Background

In 1997 the FDA approved the first double-red-blood-cell (2RBC) collection device. Soon after, travel deferral for variant Creutzfeldt-Jakob disease (vCJD) risk was adopted. To show the importance of including 2RBCs in predictive models of the blood supply, an existing whole-blood (WB) model was updated to include 2RBC collection and then run to simulate the effect of vCJD deferral on total RBC availability.

Study design and methods

The model simulates donation of allogeneic WB and 2RBCs, with donors stratified into eight age and sex groups. The model was updated with 2003 donation and economic data from 16 blood centers.

Results

The distribution of donations by demographic group differed both within and between WB and 2RBCs. Overall, 2RBC donation made up 24 percent of transfusable RBC units, at a lower per-unit acquisition cost from both the blood bank and the societal perspectives. Component fees from hospitals would alter this interpretation. The model predicts that vCJD travel deferral led to a 3.3 percent (95% confidence interval [CI], 2.3-4.1) decrease in the total number of RBC units, which was more than offset by 2RBC collection, resulting in a 10.4 percent (95% CI, 9.8%-11.1%) net increase in RBC units. Modeled 2RBC results match operational records, whereas vCJD deferral is overestimated.

Conclusion

Shifting to 2RBC collection led to a substantial gain in available RBCs: even with policies that adversely affect the quantity of RBCs in the supply, 2RBC collection results in a net gain. The economics of 2RBC collection are not as clear, however.

BACKGROUND: COVID-19 Convalescent Plasma (CCP) is a promising treatment for COVID-19. Blood collectors have rapidly scaled up collection and distribution programs. METHODS: We developed a detailed simulation model of CCP donor recruitment, collection, production, and distribution processes. We ran our model using varying epidemic trajectories from 11 U.S. states and with key input parameters drawn from wide ranges of plausible values to identify key drivers of ability to scale collections capacity and meet demand for CCP. RESULTS: Utilization of available CCP collections capacity followed increases in COVID-19 hospital discharges with a lag. Utilization never exceeded 75% of available capacity in most simulations. Demand was met for most of the simulation period in most simulations, but a substantial portion of demand went unmet during early, sharp increases in hospitalizations. For epidemic trajectories that included multiple epidemic peaks, second wave demand could generally be met due to stockpiles established during the decline from an earlier peak. Apheresis machine capacity (number of machines) and probability that COVID-19 recovered individuals are willing to donate were the most important supply-side drivers of ability to meet demand. Recruitment capacity was important in states with early peaks. CONCLUSIONS: Epidemic trajectory was the most important determinant of ability to meet demand for CCP, although our simulations revealed several contributing operational drivers of CCP program success.

Background

Front-line staff at blood collection organizations (BCOs) play important roles in keeping the blood supply safe, yet research on their professional practice and perspectives on training needs is sparse. This qualitative study explored these topics with regard to the then-impending change in donor eligibility for men reporting sex with another man (MSM).

Study design and methods

Semistructured, individual interviews with BCO staff (n = 13) in Northern California covered experiences of and opinions on indefinite deferral, the revised 1-year deferral, and anticipated potential challenges arising from the new policy. Transcripts were thematically coded, using deductive and inductive approaches. Analysis identified recurrent and divergent themes.

Results

Interviewees reported strong values of professionalism and respect for donors and supported the change to a 1-year deferral for MSM donors. Nonetheless, nearly all voiced the need for more in-depth training to maximize the likelihood of successful implementation. Specific recommendations included the use of role-play, provision of science-based talking points or FAQs, and empathy for donors and staff.

Conclusion

More than the usual training may be required to help BCO staff feel prepared to educate the public about changes to MSM-related deferrals and communicate effectively with donors about potentially deferrable behavior. Overall, these findings suggest that before future policy changes, BCO staff's opinions about and role in implementing new donor eligibility screening procedures merit consideration.

The aim of this study was to investigate the association of religiosity with blood donation in a representative/stratified sample of primary healthcare users of Ribeirão Preto, São Paulo, Brazil. A cross-sectional study was conducted using the Duke University Religious Index-DUREL (dimensions: organizational, non-organizational, and intrinsic religiosity). Odds ratios adjusted by sex and age were used as measures of association. A total of 1055 individuals participated (79.7% females; mean age = 40.6 years); 23.3% had previously donated blood. Most reported having a religion and grew up in a religious environment. High frequencies of religiosity were observed. Similar DUREL scores were observed among participants who donated blood and those who did not. Family members and close friends had significant influence on participants blood donation practices. Religiosity was not directly associated with blood donation despite the high prevalence and scores of religiosity. However, possible associations between religion and blood donation should consider mediating variables in future studies.

