First donor haemovigilance system at a national level in China: Establishment and improvement.

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

Education in transfusion medicine, Part III - The importance of haemovigilance education.

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

Longitudinal analysis of annual national hemovigilance data to assess pathogen reduced platelet transfusion trends during conversion to routine universal clinical use and 7-day storage.

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

The impact of revised definitions for transfusion-associated circulatory overload and transfusion-related acute lung injury on haemovigilance reporting.

BACKGROUND AND OBJECTIVES: Transfusion-associated circulatory overload (TACO) and transfusion-related acute lung injury (TRALI) are serious adverse transfusion reactions. Standardized surveillance definitions are important to ensure consistent reporting of cases. Recently, revised definitions have been developed for TACO and TRALI, the latter of which has not yet been widely implemented. This study aimed to assess the impact of the new TACO and TRALI definitions on haemovigilance reporting. MATERIALS AND METHODS: The Australian Red Cross Lifeblood Adverse Transfusion Reaction database was accessed to identify all cases of suspected or confirmed TACO and TRALI referred from 1 July 2015 to 30 June 2019. Cases were assessed against both the former and new definitions and the results were compared. RESULTS: A total of 73 cases were assessed. There were 48 TACO cases identified. Only 26 of 48 cases strictly met the former 2011 International Society of Blood Transfusion (ISBT) definition of TACO; 6 cases did not meet the definition and 16 cases lacked sufficient clinical details. In comparison, 46 cases met the revised 2018 ISBT definition, with only 2 cases having insufficient details. There were 24 cases of TRALI according to the existing 2004 Canadian Consensus Conference (CCC) definition compared with 25 cases according to the proposed 2019 revised definition. CONCLUSION: The revised TACO definition captured more cases than the former definition. No significant differences were observed in the number of TRALI cases under the proposed new definition. This is the first study to provide validation data for the revised TRALI definition.

Indicadores para a avaliação do processo transfusional: revisão integrativa* / Indicadores para la evaluación del proceso transfusional: revisión integradora / Transfusion process assessment indicators: integrative review

Objetivo: identificar os indicadores relacionados ao processo transfusional. Método: revisão integrativa de literatura realizada entre março e maio de 2022, em nove fontes de informação no período de 2001 a 2021. Como estratégia de busca, utilizaram-se os descritores "Indicadores de Qualidade em Assistência à Saúde", "Indicadores de Serviços", "Indicadores Básicos de Saúde", "Serviço de Hemoterapia", "Transfusão de Sangue", "Segurança do Sangue", com os operadores boleanos "AND" e "OR" em três idiomas, sendo analisados 49 artigos. Resultados: foram identificados 53 indicadores, os quais se agruparam para: gestão do estoque de hemocomponentes, de produção do processo transfusional, para avaliação do processo transfusional e de suporte do processo transfusional. Conclusão: os indicadores identificados possibilitam avaliação do processo transfusional, apesar de atividades, como a avaliação do cuidado, apresentarem poucos indicadores, evidenciando a necessidade de estudos sobre a temática e construção de novos indicadores para dar sustentação à avaliação mais aprimorada do processo transfusional.

Objective: to identify transfusion-related indicators. Method: an integrative literature review carried out between March and May 2022, in nine sources of information from 2001 to 2021. As a search strategy, the descriptors "Quality Indicators in Health Care", "Service Indicators", "Basic Health Indicators", "Hemotherapy Service", "Blood Transfusion", "Blood Safety" were used, with Boolean operators "AND" and "OR" in three languages, with 49 articles being analyzed. Results: a total of 53 indicators were identified, which were grouped for: blood component stock management, transfusion process production, transfusion process assessment and transfusion process support. Conclusion: the identified indicators make it possible to assess the transfusion process, although activities, such as care assessment, present few indicators, highlighting the need for studies on the subject and the construction of new indicators to support a more improved transfusion process assessment.

Objetivo: identificar indicadores relacionados con el proceso de transfusión. Método: revisión integrativa de la literatura, realizada entre marzo y mayo de 2022, en nueve fuentes de información de 2001 a 2021. Como estrategia de busca, se utilizaron los descriptores "Indicadores de Calidad en la Atención de Salud", "Indicadores de Servicio", "Indicadores Básicos de Salud", "Servicio de Hemoterapia", "Transfusión de Sangre", "Seguridad de la Sangre", con operadores booleanos "AND" y "OR" en tres idiomas, analizando 49 artículos. Resultados: se identificaron 53 indicadores, los cuales fueron agrupados en: gestión del stock de hemocomponentes, producción del proceso transfusional, evaluación del proceso transfusional y apoyo al proceso transfusional. Conclusión: los indicadores identificados posibilitan la evaluación del proceso transfusional, aunque actividades, como la evaluación del cuidado, presenten pocos indicadores, destacando la necesidad de estudios sobre el tema y la construcción de nuevos indicadores que apoyen una evaluación más perfeccionada del proceso de transfusión.

The impact of COVID-19 on blood safety and availability in the Islamic Republic of Iran.

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.

Evolution of Blood Safety in Switzerland over the Last 25 Years for HIV, HCV, HBV and Treponema pallidum.

