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OBJECTIVE: To propose a rational basis for donor testing in cases of suspected antibody-mediated transfusion-related lung injury (AMT). BACKGROUND: Anti-leukocyte antibodies in donated blood are established causes of transfusion-related lung injury (TRALI). However, the question of whether to test donors for antibodies is not identical to whether the case meets definition criteria for TRALI. There is a balance between the potential benefits of testing and the costs of donor deferral and investigation. We propose that a decision-making process based on optimising the balance between risk and benefit requires a subjective choice of the relative value of different outcomes of testing. METHODS: We have developed a formal decision model to illustrate how these choices affect testing decisions. RESULTS: Using a Bayesian probability model, we show that the diagnostic benefit and TRALI prevention benefit of testing donors have a complex interrelationship with the number of implicated donors and clinical suspicion of antibody-mediated TRALI (AMT) and that rational testing choices vary according to value assigned to outcomes. CONCLUSIONS: The challenges to the use of a formal decision model for clinical testing are discussed and conclude that a formal model is a useful consensus-building tool for improving consistency and openness in decision making.

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BACKGROUND AND OBJECTIVES: There is no consensus on a universally accepted threshold to categorize a patient as multitransfused. In 2019, Colombia established the definition of a multitransfused patient as someone who has received six or more blood components, irrespective of the time frame. This study aims to delineate the characteristics, adverse transfusion reactions (ATRs, definitions according to the International Society of Blood Transfusion [ISBT]) and survival rates in this population. MATERIALS AND METHODS: We performed an analysis from the data of all institutions engaged in blood component transfusions at the national level who notified events to the National Information System of Haemovigilance (SIHEVI-INS), from January 2018 to December 2022. The selection criteria focused on individuals who not only exhibited ATRs but also received six or more blood components. RESULTS: Among the 1,784,428 patients who received 6,637,271 blood components, an average of 3.7 components per patient was noted. Concurrently, 8378 ATRs were reported (12.6 ATRs/10,000 transfused components). Within this cohort, 691 patients met the criteria for multitransfusion. Predominantly women (51.8%), these individuals received between 6 and 14 blood components. Out of the 691 multitransfused individuals who experienced ATR, 541 had an allergic reaction. Conversely, out of the 6479 non-multitransfused individuals who experienced ATR, 3835 had an allergic reaction (odds ratio: 2.49, 95% confidence interval: 2.06-3.0). Notably, 271 multitransfused individuals (39.2%) were documented as deceased, with 76% succumbing within 12 months of encountering their most recent ATR. CONCLUSION: Multitransfused individuals in Colombia, being a high-risk group, exhibit a heightened susceptibility to allergic reactions, surpassing the frequency observed in other transfusion populations. This underscores the necessity for tailored medical care specific to this group.

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BACKGROUND AND OBJECTIVES: Haemovigilance (HV) systems aim to improve transfusion outcomes in patients and donor safety. An important question for blood regulators is how to ensure an effective HV system. MATERIALS AND METHODS: We retrospectively analysed the HV reports submitted to Paul-Ehrlich-Institut over the last two decades. RESULTS: Between 2011 and 2020, 50.86 million units of blood components were used, and 8931 suspected serious donor and recipient adverse reactions (SARs), 874 serious adverse events (SAEs) and 12,073 donor look-backs were reported. Following implementation of specific risk-minimization measures (RMMs) between 2000 and 2010, SAR reporting rates decreased for transfusion-transmitted viral infections (TTVIs), transfusion-related acute lung injury (TRALI) and transfusion-transmitted bacterial infections (TTBIs), while increasing for other serious adverse transfusion reactions. Within this decade, the overall blood component use decreased. CONCLUSION: Long-term data collection forms the basis to establish trends and changes in reporting and to evaluate the effect of RMM. Standardized criteria for reaction types, seriousness and imputability assessments and availability of a denominator are important elements. Central data collection and independent assessment allow for monitoring HV data in a nationwide context over time. Stakeholder involvement and transparent feedback on the benefit of RMM will help to achieve the objectives of HV.

