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(e) The designated osteopathic physician of a pain-management clinic shall notify the applicable board in writing of the date of termination of employment within 10 days after terminating his or her employment with a pain-management clinic that is required to be registered under subsection (1). Each osteopathic physician practicing in a pain-management clinic shall advise the Board of Osteopathic Medicine in writing within 10 calendar days after beginning or ending his or her practice at a pain-management clinic.

(f) Each osteopathic physician practicing in a pain-management clinic is responsible for ensuring compliance with the following facility and physical operations requirements:

1. A pain-management clinic shall be located and operated at a publicly accessible fixed location and must:

a. Display a sign that can be viewed by the public that contains the clinic name, hours of operations, and a street address.

b. Have a publicly listed telephone number and a dedicated phone number to send and receive faxes with a fax machine that shall be operational 24 hours per day.

c. Have emergency lighting and communications.

d. Have a reception and waiting area.

e. Provide a restroom.

f. Have an administrative area including room for storage of medical records, supplies, and equipment.

g. Have private patient examination rooms.

h. Have treatment rooms, if treatment is being provided to the patient.

i. Display a printed sign located in a conspicuous place in the waiting room viewable by the public with the name and contact information of the clinic-designated physician and the names of all physicians practicing in the clinic.

j. If the clinic stores and dispenses prescription drugs, comply with ss. 499.0121 and 893.07.

2. This section does not excuse an osteopathic physician from providing any treatment or performing any medical duty without the proper equipment and materials as required by the standard of care. This section does not supersede the level of care, skill, and treatment recognized in general law related to health care licensure.

(g) Each osteopathic physician practicing in a pain-management clinic is responsible for ensuring compliance with the following infection control requirements.

1. The clinic shall maintain equipment and supplies to support infection prevention and control activities.

2. The clinic shall identify infection risks based on the following:

a. Geographic location, community, and population served.

b. The care, treatment, and services it provides.

c. An analysis of its infection surveillance and control data.

3. The clinic shall maintain written infection prevention policies and procedures that address the following:

a. Prioritized risks.

b. Limiting unprotected exposure to pathogens.

c. Limiting the transmission of infections associated with procedures performed in the clinic.

d. Limiting the transmission of infections associated with the clinic’s use of medical equipment, devices, and supplies.

(h) Each osteopathic physician practicing in a pain-management clinic is responsible for ensuring compliance with the following health and safety requirements.

1. The clinic, including its grounds, buildings, furniture, appliances, and equipment shall be structurally sound, in good repair, clean, and free from health and safety hazards.

2. The clinic shall have evacuation procedures in the event of an emergency which shall include provisions for the evacuation of disabled patients and employees.

3. The clinic shall have a written facility-specific disaster plan which sets forth actions that will be taken in the event of clinic closure due to unforeseen disasters and shall include provisions for the protection of medical records and any controlled substances.

4. Each clinic shall have at least one employee on the premises during patient care hours who is certified in Basic Life Support and is trained in reacting to accidents and medical emergencies until emergency medical personnel arrive.

(i) The designated physician is responsible for ensuring compliance with the following quality assurance requirements. Each pain-management clinic shall have an ongoing quality assurance program that objectively and systematically monitors and evaluates the quality and appropriateness of patient care, evaluates methods to improve patient care, identifies and corrects deficiencies within the facility, alerts the designated physician to identify and resolve recurring problems, and provides for opportunities to improve the facility’s performance and to enhance and improve the quality of care provided to the public. The designated physician shall establish a quality assurance program that includes the following components:

1. The identification, investigation, and analysis of the frequency and causes of adverse incidents to patients.

2. The identification of trends or patterns of incidents.

3. The development of measures to correct, reduce, minimize, or eliminate the risk of adverse incidents to patients.

4. The documentation of these functions and periodic review no less than quarterly of such information by the designated physician.

(j) The designated physician is responsible for ensuring compliance with the following data collection and reporting requirements:

1. The designated physician for each pain-management clinic shall report all adverse incidents to the department as set forth in s. 459.026.

2. The designated physician shall also report to the Board of Osteopathic Medicine, in writing, on a quarterly basis, the following data:

a. The number of new and repeat patients seen and treated at the clinic who are prescribed controlled substance medications for the treatment of chronic, nonmalignant pain.

b. The number of patients discharged due to drug abuse.

c. The number of patients discharged due to drug diversion.

d. The number of patients treated at the pain clinic whose domicile is located somewhere other than in this state. A patient’s domicile is the patient’s fixed or permanent home to which he or she intends to return even though he or she may temporarily reside elsewhere.

(4) INSPECTION.—

(a) The department shall inspect the pain-management clinic annually, including a review of the patient records, to ensure that it complies with this section and the rules of the Board of Osteopathic Medicine adopted pursuant to subsection (5) unless the clinic is accredited by a nationally recognized accrediting agency approved by the Board of Osteopathic Medicine.

(b) During an onsite inspection, the department shall make a reasonable attempt to discuss each violation with the owner or designated physician of the pain-management clinic before issuing a formal written notification.

(c) Any action taken to correct a violation shall be documented in writing by the owner or designated physician of the pain-management clinic and verified by followup visits by departmental personnel.

(5) RULEMAKING.—

(a) The department shall adopt rules necessary to administer the registration, exemption, and inspection of pain-management clinics which establish the specific requirements, procedures, forms, and fees.

(b) The Board of Osteopathic Medicine shall adopt rules setting forth training requirements for all facility health care practitioners who are not regulated by another board.

(6) PENALTIES; ENFORCEMENT.—

(a) The department may impose an administrative fine on the clinic of up to $5,000 per violation for violating the requirements of this section; chapter 499, the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug Abuse Prevention and Control Act; chapter 893, the Florida Comprehensive Drug Abuse Prevention and Control Act; or the rules of the department. In determining whether a penalty is to be imposed, and in fixing the amount of the fine, the department shall consider the following factors:

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