Economic Evaluation of National Patient Blood Management Clinical Guidelines in Cardiac Surgery.

OBJECTIVES: To the best of our knowledge, no published clinical guidelines have ever undergone an economic evaluation to determine whether their implementation represented an efficient allocation of resources. Here, we perform an economic evaluation of national clinical guidelines designed to reduce unnecessary blood transfusions before, during, and after surgery published in 2012 by Australia's sole public blood provider, the National Blood Authority (NBA). METHODS: We performed a cost analysis from the government perspective, comparing the NBA's cost of implementing their perioperative patient blood management guidelines with the estimated resource savings in the years after publication. The impact on blood products, patient outcomes, and medication use were estimated for cardiac surgeries only using a large national registry. We adopted conservative counterfactual positions over a base-case 3-year time horizon with outcomes predicted from an interrupted time-series model controlling for differences in patient characteristics and hospitals. RESULTS: The estimated indexed cost of implementing the guidelines of A$1.5 million (2018-2019 financial year prices) was outweighed by the predicted blood products resource saving alone of A$5.1 million (95% confidence interval A$1.4 million-A$8.8 million) including savings of A$2.4 million, A$1.6 million, and A$1.2 million from reduced red blood cell, platelet, and fresh frozen plasma use, respectively. Estimated differences in patient outcomes were highly uncertain and estimated differences in medication were financially insignificant. CONCLUSIONS: Insofar as they led to a reduction in red blood cell, platelet, and fresh frozen plasma use during cardiac surgery, implementing the perioperative patient blood management guidelines represented an efficient use of the NBA's resources.

Kit para fraccionamiento automatizado de hemocomponentes con filtro leucorreductor en un solo paso / Kit for automated fractionation of blood components with leukoreductive filter in a single step

INTRODUCIÓN: Los pacientes con diagnóstico de neoplasias onco-hematológicas son una población que amerita una gran cantidad de transfusiones de hemocomponentes. El fraccionamiento semi-automatizado es una forma de obtención de hemocomponentes utilizado en muchas unidades de banco de sangre en nuestro país. Sin embargo, cuenta con limitaciones que dificultan una obtención rápida, la calidad de los hemocomponentes y la estandarización de procesos de fraccionamiento. El fraccionamiento automatizado ha surgido como una alternativa del procesamiento de hemocomponentes con múltiples beneficios. ESTRATEGIA DE BÚSQUEDA DE INFORMACIÓN: a) Pregunta Clínica: En los pacientes con diagnóstico oncológico del INEN que tienen indicación para transfusión de hemocomponentes, ¿Cuál es el beneficio del fraccionamiento automatizado de hemocomponentes con filtro leucorreductor comparado con el fraccionamiento semi-automatizado de hemocomponentes? b) RECOLECCIÒN DE LOS MANUSCRITOS A REVISAR: Tipos de estudios: La estrategia de búsqueda sistemática de información científica para el desarrollo del presente informe se realizó siguiendo las recomendaciones de la Pirámide jerárquica de la evidencia propuesta por Haynes y se consideró los siguientes estudios: Sumarios y guías de práctica clínica. Revisiones sistemáticas y/o meta-análisis. Ensayos Controlados Aleatorizados (ECA). Estudios Observacionales (cohortes, caso y control, descriptivos) No hubo limitaciones acerca de la fecha de publicación o el idioma para ningún estudio. DISCUSION: Los pacientes con neoplasias hematológicas suelen presentar disminución espontánea de las constantes corpusculares de forma moderada-severa. Los pacientes con neoplasias sólidas que reciben tratamiento con quimioterapia suelen presentar eventos adversos. Entre los más frecuentes bicitopenias y pancitopenias que ameritan muchas veces múltiples transfusiones de hemocomponentes y que incluso acuden a los servicios de emergencias para transfusión de hemocomponentes. La automatización del proceso de fraccionamiento permite la homogenización de los procedimientos del fraccionamiento. Permite disminuir la variable "error humano", permite mejor la calidad interna de las muestras y disminuir la cantidad de muestras desechadas. Recalcamos particularmente el menor tiempo en que demora el fraccionamiento automatizado, recordando que un buen porcentaje de pacientes amerita transfusión de hemocomponentes de forma rápida por alto riesgo de mortalidad y que el método automatizado genera hemocomponentes de forma más rápidas. La aplicación del fraccionamiento automatizado permitiría realizar la leucoreducción en banco de sangre, lo cual nos ofrece múltiples ventajas. Los estudios descritos encontraron que los métodos de fraccionamiento automatizados necesitaron menor tiempo del procesamiento y presentaron una mayor eficacia en comparación con la leucoreducción fuera del banco de sangre. La leucoreducción disminuye el riesgo de reacciones transfusionales. CONCLUSIONES: 1. Con la aplicación del fraccionamiento automatizado REVEOS obtenemos: homogeneidad de procedimientos, menor tiempo de fraccionamiento, disminuimos variable "Error Humano", optimizamos leucoreducción, mejoramos calidad de hemocomponentes y la disminuimos la eliminación de hemocomponentes. 2. La aplicación del fraccionamiento automatizado beneficiaria de múltiples formas el proceso de transfusión que es tan frecuente en la población oncológica.

