Haemovigilance Systems Research Articles

Stratified analysis of risk factors affecting vasovagal reactions in first-time whole blood donors: A regional multi-center donor hemovigilance data study

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

A national surveillance system for continuous monitoring of blood transfusion safety: German haemovigilance data.

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

Haemovigilance resources available for everyone: A report from the International Haemovigilance Tools Collaborative Project.

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

Guideline on the investigation and management of acute transfusion reactions.

Guideline on the investigation and management of acute transfusion reactions.

Haemovigilance: Giving it our best SHOT!

Haemovigilance: Giving it our best SHOT!

Solving problems in Blood transfusion with efficient technology

Blood transfusion is a life-sustaining procedure. But there are several hurdles in safe blood administration which can cause transfusion transmitted infections (TTI) and acute transfusion reactions and even death. Besides, human errors anywhere in the transfusion chain add fuel to the fire. Blood borne Infections like Hepatitis B and Hepatitis C are highly prevalent in Pakistan affecting about 7.4% of the general population. Among acute transfusion reactions, Febrile nonhemolytic reaction and the allergic reaction are the most common. Moreover, a variety of human errors and near-miss events in transfusion have been reported in the past. Technology has played an important contribution in upgrading the quality of life and healthcare. The main goal of this review is to point out the problems in blood transfusion and to hint at possible solutions with the use of Technology. In addition to following the WHO strategies for safe blood transfusion, blood safety can be ensured by incorporating haemovigilance systems, pathogen reduction technologies and certain approaches to reduce the risk of bacterial contamination. Human errors can be halted via a Management Information System called “Blood Bank Management Information System (BBMIS)” which can recognize and arrest such errors simultaneously.

Adverse reactions following transfusion of blood components, with a focus on some rare reactions: Reports to the International Haemovigilance Network Database (ISTARE) in 2012-2016.

The International Haemovigilance Network's (IHN) ISTARE database collects surveillance data on all adverse reactions (AR) associated with transfusion of blood and blood components, facilitating the sharing of best practice and benchmarking for improving blood safety and quality. Up to 2012, no publications discussed certain rare AR. The aim of this study is to examine ISTARE data on AR from 2012 to 2016, focusing on hypotensive reactions, post-transfusion purpura (PTP), transfusion-associated graft versus host disease (TA-GvHD), hyperkalemia and hypocalcemia. National Haemovigilance Systems (HVS), provided aggregate annual data on AR by type of reaction, severity, imputability to transfusion, and blood component implicated. Twenty-nine HVS provided 104 annual reports covering 107,778,290 blood units issued. Among AR reported, 25% were serious, including 368 deaths. The 284 transfusion-transmitted infections included 187 bacterial infections, 84 viral and 13 parasitic or fungal; nine deaths resulted. AR related to the respiratory system transfusion-associated circulatory overload, transfusion-related acute lung injury and transfusion-associated dyspnoea accounted for 8.3% of all AR, 20.1% of serious, and 52.2% of deaths. Of 1634 rare AR, 1565 were hypotensive, 38 PTP, 17 GvHD, 9 hyperkalemia and 5 hypercalcemia. Half were serious and 16 fatalities were recorded (13 hypotensive, 2 GvHD, one PTP). Among 14 countries that reported any hypotensive AR, incidences diverged widely. ARs in this group are frequently severe or life-threatening. Hypotensive AR are the most common, but may have been overlooked and counted under allergic and other AR presenting with hypotension. Compliance with the ISBT definition may be suboptimal, thus its real incidence may be higher. Data on GvHD may contribute to clarifying the role of leukodepletion with or without irradiation. ISTARE continues to be a useful surveillance tool for all transfusion AR and provides relevant insights into overlooked and rare AR, thus offering important contributions towards maximising transfusion safety.

Vasovagal reactions in whole blood and apheresis donors: a cross-sectional study on donor haemovigilance data from 2016 to 2019 in Italy.

Acute and delayed vasovagal reactions (VVR) are the most frequent adverse reactions (AR) associated with donations. The aim of this study was to provide the data of the Italian donor haemovigilance system and contextualise the VVR data within the international framework, as well as evaluating, among first-time donors, the association of gender and age and the prevalence of VVR compared to other AR. The prevalence analysis was performed on VVR and other AR notified to the Italian haemovigilance system from 2016 to 2019. The analysis on the association of gender and age group and VVR prevalence was performed on first-time donations. The definitions and severity of AR were as set out in the 2014 ISBT/IHN international standards. From 2016 to 2019, 34,519 AR were notified, of which 87.1% were VVR. The overall VVR prevalence was 25.0/10,000 donations and the overall prevalence of other AR was 3.7/10,000 donations. All the estimated prevalences of AR were higher for first-time donations than for regular donations and lower for whole blood than for apheresis donations. No difference was noted between whole blood and apheresis donations for VVR with complications or injuries. The prevalence of AR among first-time donors was higher in females than in males. The prevalence of VVR decreased as donor age increased. The prevalence of VVR related to blood donation was very low and similar to those calculated by other haemovigilance systems. Among first-time donors, the prevalence of AR was higher in females than in males. The higher prevalence of VVR in young donors and a significant decreasing trend by age group confirmed the results reported in the literature. Finally, no trend by age group in first-time donors was observed for other AR to donations.

The international experience of bacterial screen testing of platelet components with automated microbial detection systems: An update.

