Safety of office-based surgeries questioned

Medical leaders said a new study shows the need for more regulation, greater oversight of these procedures.

By Damon Adams, amednews staff. Nov. 3, 2003.

During a two-year span, patients in Florida were 10 times more likely to die or be injured in surgeries performed at doctors' offices than those performed at surgical centers.

Hector Vila Jr., MD, and fellow researchers detailed the rate in the September issue of the Archives of Surgery. While their study focused solely on Florida, Dr. Vila suspects that more states have office-surgery problems.

Links
See related content

"There would be no reason to believe that it would be better [in other states]," said Dr. Vila, lead author of the study on surgeries in doctors' offices and ambulatory surgery centers.

In response to the findings, some physicians and consumer advocates are calling for closer scrutiny of office-based surgeries, saying state medical boards should do a better job of regulating such procedures to reduce deaths and injuries.

"It certainly is an eye-opener when you discover there is a tenfold increase in mortality. It does point out a need for greater oversight for that portion of medical care," said James Thompson, MD, chief executive officer of the Texas-based Federation of State Medical Boards. "My guess is what we're going to see is an increase in the number of states requiring reporting of office-based procedures and perhaps greater oversight."

About 1.2 million office surgeries are performed each year, Dr. Vila said. In the 1980s, surgical procedures previously done in hospitals were being offered at surgery centers, he said. A second shift occurred in the 1990s, when more doctors started performing procedures in their offices. While surgical centers are highly regulated by agencies, doctors' offices are not, the study said. In the past decade, deaths and injuries in office-based settings raised public awareness and prompted action.

Twenty-two states have some regulations or guidelines on office-based procedures. Most of them adopted guidelines and rules in recent years, according to the FSMB.

"[Medical boards] are beginning to start to take notice, but they have been asleep at the wheel," said Dr. Vila, chief of anesthesiology at the H. Lee Moffitt Cancer Center & Research Institute in Tampa, Fla.

National guidelines established

In 2001, the FSMB appointed a committee to develop recommendations on oversight of office-based surgery. In April 2002, the federation's house of delegates adopted the guidelines, which deal with licensing, anesthesia, accreditation and incident reporting requirements.

This year, the AMA House of Delegates discussed guidelines for regulation of office-based surgery. The principles were approved in October by the Board of Trustees and are designed to guide decision-making by legislative and regulatory bodies in setting standards for such surgeries.

22 states have regulations or guidelines on office-based procedures.

Some consumer advocates said more needs to be done to protect patients. "Guidelines are a beginning. They don't necessarily cure the problem," said Arthur Levin, director of the Center for Medical Consumers in New York.

In the Archives of Surgery study, researchers examined 182 office-surgery incidents in Florida from April 2000 to April 2002 and state data on surgery centers. There were 13 office deaths, including a heart attack during a colonoscopy and patients who bled to death during a liver biopsy and a tonsillectomy. Researchers found a rate of 9.2 deaths per 100,000 procedures in doctors' offices and a 0.78 rate in surgery centers. The rate of injuries was 66 per 100,000 surgeries in offices and 5.3 in surgery centers. The study said if the surgeries performed in offices had been done in surgery centers, 43 injuries and six deaths a year could have been avoided.

In 1994, the Florida Board of Medicine issued a standard of care for office surgeries. In 2000, the board instituted a 90-day ban on surgeries and revised its rules, which include accrediting offices, mandatory reporting of adverse incidents and credentialing of surgeons.

"We knew what was going on, and that's why we made ... rule changes. The board of medicine continually looks at these centers," said board spokeswoman Maureen Doherty.

To increase patient safety nationwide, Dr. Vila said: "The solution is to have the exact same standard of care whether they're in a physician's office or an ambulatory surgery center. If you're flying in an airplane, whether you're in a 727 or 747, they all have the same safety standards. It should be the same for patients having surgery."