The purpose and effect of this rule development is to update the existing language in this rule.

DEPARTMENT OF HEALTH
Board of Osteopathic Medicine

RULE NO: RULE TITLE
64B15-14.006: Standards of Practice for Surgery
PURPOSE AND EFFECT: The purpose and effect of this rule development is to update the existing language in this rule.
SUMMARY: The existing language of the rule is updated.
SUMMARY OF STATEMENT 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: 459.005, 459.015(1)(z) FS.
LAW IMPLEMENTED: 459.015(1)(x), (z), (aa) 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: Pamela King, Executive Director, Board of Osteopathic Medicine/MQA, 4052 Bald Cypress Way, Bin #C06, Tallahassee, Florida 32399-3256

THE FULL TEXT OF THE PROPOSED RULE IS:

64B15‑14.006 Standards of Practice for Surgery.

The Board of Osteopathic Medicine interprets the standard of care requirement of Section 459.015(1)(x), F.S., and the delegation of duties restrictions of Section 459.015(1)(aa), 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 allopathic or osteopathic physician who is to perform the surgery. In addition, it is the responsibility of the treating physician operating surgeon or an equivalently trained allopathic or osteopathic 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 operating surgeon obtain or witness the signature of the patient on the written form evidencing informed consent.

(2) No change.

(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.

(5) The rule shall have no application to anesthesia‑related activities performed in accordance with Florida law.

Specific Authority 459.005, 459.015(1)(z) FS. Law Implemented 459.015(1)(x), (z), (aa) FS. History–New 10-16-01, Amended 4-5-05,                _________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Osteopathic Medicine
NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Board of Osteopathic Medicine
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 10, 2007
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: June 22, 2007