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Plasma-derived medicinal products (PDMPs) are recognized internationally as essential medicines required to treat various acute and chronic conditions including congenital deficiencies of plasma proteins in haemophilia and primary immune deficiency. Global provision of these medicines is dominated by a small number of commercial companies, influencing the price and availability of the products. Achieving a level of strategic independence from this dominance is now seen as a public health priority in many countries. During the Regional Congress of the International Society for Blood Transfusion (ISBT) in Cape Town, South Africa, in November 2023, around 50 delegates from 24 countries participated in a workshop (WS) organized jointly by the International Plasma and Fractionation Association (IPFA) and the ISBT Working Party on Global Blood Safety on pathways towards provision of PDMPs from domestic plasma independent of commercial purchase in the open market. The WS was structured around three themes, each addressed by a separate group: Quality/safety requirements for plasma for fractionation (PfF) Stepwise access for safe plasma proteins Approaching contract fractionation A synthesis of conclusions from these groups included the following: The need to acquire support from government authorities for a national plasma policy, recognizing the difficulties posed by unstable political and bureaucratic environments. The value of embedding plasma and PDMPs within a patient blood management (PBM) paradigm to promote optimal clinical use of PDMPs. Training of blood/plasma collection personnel in the relevant principles of Good Manufacturing Practice (GMP), coupled with regulatory oversight of plasma product production in the engaged jurisdictions. Appreciation that limited access to contract fractionation may necessitate a stepwise approach, which may include small-scale preparation of versions of essential plasma proteins as an intermediate phase towards the manufacture of industrial-scale PDMPs from domestic plasma., (© 2024 The Author(s). Vox Sanguinis published by John Wiley & Sons Ltd on behalf of International Society of Blood Transfusion.)

Background: Less discriminatory donor selection policies for men who have sex with men (MSM) may impact transfusion safety in terms of higher residual risks for known transfusion-transmitted infections (TTIs), increased vulnerability toward new TTIs that are also transmitted via sex, and HIV infections masked by pre-exposure prophylaxis (PrEP)., Study Design and Methods: TTI trends in Dutch donors were studied over a 13-year period (2011-2023), characterized by successive relaxations of MSM deferral criteria. Structured posttest counseling was performed to determine risk factors in TTI-positive donors. PrEP drug levels were measured in 9977 donations from male donors living in urban areas and in 67 donors with active or resolved syphilis., Results: HIV incidence (from 5.8 to 1.5 per 1,000,000 donor years (DY)) and HBV incidence (from 12.4 to 4.5 per 1,000,000 DY) in Dutch donors decreased with less stringent MSM deferral criteria, while syphilis prevalence (from 26.4 to 44.1 per 100,000 new donors) and syphilis incidence (from 18.3 to 46.3 per 1,000,000 DY) increased over time. The proportion of MSM-related syphilis rose from 2% to 32% in new donors and from 12% to 27% in repeat donors. PrEP was detected in 2 of 9977 (0.02%) donations from male donors living in urban areas, and in 1 of 39 (2.6%) male donors with syphilis., Discussion: To date, phasing out donor deferral for MSM had no significant impact on transfusion safety in the Netherlands. However, rising syphilis rates and (recent) PrEP use in the blood donor population, albeit rare, suggest an influx of donors with higher sexual risk profiles and requires intensified TTI surveillance in donors., (© 2024 AABB.)

Arboviruses represent a threat to transfusion safety for several reasons: the presence of vectors and the notification of autochthonous cases in our region, the recent increase in the number of cases transmitted through blood and/or blood component transfusion, the high prevalence rates of RNA of the main arboviruses in asymptomatic blood donors, and their ability to survive processing and storage in the different blood components. In an epidemic outbreak caused by an arbovirus in our region, transfusion centres can apply different measures: reactive measures, related to donor selection or arbovirus screening, and proactive measures, such as pathogen inactivation methods. The study of the epidemiology of the main arboviruses and understanding the effectiveness of the different measures that we can adopt are essential to ensure that our blood components remain safe., (Copyright © 2024 Elsevier España, S.L.U. All rights reserved.)

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.)

Objectives: To understand the use, functionality and interoperability of laboratory information management systems (LIMS) in UK transfusion laboratories., Background: LIMS are widely used to support safe transfusion practice. LIMS have the potential to reduce the risk of laboratory error using algorithms, flags and alerts that support compliance with best practice guidelines and regulatory standards. Reporting to Serious Hazards of Transfusion (SHOT), the United Kingdom (UK) haemovigilance scheme, has identified cases where the LIMS could have prevented errors but did not. Shared care of patients across different organisations and the development of pathology networks has raised challenges relating to interoperability of IT systems both within, and between, organisations., Methods and Materials: A survey was distributed to all SHOT-reporting organisations to understand the current state of LIMS in the UK, prevalence of expertise in transfusion IT, and barriers to progress. Survey questions covered LIMS interoperability with other IT systems used in the healthcare setting., Results: A variety of LIMS and version numbers are in use in transfusion laboratories, LIMS are not always updated due to resource constraints. Respondents identified interoperability and improved functionality as the main requirements for transfusion safety., Conclusion: A nationally agreed set of minimum standards for transfusion LIMS is required for safe practice. Adequate resources, training and expertise should be provided to support the effective use and timely updates of LIMS. A single LIMS solution should be in place for transfusion laboratories working within a network and interoperability with other systems should be explored to further improve practice., (© 2023 British Blood Transfusion Society.)

