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 registered nurse practitioners 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.

(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.

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.