The proposed rule amendment is intended to clarify the appropriate medications and supplies to be utilized on the crash cart in certain office surgery settings.

 

DEPARTMENT OF HEALTH
Board of Medicine

RULE NO.: RULE TITLE:
64B8-9.009: Standard of Care for Office Surgery
PURPOSE AND EFFECT: The proposed rule amendment is intended to clarify the appropriate medications and supplies to be utilized on the crash cart in certain office surgery settings.
SUMMARY: The proposed rule amendment sets forth the appropriate medications and supplies to be utilized on the crash cart in certain office surgery settings.
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(1), 458.331(1)(v) FS.
LAW IMPLEMENTED: 458.331(1)(v), 458.351 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:

64B8-9.009 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) through (3) No change.

(4) Level II Office Surgery.

(a) No change.

(b) Standards for Level II Office Surgery.

1. -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. A Benzodiazepine must be stocked, but not on the crash cart.

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

i. Adequate operating room lighting.

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

i.k. Sterilization Appropriate sterilization equipment.

j.l. IV solution and IV equipment.

4. No change.

(5) through (6)  No change.

Rulemaking Authority 458.309(1), 458.331(1)(v) FS. Law Implemented 458.331(1)(v), 458.351 FS. History–New 2-1-94, Amended 5-17-94, Formerly 61F6-27.009, Amended 9-8-94, 11-15-94, Formerly 59R-9.009, Amended 2-17-00, 12-7-00, 2-27-01, 8-1-01, 8-12-01, 3-25-02, 3-22-05, 4-19-05, 10-23-05, 10-10-06, 4-18-07, 9-3-07, 3-25-10, 8-6-12,                    .

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