Ala. Admin. Code r. 540-X-10-.01

Current through Register Vol. 43, No. 1, October 31, 2024

Section 540-X-10-.01 - Preamble

(1) Office-based surgery is surgery 1 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 protocols 3. 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.

Ala. Admin. Code r. 540-X-10-.01

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

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