Editor: Deborah Sesok-Pizzini, MD, MBA, professor, Department of Clinical Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, and chief, Division of Transfusion Medicine, Children’s Hospital of Philadelphia.
Financial impact of approaches to reduce bacterial contamination of platelet transfusions
August 2019—The leading infection risk from blood transfusion is bacterial contamination, which is most likely due to the entry of small quantities of skin flora at the time of blood donation or collection from asymptomatic donors with unknown bacteremia. FDA standards require that blood centers conduct a routine culture on all platelets a minimum of 24 hours after collection and prior to releasing them to hospital transfusion services. But these efforts have not eliminated the residual risk of bacterial contamination. An FDA draft guidance was issued in 2016 to promote additional measures to prevent or detect bacterial contamination in platelets. These measures include using the FDA-approved pathogen-reduction technology psoralen/ultraviolet irradiation system (Intercept) or secondary testing using a secondary bacterial culture (SBC) system or point-of release test (PORt), such as Verax. The authors performed a comprehensive financial analysis of these three alternative risk-reduction strategies. They created a Markov-based decision tree to model the financial and clinical impact of pathogen reduction, PORt, and SBC, and a baseline strategy involving routine testing only. The model assumed that hospitals received leukoreduced apheresis platelets on day three after collection and that they expired on day five for pathogen reduction and SBC and day seven for PORt. Monte Carlo simulations were used to assess the direct medical costs for platelet acquisition, testing, and transfusion, and for possible complications. The authors inferred sensitivity and specificity from the literature, and costs were based on hospital perspective. The total costs per unit acquired by the hospital were $651.45 for the baseline strategy, $827.82 for pathogen reduction, $686.33 for PORt, and $668.50 for SBC. All of the risk-reduction strategies were shown to decrease septic transfusion reactions and associated expenses. The greatest risk reductions were noted with pathogen reduction. However, this strategy added up-front costs and was associated with an inflation factor of 1.14 due to low platelet increments. All of the reduction strategies would increase total costs relative to baseline. However, SBC is likely to be less costly per unit compared with pathogen reduction or PORt based on this analysis. The authors concluded that the cost and probability input parameters used in this model may not reflect all hospital settings. For example, PORt is based on assumptions about usage, the percentage of units transfused on day three, and the exact schedule for testing units daily. The input parameters are also based on FDA guidance and regulations. For example, if the FDA requires both an aerobic and anaerobic culture bottle for the SBC approach, the costs using this strategy will increase. Overall, this study demonstrates that pathogen reduction, PORt, and SBC are financially viable approaches for reducing bacterial contamination of platelets, although they would increase overall costs. SBC is likely to incur the lowest per unit cost for risk reduction, especially if the platelet outdate is extended to day seven.
Kacker S, Bloch EM, Ness PM, et al. Financial impact of alternative approaches to reduce bacterial contamination of platelet transfusions. Transfusion. 2019;49:1291–1299.
Correspondence: Dr. Aaron A. R. Tobian at atobian1@jhmi.edu
Safety of blood donation by the elderly and influence of the elderly on blood supply
An upper age limit on whole blood and double red blood cell donation is imposed in some countries due to concerns about donor safety and reactions. Excluding older donors may affect the potential donor pool in countries that have an aging donor population. The Biomedical Excellence for Safer Transfusion (BEST) Collaborative conducted a study to evaluate the safety of blood donations in people 71 years and older and that population’s contribution to the blood supply in Canada, New Zealand, England, and the United States, which have no upper age limit for whole blood and double RBC donation, and Australia, which has an upper age limit of 80 years. Twelve blood center members of the BEST Collaborative provided 2016 data on donors and donations, deferral rates, and vasovagal reactions by donor age and gender. Donors younger than 24 years old were included in the number of total donors and donations but not in deferral and reaction rate comparisons. The results showed that older donors accounted for a low of 1.0 percent of the donor population in New Zealand up to a high of 4.2 percent in the United States and accounted for a low of 1.5 percent of total donations in New Zealand up to a high of 5.6 percent in the United States. The older donors were primarily between 71 and 76 years old. The authors showed that the overall deferral rate for all countries was higher for males in the older population compared with 24- to 70-year-old males, but very similar between older and younger females. Vasovagal reactions with and without loss of consciousness were lower for older male donors, while such reactions were lower for female donors without loss of consciousness but similar for younger and older female donors with loss of consciousness. The authors concluded that a donor criterion based on an upper age limit may be unwarranted based on safety concerns for donor reactions. With a large cohort of late-middle–aged baby boomers entering their 70s, indiscriminately deferring these donors based on age may result in the loss of many dedicated and safe donors.
Goldman M, Germain M, Gregoire Y, et al. Safety of blood donation by individuals over age 70 and their contribution to the blood supply in five developed countries: a BEST Collaborative group study. Transfusion. 2019;
59:1267–1272.
Correspondence: Dr. Mindy Goldman at mindy.goldman@blood.ca