Florida Board of Medicine: Take a Pause

The Florida Board of Medicine’s Surgical Care/Quality Assurance Committee has been reviewing Rule 64B8-9.007, Florida Administrative Code – Standards of Practice in an effort to reduce the number of wrong patient, wrong site and/or wrong procedure disciplinary cases. This rule outlines requirements for taking a pause prior to beginning surgery to ensure you have the right patient, the right site and are performing the right surgery as described in the Informed Consent signed by the patient. The Board continues to see disciplinary cases in which the required “pause” is performed but surgery is still performed on the wrong patient, wrong site or the wrong procedure is performed. The Committee met three times and heard public testimony. During that testimony, it was determined the definition of surgery also needed to be clarified. Changes to the rule include:

  • Physicians are required to confirm the patient’s identity, confirm the procedure being performed and confirm the correct surgical site with another healthcare practitioner
  • “Pause” must be performed again if the physician leaves the room at any time during the procedure or surgery
  • Clarification of the definition of surgery

These changes are effective January 29, 2013 and are underlined in the rule language below:

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. In addition, it is the responsibility of the treating physician 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 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 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, ocular surgery, liposuction, lipoplasty, and Mohs, are not minor surgeries/procedures.

(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. If the surgery/procedure is performed in a facility licensed pursuant to Chapter 395, F.S., or a level II or III surgery/procedure is performed in an office surgery setting, the physician(s) performing the procedure and another Florida licensed health care practitioner shall verbally and simultaneously confirm the patient’s identification, the intended procedure and the correct surgical/procedure site prior to making any incision or initiating the procedure. The medical record shall specifically reflect when this confirmation procedure was completed and which personnel on the team confirmed each item.

(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) 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 initiated, if the physician(s) leave(s) the room where the procedure is being performed, upon his or her return, the pause set forth in subsection (b) above must be performed again.

(3) Management of postsurgical care is the responsibility of the operating surgeon.

(4) The operating surgeon can delegate discretionary postoperative activities to equivalently trained licensed doctors of medicine or osteopathy or to physicians practicing within Board approved postgraduate training programs. Delegation to any health care practitioner is permitted only if the other practitioner is supervised by the operating surgeon or an equivalently trained licensed doctor of medicine or osteopathy or a physician practicing within a Board approved postgraduate training program.

Rulemaking Authority 458.309, 458.331(1)(v) 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, 1-29-13(2)(b), (c), (e).
Author:
Crystal A. Sanford, CPM
Ms. Sanford is currently a Program Operations Administrator in the Board of Medicine
and has worked in the Board for over 22 years. info@FLBoardofMedicine.gov

An official website of the State of Florida How You Know

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

File A Complaint

✕
✕
✕
Processing Times
✕
✕

Latest News

Florida Board of Medicine: Take a Pause

The Florida Board of Medicine’s Surgical Care/Quality Assurance Committee has been reviewing Rule 64B8-9.007, Florida Administrative Code – Standards of Practice in an effort to reduce the number of wrong patient, wrong site and/or wrong procedure disciplinary cases. This rule outlines requirements for taking a pause prior to beginning surgery to ensure you have the right patient, the right site and are performing the right surgery as described in the Informed Consent signed by the patient. The Board continues to see disciplinary cases in which the required “pause” is performed but surgery is still performed on the wrong patient, wrong site or the wrong procedure is performed. The Committee met three times and heard public testimony. During that testimony, it was determined the definition of surgery also needed to be clarified. Changes to the rule include:

  • Physicians are required to confirm the patient’s identity, confirm the procedure being performed and confirm the correct surgical site with another healthcare practitioner
  • “Pause” must be performed again if the physician leaves the room at any time during the procedure or surgery
  • Clarification of the definition of surgery

These changes are effective January 29, 2013 and are underlined in the rule language below:

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. In addition, it is the responsibility of the treating physician 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 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.