3323 - Failure Modes and Effects Analysis Applied to Total Body Irradiation

H. Zhang¹, M. Ward², C. Weiner³, M. Smith¹, B. N. Kelly¹, T. Thompson¹, T. Murphy¹, T. Stenson¹, D. Piantino¹, and C. J. Hampton¹; ¹Atrium Health Levine Cancer, Charlotte, NC, ²SERO Group/Atrium Health Levine Cancer, Charlotte, NC, ³Atrium Health, Charlotte, NC

Purpose/Objective(s): Total Body Irradiation (TBI) is a complex special procedure performed prior to bone marrow transplant. TBI is an integral component of a timed series of events, and unchecked errors may seriously disrupt the entire care workflow and compromise outcome. The simulation and treatments are clinical by nature and mostly performed without hard stops or automatic interlocks. Thus, TBI has a potentially higher risk for error than more automated radiation treatments. Our institutional incident learning system received 3 reports of near miss event in the 3 preceding years. Therefore, a detailed failure modes and effects analysis (FMEA) was initiated, the findings of which are presented here. Materials/

Methods: A multidisciplinary FMEA committee was formed consisting of experienced staff, including a hospital patient-safety coordinator as the facilitator, a physician, clerical staff, physicists, therapists, and administrators. The committee met regularly starting in August of 2022 through March of 2023 with a majority for quorum at each meeting. The TBI workflow was studied extensively for every step from scheduling to treatment.
Results: 97 failure modes were proposed for which a risk priority number (RPN) was given. 16 failure modes with the highest RPNs and severity were identified for actions. Based on the identified failure modes, action plans including changes in standard operating procedures (SOPs), creation of checklists, and standardization of processes were assigned to relevant members of the FMEA team with deadlines, and the committee met to ensure all actions were completed. For unchecked steps, second checks were added, e.g., a film reader pre-procedure QA was added to the SOP and a method of communicating the physician’s planning decision to the transplant team and navigator for 2^nd check was added. For critical steps that can only be done manually without interlocks, ample redundancies were added to the communication through the team by leveraging the electronic information system, e.g. shielding checks were added to the standardized prescription template, beam name conventions were standardized and physics 2^nd check checklists and additional treatment alerts were added. 20 months after FMEA started, the committee resumed meetings to evaluate FMEA effectiveness. The 16 failure modes RPNs were re-scored and new scores were all dramatically lowered. During the intervening 20 months, no new incident learning reports were received.
Conclusion: Though time consuming and requiring department-wide commitment, the FMEA process has offered better insight of the TBI workflow systematically and raised awareness and knowledge of risks. It has helped provide strategies to reduce the risk of error reaching the patient. FMEA has proved effective and further FMEA reevaluation is needed periodically with the goal of safety and quality improvement through culture change.