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).)

Blood and blood products are listed as one of the essential medicines by the World Health Organization (WHO). In addition to inadequate supply, most sub-Saharan Africa (SSA) nations fail to meet their blood needs because many donated blood units are discarded because they are contaminated with transfusion-transmitted infections (TTIs). We sought to estimate the prevalence of TTIs, identify the risk factors for TTIs among blood donors, and identify the efforts and interventions that have been made to improve blood safety in Southern African nations, particularly the nations of the South African Development Community (SADC). We investigated the prevalence and risk factors for TTIs, blood safety interventions, and blood quality improvement in the SADC region from major PubMed/MEDLINE, Cochrane Library, and HINARI databases from 1 January 2011 to 31 April 2021. All investigations followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). In meta-analysis, we estimated the pooled TTIs prevalence and summarised the same using forest plots. A total of 180 articles published from the SSA region were identified covering our three targeted themes: TTI prevalence, risk factors for TTIs, and blood safety improvements. Of these 180 articles, only 27 (15%) focused on the SADC region. The overall pooled TTI prevalence estimate was 2.0% (95% CI: 1.0-3.0) and hepatitis B was the most prevalent TTI in the region (prevalence = 3.0; 95% CI: 2.0-5.0). The prevalence of HIV, HCV, and syphilis was 2.0% (95% CI: 1.0-4.0), 1.0% (95% CI: 0.0-2.0), and 2.0% (95% CI: 0.0-8.0), respectively. In general, replacement donors and first-time donors were more likely to be infected with TTIs than repeat donors. Twelve articles explored blood safety research in the region; however, they vary greatly highlighting the need for consistent and more comprehensive research. Few publications were identified that were from the SADC region, indicating lack of research or resources towards improving both quantity and quality of blood donation. TTI prevalence remains one of the highest in the world and blood safety recommendations vary across the region. More effort should be directed towards developing a cohesive regional blood transfusion policy and effective blood monitoring and evaluation strategies., (© 2023 British Blood Transfusion Society.)

Background: Hemovigilance (HV) is usually based on voluntary reports (passive HV). Our aim is to ascertain credible incidence, severity, and mortality of transfusion-associated adverse events (TAAEs) using an active HV program., Study Design and Methods: Prospective cohort study to estimate transfusion risk after 46,488 transfusions in 5830 patients, using an active HV program with follow-up within the first 24 h after transfusion. We compared these results to those with the previously established passive HV program during the same 30 months of the study. We explored factors associated with the occurrence of TAAEs using generalized estimating equations models., Results: With the active HV program TAAEs incidence was 57.3 (95% CI, 50.5-64.2) and mortality 1.1 (95% CI, 0.13-2.01) per 10,000 transfusions. Incidence with the new surveillance model was 14.0 times higher than with the passive. Most events occurred when transfusions had already finished (60.2%); especially pulmonary events (80.4%). Three out of five deaths and 50.3% of severe TAAEs were pulmonary. In the multivariate analysis surgical patients had half TAAEs risk when compared to medical patients (OR, 0.53; 95% CI, 0.34-0.78) and women had nearly twice the risk of a pulmonary event compared to men (OR, 1.84; 95% CI, 1.03-3.32). Patient's age, blood component type, or blood component shelf-life were unrelated to TAAEs risk., Discussion: Active hemovigilance programs provide additional data which may lead to better recognition and understanding of TAAEs and their frequency and severity., (© 2023 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.)

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., (© 2023 International Society of Blood Transfusion.)

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.)

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.)

Haemovigilance is the monitoring of the essential components of blood transfusion from its initial stages to the final outcome considering all the safety parameters and hazards that co-exist with it. It primarily aims to ensure the quality as well as safety related to the use of blood and blood products utilizing the standard healthcare framework and a tailored vigilance program for efficient outcomes. Initially, the art of vigilance was started with the therapeutic products available in the market giving some groundbreaking data on their safety which later led to the implementation of timely measures to control adverse events significantly. Several incidents have occurred during the collection, transport, storage, and transfusion of blood and to stop these incidences of hazard, haemovigilance came into existence with France becoming the first country to step in followed by several nations across the world with customized guidelines directing it to the best. The majorly reported problems include bacterial infections, hemolytic and immune reactions. The present writeup reviews the inception and development of haemovigilance programs with a global scenario, a detailed study of the haemovigilance program adopted in India, and the updated status of these programs in various countries across the globe., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Background: The COVID-19 pandemic has affected blood inventory and donation worldwide. The Islamic Republic of Iran was among the first countries to report the COVID-19 pandemic and it faced a significant blood shortage during the first weeks of the pandemic., Aims: We aimed to evaluate the impact of COVID-19 pandemic on the number, type, and safety of blood donations, comparing the periods before and during the pandemic., Methods: This retrospective study evaluated data from all volunteers who attended the blood transfusion centres in the Islamic Republic of Iran from March to December 2020 (during the COVID-19 pandemic) and during the same period in 2019, i.e. pre-pandemic. Data on the number of blood collections, confirmed transfusion transmissible infection marker test results, and donor demographic information were collected from the Iranian Blood Transfusion Organization integrated donor database., Results: Total blood donations decreased by 8.38%. The number of first-time, lapsed, and female blood donors increased by 4.41%, 0.17%, and 0.90% respectively. Regular blood donation decreased by 4.58%. The distribution of the 3 main blood products, red cell concentrate, frozen fresh plasma and platelets, decreased by 7.86%. All changes were statistically significant. The prevalence rates of hepatitis C virus and hepatitis B surface antigen increased significantly during the pandemic., Conclusion: COVID-19 had a negative effect on blood safety and availability in the Islamic Republic of Iran. To improve blood supply and enhance regular blood donation, the Iranian Blood Transfusion Organization needs to reassure blood donors of the safety and hygiene measures being observed at blood collection sites., (Copyright © Authors 2022; Licensee: World Health Organization. EMHJ is an open access journal. This paper is available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo).)

