Enhancing safety: Multi-institutional FMEA and FTA on 177 Lu $^{177}{\rm Lu}$ -based radio-pharmaceutical therapy.

Purpose: This study investigates potential failure modes and conducts failure mode and effects analysis (FMEA) and fault tree analysis (FTA) on the administration of ${}^{177}\mathrm{Lu}$ DOTATATE (LUTATHERA) and ${}^{177}\mathrm{Lu}$ PSMA-617 (PLUVICTO). The quality management (QM) process in radiopharmaceutical therapies (RPTs) requires collaboration between nuclear medicine (NM) and radiation oncology (RO) departments. As part of a multi-institutional study, we surveyed various departments to identify and analyze failure modes, leading to a proposed comprehensive QM program. RPT teams in RO or NM clinics can benefit from this study by continually improving their practice.

Methods: We reviewed the literature to investigate the administration of Pluvicto and Lutathera, focusing on prospective procedural failures and potential failure modes (PFMs) and their outcomes. We distributed an FMEA survey to multiple experienced centers in ${}^{177}\mathrm{Lu}$ -based RPTs and calculated risk priority number (RPN) for various PFM. We conducted an FTA using this information to pinpoint the root causes of potential failures.

Results: The findings from the literature review and survey responses on the prospective study have identified several critical areas at risk of failure. These areas include non-optimized treatment delivery, inadequate patient monitoring, and lack of safety training, leading to radiation contamination from the dose excreted by the patients after treatment administration. A segmented FTA was created based on the FMEA results, focusing on radiation contamination with a high RPN value.

Conclusion: By identifying the root causes of failures and proposing targeted improvements to the existing QM measures, this analysis enhances safety in treatment delivery of ${}^{177}\mathrm{Lu}$ -based RPTs. Given the limited number of prospective risk analysis studies in RPTs, our research addresses the necessity for more such studies and recommends methods to apply this study to other RPTs.