Real-world Effectiveness of mRNA COVID-19 Vaccines Among US Nursing Home Residents Aged ≥65 Years in the Pre-Delta and High Delta Periods.

Background: Long-term care residents were among the most vulnerable during the COVID-19 pandemic. We estimated vaccine effectiveness of mRNA COVID-19 vaccines in Medicare nursing home residents aged ≥65 years during pre-Delta and high Delta periods. Methods: We conducted a retrospective cohort study from 13 December 2020 to 20 November 2021 using Medicare claims data. Exposures included 2 and 3 doses of Pfizer-BioNTech and Moderna COVID-19 vaccines. We used inverse probability weighting and Cox proportional hazards models to estimate absolute and relative vaccine effectiveness. Results: Two-dose vaccine effectiveness against COVID-19-related death was 69.8% (95% CI, 65.9%‒73.3%) during the pre-Delta period and 55.7% (49.5%‒61.1%) during the high Delta period, without adjusting for time since vaccination. We observed substantial waning of effectiveness from 65.1% (54.2%‒73.5%) within 6 months from second-dose vaccination to 45.2% (30.6%‒56.7%) ≥6 months after second-dose vaccination in the high Delta period. Three doses provided 88.7% (73.5%‒95.2%) vaccine effectiveness against death, and the incremental benefit of 3 vs 2 doses was 74.6% (40.4%‒89.2%) during high Delta. Among beneficiaries with a prior COVID-19 infection, 3-dose vaccine effectiveness for preventing death was 78.6% (50.0%‒90.8%), and the additional protection of 3 vs 2 doses was 70.0% (30.1%‒87.1%) during high Delta. Vaccine effectiveness estimates against less severe outcomes (eg, infection) were lower. Conclusions: This nationwide real-world study demonstrated that mRNA COVID-19 vaccines provided substantial protection against COVID-19-related death. Two-dose protection waned after 6 months. Third doses during the high Delta period provided significant additional protection for individuals with or without a prior COVID-19 infection.

COVID-19 convalescent plasma donors: Unique motivations in unique times?

BACKGROUND: Early in the SARS-CoV-2 pandemic, many blood collection organizations (BCOs) were asked to collect and distribute COVID-19 convalescent plasma (CCP) as a potential treatment for this new virus and resulting disease. However, recruiting CCP donors presented unique challenges for BCOs, as there were few recovered patients at this time, and like the general population, most potential CCP donors had no blood donation experience. Thus, many CCP donors were new donors, and their donation motivations were unknown. MATERIALS AND METHODS: Donors who gave CCP at least once between April 27th and September 15th, 2020, were emailed a link to an online survey regarding their experience with COVID-19 and their motivations for donating CCP and blood. RESULTS: Of the 14,225 invitations sent, 3471 donors responded (24.4%). Most donors had never donated blood before (n = 1406), followed by lapsed donors (n = 1050), and recent donors (n = 951). There was a significant relationship between self-reported donation experience and fear of CCP donation (X2  = 119.2, p < .001). Motivations ranked "very important" by responding donors were wanting to help someone in need, a feeling of responsibility, and feeling a duty to donate. Donors with more severe disease were more likely to respond with feelings of a sense of duty to donate CCP (Χ2  = 8.078, p = .044) or altruism (Χ2  = 8.580, p = .035). CONCLUSIONS: Overwhelmingly, altruism and a sense of duty and responsibility were the reasons that CCP donors decided to donate. These insights can be useful for motivating donors for specialized donation programs or if wide scale CCP recruitment is needed in the future.

Whole blood donor return rates after deferral for tattooing or body piercing-Survey across blood donation services: The BEST collaborative study.

