Implementation of a patient blood management program based on a low-income country-adapted clinical decision support system

ABSTRACT Introduction: Patient blood management (PBM) programs are associated with better patient outcomes, a reduced number of transfusions and cost-savings The Clinical Decision Support (CDS) systems are valuable tools in this process, but their availability is limited in developing countries This study assesses the feasibility and effectiveness of an adapted CDS system for low-income countries. Methods: This was a prospective study of the PBM program implementation, in a 200-bed tertiary hospital, between February 2019 and May 2020. Outcome measures were red blood cell (RBC), fresh frozen plasma (FFP) and platelet unit transfusions, the transfusion of a single unit of red blood cells and an RBC adequacy index (RAI). Results: Comparing the post-PBM program era with the pre-PBM system era, there was a decrease in red blood cell transfusions (p = 0.05), with an increase in single unit red blood cell transfusions (p = 0.005) and RAI (p < 0.001). Conclusions: The PBM programs, including electronic transfusion guidelines with pre-transfusion medical auditing, was associated with improved transfusion practices and reduced product acquisition-related costs.

Patient blood management and blood conservation - Complimentary concepts and solutions for blood establishments and clinical services in South Africa and beyond.

Blood transfusions come with risks and high costs, and should be utilized only when clinically indicated. Decisions to transfuse are however not always well informed, and lack of clinician knowledge and education on good clinical transfusion practices contribute to the inappropriate use of blood. Low and middle-income countries in particular take much strain in their efforts to address blood safety challenges, demand-supply imbalances, high blood costs as well as high disease burdens, all of which impact blood usage and blood collections. Patient blood management (PBM), which is a patient-focused approach aimed at improving patient outcomes by preemptively diagnosing and correcting anaemia and limiting blood loss by cell salvage, coagulation optimization and other measures, has become a major approach to addressing many of the challenges mentioned. The associated decrease in the use of blood and blood products may be perceived as being in competition with blood conservation measures, which is the more traditional, but primarily product-focused approach. In this article, we hope to convey the message that PBM and blood conservation should not be seen as competing concepts, but rather complimentary strategies with the common goal of improving patient care. This offers opportunity to improve the culture of transfusion practices with relief to blood establishments and clinical services, not only in South Africa and LMICs, but everywhere. With the COVID-19 pandemic impacting blood supplies worldwide, this is an ideal time to call for educational interventions and awareness as an active strategy to improve transfusion practices, immediately and beyond.

The wider perspective: cord blood banks and their future prospects.

Over the past three decades, cord blood transplantation (CBT) has established its role as an alternative allograft stem cell source. But the future of stored CB units should be to extend their use in updated transplant approaches and develop new CB applications. Thus, CBT will require a coordinated, multicentric, review of transplantation methods and an upgrade and realignment of banking resources and operations. Significant improvements have already been proposed to support the clinical perspective including definition of the cellular threshold for engraftment, development of transplantation methods for adult patients, engraftment acceleration with single cell expansion and homing technologies, personalised protocols to improve efficacy, use of adoptive cell therapy to mitigate delayed immune reconstitution, and further enhancement of the graft-versus-leukaemia effect using advanced therapies. The role of CB banks in improving transplantation results are also critical by optimizing the collection, processing, storage and characterization of CB units, and improving reproducibility, efficiency and cost of banking. But future developments beyond transplantation are needed. This implies the extension from transplantation banks to banks that support cell therapy, regenerative medicine and specialized transfusion medicine. This new "CB banking 2.0" concept will require promotion of international scientific and technical collaborations between bank specialists, clinical investigators and transplant physicians.

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.

Cord blood beyond transplantation: can we use the experience to advance all cell therapies?

Unrelated cord blood (CB) units, already manufactured, fully tested and stored, are high-quality products for haematopoietic stem cell transplantation and cell therapies, as well as an optimal starting material for cell expansion, cell engineering or cell re-programming technologies. CB banks have been pioneers in the development and implementation of Current Good Manufacturing Practices for cell-therapy products. Sharing their technological and regulatory experience will help advance all cell therapies, CB-derived or not, particularly as they transition from autologous, individually manufactured products to stored, 'off-the shelf' treatments. Such strategies will allow broader patient access and wide product utilisation.

SARS-CoV-2/COVID-19 pandemic: first wave, impact, response and lessons learnt in a fully integrated Regional Blood and Tissue Bank. A narrative report.

