaid recipients with proof of ESI through a spouse or other family member for whom AHCA has made a determination of cost effectiveness, participation shall be voluntary.

Loss of Medicaid eligibility.
Loss of access to ESI coverage.
A determination of non-cost effectiveness.

(3) Health Insurance Premium Payment assistance cost effectiveness determination.

(a) When determining cost effectiveness, the following data elements shall be considered:

The amount of the Medicaid managed care premium that would have been paid for that recipient.
The amount of the recipient’s share of the ESI premium.
The amount of copayments, coinsurance, deductibles and other cost sharing obligations as determined by the average fee-for-service expenditures for recipients with other comparable insurance coverage.
The amount of AHCA’s administrative cost.

(b) The calculation used to determine whether a recipient qualifies for HIPP assistance shall be a ≥ (b+c+d). The Medicaid managed care premium (a), must be greater than or equal to amount of the recipient’s share of the ESI premium (b), plus the amount for copayments, coinsurance, deductibles and other cost sharing obligations (c), plus the amount of any administrative cost (d).

(4) HIPP premium payments.

Any financial assistance provided towards the payment of a recipient’s share of the ESI premium shall be in the form of a reimbursement issued after receipt of the proper documentation. Recipients must pay their ESI premium and submit a request with supporting documentation for reimbursement to AHCA, or its designee.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.977(4) FS. History–New 3-30-15.

Fla. Admin. Code R. 59G-7.073 Proceeds of Tort Recovery Required to Be Held in Trust

History

Rulemaking Authority 409.026(8), 409.910(23), 409.919 FS. Law Implemented 409.910 FS. History–New 11-13-91, Formerly 10C-35.073, Amended 10-3-96, Repealed 5-10-12.

Chapter 59G-8 MANAGED CARE

Fla. Admin. Code R. 59G-8.100 Medicaid Contracts for Prepaid Health Plans

History

Rulemaking Authority 409.9124, 409.919 FS. Law Implemented 409.9124(1) FS. History–New 3-9-81, Amended 7-9-84, Formerly 10C-7.524, Amended 4-5-89, Formerly 10C-7.0524, Amended 8-4-02, 1-23-05, 5-9-06, Repealed 8-18-15.

Fla. Admin. Code R. 59G-8.200 Home and Community Based Services Waivers

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.908, 409.910, 409.412, 409.413 FS. History–New 4-20-82, Formerly 10C-7.527, Amended 3-22-87, 11-23-89, Formerly 10C-7.0527, Amended 1-16-96, 7-23-97, 1-6-02, 10-27-02, 6-11-03, 11-24-03, 1-16-05, 6-23-05, Transferred to 59G-13.080.

Fla. Admin. Code R. 59G-8.300 Medicaid Case Management

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906(11), 409.912(7) FS. History–New 9-20-88, Formerly 10C-7.0381, Amended 2-13-96, Repealed 7-26-09.

Fla. Admin. Code R. 59G-8.400 Medicaid Physician Access System

History

Rulemaking Authority 409.919 FS. Law Implemented 409.9121, 409.9122 FS. History–New 6-10-91, Formerly 10C-7.067, Amended 12-18-94, Repealed 8-18-15.

Fla. Admin. Code R. 59G-8.600 Disenrollment from Managed Care Plans

(1) Purpose. A Florida Medicaid recipient (herein referred to as an enrollee) who is required to enroll in the Statewide Medicaid Managed Care (SMMC) program, may request to change managed care plans. Requests must be submitted via telephone or in writing to the Agency for Health Care Administration (AHCA) or its enrollment broker. Enrollees required to enroll in SMMC programs should not interpret this rule as an exemption from participation in Florida Medicaid’s SMMC program. This rule applies to the process and reasons that SMMC managed care plan enrollees may change plans.

(2) Requests for disenrollment must be completed in accordance with Section 409.969, Florida Statutes (F.S.), and Title 42, Code of Federal Regulations (CFR), section 438.56 (42 CFR 438.56).

(3) For Cause Reasons.

(a) Reasons outlined in 42 CFR 438.56(d)(2) and Section 409.969(2), F.S., constitute cause for disenrollment at any time from a managed care plan:

The managed care plan does not cover the service the enrollee seeks because of moral or religious objections.
The enrollee would have to change his or her residential or institutional provider based on the provider’s change in status from an in-network to an out-of-network provider with the managed care plan.
Fraudulent enrollment.

(b) Reasons outlined in 42 CFR 438.56(d)(2) and Section 409.969(2), F.S., constitute cause for disenrollment from a managed care plan when the enrollee first seeks resolution through the managed care plan’s grievance process, as confirmed by AHCA, in accordance with 42 CFR 438.56(d)(5), except when there is an allegation of immediate risk of permanent damage to the enrollee’s health:

The enrollee needs related services to be performed concurrently, but not all related services are available within the managed care plan’s network, and the enrollee’s primary care provider or another provider has determined that receiving the services separately would subject the enrollee to unneccessary risk.
Poor quality of care.
Lack of access to services covered under the managed care plan’s contract with AHCA, including lack of access to medically-necessary specialty services.
There is a lack of access to managed care plan providers experienced in dealing with the enrollee’s health care needs.
The enrollee experienced an unreasonable delay or denial of service pursuant to Section 409.969(2), F.S.

(4) The Agency for Health Care Administration, or its designee, will review any relevant documentation submitted by the enrollee or the managed care plan regarding the disenrollment request and make a final determination about whether to grant the disenrollment request. The Agency for Health Care Administration will send written correspondence to the enrollee of any disenrollment decision. Enrollees dissatisfied with AHCA’s determination may request a Florida Medicaid fair hearing, pursuant to 42 CFR Part 431, Subpart E.

(5) The Agency will review this rule five years from the effective date and repromulgate, amend or repeal the rule as appropriate, in accordance with Section 120.54, F.S., and Chapter 1-1, F.A.C.

History

Rulemaking Authority 409.961 FS. Law Implemented 409.969 FS. History–New 2-26-09, Amended 11-8-16, 1-30-19, 2-15-21.

Fla. Admin. Code R. 59G-8.700 Child Health Services Targeted Case Management

Individuals enrolled as Child Health Services targeted case managers must be in compliance with the Child Health Services Targeted Case Management Coverage and Limitations Handbook, June 2012, https://www.flrules.org/Gateway/reference.asp?No=Ref-01329, which is incorporated by reference. Medicaid will reimburse only targeted case management services that are provided by enrolled individual treating providers employed or contracted with an enrolled targeted case management group provider or agency. Such enrolled provider or agency is not permitted to subcontract with another provider or agency for service delivery. The handbook is available from the Medicaid fiscal agent’s Web site at mymedicaid-florida.com. Select Public Information for Providers, then Provider Support, and then Provider Handbooks. Paper copies of the handbook may be obtained by calling the Medicaid fiscal agent at 1(800) 289-7799 and selecting option 7.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History–New 8-8-12.

Fla. Admin. Code R. 59G-8.800 Financial Compliance Audits of Medicaid Prepaid Plans

(1) Pursuant to Section 409.967(3)(b), Florida Statutes (F.S.), the Agency for Health Care Administration (hereafter referred to as Agency) shall contract with independent certified public accountants to conduct compliance audits of Florida Medicaid prepaid health plans.

(a) Certified public accountants that participate in the preparation of a plan’s financial audits or annual statements submitted by the plan pursuant to Sections 409.967(3)(a)1. and 2., F.S., will be deemed to have a conflict of interest and are not independent regarding preparation of a compliance audit for that plan pursuant to Section 409.967(3)(c)1., F.S.

(b) The Agency will procure, pursuant to Chapter 287, F.S., services from Florida licensed certified public accountants to perform compliance audits required by Section 409.967(3)(b), F.S. Rates established for the services utilized for compliance audits will be established through the procurement process and will be comparable to market rates the Agency pays for similar accounting and auditing services.

(c) A Florida Medicaid prepaid health plan audited pursuant to Section 409.967(3)(b), F.S., must pay the Agency costs, charges, and expenses for the compliance audit at the rates established by the Agency pursuant to the procurement process. The rates established by the Agency for compliance audits will include:

Travel reimbursement.
Compensation of professional and support services.
The Agency’s administrative costs directly related to the audit.

