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Background and Objectives: Vasovagal reactions (VVR) are the most common adverse reactions in blood donation. This study aimed to provide and analyze the data of the regional hemovigilance system in Chongqing, China from 2020 to 2022, report the prevalence and explore the risk factors of VVR., Materials and Methods: R software (version 4.2.3) was used for all statistical analyses. Frequency and composition rates were used to describe the data of total donation, as well as data on the different types of ADR. The Chi-square test was used to analyze risk factors for VVR and inter-group comparisons of VVR stratified by gender (female/male), age (18-22; 23-29; 30-39; 40-49; 50-60) and season(Spring (Mar.-May.); Summer (Jun.-Aug.); Autumn (sep.-Nov.); Winter (Dec.-Feb.))., Results: The reported incidence rate of VVR was 8.69‰ during whole blood donations and 1.02‰ during platelet-apheresis donations.The stratified analysis revealed that female donors aged 18-22 years old and 30-39 years old were reported to have lower VVR rates than male donors, oppositely, higher in females in 50-60 years old. Statistically significant differences in the incidence rate of VVR were observed between winter and summer, and between winter and spring in 18-49 years old. No seasonal variation was found in 50-60 years old., Conclusions: The reported incidence rate of VVR related to blood donation was very low and varied from those calculated by other haemovigilance systems. The higher prevalence of VVR in young, first-time donors, college students, donating in mobile vehicles, males and in spring. Among first-time donors, the prevalence of VVR was higher in males than in females; and stratified analysis revealed there were seasonal variation and gender differences within a same age group., Competing Interests: Conflicts of interest The authors have no conflicts of interest to declare., (Copyright © 2024 Society francophone de transfusion sanguine (SFTS). Published by Elsevier Masson SAS. All rights reserved.)

Introduction: Transfusion is an important question of daily clinical practice. Transfusion is governed by rigorous security rules., Aim: To assess the knowledge of healthcare personnel regarding transfusion., Methods: This descriptive study was carried out by an anonymous survey, with anaesthetist resident, surgery resident, interns, anaesthetist, and nurses. This study was from January 1 to February 29, 2020. It was approved by the local ethics committee., Results: We included 196 participants. 94.9% knew that red blood cells must be stored in the refrigerator. 58.2% thought that red blood cells should be transfused within 30 minutes of warming, and 31.6% said it should be transfused within 3 hours. We found that 85% knew that fresh frozen plasma should be stored in the freeze, and 59.7% said that the frozen plasma should be thawed within 30 minutes at most and 38.3% thought that the thawing should take at least one hour. Regarding the pretransfusion bedside test, 84.4% knew that it must be done by two personnel one of whom must be a doctor. 40.8% thought that the test consists of mix a drop of patient blood and a drop of bag blood., Conclusion: Several insufficiencies were found. There is a necessity of launching periodic training courses focusing on the management of blood products and the transfusion procedure.

Background and Objectives: Transfusion safety may be becoming dependent on the financial resources made available for transfusion structures and may vary between high-income countries (HIC) and low-to-middle-income countries (LMIC). To assess whether there is a difference in the reported TR between these two groups of countries, we examined TR reported in Tunis the capital of Tunisia, a LMIC, and compared their frequency with reported TR in HIC., Materials and Methods: Data of TR were collected from transfusion incident report (TIR) forms declared by healthcare facilities in Tunis between 2015 and 2019. They were analysed and compared to reported TR in France (ANSM) and UK (SHOT)., Results: The incidence of TR was 70.6/100 000 blood components (BP) issued. A third of TR (36.8%) occurred at night. Febrile non-hemolytic transfusion reactions (43.7%) and allergic reactions (35%) were the most reported TR respectively 22.4/100 000 BP and 17.9/100 000 BP. The rate of ABO incompatibilities was 1.96/100 000 red blood cell units (RBC): they were all caused by human error. The rates of TRALI, TACO and bacterial contaminations were respectively 1.26/100 000 BP, 1.4/100 000 RBC and 0.7/100 000 BP., Conclusion: While advanced technologies applied to transfusion have improved transfusion safety, this study shows that their impact has been relatively minor, as reported TR in LMIC are still comparable to those in HIC. ABO-incompatibilities are still higher in LMIC: this should be addressed by reinforcing the training of all healthcare personnel involved in transfusion medicine., Competing Interests: Conflict of Interest The authors have no conflict of interest., (Copyright © 2024. Published by Elsevier Ltd.)

Background: Due to chemotherapy-induced neutropenia or hematologic malignancies, immunocompromised cancer patients may have higher incidence of febrile nonhemolytic transfusion reactions compared with the general population and frequently require platelet transfusions. This quality improvement project compared the safety of transfusion using prestorage leukocyte-reduced and pooled whole blood-derived platelets (Acrodose/WBD) with conventionally produced poststorage WBD platelets (RDP) using an active hemovigilance system., Methods: Every patient receiving a blood product at the hospital was virtually monitored in real time by trained nurses from a remote hemovigilance unit. These nurses monitor a digital dashboard, which populates a watch list of patients from the time blood product administration is initiated until 12 hours posttransfusion. Over the course of 6 months, 371 patients receiving 792 RDP transfusions and 423 patients receiving 780 Acrodose/WBD platelets transfusions were monitored for transfusion reactions., Results: We identified 26 transfusion reactions in RDP but only 12 transfusion reactions in the Acrodose/WBD platelet group., Conclusion: Acrodose platelet transfusion was associated with fewer transfusion reactions, which resulted in significant cost savings., (© The Author(s) 2024. Published by Oxford University Press on behalf of American Society for Clinical Pathology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Despite their use in life-saving treatment, blood and blood products can cause life-threatening complications. To administer blood transfusion safely, national guidelines and protocols should be consulted in healthcare organizations. In Türkiye, there are guides and regulations published by the Ministry of Health. With the definition of hemovigilance in the regulations; training in clinical use of blood and transfusion practice fields is now mandatory. This study presents data from a survey designed to assess transfusion knowledge levels of clinical departments for the purpose of planning our training programs. A two-part survey was conducted on 110 nurses from various departments. Questions included sociodemographic attributes, department they worked in, employment duration, knowledge level on transfusion practices. Statistical analysis was performed. Of the nurses that participated; 52.7% were above 40 years old, 15.5% were 31-40 years old and 31.8% were below 30 years old. For education; 84.5% of the nurses were graduates or postgraduates. For work experience; 64.5% were working in internal medicine departments, 58.2% had been working as a nurse for 10 or more years while 85.5% worked in the same department for less than 5 years. It was determined that the nurses should know more about transfusion. Beginner nurses in the intense care unit were found to have lower levels of transfusion practice knowledge, from this it was deduced additional training should be scheduled for beginner nurses with low transfusion knowledge. In addition to theoretical instructions, one-on-one training on operation controls and "observation and guidance" style practical training should be implemented. Theoretical and practical topics with inadequate knowledge should be instructed in finer detail to increase the knowledge level in these subjects., Competing Interests: Conflicts of interest The authors declare no conflict of interest., (Copyright © 2024. Published by Elsevier Masson SAS.)