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Introduction: blood transfusion remains an essential therapeutic intervention, but the occurrence of transfusion reactions makes its administration even more complex. Vigilant reporting of such reactions by recipients of blood products is essential for effective haemovigilance. This study aimed to determine the frequency and nature of transfusion reactions. Methods: conducted over five years (2017-2021) at the Haemovigilance Department of the Rabat Regional Blood Transfusion Centre, this retrospective study exploited incident forms notified by health establishments and data from the regional blood transfusion centre's computer system. Results: from 1 January 2017 and 31 December 2021, the Rabat Regional Blood Transfusion Centre distributed 435,651 labile blood products to various healthcare establishments, which reported 191 transfusion reactions involving 191 patients. The median age of the patients was 44.3 years, with an overall cumulative incidence of transfusion reactions of 0.44 per 1000 labile blood products delivered. The predominant reactions were non-haemolytic febrile and allergic reactions, accounting for 41.36% and 35.60% respectively. Grade 1 reactions accounted for 87% of all reactions recorded. During the study period, three deaths were recorded, with ABO incompatibility and transfusion-related acute lung injury (TRALI) accounting for two and one case respectively. Transfusion reactions involving erythrocyte components were significantly more frequent than those involving platelet and plasma components. Conclusion: this study revealed a relatively low incidence of transfusion reactions (0.44%), dominated by non-haemolytic febrile and allergic reactions. Several levels of failure were identified, in particular under-reporting of reactions and inadequate training in transfusion practices and haemovigilance, as well as the need for an effective electronic transfusion reaction reporting system to facilitate reporting and identification of underlying problems and risk factors to improve the quality of transfusion care provided to patients.

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The field of haemovigilance continues to develop, building on more than forty years of international experience. This review considers the current scope and activities of haemovigilance around the world and explores aspects of preparation for the advent of new blood products and alternative therapies to transfusion; new tools for data acquisition (including patient- and donor-reported outcomes, and data from 'wearables') and the analysis and communication of haemovigilance results.

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BACKGROUND AND OBJECTIVES: The aim of this study was to analyse the reports received in the Norwegian Haemovigilance System from 2004 to 2020 on acute and delayed haemolytic transfusion reactions caused by non-ABO red cell antibodies. MATERIALS AND METHODS: Antibody specificity, clinical symptoms and outcomes were included when available. RESULTS: After transfusion of 3.7 million red cell concentrates, reports on 78 cases of haemolytic transfusion reactions caused by non-ABO red cell antibodies were received, corresponding to an incidence of 1 in 47,000 transfused red cell concentrates. There were 30 acute and 48 delayed haemolytic transfusion reactions. A total of 113 red cell antibodies were found: 82 alloantibodies, 6 autoantibodies and 25 cases where the antibody specificity could not be determined. Two fatalities occurred: one caused by anti-Wra and one caused by an unidentified red cell antibody. The most frequently reported antibody specificities were those in the Rh and Kidd blood group systems, representing 24% and 14%, respectively, of all the antibodies identified. In six cases, errors occurred, leading to the issuing of blood units without the required phenotype match. CONCLUSIONS: Despite the possible underreporting, the low number of serious haemolytic transfusion reactions reflects an adequate pre-transfusion practice by the Norwegian blood banks.

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BACKGROUND: Blood donation is a safe process though reactions may still occur. We describe a rare vascular complication in a frequent donor, with improvements in the collection process aimed at avoiding future events. METHODS: A 63-year-old woman presented with local pain and an apparent collection in the left arm 8 days after donation. Duplex ultrasound identified a superficial liquid collection and signs of arteriovenous fistula (AVF) between the cubital vein and an arterial branch. A computed tomography (CT)-angio performed 1 day after ultrasound did not identify signs of AVF, followed by a new duplex which confirmed CT-angio findings. It was assumed that a traumatic AVF evolved with spontaneous thrombosis. In the early follow-up (18 days), a progressive regression of hematoma was observed without any sequelae. RESULTS: Investigation showed a faster whole blood bag collection time (3 min; normal: 5-9 min), and the processed packed red blood cell had a brighter red color than usual. The donor reported local bleeding after needle withdrawal, not observed in previous donations and a bruise forming on the same day. No arterial puncture (AP) was noticed by the collection staff during the procedure. The staff was retrained and actions were taken focusing on more active surveillance of late reactions, highlighting the importance of post-donation information by the donors, regardless of any adverse reaction observed, to detect late complications. CONCLUSION: We described an uncommon AP in a donor that was not identified, leading to an AVF that spontaneously thrombosed.

