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Full Disclosure

Rocked by a series of sterilization scares, VA errs on the side of patient safety.

Army veteran Gary Simpson, 59, thought he was doing the right thing in 2007 when he went in for a colonoscopy at the VA hospital in Murfreesboro, Tenn., about 60 miles from his home in Spring City. "I had no symptoms, but my doctor recommended that I be tested for colon cancer as a precaution," he recalls.

Three years later, Simpson received an alarming letter. A valve on the equipment used for colonoscopies at the Alvin C. York VA Medical Center may have been wrongly connected. As a result, patients who had colonoscopies at the facility between April 23, 2003, and Dec. 1, 2008, could have been exposed to potentially life-threatening infectious diseases transmitted through body fluids - specifically, hepatitis B, hepatitis C and HIV.

The letter Simpson received from VA advised him to be tested for the viruses. He had the tests done, "and they gave me the all-clear." Still, he says, "every day, it's a source of worry for me."

Simpson is one of about 13,000 veterans who have received letters advising them to be tested for infectious diseases, after VA inspectors found issues with the way reusable medical equipment was handled at various VA facilities, from hospitals to dental clinics. "(In the last four years), we have had five VA facilities where we have needed to disclose a possible risk to veterans," says Dr. George Arana, the Veterans Health Administration acting assistant deputy undersecretary for clinical operations and management.

In addition to Murfreesboro, breaches in medical-equipment sterilization procedures were discovered at VA facilities in Miami and Augusta, Ga. In Miami, routine inspections uncovered that a colonoscopy tube that was supposed to be fully cleaned after each procedure was instead cleaned at the end of each day. And in Augusta, scopes used for ear, nose and throat procedures weren't being cleaned according to proper procedures.

Issues also were found at VA dental clinics in St. Louis and Dayton, Ohio. In St. Louis, dental technicians were washing equipment by hand that should have been sterilized. In Dayton, a concern was raised about a dentist who was not complying with infection-control guidelines. In each case, the risk of infection was extremely low, but VA felt "compelled to disclose," Arana says.

Dr. Andrea Buck, Veterans Health Administration national director of medicine, says that VA's policy is to disclose risk, no matter how negligible. "The risk can be vanishingly small, or even only theoretical risk, and we still will disclose, because if there is an absence of literature on a given topic, as there often is, then VA errs on the side of disclosure in keeping with our commitment to patient safety."

Since receiving letters from VA facilities, nearly 12,000 veterans have been tested. Of them, 15 cases of hepatitis B were identified, 44 were found to have hepatitis C, and seven tested positive for HIV. "None of these results have been biologically linked to exposure to improperly processed medical equipment in VA medical facilities dating back to 2009," Arana says.

In fact, Arana says, the testing produced the benefit of timely, free treatment for those who came back positive. "These 66 veterans are no longer unaware of their condition," Arana says. Regardless of the source, VA is providing each of them treatments at no cost.

That some tested positive is not alarming, Arana says. Any time any group of veterans is tested, "you're going to find some positive hepatitis B, hepatitis C and HIV." The rates of confirmed infections from the group that received letters and were tested are lower than if 10,000 veterans had been randomly tested for hepatitis and HIV.

According to public-health officials, the expected number of positive results after randomly testing 10,000 veterans would be 370 (3.7 percent) for HIV, 700 (7 percent) for hepatitis B, and 540 (5.4 percent) for hepatitis C.

Also, Arana says, the numbers aren't final, because "if the veterans were exposed yesterday, you have to wait six to seven months to complete the testing. And we have some situations that occurred up until a few months ago. So we're still waiting to finalize the testing."

Simpson was told that the viruses could lie dormant and that he might test positive someday. The possibility, he says, keeps him up at night and has strained his marriage. Arana says that "in terms of positive or negative, we can nail that down in six months."

