Formation of Single-Species and Multispecies Biofilm by Isolates from Septic Transfusion Reactions in Platelet Bag Model.

During 2018-2021, eight septic transfusion reactions occurred from transfusion of platelet units contaminated with Acinetobacter spp., Staphylococcus saprophyticus, Leclercia adecarboxylata, or a combination of those environmental organisms. Whether biofilm formation contributed to evasion of bacterial risk mitigations, including bacterial culture, point-of-care testing, or pathogen-reduction technology, is unclear. We designed a 12-well plate-based method to evaluate environmental determinants of single-species and multispecies biofilm formation in platelets. We evaluated bacteria isolated from septic transfusion reactions for biofilm formation by using crystal violet staining and enumeration of adherent bacteria. Most combinations of bacteria had enhanced biofilm production compared with single bacteria. Combinations involving L. adecarboxylata had increased crystal violet biofilm production and adherent bacteria. This study demonstrates that transfusion-relevant bacteria can produce biofilms well together. More work is needed to clarify the effect of biofilms on platelet bacterial risk control strategies, but US Food and Drug Administration-recommended strategies remain acceptable.

Classification of posttransfusion adverse events using a publicly available artificial intelligence system.

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.

Cutibacterium acnes contamination does not enhance the proinflammatory profile of platelet concentrates.

BACKGROUND: Cutibacterium acnes, a common anaerobic platelet concentrate (PC) contaminant, has been associated with rare mild adverse transfusion reactions and is often considered a harmless commensal. Notably, C. acnes can cause chronic infections and has been shown to induce the release of proinflammatory cytokines by immune cells. Since elevated concentrations of proinflammatory factors in PCs have been linked to noninfectious adverse reactions, this study aimed to assess whether C. acnes could elicit the release and accumulation of proinflammatory factors during PC storage, thereby enhancing the risk of such reactions. STUDY DESIGN/METHODS: Four ABO-matched buffy coat PCs were pooled and split into six units, each were inoculated with either saline (negative control), a Staphylococcus aureus isolate (positive control, 30 colony forming units [CFU]/unit), or four C. acnes PC isolates (10 CFU/mL) and stored at 20-24°C with agitation. Bacterial counts, platelet activation, and concentration of proinflammatory factors were assessed on days 0, 3, and 5. N = 3. RESULTS: C. acnes counts remained stable, while S. aureus proliferated reaching 108CFU/mL by the end of PC storage. By day 5, no significant differences in platelet activation or proinflammatory cytokine profiles were observed in C. acnes-contaminated PCs compared to the negative control (p > .05), while there was a significant increase (p ≤ .05) in sCD40L concentration (day 3), and platelet activation and IL-8 concentration (day 5) in S. aureus-contaminated units. DISCUSSION: C. acnes contamination does not promote the accumulation of proinflammatory factors in the absence of proliferation during storage and may not enhance the risk of inflammatory reactions when transfused to patients.

Infusion Reactions With Alternative Therapies During the National Shortage of Iron Dextran.

Prior to the national shortage of iron dextran in early 2023, it was the most commonly administered intravenous iron infusion at our institution. After the shortage impacted the health system, alternatives such as iron sucrose and sodium ferric gluconate/sucrose were required that utilized lower doses given at more frequent patient visits. Coinciding with their more prevalent use, an increase in iron infusion reactions was observed. Our study analyzed 880 patients who received iron infusions in three Henry Ford Hospital clinics in metropolitan Detroit, Michigan, from July 2022-June 2023. The 74 reactions that occurred were most commonly associated with iron sucrose at the 500 mg dose (41/74, 55.41%, p < 0.0001). Most reactions observed across all iron formulations and doses were mild, with 83.7% being Grade 0 or 1 as defined by the United States Drug Allergy Registry (USDAR) grading scale for immediate reactions. Patients who experienced an infusion reaction were less likely to complete their infusion plans (OR 0.004 for iron dextran, OR 0.128 for iron sucrose, p < 0.0001), with infusions most commonly being completely discontinued thereafter, with a minority pursuing alternative options. More patients with lower number of doses scheduled for iron dextran completed their infusion schedules than those with more doses, but the opposite was seen for iron sucrose. We assessed the impact of the national shortage of iron dextran examining infusion reactions with various iron infusions and doses.

Eculizumab for management of hyperhemolysis syndrome in pediatric patients with sickle cell disease: A single-center case series.