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: Transfusion carries a risk of transfusion reaction that is often underdiagnosed due to reliance on passive reporting. The study investigated the utility of digital methods to identify potential transfusion reactions, thus allowing real-time intervention for affected patients., Method: The hemovigilance unit monitored 3856 patients receiving 43,515 transfusions under the hemovigilance program. Retrospective comparison data included 298,498 transfusions. Transfusion medicine physicians designed and validated algorithms in the electronic health record that analyze discrete data, such as vital sign changes, to assign a risk score during each transfusion. Dedicated hemovigilance nurses remotely monitor all patients and perform real-time chart reviews prioritized by risk score. When a reaction is suspected, a hemovigilance trained licensed clinician responds to manage the patient and ensure data collection. Board-certified transfusion medicine physicians reviewed data and classified transfusion reactions under various categories according to the Centers for Disease Control hemovigilance definitions., Results: Transfusion medicine physicians diagnosed 564 transfusion reactions (1.3% of transfusions)-a 524% increase compared to the previous passive reporting. The rapid response provider reached the bedside on average at 12.4 min demonstrating logistic feasibility. While febrile reactions were most diagnosed, recognition of transfusion-associated circulatory overload demonstrated the greatest relative increase. Auditing and education programs further enhanced transfusion reaction awareness., Discussion: The model of digitally-enabled expert real-time review of clinical data that prompts rapid response improved recognition of transfusion reactions. This approach could be applied to other patient deterioration events such as early identification of sepsis., (© 2022 AABB.)

Background and Objectives: The study was planned to determine the incidence and analyze how various epidemiological factors tend to be associated with delayed adverse donor reactions (ADR)., Material and Methods: The prospective observational study was conducted in Department of Transfusion Medicine of tertiary care hospital from January to December 2019. Eligible blood donors were observed for any adverse reactions after 15 minutes of removal of phlebotomy needle. Further, telephonic calls were made to each enrolled blood donor on day-2 and day-7 of the whole blood donation. For each day, two calls were made at an interval of 4 hours before declaring the participant to be non-responder., Results: A total of 1540 (84.1%) blood donors responded on day-2 and 1610 (87.9%) responded on day-7 of follow-up. Total 180 (11.2%) blood donors experienced delayed ADRs. Two donors (1.1%) experienced on-site while 178 (98.89%) reported off-site delayed ADRs when followed-up telephonically. The commonest delayed ADRs reported were bruise (n=72; 30.9%), arm-pain (n=61; 26.2%) and generalised weakness (n=44; 18.9%). Female donors (27.3% vs. 11.2%; P=0.004), first time donors (15.2 vs. 9.9%; P=0.002), donors with low body-weight (range of 45-60kg; 15.9% vs. 11.5% vs. 6.1%; P=0.011) and body mass index<18.5 (24% vs. 12.5% vs. 9.7% vs. 11.3%; P=0.028) experienced more delayed ADRs., Conclusion: Blood donors do experience delayed ADRs but these are not reported to the blood centers as these are usually mild. However, it is important to capture these delayed adverse donor reactions and report it to National Hemovigilance Program so that strategies can be formulated to prevent their occurrence and recurrence., (Copyright © 2021 Société française de transfusion sanguine (SFTS). Published by Elsevier Masson SAS. All rights reserved.)

Background and Objectives: Australian Red Cross Lifeblood (Lifeblood) performs red blood cell (RBC) antibody screening on every whole blood donation. An alternate strategy has been proposed whereby an antibody screen is performed on the first donation and only repeated following pregnancy, transfusion or a significant break between donations (>2 years). We assess the blood safety risks associated with removing antibody screening for every whole blood donation., Materials and Methods: A retrospective desktop analysis included all whole blood donations collected by Lifeblood between 01 May 2018 and 30 April 2019 to quantify the antibodies that would have been undetected with the alternate strategy. The strategy was further assessed using the Alliance of Blood Operators Risk-Based Decision-Making framework., Results: One hundred and seventy-one routine donors had antibodies for the first time, but reported no sensitizing event since their last donation. Forty-seven of these had antibodies of a clinically significant specificity and titre that have the potential to cause a haemolytic transfusion reaction (HTR). The calculated risk of undetected antibodies being transfused to an incompatible recipient is 1 in 82,200., Conclusion: The estimated risk of HTRs with the alternate strategy results in an increased risk. While the alternate strategy is identified as the most cost-effective option within the Australian setting, this additional residual risk was not deemed to be acceptable. Blood services would need to determine whether the increase in residual risk stemming from implementation of such a strategy is tolerable., (© 2021 International Society of Blood Transfusion.)

