VA Says Infection Control Problems Being Remedied, Defends Response Against Congressional Accusations of Secretiveness

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Washington – Despite the VA’s efforts to improve oversight in areas such as the cleaning and reprocessing of medical equipment, infection risks still exist for patients, according to a recent government report.

Members of a congressional committee blamed a “culture of secrecy” for allowing the problems to persist.

“Correcting inadequate policies and providing effective oversight of reprocessing requirements consistent with the federal standards for internal control is essential for VA to prevent potentially harmful incidents from occurring,” according to a Government Accountability Office (GAO) report released last month.

The report was released to coincide with a House Veterans Affairs Committee hearing on the topic.

During that hearing, VA officials faced off against frustrated legislators. “The time to talk is over,” declared Rep. Jeff Miller (R-Fla.). “VA has got to confront these issues head-on and make the necessary changes within the VA health-care system to prevent any future incidents that put veteran patients’ health at risk.”

The committee’s ranking Democrat, Rep. Bob Filner (D-Calif.) was incensed by the lack of communication, both between VA and the committee and between VA and the public. “It took a long time for the right people to know about these incidents,” Filner said. “Some of these incidents — the chairman of the committee was not informed for days or weeks after them. It seems to me that the culture of secrecy, the culture of covering up, is too prevalent here.”

Problems Persist

While VA officials said there was no intentional effort to cover up the information, there was little denying that infection control lapses have come to light in recent years.

Inadequate reprocessing of endoscopes was seen in Murfreesboro, TN, and Miami in 2008 and in Augusta, GA, in 2009. Last July, lapses in infection control at a dental clinic in St. Louis put 1,800 veterans at risk for HIV and hepatitis. Most recently, lapses in infection control at a dental clinic in Dayton, OH, may have resulted in as many as nine cases of confirmed hepatitis.

While investigations are ongoing at the most recent sites, many of these cases were determined to be the result of insufficient cleaning of reusable medical equipment (RME). While VA has told Congress that it was taking steps to improve standardization in reusable equipment- handling, the GAO report suggests the agency may not be moving fast enough.

Disturbing Deficiencies

GAO investigators looking at a cross-section of six VA medical centers found “disturbing deficiencies and systemic problems that need to be addressed at the national level,” according to Randall Williamson, GAO director of health care, who testified at the hearing last month.Those problems include a lack of specificity about which types of RME require device-specific training; the need to develop reprocessing training at all facilities; and conflicting guidance on the development of that training. Some facility leaders had their employees reprocess equipment exactly as the manufacturer indicated, while others had the guidelines rewritten in a way that was more easily understandable.

There also was a significant lack of national oversight on noncompliance, Williamson said. “While VA now requires that all RME inspection results be submitted to headquarters, VA does not systemically analyze this information. Such analysis is necessary to determine whether cases of noncompliance have been addressed,” he said.

The VA Office of Inspector General (OIG), which conducted separate investigations into all of the incidents, came up with similar findings.

“One of the problems is the inability of selected facilities to follow guidelines,” explained John Daigh, MD, assistant IG for health-care inspections. “They are unable to do their jobs correctly every day at every time.”

Another major problem identified by OIG is a leadership failure within VA facilities. Compromises were made in infection control standards that put veterans at risk, Daigh said. “Hospital leaders must have unfettered input from their employees, especially technicians. They run the lab; they operate the ultrasound machine; they provide and support a great deal of care that occurs in the hospital. The hospital director should speak directly to the technicians.”

The quality of medical care is put at risk by senior hospital leaders who are unresponsive to employee concerns, he added.

VA officials defended the agency, saying it already had dealt with the standardization and training issues described in the GAO report.. “We do, across the country, have standardized operating procedures for cleaning equipment,” said Robert Petzel, MD, VA Under Secretary for Health. “We do not tolerate people writing their own procedures.”

Petzel conceded that the nationwide procedures may not have been entirely up and running prior to the GAO review

Training in Place

“But the training that was described as being needed in the GAO report is in place and has been done in a vast majority of our facilities. We’ve got a process of certification for all of our technicians. We have developed an academy of SPD (Sterile Processing Department) to bring people down to go through more training processes,” he said.