BACKGROUND AND OBJECTIVES: To protect transfusion recipients from transfusion-transmissible infections, blood donors are deferred from donating after recent tattooing or piercing. To explore to what extent and how this deferral impacts donor availability, we performed an international study to investigate how many donors were deferred for a recent tattoo or piercing and how many of these donors returned to donate. MATERIALS AND METHODS: We surveyed blood centre members of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative and the European Blood Alliance Donor Studies Working Group on their numbers of donations, tattoo and piercing deferrals, and return rates in the year 2017. RESULTS: Eight blood centres participated. Overall, deferral rates were lower for repeat donors compared to new donors. Repeat donors were more likely to return than new donors. Women and young donors were more often deferred than male and older donors. Men were more demotivated by tattoo or piercing deferral, resulting in lower return rates compared to women. Return rates differed greatly between blood centres. CONCLUSION: Tattoo and piercing deferrals lead to missed donations and result in lower return rates. However, the numbers vary largely internationally, probably due to cultural and policy differences. Shortening deferral periods after tattooing or piercing may reduce the impact on donor availability, which should be investigated in single-centre studies.

Current challenges of severe acute respiratory syndrome coronavirus 2 seroprevalence studies among blood donors: A scoping review.

BACKGROUND AND OBJECTIVES: Blood donors are increasingly being recognized as an informative resource for surveillance. We aimed to review severe acute respiratory syndrome coronavirus 2 seroprevalence studies conducted among blood donors to investigate methodological biases and provide guidance for future research. MATERIALS AND METHODS: We conducted a scoping review of peer-reviewed and preprint publications between January 2020 and January 2021. Two reviewers used standardized forms to extract seroprevalence estimates and data on methodology pertaining to population sampling, periodicity, assay characteristics, and antibody kinetics. National data on cumulative incidence and social distancing policies were extracted from publicly available sources and summarized. RESULTS: Thirty-three studies representing 1,323,307 blood donations from 20 countries worldwide were included (sample sizes ranged from 22 to 953,926 donations). The majority of the studies (79%) reported seroprevalence rates <10% (ranging from 0% to 76% [after adjusting for waning antibodies]). Overall, less than 1 in 5 studies reported standardized seroprevalence rates to reflect the demographics of the general population. Stratification by age and sex were most common (64% of studies), followed by region (48%). A total of 52% of studies reported seroprevalence at a single time point. Overall, 27 unique assay combinations were identified, 55% of studies used a single assay and only 39% adjusted seroprevalence rates for imperfect test characteristics. Among the nationally representative studies, case detection was most underrepresented in Kenya (1:1264). CONCLUSION: By the end of 2020, seroprevalence rates were far from reaching herd immunity. In addition to differences in community transmission and diverse public health policies, study designs and methodology were likely contributing factors to seroprevalence heterogeneity.

HIV residual risk in Canada for apheresis source plasma donation without deferral for men who have sex with men.

BACKGROUND AND OBJECTIVES: In Canada, men having sex with men (MSM) are deferred for 3 months from last sexual contact to reduce human immunodeficiency virus (HIV) risk to recipients. The aim of this paper was to model the Canadian residual risk of HIV-positive source plasma incorporating pathogen inactivation (PI) under no MSM deferral scenarios for apheresis plasma donations. MATERIALS AND METHODS: A combined Bayesian network (BN) and Monte Carlo approach were implemented to estimate the HIV residual risk under 3-month deferral compared with no deferral without quarantine scenarios for MSM donors. Models involve the stochastic generation of donation and its infection status based on its corresponding simulated donor profile. Viral load reduction conferred by PI used by source plasma fractionators was simulated. Model parameters were derived from Héma-Québec and Canadian Blood Services data, viral loads in a large sample of HIV-positive US blood donors, CSL Behring documentation and from published data. RESULTS: In the most likely scenario for the 3-month deferral model, there were 2.71 positive donations per 1,000,000 donations (95% confidence interval [CI] 2.63-2.78). For the no-deferral model, there were 3.01 positive donations per 1,000,000 donations (95% CI 2.94-3.09). For both scenarios, the risk of having an infectious pool was 0 in 300,000 pools (95% CI 0-0.0000123) after consideration of PI. CONCLUSION: Based on simulation results, there would be a negligible HIV residual risk associated with the removal of a time-based MSM deferral without quarantine for source plasma incorporating PI.

