Neighborhood ethnic density and disparities in proximal blood donation opportunities.

BACKGROUND: Despite being the largest racial/ethnic minority group in the United States, Hispanic/Latinos (H/L) are significantly underrepresented among blood donors. A lack of proximal blood donation opportunities may be one factor contributing to these disparities. However, few studies have investigated this possibility. STUDY DESIGN AND METHODS: Proprietary data on mobile blood collections in Maricopa County, Arizona, were gathered for the period of January 01, 2022 to April 30, 2022 and paired with census tract information using ArcGIS. Maricopa County encompasses the city of Phoenix with a total population of approximately 4.5 million people, including 1.5 million H/L residents. Blood drive count was regressed on H/L ethnic density and total population, and model estimates were exponentiated to obtain odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: During the specified period, approximately 27,000 red blood cell units were collected through mobile drives. Consistent with expectations, when controlling for total neighborhood population, each 10% increase in H/L ethnic density lowered the odds of having a blood drive in the corresponding neighborhood by 12% (OR = 0.88, 95% CI (0.83, 0.92), p < .001). DISCUSSION: These findings provide initial evidence of fewer proximal donation opportunities in areas with greater H/L population density which may contribute to H/L underrepresentation in blood donation and the need for more inclusive collection efforts. Improved access to blood collection is modifiable and could help to increase the overall blood supply, enhance the ability to successfully match specific blood antigen needs of an increasingly diverse population, and bring about a more resilient blood system.

Evidence of likely autochthonous Chagas disease in the southwestern United States: A case series of Trypanosoma cruzi seropositive blood donors.

BACKGROUND: Chagas disease is a parasitic infection that can insidiously cause non-ischemic cardiomyopathy. Given the largely silent nature of this progressive disease, asymptomatic blood donors pose potential blood transfusion risk. Blood donation screening has become an unintentional form of Chagas disease surveillance, with thousands of new cases identified since national surveillance was initiated in 2007. STUDY DESIGN AND METHODS: We recruited T. cruzi-positive blood donors identified from California and Arizona blood centers for confirmatory blood screening and assessment of lifetime infection risk. RESULTS: Among eight suspected cases, we identified four confirmed US autochthonous infections. The current manuscript details the transmission sources, healthcare-seeking behaviors post-blood donation resulting, and clinical course of disease among persons without any history of travel to endemic Latin American countries. DISCUSSION: This manuscript presents four additional US-acquired Chagas disease cases and identifies an opportunity for blood centers to assist in confronting barriers surrounding Chagas disease in the US.

The international experience of bacterial screen testing of platelet components with automated microbial detection systems: An update.

In 2014, the bacterial subgroup of the Transfusion-Transmitted Infectious Diseases working party of ISBT published a review on the International Experience of Bacterial Screen Testing of Platelet Components (PCs) with an Automated Microbial Detection System. The purpose of this review, which is focused on publications on or after 2014, is to summarize recent experiences related to bacterial contamination of PCs and the use of an automated culture method to safeguard the blood supply. We first reviewed septic transfusion reactions after PC transfusion as reported in national haemovigilance systems along with a few reports from various countries on bacterial contamination of blood products. Next, we reviewed PC automated culture protocols employed by national blood services in the United Kingdom, Australia, Canada and large blood collection organization and hospital transfusion services in the United States. Then, we acknowledged the limitations of currently available culture methodologies in abating the risks of transfusion-transmitted bacterial infection, through a review of case reports. This review was neither meant to be critical of the literature reviewed nor meant to identify or recommend a best practice. We concluded that significant risk reduction can be achieved by one or a combination of more than one strategy. No one approach is feasible for all institutions worldwide. In selecting strategies, institutions should consider the possible impact on platelet components availability and entertain a risk-based decision-making approach that accounts for operational, logistical and financial factors.

Pandemic blood donor demographics - Do changes impact blood safety?

