It's estimated that physicians will perform 20 percent of all elective surgeries in 40,000 offices this year - and that only about 1,500 of them will be accredited. Despite explosive growth spurred by more surgeons doing more complex cases, office-based surgery is a largely unregulated and fragmented industry, not bound by many of the federal, state or local laws that regulate hospitals and licensed surgical centers. But many predict that a confluence of events could lead to mandatory accreditation, including

• specialty societies pushing for accreditation,
• more states requiring accreditation,
• the ability of physicians to afford the expense,
• the media's influence on highlighting the dangers of unaccredited facilities and
• an increased consumer awareness about the importance of finding a safe surgery suite.

Nine states have passed mandatory accreditation of office-based surgery facilities and another two are in the final stages of adopting similar measures (see "Making it Mandatory"). This lack of oversight might be changing. For office-based procedures requiring certain levels of anesthesia, some states require state certification. Others have adopted their own surgery/anesthesia regulations. Some have adopted standards through their state medical associations while others only require the physician to be licensed.

Medicare recognizes three accreditors for deeming status for office-based surgery. The American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) accredits 1,100 facilities (cost is $710 to $3,885), the Accreditation Association for Ambulatory Health Care (AAAHC) another 290 ($3,170 with an application fee of $595) and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) an additional 150 ($3,975). That's about 1,520 accredited office-based surgery facilities out of the 40,000 that exist.

"It is surprising that office-based surgery facilities are less regulated than ASCs," says Mike Dye, JCAHO's associate director of the ambulatory and office-based surgery programs. "There are no guarantees, but [accreditation] shows that the surgical practice took the extra step to offer the safest care possible. That is the assurance that accreditation provides."

Experts expect the trend toward state-mandated accreditation to speed up.

"Rules and laws that regulate an industry always lag behind the industry," says Jeff Pearcy, the executive director of the AAAASF. "The evolution of office-based surgery happened so quickly. It started with minor procedures, and then people were shocked by the level of sophistication of the procedures being performed."

Specialty societies
The American Society of Plastic Surgery (ASPS) a couple years ago required that its members work in accredited facilities. The other major plastic surgery group, the American Society of Aesthetic Plastic Surgery, was quick to follow suit.

"The trend for societies to have their members be accredited is something we will see more of," says Gerald Edds, MD, a facial plastic surgeon out of Owensboro, Ken., and the AAAHC president. Dr. Edds chaired the AAAHC's task force that created its office-based surgery program.

That is not to say that there wasn't some initial resistance among ASPS members. "We did have those saying that they never had a problem without accreditation, so why should they spend the money and put forward the effort. In the end we were able to convince our membership it was the right way to proceed," says says Ronald Iverson, MD, a plastic surgeon in Pleasanton, Calif., and an ASPS member.

Members also balked at the expense of accreditation, which includes paying the accrediting body for the process-oriented issues and complying with standards that specify physical, environmental parameters and ongoing equipment checks. Some physicians were forced to convert their facilities to comply with standards. Others opted to close their facilities to work in an already-accredited facility, says Dr. Iverson.

But in the end, it goes back to offering quality care, above and beyond the expense, time and extra work. "It's like you can get away with speeding on the highway, but eventually you get pulled over or into an accident," says Dr. Iverson.

The state push
Florida serves as a prime example of the reactive rather than proactive nature of change. Until four years ago, Florida hadn't created many regulations governing office-based surgery. Then, within a six-month period, five patients died during office-based surgery. The state imposed a three-month ban (for Level III surgeries) and lifted it, but with a few caveats. Physicians thereafter had to submit surgical logs for Level II and III surgery monthly for one year and were required to implement risk management systems, among other new rules. (Level II surgery involves perioperative sedation and requires post-operative monitoring. Level III surgery entails general anesthesia or major conduction anesthesia and post-op monitoring.)

A few months later, in the summer of 2001, South Carolina physicians banded together and required that offices performing Level II and Level III surgery be accredited. Although no deaths were reported in that state, many surgeons feared that leaving the industry unregulated could let unqualified physicians or staff administer anesthesia.

Washington state is now looking at a draft rule for regulating office-based surgery, which includes accreditation for offices in which procedures or surgery are performed using moderate sedation or anesthesia. California already has similar measures in place.

Educated consumers
The trend for accreditation is also tied into the economy, says Mr. Dye. Office-based surgery typically entails elective procedures, which don't offer the same Medicare reimbursement. Cash flow for physicians often depends on the consumers' willingness to spend.