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Transfusion therapy is an indispensable form of treatment, and an important element of the public health system. Due to its origin, blood's clinical use is associated with various risks that may cause adverse reactions and events. Progress in quality and safety of blood components has eliminated numerous risks, especially those of infectious origin. However, some risks cannot be predicted, while others cannot always be prevented. Globalisation and climate change constantly favour the spread of infectious agents. Against this, epidemiology plays a central role in ensuring the safety of transfusion treatment, by continuous surveillance and timely identification of risks, and in the development of routine and additional tests as measures for risk mitigation. As a quantitative discipline based on research methods, epidemiology is a method of reasoning; it relies on the generation and testing of hypotheses; it utilises other scientific resources, particularly in the field of blood donation and blood transfusion, thus having many applications. The main focus falls on transfusion-transmissible infections, and on environmental or occupational diseases, injuries, disabilities and death causes at large. The practice of epidemiology relies on a systematic approach and measurement of disease frequencies. Surveillance is a key element, involving continuously gathering, analysing, and evaluating data regarding diseases, morbidity and mortality, and disseminating the conclusions of the analyses to relevant competent authorities; in this way, action is taken for disease prevention and control. Surveillance systems also provide an important tool for risk assessment, a method to assess and characterise the critical parameters in the functionality of equipment, systems or processes of using scientific data in order to estimate the magnitude of any health effect that derives from decisions of policy makers. Epidemiological surveillance, particularly for the incidence of adverse reactions and adverse events associated with blood transfusion at the national and international levels, has demonstrated the importance of multidisciplinary cooperation between blood and public health services.

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BACKGROUND: Serum eye drops (SED) are used to treat ocular surface disease. Reactions to SED are poorly documented. METHODS: We present our experience of self-reported reactions in New Zealand to SED (25%; autologous, allogeneic, or both) between 2003 and 2023, and a focused review of the literature. RESULTS: In total, 1067 patients received SED treatment (562 autologous, 318 allogeneic, and 187 both). Three (0.5% of those treated with allogeneic SED) reported reactions. All appeared to be allergic. All were associated with allogeneic SED. We have information on two patients: one had an eye reaction; in the other, the gastrointestinal tract was involved. The literature contains few reports of reactions to SED. They have involved both autologous and allogeneic SED, and various SED concentrations. None appears to have been severe. Notably, no eye or systemic infections have been reported. CONCLUSIONS: Information on the types and frequencies of reactions to SED is poor. This may be due to: serum being less likely to cause reactions; eyes being resistant to reactions; reactions being rare, and insufficient use of SED having occurred; under-reporting related to SED use at home and reactions being mild. More robust monitoring for reactions to SED is needed.

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【Objective】 To investigate the correlation between heart rate variability (HRV) and the degree of nervousness before blood donation. 【Methods】 The psychological state of 253 blood donors before blood donation was assessed by the self-rating anxiety scale (SAS) and the degree of nervousness and their HRV were measured. The correlation between the SAS score, the degree of nervousness and the HRV parameters was analyzed, and the differences were compared among different types of donors by multivariate linear regression. 【Results】 A total of 247 blood donors were included in the study. Five HRV parameters in blood donors aged 18-24 were higher than in those aged 25 years and above(all P<0.05), and the anxiety level was higher in female donors(SAS score 41-46) than in males(SAS score 35-43)(P<0.001); the pre-donation SAS score was consistent with the assessment of the tension level (r=0.970, P<0.001); the pre-donation tension level and the SAS score were all significantly negatively correlated with VLF in HRV parameters(r=0.179, P=0.005), and the associations were independent of confounders such as age, body mass index and gender (P<0.05). 【Conclusion】 Compared with SAS and tension assessment, HRV is more objective, and can be used as one of the tests for assessing the tension level of blood donors. The inclusion of HRV in the routine screening of blood donors deserves further study for its application in assessing the anxiety level of blood donors before blood donation, identifying people prone to blood donation-related vasovagal reaction (DRVR), preventing and reducing the risk of DRVR, and improving the safety of blood donation.