Petzel agreed with Daigh that the VA is lacking in national oversight. “We need to have in place the mechanisms that allow us to be assured and allow us to assure you all, and to look at the SPD and how it’s functioning,” he said. “We need to make sure that what needs to be done is being done.”

One area of concern for legislators was the perceived lack of penalties for those VA employees found at fault in the incidents. Petzel explained that in several cases, including three physicians or dentists and several SPD chiefs, the removal of the employee was proposed and the individual resigned or retired before action was taken.

Is VA Too Secretive?

Legislators also argued that, when these safety lapses occur, VA is moving too slowly and secretively to get information to affected veterans in a timely enough manner. VA officials responded that they are following a “gold standard” in responding to these incidents.

Petzel described the process this way: When VA Central Office learns of an event that may require large-scale patient notifications, VA leaders convene a fact-finding team of subject matter experts to conduct a review. At the conclusion of the review, a Clinical Review Board (CRB) may be convened. The CRB is made up of experts on safety, public health, ethics, operations and management, patient care and VA leadership.

The CRB takes into account such factors as the population at risk, the potential severity of outcomes and the probability of those outcomes. The group then follows VA directives that, according to Petzel, provide specific guidance regarding what adverse events warrant disclosure, when disclosure should occur, and how adverse events should be communicated.

This process can take time—as much as eight weeks in the case of the dental clinic in St. Louis—and VA’s reluctance to disclose who takes part in the decisions resulted in distrust among some legislators.

“It looks like this panel is getting together to figure out what they want to keep secret,” Filner said. “It looks like you’re deciding what’s the minimum amount of information to let out so that people won’t get mad at you. You should put pressure on yourselves to go public.”

Petzel defended the process, telling legislators that the notification process meets industry standards and the approval of OIG and GAO reviewers. “I will stand by that process under any circumstances,” the VA under secretary declared. “It takes some time, but it’s transparent and it’s weighted heavily on the side of being abundantly cautious, so that we take into account every possible risk.”

Legislators argued that the process has proven imperfect. In the case of the improperly cleaned colonoscopy equipment in Miami, VA’s review process originally identified 2,400 veterans in March 2009 who may have been affected. However, a second review in July 2010 found an additional 79 veterans. A third review, in February 2011, located another 12 veterans.

According to Petzel, the discovery of those additional 91 patients was due to an incomplete roster of patients who had received colonoscopies at the Miami facility during the timeframe of the infection control lapses. The initial review used the ICD-9 codes in the electronic health record to identify patients, but there had been coding errors. VA officials did not realize this until six months after the initial round of notifications when a patient contacted the VA, saying he had a colonoscopy at the facility but had not been notified.

Asked if he felt certain all affected veterans in Miami have now been identified, Petzel told the House committee, “I’m as certain as I’m going to be.”

Aftermath in Dayton

Legislators expressed particular concern about the Dayton VAMC incident, which became public knowledge in February. A single dentist working at the dental clinic had, for up to eight years, failed to follow simple infection control practices, such as changing latex gloves and sterilizing tools between procedures. That dentist has since retired, but that his colleagues and supervisors were aware of what was going on and failed to speak up was disturbing news to VA officials and legislators alike.

“This was an absolute failure of leadership within the dental clinic,” Petzel said. “The people that worked with this individual knew it wasn’t appropriate. The technicians knew this wasn’t appropriate. The chief of the dental clinic knew this wasn’t appropriate.”

An OIG investigation of the response of higher-level VA leadership to the incident found that the department responded very quickly and acted in the best interests of patient safety. A decision to temporarily shut down the clinic in June 2010, following the revelation of the problem, was especially useful in allowing the VAMC to deal with the issue, OIG investigators found.

VA’s response also resulted in the resignation of the chief of dentistry and an ongoing investigation of the hospital’s chief of staff. “There are three administrative investigations ongoing in Dayton right now,” Petzel said.

“The fact that this kind of thing happened to just one of our patients is not a good thing,” he said. “We need to improve. We need to do better.”

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