Root Cause Analysis of an Endoscope-Reprocessing Breach

Initial remarks: This blog, which was written by Lawrence F. Muscarella, Ph.D. and is divided into 2 parts, discusses:

1. a confirmed infection-control breach in a hospital’s Endoscopy Unit;
2. the employment of a quality approach, including of a root cause analysis, to prevent the breach’s recurrence;
3. an assessment of the risk of disease transmission associated with this breach; and
4. the impact on patient safety of semantics, discretion, and whether the best word to describe this breach’s assessed infection risk is “moderate” “significant,” or “low.”

♦

PART 1 – The Breach (or Deviation):  While performing its annual internal audit, Hospital X identified a potentially significant infection-control breach:  Although the auxiliary water channel of a gastrointestinal (GI) endoscope was being properly cleaned manually using a detergent, this channel was not being high-level disinfected.

<Click here> to read Dr. Muscarella’s related article “Case Study: A Contaminated Gastrointestinal Endoscope.”

The Concern:  Published guidelines require cleaning followed by the high-level disinfection (and terminal drying) of all of the GI endoscope’s exposed (and, therefore, potentially contaminated) surfaces. The same requirement applies to the surfaces of all types of semi-critical devices, which include, for example, virtually every type of flexible endoscope. (Critical instruments, such as orthopedic implants require sterilization instead.)

Failure to clean and high-level disinfect every one of the GI endoscope’s several channels poses an increased risk of both patient exposure to infectious microorganisms, including to blood-borne pathogens, and patient-to-patient disease transmission. Several instances of infection due to an improperly reprocessed GI endoscope have been reported.

Click here to read Dr. Muscarella’s article “Disinfection or Sterilization of a Contaminated Reusable Instrument?”

This Breach’s Contributing Factors and/or Root Causes:  Several factors contributed to this breach. Management performed an investigation and determined that the staff member responsible for reprocessing Hospital X’s GI endoscopes had been hired 6 months earlier, at the time that this hospital reasonably concluded this deviation began.

—  For a number of reasons, each one of which is itself a contributing factor to this breach, this staff member had not been adequately trained and lacked knowledge about the internal designs and reprocessing requirements of every one of Hospital X’s GI endoscopes – including, most notably, those models in the hospital’s inventory that feature a dedicated auxiliary water channel.

<Click here> to read Dr. Muscarella’s article “Reprocessing the MAJ-855 Tube and the GI endoscope’s Auxiliary Water Channel.”

When asked about why he had not high-level disinfected the GI endoscope’s auxiliary water channel using the automated endoscope reprocessor the hospital had bought two years earlier – remember that the auxiliary water channel requires reprocessing after each patient examination, no matter whether the auxiliary water system, which includes this channel, was used during the GI endoscopic procedure – this employee responded in earnest that “no one had ever told him about it.”

—  The reason why this staff member had not been properly trained was in part because, as the investigation revealed, nor had Hospital X’s management itself been aware of this channel and its reprocessing requirements. Specifically, the GI endoscope’s manufacturer inadvertently had not informed the nurse manager of Hospital’s X’s Endoscopy Unit how to reprocess the GI endoscope’s dedicated auxiliary water channel using the hospital’s previously installed automated endoscope reprocessor.

<Click here> to read Dr. Muscarella’s article “A Legal Case and Verdict about Improperly Reprocessed GI Endoscopes.”

Hospital X had bought this automated endoscope reprocessor a year earlier and was told that, prior to the subsequent purchase of a number of new GI endoscope models, several of which featured a dedicated auxiliary water channel, this automated device was “compatible” with each of these new GI endoscope models.

—  Moreover, during this investigation Hospital X could not find in its drawers, where all of the other cleaning and disinfecting adapters for its GI endoscopes are stored, the specific channel adapter used by this automated endoscope reprocessor to connect to and to flush with a high-level disinfectant the GI endoscope’s auxiliary water channel. (Continued on Page 2 …)