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Introduction: In sub-Saharan Africa (SSA), an adequate supply of safe blood for transfusion is a major developmental challenge. In Ghana, deferral from blood donation for anemia accounts for nearly half of the ineligible blood donors. We conducted a longitudinal two-arm parallel-group non-inferiority trial to test if iron supplementation among blood donors with iron deficiency (ID) or anemia could increase their hemoglobin levels to near those without ID or anemia., Materials and Methods: A structured questionnaire was used to collect participants' sociodemographic and medical information after written informed consent was obtained. Blood samples were analyzed for full blood count (FBC), serum ferritin, malaria rapid test, and a peripheral blood smear. The primary outcome was hemoglobin level after 4 months comparing anemic donors who received iron supplementation to the standard of care participants, nonanemic donors who did not receive iron supplementation. All donors received nutritional counseling., Results: Adherence to low-dose iron supplementation three times a week was poor. Hemoglobin levels in the iron supplementation arm were not close enough to those in the control group after 4 months of iron supplementation to declare non-inferiority. However, non-inferiority was met when the 4 month hemoglobin comparison was restricted to female donors., Conclusion: After 4 months of iron supplementation, hemoglobin levels in the iron supplementation group did not sufficiently match those in the control group to declare non-inferiority. Data from this pilot trial informed and shaped the design of a larger randomized control type 1 pragmatic effectiveness implementation hybrid trial which is currently ongoing., (© 2024 AABB.)

Background: Balanced plasma/red blood cell transfusions have shown survival benefit in emergency scenarios. To improve plasma availability, we implemented 5-day group A thawed plasma at our pediatric hospital in February 2021., Study Design and Methods: We maintain thawed group A plasma units (5-day shelf-life) ready for immediate issue in the blood bank (since February 2021) and trauma code room (since August 2022). Group A plasma (un-titered) is issued for patients with unknown blood type during emergencies. We retrospectively reviewed records and laboratory results of recipients to assess safety and identify possible adverse events related to incompatible plasma., Results: Between February 2021 and December 2023, 173 emergency plasma requests occurred for 161 patients. Ninety-one occurred with massive transfusion protocol activations. Thirty-six patients (22.4%) were blood group B or AB, and 23 received incompatible plasma (age 0-21.3 years, weight 0.74-149.8 kg, incompatible plasma dose 4.0-428.4 mL/kg). These patients did not have any differences in survival outcomes or hospital lengths of stay (LOS) compared with compatible plasma recipients, mirroring the adult experience. None experienced adverse events related to group A plasma. No transfusion reactions were reported. No increase in wastage/outdate occurred upon thawed plasma implementation (2020 versus 2021 to 2023, 7.73% [133/1721] vs. 8.58% [497/5792], p = .284)., Conclusions: We implemented 5-day group A thawed plasma. Units are rapidly available from the blood bank and trauma code room without increased wastage. We did not identify any transfusion-associated adverse events in pediatric recipients of incompatible group A plasma., (© 2024 AABB.)

Background: Previous systematic reviews have revealed an inconsistency of outcome definitions as a major barrier in providing evidence-based guidance for the use of plasma transfusion to prevent or treat bleeding. We reviewed and analyzed outcomes in randomized controlled trials (RCTs) to provide a methodology for describing and classifying outcomes., Study Design and Methods: RCTs involving transfusion of plasma published after 2000 were identified from a prior review (Yang 2012) and combined with an updated systematic literature search of multiple databases (July 1, 2011 to January 17, 2023). Inclusion of publications, data extraction, and risk of bias assessments were performed in duplicate. (PROSPERO registration number is: CRD42020158581)., Results: In total, 5579 citations were identified in the new systematic search and 22 were included. Six additional trials were identified from the previous review, resulting in a total of 28 trials: 23 therapeutic and five prophylactic studies. An increasing number of studies in the setting of major bleeding such as in cardiovascular surgery and trauma were identified. Eighty-seven outcomes were reported with a mean of 11 (min-max. 4-32) per study. There was substantial variation in outcomes used with a preponderance of surrogate measures for clinical effect such as laboratory parameters and blood usage., Conclusion: There is an expanding literature on plasma transfusion to inform guidelines. However, considerable heterogeneity of reported outcomes constrains comparisons. A core outcome set should be developed for plasma transfusion studies. Standardization of outcomes will motivate better study design, facilitate comparison, and improve clinical relevance for future trials of plasma transfusion., (© 2024 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.)

Background: Immunoglobulin (IG) therapy is widely used to treat primary and secondary immune deficiencies and as immunomodulatory agent for various disorders. There is great concern that shortages of IG may rise, potentially affecting medical treatment options., Study Design and Methods: An international survey was developed to study how intravenous immunoglobulins (IVIGs) are used and managed within hospitals in case of shortages. Study data were collected and managed using REDCap electronic data capture tools hosted by the Biomedical Excellence for Safer Transfusion (BEST) Collaborative. The survey was directed to hospital pharmacists and blood bank transfusion professionals and disseminated through members of the BEST Collaborative network., Results: Survey respondents from institutions in the USA, Canada, Europe, Japan, and Australia (n = 13) confirmed that the primary specialties utilizing IG are neurology, hematology, and immunology. More than 60% of respondents reported IG supply shortages, but mitigation strategies were not well developed., Discussion: As IG is the leading driver in plasma demand, more studies are needed to understand current and future demand for IG from the clinical perspective. Necessity lies in establishing clinical guidance to address shortages., (© 2024 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.)

Background: Before implementation of the radio frequency identification (RFID) system, there was a high loss rate of 4.0%-4.3% of red blood cell (RBC) units every year expiring on the shelf in our transfusion service laboratory. We introduced RFID technology to improve inventory management and the burden of work on the staff. The goal of this study was to evaluate the impact of RFID technology on the inventory management of RBC units and the staff workload in a transfusion service laboratory., Study Design and Methods: Using an RFID system involves encoding RBC units with an RFID tag capturing information such as donor identification number, product code, blood type, expiration date, product volume, and negative antigen(s). Tag information is collected through retrofitted storage shelves linked to the RFID server. The study analyzed RBC usage by unit and by volume (mL) and staff work effort to carry out inventory management tasks before and after the implementation of the RFID system., Results: Implementation of the RFID technology reduced the loss, or discard, of RBC units to less than 1% annually (a statistically significant change, p < .001). The RFID computer dashboard provides a constant visual update of the inventory, allowing technologists to have accurate product counts and reducing their work burden., Discussion: Implementation of RFID technology substantially reduced RBC product loss, improved inventory management, and lessened staff work burden., (© 2024 AABB.)

