Hybrid cord blood banking in a private-public-partnership: Women's perspectives.

BACKGROUND: The increasing demand for umbilical cord blood (UCB) used in stem cell transplantation led to the establishment of cord blood (CB) banks worldwide. These include public foreign donor banks and private family-directed donor banks. Recently, our department has introduced a third banking model within a private-public-partnership. This hybrid banking allows for storage of family-directed CB units, while also getting Human leukocyte antigen (HLA)-typed and included in the national stem cell donor registry. So if the need arises, the HLA-compatible CB unit can be released to an unrelated recipient as a foreign donor stem cell graft. OBJECTIVES: The aim of this study was to evaluate women's perspectives on the different CB banking options as well as retrospective satisfaction with their decisions. METHODS: We performed a prospective survey study in postpartum women, using a validated questionnaire. RESULTS: A total of 157 women were included in this survey study; 68% of them decided to have their UCB stored or donated. Among those women, 25% of them opted for hybrid storage, 72% of respondents stored UCB publicly, and 3% decided for private family-directed storage. CONCLUSIONS: Our study shows the potential of hybrid banking as an attractive UCB storage option, as an alternative to family-directed banking rather than a substitute for public donation. Hybrid storage potentially combines advantages of family-directed banking as well as unrelated CB donation expanding the number of registered CB units available for transplantation and giving every pregnant woman the possibility to store UCB.

Routine results of an algorithm for managing the production of blood components.

BACKGROUND AND OBJECTIVES: The variability in the number of donations together with a growing demand for platelet concentrates and plasma-derived medicines make us seek solutions aimed at optimizing the processing of blood. Some mathematical models to improve efficiencies in blood banking have been published. The goal of this work is to validate and evaluate an algorithm's impact in the production of blood components in the Blood and Tissues Bank of Aragon (BTBA). MATERIALS AND METHODS: A mathematical algorithm was designed, implemented and validated through simulations with real data. It was incorporated into the fractionation area, which uses the Reveos® fractionation system (Terumo BCT) to split blood into its components. After 9 months of daily routine validation, retrospective activity data from the Blood Bank and Transfusion Services before and during the use of the algorithm were compared. RESULTS: Using the algorithm, the outdating rate of platelet concentrates (PC) decreased by 87.8% in the blood bank. The average shelf life remaining of PC supplied to Transfusion Services increased by almost 1 day. As a consequence, the outdating rate in the Aragon Transfusion Network decreased by 33%. In addition, extra 100 litres of plasma were obtained in 9 months. CONCLUSIONS: The algorithm improves the blood establishment's workflow and facilitates the decision-making process in whole blood processing. It resulted in a decrease in PC outdating rate, increase in PC shelf life and finally an increase in the volume of recovered plasma, leading to significant cost savings.

Multicenter evaluation of the IL-3-pSTAT5 assay to assess the potency of cryopreserved stem cells from cord blood units: The BEST Collaborative study.

BACKGROUND: The IL-3-pSTAT5 assay, a new, rapid, and standardized flow-cytometry-based assay may compensate for several limitations of the colony-forming unit (CFU) assay typically used for stem cell potency assessments of cord blood units (CBU). We performed an inter-laboratory evaluation of the performance of this new assay. STUDY DESIGN AND METHODS: This Biomedical Excellence for Safer Transfusion (BEST) Collaborative multicenter, international study included 15 participants from public cord blood banks (CBBs), CBB-supporting research laboratories, and stem cell laboratories. To perform the IL-3-pSTAT5 assay, participating centers received reagents, instructions, and 10 blind CBU samples, including eight normal samples and two samples exposed to a transient warming event. We measured inter-laboratory agreement qualitatively (proportion of correctly classified samples) and quantitatively (coefficient of variation [CV], correlation coefficients, receiver operating characteristics (ROC) curve, and intraclass correlation coefficient [ICC]). RESULTS: The qualitative agreement was 97.3% (i.e., 107/110; Fleiss' kappa = 0.835). The average CV on a per-sample basis was 11.57% among all samples, 8.99% among normal samples, and on a per-center basis was 9.42% among normal samples. In a correlation matrix that compared results across centers, the mean Pearson's correlation coefficient was 0.88 (standard deviation = 0.04). The ICC was 0.83 (95% confidence interval = 0.68-0.95). The area under the curve (AUC) from the ROC curve was 0.9974. DISCUSSION: Excellent qualitative and quantitative agreement was exhibited across laboratories. The IL-3-pSTAT5 assay may therefore be implemented in flow cytometry laboratories to rapidly and reliably provide standardized measures of stem cell potency in CBUs.

