Poster - Thur Eve - 19: Risk assessment of clinical radiation processes using failure modes and effect analysis

The aim of this work was to apply failure modes and effect analysis (FMEA) to assess risk in two radiation planning and treatment processes; our on-call (out-of-clinical hours) process and our tomotherapy process. The motivation was provided by analysis of 2506 adverse incidents reported over a 5 year period, the on-call process for giving rise to a higher than expected number of incidents and our tomotherapy process for the reverse. For the on-call scenario, three separate processes were analysed: our current process, our current process incorporating a software upgrade eliminating several planning steps and a fully integrated process in which the patient is imaged, planned and treated on a single platform (TomoTherapy Hi Art, Accuray Incorporated, Sunnyvale, CA). After construction of a detailed process map for each case, a multidisciplinary group identified potential failure modes for each process step, the effects of each failure and existing controls. Risk probability numbers were determined from severity, frequency of occurrence and detectability scores assigned to each failure mode according to a standard scale. The results were analysed to identify and prioritise feasible and effective process improvements. For the on-call process, our current workflow was identified as incurring the highest risk of the three processes analysed, demonstrating quantitatively the value of the software upgrade and providing a clear rationale for the associated expense. In summary, we have found FMEA to be a feasible tool for assessing relative risk in a clinical process. However, operational and resource issues must be considered separately.