Transfusion-Transmitted Babesiosis.

Babesiosis is most commonly caused by Babesia microti and is transmitted via the bite of an infected Ixodes spp tick. However, Babesia is also transmitted via blood transfusion. In the United States, the first case of transfusion-transmitted babesiosis was recognized in 1979, and in recent years, the incidence has rapidly increased. Because most of the infected blood donors do not experience any symptoms, they pose a significant risk to the blood supply. Donor deferral for a history of babesiosis is currently performed but is ineffective. In March 2018, the FDA licensed a DNA PCR and antibody assay that were used in tandem in pivotal trials for screening blood donors for B microti; with other assays still being evaluated under investigational new drug protocols. Blood donation screening is essential to reducing the risk of transfusion-transmitted babesiosis, which is why blood centers collecting in geographic regions of highest risk have been testing since approximately 2010. Investigational NAT assays of higher sensitivity are pending FDA review. Further, in July 2018, the FDA issued a draft guidance for reducing the risk of transfusion-transmitted babesiosis. Release of the final guidance may be postponed until sensitivities and specificities of all current and potential strategies have been properly evaluated.

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

BACKGROUND: US FDA draft guidance includes pathogen reduction (PR) or secondary rapid bacterial testing (RT) in its recommendations for mitigating risk of platelet component (PC) bacterial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. METHODS: A 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. RESULTS: Annual 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. CONCLUSION: The 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.

Cost of Purchased Versus Produced Plasma from Donor Recruitment Through Transfusion.

BACKGROUND: Plasma is used to treat acquired coagulopathy or thrombotic thrombocytopenic purpura, or to reverse warfarin effect. Scant data are available, however, about its costs. OBJECTIVE: To estimate total costs of plasma from production through administration, from the perspective of a US hospital blood donor center (BDC). STUDY DESIGN AND METHODS: Six sequential decision analytic models were constructed and informed by primary and secondary data on time, tasks, personnel, and supplies for donation, processing, and administration. Expected values of the models were summed to yield the BDC's total cost of producing, preparing, and transfusing plasma. Costs ($US 2015) are reported for a typical patient using three units of plasma. Models assume plasma was obtained from whole blood donation and transfused in an inpatient setting. Univariate sensitivity analyses were performed to test the impact of changing inputs for personnel costs and adverse event (AE) rates and costs. RESULTS: BDC production cost of plasma was $91.24/patient ($30.41/unit), a $30.16/patient savings versus purchased plasma. Administration and monitoring costs totaled $194.64/patient. Sensitivity analyses indicated that modifying BDC personnel costs during donation and processing has little impact on total plasma costs. However, the probability and cost of transfusion-associated circulatory overload (TACO) have a significant impact on costs. CONCLUSION: Plasma produced by our BDC may be less costly than purchased plasma. Though plasma processes have multiple tasks involving staff time, these are not the largest cost driver. Major plasma-related AEs are uncommon, but are the biggest driver of total plasma costs.