BACKGROUND: Methylene blue and visible light treatment and quarantine are two methods used to reduce adverse events, mostly infections, associated with the transfusion of fresh-frozen plasma. The objective of this study was to estimate and compare the budget impact and cost-utility of these two methods from a payers perspective. MATERIALS AND METHODS: A budget impact and cost-utility model simulating the risks of hepatitis B virus, hepatitis C virus, cytomegalovirus, a West Nile virus-like infection, allergic reactions and febrile non-haemolytic transfusion reactions achieved using plasma treated with methylene blue and visible light (MBP) and quarantine plasma (QP) was constructed for Spain. QP costs were estimated using data from one blood centre in Spain and published literature. The costs of producing fresh-frozen plasma from whole blood, apheresis plasma, and multicomponent apheresis, and separately for passive and active methods of donor recall for QP were included. Costs and outcomes over a 5-year and lifetime time horizon were estimated. RESULTS: Compared to passive QP, MBP led to a net increase of € 850,352, and compared to active QP, MBP led to a net saving of € 5,890,425 over a 5-year period. Compared to passive QP, MBP increased the cost of fresh-frozen plasma per patient by € 7.21 and had an incremental cost-utility ratio of € 705,126 per quality-adjusted life-year. Compared to active QP, MBP reduced cost by € 50.46 per patient and was more effective. DISCUSSION: Plasma collection method and quarantine approach had the strongest influence on the budget impact and cost-utility of MBP. If QP relies on plasma from whole blood collection and passive quarantine, it is less costly than MBP. However, MPB was estimated to be more effective than QP in all analyses.

Naturally occurring antibodies against ABO antigens present in human sera have been shown to neutralize ABO-expressing HIV in vitro. We investigated associations between ABO and RhD blood groups and HIV infection among blood donors from all blood collection centers in eight of South Africas nine provinces. Whole blood donations collected from first time donors between January 2012 and September 2016 were tested for HIV RNA by nucleic acid testing and HIV antibody using third generation serology assays. ABO and RhD blood types were determined using automated technology. Odds ratios for the association between HIV positivity and ABO and RhD phenotypes were calculated using multivariable logistic regression analysis. We analyzed 515,945 first time blood donors and the overall HIV prevalence was 1.12% (n = 5790). After multivariable adjustment, HIV infection was weakly associated with RhD positive phenotype (OR = 1.15, 95% CI 1.00-1.33) but not with ABO blood group. The observed association with RhD positive phenotype was marginal and likely due to residual confounding by racial group but could serve to generate hypotheses for further studies.

Background

Blood collected in the United States and Canada is screened for West Nile virus (WNV) using nucleic acid testing (NAT). The role that donor-reported symptoms of infection disclosed at or shortly after donation may play in enhancing blood safety has been debated. Little data are available on subsequent manifestations of WNV-specific disease outcomes in viremic donors.

Study design and methods

Donors with initially reactive NAT results were informed by telephone and asked to complete symptom interviews. The questionnaires are focused on three time periods: the week before, the day of, and the 2 weeks after donation. Symptoms and risk factors were compared between confirmed-positive and false-positive donors (classified based on confirmatory NAT and serology). Additional analyses comparing confirmed-positive symptomatic and asymptomatic donors were conducted.

Results

A total of 423 of 536 initially reactive donors were interviewed between 2003 and 2006: 292 confirmed-positive for WNV and 131 false-positive. Individual symptoms were not significant predictors of WNV infection, except skin rash in the week before donation (odds ratio [OR], 3.0; 95% confidence interval [CI], 1.2-7.9) and body aches in the period after donation (OR, 2.8; 95% CI, 1.1-7.4). Specific combinations of symptoms were not good predictors of infection, but donors with three or more concurrent symptoms before donation were more likely to have WNV infection (OR, 2.5; 95% CI, 1.2-5.1). Demographic characteristics, predonation symptoms, and serology profiles in confirmed-positive donors did not predict postdonation symptom severity. Thirty-five confirmed-positive donors (12%) sought medical care for WNV infection, with two hospitalizations, but no cases of neuroinvasive disease.