Chronic hemolytic anemia and vascular occlusion are hallmarks of sickle cell disease (SCD). Blood transfusions are critical for supportive and preventive management of SCD complications. Patients with SCD are at risk for hyperhemolysis syndrome (HHS), a subtype of delayed hemolytic transfusion reactions. HHS management includes intravenous immunoglobulin, corticosteroids, and avoidance of further transfusions. Not all patients respond to first-line agents. Eculizumab, which blocks terminal complement activation, has been proposed as second-line management of HHS. We describe two patients who received eculizumab for refractory HHS. In our experience, eculizumab is a safe and effective option for refractory pediatric HHS.

Enhancing clinical insight: Implementing validated questionnaires for comprehensive assessment of clinician expertise in transfusion medicine practices.

BACKGROUND: Blood transfusion is a cornerstone of modern healthcare, pivotal in saving countless lives annually. However, inadequate knowledge among healthcare providers can lead to serious complications. Despite the availability of assessment tools like the Biomedical Excellence for Safer Transfusion (BEST) test, there is a need for indigenous-validated questionnaires to address knowledge gaps effectively. This study aimed to evaluate bedside transfusion medicine knowledge among clinical residents using a validated questionnaire, focusing on knowledge gaps. STUDY DESIGN AND METHODS: A cross-sectional study was conducted at a tertiary care referral center in Northern India. The questionnaire, developed based on national and international transfusion guidelines, was validated by an expert panel, and administered to 245 clinical residents. The questionnaire covered six domains related to transfusion medicine: blood component storage, blood bank procedures, transfusion-transmitted infections, administration of blood components, transfusion reactions, and transfusion practices. RESULTS: The study revealed varying levels of knowledge across specialties and residency years. Overall, residents scored 61 % in transfusion medicine knowledge, with Pediatrics residents demonstrating the highest scores. The incremental increase in knowledge from first to third-year residents underscores the value of continuous, experience-based learning throughout the residency period. DISCUSSION: Study highlights significant knowledge gaps in bedside transfusion practices among clinical residents, emphasizing the need for structured educational interventions. Tailored programs, integrated into undergraduate and postgraduate curricula, are essential to improve transfusion safety and patient outcomes. Addressing these gaps can lead to better bedside transfusion practices, reducing risks and improving the quality of patient care.

A perspective on exogenous redox regulation mediated by transfused RBCs subject to the storage lesion.

Granted with a potent ability to interact with and tolerate oxidative stressors, RBCs scavenge most reactive oxygen and nitrogen species (RONS) generated in circulation. This essential non-canonical function, however, renders RBCs susceptible to damage when vascular RONS are generated in excess, making vascular redox imbalance a common etiology of anemia, and thus a common indication for transfusion. This accentuates the relevance of impairments in redox metabolism during hypothermic storage, as the exposure to chronic oxidative stressors upon transfusion could be exceedingly deleterious to stored RBCs. Herein, we review the prominent mechanisms of the hypothermic storage lesion that alter the ability of RBCs to scavenge exogenous RONS as well as the associated clinical relevance.

Costs and consequences of over-investigation of minor transfusion reactions.

BACKGROUND: Adverse transfusion events create a direct cost burden on the healthcare system through increased morbidity, mortality, extra investigations for diagnosis, patient treatment and increased use of hospital resources. Understanding the costs and impact minor transfusion reactions have on the healthcare system presents an opportunity for potential cost savings and improved clinical practice. AIMS: To determine the cost associated with investigating minor transfusion reactions, to identify opportunities to improve the management of blood transfusion reactions and potential cost savings through the application of current national guidelines. METHODS: A retrospective review of all suspected transfusion reactions reported to the laboratory over a 6-year period was performed. Reports were assessed for appropriateness of clinical management and associated investigations. Cost of inappropriate investigations and associated blood product discard was calculated using current national tariffs. RESULTS: Of the 274 reports, febrile non-haemolytic transfusion reactions were the most common reactions, with 96 (35%) cases. One hundred forty-eight patients were unnecessarily investigated for suspected transfusion reactions totalling AU$ 32 427.00. The initial total value of partially discarded blood products was AU$ 55 656.00. CONCLUSION: The study demonstrated that unnecessary investigation of minor transfusion reactions adds a significant financial burden to the healthcare system.

Basophil activation test for allergic and febrile non-haemolytic transfusion reactions among paediatric patients with haematological or oncological disease.

