Use of Failure Modes Effects and Criticality Analysis to Improve Patient Safety

The Joint Commission for Accreditation of Healthcare Organizations recently approved revisions to their accreditation standards that are intended to support improvements in patient safety and reduce medical errors. Key among these is the requirement to perform a Failure Modes, Effects, and Criticality Analysis (FMECA) on one high-risk process each year and propose measures to address the most critical failures. Because FMECA was developed for other industries such as nuclear, aerospace, and chemical, some adaptation of its form and use is needed. The FMECA process is normally performed by analyzing each element of an engineered system as represented on a process flow diagram. Medical processes, in contrast, are usually defined procedurally. The key elements of a medical process are more likely to be actions than equipment and components. A community project was put together to develop and test the FMECA adaptation and had good results. This collaboration consisted of safety analysts at Pacific Northwest National Laboratory in Richland, Washington and the Quality and Performance Improvement managers of the three local hospitals. This paper describes this adaptation.