Ala. Admin. Code r. 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.
Notes
Statutory Authority: Code of Ala. 1975, ยง 34-24-53.
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