BACKGROUND: The COVID-19 pandemic is placing blood and tissue establishments under unprecedented stress, putting its capacity to provide the adequate care needed at risk. Here we reflect on how our integrated organisational model has faced the first impact of the pandemic and describe what challenges, opportunities and lessons have emerged. MATERIALS AND METHODS: The organisational model of the Catalan Blood and Tissue Bank (Banc de Sang i Teixits, BST) is described. The new scenario was managed by following international recommendations and considering the pandemic in a context of volatility, uncertainty, complexity, and ambiguity (VUCA), allowing rapid measures to be taken. These aimed to: ensure donor safety, promote proper responses to patients' needs, ensure the health and well-being of personnel, and prepare for future scenarios. RESULTS: The BST has adapted its activities to the changes in demand. No shortage of any product or service occurred. Donor acceptance, safety and wellbeing were maintained except for tissue donation, which almost completely stopped. To support the health system, several activities have been promoted: large-scale convalescent plasma (CP) production, clinical trials with CP and mesenchymal stromal cells, massive COVID-19 diagnoses, and participation in co-operative research and publications. Haemovigilance is running smoothly and no adverse effects have been detected among donors or patients. DISCUSSION: Several elements have proven to be critical when addressing the pandemic scenario: a) the early creation of a crisis committee in combination with technical recommendations and the recognition of a VUCA scenario; b) identification of the strategies described; c) the integrated donor-to-patient organisational model; d) active Research and Development (R&D); and e) the flexibility of the staff. It is essential to underline the importance of the need for centralised management, effective contingency strategies, and early collaboration with peers.

The Binns Program for Cord Blood Research: A novel model of cord blood banking for academic biomedical research.

Umbilical cord blood is an important graft source in the treatment of many genetic, hematologic, and immunologic disorders by hematopoietic stem cell transplantation. Millions of cord blood units have been collected and stored for clinical use since the inception of cord blood banking in 1989. However, the use of cord blood in biomedical research has been limited by access to viable samples. Here, we present a cost-effective, self-sustaining model for the procurement of fresh umbilical cord blood components for research purposes within hospital-affiliated academic institutions.

The impact of COVID-19 pandemic on blood supplies and transfusion services in Eastern Mediterranean Region.

BACKGROUND: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has spurred a global health crisis. The safety and supply of blood during this pandemic has been a concern of blood banks and transfusion services as it is expected to adversely affect blood system activities. We aim to assess the situation in the Eastern Mediterranean Region (EMR) during the first months of the pandemic. MATERIALS AND METHODS: A survey was designed to address blood supply, transfusion demand, and donor management during the coronavirus disease-19 (COVID-19) pandemic. Medical directors of different blood banks were invited to participate. RESULTS: A total of 16 centers participated with representation from 15/19 countries in the region. In total, 75% were from national blood banks. Most centres had a decrease in the blood supply, ranging from 26-50%. Representatives from 14 countries (93.3%) believed that public fear has contributed to a decrease in donations. Most centres (n=12, 75%) had a reduction in transfusion demand, while those who did not, reported heavy involvement in treating patients with underlying haemoglobinopathies and haematological malignancies. Half of the centres activated their contingency plans. Four centres had to alter the blood donor eligibility criteria to meet demands. All centres implemented donor deferral criteria in relation to SARS-CoV-2, but were variable in measures to mitigate the risk of donor and staff exposure. CONCLUSION: Blood services in the region faced variable degrees of blood shortages. We summarize lessons learnt during this pandemic for the blood banks to consider to plan, assess, and respond proportionately to future similar pandemics.

Medidas de distanciamento social e demandas para reorganização dos serviços hemoterápicos no contexto da Covid-19 / Social distancing measures and demands for the reorganization of hemotherapy services in the context of Covid-19

Resumo O artigo tem por objetivo discutir as consequências das medidas de distanciamento social sobre a disponibilidade de sangue e a organização dos serviços hemoterápicos no início da pandemia de Covid-19 no Brasil. A partir do acesso às notícias publicadas no mês de abril de 2020 nos sites das Hemorredes estaduais do país e organizadas em matriz Excel, foram elaborados quadros-síntese e descrição de resultados. A situação crítica de abastecimento de sangue, em especial para alguns tipos sanguíneos, foi constatada em muitos estados, devido à circulação do novo coronavírus. A adoção de medidas de distanciamento social e a manutenção das demandas por transfusão para tratamentos, urgência e emergência, requereram a implantação e a implementação de estratégias e ações para reorganização dos serviços. Medidas de proteção foram incorporadas, fluxos alterados e rotinas estabelecidas. Este estudo evidencia o quanto a situação epidemiológica da Covid-19 e as medidas necessárias para o seu controle influenciaram sobre a situação dos estoques e disponibilidade de sangue, e, demandaram, mudanças na organização dos serviços hemoterápicos a fim de assegurar a proteção, mitigar os riscos de propagação do vírus e garantir o suprimento de sangue para o atendimento às necessidades do sistema de saúde.