COVID-19 convalescent plasma donor characteristics, product disposition, and comparison with standard apheresis donors.

BACKGROUND: With coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) offering an early treatment option for COVID-19, blood collectors needed to quickly overcome obstacles to recruiting and qualifying eligible donors. We provide attributes of CCP donors and products and compare to standard donors and products. STUDY DESIGN AND METHODS: Information on CCP donors was gathered from the American Red Cross qualification website through product collection. Data from 2019 for standard plasma/platelet apheresis (SA) and whole blood (WB) donor demographics and SA donations including product disposition and reactions were used for comparison. RESULTS: Of almost 59 000 donors registering on the website, 75% reported an existing COVID-19 diagnostic polymerase chain reaction or an antibody test. The majority (56.2%) of 10 231 CCP donors were first-time donors in contrast to SA or WB donor populations, which were only 3.0% and 30.6%, respectively, first-time donors. The number of female donors was 12% higher than SA donors. Older (≥ 65 years) and younger (16-19 years) were comparatively underrepresented in CCP donors. Deferral (10.2%) and Quantity Not Sufficient rates (6.4%) for presenting CCP donations were higher than SA (8.2% and 1.1%, respectively). Human leukocyte antigen antibody reactivity was the highest cause of product loss for CCP donations vs SA donations (9.6% vs 1.3%). Acute adverse events also occurred at a higher rate among both first-time and repeat CCP donations compared to SA. CONCLUSIONS: CCP donors were more likely to be first-time and female donors than WB or SA donors. CCP donations had a higher rate of donor adverse reactions, deferrals, and product loss than SA donations.

HIV, HCV, and HBV incidence and residual risk in US blood donors before and after implementation of the 12-month deferral policy for men who have sex with men.

BACKGROUND: In December 2015, the men who have sex with men (MSM) deferral was reduced to 12 months in the United States. We compared human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) incidence and residual risk before and after this policy change using data from >50% of the US blood supply. STUDY DESIGN AND METHODS: Three estimation intervals from the Transfusion-Transmissible Infections Monitoring System were compared: 15-months pre- and two consecutive, nonoverlapping 15-month post-MSM deferral implementation. Repeat, first-time, and weighted all-donor incidences were estimated. Residual risk was calculated for all incidence estimates using the incidence/window-period method. RESULTS: HIV repeat donor incidence was 1.57 per 100 000 person-years (phtpy) in the second 15-month post change and not significantly different from pre-MSM incidence of 2.19 phtpy. Similar values were seen for HCV (1.49 phtpy vs 1.46 phtpy) and HBV (1.14 phtpy vs 0.97 phtpy). In some cases, higher estimated incidence, but without significant change from pre-MSM to the second post change period occurred for males and first-time donors (eg, first-time donors, second post change period: 6.12 phtpy HIV, 6.41 phtpy HCV and 5.34 phtpy HBV). Estimated per donation residual risk was 1:1.6 million for HIV, 1:2.0 million for HCV and 1:1.0 million for HBV based on weighted incidence for all donors. CONCLUSIONS: Repeat, first-time, and overall donor incidence did not vary significantly comparing pre-MSM to either of the post-MSM estimation intervals. Residual risk estimates vary by study, but all yield residual risks in the United States of ≤1 per million, and thus far have not shown increasing risk with the 12-month MSM policy change.

Research initiatives of blood services worldwide in response to the covid-19 pandemic.

