medical examiners/10

ALABAMA BOARD OF MEDICAL EXAMINERS

ADMINISTRATIVE CODE

CHAPTER 540-X-10 OFFICE-BASED SURGERY

TABLE OF CONTENTS

540-X-10-.01 Preamble

540-X-10-.02 Definitions - Levels Of Anesthesia

540-X-10-.03 Standards For Each Level Of Anesthesia - Preoperative Assessment

540-X-10-.04 Standards For Office-Based Procedures – Local Anesthesia

540-X-10-.05 Standards For Office-Based Procedures - Minimal Sedation

540-X-10-.06 Standards For Office-Based Procedures - Moderate Sedation/Analgesia

540-X-10-.07 Standards For Office-Based Procedures - Deep Sedation/Analgesia

540-X-10-.08 Standards For Office-Based Procedures - General And Regional Anesthesia

540-X-10-.09 Recovery Area And Assessment For Discharge With Moderate And Deep Sedation/General Anesthesia - Monitoring Requirement

540-X-10-.10 Reporting Requirement

540-X-10-.11 Registration Of Office-Based Surgery/ Procedures Physician

540-X-10-.12 Penalty

Appendix A Continuum Of Depth Of Sedation

Appendix B Standards Of The American Society Of Anesthesiologists

Appendix C Guidelines For Office-Based Anesthesia

Appendix D Physician Registration Form

Appendix E American Association For Accreditation Of Ambulatory Facilities, Inc., Guidelines For Sterilization

540-X-10-.01 Preamble.

(1) Office-based surgery is surgery¹ performed outside a hospital or outpatient facility licensed by the Alabama Department of Public Health. It is the position of the Alabama Board of Medical Examiners that the physician is responsible for providing a safe environment for office-based surgery. Surgical procedures in medicine have changed over the generations from procedures performed at home or at the surgeon’s office to the hospital and, now, often back to outpatient locations. However, the premise for the surgery remains unchanged: that it be performed in the best interest of the patient and under the best circumstances possible for the management of disease and the well-being of the patient. Surgery that is performed in a physician’s office at this time varies from a simple incision and drainage with topical anesthesia to semi-complex procedures under general anesthesia. It is imperative that the surgeon evaluate the patient, advise and assist the patient with a decision about the procedure and the location for its performance and, to the best of the surgeon’s ability, assure that the quality of care be equal in any facility that the surgeon advises. If the physician performs surgery in the physician’s office, it is expected that the physician will require office standards similar to those at other sites where the physician performs such procedures. It is also expected that any physician who performs a surgical procedure is knowledgeable about sterile technique, the need for pathological evaluation of certain surgical specimens, about any drug that the physician administers or orders administered, and about potential untoward reactions and complications and their treatment. Recognizing that there have been serious adverse events in office surgical settings, both in Alabama and in other states, the Board of Medical Examiners, in conjunction with an ad hoc committee representing various medical and surgical specialties, has developed guidelines for physicians who perform surgery in their offices. These guidelines are intended to remind the physician of the minimal suggested necessities for various levels of surgery in the office setting. The physician must decide on a case-by-case basis the location and level of service that is best for the physician’s particular patient and procedure; this decision must always be made with the patient’s best interest in mind.

(2) The Alabama Board of Medical Examiners recommends the following general guidelines for office-based surgery/ procedures:

(a) Training: A procedure, whether done in an office, outpatient surgical facility or hospital, should be performed by physicians operating within their area of professional training. Appropriate training and continuing medical education should be documented and that documentation readily available to patients and the Alabama Board of Medical Examiners. Physicians who perform office-based procedures must have plans for managing emergency complications.

(b) Patient Selection: Patients must be individually evaluated for each procedure to determine if the office is an appropriate setting for the anesthesia required and for the surgical procedure to be performed.

(c) Patient Evaluation: Patients undergoing office-based surgery must have an appropriately documented history and physical examination as well as other indicated consultations and studies.

