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Blood transfusion begins with safe donor selection and testing. In the United States, the blood supply and transfusion are highly regulated. Blood transfusion safety is multifaceted, whereby each of the elements of the blood safety value chain, spanning donor recruitment and qualification, to collection, blood processing, testing, transfusion practice, and posttransfusion surveillance, must be optimized to minimize risk. Pathogen inactivation is a promising approach to decrease bacterial contamination of platelets, inactivate parasites and viruses, and decrease risks associated with emerging and unidentified pathogens. This article offers an overview of blood donor infectious and noninfectious testing in the United States.

Blood transfusions are among the most common therapeutic procedures performed in hospitalized patients. This study evaluates contemporary national trends in red blood cell (RBC), plasma, platelet, and cryoprecipitate transfusions. National Inpatient Sample, the largest all-payer inpatient database representing 94% to 97% of the US population, was evaluated from the fourth quarter (Q4) of 2015 through 2018. Quarterly trends for the percentage of hospitalizations with a transfusion procedure were separately examined for each blood product using log binomial regression and reported as quarterly percent change (QPC). The percentage of hospitalizations with an RBC transfusion decreased from 4.22% (2015Q4) to 3.79% (2018Q4) (QPC = −0.72; 95% confidence interval [CI], −1.26 to −0.19; Ptrend = .008). Although plasma transfusions also decreased, QPC = −1.33 (95% CI, −2.00 to −0.65; Ptrend < .001), platelet transfusions remained stable QPC = −0.13 (95% CI, −0.99 to 0.73; Ptrend = .766). In contrast, hospitalizations with cryoprecipitate utilization significantly increased QPC = 2.01 (95% CI, 0.57 to 3.44; Ptrend = .006). Significant quarterly reductions in RBC transfusions were also seen among many, but not all, strata of sex, race/ethnicity, patient risk severity, and admission type (elective vs nonelective). Despite significant declines in RBC transfusions among older adults, there were no significant changes among pediatric age-group (

Background Adults with sickle cell disease (SCD) on chronic transfusion therapy are exposed to a large volume of blood products, thus increasing their risk of transfusion-associated human immunodeficiency virus (HIV), hepatitis C (HCV), and hepatitis B (HBV). Methods We performed a systematic chart review of chronically transfused SCD subjects at the Johns Hopkins Sickle Cell Center for Adults between October 2014 and September 2019 to determine our Center's adherence to the 2014 National Heart, Lung and Blood Institute (NHLBI) SCD guidelines for annual screening for Transfusion Transmitted infections (TTI) and assessed HBV immunity and HBV vaccination rates. Results The study included 85 subjects with a median age of 34 years (23-63); 52% were female. No subject received annual screening; 68 subjects (80%) were screened for HIV, 60 subjects (71%) for HCV and 53 subjects (62%) for HBV infections at least once in the study period. Of those screened, one patient was newly diagnosed with HCV infection, and none with HIV or HBV infection. Among 31 subjects tested for anti-Hepatitis B surface antibody, 16 subjects (52%) tested negative. Nineteen (20%) subjects had HBV vaccination documented. Conclusions Low adherence to the NHLBI TTI screening guidelines, especially for HBV, highlights the resource intensiveness of this patient population. The low rates of anti-Hepatitis B surface antibody positivity highlight the need to confirm vaccination, provide boosters as indicated, and investigate the adults with SCD's immune response to HBV vaccination.

BACKGROUND: The United States (US) leads all high-income countries in gunshot wound (GSW) deaths. However, previous US studies have not evaluated the national blood transfusion utilization patterns in hospitalized GSW patients. METHODS: Data from 2016 to 2017 were analyzed from the Nationwide Emergency Department Sample (NEDS) and Nationwide Inpatient Sample (NIS), the largest all-payer emergency department (ED) and inpatient databases, respectively. Using stratified probability sampling, weights were applied to generate nationally representative estimates. Multivariable Poisson-regression models were used to estimate prevalence ratios (PR) of blood transfusion. RESULTS: There were 168,315 ED visits and 58,815 hospitalizations (age = 18–90 years) following a GSW. The majority of hospitalizations were men (88.5%), age 18–24 years (31.8%), and assault-related GSW (51.3%). Blacks had the largest proportion (48.7%) overall of all GSW hospitalizations; Whites accounted for the highest proportion of intentional self-harm injuries (72.4%). Blood transfusions occurred in 12.7% of hospitalizations (12.0% red blood cell [RBC], 4.9% plasma, and 2.5% platelet transfusions). Only 1.9% of cases were associated with transfusion of all three blood components. Hospitalizations with major/extreme severity of illness had significantly higher prevalence of transfusion versus those with mild/moderate severity [crude PR = 4.79 (95% CI:4.15–5.33, p < .001)]. Overall, 8.2% of hospitalizations with GSW died, of whom 26.8% required blood transfusions, which was significantly higher than survivors [crude PR = 2.34 (95%CI:2.10–2.61, p < .001)]. The vast majority (95%) of the transfusions among those who died were within 48 h since admission. CONCLUSIONS: Gun-related violence is a public health emergency in the US, and GSWs are a source of significant mortality, blood utilization, and health care costs.

BACKGROUND AND OBJECTIVES Chagas disease, caused by Trypanosoma cruzi, is endemic to Mexico, Central and South America. While initially limited to the Americas, emigration of infected persons triggered geographically broader blood safety challenges. To mitigate transfusion-transmitted Chagas (TTC), transfusion services implemented approaches including risk factor questions and serologic testing. We sought to understand and compare strategies in non-endemic countries. MATERIALS AND METHODS Transfusion services in International Society of Blood Transfusion (ISBT)-affiliated organizations and members of the ISBT Working Party on Transfusion-Transmitted Infectious Diseases were invited to complete an online survey on T. cruzi mitigation strategies. The survey queried about cases of TTC, risk factors, testing methodology, educational materials, pathogen reduction, donor/product management, donor deferral and perceived public health concerns surrounding TTC. RESULTS Responses were received from 27 institutions in 22 countries. Most countries (77.3%) reported no historical TTC cases, while 18.2% reported 1-5 cases and 4.5% reported 6-10 cases. Concern about Chagas among the general public and public health authorities was low, but 12 of 25 blood centres reported moderate/high concern. Overall, 17 countries mitigated for TTC: 15 used risk factor questions and 10tested for T. cruzi antibodies. Ten countries used pathogen reduction but not specifically to prevent TTC. CONCLUSION While Chagas is rarely cited as a public health concern, blood centres in many non-endemic countries, including those outside the Americas, implemented measures to mitigate risk. Mitigation focussed on risk factors associated with Latin American immigrants and serologic testing. Thus, despite the rarity of TTC, many non-endemic countries continue to address it as an ongoing blood safety risk.

AimsWhile the SARS-CoV-2 pandemic may be contained through vaccination, transfusion of convalescent plasma (CCP) from individuals who recovered from COVID-19 (CCP) is considered an alternative treatment. We investigate if CCP transfusion in patients with severe respiratory failure increases plasma titres of SARS-CoV-2 antibodies and improves clinical outcomes.MethodsPatients with COVID-19 (n=34) were consented for CCP transfusion and serial blood draws pretransfusion and post-transfusion. Plasma SARS-CoV-2 antireceptor binding domain (RBD) IgG and IgM titres were measured by ELISA serially, and compared with serial plasma titre levels from control patients (n=68). The primary outcome was survival at 30 days, and secondary outcomes were length of ventilator and/or extracorporeal membrane oxygenation (ECMO) support, length of stay (LOS) in the hospital and in the intensive care unit (ICU). Outcomes were compared with matched control patients (n=34). Kinetics of antibodies and clinical outcomes were compared using LOess regression and ORs, respectively.ResultsPrior to CCP transfusion, 74% of patients were anti-RBD seropositive for IgG (median 1:3200), and 81% were anti-RBD IgM seropositive (median 1:320), while 16% were seronegative. The kinetics of antibody titres in CCP recipients were similar to controls. CCP recipients presented with similar survival, duration on ventilatory and/or ECMO support, as well as ICU and hospital LOS compared with controls.ConclusionsCCP transfusion did not increase the kinetics of SARS-CoV2 antibodies and did not result in improved clinical outcomes in patients with COVID-19 with severe respiratory failure, suggesting that CCP may not be indicated in this category of patients.

