The Arizona Department of Health Services requires health-care facilities to be licensed and periodically inspected.
A patient was on a stretcher fighting for her life after her heart stopped during surgery last July at a Tempe weight-loss center.
The East Valley Surgery Center’s medical staff had started a stomach operation when the woman’s heart took on an irregular beat, state records indicate. Moments later, her heart stopped firing altogether. It’s known as pulseless electrical activity, a medical condition that’s usually fatal.
Medical staff started CPR and ambulance crews rushed the unidentified woman to a Mesa hospital.
When such a “sentinel event” causes death or serious injury at a hospital or surgery center, doctors must conduct a post-surgical review to investigate causes and make any necessary changes to ensure the next patient has greater odds of a better result.
But the surgery center, owned and operated by Weight Loss Institute of Arizona, a thriving bariatric-surgery practice, had not completed a “root-cause analysis” of the life-threatening event by the time Arizona Department of Health Services inspectors arrived at the East Southern Avenue facility in January.
The nearly six-month absence of an analysis was one of 16 citations that ADHS inspectors issued during the January survey of the non-hospital surgery center, whose owners have marketed weight-loss procedures to consumers through billboards, community forums and other outreach.
Inspectors found the surgical center stocked expired drugs that had not been discarded in a timely manner, posing a risk that patients could get a drug that doesn’t work. Among the outdated drugs: the powerful sedative propofol.
State health-department records show inspectors also cited the center for carrying expired supplies such as surgical gloves and catheters — with some material as much as seven years past their expiration date.
Inspectors also found expired supplies on a “code cart” used to rapidly deploy care in a medical emergency. And they found that the surgery center had not followed proper infection-control procedures, including failing to properly sterilize surgical instruments.
Dr. Michael Orris, a Weight Loss Institute of Arizona partner, acknowledged the inspection revealed some oversights. Those issues have been corrected, he said.
“It seems they were happy with those changes,” Orris said. “We were not sanctioned.”
Patients rarely are aware of these kinds of safety issues before choosing to undergo weight-loss or other non-emergency surgeries. And even if they bothered to look, health-care consumers likely would not find copious details about facilities in state inspection reports.
In fact, information about the quality of Arizona’s 13 accredited weight-loss surgery centers is difficult to find despite the increasing popularity of such procedures.
That’s why experts suggest prospective patients not only seek out licensing and inspection records, but ask doctors, hospitals and surgery centers about quality indicators such as complication rates before choosing to undergo non-emergency operations.
Arizona Department of Health Services inspectors typically conduct an on-site inspection, or survey, once every three years at outpatient surgery centers that are independently accredited.
There were no civil penalties levied against East Valley Surgery Center following its January survey, an agency spokesman said.
Orris said that Weight Loss Institute of Arizona has treated thousands of patients since opening the surgery center in 2010 and has low complication and wound-infection rates. No patient has ever died as a result of complications, he said.
“We have pretty much beyond excellent outcomes,” Orris said. “If you cut corners, you really are going to see that in your outcomes, and you’re not going to be around for long.”
Differences in quality cited
East Valley Surgery Center is one of Arizona’s 13 bariatric centers accredited by the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery. The two organizations created a single accreditation program in 2012 to improve quality and limit bad results, including death.
But a recent University of Michigan-led study found widespread differences in quality among 165 accredited centers that performed weight-loss procedures on 145,527 patients in Arizona and 11 other states between Jan. 1, 2010, and Dec. 31, 2013.
The study’s authors did not identify the seven Arizona weight-loss centers that were included in their study, but the lead author said only hospital-based bariatric operations were evaluated.
Weight Loss Institute of Arizona surgeons mainly operate at East Valley Surgery Center, an outpatient center that typically discharges patients the day of the operation. Some patients may require in-hospital care following a surgery, and the surgery center has agreements with hospitals to transfer patients if needed.
The study said that complication rates at Arizona’s centers ranged from 1 to 2.9 percent. In other words, people who received a weight-loss operation at the worst-performing center were nearly three times as likely to have a complication than those at the best-performing center.