Background and Objectives: In recent years, there has been an increased focus among blood bank professionals on the health and safety of blood donors. In 2019, the Danish Haemovigilance Committee designed a national donor vigilance system to improve the registration of adverse reactions (AR) in blood donors. The new donor vigilance system was implemented on 1 January 2020 and we here present the results from the first year of registration., Materials and Methods: AR categories, severity level and imputability score were defined based on the definitions from the International Society of Blood Transfusion, AABB and the European Commission directive 2005/61/EC, respectively., Results: Across all severity levels, AR in Danish blood donors were found to be rare (1498 per 100,000 donations). Only 0.2% of the registered reactions were classified as serious (2.7 per 100,000 donations). Large regional differences were seen in the registration of citrate reactions and haematomas., Conclusion: Significant differences across regions in what to categorize as an AR were persistent even when including a severity score in the reporting. The Danish Haemovigilance Committee will commence a national work to align the definitions but suggests that this matter is raised to an international level as part of the current work to agree upon definitions for assessment of donor AR., (© 2021 International Society of Blood Transfusion.)

Background: Under-transfusion is an underreported entity within most hospitals and hemovigilance systems. While critical blood shortages are being reported more frequently, without incident codes to document instances of under-transfusion due to lack of inventory, estimating its impact on patient care as it relates to hemotherapy (HT) has hampered our ability to assess and inform strategic initiatives to combat inventory issues as well as prepare for future blood supply threats., Study Design and Method: An 11-member working group of the AABB (Association for the Advancement of Blood and Biotherapies) Hemovigilance Committee was formed in October 2020 to study the topic of under-transfusion including its potential causes and clinical expressions. The group was also charged with proposing simple definition/incident codes to be used by hemovigilance systems to document such instances., Results: The working group proposed four simple incident codes under the new process code-No Blood (NB)-that can be used by hemovigilance systems to appropriately document instances of under-transfusion due to lack of inventory. The codes were described as: (1) NB 01-Inventory less than usual level due to supplier shortage; (2) NB 02-Demand for blood product exceeding usual inventory levels; (3) NB 03-Substitution with incompatible/inappropriate units; and (4) NB 04-Suboptimal dose/no transfusion given., Conclusion: The adoption of these codes within hemovigilance systems globally would assist in recognition and reporting instances of under-transfusion due to inventory, thus supporting development of better collection strategies, inventory management techniques as well as effective policies to improve blood safety and availability., (© 2022 AABB.)

Objective: This work aimed to establish the effects of the COVID-19 pandemic on blood collection and blood product usage at the end of the first year., Background: The arrival of SARS-CoV-2 to Colombia on March 6, 2020, triggered closure of borders and mandatory lockdown from March 23, 2020., Methods/materials: The Colombian National Institute of Health administers the National database of confirmed cases of SARS-CoV-2 and the National Haemovigilance System. We examined positive SARS-CoV-2 cases identified between March 6, 2020, and March 6, 2021, using positive RT-PCR testing (72.8%) or reactive antigen (27.2%). We also analysed accepted and deferred donors' information provided by 100% of blood banks and transfused patients notified by 83% of health care facilities nationwide, between March 1, 2019, to February 28, 2021., Results: Colombia registered 2 273 245 SARS-CoV-2 cases. From these, 60 412 people died from COVID-19 (2.7%) and 2 172 418 individuals recovered (95.6%). There were 11 659 216 SARS-CoV-2 processed samples nationwide. People between the ages of 20 and 39 years concentrated 44.4% of the SARS-CoV-2 cases. There were 773 569 blood donations, mainly from a 20-39-year-old population (60.5%). The pandemic caused a reduction of 155 393 blood donations (16.7%) and 51 823 total deferrals (33.7%). An 18.4% drop in volunteer donors and a 37.3% increase in donations from family/replacements members were observed. There were 399 453 transfused patients and 1 179 895 blood components administered (-8.7% and - 13.9% compared to March 2019-February 2020)., Conclusion: Mandatory lockdowns in Colombia decreased blood collection and usage, resulting in a reduction of blood components transfused to individual patients., (© 2021 British Blood Transfusion Society.)

Background: The goal of our study was to determine the frequency and type of transfusion reactions (TRs) as well as other hemovigilance activities reported at a tertiary care hospital in Turkey over a period of 3 years., Method: In this retrospective study, the notification sheets of TRs reported to the institution's local hemovigilance system between December 2017 and December 2020 were analyzed., Results: A total of 89,187 units of blood components were administered to patients during this period. A total of 197 TRs were reported to the hemovigilance system. The overall frequency of TRs was 0.22%. The most common TRs were allergic reactions (49.2%) and febrile nonhemolytic transfusion reactions (37.6%), respectively. Most of the adverse events were reported by clinical nurses., Conclusion: Our study showed that the frequency of TRs was low, and most were manageable reactions. We found that reporting of all TRs and continuous nursing education can help to strengthen the hemovigilance system. [ J Contin Educ Nurs. 2021;52(12):581-588.] .

