When its law requiring office-based surgeries be performed in accredited settings took effect last year, New York joined more than 25 other states that oversee these increasingly popular surgical venues. But New York's law, nearly a decade in the making, has gained industrywide attention as the strongest measure yet implemented.

The consequences of non-compliance are what set New York's law apart from every other state's. Beginning July 14, 2009, a physician who is found to have operated in an unaccredited office is guilty of professional misconduct and risks his license. "New York's law has teeth," says Carolyn Kurtz, JD, senior counsel and director of government and public affairs for the Accreditation Association for Ambulatory Health Care.

Some states that have mandated office oversight still don't see much accreditation activity, but "in New York, people took notice because there was a penalty in the law," says Ms. Kurtz. The New York Department of Health says 800 to 850 offices have become accredited since the law's passage. Since the state doesn't regulate physicians' offices, however, nobody knows how many office-based facilities are in the state — including those that remain unaccredited. The law's enforcement relies on the department's receiving complaints or adverse event reports on physicians or offices. Physicians performing surgery in unaccredited settings are subject to the Office of Professional Medical Conduct's professional misconduct process. The number of physicians and offices referred to the office on such violations is confidential under state law, says a department spokesman.

Causes for concern in New York
These cases, and several others that appeared before New York's Office of Professional Medical Conduct or were reported elsewhere in the nation, were driving forces behind the state's efforts to mandate accreditation for office surgery, says John Morley, MD, of the state Department of Health.

• An otolaryngologist who wasn't trained in plastic surgery both administered anesthesia to and performed breast augmentation on a 26-year-old woman in his West Seneca, N.Y., office, that lacked monitoring and emergency resuscitation equipment. The patient suffered cardiac arrest, lapsed into a coma and died. An inquiry cited the physician for failures to provide adequate anesthesia and respiratory care during the procedure.
• A pathologist MD who punctured a patient's peritoneum and small bowel during liposuction treated the resulting infections so inadequately that the patient required more than 70 days in the hospital and 9 surgeries to heal. Another patient, suffering post-op complications, was kept in the office for 36 hours before the doctor drove the unmonitored patient to a hospital 18 miles away. A third patient's pre-op evaluation was conducted by the office manager, an architect.
• A board-certified plastic surgeon who'd agreed to a probationary period following findings of negligent patient care violated that agreement by practicing medicine and planning cosmetic procedures without approval or supervision. A survey of his New York City office revealed a lack of resuscitation and monitoring equipment, an uninspected autoclave and expired emergency drugs in a dusty, cluttered facility.

"What got the attention of folks was the high-profile cases," says Dr. Morley, medical director of the department's Office of Health System Management and part of the staff that helped draft the report on which the accreditation law was built. "The identification of otherwise healthy patients who underwent procedures in office settings and suffered adverse outcomes was clearly a concern."

It wasn't the only concern, though. "When they opened the door to the issue and looked inside, it became clear that there were offices that were not set up to standards, or were operating under unacceptable standards," he says. Investigators found office-based surgical facilities that didn't follow proper sterilization techniques, didn't have defibrillators or rescue medications on site and hadn't appropriately trained their staffs. Even for offices with no obvious infractions and well-meaning, experienced physicians, a lack of standardization is a patient safety accident waiting to happen, says Dr. Morley. "There will be emergencies, and you need to be prepared."

Additionally, these concerns emerged against the background of increasingly ambulatory surgery, as new surgical techniques and anesthesia advances took more and more procedures outpatient. State health officials and lawmakers became "acutely aware that so much of healthcare was moving from the hospital to the surgery center or office setting," he says.

"When people say 'office-based surgery,' they think of these little procedures, not the big-time stuff," says Ms. Kurtz. "Then it turns out there are some big procedures that can be done in offices that they weren't aware of. That it might not just be a single-specialty practice doing little procedures, but looks a lot more like an ASC than they thought, but without the license."

That gets the attention of the authorities, especially after a bad outcome hits the headlines and a state's unsupervised office-based surgery gets a closer look, says Jennifer Hoppe, associate director for state and external relations for The Joint Commission in Oakbrook Terrace, Ill. "Physicians operating under their medical license alone is no guarantee that they're board-certified in a specialty, that they have advanced training, that they employ anesthesia providers," she says. "Under whose oversight are they operating? No one's, and it's alarming."

