Tucked invisibly in high-rise office buildings, sprawling commercial structures and shopping malls across the country are an exploding number of free-standing surgical centers that, according to one estimate, now account for almost one surgical procedure in five performed nationwide.
Compared with the early 1970's, when such centers first opened, the procedures that they perform have vastly expanded, from simple breast biopsies and cataract removals to more complex orthopedic, gastroenterological or gynecological surgeries. Cosmetic surgeons now use the centers for virtually all procedures not performed in a doctor's office.
Regulators say most centers maintain excellent levels of safety and performance. A 2004 survey by the American Association of Ambulatory Surgery Centers, for example, reported that only 12 of every 10,000 patients required emergency transfers to hospitals in 2003.
Nevertheless, some experts say the changeover has been so swift that the use of the centers - though they are licensed and monitored by federal and state agencies - raises questions about patient safety. They include whether certain higher-risk patients might be better off in a hospital even for minor surgery; whether the equipment at the centers is clean, appropriate and in good condition; whether the centers report complications promptly; whether patients can be transferred quickly to a hospital, if needed; and whether the centers indeed limit procedures to those allowed.
"What concerns us most is whether the doctors are keeping to the appropriate kinds of surgery," said Richard McGarvey, a spokesman for Pennsylvania Health Department, which recently found lapses on routine inspections. "And whether only the most appropriate people are being treated."
In New Jersey, the Fort Lee Surgery Center for Minimally Invasive Spine Surgery and Interventional Pain Management temporarily suspended operations in April after a male patient died and numerous safety, staffing and cleanliness violations were found, New Jersey health officials said. The center did not appeal but has filed a plan for correction. An assistant to Dr. James R. Lee, president of the center, said he had no comment.
Even supporters of the centers acknowledge the limitations. "If you run into complications, you don't have a diverse group of doctors right there for backup," said Dr. James Lyons, a plastic surgeon in Westport and Hamden, Conn., who has been on a panel for the Connecticut State Medical Society that has been defining standards in free-standing centers.
There are about 4,600 centers in operation, a 53 percent increase over the 3,000 five years ago, said Dan O'Connor, editor in chief of Outpatient Magazine, a trade publication. Experts expect 8.8 million operations to be conducted at the centers this year. Corporate chains like HealthSouth, Surgis and AmSurg are among the fastest-growing owners, followed by joint hospital-physician ventures.
Office-based surgery normally comes under a separate category of regulation and restrictions, said Michael Kulczycki, executive director for ambulatory care accreditation at the Joint Commission for the Accreditation of Healthcare Organizations.
As the shift from hospitals continues apace, more patients will be directed to them, Mr. Kulczycki and other experts said. They noted that the changeover resulted from advances that allow for less invasive procedures, faster acting and less debilitating anesthesia and the practice of putting patients on their feet within hours. Moreover, the centers offer insurers a more cost-effective alternative to hospitals, a fact that encouraged underwriters like Medicare to certify them.
The Federated Ambulatory Surgery Association argues that the centers are a boon for patients because infections are less likely to occur in nonhospital settings. And they are less stressful and more convenient, often letting patients stay in their neighborhoods rather than traveling to hospitals. "Surgery is definitely migrating out of the hospital," said Mr. O'Connor, the trade magazine editor.
But there can be glitches. When officials from the Pennsylvania Health Department entered two surgical centers selected at random last fall, one near Pittsburgh and the other outside Allentown, they found evidence that abdominal procedures were being conducted that were more invasive than regulations permitted, as well as exceeding the four-hour time limit normally imposed.
Nobody was hurt, but in the future any center in Pennsylvania wanting to perform similar procedures will have to apply for an exemption.
In most instances, Mr. Kulczycki said, a patient should be offered a choice of going to a hospital or to an ambulatory center. And the relative merits of each should be discussed with the surgeon in advance.
Patients, he said, should also be aware that 20 percent of the centers are not fully accredited - a higher level of certification than licensing - and that could mean that they are not staffed or equipped to meet accreditation standards. Even if a center is affiliated with a respected hospital, a patient may not be immediately admitted to a hospital room there. "These agreements generally do not specify an admissions process," Mr. Kulczycki said.
In rare cases, a patient may first have to go through a long emergency room session like any other person off the street. A spokesman for the New York State Health Department, Robert Kenny, said that was normally needed to ensure that a patient was being properly evaluated.
If an emergency room is exceptionally crowded, that could mean a wait of several hours. Dr. David Shapiro, senior vice president at Surgis in Nashville, which operates 24 centers in 11 states, has found that individual hospital policy usually dictates whether the patient must first go through the emergency room.
Even though a given procedure may be on the approved list, it may not be suitable for some patients. This is especially true for "elderly patients with poorer health conditions," noted a 2002 report, "Quality Oversight of Ambulatory Surgical Centers" from the Department of Health and Human Services.
One elderly patient, the report said, went into cardiac arrest while having routine cataract extraction and died. Another patient whose bladder was perforated was moved six blocks in a wheelchair to the nearest emergency room.
Although complications can occur anywhere and are relatively rare, the report said, such cases underscore the importance of oversight in nonhospital settings.
Patients can sometimes learn the safety record of a particular center by a Web search or through a state health department. For example, the Texas Department of State Health Services posts on its Web site enforcement actions against noncompliant surgical centers, listing accusations and disciplinary actions.
One center on a recent list was found to have expired medications on an emergency cart in the operating room. Another failed to have an effective plan to transfer patients to a hospital in an emergency.
The Joint Commission provides information on centers on its site, www.jcaho.org/quality+check/index.htm, as does the American Accreditation Association for Ambulatory Heath Care, www.aaahc.org. The Pennsylvania Health Department site lists questions to ask surgeons at www.health.state.pa.us and click "Tips for Outpatient Surgery" in the second column under "facility licensure."
But patients may find that few questions can be answered. For instance, "There is no hard data comparing the identical procedure done in a hospital or in an accredited center," said Jaime Trevino, a spokesman for the American Association for the Accreditation of Ambulatory Surgical Facilities.
Still, Mr. McGarvey said, the centers do provide an important service, as long as those who use them "realize their limitations and have a frank discussion with their doctor."