Economic Implications of Pathogen Reduced and Bacterially Tested Platelet Components: A US Hospital Budget Impact Model

Abstract

BackgroundUS FDA draft guidance includes pathogen reduction (PR) or secondary rapid bacterial testing (RT) in its recommendations for mitigating risk of platelet component (PC) bacterial contamination. An interactive budget impact model was created for hospitals to use when considering these technologies.MethodsA Microsoft Excel model was built and populated with base-case costs and probabilities identified through literature search and a survey of US hospital transfusion service directors. Annual costs of PC acquisition, testing, wastage, dispensing/transfusion, sepsis, shelf life, and reimbursement for a mid-sized hospital that purchases all of its PCs were compared for four scenarios: 100% conventional PCs (C-PC), 100% RT-PC, 100% PR-PC, and 50% RT-PC/50% PR-PC.ResultsAnnual total costs were US$3.64, US$3.67, and US$3.96 million when all platelets were C-PC, RT-PC, or PR-PC, respectively, or US$3.81 million in the 50% RT-PC/50% PR-PC scenario. The annual net cost of PR-PC, obtained by subtracting annual reimbursements from annual total costs, is 6.18% above that of RT-PC. Maximum usable shelf lives for C-PC, RT-PC, and PR-PC are 3.0, 5.0, and 3.6 days, respectively; hospitals obtain PR-PC components earliest at 1.37 days.ConclusionThe model predicts minimal cost increase for PR-PC versus RT-PC, including cost offsets such as elimination of bacterial detection and irradiation, and reimbursement. Additional safety provided by PR, including risk mitigation of transfusion-transmission of a broad spectrum of viruses, parasites, and emerging pathogens, may justify this increase. Effective PC shelf life may increase with RT, but platelets can be available sooner with PR due to elimination of bacterial detection, depending on blood center logistics.

Platelet enhancement of bacterial growth during room temperature storage: mitigation through refrigeration

“…Septic transfusion reactions (STRs) remain a significant risk associated with platelet (PLT) administration . Reports indicate that rates of bacterial contamination and STRs associated with PLT transfusions range from as low as 1 in 2000 transfused PLT units to as high as 1 in 750 . While PLTs are screened for bacterial contamination, there are significant deficiencies in bacterial detection .…”

“…While PLTs are screened for bacterial contamination, there are significant deficiencies in bacterial detection . Current AABB guidelines require only that blood banks and transfusion services collecting PLTs “have methods to limit and to detect or inactivate bacteria in all platelet components” (5.1.5.1) and that “detection methods shall either be cleared or approved by the FDA” (5.1.5.1.1) . However, many facilities only perform aerobic blood cultures on collected blood products for this purpose resulting in an inability to detect anaerobic bacterial contaminants .…”

How do we … integrate pathogen reduced platelets into our hospital blood bank inventory?

“…Other seemingly less expensive options, however, such as those aimed at mitigating bacterial contamination risk alone, may be as expensive as PR when space, equipment, training, and staffing requirements are considered. 32,[45][46][47] Furthermore, as new nonbacterial pathogens, such as viruses and protozoa, threaten the blood supply, new pathogen-specific tests would need to be developed for each agent and paid for by hospitals not using PR products. This scenario has already occurred with the Zika virus, as PR PLTs do not require testing for Zika.…”

Impact of implementing pathogen reduction technologies for platelets on reducing outdates

“…Numerous papers have analysed the financial cost of implementing PRT . One important aspect of the savings to be made by extending the shelf life of PC to 7 days is the reduction in the number of units discarded due to outdating.…”

“…For instance, there are references to reductions in outdates of between 30 and 45% based on estimates by staff in charge of production . One study argues that there could be a decrease of 1·6% per additional hour of PC shelf life, which would result in an overall figure of 77% for a 2‐day increase . Another recent study mentions a reduction in outdates of 47% with an extension of shelf life from 5 to 7 days, with an outdate rate of 9·5% for 5‐day PC and 5% for 7 days.…”