BACKGROUND: COVID-19 safety measures and possibly SARS-CoV-2 antibody testing may alter blood donor demography, which has the potential to alter blood safety. We characterized pre-pandemic and pandemic rates of donor infectious disease marker (IDM) reactivity which reflect the residual risk of transfusion-transmitted infections (TTIs) undetectable by current testing. METHODS: This cross-sectional analysis of allogeneic blood donor presentations and successful donations in a large national US blood collector identifies changes in self-reported behavioral risk factors and IDM reactivity. Data on allogeneic blood donor presentations and successful donations from March 1 through August 31, 2020 and the same period in 2019 were retrieved from the blood center's computer system. Donor demographics and deferrals for reported behavioral risk factors and confirmed-positive IDMs were compared in pre-pandemic and pandemic periods. RESULTS: With increasing mobile blood drive cancellations, pandemic donors were more likely than 2019 donors to be female, over age 30, non-Hispanic Whites, and have a post-secondary degree. First-time donations (at highest risk for confirmed-positive IDMs) did not substantially increase. Pandemic donors reported fewer behavioral risks and IDMs declined among these donors. Mid-pandemic introduction of screening for SARS-CoV-2 antibodies did not affect IDM rates. CONCLUSIONS: Unlike disasters, which tend to bring out more first-time donors with increased IDM reactivity and TTI residual risk, COVID-19 donors had lower IDM rates which were not affected by SARS-CoV-2 antibody testing. Already-low TTI residual risk is likely to have declined as a result.

The safety of COVID-19 convalescent plasma donation: A multi-institutional donor hemovigilance study.

BACKGROUND: Although the safety and therapeutic efficacy of COVID-19 convalescent plasma (CCP) has been extensively evaluated, the safety of CCP donation has not been explored in a multi-institutional context. STUDY DESIGN AND METHODS: Nine blood collection organizations (BCOs) participated in a multi-institutional donor hemovigilance effort to assess the safety of CCP donation. Donor adverse events (DAEs) were defined according to the Standard for Surveillance of Complications Related to Blood Donation, and severity was assessed using the severity grading tool. Multivariate analysis was performed to determine attributes associated with DAE severity. RESULTS: The overall DAE rate was 37.7 per 1000 donations. Repeat apheresis and apheresis-naïve donors experienced adverse event rates of 19.9 and 49.8 per 1000 donations, respectively. Female donors contributed 51.9% of CCP donations with a DAE rate of 49.4 per 1000 donations. The DAE rate for male donors was 27.4 per 1000 donations. Vasovagal reactions accounted for over half of all reported DAEs (51.1%). After adjustment, volume of CCP donated was associated with vasovagal reaction severity (odds ratio [OR] 6.5, 95% confidence interval [CI] 2.5-17.1). Donor age and donation history were also associated with DAE severity. Considerable differences in DAE types and rates were observed across the participating BCOs despite the use of standardized hemovigilance definitions. CONCLUSION: The safety of CCP donation appears comparable to that of conventional apheresis plasma donation with similar associated risk factors for DAE types and severity.

Characterization of health issues in young first-time blood donors.

BACKGROUND AND OBJECTIVES: Blood donors, especially young donors, are considered a healthy segment of the population. We sought to identify medical issues that may warrant medical referral in young first-time blood donors. MATERIALS AND METHODS: A retrospective cohort study was performed in first-time donors ages 16-22 who presented in a system of nineteen regional United States blood centres over 10 years. Donor health attributes characterized include body mass index, blood pressure, total cholesterol and pre-donation haemoglobin. Using standardized definitions, overweight and obese body mass, hypertension, elevated cholesterol and anaemia were identified and characterized in this donor population. RESULTS: Among 825 041 young first-time donors presenting between January 2009 and December 2018, with available measurements, 46·9% were either overweight or obese, 59·8% demonstrated high blood pressure (22·2% elevated blood pressure, 37·6% stage 1 or 2 hypertension), elevated cholesterol was identified among 6·3% of males and 8·8% of females, and anaemia was present in 3·5% of males and 5·2% of females. During the study period, all unfavourable health outcomes significantly increased in prevalence (P < 0·0001) when comparing 2009 vs. 2018 rates. CONCLUSION: Elevated weight and obesity are common in young first-time allogeneic United States blood donors, with fewer donors having elevated total cholesterol or anaemia. Such medical issues may have significant importance for future health and well-being as well as continued donor eligibility. Blood centres may be able to help support the identification and mitigation of important medical issues in donors and provide a public health benefit.

