The proposed rule amendments are intended to clarify the definition of surgery/procedure with regard to the appropriate standards of practice.

 

DEPARTMENT OF HEALTH
Board of Medicine

RULE NO.: RULE TITLE:
64B8-9.007: Standards of Practice
PURPOSE AND EFFECT: The proposed rule amendments are intended to clarify the definition of surgery/procedure with regard to the appropriate standards of practice.
SUMMARY: The proposed rule amendments clarify the definition of surgery/procedure as it relates to the appropriate standards of practice.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:
The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the agency.
The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.
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.
RULEMAKING AUTHORITY: 458.309 FS.
LAW IMPLEMENTED: 458.331(1)(v) FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Joy A. Tootle, 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) Definition of Surgery/Procedure. As used herein, “surgery/procedure” means the removal, incision or curettage of tissue or an organ, insertion of natural or artificial implants, electro-convulsive therapy, 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.  Paracentesis, thoracentesis, arthrocentesis, ocular surgery, liposuction, lipoplasty, and MOHS, are not minor surgeries/procedures.

(b) through (c)  No change. 

(3) through (4)  No change.

Rulemaking Authority 458.309 FS. Law Implemented 458.331(1)(v) 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, 5-6-08,               .

NAME OF PERSON ORIGINATING PROPOSED RULE: Surgical Care Committee, Board of Medicine
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Medicine
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 3, 2012
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: September 7, 2012