Background: Correct classification of transfusion reactions is important not only for effective patient care and donor management but also for accurate tracking of events in hemovigilance systems. We compared the ability of a generative artificial intelligence (AI) system to correctly diagnose hypothetical clinical situations as transfusion reactions in comparison to previous studies reporting the accuracy of transfusion medicine (TM) specialists in assessing these cases., Methods: An AI system was requested to assess 36 case scenarios to provide a diagnosis, severity, and imputability of the transfusion reactions using the CDC National Healthcare Safety Network (NHSN) criteria. Responses were compared to an expert panel's classifications and to the published responses of a panel of TM specialists. Additionally, the AI's responses were compared to the TM specialists' prior attempts to use the TrDDx web-based algorithm for the five most challenging cases., Results: The AI's classification accuracy varied widely depending on the NHSN category. The AI accurately classified all transfusion-associated circulatory overload and transfusion-related acute lung injury cases, exceeding TM specialists' assessments. Conversely, it did not correctly identify any cases in select NHSN categories such as DSTR. Overall accuracy among all diagnostic categories was 48.7% for AI responses versus 72.1% for prior TM specialist responses (p = 0.005). AI-generated responses included non-standard terminology, limited severity assessments, and no imputability determinations., Discussion: A generative AI system may have a role in helping healthcare providers to consider transfusion reaction categories that might be missed, but caution is advised in applying the AI's output to transfusion reaction classification at present., (© 2024 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.)

Background: Transfusion-related errors are largely preventable but may lead to blood product wastage and adverse reactions, resulting in patient harm. In the United States, the incidence of transfusion-related errors is poorly understood nationally. We used data from the National Healthcare Safety Network (NHSN) Hemovigilance Module to describe and quantify transfusion-related errors, as well as associated transfusion-related adverse reactions and blood product wastage., Methods: During 2014-2022, data from the NHSN Hemovigilance Module were used to analyze errors, including near misses (errors with no transfusion), incidents (errors with transfusion), and associated serious adverse reactions (severe, life-threatening, or death)., Results: During 2014-2022, 80 acute care facilities (75 adult; 5 pediatric) reported 63,900 errors. Most errors occurred during patient blood sample collection (21,761, 34.1%) and blood sample handling (16,277, 25.5%). Less than one-fifth of reported errors (9822, 15.4%) had a completed incident form. Of those, 8780 (89.3%) were near misses and 1042 (10.7%) incidents. More than a third of near misses (3363, 38.3%) were associated with a discarded blood product, resulting in 4862 discarded components. Overall, 87 adverse reactions were associated with errors; six (7%) were serious., Conclusions: Over half of the transfusion-related errors reported to the Hemovigilance Module occurred during blood sample collection or sample handling. Some serious adverse reactions identified were associated with errors, suggesting that additional safety interventions may be beneficial. Increased participation in the Hemovigilance Module could enhance generalizability and further inform policy development regarding error prevention., (Published 2024. This article is a U.S. Government work and is in the public domain in the USA.)

Background and Objective: Septic transfusion reactions due to bacterial contamination in platelet concentrates (PCs) are continually reported to hemovigilance (HV) programs. Worldwide, blood centers use different systems to avoid transfusion-associated bacterial sepsis in PCs. Herein, national HV data were gathered to compare bacterial protection systems and to assess the risk of bacterial contamination., Materials and Methods: HV data with definite transfusion-associated bacterial sepsis in PCs were obtained from Australia, Canada, the United Kingdom (U. K.), and Switzerland between 2006 and 2016. These data were reviewed to evaluate bacterial protection systems including early small-volume (ESV), early large-volume (ELV), and delayed large-volume (DLV) bacterial culture screening and pathogen inactivation (PI) treatment., Results: Implementation of DLV bacterial culture screening in the U. K. and PI treatment in Switzerland resulted in significant reductions ( P < 0.05) in transfusion-associated bacterial sepsis for the period of 2011-2016 compared to the prior 4 years (2006-2010). Approximately 1.86 million DLV bacterial culture-screened PCs and 0.21 million PI-treated PCs were issued with no reported septic fatalities nor cases of life-threatening sepsis. In Australia, two life-threatening septic transfusion reactions (1.923 per million) were reported out of almost 1.04 million ELV bacterial culture-screened PCs, and no septic fatalities were reported. Meanwhile, in Canada, four life-threatening septic transfusion reactions (3.6/million) and one fatality (0.9/million) were observed in about 1.11 million ESV bacterial culture-screened PCs., Conclusion: DLV bacterial culture and PI treatment significantly reduced the incidence of septic reactions. The advantages and disadvantages of both systems merit further investigation before implementation., Competing Interests: There are no conflicts of interest., (Copyright: © 2022 Asian Journal of Transfusion Science.)

Competing Interests: The authors declare that there are no conflicts of interest.

Background and Purpose: Hemovigilance is a set of monitoring methods that covers the blood transfusion chain, from collecting blood and blood products to monitoring the blood recipients. To this end, any error in this process can have serious and irreparable consequences for patients. The present study aimed to investigate the quality of hemovigilance process in Iran, using the first two steps of Six Sigma model., Methods: This was a quantitative cross-sectional study that was conducted over 6 months (from August 20, 2021, to February 20, 2022) at Afzalipour Hospital in Iran, using the first two steps of Six Sigma model. The study population comprised of all inpatients who needed blood or blood product transfusion in various departments of Afzalipour Hospital, among whom 477 patients were selected via stratified sampling in three shifts (morning, evening, and night). The datasheet was used to record errors in the three shifts. This research was conducted, using the DMAIC cycle's "define" and "measure" steps., Results: In the define step, the hemovigilance process at Afzalipour Hospital was divided into two categories of normal process and emergency process. Each of these processes consists of several sub-processes, including "phlebotomy," "requesting blood and blood products from the department," "preparation of application by the blood bank," " sending a request from the blood bank to the blood transfusion center," "transfusing blood and blood products," and "returning the blood and blood products to the blood bank and waste disposal." In the measure step, the quality of hemovigilance process was evaluated based on sub-processes and labels at morning, evening and night shifts. The sub-process of sending a request from the blood bank to the blood transfusion center had the highest error rate with a sigma level of 1.5. Also, the evening and night shifts had a sigma level of 1.875, and the clinical and registration labels had a sigma level of 1.875. The overall sigma level of hemovigilance process was calculated to be 2., Conclusion: The results of this study showed that the quality of hemovigilance process at Afzalipour Hospital was poor. By employing the first two steps of Six Sigma method, we identified the existing errors in the hemovigilance process of Afzalipour hospital in order to assist hospital managers to take the necessary measures to improve this process., (© 2023. The Author(s).)

Introduction: Reporting of transfusion reactions is good practice and required by many guidelines. Errors in the transfusion chain can also lead to severe patient reactions and depend on active error reporting. We aimed to characterize transfusion incidents and asked whether workup of transfusion reactions may also contribute to revealing logistical errors., Methods: Transfusion medical records from 2011 to 2019 at our tertiary medical centre, as well as forensic autopsy reports, digitized sections, and court records from 1990 to 2019 were analysed. A total of 230,845 components were transfused between 2011 and 2019 at our own institution., Results: Overall, 322 transfusion incidents were reported. Of these, 279 were from our own institution, corresponding to a frequency of 0.12% of all transfusions. The distribution of reaction types is consistent with the literature, with allergic reactions (55.9%), febrile-non-hemolytic reactions (FNHTR, 24.2%), hemolytic reactions (3.4%) and other types at smaller frequencies (<3%). Twenty-nine (10.4%) of the 279 reports revealed logistical errors, including hemoglobin above guideline threshold (4.3%), incorrect or non-performed bedside tests (3.2%), inadequate patient identification (2.5%), laboratory and issuing errors, missed product checks or failure to follow recommendations (1.1% each). Eight of 29 (27.5%) of the logistical errors were detected by serendipity during workup of incident reports. In addition, 8/932 autopsy cases under code A14 (medical treatment errors) were found to be transfusion-associated (0.9%)., Conclusion: Systematic workup of transfusion incidents can identify previously undetected errors in the transfusion chain. Passive reporting of errors through the recording of side effects may serve as a tool to assess more closely assess the frequency and quality of handling errors in real life, and thus serve to improve patient safety., Competing Interests: The authors have no conflicts of interest to declare for this work., (© 2023 Nitsche et al.)