Background: The Mirasol® Pathogen Reduction Technology System was developed to reduce transfusion-transmitted diseases in platelet (PLT) products., Study Design and Methods: MiPLATE trial was a prospective, multicenter, controlled, randomized, non-inferiority (NI) study of the clinical effectiveness of conventional versus Mirasol-treated Apheresis PLTs in participants with hypoproliferative thrombocytopenia. The novel primary endpoint was days of ≥Grade 2 bleeding with an NI margin of 1.6., Results: After 330 participants were randomized, a planned interim analysis of 297 participants (145 MIRASOL, 152 CONTROL) receiving ≥1 study transfusion found a 2.79-relative rate (RR) in the MIRASOL compared to the CONTROL in number of days with ≥Grade 2 bleeding (95% confidence interval [CI] 1.67-4.67). The proportion of subjects with ≥Grade 2 bleeding was 40.0% (n = 58) in MIRASOL and 30.3% (n = 46) in CONTROL (RR = 1.32, 95% CI 0.97-1.81, p = .08). Corrected count increments were lower (p < .01) and the number of PLT transfusion episodes per participant was higher (RR = 1.22, 95% CI 1.05-1.41) in MIRASOL. There was no difference in the days of PLT support (hazard ratio = 0.86, 95% CI 0.68-1.08) or total number of red blood cell transfusions (RR = 1.12, 95% CI 0.91-1.37) between MIRASOL versus CONTROL. Transfusion emergent adverse events were reported in 119 MIRASOL participants (84.4%) compared to 133 (82.6%) participants in CONTROL (p = NS)., Discussion: This study did not support that MIRASOL was non-inferior compared to conventional platelets using the novel endpoint number of days with ≥Grade 2 bleeding in MIRASOL when compared to CONTROL., (© 2024 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.)

Background: Red blood cell wastage occurs when blood is discarded rather than transfused, and ineffective ordering results in unnecessary crossmatch procedures. We describe how a multimodal approach to redesigning electronic ordering tools improved blood utilization in a pediatric inpatient setting and how using innovative application of time series data analysis provides insights into intervention effectiveness, which can guide future process improvement cycles., Methods: A multidisciplinary team used best practices and Toyota Production System methodology to redesign electronic blood ordering and improve administration processes. We analyzed crossmatch to transfusion ratio and red blood cell wastage time series data extracted from our laboratory information system and electronic health record. We used changepoint analysis to identify statistically discernible breaks in each time series, compatible with known interventions. We performed causal impact analysis on red blood cell wastage time series data to estimate blood wastage avoided due to the interventions., Results: Changepoint analysis estimated an 11% decrease in crossmatch to transfusion ratio and a 77% decrease in red blood cell monthly wastage rate during the intervention period. Causal impact analysis estimated a 61% reduction in expected wastage compared to the scenario if the interventions had not occurred., Discussion: Our results show that electronic health record design is an important factor in reducing waste and preventing unnecessary crossmatching, and that time series analysis can be a useful tool for evaluating the long-term impact of each stage of intervention in a longitudinal process redesign effort for the purpose of effectively targeting future improvement efforts., (© 2023 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.)

Background and Objectives: Convalescent COVID-19 plasma (CCP) was developed and used worldwide as a treatment option by supplying passive immunity. Adult studies suggest administering high-titer CCP early in the disease course of patients who are expected to be antibody-negative; however, pediatric experience is limited. We created a multi-institutional registry to characterize pediatric patients (<18 years) who received CCP and to assess the safety of this intervention., Methods: A REDCap survey was distributed. The registry collected de-identified data including demographic information (age, gender, and underlying conditions), COVID-19 disease features and concurrent treatments, CCP transfusion and safety events, and therapy response., Results: Ninety-five children received CCP: 90 inpatients and 5 outpatients, with a median age of 10.2 years (range 0-17.9). They were predominantly Latino/Hispanic and White. The most frequent underlying medical conditions were chronic respiratory disease, immunosuppression, obesity, and genetic syndromes. CCP was primarily given as a treatment (95%) rather than prophylaxis (5%). Median total plasma dose administered and transfusion rates were 5.0 ml/kg and 2.6 ml/kg/h, respectively. The transfusions were well-tolerated, with 3 in 115 transfusions reporting mild reactions. No serious adverse events were reported. Severity scores decreased significantly 7 days after CCP transfusion or at discharge. Eighty-five patients (94.4%) survived to hospital discharge. All five outpatients survived to 60 days., Conclusions: CCP was found to be safe and well-tolerated in children. CCP was frequently given concurrently with other COVID-19-directed treatments with improvement in clinical severity scores ≥7 days after CCP, but efficacy could not be evaluated in this study., (© 2023 AABB.)

Background: State of the Science (SoS) meetings are used to define and highlight important unanswered scientific questions. The National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, and the Office of the Assistant Secretary for Health (OASH), Department of Health and Human Services held a virtual SoS in transfusion medicine (TM) symposium., Study Design and Methods: In advance of the symposium, six multidisciplinary working groups (WG) convened to define research priorities in the areas of: blood donors and the supply, optimizing transfusion outcomes for recipients, emerging infections, mechanistic aspects of components and transfusion, new computational methods in transfusion science, and impact of health disparities on donors and recipients. The overall objective was to identify key basic, translational, and clinical research questions that will help to increase and diversify the volunteer donor pool, ensure safe and effective transfusion strategies for recipients, and identify which blood products from which donors best meet the clinical needs of specific recipient populations., Results: On August 29-30, 2022, over 400 researchers, clinicians, industry experts, government officials, community members, and patient advocates discussed the research priorities presented by each WG. Dialogue focused on the five highest priority research areas identified by each WG and included the rationale, proposed methodological approaches, feasibility, and barriers for success., Discussion: This report summarizes the key ideas and research priorities identified during the NHLBI/OASH SoS in TM symposium. The report highlights major gaps in our current knowledge and provides a road map for TM research., (© 2023 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.)

Background: The supply of blood in many low- and middle-income nations in Sub-Saharan Africa (SSA) does not meet the patient care needs. Lack and delay of blood transfusion cause harm to patients and slow the rate of progress in other parts of the health system. Recognizing the power of implementation science, the BLOODSAFE Program was initiated which supports three SSA research study teams and one data coordinating center (DCC) with the goal to improve access to safe blood transfusion in SSA., Study Design and Methods: The study team in Ghana is focusing on studying and decreasing iron deficiency in blood donors and evaluating social engagement of blood donors through different approaches. The study team in Kenya is building a "vein to vein" workflow model to elucidate and devise strategies to overcome barriers to blood donation and improve infrastructural components of blood product production and use. The Malawi team is studying the infectious disease ramifications of blood donation as well as blood donor retention strategies aimed at blood donors who commence their donation career in secondary schools., Results and Discussion: Together the project teams and the DCC work as a consortium to support each other through a shared study protocol that will study donor motivations, outcomes, and adverse events across all three countries. The BLOODSAFE Program has the potential to lead to generalizable improvement approaches for increasing access to safe blood in SSA as well as mentoring and building the research capacity and careers of many investigators., (© 2022 AABB.)

Background: Evidence indicates the life-saving benefits of early blood product transfusion in severe trauma resuscitation. Many of these products will be RhD-positive, so understanding the D-alloimmunization rate is important., Methods: This was a multicenter, retrospective study whereby injured RhD-negative patients between 18-50 years of age who received at least one unit of RhD-positive red blood cells (RBC) or low titer group O whole blood (LTOWB) during their resuscitation between 1 January, 2010 through 31 December, 2019 were identified. If an antibody detection test was performed ≥14 days after the index RhD-positive transfusion then basic demographic information was collected, including whether the patient became D-alloimmunized. The overall D-alloimmunization rate, and the rate stratified by the number of units transfused, were calculated., Results: Data were collected from nine institutions. Five institutions reported fewer than 10 eligible patients each and were excluded. From the remaining four institutions, all from the USA, there were 235 eligible patients; 77 (random effects estimate: 32.7%; 95% CI: 19.1-50.1%) became D-alloimmunized. Three of the institutions reported D-alloimmunization rates ≥38.6%, while the remaining institution's rate was 12.2%. In both random and fixed-effects models, the rate of D-alloimmunization was not significantly different between those who received one RhD-positive unit and those who received multiple RhD-positive units., Conclusion: In this large, multicenter study of injured patients, the overall rate of D-alloimmunization fell within the range previously reported. The rate of D-alloimmunization did not increase as the number of transfused RhD-positive units increased. These data can help to inform RhD type selection decisions., (© 2022 AABB.)