Blood Donation and COVID-19: Reconsidering the 3-Month Deferral Policy for Gay, Bisexual, Transgender, and Other Men Who Have Sex With Men.

In April 2020, in light of COVID-19-related blood shortages, the US Food and Drug Administration (FDA) reduced the deferral period for men who have sex with men (MSM) from its previous duration of 1 year to 3 months.Although originally born out of necessity, the decades-old restrictions on MSM donors have been mitigated by significant advancements in HIV screening, treatment, and public education. The severity of the ongoing COVID-19 pandemic-and the urgent need for safe blood products to respond to such crises-demands an immediate reconsideration of the 3-month deferral policy for MSM.We review historical HIV testing and transmission evidence, discuss the ethical ramifications of the current deferral period, and examine the issue of noncompliance with donor deferral rules. We also propose an eligibility screening format that involves an individual risk-based screening protocol and, unlike current FDA guidelines, does not effectively exclude donors on the basis of gender identity or sexual orientation. Our policy proposal would allow historically marginalized community members to participate with dignity in the blood donation process without compromising blood donation and transfusion safety outcomes.

Improving blood transfusion safety in resource-poor countries: a case study of using leucocyte reduced blood in Uganda.

BACKGROUND: The majority of blood transfusion safety strategies recommended by the WHO for resource-poor countries focus mainly on reducing the risk of transfusion-transmitted infections (TTIs). Other technologies such as leucocyte reduction may represent complementary strategies for improving transfusion safety. OBJECTIVE: To evaluate the role of using leucocyte reduced blood in a resource-poor country. METHODS: Pre-storage leucocyte reduced (LR) red blood cells (RBCs) were specially prepared for the Tissue Oxygenation by Transfusion in severe Anaemia and Lactic acidosis (TOTAL) study, at the Uganda Blood Transfusion Services from February 2013 through May 2015. Quality control tests were performed to evaluate the procedure, and the incremental cost of an LR-RBC unit was estimated. RESULTS: A total of 608 RBCs units were leucocyte reduced. Quality control tests were performed on 55 random RBCs units. The median (IQR) residual leucocyte count was 4 (0·5-10) WBC/uL, equivalent to 1·8x106 WBC per unit. The estimated incremental unit cost of leucocyte reduction was $37 USD per LR RBC unit. CONCLUSION: Leucocyte reduction of blood in a resource-poor country is doable although relatively costly. As such, its value in resource-poor countries should be weighed against other transfusion safety propositions.

Hong Kong Society of Clinical Blood Management recommendations for implementation of patient blood management.

Patient blood management (PBM) is a patient-centred, multidisciplinary approach to optimise red cell mass, minimise blood loss, and manage tolerance to anaemia in an effort to improve patient outcomes. Well-implemented PBM improves patient outcomes and reduces demand for blood products. The multidisciplinary approach of PBM can often allow patients to avoid blood transfusions, which are associated with less favourable clinical outcomes. In Hong Kong, there has been increasing demand for blood in the ageing population, and there are simultaneous blood safety and donor issues that are adversely affecting the blood supply. To address these challenges, the Hong Kong Society of Clinical Blood Management recommends implementation of a PBM programme in Hong Kong, including strategies such as optimising red blood cell mass, improving anaemia management, minimising blood loss, and rationalising the use of blood and blood products.

How far is Mexico from Viral Hepatitis Global Health Sector Strategy 2030 targets.