Blood transfusion begins with safe donor selection and testing. In the United States, the blood supply and transfusion are highly regulated. Blood transfusion safety is multifaceted, whereby each of the elements of the blood safety value chain, spanning donor recruitment and qualification, to collection, blood processing, testing, transfusion practice, and posttransfusion surveillance, must be optimized to minimize risk. Pathogen inactivation is a promising approach to decrease bacterial contamination of platelets, inactivate parasites and viruses, and decrease risks associated with emerging and unidentified pathogens. This article offers an overview of blood donor infectious and noninfectious testing in the United States., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Haemovigilance is an important element of blood regulation. It includes collecting and evaluating the information on adverse events resulting from the use of blood and blood components with the aim to improve donor and patient safety. We describe the results of the pilot of the integrated GBT+ Blood for the haemovigilance function in 10 sub-Saharan African countries., Methods: We piloted the integrated WHO Global Benchmarking Tool plus Blood (GBT+ Blood) to assess the haemovigilance function of national regulatory authorities (NRAs) in Ethiopia, Kenya, Malawi, Nigeria, Liberia, Rwanda, South Africa, Tanzania, Uganda, and Zimbabwe. Data obtained from documents and face to face interviews were used to determine the status of implementation and performance of the following six indicators; legal provisions regulations and guidelines, organisation and governance, human resources, regulatory processes, transparency and accountability and finally, monitoring progress and assessing impact, by estimating median scores across 20 sub-indicators. In addition, a cluster analysis was performed., Results: The countries showed inter-organisation variability in implementation and performance of the haemovigilance function. The overall median score (all sub-indicators) was 44 % (range: 7.5 % - 70 %). The lowest average performance scores were for the arrangement for effective organisation and coordination (35 %) and human resources (35 %) indicators. The highest average scores were observed for the mechanism to promote transparency and mechanism to monitor regulatory performance indicators (50 % and 60 %, respectively). We identified clusters of best-implemented sub-indicators from the procedures for haemovigilance and poorly implemented sub-indicators from the legal provisions, regulations and guidelines for haemovigilance and human resources., Conclusions: Implementation of sub-indicators and performance of haemovigilance systems varied greatly for all countries with a few countries performing reasonably well in the implementation of some sub-indicators under procedures for haemovigilance. Most countries were poorly implementing sub-indicators in the legal provisions, arrangement for effective organisation and human resources indicators. The legislative provisions in most countries were at a nascent stage. There is a need to set up targeted and customised technical support coupled with prioritised interventions to strengthen the capacities of NRAs., (© 2021. The Author(s).)

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.)

The HAS certification for healthcare organisation has gradually introduced the concepts of risk and relevance of care. Related to quality and safety of care, the transfusion act has early been part of the referential, and it seemed interesting to us to observe the changes in the requirements on this topic. After taking into account the regulations and the organization of haemovigilance in the establishment, it is now the search for the factual result for the patient which is the objective of the two main criteria devoted to transfusion. At the same time as the referential, the investigation methods have also evolved: the targeted tracer for Labile Blood Products and Blood-Derived Medicines allows a more detailed analysis geared towards the effective implementation of good transfusion practices. In conclusion, certification has moved from organizing and auditing the process to directly measuring transfusion safety for the patient., (Copyright © 2021. Published by Elsevier Masson SAS.)

Post-donation information (PDI) can be defined as any information provided by the donor or other source following a donation, that, had it been known to the blood establishment during the selection process, would have resulted in the donor's deferral. PDI reflects the shortcomings, limitations and complexity of the donor selection process. Knowledge of the causes of PDI events, their types and frequency, is a prerequisite not only for their effective management, but also for the implementation of measures to improve the selection process and the safety of donated blood. Managing PDI requires a considerable investment of time and close collaboration between the various stakeholders involved in this process. Despite its regular occurrence and the fact that PDI points to a possible problem of blood safety, very few studies have been published so far, mostly by US and Canadian authors. This review article aims at collecting and discussing available information on all aspects of PDI management, with particular reference to European experiences., (Copyright © 2021 Société française de transfusion sanguine (SFTS). Published by Elsevier Masson SAS. All rights reserved.)

Background: Pathogen-reduced platelets (PR PLT) are the emerging standard for proactive transfusion-transmitted infection (TTI) mitigation. There is, however, continued hesitation to transfuse PR PLT in children due to limited published data. We report demographics, rates of transfusion, and transfusion reactions (TR) associated with FDA-approved PR PLT in pediatric and neonatal patients at an academic medical center., Methods: Retrospective review was performed for patients <18 years receiving at least one platelet over a 300-day period at a large, tertiary care hospital. Patients were transfused PR or conventional (CONV) PLT, based on inventory availability. Statistical analysis was performed using Fisher Exact Test., Results: During the study period, 191 patients received 1010 platelet transfusions (892 units). Sixty-eight patients received PR PLT only (1.3 units/patient, 95% confidence interval [CI] 1.1-1.5; 1.8 transfusions/patient, 95% CI 1.4-2.2), and 56 patients received CONV PLT only (1.4 units/patient, 95% CI 1.1-1.7; 1.6 transfusions/patient, 95% CI 1.3-1.9). Patients with hematologic malignancies undergoing chemotherapy/radiation and allogeneic hematopoietic stem cell transplant received the most platelet transfusions and more commonly received both platelet types. Of 506 PR PLT units, 5 TRs occurred; 386 CONV PLT resulted in two TRs (p = .7052). Of 51 neonates, 37 received PR PLT without adverse events, including 13 receiving phototherapy. No TTIs were identified in any group., Conclusion: There was no significant difference in rates of transfusion or TRs between PR and CONV PLT. Our study provides additional evidence that PR PLT can be transfused to pediatric and neonatal patients without increasing the risk of acute adverse events., (© 2021 AABB.)

