Blood Demand Forecasting and Supply Management: An Analytical Assessment of Key Studies Utilizing Novel Computational Techniques.

Use of data-driven methodologies in enhancing blood transfusion practices is rising, leveraging big data, machine learning, and optimization techniques to improve demand forecasting and supply chain management. This review used a narrative approach to identify, evaluate, and synthesize key studies that considered novel computational techniques for blood demand forecasting and inventory management through a search of PubMed and Web of Sciences databases for studies published from January 01, 2016, to March 30, 2023. The studies were analyzed for their utilization of various techniques, and their strengths, limitations, and areas for improvement. Seven key studies were identified. The studies focused on different blood components using various computational methods, such as regression, machine learning, hybrid models, and time series models, across different locations and time periods. Key variables used for demand forecasting were largely derived from electronic health record data, including clinical related predictors such as laboratory test results and hospital census by location. Each study offered unique strengths and valuable insights into the use of data-driven methods in blood bank management. Common limitations were unknown generalizability to other healthcare settings or blood components, need for field-specific performance measures, lack of ABO compatibility consideration, and ethical challenges in resource allocation. While data-driven research in blood demand forecasting and management has progressed, limitations persist and further exploration is needed. Understanding these innovative, interdisciplinary methods and their complexities can help refine inventory strategies and address healthcare challenges more effectively, leading to more robust, accurate models to enhance blood management across diverse healthcare scenarios.

Proceedings of the 2022 NHLBI and OASH state of the science in transfusion medicine symposium.

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.

Early and out-of-hospital use of COVID-19 convalescent plasma: An international assessment of utilization and feasibility.

BACKGROUND AND OBJECTIVES: The use of coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) in the treatment of patients with severe acute respiratory syndrome-2 infection has been controversial. Early administration of CCP before hospital admission offers a potential advantage. This manuscript summarizes current trials of early use of CCP and explores the feasibility of this approach in different countries. MATERIALS AND METHODS: A questionnaire was distributed to the International Society of Blood Transfusion (ISBT) CCP working group. We recorded respondents' input on existing trials on early/outpatient CCP and out-of-hospital (OOH)/home transfusion (HT) practices in their countries and feedback on challenges in initiating home CCP infusion programmes. In addition, details of existing trials registered on clinicaltrials.gov were summarized. RESULTS: A total of 31 country representatives participated. Early/OOH CCP transfusion studies were reported in the United States, the Netherlands, Spain and Brazil. There were a total of six published and five ongoing trials on the prophylactic and therapeutic early use of CCP. HT was practised in Australia, the UK, Belgium, France, Japan, Nigeria, the Netherlands, Spain, Italy, Norway, the United States and some provinces in Canada. Thirty-four representatives indicated a lack of OOH CCP or HT in their institutions and countries. Barriers to implementation of OOH/HT included existing legislation, lack of policies pertaining to outpatient transfusion, and associated logistical challenges, including lack of staffing and resources. CONCLUSION: Early administration of CCP remains a potential option in COVID-19 management in countries with existing OOH/HT programmes. Legislation and regulatory bodies should consider OOH/HT practice for transfusion in future pandemics.

Neonatal and pediatric transfusion practices and policies in India: A survey-based cross-sectional assessment of blood centers.

BACKGROUND: Blood centers play a critical role in supporting neonatal and pediatric transfusions. We aim to study the variation in pediatric/neonatal transfusion policies and practices for blood centers in India. STUDY DESIGN AND METHODS: This is a survey-based (45 question) cross-sectional assessment of blood centers in India supporting pediatric/neonatal transfusions. RESULTS: One hundred three centers responded to the survey (response rate 51.2%; 103/201). As a part of pretransfusion testing, use of "microtainers" was reported by 58.4% (59/101) centers and only 57.4% (58/101) centers provide antibody screening. In case of absence of maternal sample, type O negative blood is most commonly used (48.5%; 49/101), and in case of ABO incompatibility, 68.3% (69/101) use units compatible with both mother and newborn. Leukoreduced RBCs are provided by 89% (90/101) centers and irradiated products are provided by 48.5% (49/101). 82% (83/101) of centers reported not receiving requests for CMV negative units considering the high incidence of CMV-seropositivity in donors. Fresh units are defined as <7 days old by 44.5% (45/101) and <5 days old by 31.6% (32/101) centers. 97% centers reported SAGM suspended RBCs in inventory but only 67.3% (68/101) use them for top-up transfusions to neonates. Overall >80% centers use the buffy-coat method for platelet concentrates preparation. Volume-based (ml/kg) aliquots preparation is done by 88% (89/101), mainly using the sterile connecting device (84.6%; 83/98). CONCLUSION: This survey shows heterogeneity and lack of standardization in practices across blood centers in India and highlights the need for more studies to establish best practices for this vulnerable age group.

