The proposed rule amendments are intended to clarify several of the requirements with regard to office surgery, including clarification of the various levels of office surgery; updating of the anesthesia monitoring guidelines; clarification of ...

Board of Medicine

RULE NO.:RULE TITLE:

64B8-9.009Standard of Care for Office Surgery

PURPOSE AND EFFECT: The proposed rule amendments are intended to clarify several of the requirements with regard to office surgery, including clarification of the various levels of office surgery; updating of the anesthesia monitoring guidelines; clarification of required training; and updating and clarification of equipment and supplies.

SUMMARY: The proposed rule amendments clarify the various levels of office surgery; update the anesthesia monitoring guidelines; clarify the training requirements and provide updates and clarifications to required equipment and supplies.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COST AND LEGISLATIVE RATIFICATION: The agency, after conferring with representatives of the Florida Society of Anesthesiologists and interested physicians, determined that the rules in question may very well have some adverse impact on office surgery facilities that will qualify as small business. A SERC has 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.  In summary, the rule is expected to require some offices performing Level I procedures to obtain additional equipment and supplies and to provide additional training to employees. However, as set forth in the SERC, many of these offices already have the requisite equipment, supplies, and training. Additionally, some Level I offices are exempt from the additional requirements because they perform only minor procedures. Level II and Level III offices will also have some additional impact with regard to the required list of medications and training. However, most of these offices are already in compliance with the proposed changes and will see minimal impact from the rule amendments. The requirement for Level III facilities to review policies and procedures will require additional staff time and will also result in additional costs to these offices. The SERC prepared by the Board staff estimates that the costs to small business to be approximately $213,245 in one year and $983,005 over five years.

Representatives from the Florida Society of Anesthesiologists, various risk management consultants, and others who perform office surgery procedures appeared and provided testimony to the Board of Medicine and Board of Osteopathic Medicine Office Surgery Joint Subcommittee at several meetings and submitted additional information regarding the economic impact and the various costs associated with the proposed changes in equipment, supplies and training.

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: Allison M. Dudley, 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) Definitions.

(a) through (b) No change.

(c) Equipment. For the purpose of this rule, implicit within the use of the term of equipment is the requirement that the specific item named must meet current performance standards according to manufacturer’s guidelines.

(d) through (g) No change.

(2) General Requirements for Office Surgery.

(a) The surgeon must examine the patient immediately before the surgery to evaluate the risk of anesthesia and of the surgical procedure to be performed. The surgeon may delegate the preoperative heart lung evaluation to a qualified anesthesia provider within the scope of the provider’s practice and, if applicable, protocol. The surgeon must maintain complete records of each surgical procedure, as set forth in Rule 64B8-9.003, F.A.C., including anesthesia records, when applicable and the records shall contain written informed consent from the patient reflecting the patient’s knowledge of identified risks, consent to the procedure, type of anesthesia and anesthesia provider, and that a choice of anesthesia provider exists, i.e., anesthesiologist, anesthesiologist assistant, another appropriately trained physician as provided in this rule, certified registered nurse anesthetist, or physician assistant qualified as set forth in subparagraph 64B8-30.012(2)(b)6., F.A.C.

(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, documentation of  completion of the the name of the physician who provided medical clearances as performed by the anesthesiologist or the operating physician, the surgeon’s name, diagnosis, CPT Codes, patient ASA classification, and the type of procedure, the level of surgery, the anesthesia provider, the type of anesthesia used, the duration of the procedure, and any adverse incidents, as identified in Section 458.351, F.S.  If not documented elsewhere in the patient record, the surgical log must note  the type of post-operative care, duration of recovery, disposition of the patient upon discharge, and list of medications used during surgery and recovery, and any adverse incidents, as identified in Section 458.351, F.S. 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 (f) No change.

(g) The Board of 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 21, 1998, as the standards for anesthetic monitoring by any qualified anesthesia provider.

1. These standards apply to general anesthetics, regional anesthetics, and monitored anesthesia care (Level II and III as defined by this rule) although, in emergency circumstances, appropriate life support measures take precedence. These standards may be exceeded at any time based on the judgment of the responsible supervising physician or anesthesiologist. They are intended to encourage quality patient care, but observing them cannot guarantee any specific patient outcome. They are subject to revision from time to time, as warranted by the evolution of technology and practice. This set of standards addresses address only the issue of basic anesthesia monitoring, which is one component of anesthesia care.

