Purpose: Failure Mode and Effects Analysis (FMEA) is a systematic, multidisciplinary team-based method for risk assessment and analysis as a quality management program. This study reports our experience in using FMEA technique in delivery of IMRT treatment plans in order to prevent errors, enhance patient safety and improve the quality of treatment processes.
Methods: An institutional database including 12 steps, 72 tasks and 139 identified failure modes was used to evaluate the safety in the IMRT clinical process. We obtained Risk Priority Numbers (RPN) as a product of assigned scores for the (S) severity, (O) occurrence, and (D) detectability for each potential failure mode, based on recommendations of AAPM TG-100 protocol. A standard scoring method in which RPN varies from 1 to 10 was applied in this work.
Results: Evaluation of our process map characterizing the use of IMRT demonstrated that the largest number of failure modes was associated with treatment planning subprocess. However, the maximum RPN value was found during the imaging subprocess. â€œIncorrect interpretation of tumor or normal tissueâ€? was identified as the failure mode with the highest risk priority number. Inadequate staff training, lack of communication, and human errors are considered potential causes of this failure mode. Evaluation of individual severity and detectability showed twenty-five failure modes identified with â€œSâ€? scores greater than 8 and two with â€œDâ€? scores above 6.
Conclusion: FMEA is a useful approach to planning actions to minimize harm from failure modes. It enabled us to identify risks to patients and predict potential areas of failure before they occur and effect patient care. As a continuous quality improvement tool, this database will provide ways and means to reduce failure in clinical delivery of IMRT and is an excellent method for providing real data to reviewers when department is preparing for any accreditation process.