BACKGROUND AND OBJECTIVES: Allergic transfusion reactions (ATRs) and febrile non-haemolytic transfusion reactions (FNHTRs) are common, although their mechanisms remain unclear. Immunoglobulin E (IgE)-mediated type I hypersensitivity may be involved in the pathogenesis of ATR. A basophil activation test (BAT) may help elucidate this process. MATERIALS AND METHODS: The BAT was based on peripheral blood samples from paediatric patients with a haematological or oncological disease and on samples of residual blood products transfused in each case. Dasatinib was used to evaluate whether basophil activation was mediated by an IgE-dependent pathway. RESULTS: Twenty-seven patients with and 19 patients without ATR/FNHTR were included in this study, respectively. The median BAT values associated with ATR- (n = 41) and FNHTR-causing (n = 5) blood products were 22.1% (range = 6.1%-77.0%) and 27.8% (range = 15.2%-47.8%), respectively, which were higher than the median value of 8.5% (range = 1.1%-40.9%) observed in blood products without a transfusion reaction. Dasatinib suppressed basophil activity. BAT values were comparable in patients with ATR regardless of severity. Meanwhile, BAT values analysed with blood products non-causal for ATR/FNHTR were higher in patients with ATR/FNHTR than in those without. CONCLUSION: The IgE-mediated type I hypersensitivity may be involved in the pathogenesis of ATR and FNHTR. BAT analyses may help elucidate the underlying mechanisms and identify patients at risk.

Associated criteria used in investigating suspected septic transfusion reactions: A scoping review.

BACKGROUND AND OBJECTIVES: Septic transfusion reactions (STRs) occur as a result of bacterial contamination of blood or blood products, resulting in sepsis. This scoping review aimed to identify, explore and map the available literature on the STR criteria triggering the investigation of STR. MATERIALS AND METHODS: Four electronic databases (MEDLINE, Web of Science, Science Direct, Embase) were searched to retrieve scientific literature reporting such criteria, published from 1 January 2000 to 5 May 2022. Grey literature was also searched from open web sources. RESULTS: Of 1052 references identified, 43 (21 peer-reviewed and 22 grey literature) met the eligibility criteria for inclusion and data extraction after full article screening. Of them, most (27/43, 62.79%) were found to report a single set of criteria, and only two reported four or more sets of criteria. The analysis of 66 sets of criteria collected from the selected references revealed 57 different sets. A few sets of criteria used only one sign and symptom (s/s) (12.12%, n = 8), whereas 16 sets used 7-15 s/s (n = 16/66; 24.24%). Of the total 319 occurrences of s/s associated with the 66 sets of criteria, post-transfusion hyperthermia, body temperature increase and hypotension were the most common s/s categories. Of all the literature available, only one study tested the diagnostic accuracy of the STR criteria. CONCLUSION: This scoping review revealed a substantial variation in criteria used to identify suspected STR. Consequently, conducting further studies to enhance the diagnostic accuracy of these criteria, which trigger STR investigations, is imperative for advancing clinical practice.

Should adding pain, oxygen saturation and physical assessment to vital signs become the new standard of care for detecting blood transfusion reactions?

BACKGROUND AND OBJECTIVES: Clinicians sought to ascertain what frequency of vital signs best detects blood transfusion reactions. This review discusses early and delayed blood product transfusion reaction detection through the lens of scientific literature. METHODS: A comprehensive appraisal of published literature was conducted using Integrative Research Review methodology through June 2022 not limited to English or research in Cumulative Index to Nursing and Allied Health Literature, Cochrane Library of Systematic Reviews, Medline and PubMed. RESULTS: Full-text articles in the final sample included four articles discussing vital signs detecting blood transfusion reactions and four articles reporting the importance of adding physical assessments for early reaction detection. None of the studies provided evidence regarding how often vital signs should be monitored to detect transfusion reactions. No studies included identical screening components for detecting blood product transfusion reactions. Main themes emerged including variations in what was included in vital signs, importance of respiratory assessment, inclusion of physical assessment, nurse documentation and reporting compliance, and patient and family inclusion in transfusion reaction recognition. CONCLUSION: Vital sign components varied across reviewed studies. Respiratory rate and pain were not always included in 'vital signs' to identify transfusion reactions. Only low-level data and no clinical trials loosely informing frequency of vital sign monitoring to transfusion reaction detection were found. Respiratory (to include oxygen saturation, lung sounds and respiratory rate) and pain assessment emerged as crucial to acute and delayed transfusion reaction recognition. The disconnect between 'vital signs' and the varied vital sign components reported to detect transfusion reactions in scientific literature requires further exploration.