Background: Chagas disease (CD) serological screening at blood banks is usually performed by a single highly sensitive serological assay, with chemiluminescent immunoassays (CLIAs) being the method of choice. CLIAs employ recombinant, fusion peptides and/or chimeric antigens that selectively capture anti-Trypanosoma cruzi antibodies. However, despite high sensitivity, the ability of these tests to identify CD-positive cases should be evaluated against T. cruzi strains circulating in specific locales. Herein, we used a latent class analysis (LCA) approach employing an array of four chimeric antigens to assess the diagnostic performance of the Liaison XL Murex Chagas CLIA for the detection of anti-T. cruzi IgG in serum samples., Study Design and Methods: The study included a panel of 5014 serum samples collected from volunteer blood donors at the Hematology and Hemotherapy Foundation of the State of Bahia, submitted to anti-T. cruzi antibody detection using Liaison Chagas CLIA and LCA as a reference test in the absence of a gold standard., Results: LCA classified 4993 samples as negative, while positivity for T. cruzi antibodies was predicted in 21 samples. Compared with LCA, CLIA demonstrated sensitivity and specificity of 76.2% and 99.5%, respectively, providing an overall accuracy of 99.4%., Discussion: In blood banks lacking a de facto highly sensitive screening immunoassay, the low sensitivity offered by Liaison Chagas CLIA renders it unsuitable for standalone use in serological screening procedures for CD. Moreover, blood banks are encouraged to carefully assess the ability of diagnostic methods to identify local T. cruzi strains in circulation., (© 2021 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.)

Introduction: The coronavirus disease 2019 (COVID-19) pandemic has disrupted healthcare services worldwide. However, little has been reported regarding the impact on blood utilization. We quantified the impact of COVID-19 on blood utilization and discards among facilities reporting to the National Healthcare Safety Network Hemovigilance Module., Methods: Facilities continuously reporting data, during January 2016-June 2020, on transfused and discarded blood components, stratified by component type (red blood cells [RBC], platelets, and plasma), were included. Interrupted time-series analysis with generalized estimating equations, adjusting for facility surgical volume and seasonality, was used to quantify changes in blood utilization and discards relative to a Centers for Medicare & Medicaid Services notification delaying nonessential medical procedures (March 2020)., Results: Seventy-two facilities included in the analyses, on average, transfused 44,548 and discarded 2,202 blood components monthly. Following the March 2020 notification and after multivariable adjustment, RBC and platelet utilization declined, -9.9% (p < .001) and -13.6% (p = .014), respectively. Discards increased for RBCs (30.2%, p = .047) and platelets (60.4%, p = .002). No statistically significant change in plasma was found. Following these abrupt changes, blood utilization and discards rebounded toward baseline with RBC utilization increasing by 5.7% (p < .001), and platelet and RBC discards decreasing -16.4% (<0.001) and -12.7 (p = .001), respectively., Conclusion: Following notification delaying elective surgical procedures, blood utilization declined substantially while blood discards increased, resulting in substantial wastage of blood products. Ongoing and future pandemic response efforts should consider the impact of interventions on blood supply and demand to ensure blood availability., (© 2021 AABB. This article has been contributed to by US Government employees and their work is in the public domain in the USA.)

Background: Although the safety and therapeutic efficacy of COVID-19 convalescent plasma (CCP) has been extensively evaluated, the safety of CCP donation has not been explored in a multi-institutional context., Study Design and Methods: Nine blood collection organizations (BCOs) participated in a multi-institutional donor hemovigilance effort to assess the safety of CCP donation. Donor adverse events (DAEs) were defined according to the Standard for Surveillance of Complications Related to Blood Donation, and severity was assessed using the severity grading tool. Multivariate analysis was performed to determine attributes associated with DAE severity., Results: The overall DAE rate was 37.7 per 1000 donations. Repeat apheresis and apheresis-naïve donors experienced adverse event rates of 19.9 and 49.8 per 1000 donations, respectively. Female donors contributed 51.9% of CCP donations with a DAE rate of 49.4 per 1000 donations. The DAE rate for male donors was 27.4 per 1000 donations. Vasovagal reactions accounted for over half of all reported DAEs (51.1%). After adjustment, volume of CCP donated was associated with vasovagal reaction severity (odds ratio [OR] 6.5, 95% confidence interval [CI] 2.5-17.1). Donor age and donation history were also associated with DAE severity. Considerable differences in DAE types and rates were observed across the participating BCOs despite the use of standardized hemovigilance definitions., Conclusion: The safety of CCP donation appears comparable to that of conventional apheresis plasma donation with similar associated risk factors for DAE types and severity., (© 2021 AABB.)

