Mitigating Risk When the Unthinkable Happens

By Karin Lillis

Contamination. Outbreak. Infection. These are words no healthcare facility wants to hear - especially when they are linked with events that have occurred within their own institutions.

Recently, contaminated duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures have been linked to exposing patients - and in some cases infecting - to the superbug carbapenem-resistant Enterobacteriaceae (CRE). ERCP combines endoscopy and fluoroscopy to treat certain diseases and disorders of the biliary and pancreatic ductal systems. At the heart of the issue is a movable “elevator” mechanism at the tip of duodenoscopes. The elevator allows the doctor to move the scope into the bile or pancreatic ducts in order to treat problems like fluid drainage.

“The design of these specific scopes are intricate due to the nature of the test and the need for visualization of the biliary tract,” says Phenelle Segal, RN, CIC, president of Delray Beach, Fla.-based Infection Control Consulting Services. “If these scopes are not adequately cleaned prior to high-level disinfection, they will harbor bioburden - and could continue to result in infections and death.”

Recent media reports include the following examples:

In February, nearly 180 patients were exposed to CRE after undergoing ERCP procedures at UCLA’s Ronald Reagan Medical Center in Los Angeles. At least seven people tested positive for the CRE, and two of those patients died. The patients said to be exposed to CRE underwent ERCP procedures between October 2014 and January 2015.

In March, at least four patients were infected with CRE after undergoing ERCP procedures at Cedars-Sinai Medical Center, another facility in Los Angeles.
At Virginia Mason Medical Center, Seattle, at least 32 patients were infected with CRE-contaminated duodenoscopes between 2012 and 2014. It was reported that 11 of those patients died but it was not clear if those deaths were related to the contaminated scopes.

In December 2013, 243 patients were exposed to CRE after undergoing ERCP procedures at Lutheran General Hospital in Park Ridge, Ill.

In November 2012, several patients at UPMC Presbyterian tested positive for CRE and 18 had matching cultures to an infected duodenoscope used in an ERCP procedure. None of the patients died as a result of the Pittsburgh cases.

Another case that recently made headlines centers on a hospital in Connecticut. While the bacteria is not the same strain found in the other cases, Hartford Hospital reported that 281 patients were potentially exposed to E. coli after undergoing ERCP procedures with a contaminated duodenoscope.

Segal calls the outbreaks “very worrisome.” “With the surge in completely resistant organisms like CRE combined with the complexities of equipment like duodenoscopes, we are going to see ongoing issues - unless drastic steps are taken to change processes, which in this instance are challenging,” she notes.

Handling Cases of Harm
So how should a healthcare institution proactively respond when it faces a scenario of patient harm or a system breakdown?

David Ropeik, a risk communication, perception and management consultant, advises that first - when a hospital experiences an issue or mistake - to be as forthright as early as possible and sincerely apologetic. “People can read an apology that looks like it’s just PR, and it does more harm than good,” he said.
Second, the apologies need to be backed up by action. “You prove trust more by what you do than what you say. That’s going to be directly related to the hospital’s financial well-being and vulnerability to legal action,” notes Ropeik, who heads the firm Ropeik and Associates in Concord, Mass.

“Sometimes the tendency when we make a mistake is to say, ‘Uh-oh. I hope no one finds out.’ It’s called the fear of fear. We don’t want to admit we made a mistake because we think it will scare people, and we’ll look bad,” he explains.

“That tends to make organizations cautious about being open and honest. But it allows the opportunity for someone else to paint the picture first, to make the story public in their way. That’s a lost opportunity and it comes with a cost - once something is framed a certain way, subsequent responses will be in the context of how the situation was first heard about.”

The hospital - or any other organization - will find itself “digging out of a hole that it didn’t have to be in the first place,” Ropeik says.

Responses will vary depending on the individual circumstances of a mistake or a systemic problem. The first response, Ropeik says, needs to “recognize sincerely who is the most harmed and reach out to them first. What’s the best way to reach them? If you harmed a patient, you’re going to talk to that patient. If it’s a systemic error, you might want to think about reaching out to the broader community.

“The emotional way people respond to risk is real - and it carries real risks to institutions. That needs to be built into the concept of risk management. The scientific, legal and financial people look at the cold, hard facts and think that’s all they have to manage - but that’s just not enough.”