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BACKGROUND AND OBJECTIVES: Haemovigilance systems are intended to collect and analyse data, and report findings relating to transfusion complications, such as blood product safety, procedural incidents, and adverse reactions in donors and patients. A common problem among developing haemovigilance programs is the lack of resources and tools available to countries striving to establish or enhance their haemovigilance system. MATERIALS AND METHODS: World Health Organization, in collaboration with International Society for Blood Transfusion (ISBT), International Haemovigilance Network and other haemovigilance experts embarked on a Haemovigilance Tools Project to collect and provide materials and resources to assist with the stepwise implementation of haemovigilance. RESULTS AND CONCLUSIONS: Resources are housed as a virtual compendium on the ISBT website under the Haemovigilance Working Party. These are managed by a subcommittee of the Working Party and are freely available and downloadable to all without requiring ISBT membership.

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BACKGROUND AND OBJECTIVES: Data from 21 years (2000-2020) of haemovigilance were used to assess human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) incidence rates in repeat blood donors and the occurrence of transfusion-transmitted (TT) viral infections. MATERIALS AND METHODS: Blood donors who converted for HIV, HCV or HBV markers within serial three-year analysis periods were included. Epidemiological and virological data were retrieved from the national epidemiological donor database and were supplemented with information on blood components and the infection status of recipients of the previous negative donation (D.N-1) of donors who seroconverted. RESULTS: Incidence rates declined from 1.27 to 0.35/100,000 person-years for HIV, from 0.59 to 0.19 for HCV and from 1.66 to 0.18 for HBV. Risk factors and lookback for 232 HIV, 90 HCV and 74 HBV seroconversions were investigated. The main risk factor identified at post-donation interview was having sex with men (47.8% of males) for HIV and a sexual risk for HCV (30.6%) and HBV (37.1%). The viral loads and sequences were retrospectively tested in 191 HIV, 74 HCV and 62 HBV D.N-1 archived samples. Six (five HBV and one HIV-1) were positive all low viral loads. Two recipients were infected by red blood cells from two HBV seroconverting donors before the introduction of HBV-nucleic acid testing. CONCLUSION: HIV, HCV and HBV incidence rates in blood donors declined over the two past decades in France. There is a very small risk of a blood component that tests negative entering the blood supply resulting in TT infections, especially after introduction of molecular assays in donor screening.

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BACKGROUND AND OBJECTIVES: Haemolysis can occur following intravenous immunoglobulin (IVIG) infusion. Haemovigilance data were analysed using a novel approach for including two control groups with no haemolysis to IVIG. Objectives included a summary of all reactions to IVIG, rate estimates and analysis of haemolytic reactions including risk factors. MATERIALS AND METHODS: Canadian haemovigilance data from Ontario (2013-2021), IVIG distribution and transfusion data from the blood supplier, and data from a large local transfusion registry were used. An 'other-reactions' control group included patients with IVIG reactions that were not haemolytic, and registry patients with no-reaction were the 'no-reaction controls'. Descriptive analysis and two logistic regression models for the different control groups were performed. RESULTS: One thousand one hundred and seventy reactions were included. Most common were febrile non haemolytic (26.1%), minor allergic (24.5%) and IVIG headache (15.3%) followed by haemolytic 10.9% (128/1170). Haemolytic reaction rates decreased over time: rates since 2020 estimated between 1.5 and 2.9/1000 kg IVIG used. The regression model for other-reaction controls identified two risk factors for haemolysis: non-O blood group recipients compared with group O recipients (p value = 0.0106) and IVIG dose per 10 g increase (OR 1.359; 95% CI 1.225-1.506). The model using no-reaction controls gave similar results and also showed no pre-medication was associated with a higher risk of haemolysis (OR 29.084; 95% CI 1.989-425.312). CONCLUSION: The frequency of haemolytic reactions has decreased over time. We confirmed non-O blood group recipients and IVIG dose as risk factors for haemolysis and raise the hypothesis that no pre-medication may increase the risk of haemolysis.

