Date: 09-24-2001; Publication: Newsday; Author: Donna Kutt Nahas

Guidelines Spark Debate On Office Surgery Safety By Donna Kutt Nahas. Donna Kutt Nahas is a freelance writer. IT WAS AN office surgery that took a tragic turn. A 26-year-old mother of two died after a breast augmentation procedure in her plastic surgeon' s private office. The doctor, who was later cited by the New York State Department of Health for negligence, incompetence and fraud, had given her high doses of anesthesia medications in inappropriate combinations, according to the citation, and claimed he was board-certified in plastic surgery when he wasn't. The patient died when her heart failed. After that widely publicized 1997 case in upstate Finger Lakes and a few others that didn't grab headlines, state lawmakers and health care industry executives began to question the safety of surgical procedures performed in private doctors' offices, which are not subject to the same stringent controls that govern hospitals and licensed surgical centers. That same year, the state Department of Health and the New York State Public Health Council followed the lead of several national medical societies to develop voluntary guidelines to safeguard office surgeries. The guidelines, applying to procedures from facelifts to general surgery such as hernia repair and vasectomies, were adopted by the public health council, setting standards for such things as the administration of anesthesia, infection control practices, credentialing workers and emergency protocols. For example, the guidelines recommend "appropriate emergency supplies, equipment and medications" be available and that a practitioner trained in lifesaving techniques and emergency treatment be on the premises.

But because they are only guidelines, they cannot mandate practices. Such minor surgeries as removal of a mole or sewing up a laceration are exempt, state officials say, because they require only topical anesthesia. Dr. Bernard Rosof, senior vice president for clinical affairs and quality at the North Shore-Long Island Jewish Health System and senior vice president for academic and external affairs at Huntington Hospital, said the guidelines come at a time when the number and complexity of procedures performed in private offices are on the rise. According to the Joint Commission on Accreditation of Healthcare Organizations, more than 8.3 million office surgeries were performed last year. Hospital surgeries numbered 26 million in 1999, according to a spokeswoman for the American Hospital Association. Experts predict that the number of office procedures will surpass hospital surgeries by 2002. The Medical Society of the State of New York, a trade group representing 26,000 medical doctors in the state, supports the guidelines. Since February, the group has sponsored a half-dozen educational seminars for doctors and their office staff. But even as the guidelines were published, they set off debate over how they would ensure patient safety and improve standards of care. For now, consumer advocates suggest that patients who are considering surgery in a private office do their homework. And homework, they warn, doesn't mean just shopping for the lowest cost.

"They should know what personnel will be on hand during the procedure, such as who will provide the anesthesia and in case of an emergency, will some doctor other than the surgeon be present," advises Arthur Levin, director of the Center for Medical Consumers, a nonprofit watchdog group in Manhattan. "Also, find out whether the doctor is credentialed to perform the same procedure in a hospital he or she is affiliated with. It's no guarantee, but at least someone has decided that they have the training to do this procedure in a hospital." Dr. Rebecca Twersky, professor of anesthesiology at State University Health Science Center at Brooklyn and a member of the state Health Department committee set up to draft the guidelines, said they don't go far enough. She argues that in a state-licensed hospital or surgery center, medical boards review the credentials of its doctors. But in a private office, doctors can legally practice outside of their specialties. The guidelines cannot prevent medical doctors with no training in dermatology or plastic surgery, for instance, from performing liposuction after taking a weekend seminar. "A medical license in New York State permits a physician to practice medicine and surgery. But where is the accounting mechanism in an office to review the physicians' qualifications, competency and experience?" she asked. "Regulations that set the same safe standard of care for all health facilities should be the next step." Levin says the guidelines create an "uneven playing field." "It is only rational to say that if we were concerned about risk in the hospital setting and a licensed ambulatory surgery center, then that level of concern should be at least equal if not greater in a doctor's office setting," Levin said.

"Intuitively, one would suspect that when things go wrong, there's simply less ability to handle it in a doctor's office." Offices can volunteer for accreditation from national accrediting organizations, which, for a fee, will survey and accredit offices where surgery is performed, ensuring that the qualifications of medical workers, office policies and procedures and medical care are regularly examined. For Dr. Lawrence Reed, a Manhattan plastic surgeon, accreditation comes at a price - but one that he can't afford not to pay. His accreditation membership dues are roughly $1,000 a year, and he sends his staff of eight for advanced and basic life support training each year. At a cost of $2,000 nearly every two years, he stocks his pharmacy with a drug that reverses a rare complication of anesthesia. "You can't do this and not safeguard your patients, your employees and yourself," he said. Other critics say regulation is too punitive and doesn't accomplish the central goal: to improve patient safety. "If someone has been a bad boy, then you close him down," said Dr. Daniel Morello, past president of the American Association for Accreditation of Ambulatory Surgery Facilities and a plastic surgeon in Westchester. "Why don't we use preventive medicine? The better medicine is to acquire accreditation in the beginning." For the most part, doctors perform surgery in their private

offices for the economic incentives - there's no hospital to collect fees, so the doctor's office not only collects the surgery fee but also bills for the cost of supplies, anesthesia and use of the office and staff. Private offices are not obligated to report adverse "incidents" or medical mishaps that occur in the office. Without a database on infection rates, botched procedures, misuse of anesthesia and even deaths, Levin argues, it is difficult to determine whether office surgery is safe. The guidelines contain no provision for such reporting. News of such events reaches the Department of Health only when a patient is transferred to a hospital in an emergency or near-emergency. This in turn triggers a review of the case by the state's Office of Professional Medical Conduct, said Wayne Osten, director of the Office of Health Systems Management for the state Department of Health. For Assemb. Richard N. Gottfried (D-Manhattan), the guidelines are only a starting point. He proposed legislation to require the state's health and education departments to regulate the practice of office surgery, but the measure didn't get out of the Assembly.

A Senate bill awaits consideration. The proposed legislation would have established penalties of fines and possible suspension or revocation of a doctor's license. Gottfried said the measure would have given the Health Department "the ability to act without having to come in with a sledgehammer." The proposal grew out of a 1999 study by the New York Senate Committee on Investigations, Taxation and Government Operations that outlined dangers that accompany surgery in a doctor's office. So far only a handful of states have comprehensive laws governing surgeries and the delivery of anesthesia in doctors' offices. California, New Jersey, Rhode Island, Texas and Florida have passed legislation requiring the medical board, department of health or board of medical examiners to develop regulations that would mandate reporting of incidents, accreditation and certification standards, standards of care for the use of anesthesia, equipment, and safety and emergency procedures. After several injuries and deaths, the Florida board of medicine last year initiated a 90-day moratorium on office surgery requiring general or spinal anesthesia. After the moratorium was lifted, the board of medicine instituted a number of stringent restrictions and safety requirements. Georgia has passed legislation that requires accreditation of doctors who perform office surgery and provide anesthesia. It mandates that doctors be credentialed by an accrediting organization or have staff privileges at a local hospital where they perform the same procedure they perform in the office. Officials at the Department of Health said they plan to survey doctors throughout the state over the next year to measure the impact the guidelines have had on the quality and safety of office surgery. Critics point out, however, that the survey is voluntary and that respondents would most likely be those who are complying with the guidelines. Donna Kutt Nahas, Guidelines Spark Debate On Office Surgery Safety. , Newsday, 09-24-2001,