(d) Anesthesia: When deep sedation, major regional anesthesia or general anesthesia is provided in the office setting, it must be administered by a qualified person(s)² other than the person performing the procedure. Anesthesia personnel should be familiar with variations in technique based on the specifics of the patient and the procedure, particularly patients requiring large volumes of fluids and/or requiring airway management. Patients must be properly monitored before, during and after the procedure. Anesthesia personnel should be currently trained in ACLS.

(e) Office Setting: The office should be set up with patient safety as a primary consideration. Safety issues should include, but not be limited to, accessibility, sterilization and cleaning routines, storage of materials and supplies, supply inventory, emergency equipment, and infection control.

(f) Emergency Planning: Planning should include, but not be limited to, emergency medicines, emergency equipment, and transfer protocols³. Practitioners should be trained and capable of recognizing and managing complications related to anesthesia that he/she administers and the procedures that he/she performs.

(g) Follow-up Care: As with any surgical treatment or procedure, follow-up care by the responsible surgeon is a requirement. Arrangements shall be made for follow-up care and for treatment of complications outside normal business hours. The patient, or a responsible adult, should be aware of these arrangements and of any medications prescribed after the procedure.

(h) Quality Improvement: Continuous quality improvement should be a goal.

(i) Facility accreditation is encouraged for those settings where deep sedation/analgesia (level 4) and general anesthesia (level 5) are provided.

(3) These rules shall not apply to an oral surgeon licensed to practice dentistry who is also a physician licensed to practice medicine, if the procedure is exclusively for the practice of dentistry. An oral surgeon licensed to practice dentistry who is also a physician licensed to practice medicine and who performs office-based surgery other than the practice of dentistry shall comply with the requirements of these regulations for those procedures which fall outside the scope of practice of dentistry.

Authors: Alabama Board of Medical Examiners ad hoc Committee: Arthur F. Toole, III, M.D.; Jorge A. Alsip, M.D.; James G. Chambers, III, M.D.; Craig H. Christopher, M.D.; Alcus Ray Hudson, M.D.; Pamela D. Varner, M.D.; James E. West, M.D.; and Task Force Sub-Committee: Jeff Plagenhoef, M.D.; Eric Crum, M.D.; Dan J. Coyle, Jr., M.D.; Gary Monheit, M.D.; Robert Hurlbutt, IV, M.D.; C. Paul Perry, M.D.; W. Guinn Paulk, M.D.; Mark McIlwain, D.M.D., M.D.; Jerald Clanton, D.M.D., M.D.; Patrick J. Budny, M.D.; James W. Northington, M.D.; David Franco, M.D.; Thomas E. Moody, M.D.

Statutory Authority: Code of Ala. 1975, §34-24-53.

History: New Rule: Filed October 17, 2003; effective November 21, 2003.

540-X-10-.02 Definitions - Levels Of Anesthesia⁴.

(1) Local Anesthesia. The administration of an agent which produces a localized and reversible loss of sensation in a circumscribed portion of the body.

(2) Minimal Sedation (anxiolysis). A drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected.

(3) Moderate Sedation/Analgesia ("Conscious Sedation"). A drug-induced depression of consciousness during which a patient responds purposefully to verbal commands, either alone or accompanied by light tactile stimulation. Reflex withdrawal from painful stimulation is NOT considered a purposeful response. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.

(4) Deep Sedation/Analgesia. A drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. Reflex withdrawal from painful stimulation is NOT considered a purposeful response. 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.

(5) General Anesthesia. 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.

(6) Regional Anesthesia ("Major conduction blockade") is considered in the same category as General Anesthesia.⁵

(7) Because sedation is a continuum, it is not always possible to predict how an individual patient will respond. Hence, practitioners intending to produce a given level of sedation should be able to rescue patients whose level of sedation becomes deeper than initially intended. Individuals administering Moderate Sedation/Analgesia ("Conscious Sedation") should be able to rescue patients who enter a state of Deep Sedation/Analgesia, while those administering Deep Sedation/ Analgesia should be able to rescue patients who enter a state of general anesthesia.