While the study reports that patients are more likely to have better results at some centers than others, the study does not provide results from each center that consumers can independently evaluate.
The study monitored for serious complication rates such as infection, blood clots, bleeding or leaking. Over the three years, 72 patients died.
Dr. Andrew Ibrahim, the report’s lead author, suggested that consumers quiz prospective surgery centers about their complication rates. That’s especially important because the study found large differences in complication rates among centers located close to one another.
If consumers are seeking information from ADHS inspection reports, they will find that little is publicly available. The agency’s searchable database has information on inspections that resulted in citations, or deficiencies, over the past three years.
The state database currently lists only four of Arizona’s 13 accredited bariatric centers. The rest do not have inspection records of their own.
Two of the four listed — Banner Gateway and Banner Estrella — did not have a survey during the three-year period. An HonorHealth bariatric center and East Valley Surgery Center, the other two centers listed, both were inspected during the last three years.
With such limited information on the quality of accredited centers publicly available to consumers, Ibrahim said patients should quiz prospective surgeons.
“Patients can ask their surgeon about their outcomes,” Ibrahim said by email, adding that all accredited centers should know how their own data compares with peers. “Unfortunately, the accreditation alone does not ensure uniform high-quality care for bariatric procedures.”
Partner: Center makes changes
Weight Loss Institute of Arizona’s surgery center has made changes following the state’s January inspection, according to Orris.
He said the lack of a root-cause analysis after a patient’s heart stopped beating last July was an oversight.
Orris said while the woman was being transported to the Mesa hospital, he personally called the emergency department’s on-duty doctor to make sure the medical staff had her information to get her the best treatment possible.
Orris said he and the East Valley Surgery Center anesthesiologist involved in the woman’s care personally visited her in the hospital. She survived, Orris said.
The surgery center eventually completed and gave an analysis to state inspectors. In a handwritten response to state inspectors, the center said it “implemented root-cause analysis for adverse events” when a patient requires CPR, is transferred to a hospital or has an unplanned return to the operating room. It also would conduct these reviews when equipment issues harm the patient.
He added that the woman had no lingering health issues such as brain injuries that can occur after a person is resuscitated. He added that she plans to return for a weight-loss operation.
“She feels well enough that she’s coming back to us,” Orris said. “Obviously we cared about this patient.”
The surgery center also made other changes following the January inspection.
For example, state inspectors reported finding expired drugs such as propofol and albuterol in the center’s pre-operation room and anesthesia cart, used by doctors to administer drugs to patients. An inspector observed that an anesthesiologist removed propofol from the anesthesia cart to use on a patient, the report said.
Those expired drugs should have been discarded or stored in an area to ensure they were not easily accessible. Failing to do so “poses a high potential risk that patients will receive treatment with ineffective, outdated medications,” the report said.
The surgery center said it corrected the risk by completing and documenting monthly reviews to ensure outdated drugs are discarded.
“We are not using expired medications,” Orris said. “Anything that is outdated is gone. Anything that is on the code cart is up to date.”
The report also noted the surgery center failed to examine the heart and lungs of two patients before they were given anesthesia. The rule exists to check for any changes in a patient’s condition “which could lend to a potential risk to the patient from use of anesthesia during surgery.”
Orris noted that all patients had examinations, laboratory-test reviews and medical histories taken within 30 days of operations.
Following the inspection, the surgery center said it would require anesthesiologists to assess a patient’s heart and lungs before all procedures.
State inspectors also cited the surgery center in several “infection control” areas for not discarding opened but unused items; failing to discard expired supplies; not cleaning dust and particles from equipment, doors and counters; and failing to store clean and dirty medical equipment separately.
The inspection report also noted that employees did not always wash their hands. Examples include a center employee who failed to sanitize hands after lifting a bed rail. That employee then put on a pair of gloves and administered an injection to a patient, the inspection report said.
The center said it corrected those citations by removing outdated supplies each month, training employees on hand hygiene and creating a monthly cleaning schedule. The center also informed its cleaning contractor of the citations.
Orris added that center staff routinely conduct “white-glove” inspections to ensure cleanliness. If there is any evidence that the center is not properly cleaned, Orris said he would not hesitate to replace the cleaning contractor.