ObjectiveAntenatal anaemia is associated with increased peripartum transfusion requirement in South Africa. We studied whether HIV was associated with the response to treatment of iron-deficiency anaemia.DesignProspective cohort study.SettingHospital-based antenatal anaemia clinic in South Africa.SampleEqual-sized cohorts of pregnant women testing positive for HIV (HIV+) and testing negative for HIV (HIV-) with iron-deficiency anaemia.MethodsHaemoglobin trajectories of women with confirmed iron-deficiency anaemia (ferritin&nbsp

Background and objectives Use of convalescent plasma for coronavirus disease 2019 (COVID-19) treatment has gained interest worldwide. However, there is lack of evidence on its dosing, safety and effectiveness. Until data from clinical studies are available to provide solid evidence for worldwide applicable guidelines, there is a need to provide guidance to the transfusion community and researchers on this emergent therapeutic option. This paper aims to identify existing key gaps in current knowledge in the clinical application of COVID-19 convalescent plasma (CCP). Materials and methods The International Society of Blood Transfusion (ISBT) initiated a multidisciplinary working group with worldwide representation from all six continents with the aim of reviewing existing practices on CCP use from donor, product and patient perspectives. A subgroup of clinical transfusion professionals was formed to draft a document for CCP clinical application to identify the gaps in knowledge in existing literature. Results Gaps in knowledge were identified in the following main domains: study design, patient eligibility, CCP dose, frequency and timing of CCP administration, parameters to assess response to CCP treatment and long-term outcome, adverse events and CCP application in less-resourced countries as well as in paediatrics and neonates. Conclusion This paper outlines a framework of gaps in the knowledge of clinical deployment of CPP that were identified as being most relevant. Studies to address the identified gaps are required to provide better evidence on the effectiveness and safety of CCP use.

A cluster-randomized clinical trial showed that biannual single-dose azithromycin reduced mortality in preschool children; we sought to determine the effect on anemia. A simple random sample of 30 communities from Kilosa district, Tanzania, were themselves randomized to receive either 6-monthly treatment of children aged 1–59 months with single-dose azithromycin or placebo. From each community, 40 preschool children were randomly selected at baseline, 12 months, and 24 months. At surveys, the children underwent hemoglobin testing; WHO definitions for anemia were applied. After adjusting for community clustering, the prevalence of anemia was not significantly different by treatment assignment at baseline, 12 months, and 24 months. In each of the cross-sectional surveys, anemia prevalence was associated with younger age; the odds of being anemic was highest in those aged < 12 months. There was also a general decrease in the prevalence of anemia during the study. Although azithromycin was not shown to affect anemia, significantly, the study highlights burden of anemia in rural, African communities.

The Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance study showed that administration of biannual, single-dose azithromycin to preschool children reduces mortality. We sought to evaluate its impact on azithromycin resistance. Thirty randomly selected communities in Kilosa district, Tanzania, were randomized to receive 6-monthly single-dose azithromycin (∼20 mg/kg) versus placebo treatment of children aged 1–59 months. From each community, 40 children (aged 1–59 months) were randomly selected at baseline, 12 and 24 months. Isolation and resistance testing of Streptococcus pneumoniae and Escherichia coli were evaluated using nasopharyngeal and rectal swabs, respectively. The carriage prevalence and the proportion of azithromycin-resistant isolates were determined using disk diffusion. At baseline, the characteristics of the randomly selected children were similar by treatment arms. Both at baseline and in annual cross-sectional surveys, rates of S. pneumoniae and E. coli isolation between treatment arms were similar. The proportions of azithromycin-resistant S. pneumoniae isolates in the children in communities treated with azithromycin versus placebo at baseline, 12 months, and 24 months were 26.5% (18.1%; P = 0.26), 26.8% (16.5%; P = 0.29), and 13.4% (17.0%; P = 0.57), respectively. The proportions of azithromycin-resistant E. coli isolates at baseline, 12 months, and 24 months in the azithromycin (versus placebo) arms were 14.9% (18.9%; P = 0.16), 21.5% (16.6%; P = 0.10), and 14.9% (14.7%; P = 0.95), respectively. Over the 24 months, the mean treatment coverage for the azithromycin and placebo was 76.9% and 74.8%, respectively (P = 0.49). Biannual administration of single-dose azithromycin to children did not appear to result in excess azithromycin resistance in S. pneumoniae and E. coli isolates over 24 months of follow-up.

BACKGROUND With improved safety of allogeneic blood supply, the use of preoperative autologous donations (PADs) and perioperative autologous cell salvage (PACS) has evolved. This study evaluated temporal trends in PAD and PACS use in the United States. METHODS The National Inpatient Sample database, a stratified probability sample of 20% of hospitalizations in the United States, was used to compare temporal trends in hospitalizations reporting use of PADs and PACS from 1995 to 2015. Factors associated with their use were examined between 2012 and 2015 with use of multivariable Poisson regression. Sampling weights were applied to generate nationally representative estimates. RESULTS There was a steady decrease in hospitalizations reporting PAD transfusions from 27.90 per 100 000 in 1995 to 1.48 per 100 000 hospitalizations in 2015 (P-trend

BACKGROUND: Factors associated with red blood cell (RBC), plasma, and platelet transfusions in hospitalized neonates and children across the United States have not been well characterized. METHODS: Data from the Kids’ Inpatient Database (KID) 2016 were analyzed. KID is a random sample of 10% of all uncomplicated in-hospital births and 80% of remaining pediatric discharges from approximately 4200 US hospitals. Sampling weights were applied to generate nationally representative estimates. Primary outcome was one or more RBC transfusion procedures; plasma and platelet transfusions were assessed as secondary outcomes. Analysis was stratified by age: neonates (NEO; ≤28 d), and nonneonates (PED; >28 d and

Severe acute respiratory syndrome coronavirus 2 (SARS–CoV-2), the cause of coronavirus disease 2019 (COVID-19), has spurred a global health crisis. To date, there are no proven options for prophylaxis for those who have been exposed to SARS–CoV-2, nor therapy for those who develop COVID-19. Immune (i.e., “convalescent”) plasma refers to plasma that is collected from individuals following resolution of infection and development of antibodies. Passive antibody administration through transfusion of convalescent plasma may offer the only short-term strategy for conferring immediate immunity to susceptible individuals. There are numerous examples in which convalescent plasma has been used successfully as postexposure prophylaxis and/or treatment of infectious diseases, including other outbreaks of coronaviruses (e.g., SARS-1, Middle East respiratory syndrome [MERS]). Convalescent plasma has also been used in the COVID-19 pandemic; limited data from China suggest clinical benefit, including radiological resolution, reduction in viral loads, and improved survival. Globally, blood centers have robust infrastructure for undertaking collections and constructing inventories of convalescent plasma to meet the growing demand. Nonetheless, there are nuanced challenges, both regulatory and logistical, spanning donor eligibility, donor recruitment, collections, and transfusion itself. Data from rigorously controlled clinical trials of convalescent plasma are also few, underscoring the need to evaluate its use objectively for a range of indications (e.g., prevention vs. treatment) and patient populations (e.g., age, comorbid disease). We provide an overview of convalescent plasma, including evidence of benefit, regulatory considerations, logistical work flow, and proposed clinical trials, as scale-up is brought underway to mobilize this critical resource.