Authors: Alabama Board of Medical Examiners ad hoc Committee: Arthur F. Toole, III, M.D.; Jorge A. Alsip, M.D.; James G. Chambers, III, M.D.; Craig H. Christopher, M.D.; Alcus Ray Hudson, M.D.; Pamela D. Varner, M.D.; James E. West, M.D.; and Task Force Sub-Committee: Jeff Plagenhoef, M.D.; Eric Crum, M.D.; Dan J. Coyle, Jr., M.D.; Gary Monheit, M.D.; Robert Hurlbutt, IV, M.D.; C. Paul Perry, M.D.; W. Guinn Paulk, M.D.; Mark McIlwain, D.M.D., M.D.; Jerald Clanton, D.M.D., M.D.; Patrick J. Budny, M.D.; James W. Northington, M.D.; David Franco, M.D.; Thomas E. Moody, M.D.

Statutory Authority: Code of Ala. 1975, §34-24-53.

History: New Rule: Filed October 17, 2003; effective November 21, 2003.

540-X-10-.03 Standards For Each Level Of Anesthesia - Preoperative Assessment. A medical history, a physical examination consistent with the type and level of anesthesia and/or analgesia and the level of surgery to be performed, and the appropriate laboratory studies should be performed by a practitioner qualified to assess the impact of co-existing disease processes on surgery and anesthesia. A pre-anesthetic examination and evaluation should be conducted immediately prior to surgery by the physician or by a qualified person who will be administering or directing the anesthesia. If a qualified person will be administering the anesthesia, the physician shall review with the qualified person the pre-anesthesic examination and evaluation. The data obtained during the course of the pre-anesthesia evaluations (focused history and physical, including airway assessment and significant historical data not usually found in a primary care or surgical history⁶ that may alter care or affect outcome) should be documented in the medical record.

Statutory Authority: Code of Ala. 1975, §34-24-53.

History: New Rule: Filed October 17, 2003; effective November 21, 2003.

540-X-10-.04 Standards For Office-Based Procedures - Local Anesthesia.

(1) Equipment and supplies: Oral airway positive pressure ventilation device, epinephrine, and atropine should be available.

(2) Training required: The physician is expected to be knowledgeable in proper drug dosages, recognition and management of toxicity or hypersensitivity to local anesthetic and other drugs. It is recommended that the physician be currently trained in Basic Cardiac Life Support (BCLS).

(3) Assistance of other personnel: No other assistance is required, unless dictated by the scope of the surgical procedure.

Statutory Authority: Code of Ala. 1975, §34-24-53.

History: New Rule: Filed October 17, 2003; effective November 21, 2003.

540-X-10-.05 Standards For Office-Based Procedures - Minimal Sedation.

(1) Equipment and supplies: Oral airway positive pressure ventilation device, epinephrine, and atropine should be available.

(3) Assistance of other personnel: Anesthesia should be administered only by licensed, qualified and competent practitioners who have training and experience appropriate to the level of anesthesia administered and function in accordance with their scope of practice. Practitioners must have documented competence and training to administer local anesthesia with sedation and to assist in any support or resuscitation measures as required. Scrub or Circulating nurse(s) and/or assistant(s) must be trained in their specific job skills as determined by the supervising physician.

Statutory Authority: Code of Ala. 1975, §34-24-53.

History: New Rule: Filed October 17, 2003; effective November 21, 2003.

540-X-10-.06 Standards For Office-Based Procedures - Moderate Sedation/Analgesia.

(1) Physician Registration Requirement: The Alabama Board of Medical Examiners requires each physician who offers office-based surgery that requires moderate sedation, deep sedation or general anesthesia, as defined in these rules to register with the State Board of Medical Examiners as an office-based surgery physician.⁷

(2) Equipment and supplies: Emergency resuscitation equipment, emergency life-saving medications, suction, and a reliable source of oxygen with a backup tank must be readily available. When medication for sedation and/or analgesia is administered intravenously (IV), monitoring equipment should include: blood pressure apparatus, stethoscope, pulse oximetry, continuous EKG, and temperature monitoring for procedures lasting longer than thirty (30) minutes. Patient’s vital signs, oxygen saturation, and level of consciousness should be documented prior to the procedure, during regular intervals throughout the procedure, and prior to discharge. Facility, in terms of general preparation, should have adequate equipment and supplies, provisions for proper record keeping, and the ability to recover patients after anesthesia.