Access to and safety of COVID-19 convalescent plasma in the United States Expanded Access Program: A national registry study.

BACKGROUND: The United States (US) Expanded Access Program (EAP) to coronavirus disease 2019 (COVID-19) convalescent plasma was initiated in response to the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19. While randomized clinical trials were in various stages of development and enrollment, there was an urgent need for widespread access to potential therapeutic agents. The objective of this study is to report on the demographic, geographical, and chronological characteristics of patients in the EAP, and key safety metrics following transfusion of COVID-19 convalescent plasma. METHODS AND FINDINGS: Mayo Clinic served as the central institutional review board for all participating facilities, and any US physician could participate as a local physician-principal investigator. Eligible patients were hospitalized, were aged 18 years or older, and had-or were at risk of progression to-severe or life-threatening COVID-19; eligible patients were enrolled through the EAP central website. Blood collection facilities rapidly implemented programs to collect convalescent plasma for hospitalized patients with COVID-19. Demographic and clinical characteristics of all enrolled patients in the EAP were summarized. Temporal patterns in access to COVID-19 convalescent plasma were investigated by comparing daily and weekly changes in EAP enrollment in response to changes in infection rate at the state level. Geographical analyses on access to convalescent plasma included assessing EAP enrollment in all national hospital referral regions, as well as assessing enrollment in metropolitan areas and less populated areas that did not have access to COVID-19 clinical trials. From April 3 to August 23, 2020, 105,717 hospitalized patients with severe or life-threatening COVID-19 were enrolled in the EAP. The majority of patients were 60 years of age or older (57.8%), were male (58.4%), and had overweight or obesity (83.8%). There was substantial inclusion of minorities and underserved populations: 46.4% of patients were of a race other than white, and 37.2% of patients were of Hispanic ethnicity. Chronologically and geographically, increases in the number of both enrollments and transfusions in the EAP closely followed confirmed infections across all 50 states. Nearly all national hospital referral regions enrolled and transfused patients in the EAP, including both in metropolitan and in less populated areas. The incidence of serious adverse events was objectively low (<1%), and the overall crude 30-day mortality rate was 25.2% (95% CI, 25.0% to 25.5%). This registry study was limited by the observational and pragmatic study design that did not include a control or comparator group; thus, the data should not be used to infer definitive treatment effects. CONCLUSIONS: These results suggest that the EAP provided widespread access to COVID-19 convalescent plasma in all 50 states, including for underserved racial and ethnic minority populations. The study design of the EAP may serve as a model for future efforts when broad access to a treatment is needed in response to an emerging infectious disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT#: NCT04338360.

Transfusion practices in a large cohort of hospitalized children.

BACKGROUND: While previous studies have described the use of blood components in subsets of children, such as the critically ill, little is known about transfusion practices in hospitalized children across all departments and diagnostic categories. We sought to describe the utilization of red blood cell, platelet, plasma, and cryoprecipitate transfusions across hospital settings and diagnostic categories in a large cohort of hospitalized children. STUDY DESIGN AND METHODS: The public datasets from 11 US academic and community hospitals that participated in the National Heart Lung and Blood Institute Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) were accessed. All nonbirth inpatient encounters of children 0-18 years of age from 2013 to 2016 were included. RESULTS: 61,770 inpatient encounters from 41,943 unique patients were analyzed. Nine percent of encounters involved the transfusion of at least one blood component. RBC transfusions were most common (7.5%), followed by platelets (3.9%), plasma (2.5%), and cryoprecipitate (0.9%). Children undergoing cardiopulmonary bypass were most likely to be transfused. For the entire cohort, the median (interquartile range) pretransfusion laboratory values were as follows: hemoglobin, 7.9 g/dl (7.1-10.4 g/dl); platelet count, 27 × 109 cells/L (14-54 × 109 cells/L); and international normalized ratio was 1.6 (1.4-2.0). Recipient age differences were observed in the frequency of RBC irradiation (95% in infants, 67% in children, p < .001) and storage duration of RBC transfusions (median storage duration of 12 [8-17] days in infants and 20 [12-29] days in children, p < .001). CONCLUSION: Based on a cohort of patients from 2013 to 2016, the transfusion of blood components is relatively common in the care of hospitalized children. The frequency of transfusion across all pediatric hospital settings, especially in children undergoing cardiopulmonary bypass, highlights the opportunities for the development of institutional transfusion guidelines and patient blood management initiatives.