Objectives We evaluated the impact of electronic medical record (EMR)–guided pooled cryoprecipitate dosing vs our previous practice of requiring transfusion medicine (TM) resident approval for every cryoprecipitate transfusion. Methods At our hospital, cryoprecipitate pooled from five donors is dosed for adult patients, while single-donor cryoprecipitate is dosed for pediatric patients (defined as patients Results In the 6 months prior to intervention, 178 ± 13 doses of pooled cryoprecipitate were used per month vs 187 ± 15 doses after the intervention (P = .68). Wastage of pooled cryoprecipitate increased from 7.7% ± 1.5% to 12.7% ± 1.4% (P = .038). There was no change in wastage of pediatric cryoprecipitate doses during the study period. These trends remained unchanged for a full year postimplementation. Conclusions Electronic dosing guidance resulted in similar cryoprecipitate usage as TM auditing. Increased wastage may result from reduced TM oversight. Product wastage should be balanced against the possibility that real-time audits could delay a lifesaving therapy.

BACKGROUND: In April 2015, the government of Georgia (country) initiated the world’s first national hepatitis C elimination program. An analysis of blood donor infectious screening data was conducted to inform a strategic plan to advance blood transfusion safety in Georgia. STUDY DESIGN AND METHODS: Descriptive analysis of blood donation records (2015–2017) was performed to elucidate differences in demographics, donor type, remuneration status, and seroprevalence for infectious markers (hepatitis C virus antibody [anti-HCV], human immunodeficiency virus [HIV], hepatitis B virus surface antigen [HBsAg], and Treponema pallidum). For regression analysis, final models included all variables associated with the outcome in bivariate analysis (chi-square) with a p value of less than 0.05. RESULTS: During 2015 to 2017, there were 251,428 donations in Georgia, representing 112,093 unique donors; 68.5% were from male donors, and 51.2% of donors were paid or replacement (friends or family of intended recipient). The overall seroprevalence significantly declined from 2015 to 2017 for anti-HCV (2.3%−1.4%), HBsAg (1.5%−1.1%), and T. pallidum (1.1%−0.7%) [p < 0.0001]; the decline was not significant for HIV (0.2%−0.1%). Only 41.0% of anti-HCV seropositive donors underwent additional testing to confirm viremia. Infectious marker seroprevalence varied by age, sex, and geography. In multivariable analysis, first-time and paid donor status were associated with seropositivity for all four infectious markers. CONCLUSION: A decline during the study period in infectious markers suggests improvement in blood safety in Georgia. Areas that need further improvement are donor recruitment, standardization of screening and diagnostic follow-up, quality assurance, and posttransfusion surveillance.

Background Malaria remains a leading transfusion associated infectious risk in endemic areas. However, the prevalence of malaria parasitemia has not been well characterized in blood donor populations. This study sought to determine the prevalence of Plasmodium in red blood cell (RBC) and whole blood (WB) units after the rainy season in Uganda. Methods and materials Between May and July 2018, blood was collected from the sample diversion pouch of 1000 WB donors in Kampala and Jinja, Uganda. The RBC pellet from ethylenediamine tetraacetic acid (EDTA) anticoagulated blood was stored at -80°C until testing. DNA was extracted and nested PCR was used to screen samples at the genus level for Plasmodium, with positive samples further tested for species identification. Results Malaria parasitemia among asymptomatic, eligible blood donors in two regions of Uganda was 15.4%; 87.7% (135/154) of infections were with P. falciparum, while P. malariae and P. ovale were also detected. There were 4.3% of blood donors who had mixed infection with multiple species. Older donors (>30 years vs. 17-19 years; aPR = 0.31 [95% CI = 0.17-0.58]), females (aPR = 0.60 [95% CI = 0.42-0.87]), repeat donors (aPR = 0.44 [95% CI = 0.27-0.72]) and those donating near the capital city of Kampala versus rural Jinja region (aPR = 0.49 [95% CI = 0.34-0.69]) had a lower prevalence of malaria parasitemia. Conclusions A high proportion of asymptomatic blood donors residing in a malaria endemic region demonstrate evidence of parasitemia at time of donation. Further research is needed to quantify the risk and associated burden of transfusion-transmitted malaria (TTM) in order to inform strategies to prevent TTM.

The MORDOR study, a masked, community-level randomized clinical trial conducted in Niger, Malawi and Tanzania (2015 to 2017), showed that biannual administration of single-dose azithromycin to preschool children reduced all-cause mortality. We sought to evaluate its impact on causes of death in children aged 1–59 months in Tanzania. A random sampling of 614 communities was conducted in Kilosa District, Tanzania, with simple random assignment of communities to receive either azithromycin or placebo. In these communities, a census was carried out every 6 months and children aged 1–59 months received biannual (every 6 months), single-dose azithromycin (~20mg/kg) or placebo depending on community assignment, over a 2-year period. Mortality was determined at the time of the biannual census. For child deaths, a verbal autopsy was performed to ascertain the cause using a standardized diagnostic classification. A total of 190- (0.58 /100 person-years) and 200 deaths (0.59/100 person-years) were reported in the azithromycin and placebo arms, respectively. Malaria, pneumonia and diarrhea, accounted for 71% and 68% of deaths in the respective arms. Overall, the mortality was not different by treatment arm, nor were the distribution of causes of death after adjusting for community clustering. The cause-specific mortality for diarrhea/pneumonia was no different over time. In children aged 1–5 months, 32 deaths occurred in the placebo arm and 25 deaths occurred in the azithromycin arm; 20 (62.5%) deaths in the placebo- and 10 (40%) in the azithromycin arm were attributed to diarrhea or pneumonia. Neither differences in the number of deaths nor the diarrhea/pneumonia attribution was statistically significant after adjusting for community clustering. In conclusion, azithromycin was not associated with a significant decline in deaths by specific causes compared to placebo. The non-significant lower rates of diarrhea or pneumonia in children Trial registration: NCT02048007.

Background The MORDOR study, a cluster randomized clinical trial, showed that single-dose azithromycin (20 mg/kg) administered biannually for 2 years to preschool children reduced mortality; a study was conducted to determine its effect on clinical symptomatic episodes of malaria as a potential mechanism for mortality benefit. Methods A randomized control trial (RCT) was conducted, whereby 30 randomly selected communities in Kilosa District, Tanzania were randomized to receive 6-monthly treatment of children ages 1–59 months with single-dose azithromycin (20 mg/kg) vs. placebo. A prospective cohort study was nested within the RCT: children, aged 1 to 35 months at baseline, were randomly selected in each community and evaluated at 6-monthly intervals for 2 years. At each visit, the children were assessed for recent or ongoing fever and anti-malarial treatment; a rapid diagnostic test (RDT) for malaria was performed. The two major outcomes of interest were prevalence of RDT positivity and clinical malaria. The latter was defined as RDT-positivity with fever at time of evaluation and/or reported fever in the 3 days prior to evaluation. Methods that account for correlations at community level and within individuals over time were used to evaluate associations. Results At baseline, the prevalence rates in the children in the azithromycin and placebo arms were 17.6% vs. 15.5% for RDT positivity (p = 0.76) and 6.1% vs. 4.3% (p = 0.56) for clinical malaria. There was a decline in both RDT-positivity and clinical malaria over time in both arms. The difference by treatment assignment was not significant for clinical malaria; it was significant for RDT-positivity with greater odds of decline in the placebo arm (p = 0.01). Conclusions Lack of evidence for a significant difference in the prevalence of clinical malaria in children at any visit following treatment suggests that the effect of single-dose azithromycin on malaria is at best transient and limited in scope. Chance overrepresentation of non-seasonal transmission in the communities in the azithromycin arm may account for higher rates of RDT-positivity and less decline over time. Trial registration Clinicaltrials.gov NCT02047981

