17 centers posed an 'immediate jeopardy' to patient health and safety
State Sen. Joseph Vitale in this 2008 file photo.TRENTON — Patients who come to Affiliated Dermatology in Morristown to enhance their silhouette with liposuction put themselves in the hands of one of “the nation’s pre-eminent cosmetic surgeons,” according to the practice’s website.
What patients won’t get here is treatment from a licensed facility that regularly undergoes state inspections. New Jersey doesn’t license surgery centers like Affiliated that have just one operating room. Only surgery centers with two or more operating rooms must be licensed and submit to inspections about every three years.
New Jersey’s 300-plus same-day surgery centers are big business in New Jersey, appealing to patients who want convenient quick service for elective surgery and physicians who have used them to recoup the income squeeze from managed care companies. But a review of never-released inspection reports and interviews with health care experts shows there is rising concern they are not getting the scrutiny they need.
The state Department of Health and Senior Services randomly inspected 40 unlicensed surgical centers between August 2009 and February 2011, using a one-time federal grant to pay for the work.
The inspection team found 17 centers posed an “immediate jeopardy” to patient health and safety and temporarily shut seven of them until they corrected their problems, according to inspection reports. The state also inspected 51 licensed centers, found eight posing “immediate jeopardy” and closed two down temporarily.
The problems cited by the inspectors included:
• Improperly sterilizing equipment.
• Failing to correct unsanitary conditions.
• Administering drugs beyond their expiration date, prefilling unlabeled syringes and splitting single-dose medications between multiple patients.
• Discharging patients before a doctor’s examination.
Calling the overall findings of the 91 inspections “alarming,” David Knowlton, president and CEO of the New Jersey Health Care Quality Institute, is leading a chorus of health advocates calling on the state to require the routine inspection of all ambulatory surgical centers.
“We need to know who these surgery centers are, and require they be inspected. And the public needs to know the outcome,” Knowlton said. “People need to know their facility is safe. They have a right to expect this from their government.”
Knowlton, in his role as a member of a health care quality panel, obtained the inspection reports through the state and provided them to The Star-Ledger.
The institute has posted a report identifying the facilities and highlights of the inspections at njhcqi.org.
Larry Trenk, president of the New Jersey Association of Ambulatory Surgical Centers, called the inspection findings “concerning,” but added: “I would hesitate to use these outliers as a barometer for the rest of the industry.”
Surgery centers employ 6,000 people, pay $60 million in taxes, and pump $2.6 billion into the state’s economy, according to an economic analysis the association commissioned. Trenk said he suspects some of the people pushing for closer scrutiny are motivated by professional jealousy.
“The surgery center industry has blossomed and I’m sure that impacts other players, like hospitals,” he said.
The state closed Affiliated Dermatology three times — including once from August 2009 to February 2010 — after inspectors reported employees improperly sterilized equipment, sterilized equipment labeled for one-time use only and neglected to wash their hands between patients. Management also lacked a written agreement with a hospital to admit patients in a medical crisis.
Emil Bisaccia, a surgeon and co-founder of Affiliated Dermatology, said the practice has undertaken major improvements since the inspections.
“We hired consultants to improve protocols for infection control. We hired a certified sterilization technician and our infection rate is zero,” Bisaccia said, noting the state had worked with his office very closely.
“We have corrected our facilities,” he said. “Not six weeks ago, we were inspected by the board of medical examiners and we passed with flying colors again.”
Poonam Alaigh, the state’s former health commissioner and a physician, said she agrees ambulatory surgical centers need to be accountable, but she isn’t convinced more regulation is the answer.
“A patient who goes to a hospital or an ambulatory surgical center should have the same high-quality outcome, wherever it is being done,” she said. But rather than “government be(ing) a part of everything,” Alaigh said she would rather the department work cooperatively with center operators by showing them how to improve.
A March 2009 law mandating same-day surgery centers seek accreditation from an independent health care entity and report infection data to the state has not yet been implemented. Alaigh said the program’s rules would be available April 18 for public review.
“These rules ensure that patients who have surgery in an outpatient setting are being treated in facilities that meet quality and safety standards set either by the government or nationally recognized accreditation bodies,” acting Health Commissioner Mary O’Dowd said.
Sen. Joseph Vitale (D-Middlesex) said the law doesn’t go far enough. Vitale introduced a bill last month requiring state inspections for every surgical center.
“A site that has 10 suites or one suite, you are doing the same work. They should be regulated and licensed and inspected,” Vitale said.
Until policies change, Knowlton said consumers should use only licensed centers.
“I recognize this is unfair because some single-operating room facilities don’t have the option — they couldn’t get the department to license them if they wanted to,” he said. “But I think safety trumps fairness right now.”
For more information, go to http://www.state.nj.us/health/healthfacilities/asc_info.shtml.