(2) The Agency will prepare and provide each Florida Medicaid prepaid health plan audited a detailed statement of the costs, charges, and expenses for the audit. A plan must pay the Agency the costs, charges, and expenses identified in the detailed statement within 15 days of the Agency’s presentation of the statement to the plan.

History

Rulemaking Authority 409.961, 409.967 FS. Law Implemented 409.967 FS. History‒New 5-1-14.

Chapter 59G-9 OVERSIGHT OF INTEGRITY

Fla. Admin. Code R. 59G-9.060 Utilization Control in Institutional Care Facilities

History

Rulemaking Authority 409.266(15) FS. Law Implemented 409.026(1), (6), 409.266 FS. History–New 7-16-79, Amended 7-5-81, 1-2-84, 10-15-85, Formerly 10C-7.58, Amended 12-21-87, 5-17-90, Formerly 10C-7.058, Repealed 7-26-09.

Fla. Admin. Code R. 59G-9.070 Administrative Sanctions on Providers, Entities, and Persons

(1) Purpose. This rule provides notice of administrative sanctions imposed upon a provider, entity, or person for each violation of any Medicaid-related law.

(2) Applying and reporting sanctions. Notice of the application of sanctions will be by way of written correspondence, and the final notice shall be the point of entry for administrative proceedings pursuant to Chapter 120, F.S. Satisfaction of an overpayment following a preliminary audit report, will not avoid the application of sanctions at a final audit report, unless the Agency for Health Care Administration (Agency) offers amnesty pursuant to section 409.913(25)(e), F.S. The Agency shall report all sanctions imposed upon any provider, entity, or person, or any principal, officer, director, agent, managing employee, or affiliated person of a provider, who is regulated by another state entity, regardless of whether enrolled in the Medicaid program, to that other state entity. Sanctions are imposed upon the Final Order being filed with the Agency Clerk.

(3) Definitions.

(a) “Audit report” is the written notice of determination that a violation of Medicaid laws has occurred, and where the violation results in an overpayment, it also shows the calculation of overpayments.

(b) “Claim” is as defined in section 409.901(6), F.S., and includes the total monthly payment to a provider for per diem payments, and the payment of a capitation rate for a Medicaid recipient.

(c) “Contemporaneous records” means records created at the time the goods or services were provided, unless otherwise specified in Medicaid laws, or the laws that govern the provider’s profession.

(d) A “Corrective action plan” is an activity to address the specific areas of non-compliance, determined by the Agency, to reduce the risk of future non-compliance.

(e) An “Erroneous claim” is an application for payment from the Medicaid program, or its fiscal agent, that contains an inaccuracy.

(f) “Fine” is a monetary sanction. The amount of a fine shall be as set forth within this rule.

(g) A “False claim” is as provided for in the Florida False Claims Act, set forth in Chapter 68, F.S.

(h) “Offense” means the occurrence of one or more violations as set forth in a final audit report. For purposes of the progressive nature of sanctions under this rule, offenses are characterized as “first,” “second,” “third,” or “subsequent” offenses; subsequent offenses are any occurrences after a third offense.

(i) “Patient record” means the patient’s medical record, including all documentation maintained by the provider, entity, or person to document furnishing, ordering, or authorizing goods or services, and includes the documentation in multiple files if the practitioner maintains separate files for different types of documentation.

(j) “Patient record request” means a request by the Agency for Medicaid-related documentation or information. Such requests are not limited to Agency audits to determine overpayments or violations, and are not limited to enrolled Medicaid providers. Each requesting document constitutes a single patient record request.

(k) “Pattern of erroneous claims” is defined as when more than 5% of the claims reviewed are found to contain an error, or the reimbursements for the claims found to contain an error, are more than 5% of the total reimbursement for the claims reviewed.

(l) “Provider” is as defined in section 409.901(17), F.S., and includes all of the provider’s locations that have the same base provider number (with separate locator codes).

(m) “Provider group” is more than one individual provider practicing under the same tax identification number, enrolled in the Medicaid program as a group for billing purposes, and having one or more locations.

(n) “Sanction” shall be any monetary or non-monetary disincentive imposed pursuant to this rule; a monetary sanction may be referred to as a “fine.”

(o) “Suspension” is a one-year preclusion from furnishing, supervising a person who is furnishing, or causing a person to furnish goods or services that result in a claim for payment to the Medicaid program. Suspension applies to any person, corporation, partnership, association, clinic, group, or other entity, whether or not enrolled in the Medicaid program.

(p) “Termination” is a twenty-year preclusion from furnishing, supervising a person who is furnishing, or causing a person to furnish goods or services that result in a claim for payment to the Medicaid program. Termination applies to any person, corporation, partnership, association, clinic, group, or other entity, whether or not enrolled in the Medicaid program; however, if termination is imposed against a provider enrolled in the Medicaid program, the provider agreement shall also be terminated. A termination pursuant to this rule is also called a “for cause” or “with cause” termination.

(q) “Violation” means any omission or act performed by a provider, entity, or person that is contrary to Medicaid laws, the laws that govern the provider’s profession, or the Medicaid provider agreement.

For purposes of this rule, each day that an ongoing violation continues, and each instance of an act or omission contrary to a Medicaid law, a law that governs the provider’s profession, or the Medicaid provider agreement shall be considered a “separate violation.”
For purposes of determining first, second, third, or subsequent offenses under this rule, prior Agency actions during the preceding five years will be counted where the provider, entity, or person was deemed to have committed the same violation.
The failure to comply with a corrective action plan constitutes a violation, and is an ongoing violation, for each day following the deadline for submission of the corrective action plan that the failure continues.
For purposes of determining a violation regarding including an unallowed cost in a cost report (paragraph (7)(k) and section 409.913(15)(k), F.S.), if the unallowed cost or costs are the subject of an administrative hearing pursuant to Chapter 120, F.S., inclusion of the unallowed cost, or costs, in a cost report is not a violation until the conclusion of the administrative proceedings.
For purposes of violations under paragraph (7)(n) of this rule, regarding purchase shortages (as opposed to shortages of time), each good found to be short, by units of each type of goods, such as each tablet of a particular drug, is a violation.
For purposes of violations under paragraph (7)(q) of this rule (generally, non-payment on a payment plan), a second, third, or subsequent offense occurs when there has been a prior violation on any repayment agreement.

(4) Limits on sanctions.

(a) Where a sanction is applied for violations of Medicaid laws (under paragraph (7)(e) of this rule), for a pattern of erroneous claims (under paragraph (7)(h) of this rule), or shortages of goods (under paragraph (7)(n) of this rule), and the violations are a “first offense” as set forth in this rule, if the cumulative amount of the fine to be imposed as a result of the violations giving rise to that overpayment exceeds 20% of the amount of the overpayment, the fine shall be adjusted to 20% of the amount of the overpayment.

(b) Where a sanction is applied for violations of Medicaid laws (under paragraph (7)(e) of this rule), for a pattern of erroneous claims (under paragraph (7)(h) of this rule), or shortages of goods (under paragraph (7)(n) of this rule), and the violations are a “second offense” as set forth in this rule, if the cumulative amount of the fine to be imposed as a result of the violations giving rise to that overpayment exceeds 40% of the amount of the overpayment, the fine shall be adjusted to 40% of the amount of the overpayment.

(c) Where a sanction is applied for violations of Medicaid laws (under paragraph (7)(e) of this rule), for a pattern of erroneous claims (under paragraph (7)(h) of this rule), or shortages of goods (under paragraph (7)(n) of this rule), and the violations are a “third” or “subsequent” offense, if the cumulative amount of the fine for violations giving rise to the overpayment exceeds 50% of the amount of the overpayment, the fine shall be adjusted to 50% of the amount of the overpayment.

(d) Where the audit report does not include an overpayment determination, it only applies a sanction, and where a fine is assessed for violations that are a “first offense” as set forth in this rule, the cumulative amount of the fine shall not exceed $20,000; where the violations are a “second offense” as set forth in this rule, the cumulative amount of the fine shall not exceed $50,000; where the violations are a “third or subsequent offense” as set forth in this rule, there are no limits on the cumulative amount of the fine to be applied.

(e) Where a sanction would apply pursuant to this rule, no sanction will be imposed if the Agency has instituted an amnesty pursuant to section 409.913(25)(e), F.S.