BACKGROUND AND OBJECTIVES Platelet dosing has been studied in adult oncology inpatients, but there is almost no published evidence to guide platelet dosing for adult outpatients. We evaluated transfusion indices after 1 unit and 2 unit apheresis platelet transfusions at our hospital to determine whether a benefit to 2-unit transfusions could be detected. MATERIALS AND METHODS A retrospective chart review was conducted of all adult oncology patients who received an outpatient platelet transfusion over a 16-month period (July 2016-November 2017). Pre- and post-transfusion platelet count, and chronology of subsequent platelet transfusions were compared. RESULTS A total of 8467 platelet transfusions were administered to 602 patients during the study period. 59·8% of patients (n = 360) were transfused interchangeably with one or two platelets throughout the study period. The primary study population were comprised of these patients. On average, a 2-unit platelet transfusions resulted in a higher immediate post-transfusion platelet count (43 vs. 37 x 103 /μl, P

BACKGROUND Bacterial contamination of platelets remains the leading infectious risk from blood transfusion. Pathogen reduction (PR), point-of-release testing (PORt), and secondary bacterial culture (SBC) have been proposed as alternative risk control strategies, but a comprehensive financial comparison has not been conducted. STUDY DESIGN AND METHODS A Markov-based decision tree was constructed to model the financial and clinical impact of PR, PORt, and SBC, as well as a baseline strategy involving routine testing only. Hospitals were assumed to acquire leukoreduced apheresis platelets on Day 3 after collection, and, in the base case analysis, expiration would occur at the end of Day 5 (PR and SBC) or 7 (PORt). Monte Carlo simulations assessed the direct medical costs for platelet acquisition, testing, transfusion, and possible complications. Input parameters, including test sensitivity and specificity, were drawn from existing literature, and costs (2018 US dollars) were based on a hospital perspective. RESULTS The total costs per unit acquired by the hospital under the baseline strategy, PR, PORt, and SBC were $651.45, $827.82, $686.33, and $668.50, respectively. All risk-reduction strategies decreased septic transfusion reactions and associated expenses, with the greatest reductions from PR. PR would add $191.09 in per-unit acquisition costs, whereas PORt and SBC would increase per-unit testing costs by $31.79 and $17.26, respectively. Financial outcomes were sensitive to platelet dating; allowing 7-day storage with SBC would lead to a cost savings of $12.41 per transfused unit. Results remained robust in probabilistic sensitivity analyses. CONCLUSIONS All three strategies are viable approaches to reducing bacterially contaminated platelet transfusions, although SBC is likely to be the cheapest overall.

Background and objectives Globally, blood safety interventions have been successful in mitigating risk of the major transfusion-transmitted (TT) viruses. However, strategies that address risk from parasites are comparatively limited. TT parasites are often regional in nature, posing unique challenges; we sought to understand their impact on blood safety. Materials and methods An electronic questionnaire was distributed to transfusion medicine leaders in 100 countries. The survey focused on specific questions pertaining to four parasitic diseases: babesiosis, Chagas, leishmaniasis and malaria. Respondents provided data on historical TT cases, local epidemiology, policies to mitigate risk and an assessment of public health perceptions for each aetiologic agent. Results Twenty-eight (28%) surveys were returned from countries in Europe (n = 13), the Americas (n = 6), Africa (n = 4), Asia (n = 3) and Oceana (n = 2). Historically, no cases of TT leishmaniasis were reported, TT babesiosis was exclusive to Canada and the USA, TT Chagas was limited to the Americas and Spain, while TT malaria was cosmopolitan. Mitigation efforts varied widely; malaria was the most frequently tested parasitic disease. The public's perception of risk for parasitic agents was low, while that of health authorities in endemic countries was higher. Conclusion The global impact of parasitic infections on blood safety and related mitigation efforts varied widely by parasite epidemiology, test availability, public health priorities and socioeconomic constraints. While parasites continue to pose a risk to blood safety, the successful mitigation of viral risk has elevated the prominence of TT parasites in many locations, thereby requiring consideration of mitigation efforts.

Rapid point-of-care tests (POCTs) for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific antibodies vary in performance. A critical need exists to perform head-to-head comparisons of these assays. The performances of 15 different lateral flow POCTs for the detection of SARS-CoV-2-specific antibodies were compared on a well-characterized set of 100 samples. Of these, 40 samples from known SARS-CoV-2-infected, convalescent individuals (collected an average of 45 days after symptom onset) were used to assess sensitivity. Sixty samples from the prepandemic era (negative control) that were known to represent infections with other respiratory viruses (rhinoviruses A, B, and C and/or coronavirus 229E, HKU1, and NL63 OC43) were used to assess specificity. The timing of seroconversion was assessed using five lateral flow assays (LFAs) and a panel of 272 longitudinal samples from 47 patients for whom the time since symptom onset was known. Among the assays that were evaluated, the sensitivity and specificity for any reactive band ranged from 55% to 97% and from 78% to 100%, respectively. Assessing the performance of the IgM and the IgG bands alone, sensitivity and specificity ranged from 0% to 88% and 80% to 100% for IgM and from 25% to 95% and 90% to 100% for IgG, respectively. Longitudinal testing revealed that the median times after symptom onset to a positive result were 7 days (interquartile range [IQR], 5.4 to 9.8) for IgM and 8.2 days (IQR, 6.3 to 11.3) for IgG. The testing performances differed widely among LFAs, with greatest amount of variation related to the sensitivity of the assays. The IgM band was the band most likely to misclassify prepandemic samples. The appearances of IgM and IgG bands occurred almost simultaneously.

Background:Blood transfusion is lifesaving for patients experiencing acute blood loss and severe anemia. In low- and middle-income countries (LMIC), availability of blood products impairs timely blood transfusion. A transfusion service (TS) is a clinical laboratory preparing blood products for patients. TS capabilities at the hospital level may contribute to preventable patient outcomes. We sought to learn more about the practices, capabilities, and challenges of TSs in LMIC . Materials and Methods: A cross-sectional survey explored hospital-level TS access to blood supplies, testing methods, policies, and structure. Surveys were administered in English, Spanish, French, and Russian, followed by a mixed methods analysis. Results: Responses (71) from 124 invitations comprised 50 TSs from 27 nations in low (4), low-middle (11), and upper-middle (12) income countries. Most LMIC TSs collected blood (36, 77%); only 11 (23%) relied on an external supply of blood products. Testing methods varied. The top reason for blood transfusion was adult anemia for non-malignant conditions (17, 15%). Blood transfusion delays (17, 57%) primarily involved inadequate blood supplies (15, 54%). Additional challenges involved educational access (8, 27%), financial models (4, 13%), or other barriers (8, 27%). Conclusions: This is the most-comprehensive survey into the status of hospital TSs in LMIC. Availability of blood products remains a dominant problem, requiring TSs to generate the facility’s blood supply. Blood shortages effect delays that are rarely reported as a patient-specific adverse event. Continued education and multi-disciplinary transfusion approaches were lacking. Safe and available blood transfusion extends beyond the TS, to governments and society. Funding: None to declare. Declaration of Interest: None to declare. Ethical Approval: The Children’s National Health System IRB provided ethical review for the protection of human subjects.