Conclusion

The number rather than type of symptoms is associated with confirmed WNV infection, but the overall predictive value is low. Very few infected donors develop clinically significant disease.

Background

Concern about West Nile virus (WNV) transfusion-transmitted infections missed by minipool (MP) nucleic acid testing (NAT) has prompted consideration of the use of individual-donation (ID) NAT. Strategies were investigated for the application of limited ID-NAT capacity in 2004.

Study design and methods

Patterns of WNV MP-NAT-reactive donations tested by the Blood Systems Laboratory each week for 79 blood centers from June 29 to November 23, 2003 (196 MP-NAT repeat-reactive [RR] donations among 801,697 units), were analyzed. ID-NAT initiation strategies were developed consisting of counts of RR donations and/or weekly RR rates, together with three ID-NAT discontinuation strategies, and ID testing burden was assessed based on these combined start and stop strategies.

Results

The effectiveness, reported as the percentage of MP-RR donations that would trigger ID-NAT based on each initiation strategy, ranged from 57 to 100 percent. The addition of a 1- or 2-week no-yield requirement for ID discontinuation substantially increased testing burden. Combined strategies resulted in projected ID-NAT of between 10 and 50 percent of donations for a 10- to 20-week period. For this organization, the most feasible ID-NAT initiation strategy was 2 MP-reactive donations and a weekly rate of 1 in 1000, which had an effectiveness of 81 percent and led to peak weekly ID-NAT of 20 to 25 percent of donations depending on the discontinuation rule.

Conclusion

This new approach of targeted ID-NAT based on ongoing monitoring of MP-NAT yield may prove to be a rational policy for agents like WNV that cause seasonal and regional epidemics.

Background

Blood centers rely heavily on adolescent donors to meet blood demand, but presyncope and syncope are more frequent in younger donors. Studies have suggested administration of water before donation may reduce syncope and/or presyncope in this group.

Study design and methods

We conducted a randomized, controlled trial to establish the effect of preloading with 500 mL of water on the rate of syncope and presyncope in adolescent donors. School collection sites in Eastern Cape Province of South Africa were randomized to receive water or not. Incidence of syncope and presyncope was compared between randomization groups using multivariable logistic regression.

Results

Of 2464 study participants, 1337 received water and 1127 did not; groups differed slightly by sex and race. Syncope or presyncope was seen in 23 (1.7%) of the treatment and 18 (1.6%) of the control arm subjects. After adjusting for race, sex, age, and donation history, there was no difference in outcome between the water versus no water arms (adjusted odds ratio [OR], 0.80; 95% confidence interval [CI], 0.42-1.53). Black donors had sevenfold lower odds of syncope or presyncope than their white counterparts (adjusted OR, 0.14; 95% CI, 0.04-0.47).

Conclusion

Preloading adolescent donors with 500 mL of water did not have a major effect in reducing syncope and presyncope in South African adolescent donors. Our adolescent donors had lower overall syncope and presyncope rates than similar populations in the United States, limiting the statistical power of the study. We confirmed much lower rates of syncope and presyncope among young black donors.

BACKGROUND: The way in which the donor history questionnaire is conducted plays a crucial role in the self-disclosure of behavioral risk factors for human immunodeficiency virus (HIV) infection by prospective donors. The South African National Blood Service changed its policy on the process of donor assessment in May 2015 by implementing a compulsory interviewer script used to assess donor eligibility. STUDY DESIGN AND METHODS: A pre- and postevaluation study to determine the impact of scripted interviews on high-risk deferrals and recently acquired HIV infections. We used historical data to compare 18 months before and after the implementation of the script. RESULTS: We recorded a total of 3,169,656 donor presentations during the two 18-months periods, of which 52.2% (1,655,352) were made during the scripted period. A multivariable logistic regression analysis adjusting for donor and demographic characteristics found the odds of high-risk deferral to be slightly greater (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.05-1.07) during the scripted period. A separate multivariate logistic regression model, also adjusting for donor and demographic characteristics, showed that the odds of recently acquired HIV infection were significantly lower (OR, 0.88; 95% CI, 0.79-0.97) during the scripted period. CONCLUSION: This study showed that implementation of a scripted interview was associated with increased HIV risk deferral and decreased recent HIV infection. This study indicates potential improvement in blood safety with the implementation of a scripted donor interview and has relevance to blood safety in other sub-Saharan African countries.