An international comparison of HIV prevalence and incidence in blood donors and general population: a BEST Collaborative study.

BACKGROUND AND OBJECTIVES: Efficiency in mitigating HIV transmission risk by transfusion may vary internationally. We compared HIV prevalence and incidence in blood donors across different jurisdictions in relation to those rates in the general population and differences in deferral practices. MATERIALS AND METHODS: Data from 2007 to 2016 were collected in Australia, Brazil (São Paulo), Canada, England, France, Italy, Ireland, Japan, the Netherlands, New Zealand, Norway, Spain (Basque Country), USA (Vitalant) and Wales. For each country/region, the number of HIV antibody-positive donations and nucleic acid testing (NAT)-only-positive donations was broken down according to first-time or repeat donor status, along with the relevant denominators. RESULTS: There is a modest correlation between HIV prevalence among first-time donors and HIV prevalence in the general population. However, rates of HIV-positive donations in repeat donors, a proxy for incidence, do not correlate with incidence rates in the general population. Rates in donors from Italy and Basque Country, where deferral criteria for men having sex with men are less stringent, are higher compared with most other jurisdictions. Rates of NAT-only-positive donations are extremely low and do not differ significantly after adjustment for multiple comparisons. CONCLUSION: Donor HIV rates are only weakly associated with those observed in the general population. Countries with less stringent deferral criteria have higher HIV rates in their donor population, but the rates remain very low.

The prevalence and demographic determinants of blood donors receiving testosterone replacement therapy at a large USA blood service organization.

BACKGROUND: Blood donors receiving testosterone replacement therapy (TRT) often require therapeutic phlebotomy due to erythrocytosis. Red blood cells (RBCs) donated by eligible TRT donors are approved for collection and transfusion. This study was aimed at defining the prevalence and demographic determinants of TRT donors at a large USA blood service organization. STUDY DESIGN: Donation data from TRT donors and matched controls was collected from a de-identified electronic donor database across 16 blood centers in 2017-2018. Demographic determinants included race, sex, age, hemoglobin (Hb), body mass index (BMI), mean arterial pressure (MAP), and the frequency of donations in the 2-year period. RESULTS: TRT donors comprised 1.6% of the donor population and produced 2.2% of RBC units during 2018. TRT donors were likely to be middle-aged white or Hispanic men, with high prevalence of obesity (50.8% of TRT donors had BMI ≥30 kg/m2 compared with 36.2% in controls) and intensive donation frequency (1 to 29 donations in 2 years vs. 1 to 12 in controls). TRT donors had significantly (p < 0.0001) higher MAP and Hb compared with controls (MAP 99.9 ± 9.81 vs. 96.5 ± 10.1 mmHg; Hb 17.8 ± 1.44 vs. 15.6 ± 1.37 g/dL). One year of donations was associated with significant decreases in MAP and Hb for TRT donors. CONCLUSIONS: TRT is associated with high prevalence of erythrocytosis and obesity that may explain the intensive donation frequency, high MAP, and Hb. Frequent phlebotomies had a moderately positive effect on blood pressure and Hb levels. Potential implications of TRT on the quality of the RBC products require further evaluation.

Development and validation of donor adverse reaction severity grading tool: enhancing objective grade assignment to donor adverse events.

BACKGROUND: Uniform and consistent reporting and comparison of donor adverse events (DAEs) and severity are well-recognized challenges for donor hemovigilance (DHV). While the 2014 Standard for Surveillance of Complications Related to Blood Donation (SSCRBD), developed by hemovigilance experts from AABB, the International Society of Blood Transfusion, and International Hemovigilance Network, established the DAE definitions, no specific guidelines were provided to grade severity. A group of subject matter experts developed the Severity Grading Tool for Blood Donor Adverse Events (SGT) to enhance objective assignment of severity and conducted a study to validate the tool. STUDY DESIGN AND METHODS: Between January 8, 2019, and February 28, 2019, participants graded severity of 32 cases (34 DAEs) using the SGT. Comments boxes allowed participants to provide rationale for selecting a severity grade for each case. Agreement with expert grading among study participants was evaluated using percentage agreement. Inter-rater reliability was evaluated by Kendall's coefficient of concordance (W). The final SGT was revised based on validation study results and feedback received. RESULTS: The overall agreement was almost perfect with W = 0.84 (confidence interval [CI], 0.78-0.90). Of 34 DAEs, respondent agreement with expert grading of more than 90% was reached for 18 DAEs, 80% to 90% for six DAEs, 70% to 80% for six DAEs, and less than 70% for four DAEs. CONCLUSION: The development and validation of a uniform SGT with objective criteria for assigning severity of DAEs used together with standard reaction definitions will provide opportunities for comparison between blood centers and systems to enhance the field of DHV.