Background and objectives: COVID-19 convalescent plasma (CCP) has been used, predominantly in high-income countries (HICs) to treat COVID-19; available data suggest the safety and efficacy of use. We sought to develop guidance for procurement and use of CCP, particularly in low- and middle-income countries (LMICs) for which data are lacking. Materials and methods: A multidisciplinary, geographically representative group of individuals with expertise spanning transfusion medicine, infectious diseases and haematology was tasked with the development of a guidance document for CCP, drawing on expert opinion, survey of group members and review of available evidence. Three subgroups (i.e. donor, product and patient) were established based on self-identified expertise and interest. Here, the donor and product-related challenges are summarized and contrasted between HICs and LMICs with a view to guide related practices. Results: The challenges to advance CCP therapy are different between HICs and LMICs. Early challenges in HICs related to recruitment and qualification of sufficient donors to meet the growing demand. Antibody testing also posed a specific obstacle given lack of standardization, variable performance of the assays in use and uncertain interpretation of results. In LMICs, an extant transfusion deficit, suboptimal models of donor recruitment (e.g. reliance on replacement and paid donors), limited laboratory capacity for pre-donation qualification and operational considerations could impede wide adoption. Conclusion: There has been wide-scale adoption of CCP in many HICs, which could increase if clinical trials show efficacy of use. By contrast, LMICs, having received little attention, require locally applicable strategies for adoption of CCP.

Background and objectives Filariae are parasitic worms that include the pathogens Loa loa, Onchocerca volvulus, Wuchereria bancrofti, Brugia spp. and Mansonella spp. which are endemic in parts of Africa, Asia, Asia-Pacific, South and Central America. Filariae have a wide clinical spectrum spanning asymptomatic infection to chronic debilitating disease including blindness and lymphedema. Despite successful eradication programmes, filarial infections remain an important -albeit neglected - source of morbidity. We sought to characterize the risk of transfusion transmission of microfilaria with a view to guide mitigation practices in both endemic and non-endemic countries. Materials and methods A scoping review of scientific publications as well as grey literature was carried out by a group of domain experts in microbiology, transfusion medicine and infectious diseases, representing the parasite subgroup of the International Society of Blood Transfusion. Results Cases of transfusion-transmitted filariasis are rare and confined to case reports of variable quality. Transfusion-associated adverse events related to microfilariae are confined to isolated reports of transfusion reactions. Serious outcomes have not been reported. No known strategies have been implemented, specifically, to mitigate transfusion-transmitted filariasis yet routine blood donor screening for other transfusion-transmissible infections (e.g. hepatitis B, malaria) may indirectly defer donors with microfilaremia in endemic areas. Conclusion Rare examples of transfusion-transmitted filariasis, without serious clinical effect, suggest that filariasis poses low transfusion risk. Dedicated mitigation strategies against filarial transfusion transmission are not recommended. Given endemicity in low-resource regions, priority should be on the control of filariasis with public health measures.

Background Bacterial contamination of blood components (notably platelets) remains a leading infectious risk to the blood supply. There has been extensive research in high-income countries to characterize the risk of bacterial contamination along with adoption of strategies to mitigate that risk. By contrast, related data in Africa are lacking. Study design and methods An electronic survey was distributed to members of African Society of Blood Transfusion to assess existing or planned measures at African blood centers and hospitals to mitigate bacterial contamination of blood products. A literature review of studies pertaining to related transfusion-associated risk in Africa was conducted to complement the findings. Results Forty-five responses were received, representing 16 African countries. All respondents were urban, either in blood centers (n = 36) or hospital-based transfusion services (n = 9). Reported measures included skin disinfection (n = 41 [91.1%]); diversion pouches (n = 14 [31.1%]); bacterial culture (n = 9 [20%]); pathogen reduction (PR) (n = 3 [6.7%]); and point-of-release testing (PoRT) (n = 2 [4.4%]). Measures being considered for implementation included: skin disinfection (n = 2 [4.4%]); diversion pouches (n = 2 [4.4%]); bacterial culture n = 14 (31.1%); PR (n = 11 [24.4%]); and PoRT (n = 4 [8.9%]). Of the 38 respondents who reported collection of platelets, 14 (36.8%) and 8 (21.1%) reported using diversion pouches and bacterial culture, respectively. The literature review identified 36 studies on the epidemiology of bacterial contamination and septic transfusion reactions in Africa; rates of contamination ranged from 0% to 17.9%. Conclusions The findings suggest that prevention of bacterial contamination of blood components and transfusion-associated sepsis in Africa remains neglected. Regional preventive measures have not been widely adopted.

OBJECTIVESTo investigate if COVID-19 convalescent plasma (CCP) transfusion in patients with severe respiratory failure will increase plasma levels of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antibody titers while improving survival and clinical outcomes.DESIGNObservational, retrospective, control study of anti-Receptor binding domain (RBD) of SARS-CoV-2 IgG and IgM titers from serial plasma samples drawn before and after CCP administration. Clinical improvement in CCP recipients is assessed and compared to COVID-19 control patients.SETTINGPatients hospitalized with severe COVID19, United States, between April 17 and July 19, 2020PARTICIPANTS34 patients hospitalized with severe or life threatening COVID-19 and who consented and received a CCP transfusion, 95 control patients with COVID-19 not transfused with CCP. 34 out the 95 control patients were matched for age, sex, and the level of respiratory support required. Patients less than 18 years old were excluded.MAIN OUTCOME MEASURESSerial trends of anti-RBD of SARS-CoV-2 IgG and IgM titers in CCP recipients are compared to those in control patients. The primary outcome is survival at 30 days, and the secondary outcomes are length of ventilatory and/or extracorporeal membrane oxygenation (ECMO) support, length of stay (LOS) in the hospital, and LOS in the ICU.RESULTSCCP transfusion occurred in 34 patients at a median of 12 days following COVID-19 symptom onset. Immediately prior to CCP transfusion, patients median anti-RBD SARS-CoV-2 IgG and IgM titers were 1:3200 (IQR, 1:50 to 1:9600) and 1:320 (IQR, 1:40 to 1:640) respectively. Following a Loess regression analysis, the kinetics and distribution of anti-RBD of SARS-CoV-2 IgG and IgM in plasma from CCP recipients were comparable to those from a control group of 68 patients who did not receive CCP. CCP recipients presented with similar survival, similar duration on ventilatory and/or ECMO support, as well as ICU and hospital LOS, compared to a matched control group of 34 patients.CONCLUSIONIn the present study, hospitalized COVID-19 patients with severe respiratory failure transfused with CCP presented with high titers of SARS-CoV-2 IgG antibodies before transfusion and did not show improved survival at 30 days.