Background: Pulmonary complications of blood transfusion, including transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO), and transfusion-associated dyspnea, are generally underdiagnosed and under-reported. The international TRALI and TACO definitions have recently been updated. Currently, no standardized pulmonary transfusion reaction reporting form exists and most of the hemovigilance forms have not yet incorporated the updated definitions. We developed a harmonized reporting form, aimed at improved data collection on pulmonary transfusion reactions for hemovigilance and research purposes by developing a standardized model reporting form and flowchart., Materials and Methods: Using a modified Delphi method among an international, multidisciplinary panel of 24 hemovigilance experts, detailed recommendations were developed for a standardized model reporting form for pulmonary complications of blood transfusion. Two Delphi rounds, including scoring systems, took place and several subsequent meetings were held to discuss issues and obtain consensus. Additionally, a flowchart was developed incorporating recently published redefinitions of pulmonary transfusion reactions., Results: In total, 17 participants completed the first questionnaire (70.8% response rate) and 14 participants completed the second questionnaire (58.3% response rate). According to the results from the questionnaires, the standardized model reporting form was divided into various subcategories: general information, patient history and transfusion characteristics, reaction details, investigations, treatment and supportive care, narrative, and transfused product., Conclusion: In this article, we present the recommendations from a global group of experts in the hemovigilance field. The standardized model reporting form and flowchart provide an initiative that may improve data collected to address pulmonary transfusion reactions., (© 2023 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.)

Purpose: In Norway, blood donors using antihypertensive medication were deferred until 2015. Following revision of the national directive, these donors could be allowed, providing stable dose for at least 3 months, adequate blood pressure control and no adverse effects caused by the therapy. The new practice was evaluated by a quality study where the major aim was to establish whether donations from blood donors on antihypertensive medication pose a risk to the donor. The risk was assessed by counting the number and categorizing the adverse events related to blood donation. In addition, the quantitative effect of including these donors was calculated., Subjects and Methods: In this retrospective quality study, blood donors on antihypertensive therapy were recruited from four different blood centers to fill out a questionnaire. A total of 265 donors answered questions regarding their health status, type of medication used, and adverse events connected to blood donation both before and after starting the therapy., Results: No severe adverse events were observed in donors on antihypertensive medications. The amount of mild adverse events, as exhibited by only 7 persons (0.46%) in this donor population, was the same as for donors without hypertensive treatment., Conclusion: Blood donation from persons on antihypertensive therapy poses no extra risk of severe adverse events, given the use of screening criteria to identify and bleed only low-risk donors., Competing Interests: The authors report no conflicts of interest in this work., (© 2023 Johnsen et al.)

Background: France converted to universal pathogen reduced (PR; amotosalen/UVA) platelets in 2017 and extended platelet component (PC) shelf-life from 5- to 7-days in 2018 and 2019. Annual national hemovigilance (HV) reports characterized longitudinal PC utilization and safety over 11 years, including several years prior to PR adoption as the national standard of care., Methods: Data were extracted from published annual HV reports. Apheresis and pooled buffy coat [BC] PC use was compared. Transfusion reactions (TRs) were stratified by type, severity, and causality. Trends were assessed for three periods: Baseline (2010-14; ~7% PR), Period 1 ([P1] 2015-17; 8%-21% PR), and Period 2 ([P2] 2018-20; 100% PR)., Results: PC use increased by 19.1% between 2010 and 2020. Pooled BC PC production increased from 38.8% to 68.2% of total PCs. Annual changes in PCs issued averaged 2.4% per year at baseline, -0.02% (P1) and 2.8% (P2). The increase in P2 coincided with a reduction in the target platelet dose and extension to 7-day storage. Allergic reactions, alloimmunization, febrile non-hemolytic TRs, immunologic incompatibility, and ineffective transfusions accounted for >90% of TRs. Overall, TR incidence per 100,000 PCs issued declined from 527.9 (2010) to 345.7 (2020). Severe TR rates declined 34.8% between P1-P2. Forty-six transfusion-transmitted bacterial infections (TTBI) were associated with conventional PCs during baseline and P1. No TTBI were associated with amotosalen/UVA PCs. Infections with Hepatitis E (HEV) a non-enveloped virus resistant to PR, were reported in all periods., Discussion: Longitudinal HV analysis demonstrated stable PC utilization trends with reduced patient risk during conversion to universal 7-day amotosalen/UVA PCs., (© 2023 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.)

Background: National Hemovigilance Programme aims at improving patient and donor outcomes by monitoring adverse reactions. This requires an additional effort by existing manpower that is already a handful and may offer a leeway if not mandated and designated to a hemovigilance nurse., Aims and Objectives: To analyse the reported adverse transfusion reactions (ATR) and their subsequent uplink/upload into the Hemovigilance program of India (HvPI) and to observe subjective discrepancy in the diagnosis of ATR and their imputability to transfusion., Material and Methods: ATR were analysed from May 2016 to October 2021 in a hospital-based blood centre in India. Two groups were formed, Group I constituted ATR that were reported and uplinked to HvPI, and Group II constituted all reported ATR irrespective of the uplink/upload. All ATR were reanalysed for a subjective discrepancy in diagnosis and imputability levels. Results were analysed online statistical software MedCalc using the "Exact Poissons Method" and the Chi-square test with a significant p-value of <0.05., Results: In total 169 ATR were reported in 166 patients and 89 (52.6%) were uplinked, with an incident rate of 1 in 1412 and 1 in 743 in Group I and Group II respectively. The difference was statistically significant (p < 0.0001). Allergic reactions were the most common type in both groups followed by FNHTR with PRBC as the most implicated blood product. A discrepancy of around 4.3% and 17.9% in diagnosis and imputability level respectively was observed., Conclusions: The difference in incidence rates in the two groups indicates a mandate for dedicated hemovigilance nurses in every centre to aid in accurate data sharing with the National hemovigilance systems. Discrepancies in diagnosis can be mitigated by identification and understanding of ATR through case-based objective approach. Discrepancy in assigning imputability levels to adverse reactions can be minimised by objectifying the scales followed by spreading awareness though campaigns. These initiatives can effectively be aided by the hemovigilance nurse., (Copyright © 2022 Société française de transfusion sanguine (SFTS). Published by Elsevier Masson SAS. All rights reserved.)

Many patients worldwide receive platelet components (PCs) through the transfusion of diverse types of blood components. PC transfusions are essential for the treatment of central thrombocytopenia of diverse causes, and such treatment is beneficial in patients at risk of severe bleeding. PC transfusions account for almost 10% of all the blood components supplied by blood services, but they are associated with about 3.25 times as many severe reactions (attributable to transfusion) than red blood cell transfusions after stringent in-process leukoreduction to less than 10 6 residual cells per blood component. PCs are not homogeneous, due to the considerable differences between donors. Furthermore, the modes of PC collection and preparation, the safety precautions taken to limit either the most common (allergic-type reactions and febrile non-hemolytic reactions) or the most severe (bacterial contamination, pulmonary lesions) adverse reactions, and storage and conservation methods can all result in so-called PC "storage lesions". Some storage lesions affect PC quality, with implications for patient outcome. Good transfusion practices should result in higher levels of platelet recovery and efficacy, and lower complication rates. These practices include a matching of tissue ABH antigens whenever possible, and of platelet HLA (and, to a lesser extent, HPA) antigens in immunization situations. This review provides an overview of all the available information relating to platelet transfusion, from donor and donation to bedside transfusion, and considers the impact of the measures applied to increase transfusion efficacy while improving safety and preventing transfusion inefficacy and refractoriness. It also considers alternatives to platelet component (PC) transfusion., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Société française de transfusion sanguine (SFTS). Published by Elsevier Masson SAS. All rights reserved.)