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.

The impact of age and sex on first-time donor return behavior.

BACKGROUND: This study examined the impact of age and sex of first-time donors who had not experienced an adverse event or deferral on their likelihood of and time to return. STUDY DESIGN AND METHODS: On behalf of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative, international blood collection agencies (BCAs) were invited to provide data on first-time whole blood donors in 2014, including initial presentation date, collection site type, age, sex, blood type, return to donate within 24 months (yes/no), and subsequent presentation date. RESULTS: Eight BCAs contributed 706,789 records. The overall odds of returning to donate were slightly lower in female versus male donors, and the overall age trend was U-shaped with younger and older donors having higher odds for returning relative to middle-aged donors. However, variations by BCA were observed. Specifically, in three BCAs, women had higher odds of returning to donate than men. Further, while across seven BCAs the smallest cohort of older first-time donors returned at a higher rate and returned more quickly than middle-aged first-time donors, the behavior of younger donors varied substantially between BCAs. CONCLUSION: While older first-time donors are more likely to return and return more quickly than middle-aged donors they make up only a small proportion of first-time donors, whereas the larger group of younger donors exhibits less clear patterns of return compared to middle-aged donors. Further research is needed to determine whether targeting the recruitment of older donors or bolstering retention of middle-aged donors would be most effective in maintaining the blood supply.

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.

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.

Ferritin testing to characterize and address iron deficiency in young donors.

BACKGROUND: Iron deficiency is observed in blood donors who meet hemoglobin requirements for donation. Frequent donation results in negative iron balance, and teenage donors may thus be at risk for adverse health consequences. STUDY DESIGN AND METHODS: Blood Systems implemented ferritin testing on all successful 16- to 18-year-old (teen) donations. Low ferritin (LF) was defined as less than 20 ng/mL in females and less than 30 ng/mL in males. Donors with LF were deferred from red blood cell (RBC) donations (12 months for females, and 6 for males) and counseled to take low-dose iron for 60 days. A ferritin value less than 26 ng/mL indicated iron-deficient erythropoiesis and less than 12 ng/mL absent iron stores. RESULTS: Over 16 months, 110,417 teen donations were tested and represented 10.5% of all successful donations. The rate of absent iron stores was 9.0% (1.9% male; 15.9% female) and of iron-deficient erythropoiesis, 31.9% (12.4% male; 50.6% female). The rate of LF deferrals was 26.9% (16.7% male; 36.6% female). The proportion of LF donors decreased with increasing predonation hemoglobin and rose with increasing RBC donations in the prior 24 months. Seasonality in LF deferrals and the RBC contribution from teen donors was observed. CONCLUSIONS: Ferritin testing of teen donors identified individuals with LF who might benefit from risk mitigation. LF is more common in teenage female than male donors and those with RBC donations in the prior 24 months. An appreciable number of new/lapsed donors presented with LF, however. These data may be useful in guiding future risk mitigation efforts.

Changes in plasma unit distributions to hospitals over a 10-year period.

