Effective date: 12/22/2014
(a) Every licensed physician who holds an active Florida license and performs liposuction procedures where more than 1,000 cubic centimeters of supernatant fat is removed, Level II surgical procedures in Florida with a maximum planned duration of more than five (5) minutes or any Level III office surgery, as fully defined in Rule 64B8-9.009, F.A.C., shall register the office with the Department of Health. It is the physician’s responsibility to ensure that every office in which he or she performs liposuction procedures where more than 1,000 cubic centimeters of supernatant fat is removed, Levels II or III surgical procedures as described above is registered, regardless of whether other physicians are practicing in the same office or whether the office is non-physician owned. Physicians participating in post-graduate training programs, and registered pursuant to Florida Statutes § 458.345, may provide services under the direct supervision of a Florida physician, licensed pursuant to Section 458.311 or 458.313, F.S., in an office surgery facility and under the auspices of their training program for a period of time not to exceed three months without registering pursuant to this rule.
(b) In order to register an office for surgical procedures, the physician must comply with the Department’s Rule 64B-4.003, F.A.C., and provide documentation to support compliance with Rule 64B8-9.009, F.A.C.
(c) The physician must immediately notify the Department, in writing, of any changes to the registration information.
(d) The registration shall be posted in the office.
(e) If a physician intends to perform liposuction procedures where more than 1,000 cubic centimeters of supernatant fat is removed, Level II surgical procedures with a maximum planned duration of more than five (5) minutes, or any Level III office surgery, the physician must document compliance with the transfer agreement requirements set forth in subparagraph 64B8-9.009(4)(b)1., F.A.C., and the training requirements set forth in sub-subparagraph 64B8-9.009(4)(b)2.a., F.A.C., prior to performing such procedures.
(f) This rule shall not be interpreted as requiring a physician to register with the Department of Health or to obtain any other form of authorization from the Department of Health to perform office surgery in an office that has been registered in accordance with this rule.
(a) Unless the physician has previously provided written notification of current accreditation by a nationally recognized accrediting agency or an accrediting organization approved by the Board the physician shall submit to an annual inspection by the Department. Nationally recognized accrediting agencies are the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), Accreditation Association for Ambulatory Health Care (AAAHC) and Joint Commission on Accreditation of Healthcare Organizations (JCAHO). All nationally recognized and Board-approved accrediting organizations shall be held to the same Board-determined surgery and anesthesia standards for accrediting Florida office surgery sites.
(b) The office surgery inspection fee set forth in the Department’s Rule 64B-4.002, F.A.C., shall be remitted for each practice location.
(c) The inspection conducted pursuant to this rule shall be announced at least one week in advance of the arrival of the inspector(s).
(d) The Department shall determine compliance with the requirements of Rule 64B8-9.009, F.A.C.
(e) If the office is determined to be in noncompliance, the 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 physician shall be given 30 days from the date of inspection to correct any documented deficiencies and notify the Department of corrective action. Upon written notification from the physician that all deficiencies have been corrected, the Department is authorized to re-inspect for compliance. If the 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 deficiency notice and any subsequent documentation shall be reviewed for consideration of disciplinary action under any of the following circumstances:
1. When the initial notice of deficiencies contain deficiencies that constitute immediate and imminent danger to the public;
2. The physician fails to provide the Department with documentation of correction of all deficiencies within thirty (30) days from the date of inspection;
3. Upon a finding of noncompliance after a reinspection has been conducted pursuant to paragraph (2)(e) of this rule.
(g) Documentation of corrective action shall be considered in mitigation of any offense.
(h) Nothing herein shall limit the authority of the Department to investigate a complaint without prior notice.
(a) The physician shall submit written notification of the current accreditation survey of his or her office(s) from a nationally recognized accrediting agency or an accrediting organization approved by the Board in lieu of undergoing an inspection by the Department.
(b) A physician shall submit, within thirty (30) days of accreditation, a copy of the current accreditation survey of his or her office(s) and shall immediately notify the Board of Medicine of any accreditation changes that occur. For purposes of initial registration, a physician shall submit a copy of the most recent accreditation survey of his or her office(s) in lieu of undergoing an inspection by the Department.
(c) If a provisional or conditional accreditation is received, the physician shall notify the Board of Medicine in writing and shall include a plan of correction.
Rulemaking Authority 458.309(1), (3) FS. Implements Florida Statutes § 456.069, 458.309(3). History-New 5-15-00, Amended 9-18-01, 8-5-03, 9-1-03, 2-9-05, 8-22-06, 10-30-07, 1-9-13, 3-3-13, 12-22-14.