The complexities of transfusion reactions: Coexistence of a delayed haemolytic transfusion reaction and post-transfusion purpura.

BACKGROUND AND OBJECTIVES: Immune-mediated acute or delayed transfusion reactions occur when there is immunological incompatibility between transfused blood products and recipient's antibodies. Acute haemolytic transfusion reactions occur within 24 h and are delayed after 24 h up to 10 days following transfusion, whereas post-transfusion purpura (PTP) typically occurs 7-10 days post-transfusion. We present a case of a previously transfused and recently post-partum female who developed both delayed haemolytic transfusion reaction (DHTR) and PTP. CASE REPORT: A 42-year-old woman, G2P1, with non-alcoholic liver disease, portal hypertension and previous transfusion history with allogeneic anti-E, developed a severe DHTR and PTP following a complicated post-partum course and multiple transfusions. The antenatal and initial post-partum pre-transfusion antibody screens were negative. Subsequently five red cell antibodies, including anti-c, anti-Fya, anti-Jkb and anti-S and the reappearance of anti-E were, however, identified during follow-up investigations along with the anti-platelet antibody HPA-3a and human leukocyte antigen class I antibodies. Anti-E, anti-Jkb and anti-S were eluted from the circulating red blood cells. CONCLUSION: To our knowledge, there have been only two other case reports of DHTR and PTP occurring in the same patient.

Towards the crux of sex-dependent variability in red cell concentrates.

Donor sex can alter the RBC 'storage lesion' progression, contributing to dissimilarities in blood product quality, and thus adverse post-transfusion reactions. The mechanisms underlying the reduced sensitivity of female RBCs to storage-induced stress are partially ascribed to the differential effects of testosterone, progesterone, and estrogen on hemolytic propensity. Contributing to this is the increased proportion of more robust, biologically 'young' subpopulations of RBCs in females. Herein, we discuss the impact of sex hormones on RBCs and the relevance of these biological subpopulations to provide further insight into sex-dependent blood product variability.

Understanding the nursing practices and perspectives of transfusion reaction reporting.

AIMS AND OBJECTIVES: The aim of this study was to investigate nurse perspectives on transfusion-related adverse reaction reporting practices. BACKGROUND: Transfusion-related adverse reaction reporting is an essential component of hemovigilance in Canada, but reporting rates vary and under-reporting of minor transfusion-related adverse reactions exists. To our knowledge, this is the first report of nursing transfusion-related adverse reaction reporting attitudes. DESIGN: This qualitative descriptive study explored the nursing practices and perspectives of transfusion-related adverse reaction reporting by conducting one-on-one interviews with nurses (n = 25) working in adult oncology inpatient and outpatient units. METHODS: Data were thematically analysed; data collection ended when saturation was reached. The COREQ checklist was used to guide this study. RESULTS: The study revealed that the nursing practices of transfusion-related adverse reaction reporting are not standardised to meet the institutional reporting guidelines. Under-reporting of febrile reactions exists at this institution. Major concepts uncovered included the factors impacting nurses' transfusion-related reporting practices, as well as barriers and facilitators to transfusion reporting. CONCLUSION: A practice change in transfusion-related adverse reaction reporting is needed to achieve optimal hemovigilance at this institution. Using the barriers and facilitators identified in this study, institutions can better inform future interventions by employing strategies like TR reporting education in order to improve reporting of transfusion-related adverse reactions in this hospital and other similar institutions. RELEVANCE TO CLINICAL PRACTICE: This study informs clinical practice and decision-making for nurses and nursing educators who manage blood transfusion administration procedures.

Patient ABO blood type is a major predictor of a positive DAT following a transfusion reaction.