Background: The COVID-19 pandemic has brought tremendous challenges to the United States blood supply. Decreased collections have caused blood product shortages. The number of hospital-based donor centers (HBDCs) has decreased in the past decades, but they provide important support to their hospital systems., Materials/methods: We identified 79 active HBDCs through an information request to the FDA. These centers were invited to participate in a survey about their activities, blood product collections, and perceived value., Results: Thirty-six centers responded (46% response rate). The centers represented a wide range of states and geographic settings. Whole blood collection was most common, but some respondents also prepared specialized products such as COVID-19 convalescent plasma and pathogen-reduced platelets. Positive impacts of HBDCs included inventory availability, cost-effectiveness/savings, community outreach, supporting special patient populations, and collecting specialty products. All respondents anticipate at least stable operations, if not growth, in the future., Conclusion: HBDCs continue to be valuable assets in addressing emerging patient transfusion needs. Their unique offerings are tailored to the populations their hospitals support, and demonstrate the value in having the collection infrastructure in place to rapidly respond to critical shortages. This survey provides benchmark data about a broad group of HBDCs including products prepared, inventory self-sufficiency levels, and reasons for positive impact., (© 2021 AABB.)

Background: As evidence demonstrating the importance of early transfusions in trauma resuscitation accumulates, when RhD-negative products might not be available, it is important to understand the nature of the RhD-type of products provided to bleeding pediatric patients of potentially unknown RhD-type., Methods: A survey link was electronically sent to the transfusion service medical director and/or laboratory manager at American pediatric Level I and Level II hospitals inquiring about their practices for selecting RhD-type of uncrossmatched red blood cells (RBC) or low titer group O whole blood (LTOWB) for boys and girls., Results: There were 55/117 (47.0%) analyzable responses; 43/55 (78.2%) from Level I and 12/55 (21.8%) from Level II hospitals. For in hospital transfusions, 51/55 (92.7%) of centers use only RhD-negative blood products to resuscitate girls ≤18 years old while 30/55 (54.5%) of centers do the same for boys ≤18 years old. Most centers 41/55(74.5%) store RBCs and/or LTOWB in in-hospital remote refrigerators; 27 store only RhD-negative RBCs and 2 store only RhD-negative LTOWB units in these refrigerators. A total of 24/55 (43.6%) centers have RBCs and/or LTOWB available on road ambulances or helicopters for prehospital transfusion; 12 transport only RhD-negative RBCs and two transport only RhD-negative LTOWB. Most centers, 35/55 (63.6%), address the prophylaxis of an RhD-negative female recipient of RhD-positive transfusion on a case-by-case basis., Conclusion: While there is some variability, most of the responding pediatric trauma centers routinely utilized RhD-negative RBCs for emergency transfusion for patients ≤18 years old of unknown RhD-type., (© 2021 AABB.)

Background: Wrong blood in tube (WBIT) errors can lead to ABO mistransfusions. It is unknown if WBIT errors are more likely in specific healthcare locations or if specific collection practices influence the commission of WBIT errors., Study Design and Methods: Data on pretransfusion samples from calendar year 2019 were collected retrospectively by 39 transfusion services in nine countries. We compared the proportion of WBIT errors made in emergency departments (EDs), inpatient wards, and outpatient clinics., Results: In total, 143 WBIT errors were detected among 1,394,862 samples for an unadjusted aggregate WBIT proportion of 1.03/10,000 samples. Using a pooled random effects model, the WBIT proportion was estimated to be significantly higher in EDs (1.23/10,000 samples, 95% CI 0.62-2.43) than inpatient wards (0.71/10,000, 95% CI 0.44-1.14; p < .001) or outpatient clinics (0.24/10,000, 95% CI 0.08-0.65; p < .001) and significantly higher in inpatient wards than outpatient clinics (p = .043). The use of electronic positive patient identification (ePPID) systems was associated with a significantly lower WBIT proportion in the ED (odds ratio, OR: 0.32, 95% CI: 0.11-0.96, p = .041), but not in inpatient wards (OR: 0.45, 95% CI: 0.20-1.01, p = .054) or outpatient clinics (OR: 1.95, 95% CI: 0.39-9.74, p = .415)., Discussion: Normalized for the number of samples drawn per location, the WBIT proportion in EDs was 1.7 times higher than inpatient wards and 5.1 times higher than outpatient clinics. EDs represent higher-risk clinical locations for WBIT errors, and electronic positive patient identification (ePPID) may provide a greater impact on safety in EDs relative to other clinical areas., (© 2021 AABB.)

Background: Transfusions are a common intervention within pediatrics and require unique considerations to optimize patient care. Poor knowledge of evidence-based transfusion practice can lead to misuse of transfusion therapy and harm. While there have been assessments of transfusion medicine knowledge of physicians caring for adult patients, there is little data regarding pediatricians., Study Design and Methods: Using a published transfusion medicine knowledge exam for internal medicine physicians as a backbone, pediatric transfusion medicine experts, using an iterative process, developed a pediatric-specific examination. Pilot testing and Rasch analysis, a method used in high-stakes testing, was used to validate the exam. The exam and a previously validated survey on transfusion medicine training, attitudes, and perceived ability were administered to pediatric residents. Analysis consisted of descriptive statistics as well as comparisons of exam scores based on survey responses., Results: 330 pediatric residents from 19 sites in 6 countries participated in the study. The vast majority (91%) of residents had obtained blood product consent. The mean exam score was 37.1% (range 9.5%-71.4%) with no statistical differences based on amount or perceived quality of transfusion medicine education or perceived ability., Discussion: A rigorously validated exam has now been developed that can be used to assess pediatric transfusion medicine knowledge. A large international group of pediatric residents performed poorly on the exam demonstrating a pressing need for improved transfusion medicine education to ensure safe and appropriate administration of blood components to infants and children., (© 2021 AABB.)

Background: There are limited standards guiding the selection and processing of blood components specific for neonatal and pediatric transfusions. Therefore, blood banks (BBs) and transfusion services must create their own policies and procedures., Study Design and Methods: The American Association of Blood Banks (AABB) Pediatric Transfusion Medicine Subsection Committee developed a 74-question survey to capture neonatal and pediatric BB practices in the United States., Results: Thirty-five centers completed the survey: a response rate 15.8%. Responses indicated that most carry a mixed inventory of red blood cells (RBCs); 94.2% allow more than one type of RBC product for small-volume (SV) and large-volume (LV) transfusions to neonatal and pediatric patients. Many had storage age thresholds for RBCs transfused to neonates (SV = 60%, LV = 67.7%) but not older pediatric patients. The use of Group O for nonurgent RBC transfusion in neonates was common (74.2%). Responses related to special processing of RBCs and platelets indicated that 100% RBC and platelets are leukocyte-reduced (LR) for neonates and 97% for non-neonates. Irradiation of RBCs and platelets was commonly performed for neonatal transfusion (88.6%). Providing cytomegalovirus (CMV) seronegative products, volume reduction, and washing were variable. All centers transfused single-donor apheresis platelets; 20% allowed pathogen reduction (PR). The majority of centers have strategies limiting the amount of incompatible plasma transfused; however, few titrate ABO isoagglutinins in plasma-containing products (20% for platelets and 9.1% for plasma)., Conclusions: Variability exists in BB practice for neonatal and pediatric transfusion. Future studies are needed to understand and define best BB practices in these patient populations., (© 2021 AABB.)