Using Interactive Visual Analytics to Optimize Blood Products Inventory at a Blood Bank.

Blood products and their derivatives are perishable commodities that require an efficient inventory management to ensure both a low wastage rate and a high product availability rate. To optimize blood product inventory, Blood Transfusion Services (BTS) need to reduce wastage by avoiding outdates and improving availability of different blood products. We took a blood product lifecycle approach and used advanced visualization techniques to design and develop a highly interactive web-based dashboard to audit retrospective data and consequently, to identify and learn from procedural inefficiencies based on analysis of transactional data. We present pertinent scenarios to show how the blood transfusion staff can use the dashboard to investigate blood product lifecycles so as to probe transition sequence patterns that led to wastage as a means to discover causes of procedural inefficiencies in the BTS.

Impact of COVID-19 on the efficacy of meeting the transfusion demand by a Brazilian blood banks network.

One of the effects of the pandemic in the hemotherapy services was the reduction in the attendance of blood donors and production of blood components. It is relevant to investigate how the capacity to meet the demand for blood components was affected, especially in blood centers located in the regions most affected by the pandemic, such as Brazil. This study aimed to describe the impact of the pandemic on the capacity to meet the demand for different types of blood components by a Brazilian blood center in 2020, compared to the historical series of 2016-2019 and to discuss the measures adopted to mitigate the effects of the pandemic. Retrospective cross-sectional study was carried out with comparative analysis of the blood components requested and attended in the period from 2016 to 2020. Data analysis was performed by Graphpad Prism 5. The spread of COVID-19 cases since March 2020 had impact on the blood components production and transfusions. The reduction in the production of blood components was observed prior to the restriction measures, in March 2020. In comparison to 2016-2019, there was a reduction in the number of transfusions performed in all months of 2020. The results suggest that the measures adopted in a Brazilian blood center to face the COVID-19 pandemic resulted in reasonable regularity in the supply of blood components. The sharing of experiences between blood banks in different regions, social and epidemiological contexts can contribute to the improvement of strategies to reduce the impact of COVID-19 in transfusion medicine.

Transfusion-Associated Delirium in Children: No Difference Between Short Storage Versus Standard Issue RBCs.

OBJECTIVES: Primary objective is to determine if transfusion of short storage RBCs compared with standard issue RBCs reduced risk of delirium/coma in critically ill children. Secondary objective is to assess if RBC transfusion was independently associated with delirium/coma. DESIGN: This study was performed in two stages. First, we compared patients receiving either short storage or standard RBCs in a multi-institutional prospective randomized controlled trial. Then, we compared all transfused patients in the randomized controlled trial with a single-center cohort of nontransfused patients matched for confounders of delirium/coma. SETTING: Twenty academic PICUs who participated in the Age of Transfused Blood in Critically Ill Children trial. PATIENTS: Children 3 days to 16 years old who were transfused RBCs within the first 7 days of admission. INTERVENTIONS: Subjects were randomized to either short storage RBC study arm (defined as RBCs stored for up to seven days) or standard issue RBC study arm. In addition, subjects were screened for delirium prior to transfusion and every 12 hours after transfusion for up to 3 days. MEASUREMENTS AND MAIN RESULTS: Primary outcome measure was development of delirium/coma within 3 days of initial transfusion. Additional outcome measures were dose-response relationship between volume of RBCs transfused and delirium/coma, and comparison of delirium/coma rates between transfused patients and individually matched nontransfused patients. We included 146 subjects in the stage I analysis; 69 were randomized to short storage RBCs and 77 to standard issue. There was no significant difference in delirium/coma development between study arms (79.5% vs 70.1%; p = 0.184). In the stage II analysis, adjusted odds for delirium in the transfused cohort was more than eight-fold higher than in the nontransfused matched cohort, even after controlling for hemoglobin (adjusted odds ratio, 8.9; CI, 2.8-28.4; p < 0.001). CONCLUSIONS: RBC transfusions (and not anemia) are independently associated with increased odds of subsequent delirium/coma. However, storage age of RBCs does not affect delirium risk.

