The Wild West: Patient Safety in Office-Based Anesthesia
Over the last decade, surgical operations and interventional procedures have been performed increasingly in offices with the administration of office-based anesthesia (OBA).(1) Economic considerations and convenience have driven this increase. Schultz reported that the cost of a conventional inguinal hernia repair done in the office setting was $895, compared to $2,237 for the same procedure performed in the hospital.(2) Although cost savings come from several sources, the main one is that the office has far lower overhead than the hospital. Furthermore, surgeons enjoy much greater flexibility in scheduling office-based procedures than those performed in hospital settings. The result of these forces has been the rapid growth of office-based surgical procedures, with an estimated 20% to 25% of all surgical procedures being performed in office-based settings in recent years.(1,3) This increase varies by surgical type, with 51% of all cosmetic plastic surgery, for example, performed in office-based surgery facilities in 2001.(4)
Unfortunately, this rapid growth in the use of OBA has not been widely accompanied by adherence to the safety standards present in hospital settings or ambulatory surgical facilities. For this article, we are particularly concerned with the provision of deep sedation or general anesthesia as defined by the American Society of Anesthesiologists (ASA).(5) We are not referring to minimal or moderate sedation, although there are important safety considerations in these situations, particularly if the patient's level of sedation becomes deeper than initially intended.
In hospitals and ambulatory surgical facilities, certain standards for personnel, equipment, monitors, drugs, facilities, and administrative policies are regulated, and compliance is required for accreditation.(6,7) The absence of similar standards in OBA poses significant threats to patient safety, sometimes with devastating ramifications. Some examples include the following:
- A 27-year-old woman from Alabama died from respiratory failure shortly after returning home from office-based breast augmentation. Her death was attributed to effects of sedation administered during the procedure.(8)
- A 28-year-old woman from Virginia Beach, Virginia developed malignant hyperthermia during office anesthesia for breast augmentation. No dantrolene was available in the office setting. By the time she was transferred to an emergency department, her temperature was 107 degrees. She subsequently died.(8)
- A 3-year-old child from West Virginia underwent laser removal of port wine stains by an emergency department physician assisted by a dentist. The child had a seizure followed by cyanosis. No supplemental oxygen was available in the office. Paramedics transported the child to the emergency department of a local hospital where she subsequently died.(8)
- Five California children died during dental office procedures; four had been given oral chloral hydrate.(8)
A variety of deficiencies in personnel, equipment, monitors, drugs, facilities, and administrative policies are present in OBA today. Many of these problems are not unique to OBA but may be exacerbated by the lack of regulation in this setting. For example, in office settings, the equipment utilized is not standardized. Surprisingly, office-based surgical practices are not always equipped with defibrillators, resuscitation drugs, and backboards. Emergency resuscitation carts are not uniformly available. There may also be a lack of routine preventive maintenance of critical equipment, as is routinely provided in hospital or ambulatory surgical settings.
Concerns have surfaced over other aspects of the patient-care environment. For example, in order to reduce costs for compressed gases, oxygen concentrators are frequently substituted for oxygen tanks. Oxygen concentrators are devices that take in room air and concentrate the oxygen portion to concentrations as high as 90%.(9) In some cases, mechanical failures in these devices have resulted in unrecognized lower concentrations of oxygen than expected, because measurement of oxygen concentration is not built into these devices. In addition, in hypoxemic emergencies, oxygen concentrators may not be suitable, because 100% oxygen cannot be provided through these devices.
Personnel issues may become important in OBA. Gastroenterologists are presently lobbying to administer propofol, a potent intravenous anesthetic induction agent, without the presence of an anesthesia professional.(10) Should the patient develop airway obstruction or apnea, a not-rare complication, resuscitation would be markedly compromised.
Moreover, facilities for recovery are not available in all practices. Even when a facility is available, there is no set of uniform procedures to determine whether the patient is safe to be discharged. The basic hospital requirement that a responsible adult accompany the patient at discharge is not consistently enforced in OBA. Reports of several patient injuries following early discharge suggest that postoperative complications may be pushed into the unmonitored home setting as patients are discharged more rapidly.
Several potential solutions may help address patient safety problems in OBA. Improved state regulation with tough licensing laws is one important option. For example, the death of a 26-year-old woman in Virginia as a consequence of receiving 25 mg of midazolam (Versed) prior to an office-based abortion in 2002 prompted the State of Virginia to implement state regulations on the safety of OBA in 2003.(11) At present, only 19 states have statutes, regulations, or guidelines regarding OBA.(12) Unfortunately, even in states with regulations, their scope and level of enforcement vary widely.
Accreditation is another potential solution. Accreditation of office-based practices is not required in the majority of states, although several are considering it as a means to evaluate practices without expending limited state resources. Moreover, requirements for accreditation are not uniform. Accreditation of office-based practices are currently conducted by the three major accrediting bodies: JCAHO (Joint Commission on Accreditation of Healthcare Organizations), AAAHC (Accreditation Association for Ambulatory Health Care), and AAAASF (American Association for Accreditation of Ambulatory Surgery Facilities), with the AAAASF performing the majority of office-based accreditations.(13) Patient safety in OBA would be greatly improved if these three organizations were to agree on a uniform set of standards and enforce them.
