ABSTRACT
PURPOSE: Explore the feasibility of adopting failure modes and effects analysis (FMEA) for risk assessment of a high volume clinical service at a UK radiotherapy center. Compare hypothetical failure modes to locally reported incidents. METHOD: An FMEA for a lung radiotherapy service was conducted at a hospital that treats ~ 350 lung cancer patients annually with radical radiotherapy. A multidisciplinary team of seven people was identified including a nominated facilitator. A process map was agreed and failure modes identified and scored independently, final failure modes and scores were then agreed at a face-to-face meeting. Risk stratification methods were explored and staff effort recorded. Radiation incidents related to lung radiotherapy reported locally in a 2-year period were analyzed to determine their relation to the identified failure modes. The final FMEA was therefore a combination of prospective evaluation and retrospective analysis from an incident learning system. RESULTS: Thirty-six failure modes were identified for the pre-existing clinical service. The top failure modes varied according to the ranking method chosen. The process required 30 h of combined staff time. Over the 2-year period chosen, 38 voluntarily reported incidents were identified as relating to lung radiotherapy. Of these, 13 were not predicted by the identified failure modes, with six relating to delays in the process, three issues with appointment times, one communication error, two instances of a failure to image, and one technical fault deemed unpredictable by the manufacturer. Four additional failure modes were added to the FMEA following the incident analysis. CONCLUSION: FMEA can be effectively applied to an established high volume service as a risk assessment method. Facilitation by an individual familiar with the FMEA process can reduce resource requirement. Prospective evaluation of risks should be combined with an incident reporting and learning system to produce a more comprehensive analysis of risk.