During the last few decades, efforts to increase the safety of blood and blood products have mainly focused on preventing the viral infections HCV, HIV, HBV and Treponema pallidum. The evolution of these approaches and the achieved increase in safety is shown for the last 25 years in Switzerland. In detail, the prevalences and incidences of the infection disease and the theoretical estimated residual risks (RR) of these blood-borne infections are presented. Prevalences, incidences and, in particular, the RR have decreased considerably over the last 25 years. This was achieved primarily by the adoption of strict criteria for the selection of blood donors, refined questionnaires, the introduction of increasingly sensitive serological screening tests and the implementation of nucleic acid testing (NAT) for these blood-borne pathogens. These NAT assays have significantly shortened the window period between infection and the first detection of the infectious agent in the blood of an infected individual. A form of "real life" comparison or confirmation is provided by the reported lookback procedures (LBP) and the haemovigilance data of the Swiss competent authority, Swissmedic. These data are in agreement, and thus support the very low prevalences, incidences and RR.

Eastern Mediterranean Health Journal [2022; Vol.28, Issue 11]

Eastern Mediterranean Health Journal is the official health journal published by the Eastern Mediterranean Regional Office of the World Health Organization. It is a forum for the presentation and promotion of new policies and initiatives in health services; and for the exchange of ideas concepts epidemiological data research findings and other information with special reference to the Eastern Mediterranean Region. It addresses all members of the health profession medical and other health educational institutes interested NGOs WHO Collaborating Centres and individuals within and outside the Region.

المجلة الصحية لشرق المتوسط هى المجلة الرسمية التى تصدرعن المكتب الاقليمى لشرق المتوسط بمنظمة الصحة العالمية. وهى منبر لتقديم السياسات والمبادرات الجديدة فى الصحة العامة والخدمات الصحية والترويج لها، و لتبادل الاراء و المفاهيم والمعطيات الوبائية ونتائج الابحاث وغير ذلك من المعلومات، و خاصة ما يتعلق منها باقليم شرق المتوسط. وهى موجهة الى كل اعضاء المهن الصحية، والكليات الطبية وسائر المعاهد التعليمية، و كذا المنظمات غير الحكومية المعنية، والمراكز المتعاونة مع منظمة الصحة العالمية والافراد المهتمين بالصحة فى الاقليم و خارجه

La Revue de Santé de la Méditerranée Orientale est une revue de santé officielle publiée par le Bureau régional de l’Organisation mondiale de la Santé pour la Méditerranée orientale. Elle offre une tribune pour la présentation et la promotion de nouvelles politiques et initiatives dans le domaine de la santé publique et des services de santé ainsi qu’à l’échange d’idées de concepts de données épidémiologiques de résultats de recherches et d’autres informations se rapportant plus particulièrement à la Région de la Méditerranée orientale. Elle s’adresse à tous les professionnels de la santé aux membres des instituts médicaux et autres instituts de formation médico-sanitaire aux ONG Centres collaborateurs de l’OMS et personnes concernés au sein et hors de la Région.

The impact of COVID-19 on blood safety and availability in the Islamic Republic of Iran

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.

Adverse events of red blood cell transfusions in patients with sickle cell disease.

Blood transfusion is a common medical intervention for patients with sickle cell disease (SCD) and disease related complications. While patients with SCD are at risk for all transfusion related adverse events defined by the National Healthcare Safety Network (NHSN) Biovigilance Component Hemovigilance Module Surveillance Protocol, they are uniquely susceptible to certain adverse events. This review discusses risk factors, mitigation strategies, and management recommendations for alloimmunization, hemolytic transfusion reactions, hyperviscosity and transfusion-associated iron overload in the context of SCD.

An Outbreak of Japanese Encephalitis Virus in Australia; What Is the Risk to Blood Safety?

A widespread outbreak of Japanese encephalitis virus (JEV) was detected in mainland Australia in 2022 in a previous non-endemic area. Given JEV is known to be transfusion-transmissible, a rapid blood-safety risk assessment was performed using a simple deterministic model to estimate the risk to blood safety over a 3-month outbreak period during which 234,212 donors attended. The cumulative estimated incidence in donors was 82 infections with an estimated 4.26 viraemic components issued, 1.58 resulting in transfusion-transmission and an estimated risk of encephalitis of 1 in 4.3 million per component transfused over the risk period. Australia has initiated a robust public health response, including vector control, animal control and movement, and surveillance. Unlike West Nile virus, there is an effective vaccine that is being rolled-out to those at higher risk. Risk evaluation considered options such as restricting those potentially at risk to plasma for fractionation, which incorporates additional pathogen reduction, introducing a screening test, physicochemical pathogen reduction, quarantine, post donation illness policy changes and a new donor deferral. However, except for introducing a new deferral to potentially cover rare flavivirus risks, no option resulted in a clear risk reduction benefit but all posed threats to blood sufficiency or cost. Therefore, the blood safety risk was concluded to be tolerable without specific mitigations.

Transfusion-Associated Adverse Events: A Case Report of Nurse Hemovigilance and Recognition of Respiratory Distress.

Although blood transfusions are considered a potentially life-saving therapy, noninfectious and infectious adverse events can lead to significant morbidities and even mortality. Vital signs and visual observation of patients during blood transfusions are thoroughly taught in nursing school. Updated terms of hemovigilance and transfusion-associated adverse events ( TAAEs ) are presented through this case study. A patient with factor V deficiency, which requires chronic plasma transfusions, experienced 2 types of TAAEs, anaphylaxis and transfusion-associated circulatory overload. The patient's history and TAAEs are presented and discussed to provide evidence for the importance of vigilant bedside surveillance. Early identification of TAAEs may prevent unnecessary morbidity and/or mortality. The primary nursing functions and responsibilities are presented with algorithmic supplementation to facilitate better understanding of best practice. Ongoing assessment of hemovigilance practices is indicated to ascertain which monitoring tools can lead to optimal patient care.