The comparative outcomes study by physicians at H. Lee Moffitt Cancer Center and Research Institute and the University of South Florida College of Medicine is reported in the September issue of the journal Archives of Surgery. It has attracted widespread attention from states across the country as they move toward more stringent regulation of office-based surgery, which until recently had little regulation or oversight.
Today more surgeries are performed as outpatient procedures than in the hospital, and the proportion of operations in physician offices continues to rise. Many cancer screening procedures, such as endoscopies and biopsies, and cosmetic procedures, such as liposuction and tummy tucks, are performed in physician offices.
Ambulatory surgery centers, licensed outpatient clinics where patients can go home on the same day as surgery, are highly regulated by governmental agencies.
Against this backdrop, the researchers posed the question: Are there differences in patient safety standards at ambulatory surgery centers and physician offices in Florida?
"The answer was an overwhelming yes. The incidence of death and injury was 10 times higher for a surgical procedures performed in an office setting," said lead researcher Hector Vila Jr., an assistant professor of anesthesiology and interdisciplinary oncology at USF and chief of anesthesiology at H. Lee Moffitt Cancer Center and Research Institute.
"The bottom line is that patients are entitled to the same high standard of care whether they're having their surgery in a hospital, an ambulatory surgery center or a physician's office. Even a minor procedure can quickly turn into a major problem for someone with an undetected heart problem."
In March 2000, spurred by reports of office surgery deaths, the Florida Board of Medicine implemented new office policies, including accreditation of facilities, surgeon credentialing and mandatory reporting of adverse incidents. In April 2002, Florida also mandated that an anesthesiologist be present for all office procedures requiring deep sedation or general anesthetics.
Dr. Vila emphasized that further study is needed to determine whether the full impact of these regulations has made a difference in patient outcomes. "The state should be commended for moving to fix the problem," he said. "We just don't know yet how well the fix has worked."
Although limited to Florida -- one of 14 states that regulate office surgeries -- the study has national implications, said Roy Soto, MD, a co-investigator and assistant professor of anesthesiology at USF. "Florida, which has a very high volume of outpatient surgeries, is a good indicator of what's happening elsewhere.
"Hopefully, this study might help prompt a national database to monitor trends like differences in outcomes among regions of the country or between younger and older patients. You could determine, for instance, if the supervision of anesthesia impacted safety depending on where the outpatient surgery was done."
The researchers independently reviewed 182 incident reports of injuries, including 13 deaths, during office surgeries in Florida from April 2000 to April 2002. They also examined Florida Agency for Health Care Administration death and injury data reported by the state's freestanding ambulatory surgery centers for the year 2000.
The death rate in offices was 9.2 per 100,000 operations, compared to a death rate of 0.78 per 100,000 operations in surgery centers. The incidence of all adverse incidents -- death, injuries and conditions requiring transfer to a hospital -- was 66 per 100,000 procedures in offices and 5.3 per 100,000 in surgery centers.
With the lack of national data on office surgeries, the researchers did not have enough information to explain why rates of death and injury were higher in physician offices than in surgery centers. However, in the Archives of Surgery article, they point out that anesthesiologists were present in only 15 percent of the office procedures resulting in death (they are present in nearly all ambulatory surgery centers), and less than half the physicians' offices met the state's newly enacted accreditation requirement.
Because credentialing standards and regulations vary from state to state, Dr. Vila added, patients need to ask about the facility where their outpatient surgery will be performed. Important questions include: Is the facility accredited? Is the anesthesia provider credentialed to perform the same anesthetics at a hospital? Is resuscitative equipment available if complications arise?
The other authors of the Florida study were Moffitt Cancer Center biostatistician Alan Cantor, PhD, and University of Florida College of Medicine anesthesiologist David Mackey, MD.
The researchers continue to track reported deaths and injuries in physician offices compared to surgery centers in the year since Florida tightened its anesthesia supervision requirement for offices. Dr. Vila will present an update of the study Oct. 15 at the annual American Society of Anesthesiologists meeting in San Francisco.