(5) Mandatory termination or suspension. Whenever the Agency is required to terminate or suspend participation in the Medicaid program and the required period of time for the exclusion exceeds one year, the sanction of termination shall apply.

(6) Additional requirements regarding suspension and termination.

(a) For purposes of this rule a “suspension” precludes participation for one year, or such shorter period of time as is set forth in this rule. The suspension period begins from the date of the Final Order that imposes the Agency action.

To resume participation following the suspension period, a written request must be submitted to the Agency’s Bureau of Medicaid Program Integrity seeking to be reinstated in the Medicaid program. The request must include a copy of the notice of suspension and a statement regarding whether the violation(s) that brought rise to the suspension have been remedied. If the provider, entity, or person was not enrolled in the Medicaid program at the time of the suspension, the request must also include a complete and accurate provider enrollment application, even if the person or entity seeks only to prescribe, or otherwise order or authorize goods or services, and does not seek to directly furnish goods or services to Medicaid recipient; the application will be processed, and accepted or denied in the standard course of business by the Agency.
Participation in the Medicaid program may not resume until written confirmation is issued from the Agency indicating that participation has been authorized. Where a Medicaid provider application is required, authorization is at the point where the person or entity is enrolled as a provider; if the application is not granted, the person or entity may not resume participation.

(b) For purposes of this rule, a “termination” shall preclude participation in the Medicaid program for twenty years from the date of the Agency action. The termination period begins from the date of the Final Order that imposes the Agency action, unless the termination is an “immediate termination.” An immediate termination period begins from the date of notice of the termination.

To resume participation, the provider, entity, or person must submit a complete and accurate provider enrollment application, which will be processed, and accepted or denied in the standard course of business by the Agency. In addition to the application, the provider, entity, or person must include a copy of the notice of termination issued by the Agency, and a written acknowledgement regarding whether the violation(s) that brought rise to the termination has been remedied.

(7) Sanctions. In addition to the recoupment of the overpayment, if any, the Agency will impose sanctions as outlined in this subsection. Except when the Secretary of the Agency determines not to impose a sanction, pursuant to section 409.913(16)(j), F.S., sanctions shall be imposed as follows:

(a) A required license is not renewed, or is revoked, suspended, or terminated: For a first offense of suspension, suspension for the duration of the licensure suspension; for all other violations, including suspension after a first offense, termination (section 409.913(15)(a), F.S.).

(b) For failure to make available, or refused access to Medicaid-related records necessary to review, investigate, analyze, audit, or any combination thereof, to determine if care, services, or goods were provided in compliance with applicable Medicaid laws, regulations, and policy. Making available only partial records or access is a violation: For a first offense, $2,500 fine, per record request or instance of refused access, and suspension until the records are made available or access is granted; if after 10 days the violation continues, an additional $1,000 fine, per day; and, if after 30 days the violation remains ongoing, termination. For a second offense, $5,000 fine, per record request or instance of refused access, and suspension until the records are made available or access is granted; if after 10 days the violation continues, an additional $2,000 fine, per day; and, if after 30 days the violation remains ongoing termination. For a third, or subsequent offense, termination (section 409.913(15)(b), F.S.).

(c) For failure to make available or furnish all Medicaid-related records necessary to be used in determining whether, and what amount should have, or should be, reimbursed. Submission of partial or incomplete records does not comply with the records request and is a violation: For a first offense, $2,500 fine, per record request, and suspension until the records are made available; if after 10 days the violation continues, an additional $1,000 fine, per day; and, if after 30 days the violation remains ongoing, termination. For a second offense, $5,000 fine, per record request, and suspension until the records are made available; if after 10 days the violation continues, an additional $2,000 fine, per day; and, if after 30 days the violation remains ongoing, termination. For a third, or subsequent offense, termination (section 409.913(15)(c), F.S.).

(d) For failure to maintain contemporaneous documentation if the records not maintained are necessary to know that care, services, or goods were provided. Contemporaneous records that are partial or incomplete are a violation: For a first offense, $250 fine, per claim; however, if there are more than two claims for the same patient without records, or more than two patients for which no records are maintained, $2,500 fine, per patient for which there are any claims without records. For a second offense, $500 fine, per claim; however, if there are more than two claims for the same patient without records, or more than two patients for which no records are maintained, $5,000 fine, per patient for which there are any claims without records. For a third or subsequent offense, termination (section 409.913(15)(d), F.S.).

(e) For failure to comply with the provisions of the Medicaid laws: For a first offense, $1,000 fine, per claim found to be in violation. For a second offense, $2,500 fine, per claim found to be in violation. For a third, or subsequent offense, $5,000 fine, per claim found to be in violation. For a violation of law that would mandate exclusion, termination; for a violation of law that could result in patient harm, termination; for violations of prerequisites to enrollment, termination (sections 409.907(10), and 409.913(14) and (15)(e), F.S.).

(f) For furnishing, authorizing, or ordering goods or services that are inappropriate, unnecessary, excessive, of inferior quality, or harmful: For a first offense, $1,000 fine; however, if there is more than one instance, $5,000 fine, per instance; For a second offense, $5,000 fine; however, if there is more than one instance, $5,000 fine per instance, and suspension; For a third and subsequent offense, $5,000 fine per instance, and suspension, however; if there is more than one instance, termination (section 409.913(15)(f), F.S.).

(g) For a pattern of failure to provide necessary care: For a first offense, $5,000 fine for each instance, and suspension. For a second or subsequent offense, termination (section 409.913(15)(g), F.S.).

(h) For false, or a pattern of erroneous, Medicaid claims:

For false claims, termination.
For a first offense of a pattern of erroneous claims, $1,000 fine, per claim found to be erroneous. For a second offense of a pattern of erroneous claims, $2,500 fine, per claim found to be erroneous. For a third, or subsequent offense of a pattern of erroneous claims, $5,000 fine, per claim found to be erroneous (section 409.913(15)(h), F.S.).

(i) For an application, renewal, prior authorization, drug exception request, or cost report with materially false or materially incorrect information: For a first offense, $10,000 fine, for each instance of false or incorrect information, and suspension. For a second, and subsequent offense, termination (section 409.913(15)(i), F.S.).

(j) For improperly collecting or billing a recipient: For a first offense, $5,000 fine, per instance, and suspension; for a second, and subsequent offense, termination (section 409.913(15)(j), F.S.).

(k) For including costs in a cost report that are not authorized under the Medicaid state plan, or that were disallowed during the audit process, after having been advised that the costs were not allowable: For a first offense, $5,000 fine; however, if after 30 days the violation continues, suspension, and $1,000 fine, per day that the violation continues. For a second offense, $5,000 fine; however, if after 30 days the violation continues, suspension, and $5,000 fine, per day that the violation continues. For a third, and subsequent offense, termination (section 409.913(15)(k), F.S.).

(l) For being charged by information or indictment under federal law or the law of any state relating to the practice of the provider’s profession, or an offense as referenced in section 409.913(13), F.S., or a criminal offense referenced in section 408.809(4), 409.907(10), or 435.04(2), F.S.: Immediate suspension for the duration of the indictment and, if convicted, termination (section 409.913(15)(l), F.S.).

(m) For negligently ordering or prescribing, which resulted in the patient’s injury or death: immediate termination (section 409.913(15)(m), F.S.).

(n) For shortages of time: For a first offense, $5,000 fine, per day found to have shortages, not to exceed the total Medicaid reimbursement for the day(s) with shortages; For a second offense, $5,000 fine, per day found to have shortages, not to exceed two-times the total Medicaid reimbursement for the day(s) with shortages; For a third or subsequent offense, termination. For shortages of goods: For a first offense, $1,000 fine, per type of good found to be short. For a second offense, $2,500 fine, per type of good found to be short. For a third, or subsequent offense, $5,000 fine, per type of good found to be short (section 409.913(15)(n), F.S.).

(o) For failure to comply with the notice and reporting requirements of section 409.907, F.S: For a first offense, $2,500 fine. For a second offense: $5,000 fine. For a third, and subsequent offense: termination (section 409.913(15)(o), F.S.).

(p) For a finding of patient abuse or neglect, or any act prohibited by section 409.920, F.S.: Immediate suspension, and if convicted: termination (section 409.913(15)(p), F.S.).

