The proposed rule amendments are intended to clarify the definition of surgery/procedure with regard to the appropriate standards of practice; to clarify language with regard to the “pause” rule; to clarify requirements in office surgery settings, ...

 

DEPARTMENT OF HEALTH

Board of Osteopathic Medicine

RULE NOS.:RULE TITLES:

64B15-14.006Standards of Practice for Surgery

64B15-14.007Standard of Care for Office Surgery

64B15-14.0076Requirement for Osteopathic Physician Office Registration; Inspection or Accreditation
PURPOSE AND EFFECT: The proposed rule amendments are intended to clarify the definition of surgery/procedure with regard to the appropriate standards of practice; to clarify language with regard to the “pause” rule; to clarify requirements in office surgery settings, including surgical logs, transfer agreements and supplies required for the crash cart. Additionally, the rule amendments clarify transfer agreement requirements.

SUMMARY: The proposed amendments in Rule 64B15-14.006, F.A.C., clarify the definition of surgery; and clarify requirements regarding the “pause” rule by requiring the patient’s identity to be confirmed utilizing two or more patient identifiers. The proposed amendments in Rule 64B15-14.007, F.A.C., require surgical logs to be maintained for at least 6 years; clarifies language regarding transfer agreements, and sets forth updated supplies and medications to be kept on the crash cart. The proposed amendment to Rule 64B15-14.0076, F.A.C., clarifies language regarding transfer agreements and office registration.

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: 459.005, 459.015(1)(z), 459.026 FS.

LAW IMPLEMENTED: 456.069, 459.005(2), 459.015(1)(g), (x),(z),(aa), 459.026 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Anthony Jusevitch, 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/Procedure.

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) 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, 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 in the surgery/procedure operating room and immediately prior to the initiation of any procedure, the surgery/procedure surgical 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 performing the surgery/procedure 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 surgery/procedure and the correct surgical/procedure site prior to making any incision or initiating the procedure. The notes of the surgery/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) 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 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) through (4) No change

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, 11-5-07,________.

 

64B15-14.007 Standard of Care for Office Surgery.

NOTHING IN THIS RULE RELIEVES THE SURGEON OF THE RESPONSIBILITY FOR MAKING THE MEDICAL DETERMINATION THAT THE OFFICE IS AN APPROPRIATE FORUM FOR THE PARTICULAR PROCEDURE(S) TO BE PERFORMED ON THE PARTICULAR PATIENT.

(1) No change.

(2) General Requirements for Office Surgery.

(a) through (b) No change.

(c) The surgeon must maintain a log of all liposuction procedures where more than 1,000 cubic centimeters of supernatant fat is removed, and Level II and Level III surgical procedures performed, which must include a confidential patient identifier, time of arrival in the operating suite, the name of the physician who provided medical clearances, the surgeon’s name, diagnosis, CPT Codes, patient ASA classification, the type of procedure, the level of surgery, the anesthesia provider, the type of anesthesia used, the duration of the procedure, the type of post-operative care, duration of recovery, disposition of the patient upon discharge, list of medications used during surgery, and recovery, and any adverse incidents, as defined in Section 459.026, F.S. The log and all surgical records shall be provided to investigators of the Department of Health upon request. The log and all surgical records shall be provided to investigators of the Department of Health upon request and must be maintained for six (6) years from the last patient contact.

(d) through (m) No change.

(3) No change.

(4) Level II Office Surgery.

(a) No change.

(b) Standards for Level II Office Surgery.

1. Transfer Agreement Required. The physician, or the facility where the procedure is being performed, must have a transfer agreement with a licensed hospital within reasonable proximity if the physician does not have staff privileges to perform the same procedure as that being performed in the out-patient setting at a licensed hospital within reasonable proximity. “Reasonable proximity” is defined as not to exceed thirty (30) minutes transport time to the hospital.

2. No change.

3. Equipment and Supplies Required.

a. Full and current crash cart at the location the anesthetizing is being carried out. The crash cart must include, at a minimum, the following resuscitative medications:

I. through XVI. No change.

XVII. A beta blocker Propranolol 1 mg x 1

XVIII. through XXI. No change.

b. No change.

c. Suction devices, endotracheal tubes, laryngoscopes, etc.

c.d. Positive pressure ventilation device (e.g., Ambu) plus oxygen supply.

d. End tidal CO2 detection device.

e. Double tourniquet for the Bier block procedure.

e. f. Monitors for blood pressure/EKG/Oxygen saturation.

f. g. Emergency intubation equipment, which shall at a minimum include suction devices, endotracheal tubes, laryngoscopes, oropharyngeal airways, nasopharyngeal airways and bag valve mask apparatus that are patient-size specific.

g. Defibrillator or an Automated External Defibrillator unit (AED).

h. Adequate operating room lighting.

h.i. Emergency power source able to produce adequate power to run required equipment for a minimum of two (2) hours.

i. j. Sterilization Appropriate sterilization equipment.

j. k. IV solution and IV equipment.

4. No change.

(5) through (6) No change.

Rulemaking Authority 459.005(1), 459.015(1)(z), 459.026 FS. Law Implemented 459.015(1)(g), (x), (z), (aa), 459.026 FS. History–New 11-29-01, Amended 2-23-03, 11-2-05, 6-4-09, 8-30-10, 3-20-13,__________.

 

64B15-14.0076 Requirement for Osteopathic Physician Office Registration; Inspection or Accreditation.

(1) Registration.

(a) through (d) No change.

(e) If an osteopathic physician intends to perform liposuction procedures where more than 1,000 cubic centimeters of supernatant fat is removed, Level II surgical procedures with a maximum planned duration of more than five (5) minutes, or any Level III office surgery in an office that is already registered pursuant to this rule, the osteopathic physician must document compliance with the transfer agreement requirements set forth in subparagraph 64B15-14.007(4)(b)1., F.A.C., and the training requirements set forth in sub-subparagraph 64B15-14.007(4)(b)2.a., F.A.C., prior to performing such procedures.

(f) This rule shall not be interpreted as requiring a physician to register with the Department of Health or to obtain any other form of authorization from the Department of Health to perform office surgery in an office that has been registered in accordance with this rule.

(2) through (3) No change.

Rulemaking Authority 459.005(1), (2) FS. Law Implemented 456.069, 459.005(2) FS. History–New 2-12-02, Amended 11-20-03, 6-4-09, 7-19-10, 3-20-13,_________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Osteopathic Medicine

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Osteopathic Medicine

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: May 17, 2013

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 25, 2013