Last month, office surgeons took two more regulatory hits. After receiving reports of four deaths from pulmonary emboli after combination liposuction procedures, the Florida Board of Medicine placed a 90-day moratorium on office-based liposuction/abdominoplasty procedures in the state, told office surgeons to wait 14 days between these procedures when performed on the same patient and required the surgeons to submit l8 months of historical logs for all level II and III surgeries. Soon thereafter, the American Association for the Accreditation of Ambulatory Surgery Facilities (AAAASF), the primary accreditor of office-based surgical suites, said it would require the 934 facilities it accredits to have a dedicated anesthesiologist or CRNA administer and monitor IV sedation and general anesthesia. The agency said it issued the new standard after receiving several reports of adverse events, including the death of a cosmetic surgery patient, after RNs administered propofol in the office.

Research before we regulate
Although actions like these may be justified and, as some argue, overdue, others worry they portend a hastened expansion of unnecessarily restrictive office surgery regulations. "Regulation that does not allow some flexibility for good clinical judgement and decision-making is onerous for surgeons," says Yoav Barnavon, MD, a Hollywood, Fla.-based plastic surgeon and president of the Florida Society of Plastic Surgeons. Florida's actions are particularly important for office surgeons because, as one of the first states to regulate office surgery and require adverse-incident reporting, the state is considered a bellwether for the rest of the nation.

Noting that the board sometimes "reacts without hard data," Dr. Barnavon is calling on the board to uncover as much as it can about the cases before acting any further, including type of abdominoplasty (mini versus full, for example), patient comorbidities, surgeon qualifications, type of anesthesia and anesthesia provider, additional consecutive procedures, and facility/ emergency preparedness - something board spokeswoman Jackie DiPietre says it is doing.

Hard data needed?
Many of those concerned about over-regulation of office surgery express concern about the need for hard data. Some are even trying to expose weaknesses in the data that already exist in an effort to slow the feared regulatory onslaught. The seminal Archives of Surgery study in which researchers found a 10-fold increased risk of adverse incidents and death in Florida surgical offices (as compared with the state's ASCs), in particular, has drawn a flurry of criticism.

Brett Coldiron, MD, FACP, clinical assistant professor with the University of Cincinnati College of Medicine's Department of Dermatology, was so concerned that the motive of the Archives study was intra-specialty territorialism between anesthesiologists and CRNAs, and plastic surgeons and dermatologists, that he reassessed the data using different methodology and came to a very different conclusion - that mortality and adverse-event rates are similar among physician offices and ASCs in Florida. Among other things, Dr. Coldiron based his calculations on a dramatically higher estimation (about 15 times) of the number of office procedures performed in Florida - an approach that greatly reduced the overall event and mortality rate. Dr. Coldiron maintains that the original estimation of office surgery procedures in the Archives study was too low because uneventful procedures performed in Florida's "unregistered" office suites weren't included even though events reported by these facilities were.

Lead author of the Archives study and Anesthesiology Service Chief with the University of South Florida College of Medicine in Tampa, Fla., Hector Vila, Jr., MD, dismisses the criticisms as invalid. "What's important," he says, "is that we compared procedures likely to be done in both settings, not the lumps and bumps done almost solely in the office setting. It was an apples-to-apples comparison based on reported data." Dr. Coldiron's paper has not been published.

Dr. Vila, who works with the Florida Board of Medicine, is clearly frustrated with this slicing and dicing of the data and becomes downright emotional when he reflects on his experiences reviewing cases for the board. "When I think of the young woman who had a breast augmentation and experienced respiratory arrest and brain damage after receiving a combination of RN-administered Propofol, Demerol, Valium, versed and ketamine in the office setting, yes, I get emotional," he says. "She left three young children behind. This is needless."

Few if any researchers and surgeons think inaction is the right course. It only makes sense to seek out the root causes for the reported events, they say, and apply these lessons to surgical practice. "It could be that follow-up studies will not support the finding that office-based surgery is riskier," says Paul Barach, MD, MPH, director of the Miami Center for Patient Safety at the University of Miami School of Medicine. "But given what we have to go on now, we have no choice. Until proven otherwise, the onus is on all of us to examine this issue." Adds Dr. Barnavon: "Even one preventable death is too many, and we support the board 100 percent in trying to make office surgery as safe as it can possibly be."

Mandatory accreditation?
Those who feel patient safety is at risk want regulation now. Those who don't, don't. Dr. Vila believes that office surgery suites everywhere should, without further debate, be held to the same basic standard as other surgical facilities. This means "ensuring qualified personnel and adequate equipment" that, he says, can be achieved, at least in part, through accreditation. He says the Florida experience is proving that this approach works. Since the board mandated accreditation or state inspection of office facilities performing certain level II and all level III surgeries and required the presence of an anesthesiologist for all procedures requiring deep sedation or general anesthesia, the number of reported injuries and deaths in Florida offices has declined. Between April 2002 and March 2003, office surgeons reported three procedure-related deaths and 18 injuries to the board, says Dr. Vila. During the prior 24 months, surgeons reported 13 deaths and 93 injuries. During the latter study period, he says, more (86 percent) Florida surgical offices were inspected or accredited than during the prior study period (50 percent).

A new AAAASF study slated for publication in JAMA supports Dr. Vila's finding. The study found that surgeons in 621 AAAASF-accredited office surgery facilities reported eight deaths among just more than 411,000 procedures performed since 1999 - six of which resulted from pulmonary embolism and two from hypoxia.

"Office surgery is safe if performed in an accredited facility with board-certified surgeons who are credentialed for the same procedures in a hospital," says Geoffrey R. Keyes, MD, a Los Angeles-based plastic and reconstructive surgeon who serves on the AAAASF board.

Back to the question of how much more regulation of office surgery practices is needed: Should the Florida Board of Medicine take further action quickly in the face of the four Florida deaths from pulmonary emboli, all of which occurred in accredited facilities, even if they find the deaths were not preventable? Ultimately, says board spokeswoman Ms. DiPietre, Florida's approach will be based on what regulators feel is in patients' best interests. "Our mission is to ensure that any surgery performed in the office, or any OR for that matter, is done with processes and procedures that protect the physician as well as the patient's safety," she says. "We want to say that these procedures are safe."

Dr. Vila adds that the growing trend toward combined cosmetic procedures fueled by the extreme-makeover craze is troubling because it increases patient risk. But like office surgery safety, the question of why the combined procedures increase patient risk - and even if they definitively do - remains scientifically uncertain.