(q) For failure to comply with any of the terms of a previously agreed-upon repayment schedule: For a first offense: $5,000 fine, and suspension until the violation is corrected; if after 30 days the violation continues: termination. For a second offense: $5,000 fine, and suspension until the violation is corrected, and, if the violation is not corrected within 5 calendar days, an additional $1,000 fine, per day for which the violation continues; if after 30 days the violation continues: termination. For a third, and subsequent offense: termination (sections 409.913(15)(q) and 409.913(25)(c), F.S.).

(r) For violations under sections 409.913(13), F.S. (generally, criminal offenses related to the delivery of health care, the practice of the provider’s profession, and patient abuse or neglect), the Agency shall consider the violations identified in sections 435.04 and 408.809, F.S., as related to the provider’s profession, and shall impose immediate termination.

(s) For non-payment or partial payment where monies are owed to the Agency, and failure to enter into a repayment agreement, in accordance with sections 409.913(25)(c) and 409.913(30), F.S., the Agency shall impose the sanction of termination.

(8) Additional sanctions for multiple violations under the sanction rule. In the event the Agency issues an audit report wherein it has determined that violations of more than one provision of this rule (the sanction rule) have been committed, the Agency shall cumulatively apply the sanction associated with each section; if the violations invoke three or more provisions of this rule (the sanction rule), a corrective action plan will also be required.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.907, 409.913, 409.920 FS. History–New 4-19-05, Amended 4-26-06, 10-29-08, 9-7-10, 7-25-17.

Chapter 59G-11 FLORIDA 211 NETWORK PROVIDER CERTIFICATION REQUIREMENTS

Fla. Admin. Code R. 59G-11.001 Purpose

History

Rulemaking Authority 408.918 FS. Law Implemented 408.918 FS. History–New 4-24-03, Repealed 9-23-10.

Fla. Admin. Code R. 59G-11.002 Definitions

History

Rulemaking Authority 408.918 FS. Law Implemented 408.918 FS. History–New 4-24-03, Repealed 9-23-10.

Fla. Admin. Code R. 59G-11.003 Agency Certification Process and Requirements

History

Rulemaking Authority 408.918 FS. Law Implemented 408.918 FS. History–New 4-24-03, Repealed 9-23-10.

Fla. Admin. Code R. 59G-11.004 Revocation of a 211 Number

History

Rulemaking Authority 408.918 FS. Law Implemented 408.918 FS. History–New 4-24-03, Repealed 9-23-10.

Chapter 59G-12 RON SILVER SENIOR DRUG PROGRAM

Fla. Admin. Code R. 59G-12.001 Purpose

History

Rulemaking Authority 409.9065(4)(b) FS. Law Implemented 409.906(20), 409.9065(4)(b), 409.908, 409.912 FS. History–New 1-9-03, Repealed 5-9-10.

Fla. Admin. Code R. 59G-12.002 Definitions

History

Rulemaking Authority 409.9065(4)(b) FS. Law Implemented 409.906(20), 409.9065(4)(b), 409.908, 409.912 FS. History–New 1-9-03, Repealed 5-9-10.

Fla. Admin. Code R. 59G-12.003 Eligibility/Enrollment

History

Rulemaking Authority 409.9065(4)(b) FS. Law Implemented 409.906(20), 409.9065(4)(b), 409.908, 409.912 FS. History–New 1-9-03, Repealed 5-9-10.

Fla. Admin. Code R. 59G-12.004 Program Administration

History

Rulemaking Authority 409.9065(4)(b) FS. Law Implemented 409.906(20), 409.9065(4)(b), 409.908, 409.912 FS. History–New 1-9-03, Repealed 5-9-10.

Fla. Admin. Code R. 59G-12.005 Program Forms

History

Rulemaking Authority 409.9065(4)(b) FS. Law Implemented 409.906(20), 409.9065(4)(b), 409.908, 409.912 FS. History–New 1-9-03, Repealed 5-9-10.

Chapter 59G-13 MEDICAID WAIVER PROGRAMS

Fla. Admin. Code R. 59G-13.001 Medicaid Providers Who Bill on the Non-Institutional 081

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912 FS. History–New 2-3-05, Repealed 1-26-10.

Fla. Admin. Code R. 59G-13.015 Adult Cystic Fibrosis Waiver Services Procedure Codes and Fee Schedule

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History–New 9-21-11, Amended 11-1-13, Repealed 3-21-18.

Fla. Admin. Code R. 59G-13.030 Aged and Disabled Adult Waiver Services

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History–New 6-1-05, Amended 4-17-06, 7-8-10, Repealed 8-28-14.

Fla. Admin. Code R. 59G-13.031 Aged and Disabled Adult Waiver Services Procedure Codes and Fee Schedule

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.908, 409.912, 409.913 FS. History–New 7-8-10, Repealed 8-28-14.

Fla. Admin. Code R. 59G-13.032 Aged and Disabled Adult Waiver Disposable Incontinence Medical Supplies Fee Schedule and Minimum Quality Standards

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History–New 6-7-12, Repealed 8-28-14.

Fla. Admin. Code R. 59G-13.050 Assisted Living Waiver Services

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History–New 5-28-12, Repealed 8-28-14.

Fla. Admin. Code R. 59G-13.051 Assisted Living for the Elderly Waiver Services Procedure Codes and Fee Schedule

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906, 409.908, 409.912 FS. History–New 5-31-10, Repealed 8-28-14.

Fla. Admin. Code R. 59G-13.052 Assisted Living Waiver Disposable Incontinence Medical Supplies Fee Schedule and Minimum Quality Standards

History

Rulemaking Authority 409.919 FS. Law Implemented 409,902, 409.906, 409,907, 409.908, 409.912, 409.913 FS. History–New 6-7-12, Repealed 8-28-14.

Fla. Admin. Code R. 59G-13.070 Developmental Disabilities Individual Budgeting Waiver Services

(1) This rule applies to all providers rendering Florida Medicaid Developmental Disabilities Individual Budgeting Waiver services to recipients.

(2) All providers must be in compliance with the provisions of the Florida Medicaid Developmental Disabilities Individual Budgeting Waiver Services Coverage and Limitations Handbook, May 2023, incorporated by reference. The handbook is available on the Agency for Health Care Administration’s Web site at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at http://www.flrules.org/Gateway/reference.asp?No=Ref-15361.

(3) The following forms are included in the Florida Medicaid Developmental Disabilities Individual Budgeting Waiver Services Coverage and Limitations Handbook, May 2023, in the order they appear in the handbook, and are incorporated by reference.

(a) Medicaid Waiver Services Agreement, AHCA Form 5000-3553, September 2015.

(b) Functional Community Assessment Form, AHCA Form 5000-3556, September 2015.

(d) Financial Profile, AHCA Form 5000-3557, September 2015.

(e) Trainers/Trainer Agreement Form, AHCA Form 5000-3554, June 2018.

History

Rulemaking Authority 393.501, 409.919 FS. Law Implemented 393.0662, 409.902, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History‒New 9-3-15, Amended 7-10-17, 6-10-18, 10-19-20, 9-6-21, 5-18-23, 4-30-25.

Fla. Admin. Code R. 59G-13.075 Home and Community Based Services Settings

(1) This rule applies to all settings where Florida Medicaid waiver services are rendered to individuals enrolled in home and community-based service (HCBS) waiver programs authorized under sections 1915(c), 1915(i), and 1915(k) of the Social Security Act.

(2) All settings must be in compliance with the provisions of the home and community-based settings requirements established in accordance with the Centers for Medicare and Medicaid Services’ (CMS) Final Rule CMS-2296-F (HCB Settings Rule) March 17, 2014, incorporated by reference, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-10076 and https://federalregister.gov/a/2014-00487.

(3) The Agency for Health Care Administration, or its designee, will assess residential and non-residential settings for compliance with Title 42, Code of Federal Regulations (CFR), section 441.530, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-10077 and https://www.gpo.gov/fdsys/pkg/CFR-2017-title42-vol4/xml/CFR-2017-title42-vol4-part441.xml#seqnum441.530.

(4) Settings where HCBS services were rendered prior to March 17, 2014, and that are determined to be noncompliant with the HCB Settings Rule through site-specific assessment, must remediate deficiencies in accordance with a plan of remediation developed by the provider and agreed upon by the Agency or its designee.