Since its emergence in the early 1990s, hemovigilance has gradually evolved from a blood safety concept focused on surveillance of adverse reactions and events in patients, to a well-defined system that monitors the entire transfusion chain and improves its safety. The importance of hemovigilance has been recognized globally in a relatively short time, but the level of its implementation varies significantly between countries. The cooperation of international organizations has significantly contributed to the promotion, implementation, and education in this field. Thanks to initiatives taken, the safety of transfusion practice has been improved in many segments, primarily related to the risks of adverse events in recipients of blood components. In parallel with changing transfusion practice, the hemovigilance process has also matured. In addition to the reduction of existing risks and the early detection of emerging risks, hemovigilance has also embraced the principles of patient blood management. Research in hemovigilance is more increasingly focused on specific categories of patients, specific blood components and methods of their preparation, rare reactions, and transfusion efficacy and efficiency. A proactive approach and use of big data can play an important role in achieving these goals. Additional and sustained efforts should be made to prevent underreporting of events and to improve data comparability through clear definitions and grading systems. This review provides a historical overview of hemovigilance and its achievements, current challenges, and future plans., (Copyright © 2022 Société française de transfusion sanguine (SFTS). Published by Elsevier Masson SAS. All rights reserved.)

Introduction: Following the first assessment of the effects of safety measures taken against transfusion-transmitted bacterial infections (TTBI), the Paul-Ehrlich-Institut (PEI) decided to newly analyze risk minimization measures (RMM) using German hemovigilance data from 2011 to 2020, focusing on blood components, recipients, and bacterial strains., Materials and Methods: The PEI assessed the imputability of all reported serious adverse reactions (SAR) relying mainly on microbiological test results. Reporting rates (RR) of suspected, confirmed, and fatal confirmed TTBI were calculated and compared to the previous reporting 10-year period (2001-2010) using Poisson regression to estimate RR ratios (RRR). Furthermore, details on blood component age, patients' medical history, and bacterial pathogenicity were collected., Results: With respect to the previous 10-year period, the number of suspected TTBI increased ( n = 403), while fewer cases were confirmed ( n = 40); the number of deaths remained more or less unchanged ( n = 8). The RR for suspected TTBI were 7.9, 18.7, and 1.6 cases per million units transfused for red blood cells (RBC), platelet concentrates (PC), and fresh frozen plasma (FFP), respectively. RRR showed a statistically significant 2.5-fold increase in the RR for suspected TTBI after RBC administration from 2001-2010 to the period under review ( p < 0.0001). The RR for confirmed TTBI were 0.4, 5.0, and 0.0 cases per million units transfused for RBC, PC, and FFP, respectively. Compared to the period 2001-2010, there was a statistically significant decrease in the RR of confirmed TTBI by half for PC ( p = 0.0052). The RR for confirmed PC-caused TTBI with fatal outcome was 1.4 cases per million units transfused. Regardless of type of blood product transfused and outcome of SAR, the majority of TTBI occurred after administration of a product at the end of shelf life (40.0%) and to recipients of advanced age (median age: 68.5 years) and/or with severe immunosuppression (72.5%) due to decreased myelopoiesis (62.5%). 72.5% of the involved bacteria had a middle/high human pathogenicity., Conclusion: Despite a significant decrease in confirmed TTBI following PC transfusion in Germany after implementation of RMM, the current manufacture of blood products can still not prevent TTBI with fatal outcomes. As demonstrated in various countries, RMM like bacterial screening or pathogen reduction may measurably improve the safety of blood transfusion., Competing Interests: The authors have no conflicts of interest to declare., (Copyright © 2022 by The Author(s). Published by S. Karger AG, Basel.)

Background: Assuring the quality and safety of blood and blood components is an essential element of health care in all countries and requires government commitment and legal frameworks. Ineffective regulation of blood and blood components has far-reaching consequences that are not limited to the affected countries but also have extensive global implications., Summary: In this review, we summarize the work of the project BloodTrain funded by the German Ministry of Health within the framework of the Global Health Protection Programme to strengthen regulatory structures in Africa that are imperative to guarantee the improved availability, safety, and quality of blood and blood products., Key Messages: Intense interaction with the stakeholders in African partner countries lead to first measurable successes in the strengthening of blood regulation, as shown here for hemovigilance., Competing Interests: The authors have no conflicts of interest to declare., (Copyright © 2022 by The Author(s). Published by S. Karger AG, Basel.)

Background: Hypotensive transfusion reaction (HyTR) is rare. It is characterized by a rapid onset of hypotension during transfusion, which usually resolves quickly upon cessation of transfusion. Information on the incidence and clinical characteristics of HyTR has been reported in only a few studies., Study Design and Methods: We retrospectively reviewed HyTR cases from 10-year hemovigilance data in a tertiary care hospital in Seoul, Korea., Results: We identified 37 HyTRs in 35 patients, and the overall incidence of HyTR was 0.50 per 10,000 transfused units. Among the blood components, the incidence of HyTR was highest in filtered random donor platelets (0.75 per 10,000 units). About half of the HyTRs occurred within 15 min after the start of transfusion (19/37). Blood pressure returned to the normal range within an hour in 73.0% of the cases (27/37). All HyTR cases recovered without severe complications. Known risk factors for HyTR were not prominent in our cohort of patients, with no patients taking angiotensin-converting enzyme inhibitors and only five patients transfused with bedside filtered platelets., Discussion: HyTR can occur in patients with various conditions and types of blood components. Understanding the clinical characteristics of HyTR facilitates proper management, leading to improved transfusion safety., (© 2022 AABB.)

Wra is the most common LIA in white population. The incidence of Wra antigen in Spanish population has been estimated to be 1 in 785 in blood donors, while anti-Wra was found in 2.7 % and 3.6 % of healthy donors and transfused patients respectively. Severe, even fatal hemolytic transfusion reactions and hemolytic disease of the newborn caused by anti-Wra have been reported. Since the reagent red blood cells used for antibody screening usually lack Wra antigen, the anti-Wra is not detected and hemolytic reaction could occur if transfusion is performed by type and screen approach. We report an acute hemolytic reaction due to anti-Wra in a patient with negative antibody screening. We have also reviewed the records of the hospital hemovigilance database in order to collect the previous hemolytic cases due to anti-Wra. During a 21-year period 461,539 red blood cell units have been transfused to 81,614 patients in our hospital. Alloimmnunization was detected in 3840 patients (0.83 %) and anti-Wra was detected in 22 patients (1/3709), 10 of whom had other alloantibodies, and only in 1 occasion (this case) has been implicated in mild hemolytic acute transfusion reaction. In our experience, the risk of fatal hemolytic reaction due to LIA in hospitals with blood services using the type and screen policy is extremely low., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background and Objectives: Early in the pandemic, the transmissibility of coronavirus disease-19 (COVID-19) by transfusion was unknown. We piloted a systematic, post-donation outreach programme to contact blood donors and inquired about symptoms post-donation., Materials and Methods: Persons who donated on on May 1 and 2, 2020 were contacted 3 days post-donation, by phone to assess COVID-19-related symptoms. Half of the donors were administered a short questionnaire, consisting of only three questions. Others were questioned using a longer, more specific questionnaire. If symptoms were reported, products were quarantined until donors were contacted again by a trained nurse who more thoroughly assessed the likelihood of COVID-19. Blood products were withdrawn if symptoms indicative of COVID-19 were identified., Results: Of 654 donors, 609 (93.1%) were successfully contacted. Of 310 donors who answered the short questionnaire and 299 who answered the long questionnaire, 19 (6.1%) and 8 (2.7%) had one or more symptoms, respectively. Based on the nurses' assessment, two donations (0.3%) had to be withdrawn., Conclusion: These results suggest that actively seeking post-donation information might be feasible to mitigate emerging, unqualified transfusion risks., (© 2021 International Society of Blood Transfusion.)