(3) Training required: The physician must be able to document satisfactory completion of training such as being Board certified or being an active candidate for certification by a Board approved by the American Board of Medical Specialties or comparable formal training. Alternative credentialing for procedures outside the physician’s core curriculum must be applied for through the Alabama Board of Medical Examiners and must be approved by the Board. The physician and at least one assistant must be currently trained in Advanced Cardiac Life Support (ACLS).

Statutory Authority: Code of Ala. 1975, §34-24-53.

History: New Rule: Filed October 17, 2003; effective November 21, 2003.

540-X-10-.07 Standards For Office-Based Procedures - Deep Sedation/Analgesia.

(2) Equipment and supplies: Emergency resuscitation equipment, emergency life-saving medications, suction, and a reliable source of oxygen with a backup tank must be readily available. Monitoring equipment should include: blood pressure apparatus, stethoscope, pulse oximetry, continuous EKG, and temperature monitoring for procedures lasting longer than thirty (30) minutes. Patient’s vital signs, oxygen saturation, and level of consciousness should be documented prior to the procedure, during regular intervals throughout the procedure, and prior to discharge. Facility, in terms of general preparation, should have adequate equipment and supplies, provisions for proper record keeping, and the ability to recover patients after anesthesia.

Statutory Authority: Code of Ala. 1975, §34-24-53.

History: New Rule: Filed October 17, 2003; effective November 21, 2003.

540-X-10-.08 Standards For Office-Based Procedures - General And Regional Anesthesia.

(2) Equipment and supplies: Emergency resuscitation equipment, suction and a reliable source of oxygen with a backup tank must be readily available. When triggering agents are in the office, at least 12 ampules of dantrolene sodium must be readily available within 10 minutes with additional ampules available from another source. Monitoring equipment should include: blood pressure apparatus, stethoscope, pulse oximetry, continuous EKG, capnography, and temperature monitoring for procedures lasting longer than thirty (30) minutes. Monitoring equipment and supplies should be in compliance with currently adopted ASA standards¹⁰. Facility, in terms of general preparation, must have adequate equipment and supplies, provisions for proper record keeping, and the ability to recover patients after anesthesia.

(4) Assistance of other personnel: Anesthesia should be administered only by licensed, qualified and competent practitioners. Practitioners must have documented competence and training to administer general and regional anesthesia and to assist in any support or resuscitation measures as required. The individual administering general and regional anesthesia and/or monitoring the patient cannot assist the physician in performing the surgical procedure. Scrub or Circulating nurse(s) and/or assistant(s) must be trained in their specific job skills as determined by the supervising physician. Direction of the sedation/analgesia component of the medical procedure should be provided by a physician who is immediately and physically present, who is licensed to practice medicine in the state of Alabama, and who is responsible for the direction of administration of the anesthetic. The physician providing direction should assure that an appropriate pre-anesthetic examination is performed, assure that qualified practitioners participate, be available for diagnosis treatment and management of anesthesia related complications or emergencies, and assure the provision of indicated post anesthesia care. At least one physician currently trained in ACLS must be immediately and physically available until the last patient is past the first stage of recovery. At least one practitioner currently trained in ACLS must be immediately and physically available until the last patient is discharged from the facility¹¹.

Statutory Authority: Code of Ala. 1975, §34-24-53.

History: New Rule: Filed October 17, 2003; effective November 21, 2003.