(5) Settings that fail to comply with the HCB Settings Rule will be ineligible to participate in the provision of HCBS to Florida Medicaid recipients. The State must be in compliance with the HCB Settings Rule by March 17, 2022, in accordance with the Extension Period for Compliance with the home and Community-Based Settings Criteria informational bulletin, incorporated by reference available at http://www.flrules.org/Gateway/reference.asp?No=Ref-10079 and available on CMS’ website at https://www.medicaid.gov/federal-policy-guidance/downloads/cib050917.pdf.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History–New 12-25-18.

Fla. Admin. Code R. 59G-13.080 Home and Community-Based Services Waivers

(1) Purpose. Under authority of section 2176 of Public Law 97-35, Florida obtained waivers of federal Medicaid requirements to enable the provision of specified home and community-based (HCB) services to persons at risk of institutionalization. Through the administration of several different federal waivers, Medicaid reimburses enrolled providers for services that eligible recipients may need to avoid institutionalization. Waiver program participants must meet institutional level of care requirements. The HCB waiver services are designed to allow the recipients to remain at home or in a home-like setting. To meet federal requirements, Medicaid must demonstrate each waiver’s cost-effectiveness.

(2) Definitions. General Medicaid definitions applicable to this program are located in Rule 59G-1.010, F.A.C. Additional descriptions of services available under this program are provided in subsection (3) of this rule. The following definitions apply:

(a) “Agency” means the Agency for Health Care Administration, the Florida state agency responsible for the administration of Medicaid waivers for home and community-based (HCB) services.

(b) “Department” means the Florida Department of Elderly Affairs (DOEA).

(3) Home and Community-Based (HCB) Waiver Services are those Medicaid services approved by the Centers for Medicare and Medicaid under the authority of Section 1915(c) of the Social Security Act. The definitions of the following services are provided in the respective HCB services waiver, as are specific provider qualifications. Since several similar services with different names may be provided in more than one waiver, this section lists them as a cluster. A general description of each service cluster is provided. Individuals eligible for the respective HCB services waiver programs may need and receive the following services:

(a) Adaptive and Assistive Equipment, and Adaptive Equipment, include selected self-help items that are necessary for recipient safety and that assist recipients to increase their functional ability to perform activities of daily living.

(b) Adult Day Health Care and Day Health Care are services provided in an ambulatory care setting. They are directed toward meeting the supervisory, social, and health restoration and maintenance needs of adult recipients who, due to their functional impairments, are not capable of living independently.

(c) Caregiver Training and Support are services that encourage the provision of care for the recipient in the home or home-like settings from caregivers such as relatives, friends, and neighbors. Activities include workshops or in-home training conducted by professionals to increase the caregivers’ knowledge of caregiving skills and understanding of the aging or disease process and to provide emotional support through caregivers’ support groups.

(d) Case Aide services are adjunctive to case management and provided by paraprofessionals under the direction of case managers. These services include: assistance with implementing plans of care, assistance with obtaining access to appointments for care plan and other services, supervision of provider activities, and assisting with linkages of providers with recipients via additional telephone contacts and visits. They will not develop care plans or conduct assessments or reassessments.

(e) Case Management, Waiver Case Management, and Support Coordination are services that assist Medicaid eligible individuals in gaining access to needed medical, social, educational and other services, regardless of funding source.

(f) Chore Services and Housekeeping/Chore Services are provided to maintain the home in a clean, sanitary and safe environment. Chore services will be provided only in cases where neither the recipient, nor anyone else in the household, is capable of performing or financially providing for them, and where no other relative, caretaker, landlord, community volunteer/agency, or third party payor is capable of or responsible for their provision.

(g) Companion Services include those activities necessary to assist the recipient in performing household or personal tasks and providing social stimulation to relieve the negative effects of loneliness and isolation.

(h) Consumable Medical Supplies are expendable, disposable, and non-durable items used for the treatment of specific injuries or diseases, or for persons who have chronic medical or disabling conditions. These supplies exceed those routinely furnished by the provider in conjunction with skilled care and home health aide visits.

(i) Counseling, Mental Health Services, Education and Support, and Behavioral Analysis are services provided for the diagnosis or treatment of mental, psychoneurotic, or personality disorders, or providing assistance to recipients in identifying feasible goals, providing emotional support and guidance, providing advice about community resources, or exploring possible alternative behavior patterns.

(j) Day Training service programs support the participation of recipients in daily, valued routines of the community, which for adults may include work-like settings but exclude services directed at teaching specific job skills or meeting employment objectives of non-supported, competitive, paid or unpaid employment in the general work force. Day training programs for children are limited to children who, because of age, are not eligible for services through the local education agencies. Early developmental intervention activities are provided to maximize the development of the child. This service stresses self-help, adaptive, and social skills which are age-appropriate for the individual.

(k) Emergency Alert Response, Medical Alert and Response Service, and Personal Emergency Response Systems are methods of monitoring persons, through electronic or other means, in their own home to assure their safety by identifying their need for assistance or medical intervention and dispatching qualified personnel to the home.

(l) Environmental Modifications, Minor Physical Adaptations to the Home/Home Modifications, and Home Modifications are structural changes to the home which are necessary to enhance a recipient’s safety and well-being or to help the recipient to function with greater independence in the home. These adaptations/improvements must be of direct medical or remedial benefit to the client.

(m) Financial Education and Protection Services consist of formal instruction in budget management, sensible purchasing habits, and financial management skills to make optimum use of limited financial resources and to avoid exploitation.

(n) Home Delivered Meals and Special Home Delivered Meals are designed to provide meals to persons who have difficulty shopping for or preparing food without assistance.

(o) Home Health Aide Services include therapeutic, supportive, and compensatory health and personal care tasks and activities for recipients in their homes provided by an aide employed by a licensed home health agency working under the supervision of a registered professional nurse or another appropriate health professional.

(p) Homemaker, and Homemaker and Personal Care Services provide assistance with daily living activities and household tasks related to supporting clients in a home setting. Services include assistance with bathing, dressing, eating, maintenance of personal belongings, and performance of light housekeeping, and meal planning and preparation.

(q) Non-Residential Support Services are activities provided in an individual, community-integrated, non-residential setting. These activities are age-appropriate and geared to enhance acceptable behaviors, increase the individual’s ability to control the environment, and emphasize those qualities that are integrative and normative. For adults, these services may be provided in work-like settings in the community.

(r) Occupational Therapy is the use of prescribed activities designed for a specific remedial purpose to restore, improve, or maintain impaired functions for the purpose of increasing or maintaining independent functioning.

(s) Personal Care Services provide assistance with, or supervision of, activities of daily living. Personal care services offer an alternative to home health aide services when a client’s condition no longer requires the attention of a nurse or aide acting under regular supervision.

(t) Physical Therapy, is treatment by physical agents or methods to restore, improve, or maintain impaired bodily functions by massage, exercise, and the use of physical, chemical, and other properties of motion, heat, electromagnetic radiation, light, electricity, or sound, as defined in Chapter 486, F.S., incorporated by reference. In some waiver programs, it may include an assessment.

(u) Private Duty Nursing Services are individual and continuous care provided by licensed nurses in the recipient’s home.

(v) Residential Habilitation is assistance with acquisition, retention, or improvement in skills related to activities of daily living, such as personal grooming and cleanliness, bed making and household chores, eating and the preparation of food, and the social and adaptive skills necessary to enable the recipient to reside in a non-institutional setting.

(w) Respite Care is the provision of supervisory, supportive, and short-term emergency care necessary to maintain the health and safety of a recipient when the primary caregiver is not available to provide such care or requires relief from the stress and demands associated with daily care.

(x) Risk Reduction services provide care and guidance to caregivers, based on a plan of specific exercises for the recipient to increase physical capacity, strength, dexterity, and endurance to perform activities of daily living. This service also includes assessment and guidance for the recipient and caregiver to learn to prepare and eat nutritious meals and promote better health through improved nutrition. This service may include instructions on shopping for appropriate food, preparation, and monitoring of same. This service also provides guidance for budgeting and paying bills, which may include establishing checking accounts and direct deposits to lessen the risk of financial exploitation and abuse of the recipient.