In 2016 WHO member states endorsed the 69th World Health Assembly's Global Health Sector Strategies (GHSS) towards eliminating Hepatitis B (HBV) infections by 2030. Substantial progress has been made in Mexico regarding HBV vaccination, blood safety and health-care setting injection safety but minor progress has been identified regarding timely HBV birth-dose coverage, access to diagnostic testing and treatment. Most importantly, Mexico's lack of a national plan for the fight against viral hepatitis was identified as a major obstacle for the development and implementation of actions and procuring funding. Insight of these deficiencies, we propose six actions that are in line with GHSS strategic directions to better allow Mexico to reach the goal of eliminating viral hepatitis by 2030. 1) the creation of a National Viral Hepatitis Task Group capable of providing direction, recommendations as well as innovative solutions in the fight against viral hepatitis in Mexico; 2) the drafting of a National Plan for viral hepatitis; 3) establishing a national viral hepatitis information database; 4) development of Clinical Practice Guidelines; 5) appeal for governmental responsibility and accountability; 6) promote basic, applied science projects as well as clinical research to determine the viral, epidemiological, genomic, ethnic and cultural peculiarities of viral hepatitis infections in Mexico. These basic actions will better equip Mexico to meet GHSS targets, lead to high-impact health interventions and ultimately enhance the cascade of care, from diagnosis to chronic care. Political commitment is a requirement to the implementation of these actions but civil society involvement is also seen to be crucial.

Health economics of Patient Blood Management: a cost-benefit analysis based on a meta-analysis.

BACKGROUND AND OBJECTIVES: Patient Blood Management (PBM) is the timely application of evidence-based medical and surgical concepts designed to improve haemoglobin concentration, optimize haemostasis and minimize blood loss in an effort to improve patient outcomes. The focus of this cost-benefit analysis is to analyse the economic benefit of widespread implementation of a multimodal PBM programme. MATERIALS AND METHODS: Based on a recent meta-analysis including 17 studies (>235 000 patients) comparing PBM with control care and data from the University Hospital Frankfurt, a cost-benefit analysis was performed. Outcome data were red blood cell (RBC) transfusion rate, number of transfused RBC units, and length of hospital stay (LOS). Costs were considered for the following three PBM interventions as examples: anaemia management including therapy of iron deficiency, use of cell salvage and tranexamic acid. For sensitivity analysis, a Monte Carlo simulation was performed. RESULTS: Iron supplementation was applied in 3·1%, cell salvage in 65% and tranexamic acid in 89% of the PBM patients. In total, applying these three PBM interventions costs €129·04 per patient. However, PBM was associated with a reduction in transfusion rate, transfused RBC units per patient, and LOS which yielded to mean savings of €150·64 per patient. Thus, the overall benefit of PBM implementation was €21·60 per patient. In the Monte Carlo simulation, the cost savings on the outcome side exceeded the PBM costs in approximately 2/3 of all repetitions and the total benefit was €1 878 000 in 100·000 simulated patients. CONCLUSION: Resources to implement a multimodal PBM concept optimizing patient care and safety can be cost-effectively.

The global need and availability of blood products: a modelling study.

BACKGROUND: Blood transfusions are an important resource of every health-care system, with often limited supply in low-income and middle-income countries; however, the degree of unmet need for blood transfusions is often unknown. We therefore aimed to estimate the blood transfusion need and supply at national level to determine gaps in transfusion services globally. METHODS: We did a modelling study involving 195 countries and territories. We used blood component preparation data from 2011-13 to estimate blood availability for 180 (92%) of 195 countries from the WHO Global Status Report on Blood Safety and Availability. We calculated disease-specific transfusion needs per prevalent case for 20 causes in the USA using the National (Nationwide) Inpatient Sample dataset between the years 2000 and 2014, and the State Inpatient Databases between 2003 and 2007 from the Healthcare Cost and Utilization Project. Using prevalence estimates for the USA from the Global Burden of Disease (GBD) 2017 study, we estimated the ideal disease specific-transfusion rate as the lowest rate from the years 2000 to 2014. We applied this rate to GBD prevalence results for 195 countries to estimate transfusion needs. Unmet need was the difference between the estimated supply and need. FINDINGS: In 2017, the global blood need was 304 711 244 (95% uncertainty interval [UI] 293 064 637-314 049 479) and the global blood supply was 272 270 243 (268 002 639-276 698 494) blood product units, with a need-to-supply ratio of 1·12 (95% UI 1·07-1·16). Of the 195 countries, 119 (61%) did not have sufficient blood supply to meet their need. Across these 119 countries, the unmet need totalled 102 359 632 (95% UI 93 381 710-111 360 725) blood product units, equal to 1849 (1687-2011) units per 100 000 population globally. Every country in central, eastern, and western sub-Saharan Africa, Oceania, and south Asia had insufficient blood to meet their needs. INTERPRETATION: Our data suggest that the gap between need and supply is large in many low-income and middle-income countries, and reinforce that the WHO target of 10-20 donations per 1000 population is an underestimate for many countries. A continuous expansion and optimisation of national transfusion services and implementation of evidence-based strategies for blood availability is needed globally, as is more government support, financially, structurally, and through establishment of a regulatory oversight to ensure supply, quality, and safety in low-income and middle-income countries. FUNDING: National Institutes of Health.

