Posted on Aug 16, 2007
The Medical Consumer: State regulates doctor-office surgery... finally
By: ARTHUR LEVIN, MPH 08/14/2007
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IN A REPORT called Morbidity and Mortality Rounds on the Web posted in July 2006, patient safety and anesthesia experts reported that an estimated 20-25% of all surgery is now performed in a doctor's office. This particular report, which had the scary title The Wild West: Patient Safety in Office-Based Anesthesia, pointed out that the rapid growth in doctors'-office surgery has "not been widely accompanied by adherence to the safety standards present in hospital and ambulatory surgery centers."
The "Rounds" reports are intended to alert health care providers and practitioners to safety and quality problems and are posted on the web by the federal Agency for Health Care Research and Quality.
The public may be surprised to learn that, in the absence of specific laws, the circumstances under which doctors elect to do surgery on patients under anesthesia in their private offices is generally unregulated. This is the result of long-standing public policy that the federal and state government should avoid interference in the "private practice of medicine."
But there is one long-standing exception; in response to a complaint against a doctor by a patient or other health professional, a state medical board can investigate and, if appropriate, take disciplinary action against a doctor for violations of the state's professional misconduct laws. But the track record of the boards leaves a lot to be desired. Only about 3,000 doctors a year, out of the more than 750,000 licensed to practice in one or more of the 50 states are judged to be guilty of misconduct serious enough to warrant loss or suspension of their license or have limitations imposed on their practice (prohibited from doing a certain kind of surgery, for example).
Some experts believe this represents only a fraction of the actual number of incompetent, impaired or otherwise negligent practitioners in practice.
Over the past decade, in response to the sorts of safety concerns expressed in the "Rounds," a number of states have passed laws to regulate aspects of office-based surgery, for example prohibiting general anesthesia in such settings. More than a decade ago, New York state, in what was then a cutting edge move, convened a task force charged to develop a plan to bring office-based surgery practices under state health department oversight. But what emerged from a year of contentious meetings was a set of voluntary guidelines that had no real force and effect. The effort fell prey to strong opposition from those in organized medicine who did not want the state health department violating the "sanctity" of private practice. And even the mild, unenforceable guidelines ended up being delayed for eight years in court battles between certified nurse anesthetists and physician anesthesiologists over practice turf.
Far from being a leader, New York watched from the sidelines for the last decade as more than 20 other states enacted some control over office-based surgery. The good news is that in the near future New Yorkers will finally be protected by one of the nation's toughest laws regulating surgery performed in private doctor's offices. The new law was passed by the legislature in June and recently signed into law by Governor Eliot Spitzer. It requires a surgeon's office performing procedures involving more than minimal anesthesia (local or topical anesthesia for example), to be accredited by one of several national organizations selected by the commissioner of health. And it has real teeth; a surgeon who operates in an unaccredited office will be subject to loss of her/his medical license.
The national accrediting organizations likely to be selected by the commissioner develop and oversee safety standards and practices for office-based surgery practices. These standards require, among other things, that an office have appropriate personnel, training and equipment to deal with medical emergencies.
Another important change brought about the new law is that doctors will now be required to report serious adverse events related to surgery done in their office to the state Department of Health. A growing number of other states, including Florida, California and New Jersey, have similar requirement.
Mandating that doctors report serious patient harm is important because there are almost no data, except anecdotal, on the comparative safety of the 10 million (and growing) office-based surgeries performed each year. Some years back, a rash of botched office-based liposuctions was front-page news in Florida and led to that state requiring reporting of patient harm. A 2003 analysis of those reports found the risk of harm was 10 times greater for the same surgery done in private doctor offices as compared to outcomes in regulated surgery centers.
Patients, especially those uninsured or underinsured, or having a procedure not usually covered by insurance such as cosmetic surgery, are attracted to office-based surgery primarily because of cost savings. Estimates are that having an office procedure can be as much as 50-60% less expensive than the same surgery done in a licensed facility. In addition, surgeons like the fact that operating in their own office eliminates any competition for operating room time.
From a patient's perspective, having surgery performed in a doctor's office may appear to offer advantages in addition to lower cost. A private office may provide more attractive surroundings and greater convenience in hours and days of operation. And, given what we now know about medical errors and deadly infections running rampant in hospitals, avoiding an inpatient stay may sound like a good thing.
But all these advantages pale if patients cannot be assured that their surgeon's office meets the same safety standards required of licensed hospitals and surgery centers. In the absence of such standards, for example, there may not be resuscitation equipment or trained personnel to deal with an emergency.
While no guarantee of a good outcome, hospital based surgeons are at least required to provide some evidence of their training and competency to do specific procedures before they are permitted to operate in a hospital. And, in a licensed facility the administration of anesthesia and monitoring of patients is normally the responsibility of a trained anesthesiology staff, not a surgeon doing double duty.
New York's new laws will not go into effect immediately. Accreditation will continue to be voluntary until the beginning of 2009. Reporting of patient harm to the state health department will be required starting in 2008. For now, if you are considering having surgery in a private doctor's office you should ask if that office has voluntarily obtained accreditation with one of the following national organizations: JCAHO, AAAHC or AAAASF. Ask the surgeon if he or she has admitting privileges at a nearby hospital and if he is currently "credentialed" at the hospital to perform the same specific procedure you have scheduled at the office. You can double check out the surgeon's hospital affiliations, as well as her or his education, training, discipline and malpractice history at by logging onto www.nydoctorprofile.com .
Arthur Levin, MPH, is director of the Center for Medical Consumers in New York City, www.medicalconsumers.org , and a part-time Hudson Valley resident.