[ST-46] Statement on patient safety principles for office-based surgery utilizing moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia

[by the American College of Surgeons]

The following statement was approved by the ACS Board of Regents at its October 2003 meeting.

Over the past few years, there has been a noticeable increase in the number of invasive procedures being performed in the office setting. Recognizing that many states still haven't issued patient safety guidelines in this area, the American College of Surgeons (ACS) sponsored a resolution, which was passed at the American Medical Association's (AMA's) December 2002 Interim Meeting of its House of Delegates. In brief, the resolution called on the AMA to work with the ACS in "convening a work group of interested specialty societies and state medical associations to identify specific requirements for optimal office-based procedures and utilize those requirements to develop guidelines and model state legislation for use by state regulatory authorities to assure quality of office-based procedures."

On February 5, 2003, the ACS convened a meeting of interested surgical specialty societies to discuss the surgical community's perspective on this issue. In addition, the College invited representatives from the American Society of Anesthesiologists (ASA) to provide information and guidance regarding ASA's anesthesia guidelines. As a result of this meeting, a majority of the surgical community reached consensus on a set of 10 core principles that states should examine when moving to regulate office-based procedures.

Having observed the College's catalytic efforts in this area, the AMA quickly followed suit with a March 17, 2003, meeting of interested parties including: surgical and medical specialty societies; state medical associations; the National Committee on Quality Assurance; and the major accrediting organizations for ambulatory and office-based surgery (Joint Commission on Accreditation of Healthcare Organizations [JCAHO], Accreditation Association for Ambulatory Health Care, Inc. [AAAHC], American Association for Accreditation of Ambulatory Surgical Facilities, Inc. [AAAASF], and the American Osteopathic Association [AOA]). The March meeting, which was held in consultation with the ACS, used the 10 principles from the College's meeting as the foundation for discussion and debate.

The AMA meeting was co-chaired by LaMar S. McGinnis, Jr., MD, FACS, of the ACS and Clair Callan, MD, of the AMA. The discussion focused on a walk-through of the College's principle document with the work group debating the merits of each principle. After a few minor changes, the members of the work group unanimously approved the revised set of 10 principles.

The following principles were based on a document that was unanimously agreed to by the following groups during a March 17, 2003, ACS/AMA coordinated consensus meeting on office-based surgery:

Accreditation Association for Ambulatory Health Care, American Academy of Cosmetic Surgery, American Academy of Dermatology, American Academy of Facial Plastic and Reconstructive Surgery, American Academy of Ophthalmology, American Academy of Orthopaedic Surgeons, American Academy of Otolaryngology-Head and Neck Surgery, American Academy of Pediatrics, American Association for Accreditation of Ambulatory Surgery Facilities, American College of Obstetricians and Gynecologists, American College of Surgeons, American Medical Association, American Osteopathic Association, American Society for Dermatologic Surgery, American Society for Reproductive Medicine, American Society of Anesthesiologists, American Society of Cataract and Refractive Surgery, American Society of General Surgeons, American Society of Plastic Surgeons, American Urological Association, Federation of State Medical Boards, Indiana State Medical Society, Institute for Medical Quality-California Medical Association, Joint Commission on Accreditation of Healthcare Organizations, Kansas Medical Society, Massachusetts Medical Society, Medical Association of the State of Alabama, Medical Society of the State of New York, Missouri State Medical Association, National Committee for Quality Assurance, Pennsylvania Medical Society, and Society of Interventional Radiology.

• Core Principle #1 – Guidelines or regulations should be developed by states for office-based surgery according to levels of anesthesia defined by the American Society of Anesthesiologists' (ASA's) "Continuum of Depth of Sedation" statement dated October 13, 1999, excluding local anesthesia or minimal sedation.1
• Core Principle #2 – Physicians should select patients by criteria including the ASA patient selection Physical Status Classification System2 and so document.
• Core Principle #3 – Physicians who perform office-based surgery should have their facilities accredited by the JCAHO, AAAHC, AAAASF, AOA, or by a state-recognized entity such as the Institute for Medical Quality, or be state licensed and/or Medicare-certified.
• Core Principle #4 – Physicians performing office-based surgery must have admitting privileges at a nearby hospital, a transfer agreement with another physician who has admitting privileges at a nearby hospital, or maintain an emergency transfer agreement with a nearby hospital.
• Core Principle #5 – States should follow the guidelines outlined by the Federation of State Medical Boards (FSMB) regarding informed consent.3
• Core Principle #6 – States should consider legally privileged adverse incident reporting requirements as recommended by the FSMB3 and accompanied by periodic peer review and a program of Continuous Quality Improvement.
• Core Principle #7 – Physicians performing office-based surgery must obtain and maintain board certification from one of the boards recognized by the American Board of Medical Specialties, AOA, or a board with equivalent standards approved by the state medical board within five years of completing an approved residency training program. The procedure must be one that is generally recognized by that certifying board as falling within the scope of training and practice of the physician providing the care.
• Core Principle #8 – Physicians performing office-based surgery may show competency by maintaining core privileges at an accredited or licensed hospital or ambulatory surgical center, for the procedures they perform in the office setting. Alternatively, the governing body of the office facility is responsible for a peer review process for privileging physicians based on nationally recognized credentialing standards.
• Core Principle #9 – At least one physician, who is credentialed or currently recognized as having successfully completed a course in advanced resuscitative techniques (Advanced Trauma Life Support®, Advanced Cardiac Life Support, or Pediatric Advanced Life Support), must be present or immediately available with age- and size-appropriate resuscitative equipment until the patient has met the criteria for discharge from the facility. In addition, other medical personnel with direct patient contact should at a minimum be trained in basic life support.
• Core Principle #10 – Physicians administering or supervising moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia should have appropriate education and training.

References

1. American Society of Anesthesiologists: Continuum of Depth of Sedation. American Society of Anesthesiologists Web site. Internet (http://www.asahq.org/publicationsAndServices/standards/20.htm).
2. American Society of Anesthesiologists: ASA Physical Status Classification System. American Society of Anesthesiologists Web site. Internet (http://www.asahq.org/clinical/physical status.htm).
3. Report of the FSMB Special Committee on Outpatient [Office-Based] Surgery, adopted April 2002. American Society of Anesthesiologists Web site. Internet (http://www.fsmb.org/policydocumentsandwhitepapers/outpatient_surgery_cmt_rpt.htm).

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Reprinted from Bulletin of the American College of Surgeons
Vol.89, No. 4, April 2004

Statements

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by the American College of Surgeons, Chicago, IL 60611-3211