Breakdown in the Process
Segal says the issue of the contaminated scopes used in ERCP procedures is “a multidisciplinary problem with key stakeholders” that include the manufacturers and federal regulators like the FDA. Individual facilities also have the responsibility of hiring competent technicians who are provided with specific instructions for cleaning, preferably by the manufacturer and whom are monitored by trained supervisors to ensure compliance.”

While the hospitals mentioned above maintained that they followed the manufacturer’s instructions for use, Segal says, in her experience reviewing several endoscopic reprocessing procedures, it is “not uncommon to observe a breakdown in the process, like missed steps during cleaning. When you compound that with the complexity of duodenoscope design and difficulty in reaching all components during the cleaning cycle, could there have been a two-fold issue resulting in contamination?”

“In my mind, the real issue is that to make sure we have great training and people who are educated and know the current standards and recommendations,” says Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT, president of Seavey Healthcare Consulting in Arvada, Colo. “How are we making sure the people responsible for cleaning the scopes are competent?”

Such efforts might have to go beyond “see one, do one, teach one. Every time a scope is cleaned in this crisis period, make sure someone is watching,” notes Seavey.

Segal agrees. “Regardless of how skilled the reprocessing technicians are, there should be a trained observer taking note of the process during each scope cleaning - particularly in the instance of duodenoscopes,” she says.

Additionally, Segal points out, there is a significant amount of guidance from various infection prevention sources, including the Centers for Disease Control and Prevention and the Food and Drug Administration, and manufacturers that say each step of the disinfection process “has to be followed diligently and under supervision.”

Seavey suggests that every facility have a subject matter for reprocessing and sterilizing endoscopes and surgical equipment. There also needs to be an educator dedicated to the reprocessing departments - not just the operating room educator. Seavey also recommends that all staff who reprocess scopes attain professional certification.

More Questions
Right now, Segal notes, there are more questions than answers. “There are some questions about going back to ethylene oxide, but not every scope can go through that and not every facility has that kind of sterilizer. Every facility needs to consider what tools it has available and what it takes to get everyone up to speed,” Segal says.

Culturing scopes between procedures has some merit, she notes - but cautions that not every facility has the staff or the facilities to properly culture a scope. “You have to have trained people and a lab available to do that.”

For hospitals that routinely use ATP testing as part of environmental services and infection control monitoring, ATP may also be a useful tool to verify whether a scope is pathogen-free. “If a hospital already has a device for ATP testing, it may be relatively less expensive,” Seavey says.

Segal agrees, “It is also suggested that rapid indicator tests to identify protein material should be considered as rigorous cleaning can still yield positive results.” She concludes, “The question I have is that despite our knowledge of the need to meticulously clean prior to high-level disinfection and sterilization, will it become necessary for us to turn to increasing inventory and introduce the concept of sterilizing scopes after the rigorous cleaning? This is the latest discussion in the field. There are various ways to sterilize - although these methods have their drawbacks, too. With studies showing that even rigorous cleaning and high-level disinfection not giving us the necessary reduction in organisms, we may have to resort to sterilization beyond the current high-level disinfection practice standards. This will place a human resources and fiscal burden on facilities. I don’t believe we have solved the issues yet.”

Karin Lillis is managing editor of EndoNurse, an Informa Exhibitions publication.

A Q&A with ECRI Institute's Chris Lavanchy

Chris Lavanchy, engineering director for health services at ECRI Institute, addresses an issue on the minds of healthcare professionals.

Q: Do you think that the number of ERCP scopes contaminated with CRE and other pathogens is on the rise, or are we just more aware of the problem?

A: This question is difficult to answer since most hospitals in the past didn’t investigate and document when a contaminated scope was the cause of an infection. Although there have been reports of infections associated with ERCP scopes many years ago, for example I found one report from 1987, it also was more difficult to trace the source of an infection because tools like PCR testing to identify the genetic fingerprint of microbes weren’t available. Investigation and documentation practices may change in the future, but the impression I have is that in the past when a patient got a conventional infection following a scope procedure there was no compelling reason to investigate whether the infection came from the patient’s own flora, from a colonized scope, or from some other environmental source. The patient would simply be treated with an antibiotic and hopefully recover with no problems. Of course things were different when patients began to be infected with CRE. The difficulty of treating the unusual infection and the high mortality rate were alarming and I believe motivated people to investigate how the infection was acquired. My impression is that the number of infections probably hasn’t increased, but we are simply becoming more aware of contaminated scopes being a source thanks to CRE.