540-X-10-.09 Recovery Area And Assessment For Discharge With Moderate And Deep Sedation/General Anesthesia - Monitoring Requirement. Monitoring in the recovery area should be performed by a dedicated person, trained in their specific job skills as determined by the supervising physician, and must include pulse oximetry and non-invasive blood pressure measurement. The patient must be assessed periodically for level of consciousness, pain relief, or any untoward complication. Each patient should meet discharge criteria as established by the practice, prior to leaving the facility. Documented recovery from anesthesia should include the following: 1) vital signs and oxygen saturation stable within acceptable limits; 2) no more than minimal nausea, vomiting or dizziness; and 3) sufficient time (up to 2 hours) should have elapsed following the last administration of reversal agents to ensure the patient does not become sedated after reversal effects have worn off. The patient should be given appropriate discharge instructions and discharge under the care of a responsible third party after meeting discharge criteria. Discharge instructions should include: 1) the procedure performed; 2) information about potential complications; 3) telephone numbers to be used by the patient to discuss complications or questions that may arise; 4) instructions for medications prescribed and pain management; 5) information regarding the follow-up visit date, time and location; and 6) designated treatment facility in the event of an emergency (office-based physician’s number, not the emergency room).

Statutory Authority: Code of Ala. 1975, §34-24-53.

History: New Rule: Filed October 17, 2003; effective November 21, 2003.

540-X-10-.10 Reporting Requirement.

(1) Reporting to the Alabama Board of Medical Examiners is required within three (3) business days of the occurrence and will include all surgical related deaths and all events related to a procedure(s) that resulted in an emergency transfer of the surgical patient to the hospital, anesthetic or surgical events requiring CPR, unscheduled hospitalization related to the surgery, and surgical site deep wound infection.

(2) Office Administration. The following summarizes some of the important written documents and polices and procedures that office-based practices are encouraged to develop and implement. The policies and procedures should undergo periodic review and updating. Office-based surgery practices are encouraged to utilize on-site patient safety surveys that are performed by professional trade associations, nationally recognized accrediting agencies and/or other organizations experienced in providing emerging risk-reduction strategies associated with office-based surgery.

(a) Policies and Procedures. Written policies and procedures can assist office-based practices in providing safe and quality surgical care, assure consistent personnel performance, and promote an awareness and understanding of the inherent rights of patients. The following are important aspects of an office-based practice that should benefit from simple policy and procedure statements.

1. Emergency Care and Transfer Plan: A plan shall be developed for the provision of emergency medical care as well as the safe and timely transfer of patients to a nearby hospital should hospitalization be necessary.

(i) Age appropriate emergency supplies, equipment and medication should be provided in accordance with the scope of surgical and anesthesia services provided at the practitioner’s office.

(ii) In an office where anesthesia services are provided to infants and children, the required emergency equipment should be appropriately sized for a pediatric population, and personnel should be appropriately trained to handle pediatric emergencies (currently trained in APLS or PALS).

(iii) At least one physician currently trained in ACLS must be immediately and physically available until the last patient is past the first stage of recovery. A practitioner who is qualified in resuscitation techniques and emergency care should be present and available until all patients having more than local anesthesia or minor conductive block anesthesia have been discharged from the office (Advanced adult or pediatric life support certified).

(iv) In the event of untoward anesthetic, medical or surgical emergencies, personnel should be familiar with the procedures and plan to be followed, and able to take the necessary actions. All office personnel should be familiar with a documented plan for the timely and safe transfer of patients to a nearby hospital. This plan should include arrangements for emergency medical services, if necessary, or when appropriate escort of the patient to the hospital by an appropriate practitioner. If advanced cardiac life support is instituted, the plan should include immediate contact with emergency medical services.

2. Medical Record Maintenance and Security: The practice should have a procedure for initiating and maintaining a health record for every patient evaluated or treated. The record should include a procedure code or suitable narrative description of the procedure and should have sufficient information to identify the patient, support the diagnosis, justify the treatment and document the outcome and required follow-up care. For procedures requiring patient consent, there should be a documented informed written consent. If analgesia/sedation, minor or major conduction blockade or general anesthesia are provided, the record should include documentation of the type of anesthesia used, drugs (type, time and dose) and fluids administered, the record of monitoring of vital signs, level of consciousness during the procedure, patient weight, estimated blood loss, duration of the procedure, and any complications related to the procedure or anesthesia. Procedures should also be established to assure patient confidentiality and security of all patient data and information.