Pathogen Reduction: The State of the Science in 2019.

In the past 30 years, transfusion safety has increased substantially and blood transfusion is now a safer procedure than at any time in the past. Herein, we provide a comprehensive review of pathogen reduction, which is the new paradigm in transfusion safety. Specifically, we describe the various processes and technologies that are capable of diminishing or neutralizing infectious threats, including those that are not addressed or may not be detected by standard screening techniques. A special emphasis is placed on recent developments that are likely to impact patient care in 2019 and beyond.

Transfusion-associated circulatory overload risk mitigation: survey on hospital policies for compliance with AABB Standard 5.9.17.

BACKGROUND: AABB Standards for Blood Banks and Transfusion Services require accredited institutions to have a policy for handling requests for blood components on patients clinically identified as being at high risk for transfusion-associated circulatory overload (TACO; Standard 5.19.7, 31st edition). This survey elucidated how AABB accredited hospital transfusion services/blood banks around the world are complying with this Standard. METHODS: A link to a Web-based survey in English was e-mailed under the auspice of the AABB to each AABB accredited hospital transfusion service/blood bank (n = 851) asking for details on how their institution is complying with this Standard and for general information on any TACO risk mitigation strategies in place. RESULTS: Of the 290 responses received (34% response rate), 282 met the criteria for analysis. There were 174 of 282 (62%) respondents who indicated that their institution has a formal policy for complying with the Standard, and 108 of 282 (38%) who indicated that their institution does not have a formal policy. A diverse range of policies and practices were in place at the institutions with and without a formal policy ranging from writing advice/recommendations in the charts of patients at increased risk of TACO, promulgating policies from the transfusion service/blood bank or institution itself that would reduce the risk, or using decision support tools to provide education about reducing the risk of TACO. CONCLUSIONS: Many but not all AABB accredited institutions have policies to comply with the TACO risk mitigation Standard. However, the vast majority conduct activities that could mitigate risk for TACO.

Blood Transfusion: Cost, Quality, and Other Considerations for the Surgical Management of the Critically Ill.

This article explores the average overall costs of blood transfusion for critically ill surgical patients and in particular explores the evidence supporting reduction of transfusion as part of guideline-based care in cardiothoracic surgical patients. Average cost data compiled from various sources are presented and quality and outcome considerations in blood transfusion in the critically ill are reviewed. Multiple strategies that have a high level of evidence to support their use in this population are noted.

[Assessment of virological quality of transfused blood in the town of Bukavu, South Kivu, Democratic Republic of Congo]. / Contrôle de qualité virologique du sang transfusé dans la ville de Bukavu, Sud Kivu, République Démocratique du Congo.

INTRODUCTION: In Bukavu, transfused blood is selected using rapid diagnostic tests (RDTs). These tests are easily performed without specialized equipments. This study aims to evaluate the virological quality of transfused blood assessed using rapid diagnostic tests. METHODS: A blood sample was drawn from a blood bag and collected in a 4ml dry tube in 5 Health Care Facilities over a month. Counter analysis was performed on each sample using rapid tests and ELISA. Intrinsic and extrinsic values were calculated. Cohen's kappa coefficient was used to evaluate the reliability of RDT compared with ELISA. RESULTS: Three hundred and twelve samples were collected; 5 samples were positive for one or the other virologic marker while 307 samples were negative in all the tests. However Elisa showed, out of the 307 samples which were RDT test negative, 15 other positive samples including 3 samples positive for HIV, 3 for HCV and 9 for HBV. In addition, ELISA validated some RDT-positive samples and contradicted other results. Sensitivity and positive predictive value from rapid diagnostic tests were very low. The reliability of these tests was satisfactory, medium or low. CONCLUSION: Blood assessed using RDTs poses a non negligible risk of viral infections. This study highlights the need for more reliable and efficient tests in our Health Care Facilities.