"Safety is much higher in an accredited facility," says Lawrence S. Reed, MD, FACS, president of the American Association for Accreditation of Ambulatory Surgery Facilities and medical director of The Reed Center for Plastic Surgery in New York, N.Y. "But people left to their own devices don't always do this on their own. Mandatory accreditation standards that are universally accepted and revised when necessary keep everyone on the same page."

Long, winding road to becoming law
Interest in legislation mandating accreditation for New York's office-based surgical facilities originated in the late 1990s, says Dr. Morley, and official recommendations had been made as early as 2000. That year, the state Department of Health issued a report backing voluntary clinical guidelines that included accreditation by a national agency.

This early effort faced a court challenge from the New York State Association of Nurse Anesthetists, which argued that it constituted regulation over the practice of medicine. After years of litigation and appeals, the court sided in late 2004 with the state's argument that the indirect influence of required accreditation wasn't in fact regulation by the state.

The Committee on Quality Assurance in Office-Based Surgery reconvened in 2005 and began drafting recommendations based on the guidelines the Department of Health had adopted in 2000 for possible legislation. The committee's concerns hadn't changed in the interim: Adverse surgical events continued to emerge from unstandardized physicians' offices and the surgical industry had become, if anything, more ambulatory in 5 years.

Response to the process was generally positive, says Dr. Morley, largely because the committee was peer-driven, made up of gastroenterologists, plastic surgeons, ENT specialists and other office-based surgeons. Attendees at the committee's hearings "recognized themselves that the time had come to clean their own houses," he says, since patient safety failures in unsupervised offices threatened to tarnish entire specialties. (The American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery began requiring all procedures performed under anesthesia to be done in accredited, Medicare-certified or state-licensed facilities in 2002, and the American College of Surgeons and American Medical Association jointly issued a similar recommendation the following year.)

Resistance to the proposal tended to focus on the time, staffing and budgetary demands with which accreditation's documentation, quality improvement, equipment and other requirements would burden office practices. "This is not a one-time event," admits Michael Kulczycki, executive director of The Joint Commission's ambulatory accreditation program. "And most office-based facilities are leanly staffed, so it's not as though they have a lot of people to devote to accreditation processes."

"It definitely meant increased expenses at the same time that falling reimbursements were hitting them," says Dr. Reed. But they also believed the requirements would be more complex than they were, which he says he'd seen before. "No one's practice was upset by the HIPAA laws, but when they first got word of it, they thought the world was ending."

The committee issued its report to the Department of Health, the governor and the legislature in July 2006. "The report said there was a clear need for oversight," says Dr. Morley. "It acknowledged that medicine and health care were changing to improve access for patients, but the bigger issue was that we wanted it to be done safely."

As before, the report's major recommendation was delegating the oversight of office-based surgical facilities to AAAASF, AAAHC and The Joint Commis-sion. "We were not ready for the Department of Health to regulate directly," says Dr. Morley. "Here was an opportunity for physicians to have somebody else do the surveying, that was there to work with you. Accrediting bodies offer a clear advantage in that they're there to help you meet the standards."

Letting the agencies handle the job of supervision benefits states as well, says Mr. Kulczycki. While the organization does not advocate mandatory accreditation, "the argument we make to states is that they can use accreditation to free up their limited resources and focus on investigating complaints and adverse effects."

While lawmakers adopted the accrediting recommendation when drafting their legislation, they opted against another recommendation put forth by the committee that suggested that adverse events be reported to the Department of Health's Office of Professional Medical Conduct. Instead, reporting would be directed to the department's Patient Safety Center, with a potential follow-up by the OPMC. "We want people to be comfortable with reporting incidents," says Dr. Morley. "And a non-punitive system doesn't mean people will get a pass when they're doing something that's just plain wrong."

Senate Bill 6052, the Patient Protection Bill, was signed into law in July 2007, after which Patient Safety Center staff members met with physician groups around the state to explain the new requirements. The law took full effect on July 14, 2009, the date by which office-based surgical facilities were required to be accredited and the date after which physicians were barred from performing surgery in unaccredited settings.

Impact of implementation
It's as yet uncertain how many more states will take up the issue of mandatory accreditation for office-based surgery — "There are probably more to come," says Ms. Kurtz. "I wouldn't say it's done. Who knows where healthcare reform is taking health care? Plus, legislators and regulators believe in quality improvement." — or whether any that follow will include consequences for non-compliance in their rules. But New York's law may in time affect surgical facilities everywhere, says Dr. Morley. The data collected through the adverse outcome reporting requirement, while held confidential according to patient privacy laws, will be aggregated into studies that will influence national accreditors in their development of new standards of care.