The media is quick to highlight adverse events in healthcare settings and that triggers consumers' attention. Until recently, most people who opted for cosmetic plastic surgery didn't consider it as serious as non-elective surgery. They therefore took unnecessary risks by choosing unqualified professionals to perform cosmetic plastic surgery in non-accredited office-based surgery facilities.

"Consumers will spend more time researching the car they will buy than the surgeon and the facility where they go for surgery," says Mr. Pearcy. "They automatically assume there are currently enough regulations that they will be safe anywhere they go."

If there's any value to the headlines about adverse events that occur in outpatient settings, it's the raised awareness that consumers should do more homework.

"As the public becomes more knowledgeable, and as the media discusses the importance of safety and quality as it relates to accreditation, consumers will be more aware of accreditation," says Dr. Edds. "This is important because the better educated the public will be, the better healthcare will be."

FSMB guidelines
The Federation of State Medical Boards (FSMB) has looked to solve the riddle of how to regulate office-based surgery centers. The FSMB, a national nonprofit organization that acts as a voice for its 70 member boards to promote high standards for medical licensure and practice, can offer guidelines, but can't enact legislation.

In 2002, the FSMB released The Report of the Special Committee on Outpatient (Office-based) Surgery (go to www.fsmb.org and click on "Policy Documents" on the home page to access this report) that identified three pathways that state medical boards can use for oversight of office-based surgery in unregulated settings:

• adopt FSMB model guidelines,
• require accreditation by a recognized national or state accrediting organization and
• develop individual state standards.

"Ironically, as surgical procedures moved from hospitals to outpatient settings and subsequently to office-based settings, the logical transfer of the oversight function did not follow," reads the report's introduction.

The FSMB model guidelines aren't all-inclusive, but they outline basic policies and procedures that physicians performing office-based surgery should adopt. Each state would mandate these policies that cover key areas such as governance, patients' rights, quality of care, credentialing and patient evaluation, among others. These same areas are covered in AAAASF, AAAHC and JCAHO standards.

In requiring accreditation as a model, the state defers the setting of standards to accreditation organizations, thus avoiding the necessity for the development of independent state standards.

The individualized state regulatory model involves state regulatory agencies choosing to adopt some combination of national medical professional organization standards, recommendations from the FSMB report, and national accrediting standards to construct an individualized state regulatory model.

The advantage of the state model is it allows states to modify their regulations based on the practice patterns within the state, says James Thompson, MD, the president and CEO of the FSMB.

All state medical boards are FSMB members, so "with that impetus and all the other pressures, office-based surgery accreditation can only pick up significantly over the next four to five years," says Dr. Edds.

Dr. Thompson believes that eventually all states will enact some kind of regulation, whether it be their own regulations or requiring accreditation. And it only makes sense. "If I were performing office-based surgery, I would want to follow guidelines similar to what was recommended in our policy," he says. "All of those things are common sense and good and best practice that I think would be the right thing to do as we look toward keeping our public safe."

The human-nature factor
Other reasons exist for the slow pace of office-based regulation. For starters, it's human nature for people to resist being controlled, says Mr. Pearcy. "If I have a choice of whether to practice adequately on my own or meet some set of requirements that are imposed upon me, I will wait until they are imposed upon me rather than be an early adapter to seek accreditation," he says.

Two categories of office-based surgery accreditation actually exist, says Dr. Edds - there are those who seek accreditation because they want to and those who do because they have to.

"Many office-based surgery facilities went through voluntary accreditation years ago and they did so because they felt it demonstrated quality, looked good on their resume, and improves services," he says. "In an ideal world, that would be the most common reason to be accredited. But in our world, we find many facilities are reluctant to go through the time and expense until they are forced to do so."

Physicians are an extremely independent group of people, adds Mr. Pearcy, and don't like being told what to do. For example, when the AAAASF changed its propofol standards, there was an outcry on how horrible it would be to comply. "But we haven't lost a single facility, and as it turns out, it is the right way to practice," says Mr. Pearcy.

And the expense of accreditation is minimal compared to what one faces during a malpractice lawsuit that discovers the facility did not undergo due diligence to ensure safe care, says Mr. Pearcy. "It's the cost of doing business if you are to do so correctly," he says.

Facilities that have gone through accreditation learned how to improve on safety through the process and gained a sense of confidence that they have done all they can do to assure safe care for patients, says Mr. Pearcy. "And they can pass that onto their patients," he says. "That is part of the evolution of accreditation and why states look at it and decide to mandate it."