The proposed rule amendments are intended to clarify language and requirements with regard to office surgery, relating to anesthesia providers, training in basic life support and advanced cardiac life support and clarification of equipment and ...

 

DEPARTMENT OF HEALTH

Board of Osteopathic Medicine

RULE NO.:RULE TITLE:

64B15-14.007Standard of Care for Office Surgery

PURPOSE AND EFFECT: The proposed rule amendments are intended to clarify language and requirements with regard to office surgery, relating to anesthesia providers, training in basic life support and advanced cardiac life support and clarification of equipment and supplies.

SUMMARY: The proposed rule amendments clarify language and requirements with regard to office surgery as they relate to anesthesia providers; training in basic life support and advanced cardiac life support; and provide clarification of equipment and supplies.

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 concluded that this rule change will not have any impact on licensees and their businesses or the businesses that employ them. The changes in the rule simply clarify the language with regard to anesthesia providers; add an additional entity for the purpose of training in basic life support and advanced cardiac life support, thereby making it easier to acquire the required training; and provide clarification with regard to equipment and supplies. The rule will not increase any fees, business costs, personnel costs, will not decrease profit opportunities, and will not require any specialized knowledge to comply. This change will not increase any direct or indirect regulatory costs. Hence, the Board 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: 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: Christy Robinson, 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:

 

64B15-14.007 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 (f) No change.

(g) The Board of Osteopathic Medicine adopts the “Standards of the American Society of Anesthesiologists for Basic Anesthetic Monitoring,” approved by House Delegates on October 21, 1986, and last amended on October 20, 2010, as the standards for anesthetic monitoring by any qualified anesthesia provider.

1. through 2. No change.

3. Under extenuating circumstances, the responsible supervising osteopathic physician or anesthesiologist may waive the requirements marked with an asterisk (*); it is recommended that when this is done, it should be so stated (including the reasons) in a note in the patient’s medical record. These standards are not intended for the application to the care of the obstetrical patient in labor or in the conduct of pain management.

a. No change.

b. Standard II.

I. During all anesthetics, the patient’s oxygenation, ventilation, circulation and temperature shall be continually evaluated.

II. OXYGENATION.

(A) OBJECTIVE – To ensure adequate oxygen concentration in the inspired gas and the blood during all anesthetics.

(B) METHODS:

(I) Inspired gas: During every administration of general anesthesia using an anesthesia machine, the concentration of oxygen in the patient breathing system shall be measured by an oxygen analyzer with a low oxygen concentration limit alarm in use.*

(II) Blood oxygenation: During all anesthetics, a quantitative method of assessing oxygenation such as a pulse oximetry shall be employed.* When the pulse oximeter is utilized, the variable pitch pulse tone and the low threshold alarm shall be audible to the qualified anesthesia provider anesthesiologist or the anesthesia care team personnel.*Adequate illumination and exposure of the patient are necessary to assess color.*

III. VENTILATION.

(A) OBJECTIVE – To ensure adequate ventilation of the patient during all anesthetics.

(B) METHODS:

(I) Every patient receiving general anesthesia shall have the adequacy of ventilation continually evaluated. Qualitative clinical signs such as chest excursion, observation of the reservoir breathing bag and auscultation of breath sounds are useful. Continual monitoring for the presence of expired carbon dioxide shall be performed unless invalidated by the nature of the patient, procedure or equipment. Quantitative monitoring of the volume of expired gas is strongly encouraged.*

(II) When an endotracheal tube or supraglottic airway is inserted, its correct positioning must be verified by clinical assessment and by identification of carbon dioxide in the expired gas. Continual end-tidal carbon dioxide analysis, in use from the time of endotracheal tube/supraglottic airway placement, until extubation/removal or initiating transfer to a postoperative care location, shall be performed using a quantitative method such as capnography, capnometry or mass spectroscopy.* When capnography or capnometry is utilized, the end tidal carbon dioxide alarm shall be audible to the qualified anesthesia provider anesthesiologist or the anesthesia care team personnel.*

(III) through (IV) No change.

IV. through V. No change.

(h) through (m) No change.

(3) Level I Office Surgery.

(a) Scope. Level I office surgery includes the following:

1. No change.

(b) Standards for Level I Office Surgery.

1. Training Required. Surgeon’s continuing medical education should include: proper dosages; management of toxicity or hypersensitivity to regional anesthetic drugs. One assistant must hold current certification in an American Heart Association or American Safety and Health Institute approved Basic Life Support course, and the surgeon must hold current certification in an American Heart Association or American Safety and Health Institute approved Advanced Cardiac Life Support course.

2. through 4. No change.

(4) Level II Office Surgery.

(a) No change.

(b) Standards for Level II Office Surgery.

