64B8-9.009: Standard of Care for Office Surgery
PURPOSE AND EFFECT: The proposed rule amendments are intended to clarify the rule with regard to office surgery facilities and general office surgery requirements.
SUMMARY: The proposed rule amendments clarify general office surgery requirements with regard to requirements for office surgical logs, and appropriate qualifications for physicians.
SUMMARY OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
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: 458.309(1), 458.331(1)(v) FS.
LAW IMPLEMENTED: 458.331(1)(g), (t), (v), (w), 458.351 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: Larry McPherson, Executive Director, Board of Medicine/MQA, 4052 Bald Cypress Way, Bin # C03, Tallahassee, Florida 32399-3253.
THE FULL TEXT OF THE PROPOSED RULE IS:
64B8-9.009 Standard of Care for Office Surgery.
NOTHING IN THIS RULE RELIEVES THE SURGEON OF THE RESPONSIBILITY FOR MAKING THE MEDICALDETERMINATION THAT THE OFFICE IS AN APPROPRIATE FORUM FOR THE PARTICULAR PROCEDURE(S) TO BE PERFORMED ON THE PARTICULAR PATIENT.
(1) Definitions.(a) through (c) No change.
(d) Office surgery. For the purpose of this rule office surgery is defined as surgery which is performed outside of any facility licensed under Chapter 390 or 395, F.S. a hospital, an ambulatory surgical center, abortion clinic, or other medical facility licensed by the Department of Health, the Agency for Health Care Administration, or a successor agency. Office surgical procedures shall not be of a type that generally result in blood loss of more than ten percent of estimated blood volume in a patient with a normal hemoglobin; require major or prolonged intracranial, intrathoracic, abdominal, or major joint replacement procedures, except for laparoscopic procedures; directly involve major blood vessels; or are generally emergent or life threatening in nature.
(e) 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 surgeons name, diagnosis, CPT Codes, 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, list of medications used during surgery and recovery, and any adverse incidents, as identified in Section 458.351, F.S. The log and all surgical records shall be provided to investigators of the Department of Health upon request.(d) through (l) No change.
(m) All physicians performing office surgery must be qualified by education, training, and experience to perform any procedure in the office surgery setting.
(3) through (6) No change.
Specific Authority 458.309(1), 458.331(1)(v) FS. Law Implemented 458.331(1)(g), (t), (v), (w), 458.351 FS. History New 2-1-94, Amended 5-17-94, Formerly 61F6-27.009, Amended 9-8-94, 11-15-94, Formerly 59R-9.009, Amended 2-17-00, 12-7-00, 2-27-01, 8-1-01, 8-12-01, 3-25-02, 3-22-05, 4-19-05, 10-23-05, .
