Wendy Salo was alarmed when she learned where her doctor had scheduled her gynecologic operation — at an outpatient surgery center.
“My first thought was ‘Am I not important enough to go to a real hospital?'” recalled Salo, 48, a supermarket department manager who said she felt “very trepidatious” about having her ovaries removed outside a hospital.
Before the Sept. 30 procedure, Salo drove 20 miles from her home in Germantown, Md. to the Massachusetts Avenue Surgery Center in Bethesda, Md., for a tour. Her fears were allayed, she said, by the facility’s cleanliness and its empathetic staff. Salo later joked that the main difference between the multi-specialty center and Shady Grove Adventist Hospital — where she underwent breast cancer surgery last year — was that the former had “better parking.”
Salo’s initial concerns mirror questions about the safety of outpatient surgery centers that have mushroomed since the highly publicized death of Joan Rivers. The 81-year-old comedian died Sept. 4 after suffering brain damage while undergoing routine throat procedures at Yorkville Endoscopy, a year-old free-standing center located in Manhattan.
Federal officials who investigated Rivers’ death, which has been classified by the medical examiner as a “therapeutic complication,” found numerous violations at the accredited clinic, including a failure to notice or take action to correct Rivers’ deteriorating vital signs for 15 minutes; a discrepancy in the medical record about the amount of anesthesia she received; an apparent failure to weigh Rivers, a critical factor in calculating an anesthesia dose; and the performance of a procedure to which Rivers had not given written consent. In addition, one of the procedures was performed by a doctor who was not credentialed by the center.
Rivers’ gastroenterologist, who was the clinic’s medical director, has left the center. The clinic, which remains open, faces termination from the Medicare program in the wake of Rivers’ death; it must correct deficiencies and pass an unannounced inspection. Yorkville officials have said they have corrected the deficiencies and are cooperating with the investigation.
“Anytime there is a major or minor accident, people begin to question the safety record,” said anesthesiologist David Shapiro, past president of the Ambulatory Surgery Center Association, a national trade group and member of the board of an organization that accredits surgery centers. Rivers’ death, Shapiro said, is an aberration.
“We have an exceptional, exceptional success rate,” he said, adding that his industry is “very, very tightly regulated.” Since 2006, he noted, an industry group called the ASC Quality Collaboration has been reporting aggregate data on complications including burns, falls and surgery on the wrong site or wrong patient.
A 2013 study by University of Michigan researchers who analyzed 244,000 outpatient surgeries between 2005 and 2010 found seven risk factors associated with serious complications or death within 72 hours of surgery. Among them: overweight, obstructive lung disease and hypertension. The overall rate of complications and deaths was 0.1 percent — about 1 in 1,000 patients — and involved 232 serious complications, such as kidney failure, including 21 deaths. Comparable statistics could not be obtained for hospitalized patients because most studies involve specific procedures.
Another study found that about 1 in 1,000 surgery center patients develops a complication serious enough to require transfer to a hospital during or immediately after a procedure.
Lisa McGiffert, director of Consumers Union’s Safe Patient Project, has a significantly less rosy view than Shapiro. Surgery centers, she said, largely operate under a patchwork of state laws of varying strictness. Detailed information about outcomes and quality measures is lacking, she said, and the Rivers case raises questions about “the relaxed attitude that might have prevailed.”
“There’s not much known about what happens within the walls of these places by regulators or by the public,” McGiffert said. “Hospitals are more tightly regulated” than outpatient surgery centers. “They have to report on many more aspects of what they do, such as errors and certain infections.
The unusual thing about Rivers’ death, she added, is “that she was a famous person and everyone found out about it.”
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