(y) Skilled Nursing and Skilled Care are skilled nursing services provided to assure the client’s safety and to achieve the objectives of the physician authorized treatment plan. This care may also include the services of a licensed respiratory therapist. These skilled services may be provided in the client’s home.

(z) Special Drug and Nutritional Assessments assure that basic health care needs are being accurately prescribed. Drug assessments include a review of prescriptions to assure that multiple medications are being administered correctly. Nutritional assessments include a review of the recipient’s nutritional needs, development of special diets, and nutrition education of the recipient or caregivers.

(aa) Special Medical Home Care is nursing care and supervision required by medically fragile persons residing in small licensed group homes. The service includes 24-hour-a-day nursing service.

(bb) Specialized Personal Care Services to Foster Care Children is special care given in foster, group, and shelter care homes to children with AIDS. Additional care is given to these children primarily in the areas of monitoring, supervision, disinfection and stimulation. Payment for this service is exclusive of that paid by the Department for room and board.

(cc) Speech Therapy is the provision of services necessary for the diagnosis and treatment of speech and language disorders that have resulted in a communication disability.

(dd) Substance Abuse Treatment includes counseling and therapeutic services by licensed providers directed to assist substance abusers in understanding and resolving or ameliorating contributory behavioral patterns or life conditions and to provide support and assistance to those recipients during this process.

(ee) Supported Living Coaching services are provided to recipients living in their own home or apartment and support them in maintaining an autonomous household in the community.

(ff) Transportation is travel to and from service providers or community resources identified in the service plan. This service is available under the HCB services waiver to enable recipients to gain access to planned services when transportation to those services is not otherwise Medicaid compensable.

(4) Covered Services – General. Services provided under the HCB services waivers include those described in paragraphs (3)(a) through (ff). The availability of these services to waiver program participants is subject to approval by the Medicaid office and is subject to the availability of the services under the specific waiver program for which a recipient has been determined eligible.

(5) Service Limitations – General. The following general limitations and restrictions apply to all home and community-based services waiver programs:

(a) Covered services are available to eligible waiver program participants only if the services are part of a waiver plan of care (“care plan,” “individual support plan,” or “family support plan”). Care plan requirements are outlined in subsections (6) and (8) of this rule.

(b) The agency or its designee shall approve plans of care based on budgetary restrictions, the recipient’s necessity for the services, and appropriateness of the service in relation to the recipient, prior to their implementation for any waiver recipient.

(c) Additional service limitations applicable to specific waiver programs are specified in subsections (10) through (14) of this rule.

(6) Program Requirements – General.

(a) The Medicaid program will deny an applicant’s enrollment request if the proposed enrollment could cause the program to exceed the maximum enrollment level authorized by the Health Care Financing Administration in the applicable HCB services waiver.

(b) A person can not receive Medicaid waiver services until he is determined eligible, waiver funding is available, and is enrolled in the appropriate waiver program.

(c) The Agency or its designee will conduct home visits of waiver program applicants or participants. Assessments of the applicant’s or participant’s home situation will be made to determine if it is acceptable in providing for his general health or safety. If the applicant’s or participant’s home situation does not provide for the applicant’s or participant’s general health or safety, the Agency shall restrict the applicant or participant from participation in the waiver program.

(d) The Department or its designee will perform an evaluation of the level of care needed by an applicant for services when there is a reasonable indication that the applicant might need institutionalization in the near future, if the covered HCB services were not available.

(e) The Department or its designee will perform reevaluations of level of care at least annually, or as changes in the recipient’s condition or community care setting may warrant.

(f) The plan of care will identify the type of services to be provided, the amount, frequency, and duration of each service, and the type provider to furnish each service.

(g) Reimbursement claims for the provision of Medicaid services not listed in the plan of care of HCB services waiver program participants are subject to denial or recoupment.

(h) In providing applicants or participants freedom of choice, the Agency or its designee must:

Inform all prospective waiver program participants of the feasible alternatives available under the respective waiver program and afford recipients a freedom of choice to participate in the community program in lieu of institutional placement;
Afford recipients the opportunity to choose from those enrolled providers capable of providing the covered services identified in the recipient’s plan of care; and,
Afford all enrolled recipients the right to disenroll at any time.

(i) The Agency or its designee, will disenroll waiver program participants who:

Do not follow a recommended plan of care, as evidenced by: not keeping two consecutive appointments, or demonstrating multiple failures to avail themselves of offered services.
Demonstrate behavior that is disruptive, unruly, abusive, or uncooperative to the extent that their participation in the program seriously impairs the provider’s ability to furnish services to the participant or other participants. Prior to disenrolling participants for the above reasons, the Agency or its designee must provide the participant at least one verbal and at least one written warning that the consequence of their actions, or inactions will be disenrollment from the program.

(7) Provider Qualifications and Provider Enrollment. To enroll and participate in the waiver programs, providers must comply with the provisions of Chapter 59G-5, F.A.C. Additional provider requirements are specified in subsections (10) through (14) of this rule.

(8) Case Management Requirements. Case managers advocate for recipients during the eligibility determination process and assist applicants in complying with requests for information, interviews, or activities required for a determination of Medicaid eligibility. Case managers will conduct a comprehensive needs assessment and identify areas in the person’s life that require supports or services to reduce the risk of having to be placed in an institution. In addition, each case manager will:

(a) Begin the initial needs assessment before services are provided and complete it within 30 days of enrollment in the waiver program;

(b) Make a home visit as part of the needs assessment process;

(d) Reassess the plan of care at least every six months to review service goals, outcomes, and functional changes that may warrant the modification of the plan and reassessment of the recipient’s level of care;

(e) After the needs assessment has been completed, maintain in each client’s record case progress notes that document the provision of services;

(f) Make legible entries in the case progress notes in sufficient detail to document the case management service rendered and to allow an audit of the appropriateness of charges;

(g) Date and sign all written case record entries;

(h) Notify the Agency of all disenrollments by waiver program participants within 30 days after the effective date; and,

(i) Maintain records in an accessible location for review by authorized federal and state representatives for monitoring and auditing purposes; ensure that recipient specific information is maintained as “confidential”; ensure that program, administrative, and financial information is maintained for a period of at least five years after termination of participation as a waiver service provider. If an audit has been initiated and audit findings have not been resolved at the end of five years, the records will be retained until resolution of the audit findings.

(9) Home and Community-Based Services Waiver Programs. The following are authorized HCB services waivers: Adult Cystic Fibrosis Waiver; Adult Day Health Waiver; Aged and Disabled Adult Waiver; Alzheimer’s Disease Waiver; Assisted Living for the Elderly Waiver; Channeling Waiver; Consumer-Directed Care Waiver; Developmental Disabilities Waiver; Family Supported Living Waiver; Familial Dysautonomia Waiver; Model Waiver; Project AIDS Care Waiver; and Traumatic Brain Injury and Spinal Cord Injury Waiver.

(10) Channeling Waiver.

(a) Program Summary. The Channeling program is directed toward a group of seriously impaired, aged Medicaid eligible individuals. The core functions of outreach, screening, assessment, care planning, and case management focus community services on program participants as an alternative to institutional care.

(b) Covered Services and Provider Qualifications. The Agency contracts with the organized health care delivery system for the provision of these services to enrolled recipients. The standards applicable to the contractor’s selection of vendors and providers of covered services are outlined in the contract between the Agency and the contractor. The following services are available:

Adult Day Health Care;
Caregiver Training and Support;
Companion Services;
Consumable Medical Supplies;
Financial Education and Protection Services;
Home Health Aide Services;
Personal Care Services;
Chore Services;
In Home Counseling;
Medical Alert and Response Service;
Mental Health Services;
Minor Physical Adaptations to the Home/Home Modification;
Occupational Therapy;
Physical Therapy;
Respite Care;
Skilled Nursing;
Special Home Delivered Meals;
Special Drug and Nutritional Assessments;
Special Medical Equipment;
Special Medical Supplies;
Speech Therapy; and,
Waiver Case Management.

(c) Recipient Eligibility. Recipients eligible for services under this waiver must be Broward or Dade County residents, 65 years of age or older, and eligible under the HCB services waiver optional coverage groups as defined by 42 CFR section 435.217, or otherwise be Medicaid eligible. Recipients must be assessed as meeting level of care criteria for skilled or intermediate nursing home care as defined in Rules 59G-4.290 and 59G-4.180, F.A.C. The contractor may refuse participation in the program to otherwise qualified recipients whose estimated cost of community care exceeds 85 percent of the cost of institutional care in that recipient’s county of residence.