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BACKGROUND AND OBJECTIVES: ABO antigens are among the most immunogenic, but the haemolytic risks of ABO incompatibilities involving a donor with a weak ABO phenotype are little documented. MATERIALS AND METHODS: This retrospective case series assessed the incidence of acute haemolytic transfusion reaction (AHTR) among ABO-incompatible recipients of A3 blood in Québec (Canada). Transfusion safety officers reported laboratory AHTR indicators measured ≤24 h pre- and post-transfusion. Because the AHTR case definition of Québec's Hemovigilance System (QHS) leaves significant room for clinical judgement, a two-step approach was used to assess potential cases: Step 1 consisted in a highly sensitive-but unspecific-initial screen that identified all candidate cases per QHS case definition, and Step 2 consisted in a detailed review of candidate cases by two haematologists. RESULTS: Nine donors initially typed as Group B (N = 1) or O (N = 8) were subsequently found to display an A3 B or A3 O phenotype. Eighty-one recipients received ABO-incompatible blood, including 53 (65.4%) with interpretable data. Of these, 29 (54.7%) were classified as candidate cases after Step 1. Following Step 2, no conclusive evidence of AHTR was found: Abnormal pre- versus post-transfusion changes appeared modest, within normal range, insufficient to ascertain AHTR, or were consistent with a pre-existing condition unrelated to AHTR. Two candidate cases had a QHS-reported transfusion reaction; both were unrelated to AHTR. CONCLUSION: In this case series, no conclusive evidence of serious AHTR was found among ABO-incompatible recipients who were inadvertently transfused with A3 blood.

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BACKGROUND AND OBJECTIVES: The severity grading tool (SGT) was recently designed by the Association for Advancement of Blood and Biotherapies (AABB) to have more objectivity in severity assignment for an adverse donor reaction after blood donation. A study was performed in India to assess the knowledge (post-training) and determine the degree of agreement of the SGT between participating centres and the subject expert group. MATERIALS AND METHODS: This prospective cross-sectional survey-based study was conducted by the National Coordinating Centre (NCC) of the National Blood Donor Vigilance Programme (NBDVP) of India. Thirty-five real-world case scenarios, validated by seven national and two international experts, were sent to the participating centres, and their responses received (diagnosis and severity grade) were compared and analysed. RESULTS: A total of 50 blood centres participated in the study. The overall agreement between the participating centres and the expert group was 66.4%, with a fair Kendall's coefficient of concordance (W) of 0.271 (p-value < 0.05). The degree of agreement was observed to be more than 80% for 12 centres, 60%-80% for 27 centres and <60% for 11 centres. The overall degree/percentage of agreement for cases with single and multiple types of donor adverse reaction was 71.3% and 42.6%, respectively. CONCLUSION: The SGT will be an efficient mode to have uniform objective reporting of the adverse donor reactions and may be implemented in the NBDVP of India. This study also highlights the need for training of the blood centres on the basic definitions and categorization of the donor's adverse reaction.

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BACKGROUND: Febrile nonhemolytic transfusion reactions (FNHTRs) are the most common adverse reaction reported under the Haemovigilance Programme of India, and the use of leukodepleted blood products is recommended. The severity of the reaction may affect the morbidity associated with the reaction. This study aims to calculate the incidence of various transfusion reactions in our blood center and to evaluate the impact of buffy coat reduction on the severity of febrile reaction and other hospital resource-consuming activities. MATERIALS AND METHODS: It was an observational retrospective study in which all reported FNHTRs were evaluated during the period July 1, 2018-July 31, 2019. Patient demographic details, component transfused, and clinical presentation were analyzed to identify factors affecting the severity of FNHTRs. RESULTS: The incidence of transfusion reaction in our study period was 0.11%. Out of total 76 reactions reported, 34 (44.7%) were febrile reactions. Other reactions included allergic reactions (36.8%), pulmonary reactions (9.2%), transfusion-associated hypotension (3.9%), and others (2.7%). The incidence of FNHTR in buffy coat-depleted packed red blood cells (PRBCs) and PRBCs is 0.03% and 0.05%, respectively. FNHTRs are seen more in females with prior history of transfusion (87.5%) as compared to males (66.67%) (P = 0.046). We also found that FNHTRs are less severe with buffy coat-depleted PRBC transfusion than PRBC transfusion as mean ± standard deviation temperature rise was less in buffy coat-depleted PRBC (1.3 ± 0.8) than PRBC (1.74 ± 1.129). The febrile response to buffy coat-depleted PRBC transfusion occurred at higher volume (145 ml) transfusion than PRBC transfusion (87.2 ml), and it was statistically significant (P = 0.047). CONCLUSION AND SUMMARY: Leukoreduction remains the main modality to prevent FNHTR, but in developing countries like India, the use of buffy coat-depleted PRBC over PRBC can reduce the incidence and severity of FNHTR.