BACKGROUND: A direct antiglobulin test (DAT) checks for antibody or complement on the surface of RBCs and is often done following a transfusion reaction. While passive anti-A and anti-B antibodies are known to cause positive DATs, the extent this occurs following transfusion is unknown. STUDY DESIGN AND METHODS: DAT results, ABO type, eluate information, and blood product information were recorded on 1097 transfusion reactions at a large academic hospital over 8 years. The effect of patient blood type, product type, and plasma compatibility of blood product transfused on DAT results were determined. Statistical significance was determined using Chi-squared testing. RESULTS: Patient ABO blood type was a strong predictor of a positive DAT, with type O patients having 6.7% positive rate and non-O patients having a positive rate of 20.6% (p < .0001). Plasma compatibility of the product was a strong predictor of a positive DAT, with plasma compatible transfusions having a 9.4% positive rate while plasma incompatible transfusions were positive 44% of the time (p < .0001). Elution studies found that anti-A/B antibodies were the most common antibody identified. Platelets were more likely to be associated with a positive DAT when compared with RBC transfusions (p < .05). CONCLUSIONS: These results demonstrate the patient ABO type and plasma incompatibility are strong predictors of positive DAT results following a transfusion reaction. Anti-A and anti-B antibodies are estimated to account for about 50% of positive DATs in this study.

Changes in the incidence of transfusion reactions in hematological patients over the past 30 years.

BACKGROUND: Patients with hematological diseases are polytransfused and often immunocompromised, therefore susceptible to transfusion reactions (TR). This study aims to document the incidence of TRs in adult hematological patients and assess the effect of changes in the production of blood components and transfusion practice on their occurrence. STUDY DESIGN AND METHODS: Retrospective observational analysis of TRs reported from 1993 to 2019 was performed. For the analysis of the effect of changes on the incidence of TRs, the evaluated time was divided into two periods: the 1st period before the introduction of changes in production, when leukoreduced blood components were used only selectively, and the 2nd period, when semi-automated method of production and universal leukoreduction was introduced. RESULTS: The decrease in the incidence of TRs was observed for both red blood cell (RBC) and platelet concentrate (PC) transfusions in the 2nd period. Since platelet additive solution has been used, a further decrease in the incidence was reported. The decrease in incidence was also observed for delayed hemolytic/serological transfusion reactions and for transfusion-transmitted bacterial infections. Four cases of incorrect blood transfusions were uniquely related to the hematological patients, caused by antigen loss and transfusion ordering after ABO-incompatible hematopoietic stem cell transplantation. DISCUSSION: Our results provided evidence that the introduction of tools offered by modern transfusion medicine: universal leukodepletion, plasma replacement with additive solutions, sensitive laboratory techniques, prophylactic antigen matching policy, informatization, and automatization, decreased the incidence of TRs and improved transfusion safety.

Acquired platelet storage container leaks and contamination with environmental bacteria: A preventable cause of bacterial sepsis.

BACKGROUND: Apheresis platelets (AP) may be contaminated by environmental bacteria via container defects acquired during processing, transport, storage, or transfusion, as highlighted by a recent series of septic reactions related to Acinetobacter spp. and other bacterial strains. STUDY DESIGN AND METHODS: The frequency and nature of acquired container defect reports to one manufacturer were evaluated from January 2019 to July 2020. The published incidence of contamination and sepsis due to environmental bacteria with culture screened AP in the United States was reviewed for the period of 2010-2019. RESULTS: Review of a manufacturers' records showed 23 US reports of leaks involving 24 containers attributed to postmanufacturing damage, at a rate of 44 per million distributed storage containers. Analysis of returned containers showed evidence of scratches, impressions, and/or piercings. Literature review of US hemovigilance data revealed that environmental bacteria comprised 7% of confirmed positive primary bacterial culture screens, were responsible for 14%-16% of reported septic, and 8 of 28 (29%) fatal reactions with bacterial-culture screened AP. Sepsis cases have been reported with culture screened, point-of-issue (POI) tested, or pathogen-reduced AP. DISCUSSION: Environmental contamination of AP is rare but can cause sepsis. Container damage provides a pathway for contamination after culture screening, POI bacteria testing, or pathogen reduction. Blood collectors and transfusion services should have procedures to ensure proper inspection, handling, storage, and transport of AP to avoid damage and should enhance efforts to detect defects prior to release and to eliminate bacteria from all contacting surfaces to minimize the risk of contamination.

Detection of allergic transfusion-related adverse events from electronic medical records.

