Notice of Proposed Rule

DEPARTMENT OF HEALTH
Board of Medicine
RULE NO: RULE TITLE
64B8-9.007: Standards of Practice
PURPOSE AND EFFECT: The proposed rule amendment is intended to clarify the rule with regard to the notes of the procedure.
SUMMARY: The proposed rule amendment specifies that the medical record shall specifically reflect the confirmation of the “pause” procedure.
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: 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.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Larry McPherson, Jr., 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) No change.

(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) No change.

(b) Except in life-threatening emergencies requiring immediate resuscitative measures, once the patient has been prepared for the elective surgery/procedure and the team has been gathered and immediately prior to the initiation of any procedure, the team will pause and the 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 medical record notes of the procedure shall specifically reflect when this confirmation procedure was completed and which personnel on the 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) No change.

(3) through (4) No change.

Specific Authority 458.309 FS. Law Implemented 458.331(1)(t), (v), (w) FS. History–New 11-28-91, Formerly 21M-20.015, 21M-27.007, 61F6-27.007, 59R-9.007, Amended 2-18-04, 9-18-05, 4-25-06,_________.


NAME OF PERSON ORIGINATING PROPOSED RULE: Surgical Care Committee, Board of Medicine
NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Board of Medicine
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 1, 2008
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: February 15, 2008