Improved safety for young whole blood donors with new selection criteria for total estimated blood volume.

BACKGROUND: Young age, first-time donation status, and estimated blood volume (EBV) are leading determinants of syncopal complications after whole blood donation. We evaluated a multifaceted safety initiative and more restrictive selection criteria for whole blood donation by individuals younger than 19 years. STUDY DESIGN AND METHODS: Measures introduced over 2 years addressed donor education, drive environment and supervision, and new eligibility criteria for EBV of 3.5 L or more based on height, weight, and sex for individuals younger than 19 years. Presyncopal and syncopal reactions after whole blood donation during the school year in the baseline, transitional (2008), and full implementation (2009) periods were evaluated. RESULTS: Young donors (16- to 18-years-olds) gave 754,402 and 710,922 whole blood donations in the 2008 and 2009 school years accounting for 16% of the total collections in both 9-month study periods. The new selection criteria were associated with a significant reduction in the reaction rates among 16- to 18-year-olds. Sixteen-year-old donors had the greatest decrease in 2009 compared to baseline for presyncopal reactions (10.5% vs. 7.3%; odds ratio [OR], 0.67; 95% confidence interval [CI], 0.65-0.69) and syncope (43.1 vs. 37.1 per 10,000 donations; OR, 0.86; 95% CI, 0.77-0.96). Donor subgroup analysis by sex, age, and donation status demonstrated that age-related differences in reaction rates were eliminated in 2009. CONCLUSION: The safety initiative with new selection criteria for EBV led to decreased complications among donors 16 to 18 years old, such that the risk for 16-year-olds was no longer different from that observed for 19-year-olds in the analysis stratified by age, sex, and donation status.

The relative safety of automated two-unit red blood cell procedures and manual whole-blood collection in young donors.

BACKGROUND: Automated red blood cell (RBC) apheresis offers the advantage of collecting 2 units of RBCs (2RBC) from one donation, but may expose donors to procedure-related risks. This study evaluated the relative safety of 2RBC compared to whole-blood (WB) donation with a focus on young donors. STUDY DESIGN AND METHODS: Adverse reactions recorded at the collection site or requiring outside medical care were compared after 4,348,686 WB and 206,570 2RBC donations in 26 regional blood centers. RESULTS: 2RBC donors were more likely than WB donors to be male (91.6% vs. 50.3%) and repeat donors (84.0% vs. 81.0%). The overall complication rate was higher for 2RBC than WB collections (627.9 vs. 435.1 per 10,000; odds ratio [OR], 1.44; 95% confidence interval [CI], 1.41-1.47), but more than 96% of all reactions were minor in severity. For donors younger than 20 years, adverse events were equally or less common after 2RBC than after WB donation, but were more common after 2RBC for donors 20 years or older. The rate of major systemic complications was significantly lower for 2RBC than WB donations in all age groups (10.2 vs. 14.3 per 10,000 collections; OR, 0.71; 95% CI, 0.62-0.82). Overall, the need for outside medical care was similar for 2RBC and WB collections (3.4 vs. 4.2 per 10,000 donations, respectively), but significantly less likely after 2RBC donation for donors less than 20 years old (3.8 vs. 7.0. per 10,000 donations; OR, 0.53; 95% CI, 0.32-0.89). CONCLUSION: 2RBC collection procedures, as currently performed in the American Red Cross, are associated with fewer immediate adverse reactions in young donors and have a comparable safety profile in older donors. These data support the collection of 2RBC from young donors.

Limiting and detecting bacterial contamination of apheresis platelets: inlet-line diversion and increased culture volume improve component safety.

