DS 04 - What Could Go Wrong? Utilizing a Failure Mode and Effects Analysis to Identify Endoscope Reprocessing Process Improvement Opportunities

Background: When implemented correctly, endoscope reprocessing using high level disinfection (HLD) renders a reusable endoscope safe for the next patient. However, the amount and complexity of the steps of the HLD process make this challenging. An endoscopy department within a 191-bed acute care hospital with an average of 30 procedures per day had history of highly compliant HLD audits performed by the infection prevention team. However, due to staffing changes and increasing staff expectations, errors in the HLD process led to two patient exposures. Though mitigated swiftly, an improvement process was sought to prevent future patient exposures.

Methods: The quality department chose to facilitate a Failure Mode and Effects Analysis (FMEA) to determine what other steps could fail next. Quality department leadership composed a multidisciplinary team to review the 70+ steps in channeled endoscope reprocessing to identify failure modes. First, the infection prevention/quality manager categorized the steps. Next, endoscopy nursing leadership, an endoscope reprocessing technician, surgical services leadership, and quality/risk management delineated the possible failure modes, causes, and effects for each step. The team scored the likelihood of each failure occurring and its severity, each on a scale of 1 to 4, to find areas in need of action plans. The likelihood and severity scores were multiplied to identify highest areas of risk.

Results: Four steps of the HLD process had a risk score of eight or higher, and the group chose to focus on these for process improvement plans. These steps included portions of the manual endoscope cleaning process, new employee training and competency, and automated endoscope reprocessor parameter verification. Specific action plans will be created for these highest risk elements.

Conclusions: There are often several opportunities for improvement of complex processes such as HLD. Quality improvement tools such as the FMEA can assist infection prevention programs with prioritizing competing opportunities.