Towards a systematic approach for (de)implementation of patient blood management strategies.

Despite the increasing availability of evidence in transfusion medicine literature, this evidence does not automatically find its way into practice. This is also applicable to patient blood management (PBM). It may concern the lack of implementation of effective new techniques or treatments, or it may apply to the (over)use of techniques and treatments (e.g. inappropriate transfusions) that have proven to be of limited benefit for patients (low-value care) and could be abandoned (de-implementation). In PBM literature, the implementation of restrictive transfusion thresholds and the de-implementation of inappropriate transfusions are described. However, most implementation strategies were not preceded by the identification of relevant barriers, and the used strategies were not often supported by literature on behavioural changes. In this article, we describe implementation vs de-implementation, highlight the current situation of (de)implementation in PBM and describe a systematic approach for (de)implementation illustrated by an example of a PBM de-implementation study regarding '(cost-) effective patient blood management in total hip and knee arthroplasty'. The systematic approach used for (de)implementation is based on the implementation model of Grol, which consists of the following five steps: the detection of improvement goals, a problem analysis, the selection of (de)implementation strategies, the execution of the (de)implementation strategy and an evaluation. Based on the description of the current situation and the experiences in our de-implementation study, we can conclude that de-implementation may be more difficult than expected as other factors may play a role in effective de-implementation compared to implementation.

Addressing gaps in international blood availability and transfusion safety in low- and middle-income countries: a NHLBI workshop.

In April 2017, a workshop sponsored by the National Heart, Lung, and Blood Institute, Division of Blood Diseases and Resources, and the Center for Translation Research and Implementation Science was held to discuss blood availability and transfusion safety in low- and middle-income countries (LMICs). The purpose of the workshop was to identify research opportunities for implementation science (IS) to improve the availability of safe blood and blood components and transfusion practices in LMICs. IS describes the late stages of the translational research spectrum and studies optimal and sustainable strategies to deliver proven-effective interventions. Regional working groups were formed to focus on opportunities and challenges in East Africa, Central/West Africa, Middle East and North Africa, Latin America and the Caribbean, Southeast Asia, Western Pacific Asia, Eastern Europe, and Central Asia. The need for an "adequate supply of safe blood" emerged as the major overriding theme. Among the regional working groups, common cross-cutting themes were evident. The majority of research questions, priorities, and strategies fell into the categories of blood availability, blood transfusion safety, appropriate use of blood, quality systems, health economics and budgeting, and training and education in IS. The workshop also brought into focus inadequate country-level data that can be used as the basis for IS initiatives. A mixed approach of needs assessment and targeted interventions with sufficient evidence base to move toward sustainment is an appropriate next step for blood availability and transfusion safety research in LMICs.

Direct costs of transfusion reactions - an expert judgement approach.

BACKGROUND AND OBJECTIVES: Despite increasingly meticulous haemovigilance reporting throughout the world, a systematic assessment of the cost of transfusion reactions is still lacking. This is partly caused by the fact that such an assessment requires a subjective expert assessment of the additional costs linked to the adverse reaction. Data on the cost of transfusion reactions could support decision-making regarding blood transfusion safety measures. MATERIALS AND METHODS: Thirteen experts from nine hospitals were asked to estimate the additional care required following various types of transfusion reactions. Additional care was quantified as the proportion of reactions requiring care, and the amount of care required (e.g. hospitalization days, additional physician's time). Experts were also asked to provide, per type of transfusion reaction, an estimate of the proportion of transfusion reactions preventable. Structured quantitative expert elicitation methods were applied to obtain and combine expert estimates. RESULTS: The estimated annual in-hospital cost of transfusion reactions in the Netherlands is €933 356 per year (€1.52 per transfusion). Two-thirds (64%) of these are incurred by non-serious transfusion reactions. Circulatory overload, TRALI and anaphylaxis clearly dominate the costs of serious adverse transfusion reactions (66% in total); non-haemolytic transfusion reactions incur 46% of the cost of non-serious transfusion reactions. Additional safety measures targeting circulatory overload and new antibody formation potentially offer the highest cost reduction. CONCLUSION: In-hospital costs of transfusion reactions are substantial but contribute to less than 1% of the total cost of transfusion in the Netherlands. A considerable part of these costs (24%) might be preventable.