University of Rochester School of Medicine
Rochester, New York
This article describes the process by which an office surgery center becomes accredited. Maintenance of accreditation is also explained. In addition, the economic factors that bear upon the viability of the operation of an office surgery center are reviewed.
A number of untoward events have brought the safety of office-based procedures into question in recent years. Perhaps the most famous of these was the cardiac arrest of Joan Rivers at Yorkville Endoscopy, an office-based surgery center in New York City, on Aug. 28, 2014. She passed away on Sept. 4, 2014, after suffering complications. The 81-year-old had undergone a gastrointestinal endoscopy procedure and laryngoscopy. A sequence of events resulted in the celebrity suffering cardiopulmonary arrest. Her family initiated a medical malpractice suit that was settled for an undisclosed but “substantial” amount. Ms. River’s family released a statement that it was their intent to help improve patient safety in office-based procedures and prevent future tragedies.1
Office surgery has exploded in volume throughout the last two decades and given rise to the subspecialty of office-based anesthesia (OBA). More than 25% of all surgical procedures are being performed in offices.2 A variety of factors have influenced this trend. Medicare and other payors continue to provide augmented fees for procedures performed in the office setting. Otherwise, if the surgery is performed in a hospital or an ambulatory surgical center, the third-party payor will be required to pay a “facility fee.”
Surgery in the office setting was almost completely unregulated in almost all 50 states less than 20 years ago. More recently, most if not all states have adopted up some approach to regulateprocedures and anesthesia performed in surgery offices. The Federation of State Medical Boards keeps an updated list of state requirements for office-based surgery (OBS) practices.3 A few states have no regulations, some states have elaborate state-specific regulations, and some states, such as New York, defer accreditation to one of three major organizations.
The Joint Commission on Accreditation of Healthcare Organizations, founded in 1951, is the oldest of the three and best known for hospital accreditation. The Accreditation Association for Ambulatory Health Care was founded in 1979. The American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) was founded in 1980.
All three agencies have clearly outlined criteria for what constitutes acceptable standards in office structure, personnel, medication, and sterilization standards, which are readily available in their manuals. These standards are in alignment with the American Society of Anesthesiology’s (ASA) Office-Based Anesthesia Guidelines.4
Inspection and Initial Certification
All surgeons who perform procedures in office surgery suites must be appropriately credentialed. This credentialing will include examining hospital privileging and board certification. Any action against the medical licenses of physicians must be reported to the respective agency. Practitioners must be present who have BLS/ACLS (i.e., basic life support/advanced cardiac life support) cards.
Structure and Equipment:
All equipment must be regularly inspected by a biomedical engineer and tagged appropriately. Standard ASA monitoring must be present.
All facilities that stock malignant hyperthermia triggering agents must have an adequate supply of dantrolene to begin resuscitation. A full arsenal of code drugs and equipment must be stocked.
There must be adequate record-keeping of all sterilized instrumentation and regular testing of the sterilization equipment.
Maintenance of Certification And Reportable Events
A quality improvement program and a peer review program will be required. Recertification is scheduled periodically. Certain events can trigger immediate reinspection. It is important to remember that individual states have reporting requirements in addition to agency-specific requirements. As one example, New York requires reporting of certain adverse outcomes, namely5:
“Unplanned emergency department visits within seventy-two hours of office-based surgery. Unscheduled assignment to observation services within a hospital within seventy-two hours of the office-based surgery. Unplanned transfer to a hospital or emergency department from an OBS practice. Unscheduled admission to the hospital for longer than 24 hours within seventy-two hours of office-based surgery. Patient death within thirty days. Suspected transmission of blood-borne pathogens from staff to patients or between patients. Any other serious or life-threatening event.”
AAAASF, for example, requires:
“Any death occurring in an accredited facility, or any death occurring within thirty (30) days of a procedure performed in an accredited facility, must be reported to the AAAASF office within five (5) business days after the facility is notified or otherwise becomes aware of that death. In addition to this notification, the death must also be reported as an unanticipated procedure sequela in the semi-annual Peer Review report. In the event of a death occurring within thirty (30) days of a procedure done in an AAAASF accredited facility, an unannounced inspection may be done by a senior inspector.”6
Office surgery, which had not been regulated at all two decades ago, is now the subject of stringent regulation in many if not all states. There are three major agencies that accredit office surgery throughout the United States. To qualify as an accredited office surgery center, a facility must meet high standards with respect to personnel, equipment, medications, and sterilization protocols.
What was once an unregulated field with many reported adverse outcomes is now a more carefully monitored and regulated endeavor ensuring higher-quality patient care.
- Santora M. Settlement Reached in Joan Rivers Malpractice Case. New York Times, May 12, 2016.
- Laurito CEA. The Society for Office-Based Anesthesia, Orlando, Florida, March 7, 1998. J Clin Anesth. 1998;10:445-448.
- Federation of State Medical Boards. www.fsmb.org/ Media/ Default/ PDF/ FSMB/ Advocacy/ GRPOL_Office_Based_Surgery_A-M.pdf. Accessed July 20, 2017.
- American Society of Anesthesiologists. Guidelines for Office-Based Anesthesia. www.asahq.org/ ~/ media/ Sites/ ASAHQ/ Files/ Public/ Resources/ standards-guidelines/ guidelines-for-office-based-anesthesia.pdf. Accessed July 20, 2017.
- New York State Department of Health. Office-Based Surgery. www.health.ny.gov/ professionals/ office-based_surgery/ . Accessed July 20, 2017.
- Procedural Standards and Checklist for Accreditation of Ambulatory Facilities. American Association for Accreditation of Ambulatory Surgery Facilities, Inc. www.aaaasf.org/ docs/ default-source/ accreditation/ standards/ standards-manual-and-checklist-v3-(obp).pdf?sfvrsn=5. Accessed July 20, 2017.