As the delivery of health care services continues its transition more and more to the out-patient venue, it is logical that the number of surgical procedures done in the that setting also continues to rise. A 1999 New York State Senate report indicates that by 2001, more than 20 percent of all elective surgical procedures are likely to take place in physicians’ offices. Most importantly, note that today, the only professional requirement for an individual to perform in an office surgical procedures

• of any degree of complexity,
• related or unrelated to the individual’s education, experience, and demonstrated competencies,
• with or without the administration of anesthetic agents,

…is a valid medical (or dental) license.

These factors can put patients at risk because certain clinical and technical skills, appropriately functioning equipment, or appropriate systems and protocols, may be lacking in the office setting. Consequently, the surgical procedure, the associated anesthesia and a response in case of an emergency all may be less than optimal, and all of which could set the stage for medical malpractice claims relating to office-based surgical procedures with anesthesia. In addition, while most clinicians do carry professional liability insurance, such coverage may not be available in states without requirements for such coverage. Should there be a finding of negligent care, an injured patient may have no financial recourse. This makes OBA a topic of concern not only for involved physicians and nurses but also for professional liability insurers, regulators, and the general public.

Risk Management Issues

Risk management issues related to anesthesia care in the office setting should be of concern to any member of the health care team asked to participate in anesthesia services in an office site, any clinician undertaking the dual roles of anesthesia provider and the practitioner performing the procedure, and perhaps most important of all, the patient. For a variety of reasons, the level of interest in risk management is currently uneven among these parties.

The ASA’s October 1999 Guidelines for Office-Based Anesthesia make recommendations in key areas of clinical care, facility administration, and physical site safety for anesthesia in the office setting. The recommendations go beyond direct patient care and address areas such as fire safety, equipment needs, and emergency response capability, all to help promote a safe level of anesthesia care wherever that cares is rendered. Anesthesiologists have a long record of leading risk management and patient safety efforts, and this latest set of recommendations should prove timely and useful. However, office-based anesthesia can also involve situations where the surgeon is responsible for both the procedure and for supervising a staff member who may not have anesthesia training. In other instances, the surgeon may even assume dual responsibilities during the procedure. Gaining multidisciplinary support and actual implementation of safety guidelines in private medical offices presents a significant challenge, a challenge that must be faced if we wish to improve patient safety.

Patients who decide to undergo procedures with anesthesia administered in the office setting should have as much interest in the safety of the anesthesia they will receive as they do in the technical skills of the individual performing the procedure, what their health insurance will pay, and whether they’ll need to pay any costs themselves.

Unfortunately, this may not be the case. Individuals tend to view the office setting as a place to care for “less serious” problems, figuring that if their condition was likely to need the resources available in a more comprehensive setting (such as a hospital or accredited ambulatory surgical center) the physician would tell them, or their health insurance plan would have determined where their procedure could be safely done. When the procedure is not covered by health insurance, the patient may also be looking to control out-of-pocket costs and fail to ask about or even seriously consider other options. Educating the public about safety issues in office-based anesthesia will be as important as educating clinicians.

Risk Management Responses

There are a number of actions or proposals that could arise from the current concerns in office-based anesthesia. These could range from media exposure and resulting consumer pressure on states to enact legislation or regulations for OBA safety. Mandates from health insurance payers or accreditation bodies and requirements from professional liability insurance programs can also influence risk management. What would be the most powerful of all, though, is an alignment of patients and clinicians through educational efforts on patient safety in office-based anesthesia.

Health insurers paying surgical benefits and the entities that provide accreditation services for ambulatory surgical facilities or managed care plans may require that certain criteria be met for participation in a plan, for reimbursement, or for accreditation. Since these relationships are generally voluntary, their impact is likely to be less widespread than any formal regulation from a state or even the federal government.

Professional liability insurers are not in the business of practicing medicine. However, most companies can also decline to insure a particular risk or individual they feel presents too great a liability exposure. Where possible though, companies prefer to encourage the development of information and educational materials by clinicians that enhance the safety and quality of patient care, reduce the likelihood of an adverse event, and help in the defense of cases that may arise despite an appropriate standard of care. Loss prevention efforts (e.g. clinical practice guidelines) leading to improved professional liability experience have been used by some companies as the basis for premium reduction. For most clinicians, however, the primary motivation and benefit is an opportunity for the improvement of patient care and reduction of medical error (with the additional benefit of decreased likelihood of malpractice lawsuits).

Any guidelines for office-based anesthesia will encounter many of the same issues faced by the existing guidelines on use of conscious sedation. In both cases, clinicians from more than one specialty are involved, and the site of care for the same procedure can vary. Other professional societies, such as the American Academy of Dermatology and the American Society of Plastic and Reconstructive Surgeons have also been involved in efforts to improve the safety of office-based surgery. Collaboration and joint efforts across the most predominant specialties involved will be needed for the eventual successful implementation of any guidelines. Where possible, the relevant professional liability insurer(s) could provide important input and should therefore become active participants in the development clinical guidelines.

Ms. Trombly is a member of the APSF Board of Directors and is Director of Regulatory Services, Risk Management Foundation of the Harvard Medical Institutions, Cambridge, MA.