Because of VA's disclosure policies, it's possible that veterans who weren't exposed to the equipment in question were notified that they could be at risk, Arana says. For example, a hospital may have five scopes it uses for colonoscopies. A problem may have been discovered with only one or two of them. However, any veteran who came to the hospital for a colonoscopy when the possible errors were believed to have happened would be notified, regardless if they were exposed to the scopes in question.

"What we do is look at every single patient examined with those five scopes, whereas the risk may have been with one scope or two scopes. Still, we included (in the notifications) all those patients who were treated with those scopes," Arana says. "The default was always to overestimate the numbers, rather than underestimate."

Thanks to VA's electronic medical records, it was easy for experts to mine the data, determine who was treated at the facilities in question during the suspected breaches, and get the names of who needed to be notified. "They could look at it from eight to 10 different perspectives, (and so) we are highly confident that we got all the possibly affected veterans," Arana says.

VA has faced harsh criticism since it disclosed the incidents, sent letters and opened 24-hour hotlines veterans could call with questions. The House Committee on Veterans Affairs' Oversight and Investigations Subcommittee held hearings, and VA's Office of the Inspector General (OIG) has conducted several investigations into the incidents. In response to the breaches, President Obama has said he considers providing for the health and safety of the nation's veterans "a solemn responsibility" and has charged VA with making its medical system "a top-notch system of health care."

Several experts have applauded VA for its disclosure policies, and for accepting responsibility for testing veterans and treating them regardless of how they may have contracted the viruses. Nancy Foster, vice president for quality and patient safety at the American Hospital Association, says people are human and such mistakes could happen anywhere. She says VA has been "very diligent in contacting people who might have suffered adverse consequences as a result of care at their facilities."

An article in the September 2010 issue of the prestigious New England Journal of Medicine titled "The Disclosure Dilemma" recommends that all hospitals follow VA's example and disclose adverse events even when the probability of harm is very low. (Hospitals are not required to disclose possible adverse effects - only actual adverse effects, Buck says.) "The article says that the VA is way ahead of the pack on disclosure of potential risk, and it scolds American medicine, saying it should be doing more of this kind of thing," Arana adds.

John Daigh Jr., the OIG's assistant inspector general for health-care inspections, says a real concern with notifying patients when the risk is miniscule is that it could scare them out of getting necessary procedures. More veterans could die of colon cancer if they don't undergo screenings than could be harmed if equipment used to perform colonoscopies at some sites isn't cleaned exactly according to procedure, he says. According to the Centers for Disease Control and Prevention, the risk of infection following routine endoscopic procedures is 1 in every 1.5 million procedures.

Last November, VA instituted a rigorous review schedule of all 152 hospitals and 200 sites where it processes medical and surgical devices. "We have asked each one of those sites to review their processing protocols six times a year," Arana says. "Then we're asking regional offices to do unannounced visits of each hospital three times a year, so what we have in place is then a self-review and outside review of every hospital nine times a year."

In addition, VA has adopted the tracer method used by the joint commission that accredits VA and private hospitals. The method involves following a given device from the operating room or procedure suite to the time it is cleaned and put back on the shelf.

In March, the OIG released a report on its most recent inspection of VHA facilities' medical-equipment reprocessing practices. The report included inspections at 45 VA facilities from Jan. 1 through Sept. 30, 2010. No threats were found, says Deborah Howard, director of OIG's San Diego Office of Healthcare Inspections and author of the report. "There were opportunities for improvement, but nothing alarming."

Thanks to VA's renewed diligence, "we have sent in national experts from the VA and from outside the VA to look at those issues ... and we feel really good that we're starting to pick up (problems) before they can cause harm," Arana says.

Now retired from the Tennessee Valley Authority, Simpson says he will continue to use VA's health services despite what happened. For his peace of mind, he says he will also continue to be tested for hepatitis and HIV regularly. "They're not advising me that I have to," he says. "But it's in my best interests."

Beth W. Orenstein is a freelance medical writer living in Northampton, Pa.

 

 

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