Embargoed for release until
Tuesday, July 9, 2002
  For More Information Contact:
Janet Firshein and Linda Loranger at 301-652-1558 or
Jon Gardner, Health Affairs, 301-656-7401, ext. 230



Analysis Reveals Serious Oversight Gaps That Put Patients At Risk

Washington D.C. - To protect patients and improve quality, a new report warns that states need to do a significantly better job of regulating care rendered in outpatient settings, particularly in physician offices that perform surgery. Today's regulatory system for outpatient sites "is badly fragmented," offering very little insight into the extent or nature of adverse medical events in these settings, say authors writing in the July/August issue of the journal Health Affairs. Mandatory accreditation, combined with programs designed to ensure the safe provision of anesthesia, would do a lot to boost the quality of care in the outpatient setting and avert medical errors, the authors conclude.

Elizabeth Lapetina, a research analyst with the Lewin Group, who co-wrote the article as an undergraduate at Princeton University and Elizabeth Armstrong, an assistant professor of sociology and public affairs at Princeton University, reviewed what is known about the incidence and nature of medical errors occurring in physician offices, ambulatory care facilities, and surgicenters. Their assessment of the outpatient environment comes amid heightened public concern about the volume of medical errors in health care, and a dramatic growth in the number and scope of outpatient procedures.

Today, nearly two thirds of all surgical procedures are performed in the outpatient setting. The number of outpatient surgical procedures performed has ballooned from 400,000 in 1984 to 8.3 million in 2000. Thanks to improved technology and lower costs, the number of procedures being performed in office settings is skyrocketing, the authors report, particularly surgical procedures. They note that between 1992 and 1999, office-based liposuction procedures increased 389 percent; breast augmentation procedures, 413 percent; and eyelid surgery, 139 percent. This year alone, the authors estimate, some 10 to 20 percent of all elective surgeries will be performed in 41,000 office-based surgical facilities.

"While reducing the number of medical errors and improving patient safety have become major issues in health policy, errors occurring in the outpatient setting have not received enough attention and current regulations do not adequately protect patients," says Lapetina. Today, 20 states require ambulatory surgical facilities to be accredited by an approved accrediting organization such as the Joint Commission on Accreditation of Healthcare Organizations or the Accreditation Association for Ambulatory Health Care. But only 10 states have placed any regulations on office-based procedures, and only a handful of states have reporting systems for outpatient settings in general.

When it comes to standards for surgery or anesthesia in the outpatient setting, most states have no regulations, according to the article. New Jersey and Mississippi are the only states that mandate the reporting of adverse events that occur in physician's offices, according to their analysis. The authors say there is a "pressing need" for all states to address safety in outpatient sites and to ensure that only qualified providers perform surgical procedures in their offices.

Cosmetic surgery is raising the most concerns. As techniques improve, "an alarming number of physicians with minimal training have developed office-based practices to perform these procedures," the authors warn, noting that it's offered by physicians who sometimes merely attend a weekend seminar or watch a short training video. Nearly half of the 250,000 liposuctions performed in 1997 were performed by practitioners other than plastic surgeons. Because only two states require reporting of adverse events occurring in physician's offices, it is unclear how many complications from these procedures occur nationally, the authors say However, a review of existing studies indicate that the death rate from office-based liposuction is higher than the death rate from car crashes, according to the authors.

Regulating procedural/practice standards for office-based physicians is difficult, the researchers say. While hospitals and ambulatory surgical centers are regulated by each state's department of health, physicians and their private offices are regulated by the state's board of medical examiners and are not subject to the same scrutiny. Three states (FL, NJ, NY) have attempted to establish practice standards to reduce outpatient medical errors, either through regulations or legislation. Of the three, New Jersey has gone the farthest.

The state has implemented standards for outpatient surgical centers that are similar to hospitals. New Jersey's standards address patient monitoring during procedures, technology implementation, and equipment purchase and maintenance. General anesthesia can only be administered by an anesthesiologist or nurse anesthetist working under the supervision of an anesthesiologist. To practice in an office, an anesthesiologist must have admitting privileges at a nearby hospital. The state also has created a mandatory reporting system, requiring physicians to report any deaths, complications, or adverse events that occur during office-based procedures.

The authors conclude that states need to take stronger steps to improve patient safety in the outpatient setting, including requiring accreditation of outpatient facilities and setting standards to minimize unnecessary complications from anesthesia. For example, they say, states could mandate the use of a licensed anesthesiologist when major liposuction procedures are performed in office settings. Finally, they urge that the federal Department of Health & Human Services mandate that all states create standards of care for office-based surgery and procedures involving anesthesia as soon as possible.

Health Affairs, published by Project HOPE, is a bimonthly multidisciplinary journal devoted to publishing the leading edge in health policy thought and research. Copies of the July/August 2002 issue will be provided free to interested members of the press. Address inquiries to Jon Gardner at Health Affairs at 301-656-7401, ext. 230 or via e-mail, press@healthaffairs.org. Selected articles from the July/August issue are available free on the journal's Web site, www.healthaffairs.org.


©2002 Project HOPE–The People-to-People Health Foundation, Inc.