Florida Administrative Code

Rulemaking Authority 120.53(1)(c)5. FS. Law Implemented 120.53(1)(f) FS. History-New 6-3-93, Repealed 2-13-14.

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 History-New 6-3-93, Amended 12-23-99, Repealed 2-13-14.

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 History-New 6-3-93, Repealed 8-8-11.

Rulemaking Authority 287.0947(2) FS. Law Implemented 287.042 FS. History-New 8-17-93, Repealed 11-22-07.

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" me…

(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 …

(1) Organizational Requirements. (a) Institutional Identity. 1. The purpose of the OPO, eye bank, or tissue bank shall be clearly established and documented. 2. Documentation of institutional identity shall include whether the OPO, eye bank, or tissue bank is independent or part …

(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…

(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 th…

(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 …

(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) T…

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 whic…

(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 …

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.

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.

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.

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.

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.

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.

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.

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.

(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 Ce…

(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 advanc…

(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, (c) Protect the public health and safety. (2) The Agency shall conduct sch…

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, deno…

(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 r…

(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; (c) The benefits of out-of-hospital childbirth; and, (d) The possibility of referral or transfer if com…

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.

(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 …

(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 abnormalit…

No surgical procedures shall be performed at a birth center except episiotomy, repair of episiotomy or laceration, or circumcision. 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.

(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 …

(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 f…

(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 u…

(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 r…

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. Rulemaking Authority 383…

(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; (c) Sphygmomanometer and stethoscope; (d) Clinical thermo…

(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 clin…

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.

(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: 1. May perform trial of labor after cesarean deliveries (TOLAC) fo…

Rulemaking Authority 641.56 FS. Law Implemented 641.48 FS. History-New 1-28-88, Formerly 10D-100.001, Repealed 1-18-17.

(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 (I…

(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-a…

(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 miss…

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 …

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…

(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 ass…