Joint Trauma System, Defense Committee on Trauma, and Armed Services Blood Program consensus statement on whole blood.

Hemorrhage is the most common mechanism of death in battlefield casualties with potentially survivable injuries. There is evidence that early blood product transfusion saves lives among combat casualties. When compared to component therapy, fresh whole blood transfusion improves outcomes in military settings. Cold-stored whole blood also improves outcomes in trauma patients. Whole blood has the advantage of providing red cells, plasma, and platelets together in a single unit, which simplifies and speeds the process of resuscitation, particularly in austere environments. The Joint Trauma System, the Defense Committee on Trauma, and the Armed Services Blood Program endorse the following: (1) whole blood should be used to treat hemorrhagic shock; (2) low-titer group O whole blood is the resuscitation product of choice for the treatment of hemorrhagic shock for all casualties at all roles of care; (3) whole blood should be available within 30 min of casualty wounding, on all medical evacuation platforms, and at all resuscitation and surgical team locations; (4) when whole blood is not available, component therapy should be available within 30 min of casualty wounding; (5) all prehospital medical providers should be trained and logistically supported to screen donors, collect fresh whole blood from designated donors, transfuse blood products, recognize and treat transfusion reactions, and complete the minimum documentation requirements; (6) all deploying military personnel should undergo walking blood bank prescreen laboratory testing for transfusion transmitted disease immediately prior to deployment. Those who are blood group O should undergo anti-A/anti-B antibody titer testing.

Civilian walking blood bank emergency preparedness plan.

BACKGROUND: The current global pandemic has created unprecedented challenges in the blood supply network. Given the recent shortages, there must be a civilian plan for massively bleeding patients when there are no blood products on the shelf. Recognizing that the time to death in bleeding patients is less than 2 h, timely resupply from unaffected locations is not possible. One solution is to transfuse emergency untested whole blood (EUWB), similar to the extensive military experience fine-tuned over the last 19 years. While this concept is anathema in current civilian transfusion practice, it seems prudent to have a vetted plan in place. METHODS AND MATERIALS: During the early stages of the 2020 global pandemic, a multidisciplinary and international group of clinicians with broad experience in transfusion medicine communicated routinely. The result is a planning document that provides both background information and a high-level guide on how to emergently deliver EUWB for patients who would otherwise die of hemorrhage. RESULTS AND CONCLUSIONS: Similar plans have been utilized in remote locations, both on the battlefield and in civilian practice. The proposed recommendations are designed to provide high-level guidance for experienced blood bankers, transfusion experts, clinicians, and health authorities. Like with all emergency preparedness, it is always better to have a well-thought-out and trained plan in place, rather than trying to develop a hasty plan in the midst of a disaster. We need to prevent the potential for empty shelves and bleeding patients dying for lack of blood.

More sophisticated than a drink cooler or an old sphygmomanometer but still not adequate for prehospital blood: A market review of commercially available equipment for prehospital blood transport and administration.

