Practical implementation of failure mode and effects analysis for safety and efficiency in stereotactic radiosurgery.

PURPOSE To improve the safety and efficiency of a new stereotactic radiosurgery program with the application of failure mode and effects analysis (FMEA) performed by a multidisciplinary team of health care professionals. METHODS AND MATERIALS Representatives included physicists, therapists, dosimetrists, oncologists, and administrators. A detailed process tree was created from an initial high-level process tree to facilitate the identification of possible failure modes. Group members were asked to determine failure modes that they considered to be the highest risk before scoring failure modes. Risk priority numbers (RPNs) were determined by each group member individually and then averaged. RESULTS A total of 99 failure modes were identified. The 5 failure modes with an RPN above 150 were further analyzed to attempt to reduce these RPNs. Only 1 of the initial items that the group presumed to be high-risk (magnetic resonance imaging laterality reversed) was ranked in these top 5 items. New process controls were put in place to reduce the severity, occurrence, and detectability scores for all of the top 5 failure modes. CONCLUSIONS FMEA is a valuable team activity that can assist in the creation or restructuring of a quality assurance program with the aim of improved safety, quality, and efficiency. Performing the FMEA helped group members to see how they fit into the bigger picture of the program, and it served to reduce biases and preconceived notions about which elements of the program were the riskiest.