BACKGROUND AND OBJECTIVES: While coronavirus (COVID-19) is not transfusion-transmitted, the impact of the global pandemic on blood services worldwide is complex. Convalescent plasma may offer treatment, but efficacy and safety are not established. Measuring seroprevalence in donors would inform public health policy. Here, we survey blood services around the world to assess the different research programmes related to COVID-19 planned or in progress. MATERIALS AND METHODS: Blood collection services were surveyed in June 2020 to determine whether they were participating in serosurveys or convalescent plasma collection and clinical trials. RESULTS: A total of 48 countries (77% of those contacted) responded. Seroprevalence studies are planned or in progress in 73% of countries surveyed and in all continents, including low- and middle-income countries. Most aimed to inform public health policy. Convalescent plasma programmes have been initiated around the globe (79% of surveyed), about three quarters as clinical trials in high-, middle- and low-income countries. CONCLUSION: Blood services around the world have drawn upon their operational capacity to provide much-needed seroprevalence data to inform public health. They have rapidly implemented preparation of potential treatment when few treatments are available and mostly as clinical trials. At the same time, they must continue to provide blood products for recipients despite challenges of working in a state of emergency. It is important to track and coordinate research efforts across jurisdictions to gain a composite evidence-based view that will influence future practice and preparative strategies.

Effectiveness of the post-donation instruction sheet in conveying information to repeat blood donors.

BACKGROUND AND OBJECTIVES: Written materials are commonly used for blood donor education. While pre-donation materials are largely standardized across US blood collectors, the post-donation instruction sheet (PDIS) is variable and few have been evaluated to assess their effectiveness in conveying information as reflected by donors' attention, understanding and recall. METHODS: An online survey was sent to two independent randomly selected samples of repeat donors, before and after implementation of the enhanced PDIS. RESULTS: A total of 12 935 blood donors responded (33·4% response rate). Most donors did not read the entire PDIS - 34·3% less than half and 18·1% none. Of the 10 593 donors who reported reading any of the PDIS, 97·8% recalled instructions about immediate post-donation care (e.g. extra fluids/no exercise) and 88·0% to call with questions/problems. However, only 50·1% remembered reading about what to do if you felt dizzy/faint and 32·4% about care for bruises. Recall rates in every area were similar before and after revision; except after revision, more donors remembered seeing information about maintaining iron and fewer that you should call the centre back with additional health information (P < 0·0001). DISCUSSION: Blood collectors rely heavily on written materials to convey instructions to donors. Most repeat donors do not read the entire PDIS, and many do not recall important information. More donors recalled seeing how to maintain iron with the enhanced PDIS, but recall deficits remained on how to care for adverse reactions. Written materials alone appear to be insufficient to educate some donors about new or updated topics.

Prevalence of human immunodeficiency virus, hepatitis B virus, and hepatitis C virus in United States blood donations, 2015 to 2019: The Transfusion-Transmissible Infections Monitoring System (TTIMS).

BACKGROUND: The Transfusion-Transmissible Infections Monitoring System (TTIMS) combines data from four US blood collection organizations including approximately 60% of all donations to monitor demographic and temporal trends in infectious disease markers and policy impacts. STUDY DESIGN AND METHODS: Human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) consensus-positive definitions combined serology and nucleic acid testing results. These along with donor and donation characteristics were assembled into a single data set. Overall donation prevalence and demographic subsets were compared pre- and post-implementation of the 2015 change in men who have sex with men (MSM) deferral policy, among other prevalence comparisons. RESULTS: From October 2015 to September 2019, there were 712 HIV-, 1735 HBV-, and 5217 HCV-positive samples identified from approximately 27.5 million donations (>9.4 million donors). Prevalences per 100 000 donations were 2.6 (HIV), 6.3 (HBV), and 19.0 (HCV), and the highest for all three agents were in donations from first-time male donors. Two slight but significant increases in HIV prevalence were observed, both for comparisons of Year 1 (pre-MSM policy change) versus Year 4 (post-MSM policy change) for first-time males and first-time females; in contrast, similar comparisons demonstrated decreases in HCV prevalence (all donors and general trends for males and females). Except for HIV, prevalence increased with age; for all agents, prevalence was markedly higher in the south. CONCLUSIONS: No major trends were observed over 4 years covering the MSM policy change from indefinite to a 12-month deferral, but ongoing monitoring is warranted. Demographic trends are consistent with those observed in other donor studies and community trends.