Background: The prevalence of hepatitis B surface antigen is estimated to be 6.7% in the South African population and in April 1995 the nation introduced universal hepatitis B virus (HBV) vaccination for newborns and infants. We studied the temporal association of this program with HBV prevalence in young blood donors and the contemporary HBV incidence and residual risk of transfusion-transmitted HBV infection (TT-HBV)., Methods: We used blood donation data from January 2011 to December 2019. Estimation of HBV prevalence donations made by first-time blood donors were analyzed by birth cohort and covariates. To estimate the incidence and residual risk of TT-HBV, mathematical models used data from both first time and repeat donors., Results: HBV prevalence in first-time donors decreased from 0.84% (95% confidence interval [CI] 0.78-0.90) in 2011 to 0.66% (95% CI 0.61-0.70) in 2019. The post-1995 birth cohort had a significantly lower HBV prevalence of 0.14% (95% CI 0.13-0.15) than the pre-1985 birth cohort of 1.29% (95% CI 1.25-1.33) and the odds of HBV infection were reduced in a multivariable model (odds ratio [OR] = 0.28, 95% CI 0.24-0.34). The residual risk of TT-HBV occurring from window-period, occult, and possible vaccine breakthrough infections were estimated at 36.9, 5.8, and 2.2 per million red blood cell transfusions, respectively., Conclusion: Donors born after the start of routine HBV immunization had significantly lower prevalence of HBV infection, supporting the effectiveness of the vaccination program. The contemporary residual risk of TT-HBV has decreased and should decline further as more vaccinated young people join the donor pool., (© 2021 AABB.)

Traditional approaches to blood regulation emphasise the precautionary principle and pursue zero-risk for viral transmission; these traditional approaches have usually followed tragedy, such as the HIV and hepatitis C infections that followed the use of factor VIII concentrates. However, a much more haphazard haemovigilance system operates for general adverse events. Such imprecise assessment of hazards prevents sound benefit-risk assessment, and for blood products this is further confounded by the fact that their efficacy has attracted little systematic study. The ongoing COVID-19 pandemic has now prompted the proposal of a convalescent plasma (CP) blood product. Clearly, mere freedom from infectious agents will not suffice in assessing CP, and an objective measure of efficacy, so as to permit formal benefit-risk analysis, is essential. This is both a scientific and an ethical demand, as has been the case for other experimental COVID-19 treatments. With special reference to COVID-19 CP, the well-recognized adverse events of transfusion-associated lung injury (TRALI) and transfusion-associated circulatory overload (TACO) will be important. Furthermore, not only efficacy but also product quality attributes (e.g., antibody titre) will have to be defined. Both of these are outside the traditional regulatory philosophy for blood products and are needed to truly assess the benefit-risk of this putative therapeutic product., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Background: The PGDprime® test was updated to enable Acinetobacter spp. detection to respond to morbidity and mortality events in 2018 and 2020 involving platelets contaminated with Acinetobacter-calcoaceticus-baumannii complex (ACBC). In one morbidity event, the first-generation PGD test failed to detect ACBC. In two other reported events, pathogen-reduced (PR) platelets contaminated with ACBC and other bacteria led to patient morbidity and one death., Study Design and Methods: A polyclonal antibody to Acinetobacter was integrated in the test device and evaluated for detection of Acinetobacter spp., including the ACBC isolate recovered in one of the 2018 contamination events. Limits of Detection for various Acinetobacter strains were determined in dilution studies. Detection of Acinetobacter growing in platelets after an initial low inoculum was evaluated. Use of the updated test as a secondary test after pathogen reduction was also evaluated by testing at 12-h intervals PR platelet units inoculated with low levels of the 3 species reported in the fatal PR platelet: ACBC, Staphylococcus saprophyticus, and Leclercia adecarboxylata., Results: The test detected several Acinetobacter strains at the clinically relevant CFU/ml levels associated with septic transfusions and successfully detected Acinetobacter growing in various non-PR platelet types after an initial low inoculum. In PR platelets, the test yielded a positive result with the 3 implicated bacteria in 48 h or less after inoculation, or 48-72 h earlier than the reported time of transfusion of contaminated PR platelets., Conclusion: PGDprime was improved to detect Acinetobacter and has shown utility to interdict contaminated PR platelets., (© 2021 The Authors. Transfusion published by Wiley Periodicals LLC. on behalf of AABB.)

Background: In the setting of suspected septic transfusion reactions, bacterial culture of both the transfused patient and the residual blood component is recommended. Primary bacterial contamination can occur at the time of component collection. Clinically insignificant "secondary contamination" can occur during post-transfusion component discard, retrieval for culture, or manipulation of the bag at the time of culture sampling., Study Design and Methods: This retrospective, multi-center study analyzes positive residual component culture results and companion patient blood cultures from 15 hospitals, 1 blood center, and all cultured transfusion reactions within the province of Quebec, Canada, over a 5-year period. Imputability was assigned as "definite" (concordant growth), "possible" (discordant growth or lack of growth in patient culture), or "unable to assess" (patient not cultured)., Results: There were 373 positive component cultures from 360 unique transfusion reactions, with 276 (76.7%) companion patient blood cultures performed, of which 10 (2.8%) yielded the pathogen detected in the positive component. Of these 10 definite pathogens, 7 (2 Staphylococcus aureus, 3 other staphylococci, and 1 Streptococcus pyogenes and 1 Bacillus sp.) were associated with platelet and 3 (Aeromonas veronii, Staphylococcus epidermidis, and Enterococcus faecalis) with RBC transfusions. RBC and plasma components comprised 70% of positive component cultures., Discussion: The process of performing residual component culture is vulnerable to secondary contamination. The significance of microorganisms recovered from component culture cannot be interpreted in isolation. In the context of low prevalence of primary contamination of blood components, the positive predictive value of a positive component culture result is very low., (© 2021 AABB.)