2. No change.

3. Under extenuating circumstances, the responsible supervising 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. No change.

II. OXYGENATION.

(A) No change.

(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 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 laryngeal mask 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 laryngeal mask 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 anesthesiologist or the anesthesia care team personnel.*

(III) When ventilation is controlled by a mechanical ventilator, there shall be in continuous use a device that is capable of detecting disconnection of components of the breathing system. The device must give an audible signal when its alarm threshold is exceeded.

(IV) During regional anesthesia (with no sedation) or local anesthesia (with no sedation) and monitored anesthesia care, the adequacy of ventilation shall be evaluated, at least, by continual observation of qualitative clinical signs. During moderate or deep sedation the adequacy of ventiliation shall be evaluated by continual observation of qualitative clinical signs. Monitoring for the presence of exhaled carbon dioxide is recommended.

IV. through V. No change.

(h) through (j) No change.

(k) The surgeon shall report to the Department of Health any adverse incidents that occur within the office surgical setting. This report shall be made within 15 days after the occurrence of an incident as required by Section 458.351, F.S. 197, Chapter 99-397, Laws of Florida.

(l) through (m) No change.

(3) Level I Office Surgery.

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

1. Minor 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. The patient’s  level of sedation is that of minimal sedation and anxiolysis. Minimal sedation and anxiolysis is a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and physical coordination may be impaired, airway reflexes, and ventilatory and cardiovascular functions are unaffected.

2. through 3. No change.

4. Anesthesia Pre-operative medications not required or used other than minimal pre-operative tranquilization of the patient; anesthesia is local, topical, or none, and preoperative medicines are limited to a single anxiolytic drug not in the opiate class. The cumulative dose of the anxiolytic drug shall not exceed the maximum recommended dose (as per the manufacturer’s recommendation). No drug-induced alteration of consciousness other than minimal pre-operative tranquilization of the patient is permitted in level I Office Surgery.

5. 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 approved Basic Life Support course, and the surgeon must hold current certification in an American Heart Association approved Advanced Cardiac Life Support course Basic Life Support Certification is recommended but not required.

2. Equipment and Supplies Required. Intravenous access supplies, oxygen, oral airways, and a Oxygen, positive pressure ventilation device shall be available in the office, along with the following medications, stored per manufacturer’s recommendations:

(a) Atropine 3 mg;

(b) Diphenhydramine 50 mg;

(c) Epinephrine 1 mg in 10 ml;

(d) Epinephrine 1 mg in 1 ml vial, 3 vials total; and

(e) Hydrocortisone 100 mg., Epinephrine (or other vasopressor), Corticoids, Antihistamine and Atropine if any anesthesia is used.

3. When performing minor 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, physicans are exempt from subsections (3)(b)1. and 2., above. Current Basic Life Support certification is recommended but not required.

4.3. Assistance of Other Personnel Required. No other assistance is required, unless the specific surgical procedure being performed requires an assistant.

(4) Level II Office Surgery.

(a) Scope.

1. Level II Office Surgery is that in which peri-operative medication and sedation are used by any means altering the level of consciousness, thus making intra and post-operative monitoring necessary. Such procedures shall include, but not be limited to: hemorrhoidectomy, hernia repair, reduction of simple fractures, large joint dislocations, breast biopsies, colonoscopy, and liposuction involving the removal of up to 4000cc supernatant fat.

2. Level II Office surgery includes any surgery in which the patient's level of sedation is that of moderate sedation and analgesia or conscious sedation patient. Moderate sedation and analgesia or conscious sedation is a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is maintained. Reflex withdrawal from a painful stimulus is not considered a purposeful response is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation. Patients whose only response is reflex withdrawal from a painful stimulus are sedated to a greater degree than encompassed by this definition.

