Root Cause Analysis of an Endoscope-Reprocessing Breach

The Corrective Actions: For each identified factor that contributed to or caused this deviation, this investigation developed and implemented one or more corrective actions, as a quality approach dictates.

—  Namely, the endoscope-reprocessing competency and training of staff members responsible for cleaning, high-level disinfecting and drying GI endoscopes were re-evaluated and enhanced.

—  In addition, Hospital X’s policies and procedures were re-written to ensure that only staffer members “trained” on the internal designs and reprocessing requirements of every one of the models of GI endoscopes in inventory would be authorized to reprocess GI endoscopes and operate the automated endoscope reprocessor, not just during the week, but on weekends, too.

This required all of the Endoscopy Unit’s staff members, including management, to periodically review the respective operator’s manual, and to review the internal schematic drawings, of every GI endoscope model in inventory. Each time Hospital X purchased a new GI endoscope model, a new training session for staff would be required and scheduled.

<Click here> to read Dr. Muscarella’s article “Improper Use and Reprocessing of a Gastrointestinal Endoscope’s Auxiliary Water System.”

—  The Endoscopy Unit’s policies and procedures were also modified to require that the endoscope-reprocessing practices of staff be monitored and inspected monthly. Once a higher degree of confidence in the reprocessing of the Hospital X’s GI endoscope models had been re-established, these audits would be performed bi-annually, if once a year.

—  The manufacturer of Hospital X’s GI endoscopes:

• was promptly contacted;
• asked to perform another “in-service” of management and reprocessing staff;
• requested to contact and “work with” the manufacturer of Hospital X’s automated endoscope reprocessor; and
• to ensure that Hospital X had received all of the necessary channel adapters to reprocess every one of the GI endoscope’s internal channels, including the auxiliary water channel, using this specific automated endoscope reprocessor.

<Click here> to read Dr. Muscarella’s article “Infection risk at a hospital in New Brunswick: Prevention of disease tranmission during colposcopy.”

—  Hospital X also asked the endoscope manufacturer to provide for it in writing confirmation that the automated endoscope reprocessor was “compatible with” and had been demonstrated to effectively reprocess every one of Hospital X’s models of GI endoscopes, including the auxiliary water channel. If such confirmation were not provided for Hospital X to retain in its quality files, a meeting of management would be scheduled to discuss a plan of action.

Verification of the Corrective Actions’ Effectiveness: Crucial to the success of a quality system, confirmation of the effectiveness of an employed corrective action is required. If inadequate, the corrective action is modified or revised, to improve its effectiveness. Monitoring continues until the corrective action’s effectiveness is deemed adequate.

<Click here> to review and download a comprehensive “endoscope reprocessing toolkit.”

Hospital X therefore monitored each of these aforementioned corrective actions that it employed to confirm its effectiveness, as required of a quality approach. No inadequacies were identified, and, one month after the breach had first been identified, another audit was performed confirming this same staff member’s diligence and consistently successful reprocessing of the GI endoscope’s auxiliary water channel.

PART 2 – A Risk Assessment of this Identified Breach:

<Click here> to review Dr. Muscarella’s article “Factors Affecting the Risk of Infection Associated with an Endoscope Reprocessing Error.”

Blog by: Lawrence F Muscarella, PhD, posted on 4/20/2013; updated 11-5-2013.