Background: Patients with sickle cell disease (SCD) are frequent recipients of red blood cell (RBC) transfusions and are at risk for RBC alloimmunization. RBC alloimmunization is diagnosed by identifying RBC alloantibodies as part of pre-transfusion testing, but this testing fails to detect alloantibodies that have evanesced. It may be beneficial to screen for new RBC alloantibody development after transfusion before possible antibody evanescence., Study Design and Methods: Our institution started a new initiative for episodically transfused patients with SCD to obtain at least one antibody screen 2-6 months after transfusion as part of their clinical care. A database was created to prospectively track all transfused patients for 1 year and their post-transfusion antibody screen results. Patients received prophylactically CEK-matched RBC units., Results: During the study year, 138 patients with SCD received a total of 242 RBC transfusions. Patients with a history of an RBC alloantibody (n = 13, 9.4%) had previously received more RBC units than non alloimmunized patients (median 11 vs. 2 RBC units, p = .0002). A total of 337 post-transfusion antibody screens were obtained in 127 patients (92.0%) with 110 patients (79.7%) having at least one antibody screen 2-6 months post-transfusion. With this prospective testing, two new RBC alloantibodies (anti-C and -M) were identified in two patients., Conclusion: It is feasible to test for new RBC alloantibody development in most episodically transfused patients with SCD as part of their routine care. The yield of this screening appears low with CEK matching, but it could still provide important information for individual patients., (© 2021 AABB.)

Background: In the setting of suspected septic transfusion reactions, bacterial culture of both the transfused patient and the residual blood component is recommended. Primary bacterial contamination can occur at the time of component collection. Clinically insignificant "secondary contamination" can occur during post-transfusion component discard, retrieval for culture, or manipulation of the bag at the time of culture sampling., Study Design and Methods: This retrospective, multi-center study analyzes positive residual component culture results and companion patient blood cultures from 15 hospitals, 1 blood center, and all cultured transfusion reactions within the province of Quebec, Canada, over a 5-year period. Imputability was assigned as "definite" (concordant growth), "possible" (discordant growth or lack of growth in patient culture), or "unable to assess" (patient not cultured)., Results: There were 373 positive component cultures from 360 unique transfusion reactions, with 276 (76.7%) companion patient blood cultures performed, of which 10 (2.8%) yielded the pathogen detected in the positive component. Of these 10 definite pathogens, 7 (2 Staphylococcus aureus, 3 other staphylococci, and 1 Streptococcus pyogenes and 1 Bacillus sp.) were associated with platelet and 3 (Aeromonas veronii, Staphylococcus epidermidis, and Enterococcus faecalis) with RBC transfusions. RBC and plasma components comprised 70% of positive component cultures., Discussion: The process of performing residual component culture is vulnerable to secondary contamination. The significance of microorganisms recovered from component culture cannot be interpreted in isolation. In the context of low prevalence of primary contamination of blood components, the positive predictive value of a positive component culture result is very low., (© 2021 AABB.)

Background: We hypothesized that variability in practice exists for newborn immunohematology testing due to lack of consensus guidelines. We report the results of a survey assessing that variability at hospitals in the United States and Canada., Study Design and Methods: An AABB Pediatric Subsection working party developed and validated a survey of newborn immunohematology testing practice. The survey was sent electronically to transfusion service leadership at teaching institutions., Results: The response rate was 67% (61/91); 56 surveys meeting inclusion criteria were analyzed. Approximately 90% (50/56) were from birth hospitals and 16.1% (9/56) were from pediatric hospitals. Newborn immunohematology testing is ordered as a panel by 66.0% (33/50) of birth hospitals. ABO group and DAT is mandated before discharge in 14/56 (25.0%) and 13/56 (23.2%), respectively. About 76.8% (43/56) selectively perform a DAT according to blood blank or clinical parameters. The most common DAT practices include anti-IgG only testing by 73.2% (41/56) and use of umbilical cord specimen type by 67.9% (38/56). A positive DAT is a critical value for 26.8% (15/56) and followed with eluate testing when a maternal antibody screen is positive for 48.2% (27/56). In the setting of a non-ABO maternal red cell antibody, 55.4% (31/56), phenotype neonatal red cells when the DAT is positive. Group O RBC are transfused irrespective of the DAT result for 82.1%, (46/56)., Conclusion: There is variability in newborn immunohematology testing and transfusion practice and potential overutilization of the DAT. Evidence-based consensus guidelines should be developed to standardize practice and to improve safety., (© 2021 AABB.)

Background: Hyperkalemia is a rare life-threatening complication of red blood cell (RBC) transfusion. Stored RBCs leak intracellular potassium (K+) into the supernatant; irradiation potentiates the K+ leak. As the characteristics of patients and implicated RBCs have not been studied systematically, a multicenter study of transfusion-associated hyperkalemia (TAH) in the pediatric population was conducted through the AABB Pediatric Transfusion Medicine Subsection., Study Design: The medical records of patients <18 years old were retrospectively queried for hyperkalemia occurrence during or ≤12 h after the completion of RBC transfusion in a 1-year period. Collected data included patient demographics, diagnosis, medical history, timing of hyperkalemia and transfusion, mortality, and RBC unit characteristics., Results/findings: A total of 3777 patients received 19,649 RBC units during the study period in four facilities. TAH was found in 35 patients (0.93%) in 37 occurrences. The patient median age and weight were 1.28 years and 9.80 kg, respectively. All patients had multiple serious comorbidities. There were 79 RBC units transfused in the TAH events; 62% were irradiated, and the median age of the units was 10 days. The median total RBC volume transfused ≤12 h before TAH was 24% of patient estimated total blood volume, and the median infusion rate (IR) was19.6 ml/kg/h. Mortality rate within 1 day after the TAH event was 20%., Conclusions: The prevalence of TAH in children was low; however, the 1-day mortality rate was 20%. Patients with multiple comorbidities may be at higher risk for TAH. The IR was higher for patients who had TAH than the IR threshold for safe transfusion., (© 2021 AABB.)

Background: Bacterial contamination of platelets is the leading infectious risk to the United States (US) blood supply. On 30 September 2019, the US Food and Drug Administration (FDA) published a Final Guidance for Industry to reduce the risk of transfusing platelets contaminated by bacteria. A national survey was undertaken to assess readiness, attitudes, and the potential impact on hospital-based transfusion services., Study Design and Methods: A survey was distributed to transfusion services in all 50 US states. Summary statistics were performed along with review and categorization of email feedback and free text comments., Results: Eighty-three transfusion services from 48 states participated in this survey study. Currently, the most common approach is primary culture performed at manufacturing (n = 49/83, 59%). Of the bacterial risk mitigation strategies provided by the FDA, the most frequently preferred are (a) pathogen reduced platelets (PRP) for up to 5-day storage (n = 36/77, 47%), (b) large volume delayed sampling (LVDS) ≥48 hours for up to 7-day storage (n = 16/77, 21%), and (c) primary culture ≥24 hours + secondary rapid testing for up to 7-day storage (n = 7/77, 9%). The main motivating factors for the survey participants' selected strategies to comply with FDA final guidance were product availability from supplier, reducing the risk of septic transfusion reactions (STR), and complexity of implementing and performing a new or additional test., Conclusion: While having platelets to transfuse and preventing STR are of the utmost importance, nationwide, the majority of transfusion services do not want to take on performing new or additional testing in their laboratories., (© 2020 AABB.)