Rapid point-of-care tests (POCTs) for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific antibodies vary in performance. A critical need exists to perform head-to-head comparisons of these assays., Rapid point-of-care tests (POCTs) for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific antibodies vary in performance. A critical need exists to perform head-to-head comparisons of these assays. The performances of 15 different lateral flow POCTs for the detection of SARS-CoV-2-specific antibodies were compared on a well-characterized set of 100 samples. Of these, 40 samples from known SARS-CoV-2-infected, convalescent individuals (collected an average of 45 days after symptom onset) were used to assess sensitivity. Sixty samples from the prepandemic era (negative control) that were known to represent infections with other respiratory viruses (rhinoviruses A, B, and C and/or coronavirus 229E, HKU1, and NL63 OC43) were used to assess specificity. The timing of seroconversion was assessed using five lateral flow assays (LFAs) and a panel of 272 longitudinal samples from 47 patients for whom the time since symptom onset was known. Among the assays that were evaluated, the sensitivity and specificity for any reactive band ranged from 55% to 97% and from 78% to 100%, respectively. Assessing the performance of the IgM and the IgG bands alone, sensitivity and specificity ranged from 0% to 88% and 80% to 100% for IgM and from 25% to 95% and 90% to 100% for IgG, respectively. Longitudinal testing revealed that the median times after symptom onset to a positive result were 7 days (interquartile range [IQR], 5.4 to 9.8) for IgM and 8.2 days (IQR, 6.3 to 11.3) for IgG. The testing performances differed widely among LFAs, with greatest amount of variation related to the sensitivity of the assays. The IgM band was the band most likely to misclassify prepandemic samples. The appearances of IgM and IgG bands occurred almost simultaneously.

Since the beginning of the COVID-19 pandemic, the use of convalescent plasma as a possible treatment has been explored. Here we describe our experience as the first U.S. organization creating a COVID-19 convalescent plasma program to support its use through the single-patient emergency investigational new drug, the National Expanded Access Program, and multiple randomized controlled trials. Within weeks, we were able to distribute more than 8000 products, scale up collections to more than 4000 units per week, meet hospital demand, and support randomized controlled trials to evaluate the efficacy of convalescent plasma treatment. This was through strategic planning; redeployment of staff; and active engagement of hospital, community, and public health partners. Our partners helped with donor recruitment, testing, patient advocacy, and patient availability. The program will continue to evolve as we learn more about optimizing the product. Remaining issues to be resolved are antibody titers, dose, and at what stage of disease to transfuse.

BACKGROUND AND OBJECTIVES: Annual incidence of venous thromboembolism (VTE) including postoperative VTE in hospitalized children is rising significantly. A growing body of evidence supports the role of red blood cells (RBCs) in pathologic thrombosis. In this study, we examined the association of perioperative RBC transfusion with postoperative VTE in pediatric patients. METHODS: The pediatric databases of the American College of Surgeons’ National Surgical Quality Improvement Project from 2012 to 2017 were used. Multivariable logistic regression was used to examine the association between perioperative RBC transfusion status and the development of new or progressive VTE within 30 days of surgery. The analyses were age stratified, as follows: neonates (≤28 days), infants (>28 days and RESULTS: In this study, we included 20 492 neonates, 79 744 infants, and 382 862 children. Postoperative development of VTE was reported in 99 (0.48%) neonates, 147 (0.2%) infants, and 374 (0.1%) children. In all age groups, development of VTE was significantly more common among patients with a perioperative RBC transfusion than patients without a perioperative RBC transfusion (neonates: adjusted odds ratio [aOR] = 4.1, 95% confidence interval [CI] = 2.5–6.7; infants: aOR = 2.4, 95% CI = 1.7–3.6; children: aOR = 2.2, 95% CI = 1.7–2.9). Among children who received an intra- or postoperative transfusion, the weight-based volume of RBCs (mL/kg) transfused was associated with postoperative VTE in a dose-dependent manner: second tertile (odds ratio = 2.3, 95% CI = 1.3–4.1) and third tertile (odds ratio = 4.1, 95% CI = 2.3–7.4) versus first tertile. CONCLUSIONS: Perioperative RBC transfusions are independently associated with development of new or progressive postoperative VTE in children, infants, and neonates. These findings need further validation in prospective studies and emphasize the need for evidence-based perioperative pediatric blood transfusion decisions.

Background Bacterial contamination and associated septic transfusion reactions (STRs) remain the leading infectious risk to the blood supply. We sought to characterize the risk and clinical presentation of blood culture-positive transfusion reactions (BCPTRs) and STRs at our institution. Study design and methods A retrospective analysis was conducted of all suspected transfusion reactions reported to the transfusion service at a 1000-bed tertiary academic medical center from January 2009 to September 2016. Routine investigation included review of the clinical presentation, Gram stain, and bacterial culture of residual blood from the transfused product or associated blood bag. BCPTRs were defined by the presence of a positive bacterial culture in the blood product and/or recipient. STRs met definitive Centers for Disease Control and Prevention hemovigilance criteria for transfusion-transmitted infection, with definite imputability and concordant bacterial culture of the blood product and recipient. Results A total of 688,514 blood products were transfused during the study period, 3170 transfusion reactions were reported, and 18 (0.57%) were BCPTRs of which seven (0.22%) were STRs. Fifteen of 18 (83.3%) BCPTRs and six of seven (85.7%) were associated with transfusion of apheresis platelets. Major symptoms and signs of BCPTRs included chills (67%), fever (61%), and nausea and vomiting (50%). Four of seven (57.1%) STRs were classified as severe or life-threatening. Conclusion BCPTRs are rare yet potentially serious. The signs and symptoms of BCPTRs, and associated STRs, are not specific, posing risk of misclassification. Challenges surrounding reporting and case ascertainment underscore the need for laboratory measures to address residual risk of contamination.

BACKGROUND Obstetric hemorrhage (OH) and access to peripartum blood transfusion remains a global health challenge. The rates of peripartum transfusion in South Africa exceed those in high-income countries despite comparable rates of OH. We sought to evaluate factors associated with peripartum transfusion. STUDY DESIGN AND METHODS A case-control study was conducted at four large South African hospitals. Transfused peripartum women (cases) and nontransfused controls were stratum matched 1:2 by hospital and delivery date. Data on obstetric, transfusion, and human immunodeficiency virus (HIV) history were abstracted from medical records. Blood was obtained for laboratory evaluation. We calculated unadjusted and adjusted odds ratios (ORs) for transfusion using logistic regression. RESULTS A total of 1200 transfused cases and 2434 controls were evaluated. Antepartum hemorrhage (OR, 197.95; 95% confidence interval [CI], 104.27-375.78), hemorrhage with vaginal delivery (OR, 136.46; 95% CI, 75.87-245.18), prenatal anemia (OR, 22.76; 95% CI, 12.34-41.93 for prenatal hemoglobin level

Zika Virus and Blood-Product Safety The rapid emergence and dissemination of Zika virus across the Americas over the past 2 years has aroused serious concern regarding the safety of blood transfusion. The authors discuss the challenges associated with securing blood-product safety.

The current global pandemic, SARS-CoV-2 infection, is still extending across the world affecting millions of lives to the date. While new successful vaccines are available with promising outcomes to minimize the spread and to reduce the severity of the disease, optimal therapeutic options still remain elusive. COVID-19 convalescent plasma (CCP) is an investigational treatment option which studies suggesting signals of efficacy and favorable outcomes only for patients treated very early in course of the disease. Benefits of the use of CCP later in the disease remain highly debated and therefore are not common practice. We hereby report a case of severe SARS-CoV-2 infection in a young male patient with prolonged COVID-19 positivity who received repeat doses of CCP treatments later in the disease with temporal clinical improvement. This patient's case highlights the need of further studies evaluating efficacy of repeated dosing of CCP. This also suggests a potential of successful use of CCP later in the disease in selected COVID-19 patients.