Use of a rapid electronic survey methodology to estimate blood donors' potential exposure to emerging infectious diseases: Application of a statistically representative sampling methodology to assess risk in US blood centers.

Risk assessments of transfusion-transmitted emerging infectious diseases (EIDs) are complicated by the fact that blood donors' demographics and behaviors can be different from the general population. Therefore, when assessing potential blood donor exposure to EIDs, the use of general population characteristics, such as U.S. travel statistics, may invoke uncertainties that result in inaccurate estimates of blood donor exposure. This may, in turn, lead to the creation of donor deferral policies that do not match actual risk. STUDY DESIGN AND METHODS: This article reports on the development of a system to rapidly assess EID risks for a nationally representative portion of the U.S. blood donor population. To assess the effectiveness of this system, a test survey was developed and deployed to a statistically representative sample frame of blood donors from five blood collecting organizations. Donors were directed to an online survey to ascertain their recent travel and potential exposure to Middle East respiratory syndrome coronavirus (MERS-CoV). RESULTS: A total of 7128 responses were received from 54 256 invitations. The age-adjusted estimated total number of blood donors potentially exposed to MERS-CoV was approximately 15 640 blood donors compared to a lower U.S. general population-based estimate of 9610 blood donors. CONCLUSION: The structured donor demographic sample-based data provided an assessment of blood donors' potential exposure to an emerging pathogen that was 63% larger than the U.S. population-based estimate. This illustrates the need for tailored blood donor-based EID risk assessments that provide more specific demographic risk intelligence and can inform appropriate regulatory decision making.

HIV antiretroviral therapy and prevention use in US blood donors: a new blood safety concern.

Antiretroviral therapy (ART) to treat and pre-exposure prophylaxis (PrEP) to prevent HIV infection are effective tools to help end the HIV epidemic. However, their use could affect HIV transfusion-transmission risk. Three different ART/PrEP prevalence analyses in blood donors were conducted. First, blood samples from HIV-positive and a comparison group of infection-nonreactive donors were tested under blind using liquid chromatography-tandem mass spectrometry for ART. Second, blood donor samples from infection-nonreactive, 18- to 45-year-old, male, first-time blood donors in 6 US locations were tested for emtricitabine and tenofovir. Third, in men who have sex with men (MSM) participating in the 2017 Centers for Disease Control and Prevention National HIV Behavioral Surveillance (NHBS) from 5 US cities, self-reported PrEP use proximate to donation was assessed. In blind testing, no ART was detected in 300 infection-nonreactive donor samples, but in 299 HIV confirmed-infected donor samples, 46 (15.4%; 95% confidence interval [CI], 11.5% to 20.0%) had evidence of ART. Of the 1494 samples tested from first-time male donors, 9 (0.6%; 95% CI, 0.03% to 1.1%) had tenofovir and emtricitabine. In the NHBS MSM survey, 27 of 591 respondents (4.8%; 95% CI, 3.2% to 6.9%) reported donating blood in 2016 or 2017 and PrEP use within the same time frame as blood donation. Persons who are HIV positive and taking ART and persons taking PrEP to prevent HIV infection are donating blood. Both situations could lead to increased risk of HIV transfusion transmission if blood screening assays are unable to detect HIV in donations from infected donors.

Screening Blood Donors for HIV, HCV, and HBV at the American Red Cross: 10-Year Trends in Prevalence, Incidence, and Residual Risk, 2007 to 2016.