BACKGROUND: There are many influences on a hospital's demand for plasma. Pharmaceuticals are now being administered for many indications instead of plasma, although trauma resuscitation now emphasizes increased and early intervention with plasma. This multinational study evaluated changes in blood center plasma unit distributions over a 10-year period. STUDY DESIGN AND METHODS: Data on the total number and the ABO groups of plasma unit distributions were obtained from nine American blood collectors (ABCs) and nine national or provincial blood services (NPBS) from 2007 through 2016. Plasma distributions to trauma hospitals by five ABCs and four NPBS were also analyzed. RESULTS: The overall number of plasma unit distributions from ABCs decreased by 23.1% from 2007 to 2016, but the relative proportion of distributed AB plasma units increased during the same period. The NPBS (excluding the Japanese Red Cross [JRC]) also had a 35.4% decrease in the overall number of plasma unit distributions with an increase in the relative proportion of AB plasma distributions between 2007 and 2016. The JRC, however, reported an increase in the overall number of plasma distributions by 13.5% in 2016 compared to 2007. The proportion of low-titer A plasma distributions increased to 1.6% of total plasma distributions by ABCs in 2016. There was a trend of distributing increasing proportions of group AB plasma units to trauma hospitals over the 10-year period. CONCLUSION: Although the number of plasma unit distributions has decreased at many blood collectors over time, the proportion of AB units has increased at both ABCs and NPBS.

The effect of uterine artery ligation in patients with central placenta pevia: a randomized controlled trial.

BACKGROUND: Placenta previa is major obstetric surgical risk as it is associated with higher percentage of intraoperative and postpartum hemorrhage (PPH), increased requirement of blood transfusion and further surgical procedures. The current study aimed to evaluate uterine artery ligation prior to uterine incision as a procedure to minimize blood loss during cesarean section in patients with central placenta previa. METHODS: One hundred and four patients diagnosed with central placenta previa antenatally and planned to have elective caesarean section were recruited from the antenatal clinic at Minia Maternity University hospital. Patients were randomly allocated into either ligation group or control group. RESULTS: Both groups were similar regarding demographic features and preoperative risk factors for bleeding. The intraoperative blood loss was significantly lower in the ligation group as compared with the control group (569.3 ± 202.1 mL vs. 805.1 ± 224.5 mL respectively, p = 0.002). There was a significant increase in the requirement for blood transfusion in the control group as compared with the ligation group (786 ± 83 mL vs. 755 ± 56 mL respectively, p = 0.03) Three cases in the control group required further surgical interventions to control intraoperative bleeding, while no cases in the ligation required further surgical techniques and that was statistically significant (p = 0.001). CONCLUSION: Uterine artery ligation prior to uterine incision may be a helpful procedure to minimize intraoperative and postpartum blood loss in cases with central placenta previa. TRIAL REGISTRATION: Retrospectively registered in ClinicalTrials.gov Identifier: NCT02002026 - December 8, 2013.

Improved yield of minimal proportional sample volume platelet bacterial culture.

BACKGROUND: Reports of septic transfusion reactions (STRs) after transfusion of culture-negative platelets (PLTs) justify more effective prevention strategies. Pathogen reduction technologies or performance of additional point-of-issue testing are proposed strategies to enhance safety through Day 5 of storage. STUDY DESIGN AND METHODS: Trima leukoreduced apheresis PLTs (APs) were collected during two study periods (45 and 31 months) using standard procedures, with target settings adjusted during the second period to maintain split rate after increased culture volume. Primary testing for bacterial contamination was performed using BacT/ALERT 3D with sampling from the mother bag 24 to 36 hours after collection. Two culture approaches were compared: in Period A, an 8-mL sample in one aerobic culture bottle (CB), and in Period B a minimal proportional sample volume (PSV) of at least 3.8% of mother bag volume into one to three aerobic CBs (7-10 mL per bottle). RESULTS: In Periods A and B, 188,389 and 159,098 AP collections were tested, respectively. The true-positive (TP) rate in Period A was 0.90 per 10,000 collections and in Period B was 1.83 per 10,000 (p < 0.05). In Period B, 12 of 29 (41%) TP results had discrepant CB results (DCBRs; at least one of multiple bottles without growth). The false-positive rate in Period B, 15.05 per 10,000 collections, was significantly higher than that of Period A, 3.66 per 10,000. One contaminated collection resulting in STR(s) was reported in each study period. Implementation of PSV was operationally successful and did not impact the AP split rate. CONCLUSION: Proportional sample volume improved the sensitivity of primary testing and identified collections that could have escaped detection had only a single bottle with 8- to 10-mL volume been used. PSV may represent another approach to enhanced PLT safety for 5-day storage without a requirement for secondary testing.