Statement on Patient Safety Principles for Office-Based Surgery Utilizing Moderate Sedation/Analgesia

The American College of Surgeons (ACS) Board of Governors Surgical Care Delivery Workgroup recently revised and updated the 2004 ACS Statement on Patient Safety Principles for Office-Based Surgery Utilizing Moderate Sedation/Analgesia, Deep Sedation/Analgesia, or General Anesthesia.

The original statement was the result of an ACS-sponsored resolution at a 2002 American Medical Association meeting urging collaboration to develop requirements and guidelines to ensure quality and safety for patients undergoing office-based procedures. Eventual discussions among more than 40 stakeholder organizations led to consensus on 10 Core Principles. In the intervening years, many of the Core Principles have become standards of care, while ever-increasing numbers of surgical procedures are performed outside of the hospital operating room setting.

The following revision reflects the ACS mission to improve the care of the surgical patient and to safeguard standards of care in an optimal and ethical practice environment. The ACS Board of Regents approved the revised statement at its June 7−8, 2019, meeting in Chicago, IL.

To ensure patient safety, the ACS believes that surgical procedures using deep sedation/analgesia or general anesthesia should only be performed in accredited surgical centers.

1. Physicians who perform office-based surgery utilizing moderate sedation/analgesia should have their facilities accredited by a national or state accrediting organization and be state-licensed.
2. Physicians should select patients for office-based procedures using the American Society of Anesthesiologists (ASA) Physical Status Classification System.¹ Preprocedure patient evaluation, including history, focused examination, and any consultations with medical specialists, should be documented. ASA III and above patients should undergo surgical procedures in accredited surgical centers.
3. Informed consent for the nature and objectives of the anesthesia planned and operation to be performed should be in writing and obtained from patients before the procedure is performed. Informed consent should only be obtained after a discussion of the risks, benefits, and alternatives and should be documented in the medical record.²
4. Surgeons should perform procedures commensurate with their board certification, documented training and experience, and within their state-recognized scope of practice.
5. Anesthesia should be administered by experienced and licensed healthcare providers in accordance with national guidelines.³ Individuals trained in Advanced Cardiovascular Life Support, intravenous access, management of airway complications, and the use of pharmacologic antagonists must be present when a surgical procedure using sedation is being performed. The patient must be monitored during recovery from sedation and discharge criteria met before leaving the facility.
6. Written protocols must be in place to transfer a patient who develops complications or requires a higher acuity of care to a qualified acute care facility. The governing body of the office-based surgery practice should conduct a regular review of patient transfers and adverse events and implement focused professional reviews of involved healthcare professionals as indicated.
7. The governing body of the office-based surgery practice is required to maintain records of physician credentialing and licensure and participate in a program of ongoing professional practice evaluation.

References

1. American Society of Anesthesiologists. ASA Physical Status Classification System (updated October 15, 2014). Available at: www.asahq.org/standards-and-guidelines/asa-physical-status-classification-system. Accessed July 23, 2019.
2. Federation of State Medical Boards. Report of the Special Committee on Outpatient (Office-Based) Surgery. 2002. Available at: www.fsmb.org/siteassets/advocacy/policies/outpatient-office-based-surgery.pdf. Accessed July 23, 2019.
3. American Society of Anesthesiologists. Practice guidelines for moderate procedural sedation and analgesia 2018. Anesthesiology. 2018;128(3):437-479.