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INTRODUCTION: Since being designated as medicines by World Health Organization (WHO), blood components are subject to pharmacovigilance reporting. Using VigiBase, the WHO global database of individual case safety reports (ICSRs), we characterized reports of adverse reactions for all blood products. STUDY DESIGN AND METHODS: ICSRs involving blood products as the suspected medicine in VigiBase between 1968 and 2021 were extracted. MedDRA preferred terms and the International Society of Blood Transfusion haemovigilance definitions were used to stratify adverse reactions. Descriptive statistics were used to characterize ICSR demographics. RESULTS: A total of 111,033 ICSRs containing 577,577 suspected adverse reactions with 6152 MedDRA preferred terms were reported for 34 blood products. There were 12,153 (10.9%) reports for blood components, 98,135 (88.4%) reports for plasma-derived medicines, and 745 (0.7%) reports for recombinant products. The majority of reports (21.0% and 19.7%, respectively) were from patients aged 45-64 and over 65 years. The Americas contributed the most ICSRs (49.7%). Top reported suspected adverse reactions were for the following MedDRA preferred terms: headache (3.5%), pyrexia (2.8%), chills (2.8%), dyspnoea (1.8%), and nausea (1.8%). CONCLUSION: VigiBase already has a large number of reports on blood products. When compared to other existing haemovigilance databases, our study found reports from a broader range of countries and reporters. This may provide us with new perspectives, but for VigiBase to reach its full potential in haemovigilance some alterations in what is captured in reports are required.

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BACKGROUND AND OBJECTIVES: No systematic study has measured the incidence of adverse reactions (ARs) to blood donation at the national level in China before 2019. The objective of this study was to establish an effective reporting system to collect information on ARs to blood donation in China. MATERIALS AND METHODS: The status of donor haemovigilance (DHV) in blood collection facilities in China was evaluated, and an online DHV system was established to collect data on ARs to blood donation in July 2019. The definitions of ARs were based on the International Society of Blood Transfusion (ISBT) standards. The prevalence and data quality of ARs from 2019 to 2021 were analysed. RESULTS: A standard online reporting system has been established for ARs to blood donation. In total, 61, 62 and 81 participating sites were included in this pilot study in 2019, 2020 and 2021, respectively. From July 2019 to December 2021, 21,502 cases of whole-blood-related ARs and 1114 cases of apheresis platelet-related ARs were reported, with an incidence of 3.8‰ and 2.2‰, respectively. Data completeness for key reporting elements improved from 41.7% (15/36) in 2019 to 74.4% (29/39) in 2020. Data quality analysis for the year 2021 yielded similar results as for 2020. CONCLUSION: The construction and continuous improvement of the blood donor safety monitoring system prompted the establishment of the DHV system. Improvements have been made to the DHV system in China, with a significant increase in sentinels and higher data quality.

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According to the literature, there are significant differences in the availability of education and training in transfusion medicine worldwide, with significant heterogeneity in the existing curricula. Recognising the need for education with the aim of achieving globally standardised competencies in transfusion medicine, a group of experts collaborating in the European and Mediterranean Initiative in Transfusion medicine (EMITm) proposed a process of incremental training and education. Subsequent to two previous papers published by this group on general education in transfusion medicine, this paper specifically refers to the field of education in haemovigilance. This topic is of particular importance when one considers the role of haemovigilance in improving the safety of transfusion practice, and the fact that this role can only be realised through the cooperation of all participants in the transfusion chain. In addition to promoting the importance of education in haemovigilance, this paper provides an overview of the available literature on this topic and proposes an education programme on haemovigilance for medical students and residents.

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