(d) Provider enrollment is coordinated by the Channeling provider.

(e) Payment Methodology. Payment is based on a prospective monthly per diem reimbursement rate. Medicaid will make monthly payment to the contractor for satisfactory performance of duties and responsibilities as set forth in the contract. The per diem rate is set annually as a part of the contract renewal process. The rates are developed using historical Channeling Project data for similar services in the same geographic area, adjusted for anticipated service and cost increases.

(11) Model Waiver.

(a) Program Summary. The model waiver allows the provision of specified HCB services to persons with degenerative spinocerebellar disease. These services are provided to eligible persons who would otherwise require the level of care provided in an acute care hospital.

(b) Services Availability. Eligible program participants may receive covered services if approved by the case manager as part of a service plan developed in accordance with the requirements outlined in this section.

Persons under 21 years of age, disabled with a degenerative spinocerebellar disease as identified in the International Classification of Diseases, 9th Revision (ICD-9), 1995 Edition, effective October 1, 1994, code range beginning with the first three digits of 330 through 337, inclusive; hereby incorporated by reference;
Assessed as being at risk of hospitalization by the comprehensive assessment and review for long term care services (CARES) team administered by DOEA; or the Children’s Multidisciplinary Assessment Team (CMAT), administered by the Department of Health, Children’s Medical Services; and able to live safely at home with the Medicaid HCB services made available to him; and,
Cost-effective to the state for each individual program participant, pursuant to the approved federal waiver.

(d) Covered Services and Provider Qualifications. Provider qualifications for services available under this waiver are:

Case Management providers must be licensed as a registered nurse in the state of Florida and meet applicable state requirements, pursuant to Chapter 464, F.S.
Respite Care providers must be a Florida licensed and Medicaid participating home health agency and meet applicable state requirements, pursuant to Chapter 400, F.S.

(12) Assistive Care Services and Assisted Living for the Elderly Waiver. All Assistive Care Services and Assisted Living for the Elderly Waiver providers must comply with the provisions of the Florida Medicaid Assistive Care Services and Assisted Living for the Elderly Waiver Coverage and Limitations Handbook, July 2001, which is incorporated by reference and available from the Medicaid fiscal agent’s Web Portal at http://mymedicaid-Florida.com. Click on Public Information for Providers, then on Provider Support, and then on Provider Handbooks. Paper Copies are available by calling the Provider Contact Center at 1(800)289-7799 and selecting Option 7.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.910, 409.912, 409.913 FS. History–New 4-20-82, Formerly 10C-7.527, Amended 3-22-87, 11-23-89, Formerly 10C-7.0527, Amended 1-16-96, 7-23-97, 1-6-02, 10-27-02, 6-11-03, 11-24-03, 1-16-05, 6-23-05, Formerly 59G-8.200, Amended 11-29-07, 12-3-08.

Fla. Admin. Code R. 59G-13.081 Developmental Disabilities Individual Budgeting Waiver Services Provider Rate Table

(1) This rule applies to all providers that render Florida Medicaid Developmental Disabilities Individual Budgeting Waiver services to recipients.

(2) Florida Medicaid reimburses providers in accordance with the Florida Medicaid Developmental Disabilities Individual Budgeting Waiver Services Provider Rate Table, October 1 2025, incorporated by reference. The rate table is available on the Agency for Health Care Administration’s website at http://ahca.myflorida.com/Medicaid/review/index.shtml, and at https://flrules.org/Gateway/reference.asp?No=Ref-18974.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.908, 409.912, 409.913 FS. History–New 5-29-06, Amended 11-15-07, 10-13-08, 3-13-13, 3-14-16, 8-3-16, 6-10-18, 12-15-20, 9-6-21, 5-18-23, 1-4-24, 4-30-25, 10-12-25, 3-12-26.

Fla. Admin. Code R. 59G-13.082 Developmental Disabilities Waiver Services Procedure Codes

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906, 409.908 FS. History–New 11-22-06, Amended 12-3-08, Repealed 10-27-13.

Fla. Admin. Code R. 59G-13.083 Developmental Disabilities Waiver Services

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History–New 12-3-08, Amended 7-8-10, 5-3-12, Repealed 10-19-15.

Fla. Admin. Code R. 59G-13.084 Developmental Disabilities Waiver Residential Habilitation Services in a Licensed Facility Provider Rate Table

History

Rulemaking Authority 409.919 FS. Law Implemented 393.0661, 409.906, 409.908 FS. History–New 10-13-08, Repealed 10-27-13.

Fla. Admin. Code R. 59G-13.086 Developmental Disabilities Individual Budgeting Waiver Disposable Incontinence Medical Supplies Fee Schedule

(1) Developmental Disabilities Waiver disposable incontinence medical supplies are reimbursed according to the Florida Medicaid Developmental Disabilities Individual Budgeting Waiver Disposable Incontinence Medical Supplies Fee Schedule, October 2015, incorporated by reference, available at http://www.flrules.org/Gateway/reference.asp?No=Ref-05884.

(2) The fee schedule is available from the Medicaid fiscal agent’s Web site at http://portal.flmmis.com/flpublic.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History–New 7-1-13, Amended 10-19-15.

Fla. Admin. Code R. 59G-13.088 Consumer-Directed Care Plus Program

(1) Recipients enrolled in the Individual Budgeting (iBudget) Waiver receiving Consumer-Directed Care Plus program services, along with all program representatives, consultants, employees, vendors, and Agency for Persons with Disabilities staff must be in compliance with the provisions of the Florida Medicaid Consumer-Directed Care Plus Program Coverage, Limitations, and Reimbursement Handbook, October 2015, incorporated by reference, available at http://www.flrules.org/Gateway/reference.asp?No=Ref-05891. The handbook is available from the Medicaid fiscal agent’s Web site at http://portal.flmmis.com/flpublic. Select Public Information for Providers, then Provider Support, and then Provider Handbooks.

(2) The following appendices are incorporated by reference: CDC+ New Participant Training Program Affirmation Form, July 2012; CDC+ New Participant Training Registration, July 2012; CDC+ Participant Refresher Training Program Affirmation Form, March 1, 2011; CDC+ Participant Refresher Training Registration, March 1, 2011; CDC+ Purchasing Plan, February 14, 2012; CDC+ Quick Update to My Purchasing Plan, June 1, 2009; Florida CDC+ Weekly Timesheet, January 1, 2011; and CDC+ Participant Information Update Form, November 1, 2009. These forms are available by photocopying them from the Florida Medicaid Consumer-Directed Care Plus Program Coverage, Limitations, and Reimbursement Handbook.

History

Rulemaking Authority 409.221 FS. Law Implemented 409.221, 409.902, 409.907, 409.908, 409.912, 409.913 FS. History–New 11-12-12, Amended 10-19-15.

Fla. Admin. Code R. 59G-13.091 Family and Supported Living Waiver Provider Rate Table

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906, 409.908 FS. History‒New 10-18-07, Amended 7-29-08, Repealed 10-27-13.

Fla. Admin. Code R. 59G-13.092 Family and Supported Living Waiver Services Procedure Codes

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906, 409.908 FS. History‒New 10-18-07, Repealed 10-27-13.

Fla. Admin. Code R. 59G-13.102 Familial Dysautonomia Waiver Disposable Incontinence Medical Supplies Fee Schedule and Minimum Quality Standards

(1) This rule applies to all Familial Dysautonomia waiver services providers enrolled in the Medicaid program.

(2) All Familial Dysautonomia waiver services providers enrolled in the Medicaid program must be in compliance with the Familial Dysautonomia Waiver Disposable Incontinence Medical Supplies Fee Schedule, December 1, 2011, and Minimum Quality Standards, December 1, 2011, which are incorporated by reference, available at http://www.flrules.org/Gateway/reference.asp?No=Ref-01172. The Familial Dysautonomia Waiver Disposable Incontinence Medical Supplies Fee Schedule and Minimum Quality Standards are available from the Medicaid fiscal agent’s Web site at www.mymedicaid-florida.com. Select Public Information for Providers, then Provider Support, and then Fee Schedules. Paper copies may be obtained from the Agency for Health Care Administration, Bureau of Medicaid Services, 2727 Mahan Drive, MS #20, Tallahassee, Florida 32308.

