Nearly seven months before a patient at Charlie Norwood VA Medical Center noticed a problem with sterilizing equipment, setting off a national investigation that found thousands of patients potentially exposed to infection, an employee pointed out problems with sterilization of that equipment.
Augusta VA officials insist the employee was relying on misinformation that would not have caught or corrected the problem.
After the patient's discovery in November 2008, the VA notified more than 10,000 veterans that they might have been exposed to improperly cleaned equipment, and it offered testing. More than 50 cases of infection, from hepatitis C to HIV, have since been found, though VA officials say it's unlikely they came from the equipment.
Seven months before others noticed, in April 2008, an Augusta VA employee sent out an e-mail raising alarm about the sterilization of flexible endoscopes, according to information obtained by The Augusta Chronicle .
Infection control practitioner David Marana had attended a conference for VA infection-control workers in April 2008. Shortly after returning, Marana sent out an e-mail saying the VA was not following standards he had learned about at the conference.
"At this time, I recommend that services involving reusable flexible scopes be discontinued until we have met the standards," he wrote.
Marana, who is no longer with the VA and was reluctant to talk to The Chronicle , did say he thought some of the problems discovered later could have been headed off "if people had listened to me and took the recommendations seriously."
Catherine McAdams, a nurse in infection control, also attended the conference.
"They were told, 'Stop. Don't do it any more,' " said McAdams, who also has left the VA. "You're not doing it right. You're not doing it correctly. People are going to get hurt.' "
VA cites misinformation
The minutes from the infection control meeting, called soon after Marana's e-mail, stated that endoscope cleaning in "several areas of the hospital ... are not in compliance with standards set forth" in VA Directive 7176.
Ellen Harbeson, the Augusta VA's quality management coordinator, said the conference that Marana and McAdams attended provided misinformation about Directive 7176, particularly which VA department was supposed to oversee the department where the reprocessing is done.
Though speakers at the conference asserted that infection control was supposed to oversee that department, "that is completely false," Harbeson said. Supervision was later changed after the problems in Augusta and elsewhere were discovered, but it was not put under Infection Control, she said.
The e-mail itself was "somewhat alarming," she said, but when two senior clinical leaders checked into the allegations, they discovered "where he was talking about a deficiency was not a deficiency."
Much of the early discussion focused on having an appropriate space with the right kinds of ventilation for decontamination and sterilization, which was not an immediate patient safety issue, hospital epidemiologist Stephanie Baer said.
"Yeah, we had some quality improvement to do," Baer said. "I think we all would agree with that. But the level of alarm to stop all procedures, there was not an immediate danger to patients identified at that time to justify that degree of reaction. When we did identify a problem that was potentially a safety problem for patients, we immediately closed the clinic. And that was appropriate."
The kind of sterilization being discussed in April was different from the kind used in the ear, nose and throat clinic, so the changes suggested wouldn't have caught the problem right away, she said.
When Augusta VA Director Rebecca Wiley testified last year before the House Committee on Veterans Affairs, she referred to the April discussion and e-mails as "some questions or controversy over where the supervisory responsibility needed to be for (the reprocessing department) in the future." She has said that she stands by that characterization.
New oversights in place
The VA has changed to the more-centralized kind of processing of the flexible scopes "just to improve oversight, not because it was a mandate," Baer said.
Things are working better, and a team meets monthly to ensure that all manufacturers' cleaning guidelines on all reusable equipment are being followed, Harbeson said.
"I think it's important to recognize that we identified a problem here that was common to every health care facility, VA or non-VA," she said. "And thus you've seen a growth in the industry of companies that provide oversight and assistance in the sterilization of reusable medical equipment."
The VA has learned from its mistakes, Baer said.
"Of course we deeply regret that we had to place any patient in this situation," Harbeson said. "We do believe that we have handled this in the best way we could have."
Marana left the VA before the problem was discovered in the ear, nose and throat clinic and said he hasn't really kept up with what has happened.
"Whether it was corrected or not, I don't know," he said. "All I got was, things have changed or a lot has changed since I left. Whether those issues have been addressed, I have no idea."