Background: Anti-red blood cell (RBC) alloantibodies consisting of only the immunoglobulin G (IgG) 4 subtype are typically considered clinically insignificant. A US Food and Drug Administration-approved monoclonal anti-human globulin (16H8) is nonreactive with IgG4, which has been considered a benefit to avoid testing interference from IgG4. However, 16H8 also does not recognize two natural IgG3 variants (IgG3-03 and IgG3-13). Thus, 16H8 may miss clinically significant alloantibodies in some settings., Study Design and Methods: Novel mouse anti-human IgG hybridomas were generated and screened for reactivity with 32 human variants of anti-KEL1 across different IgG subtypes, as well as mutants to allow epitope mapping. Anti-IgG reactivity was determined using KEL1+ RBCs bound by each IgG variant as targets. Binding of anti-IgG was determined by flow cytometry., Results: 16H8 recognized an epitope involving amino acid 419, which is glutamate in IgG4, IgG3-03, and IgG3-13, explaining the lack of 16H8 reactivity with these subtypes/isoallotypes. A new monoclonal antibody (PUMA8) was isolated that, like 16H8, was nonreactive with IgG4 but without blind spots for known variants of IgG1, IgG2, or IgG3. PUMA8 recognized an epitope containing arginine at position 355, which is glutamine in IgG4. However, a recently described new IgG4 variant with an arginine at position 355 results in PUMA8 reactivity., Conclusion: PUMA8 represents an alternative to 16H8 that avoids IgG4 but without blind spots for IgG3 variants. However, PUMA8 reacts with one recently described IgG4 variant. In addition to relevance to immunohematology, these studies highlight the importance of patient variation with regards to assay performance in an era of personalized medicine., (© 2020 AABB.)

The United States Food and Drug Administration Final Guidance for Industry titled, "Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion" provides nine strategies for platelet bacterial risk mitigation. Even if it is assumed all strategies are comparable in terms of safety and efficacy, the decision of which to implement remains challenging. Some additional factors that warrant evaluation before selecting a strategy include the financial impact, process for implementation, logistics upon implementation, institutional acceptance by blood bank staff, administration and clinicians, and effect on platelet availability. To assist with this difficult choice, a panel of transfusion service physicians who have expertise on the topic and have already selected strategies for their transfusion services were recruited to provide varied perspectives. In addition, the use of a decision-making tool that objectively evaluates defined criteria for assessment of the nine strategies is described., (© 2020 AABB.)

Background: Culturing residual blood components after suspected septic transfusion reactions guides management of patients and cocomponents. Current practice, accuracy of provider vital sign assessment, and performance of the AABB culture criteria are unknown. A multicenter international study was undertaken to investigate these issues and develop improved culture criteria., Study Design and Methods: Retrospective data for all transfusion reactions resulting in residual blood component culture in 2016 were collected from participating hospitals. The performance of the AABB culture criteria were assessed for detection of positive culture results. Modifications to the AABB criteria including 1) recommending culturing in the setting of isolated high fevers, 2) defining hypotension and tachycardia using objective parameters, and 3) incorporating antipyretic use were tested to determine if modifications improved performance. Modifications associated with improvement were incorporate into the BEST criteria. The AABB and the BEST criteria were then tested against a data set enriched for positive culture results to determine which criteria were superior., Results: Data were collected from 20 centers encompassing 779,143 transfusions, 3,187 reported transfusion reactions, and 1,104 cultured components. There was marked variation in reaction reporting and culturing rates (0.0%-100.0%). Of 35 total positive component cultures, only one of 35 (2.9%) had concordant patient cultures; 12 of 34 (35.3%) did not have patient cultures performed. The BEST criteria had better sensitivity for detection of a positive culture result compared to the AABB criteria (74% vs. 41%), although specificity decreased (45% vs. 65%)., Conclusion: Compared to the AABB criteria, the BEST criteria have improved sensitivity for positive culture detection., (© 2019 AABB.)

Background: The first step in the production of chimeric antigen receptor T cells is the collection of autologous T cells using apheresis technology. The procedure is technically challenging, because patients often have low leukocyte counts and are heavily pretreated with multiple lines of chemotherapy, marrow transplantation, and/or radiotherapy. Here, we report our experience of collecting T lymphocytes for chimeric antigen receptor T-cell manufacturing in pediatric and young adult patients with leukemia, non-Hodgkin lymphoma, or neuroblastoma., Study Design and Methods: Apheresis procedures were performed on a COBE Spectra machine using the mononuclear cell program, with a collection target of 1 × 10 9 total mononuclear cells per kilogram. Data were collected regarding preapheresis and postapheresis blood counts, apheresis parameters, products, and adverse events., Results: Ninety-nine patients (ages 1.3-25.7 years) and 102 apheresis events were available for analysis. Patients underwent apheresis at a variety of absolute lymphocyte cell counts, with a median absolute lymphocyte count of 944 cells/μL (range, 142-6944 cells/μL). Twenty-two patients (21.6%) had absolute lymphocyte counts less than 500 cells/μL. The mononuclear cell target was obtained in 100% of all apheresis harvests, and chimeric antigen receptor T-cell production was possible from the majority of collections (94%). Mononuclear cell collection efficiency was 65.4%, and T-lymphocyte collection efficiency was 83.4%. Ten patients (9.8%) presented with minor adverse events during the 102 apheresis procedures, with one exception of a severe allergy., Conclusions: Mononuclear cell apheresis for chimeric antigen receptor T-cell therapy is well tolerated and safe, and it is possible to obtain an adequate quantity of CD3+ lymphocytes for chimeric antigen receptor T-cell manufacturing in heavily pretreated patients who have low lymphocyte counts., (© 2018 AABB.)

Background: To meet the needs of a diverse patient population, an adequate supply of red blood cells (RBCs) from ethnic/racial minority donors is essential. We previously described the 10-year changes in minority blood donation in the United States. This study describes donation patterns by donor status, age, and race/ethnicity., Study Design and Methods: Data on the age and the number of unique black/African American, Hispanic/Latino, Asian, and white RBC donors were obtained from eight US blood collectors for 2006, 2009, 2012, and 2015. Donors self-identified their race/ethnicity. First-time (FT) and repeat (R) donors were analyzed separately., Results: Overall, for both FT and R donor groups, whites constituted the majority of unique donors (FT 66.7% and R 82.7%) and also donated the greatest proportion of RBC units (FT 66.6% and R 83.8%). Donors less than 20 years old comprised the greatest proportion of FT donors for all racial/ethnic groups (39.2%) and had the highest mean number of RBC donations per donor (1.12) among FT donors. Conversely, R donors less than 20 years old had some of the lowest mean number of RBC donations per donor (1.55) among R donors, whereas R donors at least 60 years old had the highest mean (1.88). Year by year, the percentage of FT donors who were less than 20 years old increased for all race/ethnicities. For R donors, whites were more frequently older, while Hispanics/Latinos and Asians were younger., Conclusions: Greater efforts to convert FT donors less than 20 years into R donors should be undertaken to ensure the continued diversity of the blood supply., (© 2017 AABB.)