Promoting access to COVID-19 convalescent plasma in low- and middle-income countries.

Low- and middle-income countries (LMICs) remain neglected in the Coronavirus 19 (COVID-19) pandemic. COVID-19 convalescent plasma (CCP) (i.e. plasma collected from individuals after their recovery from COVID-19) has emerged as a leading medical treatment for COVID-19. Studies to date support the safety-and increasingly the efficacy-of CCP to treat COVID-19. This has motivated large-scale procurement and transfusion of CCP, notably in the United States (US), where inventories of CCP have been attained, and government-supported stockpiling of CCP is underway. CCP is a therapy that could be implemented in LMICs. However, systemic and transfusion-specific challenges (e.g. capacity for donor mobilization and collections) impede local procurement of this resource in sufficient volumes to meet clinical demand. This raises the question as to whether there are strategies to facilitate sharing of CCP with LMICs and/or bolstering local capacity for collection to contend with the health crisis. While compelling, there are cost-related, logistical and regulatory barriers to both approaches. For one, there is complexity in diverting national interest (e.g. in the US) away from an epidemic that displays few signs of abating. There are also concerns regarding equitable distribution of CCP in LMICs and how that might be overcome. Further, the barriers to blood donation in general apply to collection of CCP; these obstacles are longstanding, accounting for the inability of many LMICs to meet their blood transfusion needs. Nonetheless, CCP affords dual opportunity for humanitarian outreach while tackling a broader challenge of blood transfusion safety and availability.

Financial analysis of large-volume delayed sampling to reduce bacterial contamination of platelets.

BACKGROUND: Effective and financially viable mitigation approaches are needed to reduce bacterial contamination of platelets in the US. Expected costs of large-volume delayed sampling (LVDS), which would be performed by a blood center prior to shipment to a hospital, were compared to those of pathogen reduction (PR), point-of-release testing (PORt), and secondary bacterial culture (SBC). METHODS: Using a Markov-based decision-tree model, the financial and clinical impact of implementing all variants of LVDS, PR, PORt, and SBC described in FDA guidance were evaluated from a hospital perspective. Hospitals were assumed to acquire leukoreduced apheresis platelets, with LVDS adding $30 per unit. Monte Carlo simulations were run to estimate the direct medical costs for platelet acquisition, testing, transfusion, and possible complications associated with each approach. Input parameters, including test sensitivity and specificity, were drawn from existing literature and costs (2018US$) were based on a hospital perspective. A one-way sensitivity analysis varied the assumed additional cost of LVDS. RESULTS: Under an approach of LVDS (7-day), the total cost per transfused unit is $735.78, which falls between estimates for SBC (7-day) and PORt. Assuming 20,000 transfusions each year, LVDS would cost $14.72 million annually. Per-unit LVDS costs would need to be less than $22.32 to be cheaper per transfusion than all other strategies, less than $32.02 to be cheaper than SBC (7-day), and less than $196.19 to be cheaper than PR (5-day). CONCLUSIONS: LVDS is an effective and cost-competitive approach, assuming additional costs to blood centers and associated charges to hospitals are modest.

Assessment of rhesus and kell blood group antigens, phenotypes, and their allelic frequencies in North Indian blood donors.

