{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,14]],"date-time":"2026-07-14T08:09:05Z","timestamp":1784016545462,"version":"3.55.0"},"reference-count":25,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2024,11,13]],"date-time":"2024-11-13T00:00:00Z","timestamp":1731456000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["aapm.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Applied Clin Med Phys"],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>This study investigates potential failure modes and conducts failure mode and effects analysis (FMEA) and fault tree analysis (FTA) on the administration of  DOTATATE (LUTATHERA) and  PSMA\u2010617 (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\u2010institutional 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\u00a0practice.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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 \u2010based RPTs and calculated risk priority number (RPN) for various PFM. We conducted an FTA using this information to pinpoint the root causes of potential\u00a0failures.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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\u2010optimized 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>By identifying the root causes of failures and proposing targeted improvements to the existing QM measures, this analysis enhances safety in treatment delivery of \u2010based 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\u00a0RPTs.<\/jats:p><\/jats:sec>","DOI":"10.1002\/acm2.14550","type":"journal-article","created":{"date-parts":[[2024,11,13]],"date-time":"2024-11-13T13:45:32Z","timestamp":1731505532000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Enhancing safety: Multi\u2010institutional FMEA and FTA on 177Lu$^{177}{\\rm Lu}$\u2010based radio\u2010pharmaceutical therapy"],"prefix":"10.1002","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-5381-6377","authenticated-orcid":false,"given":"Siju C.","family":"George","sequence":"first","affiliation":[{"name":"Department of Radiation Oncology Miami Cancer Institute, Baptist Health  Miami Florida USA"},{"name":"Department of Physics, School of Advanced Sciences Vellore Institute of Technology  Vellore Tamil Nadu India"},{"name":"Department of Radiation Oncology Herbert Wertheim College of Medicine, Florida International University  Miami Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-5902-1995","authenticated-orcid":false,"given":"Santiago","family":"Aguirre","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology Miami Cancer Institute, Baptist Health  Miami Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7230-9793","authenticated-orcid":false,"given":"Nichole M.","family":"Maughan","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology Intermountain Health  Provo Utah USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6755-8397","authenticated-orcid":false,"given":"Ranjini","family":"Tolakanahalli","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology Miami Cancer Institute, Baptist Health  Miami Florida USA"},{"name":"Department of Radiation Oncology Herbert Wertheim College of Medicine, Florida International University  Miami Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8136-2091","authenticated-orcid":false,"given":"E. 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