Background: Treatment of necrotizing soft tissue infections (NSTIs) includes prompt surgical debridement and antibiotics, but despite standard care, the morbidity and mortality remain high. Since therapeutic plasma exchange (TPE) has been considered for treatment of severe sepsis, this study evaluates the efficacy of TPE for patients with NSTI., Study Design and Methods: This is a retrospective study of patients with diagnosis of NSTI who received treatment with and without TPE over an 11-year period. The primary outcome was in-hospital mortality., Results: Fifty-two patients with NSTI treated with TPE (TPE group) and 125 patients with NSTI not treated with TPE (non-TPE group) were assessed. Nineteen (36.5%) patients died in the TPE group, and 35 (28%) patients died in the non-TPE group. Within the TPE group, there was significant improvement in white blood cell (WBC) count and sodium levels 7 days after TPE treatment, but no improvement in creatinine. Inverse probability weighting based on propensity scores was used to compare survival in the TPE and non-TPE groups and demonstrated that TPE was associated with an increased odds of death (odds ratio, 2.8). A second analysis matched for six variables yielded 31 pairs and demonstrated no significant difference in mortality or length of stay., Conclusions: This study describes the largest series of patients with NSTIs treated with TPE and showed no evidence of clinical benefit. Further carefully designed studies with meaningful clinical endpoints would prove useful in assessing reproducibility and determining if there is a role for TPE in other forms of severe sepsis., (© 2017 AABB.)

Background: To provide the appropriately diverse blood supply necessary to support alloimmunized and chronically transfused patients, minority donation recruitment programs have been implemented. This study investigated temporal changes in minority red blood cell (RBC) donation patterns in the United States., Study Design and Methods: Data on donor race and ethnicity from 2006 through 2015, including the number of unique donors, collections, RBCs successfully donated, and average annual number of RBC donations per donor (donor fraction), were collected from eight US blood collectors. Minority donors were stratified into the following groups: Asian, black or African American, Hispanic or Latino, Native Indian or Alaska Native, Native Hawaiian or other Pacific Islander, white, multiracial/other, and no answer/not sure., Results: Over the 10-year period, white donors annually constituted the majority of unique donors (range, 70.7%-73.9%), had the greatest proportion of collections (range, 76.1%-79.8%), and donated the greatest proportion of RBC units (range, 76.3%-80.2%). These donors also had the highest annual donor fraction (range, 1.82-1.91 units per donor). Black or African American donors annually constituted between 4.9 and 5.2% of all donors during the study period and donated between 4.0 and 4.3% of all RBC units. Linear regression analysis revealed decreasing numbers of donors, collections, and donated RBC units from white donors over time., Conclusion: Although the US population has diversified, and minority recruitment programs have been implemented, white donors constitute the majority of RBC donors and donations. Focused and effective efforts are needed to increase the proportion of minority donors., (© 2017 AABB.)

Background: Red blood cell (RBC) antigen matching policies to prevent alloimmunization in females of childbearing potential (FCP) vary between centers. To inform transfusion centers responsible for making decisions about matching policies for FCPs, the causal stimulus of the antibodies implicated in severe hemolytic disease of the fetus and newborn (HDFN) must be determined., Study Design and Methods: We conducted a multinational retrospective study of women with offspring affected by severe HDFN requiring neonatal exchange transfusion and/or intrauterine transfusion. Mothers treated at centers that provide extended antigen-negative RBCs (MATCH, five centers) and those that do not (NoMATCH, nine centers) were compared., Results: A total of 293 mothers had at least one affected pregnancy: 179 at MATCH centers and 114 at NoMATCH centers. Most alloimmunization (83%) was attributed to previous pregnancy: 3% to transfusion (two cases at MATCH, six at NoMATCH centers) and 14% undetermined (both antecedent transfusion and pregnancy). Only 50 mothers had received transfusions; 13 had HDFN due to anti-K at MATCH and four at NoMATCH centers. Most (12/13, 92%) of the anti-K HDFN cases at MATCH centers had K+ paternal antigen status. Mothers at the MATCH centers do not appear to be protected from HDFN due to K, C, c, and E antibodies, although the low number of FCPs who received transfusions precluded drawing firm conclusions., Conclusion: The causal stimulus of antibodies that cause HDFN is predominantly from previous pregnancy. Although extended RBC matching for FCPs may impart some protection from allosensitization, we were unable to show a positive effect, possibly because matching policies are not uniform and there was a small number of mothers who previously received transfusions., (© 2017 AABB.)

Background: Warm-reactive autoantibodies (WAAs) are the most common cause of autoimmune hemolytic anemia (AIHA) and can also be present without clinically significant hemolysis. WAAs complicate immunohematological testing, yet there is no commonly accepted approach to laboratory evaluation and red blood cell (RBC) selection., Study Design and Methods: We searched PubMed/Cochrane Central for articles that described testing methodology and blood selection for patients with WAAs. We developed a 31-question survey regarding local practice for immunohematology testing and RBC selection in patients with WAAs (with or without AIHA)., Results: Eighty-six studies met the inclusion criteria and the aims of this review. Most of the literature was comprised of retrospective studies that often did not correlate laboratory results with clinical findings. Evidence-based protocols to guide testing and RBC selection for transfusion in patients with WAAs are lacking. Individuals representing 54 laboratories completed the survey. The responses indicated that numerous methodologies are used to identify underlying alloantibodies: 75% of respondents use autoadsorption; in patients who have a recent history of transfusion, 76% of respondents use alloadsorption; 58% of respondents perform direct antiglobulin testing (DAT) each time the indirect antiglobulin test is positive; and 48% perform eluate studies at the initial identification of WAAs. Responding laboratories may use phenotyping (98%) or genotyping (80%) at some point in the work-up. Seventy-five percent of respondents provide phenotype-matched or genotype-matched RBCs for transfusion., Conclusion: There is wide variability in immunohematology testing and RBC selection practices for patients who have WAAs (with or without AIHA). Future studies are needed to evaluate and compare the effectiveness of different testing algorithms and transfusion strategies., (© 2016 AABB.)

Background: Human immunoglobulin G (IgG) includes four different subtypes (IgG1, IgG2, IgG3, and IgG4), and it is also now appreciated that there are genetic variations within IgG subtypes (called isoallotypes). Twenty-nine different isoallotypes have been described, with 7, 4, 15, and 3 isoallotypes described for IgG1, IgG2, IgG3, and IgG4, respectively. The reactivity of anti-IgG with different isoallotypes has not been characterized., Study Design and Methods: A novel monoclonal anti-K antibody (PugetSound Monoclonal Antibody 1 [PUMA1]) was isolated and sequenced, and a panel of PUMA1 variants was expressed, consisting of the 29 known IgG isoallotypes. The resulting panel of antibodies was preincubated with K-positive red blood cells (RBCs) and then subjected to testing with currently approved anti-IgG by flow cytometry, solid phase systems, gel cards, and tube testing., Results: A US Food and Drug Administration (FDA)-approved monoclonal anti-IgG (gamma-clone) failed to recognize 2 of 15 IgG3 isoallotypes (IgG3-03 and IgG3-13) and 3 of 3 IgG4 isoallotypes (IgG4-01, IgG4-02, and IgG4-03). In contrast, an FDA-approved rabbit polyclonal anti-IgG recognized each of the known human IgG isoallotypes., Conclusion: These findings demonstrate "blind spots" in isoalloantibody detection by a monoclonal anti-IgG. If a patient has anti-RBC antibodies predominantly of an IgG3 subtype (the IgG3-03 and/or IgG3-13 variety), then it is possible that a clinically significant alloantibody would be missed. IgG-03 and IgG-13 have an estimated frequency of 1% to 3% in Caucasian populations and 20% to 30% in certain African populations. Nonreactivity with IgG4 is a known characteristic of this monoclonal anti-IgG, but IgG4 isoallotypes have not been previously reported., (© 2016 AABB.)