Babesia are tick-borne intra-erythrocytic parasites and the causative agents of babesiosis. Babesia, which are readily transfusion transmissible, gained recognition as a major risk to the blood supply, particularly in the United States (US), where Babesia microti is endemic. Many of those infected with Babesia remain asymptomatic and parasitemia may persist for months or even years following infection, such that seemingly healthy blood donors are unaware of their infection. By contrast, transfusion recipients are at high risk of severe babesiosis, accounting for the high morbidity and mortality (~19%) observed in transfusion-transmitted babesiosis (TTB). An increase in cases of tick-borne babesiosis and TTB prompted over a decade-long investment in blood donor surveillance, research, and assay development to quantify and contend with TTB. This culminated in the adoption of regional blood donor testing in the US. We describe the evolution of the response to TTB in the US and offer some insight into the risk of TTB in other countries. Not only has this response advanced blood safety, it has accelerated the development of novel serological and molecular assays that may be applied broadly, affording insight into the global epidemiology and immunopathogenesis of human babesiosis.

Supplemental Digital Content is available in the text., Given the high community prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), transplant programs will encounter SARS-CoV-2 infections in living donors or recipients in the perioperative period. There is limited data on SARS-CoV-2 viremia and organotropism beyond the respiratory tract to inform the risk of transplant transmission of SARS-CoV-2. We report a case of a living donor liver transplant recipient who received a right lobe graft from a living donor with symptomatic PCR-confirmed SARS-CoV-2 infection 3 d following donation. The donor was successfully treated with remdesivir, dexamethasone, and coronavirus disease 2019 (COVID-19) convalescent plasma. No viral transmission was identified, and both donor and recipient had excellent postoperative outcomes.

Transfusion-transmitted infection risk remains an enduring challenge to blood safety in Africa. A high background incidence and prevalence of the major transfusion-transmitted infections (TTIs), dependence on high-risk donors to meet demand, suboptimal testing and quality assurance collectively contribute to the increased risk. With few exceptions, donor testing is confined to serological evaluation of human immunodeficiency virus (HIV), hepatitis B and C (HBV and HCV) and syphilis. Barriers to implementation of broader molecular methods include cost, limited infrastructure and lack of technical expertise. Pathogen reduction (PR), a term used to describe a variety of methods (e.g. solvent detergent treatment or photochemical activation) that may be applied to blood following collection, offers the means to diminish the infectious potential of multiple pathogens simultaneously. This is effective against different classes of pathogen, including the major TTIs where laboratory screening is already implemented (e.g. HIV, HBV and HCV) as well pathogens that are widely endemic yet remain unaddressed (e.g. malaria, bacterial contamination). We sought to review the available and emerging PR techniques and their potential application to resource-constrained parts of Africa, focusing on the advantages and disadvantages of such technologies. PR has been slow to be adopted even in high-income countries, primarily given the high costs of use. Logistical considerations, particularly in low-resourced parts of Africa, also raise concerns about practicality. Nonetheless, PR offers a rational, innovative strategy to contend with TTIs; technologies in development may well present a viable complement or even alternative to targeted screening in the future.

Hospital-wide massive transfusion protocols (MTPs) primarily designed for trauma patients may lead to excess blood products being prepared for nontrauma patients. This study characterized blood product utilization among distinct trauma and nontrauma MTPs at a large, urban academic medical center.A retrospective study of blood product utilization was conducted in patients who required an MTP activation between January 2011 and December 2015 at an urban academic medical center. Trauma MTP containers included 6 red blood cell (RBC) units, 5 plasma units, and 1 unit of apheresis platelets. Nontrauma MTP containers included 6 RBC and 3 plasma units.There were 334 trauma MTP activations, 233 nontrauma MTP activations, and 77 nontrauma MTP activations that subsequently switched to a trauma MTP ("switched activations"). All nontrauma MTP activations were among bleeding patients who did not have a traumatic injury (100% [233/233]). Few patients with a nontrauma activation required ad hoc transfusion of RBC units (1.3% [95% confidence interval {CI}, 0.3%-3.7%]) or plasma (3.4% [95% CI, 1.5%-6.7%]), and only 45.5% (95% CI, 39.0%-52.1%) required ad hoc transfusion of apheresis platelets. Compared to trauma and switched activations, nontrauma activations transfused a lower median number of RBC, plasma, and apheresis platelet units (P.001 for all comparisons). There was also a lower median number of prepared but unused plasma units for nontrauma activations (3; [interquartile range {IQR}, 3-5]) compared to trauma (7; [IQR, 5-10]; P.001) and switched activations (8; [IQR, 5-11]; P.001). The median number of unused apheresis platelet units was 1 (IQR, 1-2) for trauma activations and 0 (IQR, 0-1) for switched activations. There was a high proportion of trauma and switched activations in which all of the prepared apheresis platelet units were unused (28.1% [95% CI, 23.4%-33.3%] and 9.1% [95% CI, 3.7%-17.8%], respectively).The majority of initial nontrauma MTP activations did not require a switch to a trauma MTP. Patients remaining under a nontrauma MTP activation were associated with a lower number of transfused and unused plasma and apheresis platelet units. Future studies evaluating the use of hospital-wide nontrauma MTPs are warranted since an MTP designed for nontrauma patient populations may yield a key strategy to optimize blood product utilization in comparison to a universal MTP for both trauma and nontrauma patients.

A Zika virus disease outbreak occurred in Roatán, Honduras, during September 2015–July 2016. Blood samples and clinical information were obtained from 183 patients given a clinical diagnosis of suspected dengue virus infection. A total of 79 patients were positive for Zika virus, 13 for chikungunya virus, and 6 for dengue virus.

Zika virus (ZIKV) is a mosquito-borne flavivirus that is the focus of an ongoing pandemic. ZIKV is notable for its severe neurologic sequelae in babies born to infected mothers. High rates of subclinical infection, as evidenced by the finding of ZIKV RNA in asymptomatic donors, raise concerns of risk to the blood supply. To date, a total of four suspected cases of transfusion-transmitted ZIKV have been reported (all in Brazil), none of which were associated with clinical infection in the transfusion recipients. In 2016, the US Food and Drug Administration issued a guidance mandating national blood donor screening for ZIKV in the United States. Five days after implementation of donor screening at our facility, we encountered a ZIKV-positive donor. We provide a practical approach to donor, recipient, and blood product management in the setting of a positive donor ZIKV result. Such has been informed by the challenges we faced in the workup of a ZIKV-reactive donation and recipient lookback.

BACKGROUND The pathogenesis of alloimmunization is not well understood, and initiatives that aim to reduce the incidence of alloimmunization are generally expensive and either ineffective or unproven. In this review, we summarize the current medical literature regarding alloimmunization in the sickle cell disease (SCD) population, with a special focus on the financial implications of different approaches to prevent alloimmunization. STUDY DESIGN AND METHODS A review of EMBASE and MEDLINE data from January 2006 through January 2016 was conducted to identify articles relating to complications of SCD. The search was specifically designed to capture articles that evaluated the costs of various strategies to prevent alloimmunization and its sequelae. RESULTS Currently, there is no proven, inexpensive way to prevent alloimmunization among individuals with SCD. Serologic matching programs are not uniformly successful in preventing alloimmunization, particularly to Rh antigens, because of the high frequency of variant Rh alleles in the SCD population. A genotypic matching program could offer some cost savings compared to a serologic matching program, but the efficacy of gene matching for the prevention of alloimmunization is largely unproven, and large-scale implementation could be expensive. CONCLUSIONS Future reductions in the costs associated with genotype matching could make a large-scale program economically feasible. Novel techniques to identify patients at highest risk for alloimmunization could improve the cost effectiveness of antigen matching programs. A clinical trial comparing the efficacy of serologic matching to genotype matching would be informative.

This commentary discusses blood transfusion safety and suboptimal transfusion practices in low- and lower-middle income countries, which remain a pervasive public health challenge.