Background: SARS-CoV-2 RNA prevalence in blood donors from large geographic areas of high community transmission is limited. We tested residual donor plasma minipools (MPs) to determine SARS-CoV-2 RNAemia prevalence in six United States areas., Study Design/methods: Blood donations collected from 7 March 2020 to 25 September 2020 were tested for SARS-CoV-2 RNA (vRNA) in MP of 6 or 16 donations using the Grifols Procleix SARS-CoV-2 research-use only (RUO) transcription-mediated amplification (TMA) assay. Reactive results were confirmed using an alternate target region TMA assay. Reactive MPs were tested by TMA after serial dilution to estimate viral load. Testing for anti-SARS-CoV-2 antibodies and infectivity was performed., Results: A total of 17,995 MPs corresponding to approximately 258,000 donations were tested for vRNA. Three confirmed reactive MP16 were identified. The estimated prevalence of vRNA reactive donations was 1.16/100,000 (95% CI 0.40, 3.42). The vRNA-reactive samples were non-reactive for antibody, and the estimated viral loads of the (presumed single) positive donations within each MP ranged from <1000 to <4000 copies/ml. When tested, no infectivity was observed in inoculated permissive cell cultures., Discussion: Blood donation MP-nucleic acid testing (NAT) indicated that SARS-CoV-2 RNAemia is infrequent and, when detected, the vRNA was at low concentrations. Only one RNA-reactive MP could be tested for infectivity for operational reasons and was not infectious in cell culture. These findings support current recommendations from international and national regulatory agencies to not screen donors by NAT., (© 2021 AABB.)

Call back as a procedure to report post donation symptoms or illness by donors has been established since 2009 in Iranian Blood Transfusion Organization (IBTO). During the first phase of COVID-19 outbreak, all blood donors were requested to report any respiratory infection symptoms after donation. The study investigated the callback data of COVID-19 in Tehran Blood Center during the first 3 months of the outbreak in Iran. The purpose of this study was to estimate the frequency of post donation COVID-19 related call back reports and determine its implications for blood donors and patients. A telephone interview was conducted with donors who had reported COVID-19 symptoms. Some questions were asked to evaluate donor's health at the time of blood donation. The donors categorized into three groups: laboratory-confirmed, suspected, and COVID-19 irrelevant based on their answers. In cases that the blood component obtained from a laboratory-confirmed donor had been released, the hospital was notified and asked to follow up the recipient for COVID-19. The results showed 30 donors (0.08 %) had callback related to COVID-19 and 76.63 % of the obtained component was disposed. The results also showed that only one donor had a laboratory-confirmed result with the RBC unit processed from her whole blood released for transfusion. The RBC unit recipient did not show any signs or symptoms of infection during a 46-day follow-up. Concluded that callback system was effective to remove most of the components obtained from the donors who reported to be COVID-19 suspected or confirmed. Moreover, the result did not support virus transmission through blood transfusion., (Copyright © 2021. Published by Elsevier Ltd.)

Background: Undisclosed antiretroviral drug (ARV) use among blood donors who tested HIV antibody positive, but RNA negative, was previously described by our group. Undisclosed ARV use represents a risk to blood transfusion safety. We assessed the prevalence of and associations with undisclosed ARV use among HIV-positive donors who donated during 2017., Study Design and Methods: South African National Blood Service (SANBS) blood donors are screened by self-administered questionnaire, semi-structured interview, and individual donation nucleic acid amplification testing for HIV. Stored samples from HIV-positive donations were tested for ARV and characterized as recent/longstanding using lag avidity testing., Results: Of the 1462 HIV-positive donations in 2017, 1250 had plasma availability for testing of which 122 (9.8%) tested positive for ARV. Undisclosed ARV use did not differ by gender (p = .205) or ethnicity (p = .505) but did differ by age category (p < .0001), donor (p < .0001), clinic type (p = .012), home province (p = .01), and recency (p < .0001). Multivariable logistic regression found older age (adjusted odds ratio [aOR] 3.73, 95% confidence interval [CI] 1.98-7.04 for donors >40 compared with those <21), first-time donation (aOR 5.24; 95% CI 2.48-11.11), and donation in a high HIV-prevalence province (aOR 9.10; 95% CI 2.70-30.72) compared with Northern Rural provinces to be independently associated with undisclosed ARV use., Discussion: Almost 1 in 10 HIV-positive blood donors neglected to disclose their HIV status and ARV use. Demographic characteristics of donors with undisclosed ARV use differed from those noted in other study. Underlying motivations for nondisclosure among blood donors remain unclear and may differ from those in other populations with significant undisclosed ARV use., (© 2021 AABB.)