Abstract The article aims to discuss the consequences of social distancing measures on the availability of blood and organization of blood therapy services at the beginning of the Covid-19 pandemic in Brazil. News published in April 2020 on the websites of the country's state Blood Service Networks were consulted and organized in an Excel spreadsheet, presented in summary charts, and descriptions of results were prepared. A critical situation of blood supply, especially of some blood types, has been observed in many states. This situation is influenced by the circulation of the new coronavirus. The adoption of social distancing measures associated with unchanged transfusion demands for outpatient, urgency and emergency care required the implementation of strategies and actions for the reorganization of the services. Protection measures were incorporated, flows were changed and new routines were established. This study shows the extent to which the epidemiological situation of Covid-19 and the necessary measures for its control influenced the stocks and availability of blood. Changes in the organization of blood therapy services were fundamental in order to ensure protection, mitigate the risks of spreading the virus, and ensure the blood supply to meet the needs of the health system.

Liquid plasma reduces waste and health care expenses compared with thawed plasma at a Level I trauma center.

BACKGROUND: Balanced resuscitation strategies have led to increased utilization of plasma. Fresh frozen plasma that is thawed and never used is a large source of blood component wastage. Thawed plasma (TP) and can only be stored for 5 days. Liquid plasma (LP) has never been frozen and can be stored for 26 days. Due to longer storage duration, we hypothesized that using LP would result in decreased waste and cost savings compared with TP. METHODS: We performed a retrospective review of all trauma patients at our Level I trauma center in the years 2015 to 2016. We compared 2015 when only TP was used to 2016 when both TP and LP were used. All plasma units ordered for trauma patients were tracked until the time of transfusion or wastage. Wastage rates were compared between years and plasma type. RESULTS: There were 5,789 trauma patients admitted to our institution from 2015 to 2016. There were 4,107 plasma units ordered with 487 (11.9%) units wasted. During 2015, 2,021 total units of plasma were ordered with 273 (13.5%) units wasted which was a significantly higher rate than 2016 when 2,086 total units of plasma were ordered and 214 (10.3%) units were wasted (p = 0.0013). During 2016, 1,739 units of TP were ordered and 204 (11.7%) units were wasted which was significantly higher than LP wastage, 347 units ordered and 10 (2.9%) units wasted (p < 0.001). Of the 477 wasted TP units, 76.9% were ordered no more than two times before being wasted and 95.8% were ordered no more than three times before being wasted. Of the 10 LP units wasted, 40% were ordered no more than two times before being wasted, and 50% were ordered no more than three times before being wasted. If TP was wasted at the same rate as LP, 368 fewer units of plasma would have been wasted representing US $39,376 (US $107/unit) of wasted health care expenses. CONCLUSION: At a Level I trauma center, the addition of LP to the blood bank for trauma resuscitations significantly reduced plasma wastage rates and health care expenses. LEVEL OF EVIDENCE: Level III, Economic/Decision.

Organization of the outdoor blood donation drives amid novel coronavirus pandemic and national lockdown: An experience from a tertiary care oncology institution in India.

The conduct of blood donation drives became difficult amid novel coronavirus disease pandemic and national lockdown. Despite no restriction for the outdoor blood donation drives, voluntary blood donor organizations (VBDOs) and individual donors became apprehensive regarding the possible risk of spread of the infection during blood donation. Various confidence-building measures were taken to decrease this hesitation. Numerous preventive measures were taken at the blood bank and at the donation venue to limit the possible risk of the spread of infection. With the help of these measures, the confidence of the individual blood donors and the VBDOs was restored and multiple blood drives were organized.

Zika virus and its implications on cord blood banking and transplantation.