1. No change.

2. Training Required.

a. No change.

b. One (1) assistant must be currently certified in and by an American Heart Associaton or American Safety and Health Institute approved Basic Life Support course and the surgeon must be currently certified in and by an American Heart Associaton or American Safety and Health Institute approved Advanced Cardiac Life Support course.

3. Equipment and Supplies Required.

a. Full and current crash cart at the location the anesthetizing is being carried out. Medicines shall be stored per the manufacturer’s recommendations and multi-dose vials shall be dated once opened. The crash cart must include, at a minimum, the following intravenous or inhaled medications:

I. through XIII. No change.

XIV. Lidocaine appropriate for cardiac administration 100 mg

XV. through XVIII. No change.

XIX. Paralytic agent that is appropriate for use in rapid sequence intubation Short acting muscle relaxant

XX. through XXII. No change.

In the event of a drug shortage, the physician is allowed to substitute a therapeutically equivalent drug that meets the prevailing standard of care. The office must maintain documentation of its unsuccessful efforts to obtain the required drug.

b. through j. No change.

4. Assistance of Other Personnel Required. The surgeon must be assisted by a qualified anesthesia provider as follows: An Anesthesiologist, Certified Registered Nurse Anesthetist, Anesthesiologist Assistant, or Physician Assistant qualified as set forth in subparagraph 64B15-6.010(2)(b)6., F.A.C., or a registered nurse may be utilized to assist with the anesthesia, if the surgeon is ACLS certified. An anesthesiologist assistant may assist the anesthesiologist as set forth in Rule 64B15-7.005, F.A.C. An assisting anesthesia provider cannot function in any other capacity during the procedure. If additional assistance is required by the specific procedure or patient circumstances, such assistance must be provided by a physician, osteopathic physician, registered nurse, licensed practical nurse, or operating room technician. A physician licensed under Chapter 458 or 459, F.S., a licensed physician assistant, a licensed registered nurse with post-anesthesia care unit experience or the equivalent, credentialed by an American Heart Association or American Safety and Health Institute approved Advanced Cardiac Life Support course or, in the case of pediatric patients, by an American Heart Association or American Safety and Health Institute approved Pediatric Advanced Life Support course and, must be available to monitor the patient in the recovery room until the patient is recovered from anesthesia.

(5) Level IIA Office Surgery.

(a) No change.

(b) Standards for Level IIA Office Surgery.

1. No change.

2. Assistance of Other Personnel Required. During the procedure, the surgeon must be assisted by a physician or physician assistant who is licensed pursuant to Chapter 458 or 459, F.S., or by a licensed registered nurse or a licensed practical nurse. Additional assistance may be required by specific procedure or patient circumstances. Following the procedure, a physician or physician assistant who is licensed pursuant to Chapter 458 or 459, F.S., or a licensed registered nurse must be available to monitor the patient in the recovery room until the patient is recovered from anesthesia. The monitor must be certified by an American Heart Association or American Safety and Health Institute approved Advanced Cardiac Life Support course, or, in the case of pediatric patients, by an American Heart Association or American Safety and Health Institute approved Pediatric Advanced Life Support course.

(6) Level III Office Surgery.

(a) No change.

(b) Standards for Level III Office Surgery. In addition to the standards for Level II Office Surgery, the surgeon must comply with the following:

1. Training Required.

a. No change.

b. One assistant must be currently certified by an American Heart Association or American Safety and Health Institute approved Basic Life Support course and the surgeon must be currently certified by an American Heart Association or American Safety and Health Institute approved Advanced Cardiac Life Support course.

2. No change.

3. Equipment and Supplies Required.

a. through b. No change.

c. Blood pressure monitoring equipment; EKG; end tidal CO2 monitor; pulse oximeter, stethoscope, emergency intubation equipment and a temperature monitoring device.

d. No change.

4. Assistance of Other Personnel Required. An Anesthesiologist, Certified Registered Nurse Anesthetist, Anesthesiologist Assistant, or Physician Assistant qualified as set forth in subparagraph 64B15-6.010(2)(b)6., F.A.C., must administer the general or regional anesthesia and an M.D., D.O., Registered Nurse, Licensed Practical Nurse, Physician Assistant, or Operating Room Technician must assist with the surgery. The anesthesia provider cannot function in any other capacity during the procedure. A physician licensed under Chapter 458 or 459 F.S., a licensed anesthesiologist assistant, a licensed physician assistant, or a licensed registered nurse with post-anesthesia care unit experience or the equivalent, and credentialed by an American Heart Association or American Safety and Health Institute approved Advanced Cardiac Life Support course, or in the case of pediatric patients, by an American Heart Association or American Safety and Health Institute approved Pediatric Advanced Life Support course, must be available to monitor the patient in the recovery room until the patient has recovered from anesthesia.

Rulemaking Authority 459.005, 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, 10-3-13, 12-11-14,                .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Medicine and Board of Osteopathic Medicine Joint Office Surgery Subcommittee

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 13, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: March 13, 2015