The operational and financial impact of adding anaerobic screening of platelets.

BACKGROUND AND OBJECTIVES: We evaluated the operational and safety impact of implementing anaerobic culture screening of apheresis and pooled platelets at the American Red Cross on the already established use of the aerobic culture screening of each donation performed no sooner than 24 h following collection. MATERIALS AND METHODS: Platelets were screened for bacterial contamination with the BACT/ALERT 3D® (bioMérieux, Durham, NC) microbial detection testing system. The addition of anaerobic culture to the already existing aerobic culture resulted in sampling an additional 8-10 mL from each donation. RESULTS: Implementation of anaerobic testing resulted in an approximate 3.5-fold increased rate of False Positive BACT/ALERT alarms. There was a modest increase in the rate of True Positive alarms of 1.4-fold with increased detection of Klebsiella and Propionibacterium species, including Cutibacterium acnes. In addition, there was an approximate 3.5-fold increase rate of False Positives and a 13.5-fold increase rate of Indeterminates, the majority (~57%) were due to Cutibacterium acnes. The combined costs and lost revenue associated with adding anaerobic screening increased by ~$1,000,000/year due to testing cost and product discards. CONCLUSION: The addition of anaerobic culture to aerobic culture to the original donation (without the introduction of sampling delay) resulted in a significant increase in the rate of alerts. The 40% increased rate of True Positive alarms may have modestly improved platelet safety. However, there was a disproportionate increase in the rate of False Positive and Indeterminate bacterial culture alarms, which added substantial cost and overall loss of platelet products.

Transfusion-related acute lung injury surveillance (2003-2005) and the potential impact of the selective use of plasma from male donors in the American Red Cross.

BACKGROUND: American Red Cross surveillance data on transfusion-related acute lung injury (TRALI) fatalities were analyzed to evaluate the association with components from donors with white blood cell (WBC) antibodies and to examine the potential impact of the selective transfusion of plasma from male donors. STUDY DESIGN AND METHODS: Suspected TRALI reports in 2003 through 2005 were identified and all fatalities were reviewed and classified by three physicians as "probable TRALI" or of "unrelated etiology," with independent review of the associated serologic investigation. Hospital investigational and reporting biases could not be fully controlled in this retrospective study. RESULTS: A total of 550 reports of suspected TRALI, including 72 fatalities, were investigated. The number of reports increased each year and the rate varied by geographic region. Retrospective review of fatalities revealed 38 cases of probable TRALI, the majority (24 of 38 [63%]) after plasma transfusion. A female, WBC antibody-positive donor was involved in 71 percent (27 of 38) of cases and in 75 percent (18 of 24) of cases involving plasma transfusion. Female antibody-positive donors were more likely to be associated with probable TRALI than with unrelated cases (p = 0.0001; odds ratio [OR], 9.5; 95% confidence interval [CI], 2.9-31.1]. The rate of probable TRALI among recipient fatalities was higher for plasma components (1:202,673; OR, 12.5; 95% CI, 5.4-28.9) and apheresis platelets (PLTs; 1:320,572; OR, 7.9; 95% CI, 2.5-24.8) compared to red cells (1:2,527,437). Male donors contributed 64.5 and 52.0 percent of distributed apheresis PLTs and plasma components, respectively, in 2005. CONCLUSION: Plasma components linked to female donors with WBC antibodies were responsible for the majority of probable TRALI fatalities. Prudent measures to limit transfusion of WBC antibody-containing plasma components may prevent as many as six fatalities per year in the Red Cross system.