BACKGROUND: Septic transfusion reactions to apheresis platelets (PLTs) continue to occur despite preventive measures. This study evaluated the effect of two operational changes designed to reduce bacterial risk: 1) introducing inlet-line sample diversion on two-arm procedures and 2) increasing the sample volume cultured from 4 to 8 mL from all donations. STUDY DESIGN AND METHODS: Aerobic culture results and septic transfusion reactions reported between December 1, 2006, and July 31, 2008 (Period 2), were compared to March 1, 2004, to May 31, 2006 (Period 1). RESULTS: During Period 2, a total of 781,936 apheresis PLT collections were cultured, of which 130 donations (1:6015) were confirmed positive and 9 (1:86,882) had negative culture results but were associated with 11 septic reactions. Confirmed-positive cultures from two-arm procedures decreased (27.2 to 14.7 per 105 collections; odds ratio [OR], 0.54; 95% confidence interval [CI], 0.41-0.70) in Period 2, owing to a lower rate of skin flora contamination. Detection of contamination of one-arm collections significantly increased by 54% in Period 2 (13.7 vs. 21.1 per 105 collections; OR, 1.54; 95% CI, 1.05-2.27). Fewer septic transfusion reactions occurred in Period 2, but the difference did not reach significance (1.7 vs. 1.2 per 105 donations; OR, 0.68; 95% CI, 0.30-1.53). CONCLUSION: Inlet-line diversion decreased bacterial contamination during two-arm collections by more than 46%. Concurrently, doubling the sample volume was associated with a 54% relative increase in culture sensitivity. These interventions act cooperatively to decrease bacterial risk.

The American Red Cross donor hemovigilance program: complications of blood donation reported in 2006.

BACKGROUND: The American Red Cross (ARC) initiated a comprehensive donor hemovigilance program in 2003. We provide an overview of reported complications after whole blood (WB), apheresis platelet (PLT), or automated red cell (R2) donation and analyze factors contributing to the variability in reported complication rates in our national program. STUDY DESIGN AND METHODS: Complications recorded at the collection site or reported after allogeneic WB, apheresis PLT, and R2 donation procedures in 36 regional blood centers in 2006 were analyzed by univariate and multivariate logistic regression. RESULTS: Complications after 6,014,472 WB, 449,594 PLT, and 228,183 R2 procedures totaled 209,815, 25,966, and 12,282 (348.9, 577.5, and 538.3 per 10,000 donations), respectively, the vast majority of which were minor presyncopal reactions and small hematomas. Regional center, donor age, sex, and donation status were independently associated with complication rates after WB, PLT, and R2 donation. Seasonal variability in complications rates after WB and R2 donation correlated with the proportion of donors under 20 years old. Excluding large hematomas, the overall rate of major complications was 7.4, 5.2, and 3.3 per 10,000 collections for WB, PLT, and R2 procedures, respectively. Outside medical care was recorded at similar rates for both WB and automated collections (3.2 vs. 2.9 per 10,000 donations, respectively). CONCLUSION: The ARC data describe the current risks of blood donation in a model multicenter hemovigilance system using standardized definitions and reporting protocols. Reported reaction rates varied by regional center independently of donor demographics, limiting direct comparison of different regional blood centers.

Bacterial screening of apheresis platelets and the residual risk of septic transfusion reactions: the American Red Cross experience (2004-2006).

BACKGROUND: The American Red Cross initiated systemwide bacterial testing of all apheresis platelet (PLT) collections in March 2004, yet continues to receive reports of septic reactions after transfusion of screened components. STUDY DESIGN AND METHODS: The rates of confirmed bacterial contamination of apheresis PLT collections detected by prospective quality control (QC) testing, and by surveillance of reported septic reactions to screened-negative apheresis PLTs, were analyzed according to the technology utilized for collection. RESULTS: Between March 1, 2004, and May 31, 2006, bacterial culture testing was performed on 1,004,206 donations; of these, 186 (1:5,399) had confirmed-positive culture results. Transfusion of all but 1 of the associated 293 components was prevented. A significantly higher rate of confirmed-positive bacterial cultures was seen with products collected utilizing two-arm collection procedures compared to one-arm procedures (22.7 vs. 11.9 per 10(5) donations; odds ratio [OR], 1.9; 95% confidence interval [CI], 1.4-2.7). During this period, 20 septic transfusion reactions were reported, including 3 fatalities (1:498,711 fatalities per distributed component), which implicated screened-negative apheresis PLT products. The frequency of septic reactions was 4.7-fold higher for collections utilizing two-arm procedures (1:41,173; 95% CI, 1:25,000-1:66,667) compared to collections from one-arm procedures (1:193,305; 95% CI, 1:52,632-1:500,000; OR, 4.7; 95% CI, 1.2-18.4); most septic reactions (16 of 20) were due to Staphylococcus spp. and occurred on Day 5 (13 of 20) after collection. CONCLUSION: PLT contamination with bacteria that evade detection by QC culture remains a significant residual transfusion risk, in particular for older PLTs and skin-commensal bacteria in components collected by two-arm apheresis procedures during the study period.