Umbilical cord blood is an important cellular therapy product used for hematopoietic stem cell transplantation, but the US Food and Drug Administration guidance regarding donor screening to reduce the risk of Zika transmission has decreased the number of licensed, eligible cord blood units available for transplantation. There is a crucial need for updated travel risk assessment for Zika virus transmission, validated screening tests for Zika virus in umbilical cord blood, and further research on Zika virus transmissibility due to umbilical cord blood products to ensure that umbilical cord blood and related tissues are safe and available for transplantation.

A novel protocol to maintain continuous access to thawed plasma at a rural trauma center.

BACKGROUND: Early administration of plasma improves mortality in massively transfused patients, but the thawing process causes delay. Small rural centers have been reluctant to maintain thawed plasma due to waste concerns. Our 254-bed rural Level II trauma center initiated a protocol allowing continuous access to thawed plasma, and we hypothesized its implementation would not increase waste or cost. METHODS: Two units of thawed plasma are continuously maintained in the trauma bay blood refrigerator. After 3 days, these units are replaced with freshly thawed plasma and returned to the blood bank for utilization prior to their 5-day expiration date. The blood bank monitors and rotates the plasma. Only trauma surgeons can use the plasma stored in the trauma bay. Wasted units and cost were measured over a 12-month period and compared with the previous 2 years. RESULTS: The blood bank thawed 1127 units of plasma during the study period assigning 274 to the trauma bay. When compared with previous years, we found a significant increase in waste (p < 0.001) and cost (p = 0.020) after implementing our protocol. It cost approximately US $125/month extra to maintain continuous access to thawed plasma during the study period. DISCUSSION: A protocol to maintain thawed plasma in the trauma bay at a rural Level II trauma center resulted in a miniscule increase in waste and cost when considering the scope of maintaining a trauma center. We think this cost is also minimal when compared with the value of having immediate access to thawed plasma. Constant availability of thawed plasma can be offered at smaller rural centers without a meaningful impact on cost. LEVEL OF EVIDENCE: Economic and Value-based Evaluations, Level III.

Psychosocial and cognitive engineering contributions to blood transfusion.

Among the research developed in social psychology, there is a field of study questioning the mechanisms that explain prosocial behaviors. In 1956, the first links between transfusion medicine and social psychology were formed, with the study of underlying motivations to blood donation behavior. Sixty years later, the number of "fundamental" and "applied" research has widely increased, and we now have a theoretical understanding of blood donation engagement's levers, as well as experimental demonstrations of methods to activate these levers. Thus, the literature offers several strategies experimentally verified to improve the recruitment and retaining of blood donors. These methods can go from specific speeches when soliciting donors, to changes in the blood donation environment, etc. They aim either at impacting the donation experience, at obtaining a change in the donor's behavior, or at changing the determinants of blood donation. Yet, it is clear that the knowledge from the research in social psychology is not really deployed on the field by the organizations that could benefit from it. In this article, we will try to develop the difficulty regarding the application of fundamental and experimental knowledge, and to underline the implications for the blood transfusion establishments. We will then present the psychosocial and cognitive engineering method, and argue its relevance to answer this problematic.

The global surgery blood drought: frontline provider data on barriers and solutions in Bihar, India.

BACKGROUND: Limited access to safe, timely banked blood is a critical barrier to providing basic surgical care in resource-limited settings globally. Contextual, locally driven data are required to elucidate country needs, develop effective interventions, and guide policy decisions. OBJECTIVE: We employ qualitative methodology to describe barriers faced and solutions proposed by front-line obstetric providers in Bihar - a poor, populous Indian state where maternal mortality exceeds the national average. We aim to make locally driven recommendations for ongoing policy work in India to strengthen the country's blood transfusion system. METHODS: From February to May 2016, two researchers conducted semi-structured interviews with 19 obstetric providers across Bihar. Snowball sampling was employed until thematic saturation was reached. Following immersion into de-identified texts and dual codebook development, a primary analyst completed topical coding, and a secondary analyst confirmed reproducibility. RESULTS: Providers report that pervasive banked blood shortages force hospitals to require replacement donation, but patients' families often cannot or will not donate. Providers wait one to six hours for blood, depending on availability of staff and supplies, blood bank proximity, and the ability of the patient being treated to navigate the system. Providers feel forced to refer their patients, often to distant, poorly equipped centers. Providers identify donor education, improved infrastructure, and improved local coordination as focus areas for intervention. CONCLUSIONS: A multi-stakeholder approach that aims to increase blood donation through community education, mitigate limited infrastructure through short-term workarounds, and improve local-level coordination through state support and policy change is required in Bihar. This study generates data to guide policy and future research aimed at generating affordable, contextually appropriate interventions to the blood drought.