Few data are currently available on hypersensitivity transfusion reactions (HTRs) after exposure to fresh frozen plasma (FFP). Between 2000 and 2018, three different FFP production strategies have been used in France, leading to the concomitant use of different types of FFP. The objective of this study was to describe the rate of FFP-related HTRs and to assess the relative risk of each type of FFP. HTR following FFP transfusion between 2000 and 2018 were retrospectively extracted from the national hemovigilance database of the French National Agency for Medicines and Health Products Safety (ANSM). Temporal evolution of the incidence of reactions was modeled using logistic regression. During the study period, the overall rate of FFP-related HTRs was 52.0 (95% CI 50.2-53.9) reactions per 100,000 units of FFP issued. The rate of FFP-related HTRs progressively increased over the study period, from 28.7 (95% CI 22.8-36.0) in 2000 to 88.9 (78.8-100.3) reactions per 100,000 units of FFP issued in 2018 (OR 1.08 [1.07 - 1.09], P < .001), whereas the rate of other types of adverse transfusion reactions (ATRs) decreased. Between 2000 and 2014, its period of use, Solvent-Detergent-treated Apheresis FFP (SD-APH) was associated with the lowest risk of HTR. Our results indicate that although the rate of HTRs to FFP is low in France, the risk of having such a reaction has steadily increased between 2000 and 2018. A declarative bias is unlikely as the rate of other type of FFP-related ATRs decreased over the same period. The risk of HTRs to FFP is suggested to differ according to the processing of the FFP with a lower risk for SD-APH., Competing Interests: Conflict of interest The authors have no conflict of interest to disclose in relation to the submitted review., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objectives: The objective of this study was to assess the changes in knowledge concerning quality management system (QMS) among the participants before and after attending a QMS training., Methods: After obtaining the ethical approval, a retrospective study was designed to evaluate the effectiveness of QMS. Fifty participants from district blood banks of three different states participated in the study organized at two different periods. After obtaining informed consent, the participants were subjected to set of questionnaire containing 45 questions (35 multiple choice and 10 subjective questions) as pretest on quality standards and were again subjected to posttest questionnaire containing the same set of questions after 5 days of workshop. Twenty minutes were granted to solve the questions. Each question was given one mark. There was no negative marking. An assessment of knowledge gained during training was evaluated by comparing the scores of pre- and post-assessment., Results: Of the total 50 delegates, 29 were trained in the month of July (Training I) and 21 were trained in the month of November (Training II). There were 96% ( n = 48) males and 4% ( n = 2) females. In both the training sessions, that is, Training I and II, the mean scores of objective questions in pretest were 13.629 ± 6.58 and 9.34 ± 5.74, and after the training, the posttest scores increased significantly to 17.77 ± 7.05 and 14.34 ± 7.09, respectively. Paired Student's t -test was applied which showed statistically significant increment in knowledge ( P = 0.001)., Conclusions: There was a significant positive change in the knowledge of the participants after attending QMS workshop., Competing Interests: There are no conflicts of interest., (Copyright: © 2022 Asian Journal of Transfusion Science.)

We report a transfusion-transmitted hepatitis A virus infection in an immunocompromised patient in France, detected shortly after a transfusion of pathogen-reduced pooled platelets. This case raises questions about the efficacy of donor screening methods. Additional safety measures, such as routine donation screening, should be considered.

Haemovigilance and blood safety became closely linked initially to the quality system, then very quickly to risk management in health-care institutions. The complexity of the transfusion process and the uniqueness of the transfusion act have been the source of a wide range of in-depth analyzes, via methods most often derived from the industry, that aimed at preventing the occurrence of unwanted situations with potential adverse effects on transfused patients. Though these methods have widely been successful, the experience gained over more than two decades indicates that many reported incidents are still avoidable. The time devoted to training, file analyzes (even in the absence of any reported incident), and simulating patient care remains essential. It is fundamental to bear in mind that there is no such thing as risk zero, no one is immune, and this does not happen to others. In this context, developing a different perspective, a new reflection, a vision integrating the complexity of fieldwork and the idea of risk may be an approach worthy of investigation. Indeed, an analysis centered on both of the ways a team copes with difficult situations and the variety of the interactions between professionals would allow medical practitioner to better position themselves through a better assessment and understanding of their role. Such a deeper reflection, through the mobilization of all the stakeholders of the many successful steps of the transfusion process, would increase blood safety and the overall resilience of the system., (Copyright © 2021 Société française de transfusion sanguine (SFTS). Published by Elsevier Masson SAS. All rights reserved.)

Competing Interests: Conflict of interest: The author declares no potential conflict of interest.

Objectives: To review the new current diagnostic criteria of transfusion-associated circulatory overload (TACO) and transfusion-related acute lung injury (TRALI) from the literature while highlighting distinguishing features. We provide comprehensive understanding of the importance of hemovigilance and its role in appropriately identifying and reporting these potentially fatal transfusion reactions., Methods: A review of the English language literature was performed to analyze TACO and TRALI while providing further understanding of the rationale behind the historical underrecognition and underreporting., Results: Our review demonstrates the new 2018 and 2019 case definitions for TACO and TRALI, respectively. With more comprehensive diagnostic strategies, adverse transfusion events can be better recognized from mimicking events and underlying disease. In addition, there are mitigation strategies in place to help prevent complications of blood product transfusion, with emphasis on the prevention of TACO and TRALI., Conclusions: TACO and TRALI are potentially fatal adverse complications of blood transfusion. Both have been historically underrecognized and underreported due to poor defining criteria and overlapping symptomatology. Developing a thorough clinical understanding between these two entities can improve hemovigilance reporting and can contribute to risk factor identification and preventative measures., (© American Society for Clinical Pathology, 2021.)

Background/objectives: Transfusion reactions (TRs) may cause or contribute to death. Cardiopulmonary TRs are distressing, and collectively account for most transfusion fatalities, though the degree to which they alter survival more broadly is unclear. Deaths (and their timing) after TRs may provide further insights., Materials/methods: Adult (tri-hospital network) haemovigilance data (2013-2016) recorded referrals with conclusions ranging from unrelated to transfusion (UTR) to entities such as: septic TRs, serologic/haemolytic reactions, transfusion-associated circulatory overload (TACO), transfusion-associated dyspnoea (TAD), transfusion-related acute lung injury (TRALI), allergic transfusion reaction (ATR), and others. For (in- or out-patient) visits involving suspected TRs (VISTRs), all-cause mortalities (% [95% confidence interval]) and associated time-to-death (TTD) (median days, [interquartile range]) were compared. Diagnoses were defined inclusively (possible-to-definite) or strictly (probable-to-definite)., Results: Of 1144 events, rank order VISTR mortality following (possible-to-definite) TRs, and associated TTDs, were led by: DHTR 33% [6-19], 1 death at 123d; TRALI 32% [15-54], 6 deaths: 3d [2-20]; BaCon 21% [14-31], 17 deaths: 10d [3-28]; TACO 18% [12-26], 23 deaths: 16d [6-28]; TAD 17% [11-26]: 18 deaths, 6d [3-12]. Higher-certainty TRs ranked similarly (DHTR 50% [9-91]; BaCon 29% [12-55], 4 deaths: 12d [3-22]; and TACO 25% [16-38], 15 deaths: 21d [6-28]). VISTR mortality after TACO or TRALI significantly exceeded ATR (3·3% [2·4-5·8], P < 0·00001) but was not different from UTR events (P = 0·3)., Conclusions: Only half of cardiopulmonary TRs constituted high certainty diagnoses. Nevertheless, cardiopulmonary TRs and suspected BaCon marked higher VISTR mortality with shorter TTDs. Short (<1 week) TTDs in TAD, BaCon or TRALI imply either contributing roles in death, treatment refractoriness and/or applicable TR susceptibilities in the dying., (© 2021 International Society of Blood Transfusion.)