BACKGROUND Globally, data on antenatal blood transfusion practices are scarce. We sought to characterize the epidemiology of antenatal transfusion in South Africa. STUDY DESIGN AND METHODS A cross-sectional study was conducted of women who were transfused during pregnancy (>48 hr before anticipated delivery) at two hospitals in Durban and Soweto in 2014 to 2015. Medical record data on demographics, obstetric history, anemia, HIV status, and indications for blood transfusion were abstracted. RESULTS The records on a total of 560 transfused pregnant women were evaluated; mean age was 28 years, 98% were of black African ethnicity, and 28% were HIV positive. At time of transfusion, one-half were in the first trimester. Hemorrhage was noted in 76% of women, most of which was associated with abortion (67%) or ectopic pregnancy (27%). Most women were transfused with red blood cells (RBCs; median, 2 units); 14% of women were transfused with plasma and 2% with platelets. Median pre- and posttransfusion hemoglobin levels were 6.9 g/dL and 9.2 g/dL, respectively; the latter differed by hospital (8.7 g/dL vs. 9.5 g/dL; p

Background Babesia, a tick-borne genus of intraerythrocytic parasites, is understudied in humans outside of established high-endemic areas. There is a paucity of data on Babesia in Africa, despite evidence that it is regionally present. A pilot study suggested that Babesia was present in a rural district of Tanzania. Methodology/Principal findings A cross-sectional study was conducted July-August 2017: residents in a case hamlet that had clustering of subjects with high signal-to-cut off (S/CO) ratios for antibodies against B. microti in the pilot study, and a control hamlet that had lacked significant signal, were evaluated for B. microti. Subjects aged ≥15yrs (n = 299) underwent clinical evaluation and household inspections; 10ml whole blood was drawn for Babesia transcription mediated amplification (TMA), B. microti indirect fluorescent antibody testing (IFA) and rapid diagnostic testing (RDT) for Plasmodium spp. Subjects aged, Author summary Babesia, a family of tick-borne parasites, causes babesiosis, a disease that is very similar to malaria. Babesia species are globally ubiquitous yet understudied in humans outside of a few areas of the world, most notably in the United States. There is very little, published information on Babesia in humans in Africa. We conducted a study of two rural communities in Tanzania where earlier findings had suggested Babesia was present. Dedicated study teams visited households in the two communities to collect information about the residents’ health as well as factors that could pose risk of exposure to ticks and other infectious diseases. The residents of the two communities also had samples collected for Babesia evaluation. The test results revealed that a few of the residents had likely been exposed to Babesia in the past but were not actively infected at time of the assessment. The findings provide additional support for Babesia’s presence in human populations in Africa. This is important as Babesia infection can mimic other infections, notably malaria.

Pathologists who enter the workforce must have a diverse skill set beyond that of clinical diagnostics alone. Anticipating this need, the Johns Hopkins Pathology Residency Program developed Special Expertise Tracks to enhance training in relevant subspecialty domains. Using a combination of discussions and surveys, we assessed: (1) our current resident curriculum; (2) perceived curricular strengths and needs; (3) resident career preferences and ultimate career paths; (4) perceived barriers to implementing an advanced elective curriculum; and (5) available departmental/institutional resources. Additionally, we utilized the Accreditation Council for Graduate Medical Education Pathology Milestones as a curricular guide. Six professional residency training Special Expertise Tracks were established: Education, Physician-Scientist Research, Informatics, Quality Improvement/Quality Assurance/Value-Based Care, Health Policy/Hospital Management and Global Health. After implementation in 2017, the Education track has had 4 residents complete the curriculum successfully; the Physician-Scientist Research track has had 2 residents and the Informatics and Global Health tracks have each had one resident successfully complete their respective curricula. Currently, 5 residents are pursuing the Education track, one is pursuing the Physician-Scientist Research track, one is pursuing the Informatics track, and 2 residents are pursuing the Global Health track. Five residents have completed long-term projects including developing several e-learning modules, an online free digital cytopathology atlas, peer-reviewed articles, book chapters, and books. The Johns Hopkins Pathology Resident Special Expertise Track program provides pathology residents an opportunity to gain meaningful experience and additional skills tailored to their individual career interests.

We summarize what is known about this virus and its global expansion as of mid-February 2016., Zika virus is a mosquitoborne flavivirus that is the focus of an ongoing pandemic and public health emergency. Previously limited to sporadic cases in Africa and Asia, the emergence of Zika virus in Brazil in 2015 heralded rapid spread throughout the Americas. Although most Zika virus infections are characterized by subclinical or mild influenza-like illness, severe manifestations have been described, including Guillain-Barre syndrome in adults and microcephaly in babies born to infected mothers. Neither an effective treatment nor a vaccine is available for Zika virus; therefore, the public health response primarily focuses on preventing infection, particularly in pregnant women. Despite growing knowledge about this virus, questions remain regarding the virus’s vectors and reservoirs, pathogenesis, genetic diversity, and potential synergistic effects of co-infection with other circulating viruses. These questions highlight the need for research to optimize surveillance, patient management, and public health intervention in the current Zika virus epidemic.

BACKGROUND Babesia microti is the foremost infectious risk to the US blood supply for which a Food and Drug Administration (FDA)-licensed test is unavailable for donation screening. Characterization of the antibody response to B. microti and correlation with parasitemia is necessary to guide screening and donor management policies. STUDY DESIGN AND METHODS During an FDA licensure trial, blood donors were prospectively screened (July-November 2013) using a B. microti-specific antibody enzyme immunoassay (EIA, Immunetics) in highly endemic (New York [NY]; n = 13,688), moderately endemic (Minnesota [MN]; n = 4583), and nonendemic (New Mexico [NM]; n = 8451) regions. Blood donors with repeat-reactive (RR) results participated in a 12-month prospective cohort study using B. microti EIA, immunofluorescent assay, polymerase chain reaction (PCR), blood smear, and clinical questionnaire. RESULTS Thirty-seven (61.67%; 24 NY, seven MN, six NM) of 60 eligible RR donors enrolled in the study; 20 of 37 (54%) completed the 12-month follow-up visit of which 15 (75%) were still seroreactive. Nine PCR-positive donors were identified during index screening; five participated in the follow-up study, three were PCR positive at 6 months, and two remained positive at final follow-up (378 and 404 days). Most RR donors displayed low-level seroreactivity that was either stable or waning during follow-up. The level and pattern of reactivity correlated poorly with PCR positivity. CONCLUSION The findings indicate prolonged seropositivity in blood donors. Although rare, asymptomatic, persistent PCR positivity supports the current policy of indefinite deferral for donors with a history of babesiosis or positive test results. Repeat testing by PCR and serology will be necessary if reinstatement is to be considered.

BACKGROUND Whole blood (WB) is an appealing alternative to component-based transfusion in patients with significant bleeding. Historically, WB was transfused less than 48 hours after collection and was not leukoreduced (LR). However, LR components are now standard in many hospitals and LR WB is desirable. We investigated the effect of the type of LR filter used, as well as storage duration, on coagulation laboratory testing of WB. STUDY DESIGN AND METHODS Ten units of LR WB-5 units manufactured with a Food and Drug Administration (FDA)-approved platelet (PLT)-sparing filter (WB-PS) and 5 units manufactured with an FDA-approved non-PLT-sparing filter (WB-NPS)-underwent complete blood count, PLT function analyzer (PFA [PFA-100]), thromboelastography (TEG), prothrombin time (PT), partial thromboplastin time (PTT), Factor (F)V activity, chromogenic FVIII, thrombin generation, and microparticle quantification on Storage Days 3, 5, 7, 10, and 14. RESULTS WB-PS contains more PLTs than WB-NPS (mean, 71 × 109 /L vs. 1 × 109 /L, p