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 ...

 

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 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 $53,505 in one year and $151,605 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: 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) Definitions.

(a) Surgery. For the purpose of this rule, surgery is defined as any manual or operative procedure, including the use of lasers, performed upon the body of a living human being for the purposes of preserving health, diagnosing or curing disease, repairing injury, correcting deformity or defects, prolonging life, relieving suffering or any elective procedure for aesthetic, reconstructive or cosmetic purposes, to include, but not be limited to: incision or curettage of tissue or an organ; suture or other repair of tissue or organ, including a closed as well as an open reduction of a fracture; extraction of tissue including premature extraction of the products of conception from the uterus; insertion of natural or artificial implants; or an endoscopic procedure with use of local or general anesthetic.

(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) Office surgery. For the purpose of this rule office surgery is defined as surgery which is performed outside of any facility licensed under Chapter 390 or 395, F.S. a hospital, an ambulatory surgical center, abortion clinic, or other medical facility licensed by the Department of Health, the Agency for Health Care Administration, or a successor agency. Office surgical procedures shall not be of a type that generally result in blood loss of more than ten percent of estimated blood volume in a patient with a normal hemoglobin; require major or prolonged intracranial, intrathoracic, abdominal, or major joint replacement procedures, except for laparoscopic procedures; directly involve major blood vessels; or are generally emergent or life threatening in nature.

(e) Pediatric patients are defined as those patients who are 13 years of age or under.

(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 64B15-15.004, 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 64B15-6.010(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 459.026, 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 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 (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 21, 1998, 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 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. and Mmonitoring for the presence of exhaled carbon dioxide is recommended unless precluded or invalidated by the nature of the patient, procedure, or equipment.

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 459.026 497.026, F.S.

(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:, Epinephrine (or other vasopressor), Corticoids, Antihistamine and Atropine if any anesthesia is used.

(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.

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 subparagraphs (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 intravenously, intramuscularly, or rectally, 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 patient’s level of sedation is that of moderate sedation and analgesia or conscious sedation. 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. 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 performing the procedure 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. Training Required.

a. The surgeon must have staff privileges at a licensed hospital to perform the same procedure in that hospital as that being performed in the office setting or must be able to document satisfactory completion of training such as Board certification or Board eligibility by a Board approved by the American Osteopathic Association, the American Board of Medical Specialties, the Accreditation Council on Graduate Medical Education or any other board approved by the Board of Osteopathic Medicine or must be able to establish comparable background, training, and experience. Such Board certification or comparable background, training and experience must also be directly related to and include the procedure(s) being performed by the physician in the office surgery facility.

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.

The surgeon and one assistant must be currently certified in Basic Life Support and the surgeon or at least one assistant must be currently certified in Advanced Cardiac Life Support or have a qualified anesthesia provider practicing within the scope of the provider’s license manage the anesthesia.

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

(V) 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 Narcan (naloxone) 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. 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 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. which 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. The surgeon must have staff privileges at a licensed hospital to perform the same procedure in that hospital as that being performed in the office setting or must be able to document satisfactory completion of training such as Board certification or Board qualification by a Board approved by the American Osteopathic Association, the American Board of Medical Specialties, the Accreditation Council on Graduate Medical Education or any other board approved by the Board of Osteopathic Medicine or must be able to demonstrate to the accrediting organization or to the Department comparable background, training and experience. Such Board certification or comparable background, training and experience must also be directly related to and include the procedure(s) being performed by the physician in the office surgery facility. In addition, the surgeon must have knowledge of the principles of general anesthesia.

b. One The surgeon and one assistant must be currently certified by an American Heart Association approved in Basic Life Support course and the surgeon or at least one assistant 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. No change.

e. 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 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 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 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,__________.

 

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: August 22, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: September 18, 2014