Prevalence, incidence and residual risk of HIV, HCV and HBV are critical indicators of the safety of the blood supply. The American Red Cross routinely monitors these markers. Herein the results of testing over 58 million donations from 2007 to 2016 are reported. The prevalence and incidence of these infections has declined or remained essentially stable over the 7.5 to 10-year period. In 2015 to 2016, the prevalence of HIV, HCV and HBV were respectively: 1.65, 11.47 and 5.85 per hundred thousand (pht) donations with a significant decrease over the 10-year study only for HCV. Weighted incidence rates for all positives were 1.98 pht person years (py) for HIV, 2.20 pht py for HCV and 1.25 pht py for HBV. Estimates of residual risk using these incidence rates were: HIV, 1:2.3 million; HCV, 1:2.6 million; and HBV, 1:1.5 million donations, reflecting very low risk to recipients. There have been increases in the safety of the blood supply compared to prior published estimates. Demographic factors were shown to be associated with variations in infection prevalence and incidence. Continuing changes in the structure of the donor population or changes in policy could impact these measures of safety.

Variations in hemoglobin measurement and eligibility criteria across blood donation services are associated with differing low-hemoglobin deferral rates: a BEST Collaborative study.

BACKGROUND: Determination of blood donor hemoglobin (Hb) levels is a pre-requisite to ensure donor safety and blood product quality. We aimed to identify Hb measurement practices across blood donation services and to what extent differences associate with low-Hb deferral rates. METHODS: An online survey was performed among Biomedical Excellence for Safer Transfusion (BEST) Collaborative members, extended with published data. Multivariable negative-binomial regression models were built to estimate adjusted associations of minimum donation intervals, Hb cut-offs (high, ≥13.5 g/dL in men or ≥ 12.5 g/dL in women, vs. lower values), iron monitoring (yes/no), providing or prescribing iron supplementation (yes/no), post-versus pre-donation Hb measurement and geographical location (Asian vs. rest), with low-Hb deferral rates. RESULTS: Data were included from 38 blood services. Low-Hb deferral rates varied from 0.11% to 8.81% among men and 0.84% to 31.85% among women. Services with longer minimum donation intervals had significantly lower deferral rates among both women (rate ratio, RR 0.53, 95%CI 0.33-0.84) and men (RR 0.53, 95%CI 0.31-0.90). In women, iron supplementation was associated with lower Hb deferral rates (RR 0.47, 95%CI 0.23-0.94). Finally, being located in Asia was associated with higher low-Hb deferral rates; RR 9.10 (95%CI 3.89-21.27) for women and 6.76 (95%CI 2.45-18.68) for men. CONCLUSION: Differences in Hb measurement and eligibility criteria, particularly longer donation intervals and iron supplementation in women, are associated with variations in low-Hb deferral rates. These insights could help improve both blood donation service efficiency and donor care.

HIV residual risk in Canada under a three-month deferral for men who have sex with men.

BACKGROUND AND OBJECTIVES: In Canada, the deferral for men who have sex with men (MSM) was decreased from a permanent deferral to a 5-year then a 12-month deferral. Current HIV testing can detect an HIV infection in donated blood within 2 weeks of exposure; thus, a 12-month deferral may be unnecessarily restrictive. We aimed to estimate the residual risk of HIV if the deferral were further decreased to 3 months. MATERIALS AND METHODS: Using a deterministic model with stochastic Monte Carlo simulation, residual risk of HIV was the sum of testing error, assay sensitivity and window-period risks. Data inputs were estimated from donor surveillance, donor surveys and published data. Residual risk was modelled at baseline and using three scenarios: (1) most likely - non-compliance, HIV prevalence and incidence rates of MSM are unchanged; (2) optimistic - non-compliance improves by 50%; and (3) pessimistic - non-compliance, HIV prevalence and incidence rates of MSM all double. RESULTS: HIV residual risk at baseline was 1 in 36·0 million donations (95% CI 1 in 1 504 907 million, 10·5 million); in the most likely scenario 1 in 34·2 million (1 in 225 534 million, 8·7 million); in the optimistic scenario 1 in 36·0 million (1 in 282 618 million, 9·5 million); in the pessimistic scenario 1 in 16·7 million (1 in 39 469 million, 6·0 million). All confidence intervals overlapped. CONCLUSION: With very low modelled risk under a 12-month deferral, the additional risk with a 3-month deferral is very low. This is true even with a pessimistic scenario.