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History–New 6-7-12.

Fla. Admin. Code R. 59G-13.110 Project AIDS Care Waiver Services

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906, 409.908, 409.912 FS. History–New 2-3-05, Amended 5-31-06, Repealed 3-21-18.

Fla. Admin. Code R. 59G-13.112 Project AIDS Care Waiver Disposable Incontinence Medical Supplies Fee Schedule and Minimum Quality Standards

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409,907, 409.908, 409.912, 409.913 FS. History–New 6-7-12, Repealed 3-21-18.

Fla. Admin. Code R. 59G-13.130 Traumatic Brain and Spinal Cord Injury Waiver Services

History

Rulemaking Authority 409.919 FS. Law Implemented 409.906, 409.907, 409.908, 409.912 FS. History–New 5-31-06, Repealed 3-21-18.

Fla. Admin. Code R. 59G-13.131 Traumatic Brain Injury and Spinal Cord Injury Waiver Services Fee Schedule

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History–New 8-5-09, Amended 9-21-11, 11-1-13, Repealed 3-21-18.

Fla. Admin. Code R. 59G-13.132 Traumatic Brain and Spinal Cord Injury Waiver Disposable Incontinence Medical Supplies Fee Schedule

History

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History–New 6-7-12, Amended 5-17-15, Repealed 3-21-18.

Chapter 59G-14 FLORIDA KIDCARE GRIEVANCE PROCESS

Fla. Admin. Code R. 59G-14.001 Florida Kidcare Dispute Review and Grievance Process

(1) Purpose. The Florida Kidcare Dispute Review and Grievance Process (Process) is a comprehensive review of disputes relating to eligibility and enrollment for the Title XXI, Children’s Health Insurance Program (CHIP), conducted in accordance with Title 42, Code of Federal Regulations (CFR), sections 457.1130-457.1180.

(2) Definitions. The following definitions are applicable to this rule and do not apply to any dispute or grievance processes relating to the Florida Medicaid program.

(a) Adverse action notice – Letter regarding a premium increase, denial of eligibility, suspension or termination of enrollment, or disenrollment for failure to pay the premium.

(b) Complainant – An individual listed on the enrollee’s Florida Kidcare account as a parent, caretaker, or an emancipated minor who submits a dispute or grievance.

(c) Dispute – Written request to review an eligibility or enrollment decision received within 90 calendar days of the date of an adverse action notice.

(d) Dispute Review File – Documents collected by the Florida Healthy Kids Corporation or provided by the family during the dispute review process.

(e) Enrollee – Child eligible for and receiving CHIP coverage under the Florida Kidcare Act.

(f) Florida Healthy Kids Corporation (Corporation) – Designated eligibility processor for the CHIP program. The Corporation is also responsible for conducting the dispute review process and preparing all written dispute review responses.

(g) Grievance – Written request to review an eligibility or enrollment decision after the dispute review process has been completed.

(3) Dispute Review Process.

(a) The dispute review process is conducted in accordance with time frames specified in 42 CFR 457.1160.

(b) The dispute review process begins when the Corporation receives a dispute from a complainant. For disputes received within ten calendar days of an adverse action notice, the Corporation will take the following actions when requested by the complainant:

Continue or reinstate health coverage retroactive to the first day of the month in which the request for continuation was received.
Restore the former premium amount. All premium payments must be paid in a timely manner to maintain coverage during the continuation period.

(c) The Corporation must explain the complainant’s liability to repay all premiums and cost of benefits received if the original adverse action decision is upheld.

(d) The Corporation must comply with the following time frames:

Send written acknowledgement to the complainant, within three calendar days of receipt of the dispute.
Render a written decision within 15 calendar days of receipt of the dispute.

(e) The Corporation may request additional information from the complainant and extend the dispute review period for up to 30 calendar days. Additional information requested by the Corporation must be provided within ten calendar days; if requested information is not provided, the Corporation will render a decision based on the available information.

(f) The complainant will be notified of the decision by the Corporation.

(g) The complainant may appeal the dispute review process decision to the Corporation’s Chief Executive Officer (Officer) or designee. The Officer will notify the complainant of the decision in writing within ten calendar days of the complainant’s dispute review decision appeal request, and provide information regarding additional appeal rights as described in paragraph (h).

(h) The complainant may appeal the Officer’s decision by submitting a grievance request through the Corporation to the Agency for Health Care Administration (AHCA), within ten calendar days of the Officer’s decision. The Corporation must forward the grievance request and the dispute review file to AHCA within five calendar days of receipt of the grievance request.

(4) Grievance Process.

(a) The Agency for Health Care Administration will send a letter to the complainant within five calendar days of receiving the grievance request:

Acknowledging receipt of the grievance.
Requesting additional information, if needed.
Instructing how a complainant may request a copy of the dispute review file and appoint a representative.

(b) Complainants must submit any requested additional information to AHCA within 10 calendar days.

(c) The Agency for Health Care Administration will render its final decision in writing based on the available information within 30 calendar days of receiving the grievance request.

(d) MediKids, Healthy Kids, and Title XXI Children’s Medical Services Managed Care Plan are bound by AHCA’s final decision.

History

Rulemaking Authority 409.818 FS. Law Implemented 409.818 FS. History–New 2-27-08, Amended 7-11-16.

Fla. Admin. Code R. 59G-14.002 Confidentiality

History

Rulemaking Authority 409.818 FS. Law Implemented 409.818 FS. History–New 2-27-08, Repealed 7-11-16.

Fla. Admin. Code R. 59G-14.003 Federal Compliance

History

Rulemaking Authority 409.818 FS. Law Implemented 409.818 FS. History–New 2-27-08, Repealed 7-11-16.

Fla. Admin. Code R. 59G-14.004 Florida Kidcare Dispute Review Process

History

Rulemaking Authority 409.818(3)(f) FS. Law Implemented 409.814(10) FS. History–New 2-27-08, Amended 4-8-10, Repealed 7-11-16.

Fla. Admin. Code R. 59G-14.005 Florida Kidcare Grievance Committee

History

Rulemaking Authority 409.818 FS. Law Implemented 409.818 FS. History–New 2-27-08, Repealed 7-11-16.

Fla. Admin. Code R. 59G-14.006 Florida Kidcare Grievance Procedures

History

Rulemaking Authority 409.818 FS. Law Implemented 409.818 FS. History–New 2-27-08, Repealed 7-11-16.

Fla. Admin. Code R. 59G-14.007 Health Services Complaints and Disputes

History

Rulemaking Authority 409.818 FS. Law Implemented 409.818 FS. History–New 2-27-08, Repealed 7-11-16.

Division 59GG Psychotherapy Services

Chapter 59GG-33 REGISTRATION AS TRAINEE OR INTERN FOR PSYCHOLOGICAL, CLINICAL, COUNSELING AND PSYCHOTHERAPY SERVICES

Fla. Admin. Code R. 59GG-33.001 Registration of Mental Health Trainees and Interns

History

Rulemaking Authority 490.014(5), 491.014(5) FS. Law Implemented 490.014(5), 491.014(5) FS. History–New 2-10-93, Formerly 21-33.001, 61-33.001, Repealed 5-7-12.

Division 59F Rural Health Networks

Chapter 59F-1 RURAL HEALTH NETWORKS

Fla. Admin. Code R. 59F-1.002 Definitions

History

Specific Authority 381.0406(17) FS. Law Implemented 381.0406(2), (3), (4), (11)(c) FS. History–New 12-29-93, Amended 1-29-95, 8-18-96, Transferred to 64I-5.001 .

Fla. Admin. Code R. 59F-1.005 Certification/Decertification of Rural Health Networks

History

Specific Authority 381.0406(17) FS. Law Implemented 381.0406(16) FS. History–New 1-29-95, Amended 8-18-96, Transferred to 64I-5.002.

Fla. Admin. Code R. 59F-1.006 Rural Health Network Cooperative Agreements

History

Specific Authority 381.04065(5) FS. Law Implemented 381.04065 FS. History–New 1-24-96, Transferred to 64I-5.003.