{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T18:08:53Z","timestamp":1790878133920,"version":"4.1.0"},"reference-count":36,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2022,1,8]],"date-time":"2022-01-08T00:00:00Z","timestamp":1641600000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100016318","name":"Cerus Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100016318","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2022,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>Bloodborne pathogens pose a major safety risk in transfusion medicine. To mitigate the risk of bacterial contamination in platelet units, FDA issues updated guidance materials on various bacterial risk control strategies (BRCS). This analysis presents results of a budget impact model updated to include 5\u2010 and 7\u2010day pathogen reduced (PR) and large volumed delayed sampling (LVDS) BRCS.<\/jats:p><\/jats:sec><jats:sec><jats:title>STUDY DESIGN AND METHODS<\/jats:title><jats:p>Model base\u2010case parameter inputs were based on scientific literature, a survey distributed to 27 US hospitals, and transfusion experts' opinion. The outputs include hospital budget and shelf\u2010life impacts for 5\u2010 and 7\u2010day LVDS, and 5\u2010 and 7\u2010day PR units under three different scenarios: (1) 100% LVDS, (2) 100% PR, and (3) mix of 50% LVDS \u2010 and 50% PR.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>Total annual costs from the hospital perspective were highest for 100% LVDS platelets (US$2.325M) and lowest for 100% PR\u20107\u2009units (US$2.170M). Net budget impact after offsetting annual costs by outpatient reimbursements was 5.5% lower for 5\u2010day PR platelets as compared to 5\u2010day LVDS (US$1.663 vs. US$1.760M). A mix of 7\u2010day LVDS and 5\u2010day PR platelets had net annual costs that were 1.3% lower than for 100% 7\u2010day LVDS, but 1.3% higher than for 100% 5\u2010day PR. 7\u2010day PR platelets had the longest shelf life (4.63\u2009days), while 5\u2010day LVDS had the shortest (2.00\u2009days).<\/jats:p><\/jats:sec><jats:sec><jats:title>DISCUSSION<\/jats:title><jats:p>The model identifies opportunities to minimize transfusion center costs for 5\u2010 and 7\u2010day platelets. Budget impact models such as this are important for understanding the financial implications of evolving FDA guidance and new platelet technologies.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.16778","type":"journal-article","created":{"date-parts":[[2022,1,8]],"date-time":"2022-01-08T10:16:42Z","timestamp":1641637002000},"page":"365-373","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Economic implications of FDA platelet bacterial guidance compliance options: Comparison of single\u2010step strategies"],"prefix":"10.1111","volume":"62","author":[{"given":"Katherine M.","family":"Prioli","sequence":"first","affiliation":[{"name":"Center for Health Outcomes Policy and Economics, Rutgers University  Piscataway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4222-3774","authenticated-orcid":false,"given":"Ilze","family":"Abersone","sequence":"additional","affiliation":[{"name":"Center for Health Outcomes Policy and Economics, Rutgers University  Piscataway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia M.","family":"Kopko","sequence":"additional","affiliation":[{"name":"Division of Transfusion Medicine University of California San Diego  San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jay H.","family":"Herman","sequence":"additional","affiliation":[{"name":"Division of Transfusion Medicine Thomas Jefferson University  Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6251-366X","authenticated-orcid":false,"given":"Brian","family":"Custer","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute  San Francisco California USA"},{"name":"Department of Laboratory Medicine UCSF  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura T.","family":"Pizzi","sequence":"additional","affiliation":[{"name":"Center for Health Outcomes Policy and Economics, Rutgers University  Piscataway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,1,8]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.13080"},{"issue":"2","key":"e_1_2_8_3_1","article-title":"Emerging infectious disease agents and their potential threat to transfusion safety","volume":"49","author":"Stramer SL","year":"2009","journal-title":"Transfusion"},{"key":"e_1_2_8_4_1","unstructured":"CDC.Bacterial Contamination of Platelets.https:\/\/www.cdc.gov\/bloodsafety\/bbp\/bacterial-contamination-of-platelets.html. 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