Long arm of regulation reaches out from states and anesthesia society
Look for increased scrutiny no matter what kind of facility you manage
In the past several months, state legislatures and one national health care association have stepped up their efforts to regulate surgery in office-based settings. If you think these efforts don’t apply to you because you’re not office-based — think again.
While most same-day surgery programs are Medicare-certified, state licensed, and/or accredited, these new regulations modify, and usually increase, current regulations for same-day surgery, says Michael F. McGuire, MD, FACS. McGuire is chairman of the legislative and governmental committee and national secretary for the Mundelein, IL-based American Association for Accreditation of Ambulatory Surgical Facilities. He is also an associate clinical professor of surgery at University of California, Los Angeles and president of the California Society of Plastic Surgeons in El Sobrante.
In fact, Nevada has published regulations for ambulatory surgery that actually exceed Medicare regulations; it’s the beginning of a trend, McGuire warns. "I think within the next four to five years, at least half of the states will have some type of mandatory accreditation, Medicare certification, or state licensure of all ambulatory surgery facilities. We are getting inquiries from all states about this," he says. Most recently, Rhode Island, Virginia, and Maryland have contacted the association.
"It’s a snowball effect," McGuire says. He points out that state legislators have an annual national conference at which they discuss the legislation enacted that year. "As more get on the bandwagon, it puts pressure on the remaining states to do something. I don’t see any reason why this won’t continue." (See list of other state action, p. 140.)
One reason for the attention on office-based surgery is the tremendous growth in recent years. (See chart, p. 139.) The growth can be at least partially attributed to the fact that anesthesia monitors have become lighter and anesthetics have become faster-acting, making it easier to perform surgery in physicians’ offices and send patients home afterward. Much of the concern surrounds the proliferation of cosmetic surgery performed in physician offices.
There is a growing awareness that office-based surgery is an "exploding" area of medicine that has been virtually unregulated, McGuire says. "States are under a lot of pressure from the public to have some control. Every time there is another death in an ASC [ambulatory surgery center], there’s a big impetus for states to do something before it happens in their state."
California recently took a leading role by passing the Cosmetic and Outpatient Surgery Patient Protection Act, which requires surgeons to report deaths and inpatient admissions after surgery to the state medical board. It also requires surgery facilities to have at least two staff persons on the premises, one of whom is a licensed physician and surgeon or a licensed health care professional with current certification in advanced cardiac life support, among other requirements.
And the Park Ridge, IL-based American Society of Anesthesiologists has just announced guidelines for office-based surgery that the organization’s leaders hope will be used by states and other societies as an example to craft additional standards.
"We are not trying to make an office a hospital, but we absolutely believe that the office needs to be as safe as a hospital," says Rebecca S. Twersky, MD, vice chair for research and associate professor of anesthesiology at State University of New York Health Science Center in Brooklyn. Twersky is the chair of the ASA Committee on Ambulatory Anesthesia, which developed the guidelines. "Each office has to determine what aspect of these guidelines they are not meeting and adopt appropriately. The office needs to be accountable and not place patients’ lives at risk."
Some same-day surgery leaders express great concern about the types of legislation and guidelines that are being enacted for the office-based setting. For example, the California law is "ridiculous" because it doesn’t give a good definition of office-based surgery, says Paul Rohlf, MD, FACS, president of the San Diego-based American Association of Ambulatory Surgery Centers.
The bill refers to services provided outside of an acute care hospital, Rohlf points out. "It doesn’t define excision of wart, a vasectomy, or other things done with local anesthetics from being different than a procedure that puts someone unconscious."
He also criticizes the California law’s requirement for surgeons to report deaths and inpatient admissions after surgery to the state medical board. "It’s setting up a big bureaucracy." Rohlf also expressed concern that the law labels providers who don’t provide these reports as guilty of "unprofessional conduct."
"It sounds like they’re trying to legislate ethical conduct," he says.
Highlights of ASA guidelines
Rohlf also expresses concern that the ASA guidelines don’t differentiate between providers who administer general anesthesia and local anesthesia. Any laws or regulations should focus on the type of anesthesia used and whether the anesthesia is administered in an unsupervised setting, he says.
"You have to be careful about having a regulation prohibiting a man from having a vasectomy," says Rohlf, who points out that such procedures are rarely performed in a hospital. "Don’t protect the public too much."
The ASA guidelines address qualifications of anesthesia personnel; supervisory relationships of non-MD personnel; qualifications and competency of surgeons, practitioners, and personnel; monitoring and recovering patients; and emergency equipment and drugs; among other items. (See regulations, inserted in this issue.) Here are a few highlights:
• Policies, procedures, and protocols.
"These do not have to be tomes of manuals," Twersky says. "Just commit to writing processes and protocols that document fundamental areas of medical office practice governance."
• Patient procedure and selection.
"It’s even more important [than policies, procedures, and protocols] that patients are appropriately selected and that the patients are given options to have the procedure done elsewhere if, indeed, their medical or surgical conditions place them at undue risk," Twersky says.
• Presence of the anesthesiologist until the patient is discharged from anesthesia care.
Frequently patients are recovered from surgery but need to remain in a facility until the physician thinks they are stable for discharge, Twersky says.
"Discharge still remains a physician responsibility," she says. "That is no different in a surgicenter or hospital. What is different here is that we are advocating the presence of personnel trained in advanced resuscitative techniques until the patient leaves the facility."
The ASA recognized that office-based anesthesia is a growing extension of ambulatory surgery and anesthesia, she says. However, the organization’s leaders thought separate guidelines were needed primarily because, in contrast to acute care hospitals and licensed ambulatory surgery centers (ASCs), most offices lack oversight by federal, state, and local laws, Twersky says.
"Therefore, we wanted anesthesiologists to be aware of issues that go beyond the clinical provision of anesthesia care, such as governance, construction and equipment, policies and procedures, emergency protocols, qualifications of personnel — things that we take for granted in an organization like a hospital or an ASC," she adds.
For more information on regulation of office-based surgery, contact:
• Michael F. McGuire, MD, FACS, 1301 20th St., Suite 460, Santa Monica, CA 90404. Telephone: (310) 315-0121. Fax: (310) 828-3733. E-mail: [email protected].
• Paul Rohlf, MD, FACS, President, American Association of Ambulatory Surgery Centers, P.O. Box 23220, San Diego, CA 92193. Telephone: (800) 237-3768.
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