BACKGROUND: Hemorrhage is the leading cause of death in trauma patients with most fatalities occurring before reaching a higher level of care-this applies to both the civilian setting and the military combat setting. Hemostatic resuscitation with increased emphasis on blood transfusion while limiting use of crystalloids has become routine in trauma care. However, the prehospital setting-especially in combat-presents unique challenges with regard to storage, transport, and administration. We sought to evaluate available technology on the market for storage and administration technology that is relevant to the prehospital setting. STUDY DESIGN AND METHODS: We conducted a market review of available technology through subject-matter expert inquiry, reviews of published literature, reviews of Federal Drug Administration databases, internal military publications, and searches of Google. RESULTS: We reviewed and described a total of 103 blood transporters, 22 infusers, and 6 warmers. CONCLUSIONS: The risk of on-scene fatality in trauma patients and recent developments in trauma care demonstrate the need for prehospital transfusion. These transfusions have been logistically prohibited in many operations. We have reviewed the current commercially available equipment and recommended pursuit of equipment that improves accessibility to field transfusion. Current technology has limited applicability for the prehospital setting and is further limited for the military setting.

Ultralow amounts of DNA from long-term archived serum samples produce high-quality methylomes.

BACKGROUND: Long-term stored serum is considered challenging for epigenomic analyses: as there are no cells, circulating DNA is scarce, and amplification removes epigenetic signals. Additionally, pre-analytical treatments and storage might introduce biases and fragmentation to the DNA. In particular, starting with low-input DNA can result in low-diversity libraries. However, successful whole-genome bisulphite sequencing (WGBS) of such serum samples has the potential to open biobanks for epigenetic analyses and deliver novel prediagnostic biomarkers. Here, we perform WGBS using the Accel-NGS library preparation kit on ultralow amounts of DNA from long-term archived samples with diverse pretreatments from the Janus Serum Bank. RESULTS: Ninety-four of the 96 samples produced satisfactory methylation calls; an average of 578 M reads per sample generated a mean coverage of 17× and mean duplication level of 35%. Failed samples were related to poor bisulphite conversion rather than to sequencing or library preparation. We demonstrate the feasibility of WGBS on ultralow DNA yields from serum samples stored up to 48 years. CONCLUSIONS: Our results show the potential of large serum biobank collections for future epigenomic studies and biomarker discovery.

Survey based cross-sectional study to analyse the variation of practices at blood centres during COVID-19 pandemic in India.

India has almost 3,000 blood centres collecting more than 11 million units annually. Maintaining blood supply during the COVID-19 pandemic is a huge challenge. We conducted a cross-sectional study by an online survey to analyse the variation of practices across blood centers of India during this pandemic. A total of 196 blood centers completely responded to the online survey. Most of the blood centres who responded were part of Government hospitals (60 %), part of an academic institutes (55.6 %) and were directly supporting a COVID hospital (67.5 %). Almost 95.4 % blood centers reported reduction of blood donation mainly due to lockdown (50 %) and inability to conduct camps (17.3 %). Scheduling blood donations was one of the most difficult to implement strategy for maintaining adequate blood donation (40.2 %). Blood center manpower management was also a challenge and upto 48 % blood centers operated in two batches to ensure social distancing in blood banks and reduce the risk of exposure. Hemato-oncology (36.8 %) and obstetrics (33.7 %) were major utilizer of blood during the pandemic. There were marked variations in use of PPE by blood banks staff as well as strategies adopted while conducting immunohematology tests on COVID-19 positive patients samples. This pandemic has highlighted some of the major limitations of the health services but blood services have risen to the challenge and strived to maintain the blood supply chain while ensuring blood donor and staff safety. The wide variations in the practices adopted highlights the need for uniform guidelines for blood services in future pandemics.

The impact of temporary deferrals on future blood donation behavior across the donor life cycle.