Umbilical Cord Blood Banking: Consensus Statement of the Indian Academy of Pediatrics.

JUSTIFICATION: Practitioners and people need information about the therapeutic potential of umbilical cord blood stem cells and pros and cons of storing cord blood in public versus private banks. PROCESS: Indian Academy of Pediatrics conducted a consultative meeting on umbilical cord blood banking on 25th June 2016 in Pune, attended by experts in the field of hematopoietic stem cell transplantation working across India. Review of scientific literature was also performed. All expert committee members reviewed the final manuscript. OBJECTIVE: To bring out consensus guidelines for umbilical cord banking in India. RECOMMENDATIONS: Umbilical cord blood stem cell transplantation has been used to cure many malignant disorders, hematological conditions, immune deficiency disorders and inherited metabolic disorders, even when it's partially HLA mismatched. Collection procedure is safe for mother and baby in an otherwise uncomplicated delivery. Public cord blood banking should be promoted over private banking. Private cord blood banking is highly recommended when an existing family member (sibling or biological parent) is suffering from diseases approved to be cured by allogenic stem cell transplantation. Otherwise, private cord blood banking is not a 'biological insurance', and should be discouraged. At present, autologous cord stem cells cannot be used for treating diseases of genetic origin, metabolic disorders and hematological cancers. Advertisements for private banking are often misleading. Legislative measures are required to regularize the marketing strategies of cord blood banking.

[LEVEL OF PROVISION OF THE TREATMENT INSTITUTIONS WITH THE BLOOD COMPONENTS].

The need for the blood products ­ it is a quantity of the blood and its components, which is really necessary for transfusion in a determined group of population in certain period of time. The need in erythrocytes is dependent on the medical aid type: for bed in reanimation and surgery of the first link ­ 5 ­ 7 doses, in specialized institutions ­ 25 ­ 30 doses. The investigation objective constitutes in determination the provision level of hospitals with the blood products by the physician's estimate. In the Regional Centre of the Blood a questionnaire was elaborated, distributed to 620 physicians from 29 hospitals, 423 questionnaires were accepted. The main causes, influencing the blood components application, were determined by responders in such sequence: presence of an acute states and injuries; kind of the disease; accessibility of the blood components; presence of significant quantity of patients with rare groups of the blood. Yearly application of blood components in the departments were analyzed in regional treatment institutions, central municipal hospitals and central district hospitals. In accordance to results of the investigation there was established, that official statistical instrument, estimating the clinical transfusiology state, is absent; the prognosis calculation for the yearly need is done by majority (75 ­ 83%) of physicians; control of the blood components purveyances the majority of responders accomplish in accordance to two indices ­ general quantity of erythrocytes and the patient's state worsening, witnessing submitting of urgent medical aid predominantly.

Esophageal and Gastric Cancer Pearl: a nationwide clinical biobanking project in the Netherlands.

Esophageal and gastric cancer is associated with a poor prognosis since many patients develop recurrent disease. Treatment requires specific expertise and a structured multidisciplinary approach. In the Netherlands, this type of expertise is mainly found at the University Medical Centers (UMCs) and a few specialized nonacademic centers. Aim of this study is to implement a national infrastructure for research to gain more insight in the etiology and prognosis of esophageal and gastric cancer and to evaluate and improve the response on (neoadjuvant) treatment. Clinical data are collected in a prospective database, which is linked to the patients' biomaterial. The collection and storage of biomaterial is performed according to standard operating procedures in all participating UMCs as established within the Parelsnoer Institute. The collected biomaterial consists of tumor biopsies, blood samples, samples of malignant and healthy tissue of the resected specimen and biopsies of recurrence. The collected material is stored in the local biobanks and is encoded to respect the privacy of the donors. After approval of the study was obtained from the Institutional Review Board, the first patient was included in October 2014. The target aim is to include 300 patients annually. In conclusion, the eight UMCs of the Netherlands collaborated to establish a nationwide database of clinical information and biomaterial of patients with esophageal and gastric cancer. Due to the national coverage, a high number of patients are expected to be included. This will provide opportunity for future studies to gain more insight in the etiology, treatment and prognosis of esophageal and gastric cancer.