Fatal ABO-incompatible (ABOi) transfusion is one of the most common causes of transfusion-related death, but its reporting has been limited in Korea. We comprehensively reviewed ABOi transfusion events in Korea by analyzing cases reported in literature, Korean hemovigilance system (KOHEVIS) annual reports, and written judgments. Written judgments were assessed using a written judgment management system or a comprehensive legal information system. We found nine cases of ABOi transfusion events in written judgments (from 1953 to 2019), 16 in the KOHEVIS (from 2008 to 2018), and nine in published reports (from 1978 to 2019). One case was found in all three sources. Overall, we found 32 cases of ABOi transfusion events. Four cases died and 23 survived, while the outcomes for five were unavailable. ABOi transfusion errors occurred at the administration (50%, 16/32), sample (13%, 4/32), and testing (9%, 3/32) stages. The causes of errors were unavailable for nine cases (28%, 9/32). We report the status of ABOi transfusions in Korea and expect our results to contribute to the prevention of adverse reactions due to ABOi transfusion.

Background: There are several strategies to reduce donor reactions. We report donor participation and reaction rates before and after implementing multiple measures at Canadian Blood Services., Study Design and Methods: We introduced a structured program of 500 mL of water and a salty snack pre-donation and applied muscle tension (AMT) during donation. Donors were not deferred for out of range blood pressure (BP); however, BP was measured in first time donors. Time on the donation chair post-donation was decreased from 5 to 2 min for repeat donors. We assessed participation rates using our quarterly survey of 10,000 recent donors. We extracted vasovagal reactions with loss of consciousness (LOC) from our operational database and compared pre-implementation (Oct 12,018-March 31,2019) and post-implementation (Oct 12,019-March 31,2020) periods., Results: Survey response rates varied from 11% to 16%. The percentage of donors who drank the water and ate the salty snack increased from 58% to 82% and 44% to 70% over 4 quarters; those performing AMT increased from 24% to 41%. Reactions decreased from 19.07 per 10,000 (744 reactions in 390,123 donations) to 14.04 per 10,000 (537 in 382,382 donations) (p < .0001). No first-time donors with high BP (n = 684) but 5 with low BP (n = 718) had reactions, CI were very large., Conclusions: Achieving optimal participation was challenging. After implementation of a donor wellness initiative based on best practice, rates of vasovagal reactions with LOC decreased by 25%. A larger dataset is necessary to assess the safety contribution of BP deferrals when other mitigation measures are in place., (© 2021 AABB.)

Objective: Transfusion of blood and blood components is a special type of tissue transplantation, a life-saving treatment. However, besides the benefits of blood product transfusions, there are also some undesirable side effects. In the present study, the frequency and type of transfusion reactions related to blood and blood components were investigated., Methods: In this retrospective study, types and the time of occurrence of acute transfusion reaction (ATR), the types of blood and blood components used in our hospital between January 2018 and January 2020 were evaluated for hemovigilance using unit blood products application and side effect reporting forms., Results: During the 2-year period, 61,636 blood and/or blood components were used in 9334 patients, and 53 of the transfused patients developed ATR. In two patients, ATR developed 2 times and a total of 55 ATR developed. Of the patients who developed ATR, 18 were female and 35 were male, and their ages ranged from 1 month to 85 years. The frequency of ATR was 0.09%, and 47.3% of ATRs were allergic transfusion reactions, 41.8% were febrile non-hemolytic transfusion reactions (FNHTRs), 7.3% were hypotensive transfusion reactions, and 1.8% were transfusion-related lung injury. Fifty-five ATRs were found to be associated with 61.8% erythrocyte suspension, 30.9% with FFP, 5.5% with platelet suspension, and 1.8% with whole blood., Conclusion: There are a limited number of studies evaluating transfusion reaction frequency and reaction types from our country. The most frequent ATR reported in our hospital were mild allergic reactions and FNHTR. The most common side effect of blood product type was erythrocyte suspension. It is important to monitor the transfused patients for undesired reactions during and after the transfusion to determine the frequency, type, risk factors, and safety precautions of the transfusion reactions., Competing Interests: Conflict of Interest: No conflict of interest was declared by the authors., (Copyright: © 2021 by Istanbul Northern Anatolian Association of Public Hospitals.)

Despite advances in transfusion safety, concerns with safety of platelet transfusions remain including platelet-related sepsis and higher reaction rates observed among patients receiving apheresis platelets (APLTs). National Healthcare Safety Network (NHSN) Hemovigilance Module (HM) data were analyzed to quantify the burden and severity of adverse reactions occurring from APLTs and whole blood-derived platelets (WBD-PLTs). Facilities participating in NHSN HM during 2010-2018 were included. Adverse reaction rates (number per 100,000 components transfused) were calculated for APLTs and WBD-PLTs stratified by severity, use of platelet additive solution (PAS), and pathogen reduction technology (PRT). Chi-square tests were used to compare rates. During the study interval, 2,000,589 platelets were transfused: 1,435,154 APLTs; 525,902 WBD-PLTs; and among APLTs, 39,533 PRT-APLTs. APLT adverse reaction rates were higher (478 vs 70/ 100,000, P< .01) and more often serious (34 vs 6/100,000; P< .01) compared with WBD-PLTs. Adverse reactions were higher among PRT-APLTs (572/100,000) and were less often serious (18/100,000) compared with non-PRT-APLTs (35/100,000) although this association was not statistically significant. Among components implicated in adverse reactions, 92% of APLTs were suspended in plasma. Compared with PRT-APLTs stored in PAS, rates were higher among units stored in plasma (760 vs 525/100,000). Most serious reactions (75%) were allergic. No transfusion-transmitted infections were reported among PRT-APLTs. APLTs were associated with a 6-fold and 2-fold higher serious adverse reaction risks compared with WBD-PLTs and PRT-APLTs, respectively. These findings demonstrate the importance of monitoring transfusion-related adverse reactions to track the safety of platelet transfusions and quantify the impact of mitigation strategies through national hemovigilance systems., Competing Interests: Declaration of Competing Interest The authors have stated they have no conflicts of interest., (Copyright © 2021. Published by Elsevier Inc.)

Some types of transfusion reactions occur more frequently in the pediatric than the adult population. Allergic reactions are the most common, followed by nonhemolytic transfusion reactions; male children seem most susceptible to such reactions. Platelets are often implicated and pulmonary reactions are understudied in children. Clinical sequelae in neonates, such as bronchopulmonary dysplasia/chronic lung disease and intraventricular hemorrhage, have received increasing attention in relation to transfusion. There is a need to better understand the pathophysiology of transfusion reactions in neonatal and pediatric populations so preventive strategies can be undertaken. There is also a need for robust hemovigilance systems., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background and Objective: The European consortium project TRANSPOSE (TRANSfusion and transplantation: PrOtection and SElection of donors) aimed to assess and evaluate the risks to donors of Substances of Human Origin (SoHO), and to identify gaps between current donor vigilance systems and perceived risks., Materials and Methods: National and local data from participating organizations on serious and non-serious adverse reactions in donors were collected from 2014 to 2017. Following this, a survey was performed among participants to identify risks not included in the data sets. Finally, participants rated the risks according to severity, level of evidence and prevalence., Results: Significant discrepancies between anticipated donor risks and the collected data were found. Furthermore, many participants reported that national data on adverse reactions in donors of stem cells, gametes, embryos and tissues were not routinely collected and/or available., Conclusions: These findings indicate that there is a need to further develop and standardize donor vigilance in Europe and to include long-term risks to donors, which are currently underreported, ensuring donor health and securing the future supply of SoHO., (© 2020 International Society of Blood Transfusion.)

