64B15-14.007: Standard of Care for Office Surgery
64B15-14.0076: Requirement for Osteopathic Physician Office Registration; Inspection or Accreditation
PURPOSE AND EFFECT: The Board proposes the rule amendments to update office surgery procedures.
SUMMARY: Office surgery procedures will be updated.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared. The Board determined the proposed rules will not have an impact on small business.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 459.005(1), (2), 459.015(1)(z), 459.026 FS.
LAW IMPLEMENTED: 459.005(2), 459.015(1)(g), (x), (z), (aa), 459.026 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Ronda Bryan, Acting Executive Director, Board of Osteopathic Medicine, 4052 Bald Cypress Way, Bin #C06, Tallahassee, Florida 32399-3253
THE FULL TEXT OF THE PROPOSED RULE IS:
64B15-14.007 Standard of Care for Office Surgery.
NOTHING IN THIS RULE RELIEVES THE SURGEON OF THE RESPONSIBILITY FOR MAKING THE MEDICAL DETERMINATION THAT THE OFFICE IS AN APPROPRIATE FORUM FOR THE PARTICULAR PROCEDURE(S) TO BE PERFORMED ON THE PARTICULAR PATIENT.
(1) No change.
(2) General Requirements for Office Surgery.
(a) through (b) No change.
(c) The surgeon must maintain a log of all Level II and Level III surgical procedures performed, which must include a confidential patient identifier, time of arrival in the operating suite, the name of the physician who provided medical clearances, the surgeon’s name, diagnosis, patient ASA classification, the type of procedure, the level of surgery, the anesthesia provider, the type of anesthesia used, the duration of the procedure, the type of post-operative care, duration of recovery, disposition of the patient upon discharge, during surgery, and recover the type of procedure, the type of anesthesia used, the duration of the procedure, the type of post‑operative care, and any adverse incidents, as identified in Section 459.026, F.S. The log and all surgical records shall be provided to investigators of the Department of Health upon request.
(d) through (g) No change.
(h) The surgeon must assure that the post‑operative care arrangements made for the patient are adequate to the procedure being performed as set forth in Rule 64B15‑14.006, F.A.C. Management of post‑surgical care is the responsibility of the operating surgeon and may be delegated only as set forth in subsection 64B15-14.006(3), F.A.C. If there is an overnight stay at the office in relation to any surgical procedure:
1. The office must provide at least two (2) monitors, one of these monitors must be certified in Advanced Cardiac Life Support (ACLS), and maintain a monitor to patient ratio of at least 1 monitor to 2 patients. Once the surgeon has signed a timed and dated discharge order, the office may provide only one monitor to monitor the patient. The monitor must be qualified by licensure to administer all of the medications required on the crash cart and must be certified in Advanced Cardiac Life Support. The monitor must be certified in Advanced Cardiac Life Support. The full and current crash cart required below must be present in the office and immediately accessible for the monitors.
2. The surgeon must be reachable by telephone and readily available to return to the office if needed. For purposes of this subsection, “readily available” means capable of returning to the office within 15 minutes of receiving a call.
(i) through (l) No change.
(m) All physicians performing office surgery must be qualified by education, training, and experience to perform any procedure the physician performs in the office surgery setting.
(3) through (6) No change.
Specific Authority 459.005(1), 459.015(1)(z), 459.026 FS. Law Implemented 459.015(1)(g), (x), (z), (aa), 459.026 FS. History–New 11-29-01, Amended 2-23-03, 11-2-05,__________.
64B15-14.0076 Requirement for Osteopathic Physician Office Registration; Inspection or Accreditation.
(1) Registration.
(a) No change.
(b) In order to register an office for surgical procedures, the osteopathic physician must comply with Department of Health Rule 64B-4.003, F.A.C., which is hereby incorporated by reference,and provide documentation to support compliance with Rule 64B8-9.009, F.A.C. provide to the Board of Osteopathic Medicine, his or her name, mailing address, Florida license number, and a list of each office where the covered surgical procedures are going to be performed by the osteopathic physician. The list shall also include each office name, address, telephone number, and level of surgery being performed at that location by the osteopathic physician; and if more than one physician is practicing at that location, a list of all physicians and levels of surgery being performed must be provided. The list shall also include the name of each physician assistant, ARNP and CRNA involved in the office surgery or anesthesia; copies of any protocols necessary for the supervision of any ARNP or CRNA; and any transfer agreements with local hospitals. In addition, the osteopathic physician shall submit a statement of compliance with Rule 64B15-14.007, F.A.C., when registering with the Department.
(c) through (d) No change.
(2) Inspection.
(a) No change.
(b) The office surgery inspection fee set forth in Department of Health Rule 64B-4.002, F.A.C., which is hereby incorporated by reference, shall be remitted for each practice location.
(c)(b) The initial inspection conducted pursuant to this rule shall be announced at least one week in advance of the arrival of the inspector(s).
(d)(c) The Department shall determine compliance with the requirements of Rule 64B15-14.007, F.A.C.
(e)(d) If the office is determined to be in noncompliance, the osteopathic 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 osteopathic 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 osteopathic physician that all deficiencies have been corrected, the Department is authorized to reinspect 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)(e) The deficiency notice and subsequent documentation shall be reviewed for consideration of disciplinary action. Documentation of corrective action shall be considered in mitigation of any offense.
(g)(f) Nothing herein shall limit the authority of the Department to investigate a complaint without prior notice.
(3) No change.
Specific Authority 459.005(1), (2) FS. Law Implemented 456.069, 459.005(2) FS. History–New 2-12-02, Amended 11-20-03,________.