Changing the deferral for men who have sex with men - an improved model to estimate HIV residual risk.

BACKGROUND AND OBJECTIVES: Eight published studies modelled the impact of changing from a lifetime to time-limited deferral for men who have sex with men (MSM); each predicted greater risk impact than has been observed. This study uses these previous efforts to develop an 'optimized' model to inform future changes to MSM deferrals. MATERIALS AND METHODS: HIV residual risk was calculated using observed HIV incidence/prevalence prior to the change in MSM deferral, then with the additional MSM expected under a 12-month deferral for five compliance scenarios, and finally using data observed after implementation of the deferral. Monte Carlo simulation calculated 95% confidence intervals (CI). RESULTS: The architecture of reviewed models was sound, and two were selected for combination into the optimized model. HIV risk estimated by this in the UK under MSM lifetime deferral was 0·102 (95% CI: 0·050-0·172) per million. The model predicted from a 27·8% decrease to a 47·6% increase depending upon compliance pre-implementation of the 12-month deferral. A decrease of 0·9% was observed post-implementation. For Canada, HIV risk under a 5-year deferral was 0·050 (95% CI: 0·00003-0·122) per million. Pre-implementation of the 12-month deferral, the model predicted from 30·2% decrease to 10-fold increase. A decrease of 47·0% was observed after implementation. CONCLUSION: The optimized model predicted HIV risk under 12-month MSM deferral in UK and Canada would remain low, and this was confirmed post-implementation. While the model is adaptable to other deferral scenarios, improved data quality would improve precision, particularly estimates of incidence in individuals likely to donate.

Malaria blood safety policy in five non-endemic countries: a retrospective comparison through the lens of the ABO risk-based decision-making framework.

BACKGROUND: In non-endemic countries, malaria risk is addressed by selectively testing or deferring at-risk donors. These policy decisions were made using a variety of decision-making frameworks prior to the development of the Alliance of Blood Operators Risk Based Decision-Making Framework. It is unclear whether the range of items assessed in the decision-making process would be increased if the Framework were used. We compared assessments considered in France, England and Australia for decisions to implement selective testing, plus donor selection criteria (Canada and the USA included) with those recommended by the Framework. MATERIALS AND METHODS: Elements of the Framework were identified: the intervention, safety threat, availability threat, donor impact, financial implications, risk communication, stakeholder and regulatory aspects. Decisions about selective testing and donor selection criteria were analysed separately. Assessments were compared against elements of the Framework and the level of concern for considerations rated. RESULTS: Sufficiency of the blood supply (plus safety in France) were the drivers for selective testing; main trade-offs were high operational impact and cost. In three donor criteria examples, transfusion-transmitted malaria cases prompted the change. Social concerns were high in France and Australia, political/regulatory concerns influenced decisions in France, Australia and Canada, while sufficiency was a consideration in Canada and the USA. Decision trade-offs involved moderate operational impact. DISCUSSION: The assessments considered in each country were generally consistent with the assessments recommended by the Framework. When data supported quantified risk assessment, safety and operational feasibility had the greatest weight. When risk was not well defined, contextual factors such as social and political concern had greater weight.

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.