3. Infection Control Policy: The practice should comply with state and federal regulations regarding infection control. For all surgical procedures, the level of sterilization should meet current OSHA requirements. There should be a procedure and schedule for cleaning, disinfecting and sterilizing equipment and patient care items. Personnel should be trained in infection control practices, implementation of universal precautions, and disposal of hazardous waste products. Protective clothing and equipment should be readily available¹².

4. Federal and State Laws and Regulations: Federal and state laws and regulations that affect the practice should be identified and procedures developed to comply with those requirements. The following are some of the key requirements upon which office-based practices should focus:

(i) Non-Discrimination (see Civil Rights statutes and the Americans with Disabilities Act).

(ii) Personal Safety (see Occupational Safety and Health Administration information)

(iii) Controlled Substance Safeguards.

(iv) Laboratory Operations and Performance (CLIA).

(v) Personnel Licensure Scope of Practice and Limitations

Statutory Authority: Code of Ala. 1975, §34-24-53.

History: New Rule: Filed October 17, 2003; effective November 21, 2003.

540-X-10-.11 Registration Of Office-Based Surgery/Procedures Physician.

(1) A physician who is licensed to practice medicine in Alabama, who maintains a practice location in Alabama, and who performs or offers to perform any office-based surgery/procedure which requires moderate sedation, deep sedation or general anesthesia, as defined in these rules, is hereby required to register with the State Board of Medical Examiners as an office-based surgery/procedures physician. Registration shall be accomplished on a form provided by the Board. After initially registering as an office-based surgery/procedures physician, it shall be the obligation of the registrant to advise the Board of any change in the practice location within the State of Alabama of that office-based surgery/procedures physician.

(2) For the purposes of these rules an "office-based surgery/procedures physician" shall mean any physician licensed to practice medicine in Alabama who performs or offers to perform in an office setting within the state of Alabama, any procedure that requires moderate sedation, deep sedation or general anesthesia, as defined in these rules.

(3) Within thirty (30) days after the effective date of this rule the Board of Medical Examiners shall cause a notice to be mailed to every licensed physician whose practice location is in the State of Alabama notifying them of the requirements of this rule and of the procedures for obtaining the required registration form. Every office-based surgery physician, as defined herein, is required to file the registration form with the State Board of Medical Examiners within ninety (90) days of the effective date of this rule. Any physician who, on the effective date of this rule, is not an office-based surgery/procedures physician but later elects to perform office-based surgery is required to file the registration form with the Board within thirty (30) days prior to performing any office-based surgery/procedure as defined in these rules. All physicians issued a certificate of qualification for licensure to practice medicine in Alabama will be provided with notice of the requirements of this rule.

(4) The form for registration of an office-based surgery/procedures physician is incorporated as Appendix D to these rules.

Statutory Authority: Code of Ala. 1975, §34-24-53.

History: New Rule: Filed October 17, 2003; effective November 21, 2003.

540-X-10-.12 Penalty.

(1) A physician may be guilty of unprofessional conduct within the meaning of Code of Ala. 1975, §34-24-360(2) if he fails to comply with the requirements of these rules concerning any of the following:

(a) Standards for office-based procedures for moderate sedation/analgesia or general/regional anesthesia;

(b) Reporting;

(d) Registration.

(2) A physician who has been found to be not in compliance with the requirements of this Chapter 540-X-10 may have his license revoked, suspended or otherwise disciplined by the Medical Licensure Commission.

Statutory Authority: Code of Ala. 1975, §34-24-53.

History: New Rule: Filed October 17, 2003; effective November 21, 2003.

STATE BOARD OF MEDICAL EXAMINERS

CHAPTER 540-X-10

APPENDIX A

ASA Professional Information

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