(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 approved Basic Life Support course and the surgeon must be currently certified in and by an American Heart Associaton 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 resuscitative medications:

I. Adenosine 18 mg 6 mg/2 ml x 3

II. Albuterol 2.5 mg with small volume nebulizer Inhaler

III. Amiodarone 300 mg 150 mg x 2

IV. Atropine 3 mg 0.4 mg/ml; 3 ml

V. Calcium chloride 1 gram 10%; 10 ml

VI. Dextrose 50%; 50 ml

VII. Diphenhydramine 50 mg

VIII. Dopamine 200 mg minimum

IX. Epinephrine 1 mg in 1:10,000 dilution; 10 ml

X. Epinephrine 1 mg in 1 ml vial, 3 vials total 1:1000 dilution; 1 ml x 3

XI. Flumazenil 1 mg  0.1 mg/ml; 5 ml x 2

XII. Furosemide 40 mg

XIII. Hydrocortisone 100 mg or Methylprednisolone or Dexamethasone

XIV. Lidocaine 100 mg

XV. Magnesium sulfate 2 grams 1 gm x 2

XVI. Naloxone 1.2 mg 0.4 mg/ml; 3 ml

XVII. A beta blocker class drug

XVIII. Sodium bicarbonate 50 mEq/50 ml

XIX. Short acting muscle relaxant Succinylcholine 1 vial

XX. Vasopressin 40 20 units x 2

XXI. A calcium channel blocker class drug Verapamil 5 mg x 2

XXII. Intralipid 20% 500 ml solution (only if non-neuraxial regional blocks are performed)

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. A Benzodiazepine must be present in the office stocked, but not on the crash cart.

c. through f. No change.

g. Defibrillator with defibrillator pads or defibrillator gel, or an Automated External Defibrillator unit (AED).

h. Sufficient back up power is required to allow the physician to safely terminate the procedure and to allow the patient to emerge from the anesthetic, all without compromising the sterility of the procedure or the environment of care. Emergency power source able to produce adequate power to run required equipment for a minimum of two (2) hours.

i. Sterilization equipment.

j. IV solution and IV equipment.

4. Assistance of Other Personnel Required. The surgeon must be assisted by a qualified anesthesia provider as follows: An Anesthesiologist, Certified Registered Nurse Anesthesist, Anesthesiologist Assistant, 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 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 approved  in Advanced Cardiac Life Support course or, in the case of pediatric patients, by an American Heart Association 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 approved in Advanced Cardiac Life Support course, or, in the case of pediatric patients,  by an American Heart Association approved Pediatric Advanced Life Support course.

(6) Level III Office Surgery.

(a) Scope.

1. Level III Office Surgery is that surgery in which the patient's level of sedation is that of deep sedation and analgesia or general anesthesia.  Deep sedation and analgesia is a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.  Reflex withdrawal from a painful stimulus is not considered a purposeful response. General anesthesia is a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired. The use of spinal or epidural anesthesia shall be considered Level III involves, or reasonably should require, the use of a general anesthesia or major conduction anesthesia and pre-operative sedation. This includes the use of:

a. Intravenous sedation beyond that defined for Level II office surgery;

b. General Anesthesia: loss of consciousness and loss of vital reflexes with probable requirement of external support of pulmonary or cardiac functions; or

c. Major conduction anesthesia.

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 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 is deemed to be a complicated medical patient, the patient must be referred to an appropriate consultant for medical optimization an independent medical clearance. 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 approved in Basic Life Support course and the surgeon must be currently certified by an American Heart Association approved in Advanced Cardiac Life Support course.

2. Emergency policies and procedures related to serious anesthesia complications shall should be formulated, periodically reviewed, practiced, updated, and posted in a conspicuous location. Topics to be covered shall include the following:

a.  Airway Blockage (foreign body obstruction);

b.  Allergic Reactions;

c. Bradycardia;

d. Bronchospasm;

e. Cardiac Arrest;

f.  Chest Pain;

g. Hypoglycemia;

h. Hypotension;

i. Hypoventilation;

j.  Laryngospasm;

k. Local Anesthetic Toxicity Reaction; and

l. Malignant Hyperthermia.

3. Equipment and Supplies Required.

a. Equipment and, medication, including at least 720 mg 36 ampules of dantrolene on site (if halogenated anesthetics or succinylcholine are utilized), and monitored post-anesthesia recovery must be available in the office.

b. No change.

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

d. Defibrillator or an Automated External Defibrillator Unit (AED).

d.e. Table capable of trendelenburg and other positions necessary to facilitate the surgical procedure.

f. IV solutions and IV equipment.

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 approved in Advanced Cardiac Life Support course, or in the case of pediatric patients, by an American Heart Association 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 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,__________.

 

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 Medicine

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 1, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: September 2, 2014