BACKGROUND: Some countries impose an upper age limit on whole blood and double RBC donation while others do not. We evaluated the safety of blood donation in older individuals (≥71 years), and their contribution to the blood supply of five countries. STUDY DESIGN AND METHODS: Twelve blood center members of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative from four countries with no upper age limit for whole blood and double RBC donation (Canada, New Zealand, England, and the United States) or an upper age limit of 80 (Australia) provided 2016 data on donors and donations, deferral rates, and vasovagal reactions by donor age and sex. Donors under age 24 were included in the number of total donors and donations, but not in deferral and reaction rate comparisons. RESULTS: Older donors accounted for 1.0% (New Zealand) to 4.3% (United States) of donors, and 1.5% (New Zealand) to 5.6% (United States) of donations; most were between ages 71 and 76. The deferral rate was higher in older compared to 24- to 70-year-old males, but very similar between older and younger females. In contrast, vasovagal reaction rates were either lower (male donors) or similar (female donor for reactions with loss of consciousness) in older compared to 24- to 70-year-old donors. CONCLUSIONS: Exclusion solely based on older age appears to be unwarranted based on safety concerns such as donor reactions. Healthy older individuals can continue to safely donate and make a significant contribution to the blood supply past arbitrary age limits.

Comparison of donor and general population demographics over time: a BEST Collaborative group study.

BACKGROUND: We compared donor and general population demographics over time to provide insight into current donation patterns and the future adequacy of the blood supply. STUDY DESIGN AND METHODS: Seventeen blood center members of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative from 12 countries provided the number of donors and people in the general population by demographic category for 2001 and 2011, changes in age criteria, and percentage of first-time donors. We calculated the median age of donors and the general population and determined the percentage of each group in age and sex cohorts. RESULTS: Age criteria vary, with upper limits recently liberalized in several countries. In 2011, the percentage of first-time donors ranged from 10% to 41%. The median age of the donor and general population increased from 2001 to 2011 in most countries, as did the percentage of the general population over 60. The youngest donor cohort is overrepresented to a variable degree; this tendency increased over time. Although still underrepresented, older donors contributed more in 2011. A large middle-aged cohort is aging at a rate exceeding the progression of time, while 25- to 45-year-olds are relatively underrepresented. CONCLUSIONS: All participating countries are experiencing aging of their general population. Donor demographics differ substantially between countries; this can be only partly explained by population demographics and age criteria. Many countries have an aging middle-aged donor and population cohort and are increasingly relying on their youngest donors to contribute disproportionately to the blood supply.

Quantification of body iron and iron absorption in the REDS-II Donor Iron Status Evaluation (RISE) study.

BACKGROUND: Repeated blood donation alters the iron balance of blood donors. We quantified these effects by analyzing changes in body iron as well as calculating iron absorbed per day for donors enrolled in a prospective study. STUDY DESIGN AND METHODS: For 1308 donors who completed a final study visit, we calculated total body iron at the enrollment and final visits and the change in total body iron over the course of the study. Taking into account iron lost from blood donations during the study and obligate losses, we also calculated the average amount of iron absorbed per day. RESULTS: First-time/reactivated donors at enrollment had iron stores comparable to previous general population estimates. Repeat donors had greater donation intensity and greater mean iron losses than first-time/reactivated donors, yet they had little change in total body iron over the study period, whereas first-time/reactivated donors had an average 35% drop. There was higher estimated iron absorption in the repeat donors (men: 4.49 mg/day [95% confidence interval [CI], 4.41-4.58 mg/day]; women: 3.75 mg/day [95% CI, 3.67-3.84 mg/day]) compared with estimated iron absorption in first-time/reactivated donors (men: 2.89 mg/day [95% CI, 2.75-3.04 mg/day]; women: 2.76 mg/day [95% CI, 2.64-2.87 mg/day]). The threshold for negative estimated iron stores (below "0" mg/kg stores) was correlated with the development of anemia at a plasma ferritin value of 10 ng/mL. CONCLUSIONS: These analyses provide quantitative data on changes in estimated total body iron for a broad spectrum of blood donors. In contrast to using ferritin alone, this model allows assessment of the iron content of red blood cells and the degree of both iron surplus and depletion over time.