Whether the improvement vehicle is licensing or accreditation, the ultimate goal should be to ensure that patients receive the same level of safe anesthetic care regardless of the setting in which the operation is performed. An office must have competent personnel, up-to-date equipment and monitors, preventative maintenance of equipment, an appropriate physical layout, standard patient and personnel records, and ongoing peer review and quality assurance. Such guidelines have already been developed by the ASA, although they have not been uniformly implemented or enforced.(14-19)
The field of anesthesiology has long been a front-runner in patient safety in the inpatient setting, which includes teaching others how to protect patients. It is time to extend these principles to office-based settings to provide the same level of protection for patients that they enjoy and expect in the inpatient setting.
Rainu Kaushal, MD, MPHStaff Physician, Division of General Internal MedicineBrigham and Women's HospitalAdjunct Assistant ProfessorWeill Medical College of Cornell University
Sekhar Upadhyayula, MDPrivate Practice
David M. Gaba, MDProfessor of AnesthesiaStanford University School of MedicineStaff AnesthesiologistDirector, Patient Simulation Center of InnovationVA Palo Alto Health Care System
Lucian L. Leape, MDAdjunct Professor of Health PolicyHarvard School of Public Health
4. ASPS recommends patient safety strategies for office-based plastic surgery [press release]. Arlington Heights, IL: American Society of Plastic Surgeons; December 12, 2002. Available at: http://www.plasticsurgery.org/news_room/press_releases/ASPS-Recommends-Patient-Safety-Strategies-for-Office-Based-Plastic-Surgery.cfm. Accessed May 4, 2006.
5. Continuum of Depth of Sedation: Definition of General Anesthesia and Levels of Sedation/Analgesia. Park Ridge, IL: American Society of Anesthesiologists; October 27, 2004. Available at: http://www.asahq.org/publicationsAndServices/standards/20.pdf. Accessed May 4, 2006.
6. Eligibility for Hospital and Critical Access Hospital Accreditation. Joint Commission on Accreditation of Healthcare Organizations Web site. Available at: http://www.jointcommission.org/HTBAC/HAP/hap_cah_eligibility.htm. Accessed April 11, 2006.
7. Eligibility for Office-Based Surgery Accreditation. Joint Commission on Accreditation of Healthcare Organizations Web site. Available at: http://www.jointcommission.org/HTBAC/OBS/obs_elegibility.htm. Accessed April 11, 2006.
8. Morell RC. OBA questions, problems just now recognized, being defined. Anesthesia Patient Safety Foundation Newsletter; Spring 2000. Available at: http://www.apsf.org/resource_center/newsletter/2000/spring/02-morell.htm. Accessed May 4, 2006.
10. Rex D. Propofol can be used safely by trained registered nurse/endoscopy teams. AGA Perspectives. February/March 2005;1:4. Available at: http://www.gastro.org/user-assets/Documents/AGAPerspetives_FebMar_2005.pdf. Accessed May 4, 2006.
11. Smith T. Regulations have made office-based anesthesia safer. Richmond Times-Dispatch. May 22, 2005.
12. Office-Based Anesthesia: State Statutes, Regulations and Guidelines. American Society of Anesthesiologists Web site. Available at: http://www.asahq.org/Washington/rulesregs.htm. Accessed April 11, 2006.
13. Twersky RS. Standards for office anesthesia vary widely or do not exist. Anesthesia Patient Safety Foundation Newsletter; Spring 2000. Available at: http://www.apsf.org/resource_center/newsletter/2000/spring/05-Twersky.htm. Accessed May 4, 2006.
14. Guidelines for Office-Based Anesthesia. Park Ridge, IL: American Society of Anesthesiologists: October 27, 2004. Available at: http://www.asahq.org/publicationsAndServices/standards/12.pdf. Accessed May 4, 2006.
15. Standards for Basic Anesthetic Monitoring. Park Ridge, IL: American Society of Anesthesiologists; October 25, 2005. Available at: http://www.asahq.org/publicationsAndServices/standards/02.pdf. Accessed May 4, 2006.
16. Basic Standards for Preanesthesia Care. Park Ridge, IL: American Society of Anesthesiologists; October 25, 2005. Available at: http://www.asahq.org/publicationsAndServices/standards/03.pdf. Accessed May 4, 2006.
17. Standards for Postanesthesia Care. Park Ridge, IL: American Society of Anesthesiologists; October 27, 2004. Available at: http://www.asahq.org/publicationsAndServices/standards/36.pdf. Accessed May 4, 2006.
18. Guidelines for Ambulatory Anesthesia and Surgery. Park Ridge, IL: American Society of Anesthesiologists; October 15, 2003. Available at: http://www.asahq.org/publicationsAndServices/standards/04.pdf. Accessed May 4, 2006.
19. Guidelines for Nonoperating Room Anesthetizing Locations. Park Ridge, IL: American Society of Anesthesiologists; October 15, 2003. Available at: http://www.asahq.org/publicationsAndServices/standards/14.pdf. Accessed May 4, 2006.