64B8-9.007: Standards of Practice
PURPOSE AND EFFECT: The proposed rule amendments are intended to set forth requirements for proper implementation of the “pause” rule.
SUMMARY: The proposed rule amendments require physicians to confirm the patient’s identity, confirm the procedure being performed and confirm the correct surgical site with another healthcare practitioner. The rule amendment also requires that the “pause” be performed again if the physician leaves the room at any time during in which the procedure or surgery is performed.
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) 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 and another Florida licensed healthcare practitioner will verbally and simultaneously 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 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) Confirmation of the patient’s identity shall be made by using two or more of the following corroborating patient identifiers:
1. Name.
2. Assigned identification number.
3. Telephone number.
4. Date of Birth.
5. Social security number.
6. Address.
7. Photograph.
(d)(c) The provisions of paragraph (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.
(e) At any time after the pause is completed, but before the procedure is performed, if the physician(s) leave the room where the procedure is being performed, upon his or her return, the pause set forth in paragraph (b) above must be performed again.
(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,________.