BACKGROUND: Transfusion-related adverse events can be unrecognized and unreported. As part of the US Food and Drug Administration's Center for Biologics Evaluation and Research Biologics Effectiveness and Safety initiative, we explored whether machine learning methods, such as natural language processing (NLP), can identify and report transfusion allergic reactions (ARs) from electronic health records (EHRs). STUDY DESIGN AND METHODS: In a 4-year period, all 146 reported transfusion ARs were pulled from a database of 86,764 transfusions in an academic health system, along with a random sample of 605 transfusions without reported ARs. Structured and unstructured EHR data were retrieved, including demographics, new symptoms, medications, and lab results. In unstructured data, evidence from clinicians' notes, test results, and prescriptions fields identified transfusion ARs, which were used to extract NLP features. Clinician reviews of selected validation cases assessed and confirmed model performance. RESULTS: Clinician reviews of selected validation cases yielded a sensitivity of 67.9% and a specificity of 97.5% at a threshold of 0.9, with a positive predictive value (PPV) of 84%, estimated to 4.5% when extrapolated to match transfusion AR incidence in the full transfusion dataset. A higher threshold achieved sensitivity of 43% with specificity/PPV of 100% in our validation set. Essential features predicting ARs were recognized transfusion reactions, administration of antihistamines or glucocorticoids, and skin symptoms (e.g., hives and itching). Removal of NLP features decreased model performance. DISCUSSION: NLP algorithms can identify transfusion reactions from the EHR with a reasonable level of precision for subsequent clinician review and confirmation.

The abrogated role of premedication in the prevention of transfusion-associated adverse reactions in outpatients receiving leukocyte-reduced blood components.

BACKGROUND AND OBJECTIVES: Although it remains controversial, premedication before transfusion is a common clinical practice to prevent transfusion-associated adverse reactions (TAARs) in Taiwan. Thus, we aimed to investigate whether premedication prevented outpatients from developing TAARs and whether an educational programme could improve the understanding of physicians related to the unnecessary use of premedication, and this could elicit changes in their prescribing activities without affecting the occurrence of TAARs. MATERIALS AND METHODS: Clinical data from outpatients receiving transfusion therapy, including predisposing diseases, histories of transfusion and TAARs, premedication and the occurrence of TAARs in the period April 2017 to October 2018, were retrospectively obtained. The evidence-based transfusion programme implemented to educate physicians was started in January 2018. RESULTS: A total of 5018 blood units were transfused to 803 outpatients, with 2493 transfusion events reported in the study interval. The most frequently transfused component was leukocyte-reduced packed red cells (n = 4338), followed by leukocyte-reduced apheresis platelets (n = 540) and other blood components. The overall premedication rate significantly decreased from 92.4% to 76.7% after the educational programme (p < 0.001). There was no remarkable change in the occurrence of TAARs per patient event between the periods before and after the educational programme (1.11% vs. 1.14%, p = 0.964). Besides, it was shown that the occurrence of TAARs was associated with the history of TAARs and inversely related to multiple transfusions, but not premedication. CONCLUSION: Decreased premedication was not associated with increased incidence of TAARs in outpatients; these findings provide important evidence to support the need to revise clinical practices in the era of leukocyte-reduced blood products.

Development of the Chinese Haemovigilance Network and reporting of adverse transfusion reactions from 2018 to 2020.

BACKGROUND AND OBJECTIVES: To advance blood transfusion safety, the Chinese Haemovigilance Network (CHN) was put into operation in 2018. This report describes the development of the CHN and evaluates its role by analysing reported adverse transfusion reactions (ATRs) from 2018 to 2020. MATERIALS AND METHODS: All data in this study were obtained from the CHN online reporting platform. A timeline of CHN development is presented, and the activities of CHN-enrolled facilities are analysed by year. The reported ATRs were analysed in detail for ATR types, blood components involved and adherence to case definition, severity and imputability criteria. Incidence rates were calculated and compared with international examples. RESULTS: During 2018-2020, a total of 3061 ATRs were reported through the CHN online reporting system. The rate of reported ATRs in all facilities and the 10 highest reporting facilities was 0.7‰ and 1.8‰, respectively. When analysed by year, the incidence rate showed an increasing trend from 2018 to 2020. Allergic (68.2%) and febrile non-haemolytic transfusion reaction (27.1%) were the most common. The vast majority of ATRs (92.0%) were not serious, but serious cases of transfusion-associated circulatory overload, transfusion-associated dyspnoea and hypotensive reaction were common. Most (86.0%) of reported cases were definitely or probably associated with transfusion. CONCLUSION: Under-reporting of ATRs occurs in many Chinese hospitals, but the establishment of CHN has increased ATR recognition and management. More effort will be needed in the future to detect transfusion problems and improve transfusion practice in China.