Background and Objectives: The key first step for a safe blood transfusion is patient registration for identification and linking to past medical and transfusion history. In Canada, any deviation from standard operating procedures in transfusion is an error voluntarily reportable to a national database (Transfusion Error Surveillance System [TESS]). We used this database to characterize the subset of registration-related errors impacting transfusion care, including where, when and why the errors occurred, and to identify frequent high-risk errors., Materials and Methods: A retrospective analysis was conducted on transfusion errors reported to TESS by sentinel reporting sites relating to patient registration and patient armbands, between 2008 and 2017. Free-text comments describing the error were coded to further categorize into common error types. The number of specimens received in the transfusion laboratory was used as the denominator for rates to allow for comparison between hospital sites., Results: Five hundred and fifty-four registration errors were reported from 10 hospitals, for a global error rate of 5·4/10 000 samples (median 5·0 [interquartile range 3·7-7·0]). The potential severity was high in 85·7% of errors (n = 475). The patient experienced a consequence in 10·8% of errors (n = 60), but none resulted in patient harm. Rates varied widely and differed by nature across sites. Errors most commonly occurred in outpatient clinics or procedure units (n = 160, 28·8%) and in emergency departments (n = 130, 23·5%)., Conclusion: Registration errors affect transfusion at every step and location in the hospital and are commonly high risk. Further research into common root causes is warranted to identify preventative strategies., (© 2020 International Society of Blood Transfusion.)

Objectives: This study aimed to compare the effects of teaching by three methods of teach-back, concept map, and lecture on knowledge and performance of nurses in hemovigilance process., Methods: This quasi-experimental study was performed on 108 Iranian nurses. In the lecture group, the educational intervention was conducted during a 4-hour session; and in the concept map and teach-back groups, it was performed in two 2-hour sessions. The nurses' knowledge and performance were measured by "routine blood transfusion knowledge questionnaire (RBTKQ)" and "self-reporting performance-evaluator questionnaire"., Results: After the interventions, knowledge was significantly higher in the teach-back and the concept map groups compared to the lecture group (p = 0.001), but the performance in the lecture group was higher than the other two groups (p = 0.01). No statistically significant differences were found between teach-back and concept map groups., Conclusion: Teach-back and concept map methods were effective in improving the nurses' hemovigilance knowledge, while the lecture was associated with a significant increase in their performance. Therefore, integrating the hemovigilance teaching methods is suggested., Competing Interests: The authors declare no conflict of interest., (© 2021 Published by Elsevier Ltd.)

This essay aims to discuss some aspects of blood transfusion in the perspective of the changes that occurred over time as well as modifications of the paradigms that transformed the activities and the organization of blood transfusion services. Without specific knowledge, pioneers envisioned precision and personalized medicine, rendering transfusion medicine operational. Transfusion medicine is like The Picture of Dorian Grey: always young despite being old and sometimes appearing old-fashioned. Over the years, the transfusion medicine discipline has evolved, and major progress has been achieved, despite some troublesome periods (for example, the tainted blood scandal, and-at the time being-the offending plasma market and the selling of human parts). Transfusion medicine has at all times implemented the rapidly developing biomedical technologies to secure blood components. The safety of blood components has now reached an exceptional level in economically wealthy countries, especially compared to other health care disciplines. Strengthening of the safety has mandated that blood donors and recipients are unrelated, an issue which has eased preservation and fractionation practices; blood is no longer arm-to-arm transfused and neither is whole blood, the commonest component. However, it is interesting to note that a revival is occurring as whole blood is back on stage for certain specific indications, which is one among the many paradoxes encountered while studying this discipline., (Copyright © 2020 Société française de transfusion sanguine (SFTS). Published by Elsevier Masson SAS. All rights reserved.)

Background: Blood transfusion is a life-saving procedure, but may cause adverse transfusion reactions (TRs). The reporting of TRs is often missed due to various reasons. The aim of this study was to determine the incidence of unreported acute TRs through active surveillance and to compare it with the incidence of passively reported TRs., Methods: This prospective observational study was done over a period of four months at a tertiary care hospital. A total of 500 consecutive transfusion episodes (TEs) in patients who had received blood component transfusions in the intensive care units were included in the study. Comprehensive data were collected from the blood bank records, patient records and through interviews with the attending clinical staff. The TEs were defined as all blood components issued to a single patient in 24h., Results: The overall incidence of TRs was 1.8 % (9 cases), with 0.4 % (2 cases) being reported passively, while 1.4 % (7 cases) were identified during active surveillance. The transfusion-associated cardiac overload (TACO) had the highest incidence of 1.2 % (6 cases) in active surveillance. A single case of acute hemolytic transfusion reaction was also observed during active surveillance. The passively reported TRs were one allergic reaction and one febrile non-hemolytic transfusion reaction., Conclusion: Active surveillance of TRs provided an insight into the true incidence of TRs, which is higher when compared with the passively reported TRs. The TACO was found to have the highest incidence and not a single case was reported. There is a need to improve awareness regarding TR reporting., (Copyright © 2019 Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular. Published by Elsevier Editora Ltda. All rights reserved.)

Objective  Blood transfusion being a major lifesaving frontline procedure in majority of clinical wards, has a high potential with risk for adverse events ranging in severity, thus warranting optimal usage of blood. Continuous monitoring of adverse transfusion reaction (ATR) and analysis of the reactions can promote better comprehension of various contributing risk factors. Hemovigilance being a quality indicator with data system assists in ensuring quality and safe blood transfusion. The present study was designed to analyze the incidence and nature of adverse transfusion-associated events reported to the blood bank from our teaching hospital located in the remote part of South-East Coastal region with emphasis on corrective and preventive actions. Materials and Methods  The prospective study included all the ATR reported to our hospital blood bank over a period of 42 months. The transfusion reactions report forms filled by the clinicians were analyzed and the reactions were categorized into patterns. The associated risk factors for the reaction are evaluated with substantial laboratory and clinical parameters in reference to hemovigilance. Results  Among 19,800 transfusions, 189 transfusion reactions were encountered with a ratio of 10:0.9 with age ranging from 12 to 80, with female preponderance. Reactions associated with whole blood (WB) transfusion were common (50%, p = 0.002) followed by packed red blood cells transfusion (PRBC) (1.4%, p = 0.006) and platelets (0.8%, p = 0.1). Febrile nonhemolytic transfusion reactions were predominant patterns noted in 122 cases followed by allergic reactions in 43 cases with more commonly associated PRBC transfusion whereas hemolytic reactions showed association with WB transfusion. No delayed reactions or mortalities were encountered. Conclusion  The present study concludes with novelty showing the overall incidence of transfusion-associated reactions in the study domain is slightly higher than more advanced centers in India owing to lack of leukodepletion units which could enable to substantially retard the incidence of adverse events of transfusion as a general measure and febrile reactions in particular. Hemovigilance and pattern analysis of ATR provide scope for corrective and preventive action and give referral guidelines to prevent future recurrence., Competing Interests: Conflict of Interest None declared.

Background: Malaria can be transmitted by blood transfusion through donations collected from asymptomatic donors. Transfusion-transmitted malaria (TTM) poses a great risk to blood services worldwide. A good screening tool for Plasmodium spp. detection in blood banks must have a high sensitivity for prevention of TTM. However, in Brazilian blood banks, screening for malaria still relies on microscopy., Methods: In Brazil, screening for human immunodeficiency virus type 1 (HIV), RNA/DNA for hepatitis C (HCV) and hepatitis B (HBV) viruses is mandatory for every blood donation and uses nucleic acid amplification testing (NAT). The aim of this study was to evaluate the inclusion of an assay for malaria to identify Plasmodium sp. from total nucleic acid (TNA; DNA/RNA) by targeting the 18S rRNA gene of the parasite., Results: Considering the limitations of microscopy and the wide availability of the Brazilian NAT platform in the screening of blood units for HIV, HCV, and HBV, a molecular diagnostic tool was validated for detection of Plasmodium sp. in blood banks; a pilot study showed that using this novel NAT assay could reduce the risk of TTM., Conclusion: The prototype HIV/HCV/HBV/malaria NAT assay was effective in detecting infected candidate donors and has good prospects to be applied in routine screening for preventing TTM.

