64B8-9.007: Standards of Practice
PURPOSE AND EFFECT: The proposed rule amendments are intended to clarify the application of the pause rule.
SUMMARY: The proposed rule amendments apply the pause rule to the entire team performing the procedure.
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 FS.
LAW IMPLEMENTED: 458.331(1)(t), (v), (w) FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least days before the workshop/meeting by contacting: If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
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:
64B8-9.007 Standards of Practice.
The Board of Medicine interprets the standard of care requirement of Section 458.331(1)(t), F.S., and the delegation of duties restrictions of Section 458.331(1)(w), F.S., with regard to surgery as follows:
(1) The ultimate responsibility for diagnosing and treating medical and surgical problems is that of the licensed doctor of medicine or osteopathy who is to perform the procedure surgery. In addition, it is the responsibility of the treating physician operating surgeon or an equivalently trained doctor of medicine or osteopathy or a physician practicing within a Board approved postgraduate training program to explain the procedure to and obtain the informed consent of the patient. It is not necessary, however, that the treating physician operating surgeon obtain or witness the signature of the patient on the written form evidencing informed consent.
(2) This rule is intended to prevent wrong site, wrong side, wrong patient and wrong surgeries/procedures by requiring the team to pause prior to the initiation of the surgery/procedure to confirm the side, site, patient identity, and surgery/procedure.
(a) Definition of Surgery/Procedure. As used herein, "surgery/procedure" means the incision or curettage of tissue or an organ, insertion of natural or artificial implants, electro-convulsive therapy, and endoscopic procedure or other procedure requiring the administration of anesthesia or an anesthetic agent. Minor surgeries/procedures such as excision of skin lesions, moles, warts, cysts, lipomas and repair of lacerations or surgery limited to the skin and subcutaneous tissue performed under topical or local anesthesia not involving drug-induced alteration of consciousness other than minimal pre-operative tranquilization of the patient are exempt from the following requirements.
(b) Except in life-threatening emergencies requiring immediate resuscitative measures, once the patient has been prepared for the elective surgery/procedure and the surgical team has been gathered in the operating room and immediately prior to the initiation of any surgical procedure, the surgical team will pause and the operating physician(s) performing the procedure will verbally confirm the patient's identification, the intended procedure and the correct surgical/procedure site. The operating physician shall not make any incision or perform any surgery or procedure prior to performing this required confirmation. The notes of the procedure shall specifically reflect when this confirmation procedure was completed and which personnel on the surgical team confirmed each item. This requirement for confirmation applies to physicians performing procedures either in office settings or facilities licensed pursuant to Chapter 395, F.S., and shall be in addition to any other requirements that may be required by the office or facility.
(c) The provisions of subsection (b) shall be applicable to anesthesia providers prior to administering anesthesia or anesthetic agents, or performing regional blocks at any time both within or outside a surgery setting.
(3) through (4) No change.
Specific Authority 458.309 FS. Law Implemented 458.331(1)(t), (v), (w) FS. HistoryNew 11-28-91, Formerly 21M-20.015, 21M-27.007, 61F6-27.007, 59R-9.007, Amended 2-18-04, 9-18-05, ________.