Other deficiencies dealt with how the surgery center sterilized its surgical instruments. Inspectors said hinged instruments were not in an “open” position when cleaned. Experts say that means steam may not have adequately cleaned the instruments.
“When used in surgery once the hinge is opened, you now have the possibility that an unsterile instrument is in use,” said Gail Horvath, a patient-safety consultant at the independent non-profit ECRI Institute.
The inspection report did not identify which instruments were closed and not properly sanitized. However, Orris said the violation involved one towel clip that was not closed. He said all other instruments were properly sanitized.
The center told state inspectors that all hinged instruments would be cleaned in an open position in the future.
The center also was cited for using the incorrect system to test for microbes on a machine that sterilized tiny cameras used in surgeries. The inspection report said the surgery center on Dec. 15 ran out of the correct “biological indicator” used for the sterilizer machine. The center then used a biological indicator from another company, which ran afoul of the sterilizer manufacturer’s recommendations.
During the period when the center used the incorrect biological indicator, the center performed 70 procedures or surgeries, the report said.
After inspectors noted the issue, the center reordered the correct biological indicator. However, Orris said he does not believe any patients were put at risk.
He said the replacement indicator tested for the same microbes, so center staff thought it was interchangeable with the manufacturer-recommended indicator.
He noted that the surgical instruments were packaged, and he said an indicator in the packages showed the instruments were sterile.
“These were sterilized instruments that were used,” Orris said. “If there was any indication there was non-sterilized units used on a patient, we would notify the patients.”
State and county health inspectors may require medical providers to notify patients in the event of infection-control breaches, a state health-department spokeswoman said. Neither the state nor the county required the center to notify the patients who underwent the 70 surgeries or procedures noted in the report.
More attention for sterile instruments
Patient-safety advocates said state and federal regulators are paying increasing attention to how surgical instruments are cleaned, disinfected and sterilized.
The heightened awareness follows the discovery in 2012 of a deadly bacteria on surgical instruments used at hospitals in Seattle, Pittsburgh and Chicago. Investigators traced the problem to a bacteria known as CRE that was found on endoscopes, surgical instruments with miniature cameras that are placed in the throats of patients to search for digestive diseases.
James Davis IV, an infection-prevention analyst at ECRI Institute, said that the discovery of CRE bacteria on endoscopes was a “wake-up call” for medical providers nationwide.
Part of the challenge, Davis said, is difficulty tracking patients, because symptoms may only emerge days after a procedure or surgery is performed.
Davis said problems can emerge if scopes are not properly cleaned before they are sanitized. He likened it to a plate that is caked with spaghetti sauce when it is placed in the dishwasher.
“It is really hard to get that off,” Davis said, noting some instruments are improperly cleaned before they are sanitized.
Horvath, the patient-safety consultant at ECRI, said properly cleaning, sterilizing and storing complex surgical instruments can be more challenging for outpatient surgical centers that are independent from a large hospital system.
“Surgical centers are often challenged by not having the resources of what you have in the hospital,” Horvath said. “They are very volume driven. The only way they can stay in business is to sustain volume.”
Robert Chiffelle, a former ambulatory-surgical-center administrator and consultant who has reviewed such centers before, said the state’s inspection of the surgery center uncovered some items of concern.
“There are usually a few dings in every inspection, but not relating to such basic patient-care issues,” Chiffelle said.
Orris said the state’s inspection was unannounced and came right after the surgery center’s busiest month in December, when consumers often schedule end-of-the-year operations based on insurance benefits. That busy period strained staffing levels, Orris said, adding that one of his key employees, a scrub tech, was on maternity leave at the time of the inspection.
He added that the state inspection came right after another site review from another body, the Accreditation Association of Ambulatory Health Care.
Despite findings from the state inspection, Orris said his center has a stellar safety record.
“Our center has had zero deaths,” Orris said. “I don’t think there are many hospitals since 2010 that can say they have zero deaths. In terms of outcomes, that’s the ultimate outcome.”
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Inspection at weight-loss center highlights what consumers may not know