BACKGROUND: Prevalence of rhesus (Rh) and Kell antigens in a population vary with race, ethnicity, and geographical location. With advances in immunohematology, non-D antigens, and their corresponding antibodies are increasingly being found to be culprits for alloimmunization. MATERIALS AND METHODS: Assessment of the phenotype of Rh and Kell blood group antigen in the healthy donor population from North India was done, and estimation of the frequencies of these alleles in our population was performed. RESULTS: The most common antigen in the North Indian donor population was "e" (95.6%) followed by "C" (89.6%), "c" (57.7%), and "E" (17.29%) in that order. The most prevalent phenotype in the Indian population was found to be "CDe" followed by "CcDe" and "CcDEe." "K" antigen was found to be positive in 1.81% of the population. DISCUSSION: Knowledge of the Rh antigen profiles in a given population can be very helpful in formulating transfusion guidelines specific to a particular population with an aim to minimize the cost and maximize the benefits. With this aim in mind and considering the problems encountered in developing countries like ours, we conducted Rh and Kell antigen profiling of donors. Comparative analysis with other population studies and implications for transfusion protocols is evaluated. CONCLUSION: Assessment of Rhesus antigen profile of a particular population is useful to develop cost effective ways of providing maximum benefits of blood transfusion with least resources.

Sociodemographic and behavioral characteristics associated with blood donation in the United States: a population-based study.

BACKGROUND: Contemporary population-based data on characteristics associated with blood donation in the United States (U.S.) are limited. STUDY DESIGN AND METHODS: A cross-sectional analysis was performed among 28,739 persons aged 18 years and older who participated in the 2016 National Health Interview Survey, a household survey of the noninstitutionalized U.S. civilian population. Analyses were weighted and accounted for the complex survey design. Adjusted prevalence ratios (aPR) were estimated by multivariable log-binomial regression. RESULTS: The percentage of individuals reporting a past-year history of blood donation was 5.7% (95% confidence interval [CI], 5.3%-6.1%) and was highest in the youngest age group (18-24 years, 8.4%). A past-year history of blood donation was more common in males compared to females (6.3% vs. 5.1%; aPR, 1.12 [95% CI, 0.99-1.27]) and those born in the U.S. compared to individuals born outside the U.S. (6.4% vs. 2.4%; aPR, 1.92 [95% CI, 1.49-2.47]). The percentage of individuals with a past-year history of blood donation was significantly lower in blacks (3.9%; aPR, 0.60 [95% CI, 0.47-0.75]) and Hispanics (3.0%; aPR, 0.63 [95% CI, 0.48-0.83]) in comparison to whites (6.9%). Being a college graduate, being employed, being physically active, and never being a cigarette smoker were factors positively associated with blood donation. The percentage of individuals with a past-year history of blood donation varied by geographic census region, with prevalence being higher in the Midwest (7.3%) and South (6.0%) compared to the Northeast (4.7%) and West (4.4%). CONCLUSION: Continued differences in the blood donor population with reference to the U.S. population underscore the need to understand barriers or deterrents to blood donation. Evidence-based donor recruitment and related policies remain imperative to ensure that there is a sustainable blood supply.

The impact of Daratumumab on transfusion service costs.

BACKGROUND: Daratumumab (DARA) is a human IgG1κ monoclonal antibody directed against CD38, approved for the treatment of multiple myeloma. As CD38 is expressed on RBCs, DARA can interfere with pretransfusion testing. DARA interference can be negated by denaturation of CD38 on RBCs with dithiothreitol (DTT) reagents. Because of this interference in pretransfusion testing, our hospital implemented a notification and testing/transfusion algorithm (NATTA) for pretransfusion testing and RBC product provision for DARA patients. This standardized approach combines DTT-based testing with selective genotyping and the provision of phenotypically similar RBCs for patients with clinically significant antibodies. STUDY DESIGN AND METHODS: We evaluated pretransfusion test results and transfusion requirements for 91 DARA patients in an academic medical center over 1 year to determine the incremental cost of pretransfusion testing and RBC selection. The actual costs for the NATTA approach were compared to a theoretical approach using universal genotyping with a provision of phenotypically similar RBC transfusions. RESULTS: The annual cost of testing related to DARA after NATTA implementation was $535.76 per patient. The simulated annual cost for the alternative genotyping with provision of phenotypically similar RBC transfusions approach was $934.83 per patient. CONCLUSION: In our entire cohort of DARA patients, a DTT-based testing algorithm with selective genotyping and provision of phenotypically similar RBCs only for patients with clinically significant antibodies was less expensive than a simulated model of universal genotyping and provision of phenotypically similar RBCs.