BACKGROUND: Donor retention is essential for blood banks because acquiring new donors is more expensive than retaining existing ones. Previous studies show that the temporary deferral of donors negatively impacts future donation likelihood. In this study, we analyze the impact of temporary deferrals on future donation behavior while correcting for potential endogeneity, depending on the level of donor experience and number of previous deferrals. STUDY DESIGN AND METHOD: We use data from more than 123,000 whole blood donors of the Austrian Red Cross over a period of 5.5 years. We estimate logit models to analyze how a deferral affects future donation behavior while controlling for potential selection biases because donors are not deferred randomly. We control for gender, blood type, years since first donation, and number of previous donations and deferrals. We analyze the direct deferral effect, its interaction with donor experience, and the number of previous deferrals. RESULTS: Our results confirm that temporary deferrals hurt future donation behavior. This effect varies with donor experience and the number of previous deferrals. The effect is weaker with a higher number of previous donations and is stronger with a higher number of previous deferrals. The results suggest that donors learn to cope with deferrals the more they donate. However, the negative effect of deferrals amplifies over time, and each additional deferral decreases donation likelihood. CONCLUSION: Blood banks that seek to overcome the negative effect of deferrals should be aware that this effect varies with donor experience and with the number of previous deferrals. Our results suggest that blood banks should focus on early-stage donors who are deferred because the negative deferral effect is stronger for more experienced donors. At the same time, blood banks should be careful with donor groups who have experienced deferrals in the past because every additional deferral demotivates future donation behavior. Overall, researchers should be careful to correct for endogeneity because our results suggest that ignoring these effects could lead to substantial underestimation of the negative deferral effect.

Transfusion medicine and blood banking education and training for blood establishment laboratory staff: A review of selected countries in Africa.

BACKGROUND: Avoidable human error is a significant cause of transfusion adverse events. Adequately trained, laboratory staff in blood establishments and blood banks, collectively blood facilities, are key in ensuring high-quality transfusion medicine (TM) services. Gaps in TM education and training of laboratory staff exist in most African countries. We assessed the status of the training and education of laboratory staff working in blood facilities in Africa. STUDY DESIGN AND METHODS: A cross-sectional study using a self-administered pilot-tested questionnaire was performed. The questionnaire comprised 26 questions targeting six themes. Blood facilities from 16 countries were invited to participate. Individually completed questionnaires were grouped by country and descriptive analysis performed. RESULTS: Ten blood establishments and two blood banks from eight African countries confirmed the availability of a host of training programs for laboratory staff; the majority of which were syllabus or curriculum-guided and focused on both theoretical and practical laboratory skills development. Training was usually preplanned, dependent on student and trainer availability and delivered through lecture-based classroom training as well as formal and informal on the job training. There were minimal online didactic and self-directed learning. Teaching of humanistic values appeared to be lacking. CONCLUSION: We confirmed the availability of diverse training programs across a variety of African countries. Incorporation of virtual learning platforms, rather than complete reliance on didactic, in-person training programs may improve the education reach of the existing programs. Digitalization driven by the coronavirus disease 2019 pandemic may provide an opportunity to narrow the knowledge gap in low- and middle-income countries (LMICs).

HLA diversity in the Argentinian Umbilical Cord Blood Bank: frequencies according to donor's reported ancestry and geographical distribution.

Umbilical cord blood (UCB) is a suitable source for hematopoietic stem cell transplantation. The study of HLA genes by next generation sequencing is commonly used in transplants. Donor/patient HLA matching is often higher within groups of common ancestry, however "Hispanic" is a broad category that fails to represent Argentina's complex genetic admixture. Our aim is to describe HLA diversity of banked UCB units collected across the country taking into consideration donor's reported ancestral origins as well as geographic distribution. Our results showed an evenly distribution of units mainly for 2 groups: of European and of Native American descent, each associated to a defined geographic location pattern (Central vs. North regions). We observed differences in allele frequency distributions for some alleles previously described in Amerindian populations: for Class I (A*68:17, A*02:11:01G, A*02:22:01G, B*39:05:01, B*35:21, B*40:04, B*15:04:01G, B*35:04:01, B*51:13:01) and Class II (DRB1*04:11:01, DRB1*04:07:01G/03, DRB1*08:02:01, DRB1*08:07, DRB1*09:01:02G, DRB1*14:02:01, DRB1*16:02:01G). Our database expands the current knowledge of HLA diversity in Argentinian population. Although further studies are necessary to fully comprehend HLA heterogeneity, this report should prove useful to increase the possibility of finding compatible donors for successful allogeneic transplant and to improve recruitment strategies for UCB donors across the country.