Background: Daratumumab (DARA) consistently interferes with routine blood bank serologic testing by directly binding to CD38 expressed on reagent red blood cells (RBCs). Treating RBCs with dithiothreitol (DTT) eliminates the DARA interference. We conducted an international, multicenter, blinded study aimed at validating the DTT method for use by blood bank laboratories worldwide., Study Design and Methods: Paired plasma sample unknowns were sent to 25 participating blood bank laboratories. Sample 1 was spiked with DARA only (10 µg/mL), and Sample 2 with DARA plus a clinically significant RBC antibody (anti-D [n = 6], anti-Fy a [n = 9], or anti-s [n = 10]). Sites were instructed to perform an antibody screen with and without DTT-treated RBCs and to use a DTT-treated RBC panel for antibody identification. Qualitative data about the DTT method were collected by online survey. The primary outcome was the proportion of study sites able to identify the antibody unknown in the presence of DARA., Results: All sites observed the DARA interference with the antibody screen. The DARA interference was seen with all testing methods (gel, tube, or solid phase). Using the DTT method, 25 of 25 sites (100%) successfully identified the antibody unknown in the presence of DARA. Feedback on the DTT method was positive, with 17 of 19 (90%) sites responding to the survey indicating that they planned to use the DTT method to test clinical samples from DARA-treated patients., Conclusion: The DTT method is robust and reproducible and can be implemented by transfusion services worldwide to help provide safe blood products to patients treated with DARA., (© 2016 AABB.)

Background: By consensus definition, the red blood cells (RBCs) of patients that react weak to 2+ in the serologic D test are classified as having the serologic weak D phenotype (weak D). The risk of D alloimmunization in patients with weak D is not well studied. This study retrospectively determined the incidence of D alloimmunization in patients with weak D who received D+ blood products., Study Design and Methods: Patient records at four institutions were reviewed. Eligible patients had at least 1 D typing result with agglutination strength that was weak to 2+ result in gel or tube (Institutions 1-3) or weak to 2+ result in solid phase or a positive tube weak D test using antihuman globulin reagent (Institution 4). All patients received at least 1 D+ allogeneic RBC or platelet transfusion and had a subsequent antibody detection test performed at least 30 days after the first D+ transfusion., Results: The incidence of alloanti-D formation was 0.15% (6/4011, at Institutions 1-3) and 5.1% (3/59, at Institution 4; these incidences were significantly different [p = 0.0002]). There were 0.15% (6/4011) patients who had autoanti-D detected; all were at Institutions 1 to 3., Conclusions: Until RHD genotyping is widely available, these data support the fact that patients with serologic weak D may be transfused with D+ RBCs if an urgent transfusion is required. At Institution 4, inclusion of a higher proportion of black patients compared to the other institutions may have affected the incidence of alloimmunization by perhaps including partial D recipients who are at risk of forming D antibodies., (© 2016 AABB.)

Background: The optimal mitigation strategy to prevent transfusion transmission of cytomegalovirus (TT-CMV) in preterm very low birthweight infants remains debated. Hospitals caring for this patient population have varied practices., Study Design and Methods: A prospective observational comparative effectiveness pilot study was conducted to determine the feasibility for a larger study. The pilot was carried out at hospitals using a leukoreduction (LR)-only transfusion strategy. Specimen and data collection for this study was performed in a similar approach to a study completed at Emory University that employed the CMV-seronegative plus LR approach. All testing was performed at one laboratory. The rates of TT-CMV using the two transfusion strategies were compared., Results: Zero incidence of TT-CMV was detected in infants (n = 20) transfused with LR-only blood (0/8; 95% confidence interval [CI], 0-25.3%) and is consistent with the previously reported zero incidence of TT-CMV finding in a cohort of infants transfused with CMV-negative plus LR blood (0/310; 95% CI, 0%-0.9%). The seroprevalence rate among enrolled mothers (n = 17) was 60%. Forty percent of those infants (8/20) received 43 transfusions; five were transfused with one or more CMV-seropositive blood components. One infant had tested positive for CMV before receiving blood transfusions; the infant's mother was CMV immunoglobulin (Ig)G positive and IgM negative., Conclusions: Using the LR-only transfusion approach, zero cases of TT-CMV were detected in this pilot study. A larger study is needed to reliably determine the most effective strategy for prevention of TT-CMV in this population., (© 2016 AABB.)

Background: As patient blood management becomes more widespread, fewer red blood cell (RBC) units have been transfused. This multinational study evaluated changes in blood center RBC distributions., Study Design and Methods: Data on number and ABO and D groups of RBC distributions were obtained from several large American blood centers and national or provincial blood services (NPBS) from fiscal year (FY) 2010 through FY2014. Due to relatively larger numbers of distributions and differences in ABO and D groups between the Japanese Red Cross and the other NPBS, Japanese data were not included in distributions calculations., Results: Data from seven American blood centers and eight NPBS were obtained. Overall, at both the American and the seven NPBS that were analyzed, there were declines in the number of RBC distributions between FY2010 and FY2014, 16.9 and 8.0%, respectively. The number of O- RBC distributions decreased by 9.0% at American blood centers but the proportion of RBC distributions that were O- increased by 9.3% during this time. The NPBS had 1.6% increase in O- RBC distributions and 10.5% increase in the proportion of O- distributions. The proportion of O+ distributions increased slightly over time at American centers (2.9%) while decreasing slightly (1.1%) at NPBS despite reductions in the absolute numbers of O+ distributions. Overall there was 2.6% decrease in the proportion of B+ and AB+ RBCs distributed and 13.6% absolute reduction in the number of these units distributed., Conclusion: Although overall RBC distributions have decreased over time, the proportion of O units has increased substantially., (© 2016 AABB.)

Background: Information about patient survival after transfusion of multiple blood volumes is limited, and most reports have focused on trauma patients., Study Design and Methods: Retrospective study of blood use and survival at 11 hospitals in six nations between 2009 and 2013. Ultramassive transfusion (UMT) was defined as transfusion of 20 or more red blood cell (RBC) units over the course of any 2 consecutive calendar days., Results: A total of 1975 patients received UMT and a representative sample of 1360 patients was studied in detail. Patients were grouped into seven diagnostic categories: solid organ transplantation (n = 411), cardiac or major vascular surgery (n = 317), general surgery (n = 228), trauma (n = 221), general medicine (n = 124), obstetrics (n = 23), and other (n = 36). During the 7 days after initiation of UMT, these patients used more than 120,000 blood components. The median (interquartile range) blood use was 35 (26-50) RBC units, 30 (20-47) plasma units, and 7 (4-13) platelet doses. Five- and 30-day survival significantly declined with increasing RBC use. Overall survivals of patients receiving UMT were 71% (5 day) and 60% (30 day), and in the subset of 165 patients receiving 60 or more RBC units over 2 consecutive days, 5-day survival was 54% ranging from 17% (trauma) to 75% (solid organ transplant). The decline in survival with increasing RBC transfusions was minimal for patients undergoing solid organ transplantation and was most pronounced for trauma and nonsurgical bleeding patients., Conclusion: Trauma was not the leading cause of UMT. Increasing RBC requirements were significantly associated with decreasing survival. However, survival was more strongly associated with diagnostic category than total RBCs transfused, with highest survival rates in solid organ transplant surgery., (© 2015 AABB.)

