WASHINGTON, DC—According to the results of a recent investigation, nearly half of all Department of Veterans Affairs facilities are not in compliance with proper safety protocols for the cleaning and upkeep of colonoscopy and endoscopy equipment, greatly elevating the risk of cross-infection to patients. The investigation, performed by VA’s Office of the Inspector General, came after substandard practices were discovered at four VA facilities this past winter, with over 10,000 veterans notified that they might have been exposed to infection. Subsequent blood tests of some of those patients have identified 53 veterans infected with HIV, Hepatitis B, and Hepatitis C that were not known to have been infected prior to their colonoscopies or endoscopies.

Breaches In Safety

OIG officials testified at a House VA Oversight subcommittee hearing last month on the chain of events that led to the investigation, and on what VA needs to do to comply with safety regulations. Endoscopes are small diameter devices that allow a physician to see internal organs through external orifices by utilizing a system of optics. Flexible endoscopes are complex devices that need to be reprocessed before they can be used again safely. Reprocessing procedures are defined by the endoscope manufacturer and generally involve careful cleaning of the entire external and internal surfaces with an appropriate cleaner, brushing any interior channels, and subjecting the entire scope to high level disinfection or sterilization recommended in the manufacturer’s instructions.

The first incident was reported in November 2008 at the Charlie Norwood VA Medical Center in Augusta, GA, when a patient, following an ENT endoscopic procedure, questioned why the scope was cleaned with a disposable sanitizing cloth when the box indicated that the cloth should not be used on equipment that comes into contact with mucus membrane. The next month, at the Alvin York VAMC in Murfreesboro,TN, during the colonoscopy of the third and last patient of the day, a discoloration was discovered in the auxiliary water tube, which suggested that colonic contents had refluxed into tubing connected to the endoscope. This would create a risk of cross-patient contamination.

“The one-way valve between the auxiliary water tube and the irrigation tube had been replaced by a similarly-appearing connector with no one-way valve,” explained Dr John Daigh, assistant IG for health inspections. “The auxiliary water tube was not reprocessed between each patient, and the irrigation tube was not discarded at the end of each day.”

How such a mix-up occurred investigators have been unable to determine. “The best we can surmise is that during the cleaning process at one point in time somebody took apart the tubes and then reassembled them incorrectly,” Dr. Daigh said. “The instructions did not anticipate that you would take these tubes apart and [disconnect them] from the valves they come assembled with. But that’s the best guess as to what happened.”

In December 2008, VA headquarters issued a patient safety alert that required VA facilities to evaluate safety procedures in place for the use of endoscopic equipment. Sixteen facilities voluntarily reported noncompliance with established guidelines.

The VA medical center in Miami was not one of those. On January 7, 2009, Miami VA staff gave themselves a clean bill of health as far as endoscopic safety protocols were concerned. However, in March, a more intensive review showed that the tubing used in the hospital’s colonoscopy equipment had not been cleaned or serviced properly. “Findings at Miami included that the auxiliary water tube was not reprocessed between patients, none of the irrigation tubing had been changed since purchased, and endoscopic procedures began before the auxiliary water tube was connected to the scope half of the time,” Dr Daigh told legislators. “This breach of protocol made reflux of colonic contents in to the auxiliary water tube more likely.”

To date, 6,387 patients in Tennessee, 1,069 patients in Georgia, and 3, 260 patients in Miami have been notified of the possibility they may have been infected during their routine colonoscopy or ENT endoscopic procedure. Patients were urged by VA to come in for free, voluntary blood screenings. Those screenings have identified 13 veterans who tested positive for hepatitis B, 34 for hepatitis C, and 6 for HIV whom VA was unaware had these diseases prior to their endoscopic procedures.

Why The System Failed

In May, OIG investigators conducted unannounced safety inspections of endoscope and colonoscope processing sites at a number of VA facilities. From the results of those inspections OIG estimates that 78% of VA facilities are in compliance with standard operating procedures, but only one out of two are in compliance with competency standards for employees using the equipment. The number of facilities that have both proper SOPs in place along with staff properly trained to follow them is estimated at only 42.5%.

These figures, which legislators pointed to as egregious and unacceptable, are the result of a lack of standardization as to how such equipment is maintained, and who is responsible for that maintenance, Dr Daigh explained. “When you look at GI scopes and ask who is responsible for processing them, sometimes the answer was the nurses in the GI labs, and sometimes it was the GI lab staff. I think VA needs to standardize the way they deal with reprocessing issues, and ensure that there’s one way to do it, and that methodology is tested rigorously,” Dr. Daigh said. “Currently, [reprocessing is being] done by different people with different levels of training, with some people reading the manual and some going exactly stepby-step. Some people going by how they remember to do it, even though the scope has changed and now has a biopsy port and an auxiliary water channel.”

He added that part of the compliance failure might be a mindset that treats such maintenance as less important than other safety protocols. “I think there are a number of different processes that occur in a hospital. Some require a good deal of thought and intellectual activity to derive what the treatment plan should be. Other processes are really industrial in nature.You need to supply and reprocess equipment to the right user when that equipment is needed; you need toprovide sterile equipment to the operating room on time,” Dr Daigh said. “VA needsto takethe approach that would ensure a tighter quality control methodology and a standard way to reprocess these scopes across the entire VA so that there are checks in place and people understand exactly whoisresponsible forreprocessing endoscopes.”

The report supplied to VA by the OIG following the investigation makes three major recommendations to ensure this breach of safety protocol does not happen again. Those are: ensuring compliance with relevant directives regarding endoscope reprocessing; exploring possibilities for improving the reliability of endoscope reprocessing with VA and non-VA experts; and reviewing the VA organizational structure and make the necessary changes to implement quality controls and ensure compliance with directives. VA officials have publically concurred with OIG findings and recommendations and agreed to supply OIG with an action plan

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