ACS Views on Legislative, Regulatory, and Other Issues

Office-Based Surgery—

staff contact: Jon Sutton, jsutton@facs.org

• Patient Safety Principles for Office-Based Procedures

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 ten 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 (JCAHO, AAAHC, AAAASF and AOA). The March meeting, which was held in consultation with the ACS, utilized the ten principles from the February 5 meeting as the foundation for discussion and debate.

The March 17 meeting was co-chaired by Dr. LaMar McGinnis of the ACS and Dr. Clair Callan of the AMA. The discussion focused on a walk-through of the February 5 principle document with the workgroup debating the merits of each principle. After a few minor changes, the members of the workgroup unanimously approved the revised set of ten principles.

Patient Safety Principles for Office-Based Procedures

Following ten principles were developed by representatives from over 35 healthcare organizations during a March 17, 2003 consensus meeting, which was coordinated by the American Medical Association and American College of Surgeons.

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.

Core Principle #2 - Physicians should select patients by criteria including the ASA patient selection Physical Status Classification System and so document.

Core Principle #3 - Physicians who perform office-based surgery with moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia should have their facilities accredited by JCAHO, AAAASF, AAAHC, AOA or a state recognized entity such as the Institute for Medical Quality, or are state licensed and/or Medicare certified.

Core Principle #4 - Physicians performing office-based surgery with moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia must have admitting privileges at a nearby hospital, or 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 regarding informed consent.

Core Principle #6 - For office surgery with moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia, states should consider legally-privileged adverse incident reporting requirements as recommended by the FSMB 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, American Osteopathic Association, or a board with equivalent standards approved by the state medical board. 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 with moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia 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 - For office-based surgery with moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia, at least one physician, who is credentialed or currently recognized as having successfully completed a course in advanced resuscitative techniques (ATLS, ACLS or PALS), 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 (BLS).

Core Principle #10 - Physicians administering or supervising moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia should have appropriate education and training.

March 17, 2003 Meeting Participants:

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

Revised March 31, 2005

ACS Views on Legislative, Regulatory, and Other Issues

Advocacy and Health Policy