By STEPHANIE McFEETERS
@mcfeeters
Daily Hampshire Gazette
WESTFIELD — In the wake of a disinfection lapse that left 293 patients at a small risk for HIV, hepatitis B and hepatitis C, Baystate Health officials continue to piece together the puzzle of what went wrong and why it took so long for the error to come to light.
The hospital acquired new colonoscopes in June 2012 but did not properly adjust its method for cleaning them until April 2013. Questions remain as to how that lapse occurred in the first place, and why patients were not notified when the hospital realized and fixed the mistake.
Among the complicating factors are limited records at Baystate Noble Hospital — which has been part of the Baystate system only since last July — and different manufacturers for the colonoscopes and the equipment used to clean them.
Sitting around a small conference table at the Westfield hospital one afternoon last week, hospital officials stressed that the risk of infection is extremely low, the error has been rectified and colonoscopies remain a crucial tool to combat colon cancer. Still, hospital officials said they recognize the mistake and are trying to take responsibility.
On Jan. 20, Baystate Health alerted patients who had colonoscopies at Noble Hospital between June 2012 and April 2013 that they face a small risk of infection due to improperly disinfected medical devices — flexible tubes called colonoscopes that are inserted through the anus to look for growths, as part of the recommended method of screening for colon cancer. Noble received new Olympus devices in June 2012 that had an additional water irrigation channel, but the hospital was missing an adapter it needed to run that channel through the last, automated stage of its disinfection process in a STERIS reprocessing machine — a dishwasher of sorts.
The hospital’s announcement about the lapse was sparked by a recent state inspection, and the Massachusetts Department of Public Health continues to “actively monitor the situation,” spokesman Scott Zoback said. An employee complaint prompted the DPH visit in December 2015.
In recent weeks, the hospital has offered the affected patients, including 13 in Hampshire County, free screenings, emphasizing that the chance of someone testing positive is very low.
In the history of endoscopy, there are no documented cases of HIV being transmitted, Baystate Vice President of Medical Affairs Doug Salvador said, and only a “handful” of cases of hepatitis B and hepatitis C, among millions of endoscope procedures done annually.
In addition to providing screenings, hospital staff have been working internally to determine how the error occurred, Baystate Health spokesman Ben Craft said. However, he noted that that this is somewhat difficult due to staff turnover and limited records.
What is known
Here’s what Craft said hospital officials know so far.
It appears hospital staff received some form of training from Olympus, which manufactures the colonoscopes, a couple of weeks before the new scopes arrived in June 2012. But Craft said the hospital has no record of what precisely was involved in this training.
Then, on April 11, 2013, the hospital acquired 13 adapters that connected the new, four-channel scopes to the reprocessor. This was apparently free of charge, he said.
“We have indications from at least one interview with an employee who was there at the time that a new employee at the time raised concerns about the process around that time and that that precipitated closer examination of the process and the subsequent change in process,” Craft said. “Beyond that, we don’t have specific documentation of employee concerns.”
On April 17, 2013, Noble staff were trained by STERIS, the company that manufactures the hospital’s four reprocessing machines and adapters. About a week later, on April 23 and 24, hospital staff received additional reprocessing training from Olympus, which manufactures the colonoscopes.
Speaking generally — not about this specific case — Deborah Kudla, who began her role seven months ago as director of surgery at Baystate, said that technicians are specially trained to work with scopes and the reprocessing machines, and receive one-on-one sessions with educators from the manufacturers annually, as well as when technology changes.
If this kind of training occurs, it remains unclear how in June 2012 staff did not notice that the new devices required a new piece of cleaning equipment.
“I think the important question isn’t did they notice there was a tube, but did they notice the significance of it?” Salvador said, explaining that all of the parts of the scope were cleaned with brushes and the entire scope was immersed in disinfecting solution, but the lapse occurred only in the last stage. “We don’t know whether someone noticed there wasn’t the fourth (adapter) or whether they assumed that it was being cleaned appropriately, especially since we have documentation that training happened.”
Still, Craft said, “I think we can say there certainly was a failure to seek and obtain appropriate guidance from the vendor partners at the time when the new scopes came in.”
Different manufacturers
Olympus manufactures the colonoscopes Noble uses, while a competitor, STERIS, makes the automated reprocessing machine and adapters. This points to a complicated dance that must occur among hospitals, ever-evolving medical equipment and various, sometimes competing, manufacturers.
“Ideally it’s a coordinated and collaborative effort, so it’s not: Is it an Olympus responsibility? Or STERIS responsibility? Or Baystate Noble responsibility? It’s everyone’s responsibility to get on the same page,” said Stanley Strzempko, interim chief medical officer at Baystate Noble. “All I can say, honestly, is that it didn’t happen. It’s an ongoing investigation.”
Olympus, which manufactures the scopes, is aware of the issue at Noble but declined to provide more information.
“We are aware of this matter and we are investigating,” spokesman Mark Miller wrote in an email. “Until our due diligence is completed it would not be prudent to comment.”
Representatives from STERIS did not respond to requests for comment.
In hindsight, hospital officials acknowledge that patients should have been notified in April 2013, when Noble updated its cleaning procedure.
Salvador said it’s entirely plausible that “people in good faith didn’t recognize the implication” of the change, noting that at the time there was less of a spotlight on the way endoscopes are cleaned.
The devices have come under increasing scrutiny in recent years, particularly since it was revealed a year ago that two California patients had died from what hospital officials said were inadequately cleaned duodenoscopes, which are inserted through the throat.
Now, Strzempko said, there is a “completely different zeitgeist” when it comes to scope cleaning. This attention is welcome, Salvador said, as it will hopefully lead manufacturers to update scope designs and reduce what he said is already a very small risk of infection.
As for Baystate Noble’s internal processes, officials seem confident a similar error is unlikely to arise again.
Michele Urban, who recently joined Baystate Noble as chief nursing officer, said the hospital now has better record-keeping systems in place, and maintains the educational material from all training sessions as well as lists of who attended them and when.
“That’s a concrete lesson learned,” Strzempko said. “We always documented our education, but we drew a reasonable conclusion that our documentation has to be more detailed, and now it is.”
Stephanie McFeeters can be reached at [email protected].
