(1) Registration.
    (a) Every designated physician of a pain management clinic, as defined in Florida Statutes § 458.3265, shall register the clinic with the Department of Health. It is the Designated Physician’s responsibility to ensure that the clinic is registered, regardless of whether other physicians are practicing in the same office or whether the office is non-physician owned.
    (b) In order to register a pain management clinic, the Designated Physician must comply with Department rule subsections 64B-7.001(3) and (4), F.A.C., and provide documentation to support compliance with Fl. Admin. Code R. 64B8-9.0131
    (c) The Designated Physician must notify the Board within 10 calendar days, in writing, of any changes to the registration information, including the termination of his or her employment with the pain management clinic.
    (d) Documentation of registration shall be posted in a conspicuous place in the waiting room viewable by the public.
    (2) Inspection.
    (a) Unless the Designated Physician has previously provided written notification of current accreditation by a nationally recognized accrediting agency approved by the Board the clinic shall submit to an annual inspection by the Department. All nationally recognized accrediting organizations shall be held to the same Board-determined practice standards for registering Florida pain management clinic sites.
    (b) The Department shall conduct unannounced annual inspections of pain clinics pursuant to this rule.
    (c) The Designated Physician shall cooperate with the inspector(s), make medical records available to the inspector, and be responsive to all reasonable requests.
    (d) The inspector(s) shall determine compliance with the requirements of Fl. Admin. Code R. 64B8-9.0131 This shall include review of a random selection of patient records for patients who are treated for pain, selected by the inspector(s) for each physician practicing in the clinic or who has practiced in the clinic during the past six months.
    (e) If the clinic is determined to be in noncompliance, the Designated Physician shall be notified and shall be given a written statement at the time of inspection. Such written notice shall specify the deficiencies. Unless the deficiencies constitute an immediate and imminent danger to the public, the Designated Physician shall be given 30 days from the date of inspection to correct any documented deficiencies and notify the Department of corrective action plan. Upon written notification from the Designated Physician that all deficiencies have been corrected, the Department is authorized to re-inspect for compliance. If the Designated Physician fails to submit a corrective action plan within 30 days of the inspection, the Department is authorized to re-inspect the office to ensure that the deficiencies have been corrected.
    (f) The written results of the inspection, deficiency notice and any subsequent documentation shall be forwarded to the Department. This shall include:
    1. Whether the deficiencies constituted an immediate and serious danger to the public,
    2. Whether the Designated Physician provided the Department with documentation of correction of all deficiencies within 30 days from the date of inspection; and,
    3. The results of any reinspection.
    (g) The Department shall review the results of the inspection(s) and determine whether action against the clinic registration is merited.
    (h) Nothing herein shall limit the authority of the Department to investigate a complaint without prior notice.
    (i) If the clinic is accredited by a nationally recognized accrediting agency approved by the Board, the Designated Physician shall submit written notification of the current accreditation survey of his or her office(s) in lieu of undergoing an inspection by the Department.
    (j) The Designated Physician shall submit, within thirty (30) days of accreditation, a copy of the current accreditation survey of the clinic and shall immediately notify the Board of Medicine of any accreditation changes that occur. For purposes of initial registration, the Designated Physician shall submit a copy of the most recent accreditation survey of the clinic in lieu of undergoing an inspection by the Department.
    (k) If a provisional or conditional accreditation is received, the Designated Physician shall notify the Board of Medicine in writing and shall include a plan of correction.
Rulemaking Authority 458.3265(5)(a) FS. Law Implemented 458.3265(5)(a) FS. History-New 11-28-10.