Background: There has yet to be a comprehensive analysis of blood group antigen prevalence in Asian Americans and Native Americans. There may be ethnic differences in blood group frequencies that would result in clinically important mismatches through transfusion., Study Design and Methods: Blood donors who self-identified as Asian or Native American were tested using a single-nucleotide polymorphism (SNP) DNA array (HEA BeadChip kit, Bioarray Solutions Ltd) that predicts expression of 38 human erythrocyte antigens (HEAs) and by serology for ABO, D, C, M, N, Jk(a) , and Jk(b) . The prevalence of blood group antigens was compared to published European prevalence. Discrepancies between SNP-predicted and serology-detected antigens were tallied., Results: A total of 9087 blood donors were tested from nine Asian and Native American heritages. The predicted prevalence of selected antigens in the RHCE, JK, FY, MNS, LU, CO, and DO blood group systems were variable between Asian populations, but overall not significantly different than Europeans. Compared to European frequencies, Kell blood group allele frequencies were significantly different in the Chinese, Native American, Hawaiian/Pacific Islander, South Asian, and Southeast Asian heritage blood donors; Diego antigens Di(a) and Di(b) were different in donors of Native American and South Asian ancestries (p < 0.05). Of the donors tested, 4.5% showed a SNP-serology discrepancy that segregated within specific ethnic groups., Conclusion: This study provides HEA allele frequency and antigen prevalence data in a cohort of Asian and Native Americans donors. Several ethnic groups exhibited differences in HEA frequencies compared to Europeans. Genotype-serotype discrepancies were detected in all systems studied., (© 2015 AABB.)

Background: The causes of anemia in infrequent blood donors deferred for low hemoglobin (Hb) are not well known. We sought to assess this via surveys of infrequent, non-menstruating deferred blood donors at two institutions, BloodCenter of Wisconsin and Puget Sound Blood Center., Study Design and Methods: Men at least 18 years of age and women at least 50 years of age who were deferred for low Hb (≤12.5 g/dL), had not more than one donation in the year prior to deferral, and did not successfully donate in the 3 months after their deferral were surveyed., Results: The total response rate was 380 donors or 34% of those contacted. Of the respondents, 141 had sought medical advice about their low Hb. Of these, 90 were confirmed to have anemia and 13 reported serious disease requiring medical intervention, including mantle cell lymphoma, multiple myeloma, and gastrointestinal bleeding., Conclusions: A small but concerning number of infrequent blood donors deferred for low Hb have an underlying illness that is severe and would benefit from medical attention. Donors deferred for low Hb who have a high risk for serious underlying illness should be provided targeted educational information advising them to seek additional medical care., (© 2014 AABB.)

Background: Clinical trials are investigating the potential benefit resulting from a reduced maximum storage interval for red blood cells (RBCs). The key drivers that determine RBC age at the time of issue vary among individual hospitals. Although progressive reduction in the maximum storage period of RBCs would be expected to result in smaller hospital inventories and reduced blood availability, the magnitude of the effect is unknown., Study Design and Methods: Data on current hospital blood inventories were collected from 11 hospitals and three blood centers in five nations. A general predictive model for the age of RBCs at the time of issue was developed based on considerations of demand for RBCs in the hospital., Results: Age of RBCs at issue is sensitive to the following factors: ABO group, storage age at the time of receipt by the hospital, the restock interval, inventory reserve, mean demand, and variation in demand., Conclusions: A simple model, based on hospital demand, may serve as the basis for examining factors affecting the storage age of RBCs in hospital inventories. The model suggests that the age of RBCs at the time of their issue to the patient depends on factors external to the hospital transfusion service. Any substantial change in the expiration date of stored RBCs will need to address the broad variation in demand for RBCs while attempting to balance considerations of availability and blood wastage., (© 2013 American Association of Blood Banks.)

Background: A systematic review of randomized controlled trials and observational studies assessing platelet (PLT) transfusion therapy identified gaps in the descriptions of trial design, variables of the PLT products transfused, and outcomes. We aimed to systematically develop a reporting guideline to aid in designing, reporting, and critiquing PLT trials., Study Design and Methods: With the use of expert opinion, a preliminary checklist of 23 items was created. The Delphi method, an iterative forecasting method, was used to achieve consensus among experts to systematically improve upon the preliminary checklist. Items were ranked for inclusion using a 7-point Likert scale from "definitely should not" to "very important to" include. Criteria were established a priori based on the mean score: at least 5.5 accept, 2.6 to 5.4 intermediate, and not more than 2.5 eliminate. Intermediate items were edited and sent out in subsequent rounds for review. Three rounds were undertaken to determine the final checklist., Results: Initially 33 experts participated, decreasing to 25 by the third round. The preliminary checklist consisted of 23 items spread over four sections: methods and intervention, PLT-specific outcomes, PLT-specific results, and PLT-specific adverse events. After three rounds of the Delphi method, the checklist was expanded and refined to include 30 items. The final checklist was further enhanced by adding an explanatory guide., Conclusion: Use of the Delphi method was successful in finding consensus on items to include in reports of a clinical PLT transfusion study. The final checklist and explanatory guide will be useful for authors and editors to improve the reporting of PLT transfusion trials., (© 2012 American Association of Blood Banks.)

Background: The transfusion medical record is an important tool for providing safe and appropriate blood. However, many patients seek care at more than one hospital and this record is usually not portable. We posited that a centralized transfusion service database (CTS-D) offers benefits through tracking blood types, transfusion requirements, and detecting wrong blood in tube (WBIT)., Study Design and Methods: Records held in the CTS-D from 1997 to 2010 were queried to enumerate those seen at more than one hospital versus one hospital only. Transfusion-related attributes were collected including red blood cell (RBC) antibodies, transfusion requirements, and reactions. WBITs detected due to historical ABO typing were tallied. A review of blood orders that required alteration based on requirements held in the CTS-D was completed., Results: There were 724,584 records; 10.9% of patients had been tested or received blood transfusion at more than one hospital. Of the 63,973 records with RBC alloantibodies, a greater proportion of patients were seen at more than one hospital versus one hospital only (7.11% vs. 3.97%, p < 0.005). Of the 97,687 patient records that required special processing, patients seen at one hospital had a lower rate than those at more than one hospital (12.13% vs. 24.59%, p < 0.005). There were 77 WBITs (0.18 WBITs per 1000 patients). An in-depth review of WBITs found an additional 26.3% (5 of 19) were detected because the current and historical ABO types were from two different hospitals within the CTS., Conclusions: The CTS-D provides a universal transfusion record that improves patient safety. As health care systems are enlarged, centralization of the transfusion component of the medical record should be considered., (© 2012 American Association of Blood Banks.)