Background: Blood component mistransfusion is generally due to preventable clerical errors, specifically pretransfusion misidentification of patient/blood unit at bedside. Hence, electronic devices such as barcode scanners are recommended as the standard instrument used to check the patient's identity. However, several healthcare facilities in underdeveloped countries cannot afford this instrument; hence, they usually perform subjective visual assessment to check the patient's identity. This type of assessment is prone to clinical errors, which precipitates significant level of anxiety in the healthcare personnel transfusing the blood unit. Hence, a novel objective method in performing pretransfusion identity check, the 'Sandesh Positive-Negative (SPON) protocol,' was developed., Methods: A nonrandomized study on bedside pretransfusion identity check was conducted, and 75 health care personnel performed transfusion. The intervention was performed by matching a custom-made negative label with blood component with the positive label of the same patient available at bedside who was about to receive transfusion., Results: In total, 85.3% of the subjects were anxious while performing pretransfusion identity check based on the existing standard practice. After the implementation of the SPON protocol, only 38.7% experienced either mild, moderate or severe anxiety. The overall level of satisfaction also increased from 8.0% to 38.7% and none were dissatisfied. Although only 9.3% were dissatisfied about the existing practice, approximately 70.7% felt the need for a better/additional protocol. Clerical error was not observed., Conclusions: The SPON protocol is a cost-effective objective method that reduces anxiety and increases satisfaction levels when performing final bedside identity check of blood components.

Objectives: To determine the knowledge of transfusion and related practices among doctors working at Universitas Academic Complex (UAC), Bloemfontein, South Africa. We aimed to describe training history, transfusion knowledge and reported haemovigilance reporting habits., Methods: A cross-sectional descriptive study was performed using an anonymous questionnaire distributed at departmental meetings. The study population included doctors working in adult disciplines that frequently transfuse blood from the UAC. Ethics approval was obtained from the University of the Free State, Health Sciences Research Ethics Committee. Permission to conduct the study was obtained from the Free State Department of Health. Results were summarised by frequencies and percentages., Results: Questionnaires of 152 respondents were analysed. Most of the respondents (31.5 %) were registrars and medical officers with less than 5 years' experience, followed by specialists (19.9 %). Although prescribing habits varied, 43.3 % of respondents prescribe blood at least weekly. Almost a third (29.9 %) of respondents had never received any transfusion training. A haemoglobin-based transfusion trigger is used by 76.2 % of respondents. Almost 80 % of respondents reported using a single unit of blood followed by clinical reassessment before ordering a second unit. Cost of laboratory investigations and lack of human resources were the main reported obstacles to adequately investigating anaemia. Forty percent of respondents involved with the care of patients who suffered a transfusion related adverse event reported the event to the blood service., Conclusion: At the (UAC), where blood is frequently transfused, we note infrequent training, poor knowledge of some basic transfusion principles and poor haemovigilance reporting., Competing Interests: Declaration of Competing Interest None., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

The present study aimed to propose a model for the national hemovigilance information system with a database approach, considering the importance and necessity of developing an information system for such a network. This is an applied, descriptive, and cross-sectional study, which was conducted in 2018. The research population comprised hemovigilance information systems in advanced countries, including the USA, UK, Australia, and France. Data were collected from library sources and the Internet from 2000 to 2018. The proposed model for the national hemovigilance information system was introduced using comparative tables and based on the similarities and differences of systems in the studied countries. The proposed model was then validated using the two-step Delphi technique through a researcher-made questionnaire whose validity was confirmed, and reliability was approved by a Cronbach's alpha of 94%. The final model of the national hemovigilance information system comprised five main components: goals, organizations involved in the blood transfusion process, databases of blood transfusion organizations, data transfer flow between the databases of blood transfusion organizations, and transferable datasets, and hemovigilance-related committees. This model was approved by experts with an >85% agreement coefficient. The national hemovigilance information system with a database approach can improve blood transfusion health by providing access to reliable sources on blood transfusion complications to everyone, especially the medical community. Thus, it is essential to implement this standard accurately and precisely control the practical methods of this process based on international guidelines., (©Carol Davila University Press.)

Background/Objectives : Blood is a vital resource that its utilization is ever increasing throughout the world and blood wastage is a global challenge that needs to be controlled. Most blood resources are used during complications of pregnancy, trauma, severe childhood anemia, gynecology, cancers, surgery, hematology disorders, and chronic diseases. Units that are expired, broken bags, returning the blood unit after 30 min, blood clotted units, etc., which are due to lack of awareness may result in the wastage of blood products. The objective of this study is to analyze the usage and wastage of blood and its products in Mazandaran heart center. Methods : In this retrospective study, the survey was carried out on the data that were obtained from Mazandaran heart center of Sari, Iran during 2012-2017. Data included details of usage and wastage on blood and its product units. MS Excel 2016 and SPSS 16.0 were used in analysis and diagrams. Results : A total of 35,686 blood units were consumed, which included 55.7% packed red blood cells (PRBCs), 33.9% platelets (Plts), 8.9% fresh-frozen-plasma (FFP), and 8.9% cryoprecipitates. Moreover, 823 blood units including 41.4% FFP, 37.2% PRBCs, and 21.4% Plts were wasted mostly because of inappropriate order (70.6%). Cross-match to transfusion ratio was 1.13. The intensive care unit reported the highest level of blood intake by 45.0%. The blood group O+ was the most frequent by 34.8%. In addition, blood wastage has decreased over study period by approximately 10.0%. Conclusion : Our study showed not only the increasing pattern of blood usage but also the dropping pattern of blood wastage due to hemovigilance performance and additional training in our healthcare center. We found that the main reason for the blood wastage in this center is an excessive order of blood units.

Safe blood transfusion is the primary need of all the health care delivery system. Though with the advances of transfusion medicine, the incidences of transfusion risk is gradually reduced, but the adverse transfusion reaction (ATR) of non hemolytic type still prevails. The purpose of this study was to estimate the incidence and pattern of transfusion-related adverse events at our centre. The present retrospective observational study was conducted in the Department of Transfusion Medicine from April 2011 to April 2018, at a multi-organ transplant centre in South India. All the Adverse transfusion reactions were investigated in detail in the blood bank for the clerical errors, immunohematology workup and classified according to their nature with imputability assessment. A total of 140 ATR were reported out of 100,569 blood components distributed during the study period. After the analysis and workup of the reported reactions, majority of the reactions were observed in males (71%, n = 99). Most common symptom presented was Itching/Rashes in 43.6% (n = 61) ATR. Allergic reactions (51.4%, n = 72), were the most commonly encountered ATR followed by FNHTR (25.7%, n = 36). FFP transfusions (0.2%) contributed to the majority of the reactions followed by Red cell transfusion (0.15%). ATR were observed maximum in Hepato-biliary disease and liver transplantation patients (62%) followed by oncology patients (15%). The overall incidence of ATR in our study is 0.14% which is comparatively low compared to other studies due to well established hemovigilance systems. Adoption of more equipped methods & sensitive technology in various areas of blood banking will help to bring down the unwanted adverse transfusion reactions., Competing Interests: Conflict of interestThe authors declare that they have no conflict of interest., (© Indian Society of Hematology and Blood Transfusion 2019.)