The proposed rule amendment is intended to clarify the requirements for pre-operative clearance of specific surgical patients for Level III office surgery procedures. Additionally, the rule amendments set forth an additional entity for the purpose ...

 

DEPARTMENT OF HEALTH

Board of Medicine

RULE NO.:RULE TITLE:

64B8-9.009Standard of Care for Office Surgery

PURPOSE AND EFFECT: The proposed rule amendment is intended to clarify the requirements for pre-operative clearance of specific surgical patients for Level III office surgery procedures. Additionally, the rule amendments set forth an additional entity for the purpose of providing basic life support (BLS) and advanced cardiac life support (ACLS) training.

SUMMARY: The proposed rule amendments clarify the requirements for surgical clearance of specific patients in office surgery settings. Additionally, the rule amendments set forth an additional entity for the purpose of providing basic life support (BLS) and advanced cardiac life support (ACLS) training.

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 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: 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 FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Claudia Kemp, J.D., 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 (2) No change. 

(3) Level I Office Surgery.

(a) 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, American Safety and Health Institute, or American Red Cross, or Pacific Medical Training approved Basic Life Support course with didactic and skills components, and the surgeon must hold current certification in an American Heart Association, or American Safety and Health Institute, or Pacific Medical Training approved Advanced Cardiac Life Support course with didactic and skills components.

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 Association, American Safety and Heart Institute, or American Red Cross, or Pacific Medical Training approved Basic Life Support course with didactic and skills components, and the surgeon must be currently certified in and by an American Heart Association, or American Safety and Health Institute, or Pacific Medical Training approved Advanced Cardiac Life Support course with didactic and skills components.

3. 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 Anesthesist, or Physician Assistant qualified as set forth in subparagraph 64B8-30.012(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 64B8-31.005, 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, or Pacific Medical Training approved Advanced Cardiac Life Support course with didactic and skills components or, in the case of pediatric patients, by an American Heart Association, or American Safety and Health Institute, or Pacific Medical Training approved Pediatric Advanced Life Support course with didactic and skills components 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 Chapters 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 Chapters 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, or Pacific Medical Training approved Advanced Cardiac Life Support course with didactic and skills components, or, in the case of pediatric patients, by an American Heart Association, or American Safety and Health Institute, or Pacific Medical Training approved Pediatric Advanced Life Support course with didactic and skills components.

(6) Level III Office Surgery.

(a) Scope.

1. No change.

2. Only patients classified under the American Society of Anesthesiologist’s (ASA) risk classification criteria as Class I or II are appropriate candidates for Level III office surgery.

a. No change.

b. For all ASA II patients above the age of 50 40, the surgeon must obtain, at a minimum, an EKG and a complete workup performed prior to the performance of Level III surgery in a physician office setting. If the patient has a cardiac history or is deemed to be a complicated medical patient, the patient must have a preoperative EKG and be referred to an appropriate consultant for medical optimization. The referral to a consultant This requirement may be waived after evaluation by the patient’s anesthesiologist.

(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, American Safety and Health Institute, or American Red Cross, or Pacific Medical Training approved Basic Life Support course with didactic and skills components, and the surgeon must be currently certified by an American Heart Association, or American Safety and Health Institute, or Pacific Medical Training approved Advanced Cardiac Life Support course with didactic and skills components.

2. through 3.  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 64B8-30.012(2)(c)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, or Pacific Medical Training approved Advanced Cardiac Life Support course with didactic and skills components, or in the case of pediatric patients, by an American Heart Association, or American Safety and Health Institute, or Pacific Medical Training approved Pediatric Advanced Life Support course with didactic and skills components, must be available to monitor the patient in the recovery room until the patient has recovered from anesthesia.

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, 11-22-12, 1-9-13, 3-3-13, 7-22-14, 4-6-15, 9-4-16,                                  .

 

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: June 9, 2017

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 19, 2017