A Tertiary Academic Medical Center Blood Bank's Experience With Four-Factor Prothrombin Complex Concentrate.

OBJECTIVES: The role of transfusion medicine consultative services in prospectively auditing (PA) orders for four-factor prothrombin complex concentrate (4F-PCC) was evaluated at an academic medical center. METHODS: Data from 4 years of 4F-PCC orders were obtained from the laboratory information system, and electronic health records of patients receiving concentrate were reviewed. RESULTS: 4F-PCC was ordered for 427 patients with warfarin-, apixaban-, or rivaroxaban-associated hemorrhage. Turnaround time (TAT) to prepare 4F-PCC was longer when PA-recommended dose adjustments were needed (85 vs 66 minutes, P = .03). There was no difference in TAT between patients who died and those who were ultimately discharged (60 vs 70, P = .22). TAT was shortest for orders originating in the emergency department (ED) compared with other locations (64 vs 85, P < .001), and ED TAT was not associated with patient outcomes in ED patients. PA and dose adjustments reduced amounts of concentrate issued by 27 IU per dose (P = .01). Median international normalized ratio less than 1.3 after 4F-PCC transfusion was achieved for all anticoagulants after dose adjustments. PA did not affect order cancellation or product wastage rates. CONCLUSIONS: PA can ensure 4F-PCC is dosed appropriately without affecting patient outcomes.

Worldwide survey on key indicators for public cord blood banking technologies: By the World Marrow Donor Association Cord Blood Working Group.

The Cord Blood Working Group of the World Marrow Donor Association created a survey for cord blood banks (CBBs) aimed to identify and understand the main technical procedures currently used by public CBBs worldwide regarding cord blood units (CBUs) available for unrelated hematopoietic stem cell transplantation. These technical procedures include CBU collection, (pre-) processing, packaging, testing, storage, and transport. The survey was an online survey created with SurveyGizmo and was completed individually by each CBB at the end of 2017. The information is valuable to transplant centers, CBBs as well as the global industry of public cord blood banking. In general, we can conclude from this survey that the majority of CBBs are up to standard in terms of CBB technologies. Areas of improvement include accreditation, increase standardization in testing, and setting of total nucleated cells thresholds for acceptance of CBU for public use. Furthermore, there is a need for a consensus in the way CBBs operate in term of reservation and release to facilitate a more straightforward access to the therapy.

Platelet Inventory Management Program: Development and Practical Experience.

BACKGROUND: Patients with ongoing or expected bleeding require platelet (PLT) transfusions; however, owing to the testing required after a blood donation, manufacturing PLT products may take 1.5-2.0 days after a request is made. This supply-demand mismatch leads clinicians to retain spare PLTs for transfusions, leading to increased PLT discard rates. We developed a PLT inventory management program to supply PLTs more efficiently to patients requiring PLT transfusions within the expiration date, while reducing PLT discard rates. METHODS: PLT concentrates (58,863 and 58,357 units) and apheresis products (7,905 and 8,441 units) were analyzed from May 2015 to November 2017 and from December 2017 to January 2020, respectively. We developed a program to manage total PLT inventories and prospective PLT transfusion patients based on blood type, blood product, and remaining period of efficacy; the program facilitates PLT preparation transfer to non-designated patients within the remaining period of efficacy. RESULTS: The overall PLT concentrate discard rate was 3,254 (2.78%): 1,811 (3.07%) units before and 1,443 units (2.41%) after program application (P<0.001). The discard rate owing to expiration was reduced from 69 units (3.81%) before to two units (0.14%) after program application (P<0.001). CONCLUSIONS: This program can guide the allocation of PLT preparations based on the remaining period of efficacy, enabling PLT products to be used before their expiration date and reducing PLT product discard rate.