In 2014, the bacterial subgroup of the Transfusion-Transmitted Infectious Diseases working party of ISBT published a review on the International Experience of Bacterial Screen Testing of Platelet Components (PCs) with an Automated Microbial Detection System. The purpose of this review, which is focused on publications on or after 2014, is to summarize recent experiences related to bacterial contamination of PCs and the use of an automated culture method to safeguard the blood supply. We first reviewed septic transfusion reactions after PC transfusion as reported in national haemovigilance systems along with a few reports from various countries on bacterial contamination of blood products. Next, we reviewed PC automated culture protocols employed by national blood services in the United Kingdom, Australia, Canada and large blood collection organization and hospital transfusion services in the United States. Then, we acknowledged the limitations of currently available culture methodologies in abating the risks of transfusion-transmitted bacterial infection, through a review of case reports. This review was neither meant to be critical of the literature reviewed nor meant to identify or recommend a best practice. We concluded that significant risk reduction can be achieved by one or a combination of more than one strategy. No one approach is feasible for all institutions worldwide. In selecting strategies, institutions should consider the possible impact on platelet components availability and entertain a risk-based decision-making approach that accounts for operational, logistical and financial factors.

Implementation and performance of haemovigilance systems in 10 sub-saharan African countries is sub-optimal

BackgroundHaemovigilance 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.MethodsWe 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.ResultsThe 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.ConclusionsImplementation 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.

Guideline development for prevention of transfusion-associated graft-versus-host disease: reduction of indications for irradiated blood components after prestorage leukodepletion of blood components.

Transfusion-associated graft-versus-host disease (TA-GVHD) is a rare, commonly fatal complication of transfusion preventable by irradiation of blood units. The revision of the Dutch transfusion guideline addressed the question whether irradiation is still necessary if blood components are prestorage leukodepleted. We searched for published cases of TA-GVHD following transfusion of prestorage leukodepleted blood and through contacting haemovigilance systems. Six presumed cases were found, dating from 1998 to 2013. Four out of six patients had received one or more non-irradiated units despite recognised indications for irradiated blood components. In the countries providing information, over 50 million prestorage leukodepleted, non-irradiated, non-pathogen-reduced cellular components were transfused in a 10-year period. Potential benefits of lifting indications for irradiation were considered. These include reduced irradiation costs (€ 1.5 million annually in the Netherlands) and less donor exposure for neonates. Findings were presented in an invitational expert meeting. Recommendations linked to human leukocyte antigen similarity between donor and recipient or intra-uterine transfusion were left unchanged. Indications linked to long-lasting deep T-cell suppression were defined with durations of 6 or 12 months after end of treatment (e.g. autologous or allogeneic stem cell transplantation). Need for continued alertness to TA-GVHD and haemovigilance reporting of erroneous non-irradiated transfusions was emphasised.

Complications of blood donation reported to haemovigilance systems: analysis of eleven years of international surveillance.

The International Haemovigilance Network collects aggregate data on complications of blood donation from member haemovigilance systems (HVS). We analysed the data collected in 2006-2016 in order to learn from it and consider future improvements. National HVS entered annual data on donation complications and on annual whole blood and apheresis donations in the 'ISTARE' (International Surveillance of Transfusion Adverse Reactions and Events) online database. We calculated national and aggregate donation complication rates. Twenty-four HVS provided data for 138 country years (CY; median 7 CY, IQR 2-8), covering 155 M donations. The overall complication rate was 6·3/1000 donations and the median country rate 3·2/1000 (IQR 1·1-10·1). Overall and severe complication rates varied considerably between HVS. Vasovagal reactions (VVR) were most commonly reported: 4·6/1000 donations, median country rate 3·1/1000 donations (IQR 0·6-7·7). Rare complications included generalized allergic reaction (0·10/100000) and major blood vessel injury (category available since 2015; 0·12/100000). Eighteen HVS reported complications of whole blood donation (WBD) and apheresis separately (89 CY, 101·6 M WBD and 26·3 M apheresis donations). The median country VVR rate was 3·4/1000 WBD (IQR 1·0-9·1) and 1·5/1000 apheresis donations (1·0-4·2). Rates of venepuncture-related complications tended to be higher for apheresis: the median country rate of reported haematomas was 0·39/1000 WBD (IQR 0·31-1·2) vs. 4·2/1000 apheresis donations (0·69-5·6). International reporting allows HVS to study rates of blood donation complications and capture information about very rare events. The present variability of reporting and severity assessment hampers comparisons between HVS and requires further work.

Transfusion in limited infrastructure locations – where to go decades after safe blood initiative by World Health Organization?

Transfusion demand in sub‐Saharan Africa is increasing. Establishment of large national blood services seems to be challenging. Hospital blood services maintain the basic supply. However, they lack effective communication networks. Cell phones/internet provides the infrastructure for establishing such networks and could help in establishing haemovigilance systems. Voluntary non‐remunerated donors are the minority of donors (<20%). It seems more appropriate to develop strategies to increase the safety of replacement donor blood instead of insisting on copying Western‐world models. Red cell serology is usually restricted to ABO/Rh‐D and at best Coombs crossmatch. Introduction of antibody differentiation and additional typing for C,c,E,e and K would prevent 60–70% of delayed haemolytic transfusion reactions. One of the most frequent indications for blood transfusion is major haemorrhage. Why is component therapy still recommended for resource‐limited regions, while whole blood is reintroduced in Europe/US for exactly the same indications? Plasma thawed due to electricity failures is usually discarded anyway. Leuco‐depleted products would be beneficial (multitransfused sickle‐cell patients/neonates/AIDS). An ideal blood product could be whole blood, in‐line leuco reduced by gravity filtration, treated by user‐friendly pathogen‐reduction not requiring irradiation/illumination. The transfusion medicine community should form an alliance to develop an affordable, pathogen‐reduced blood product, to train regional auditors and to bring in external expertise to aid knowledge transfer. However, standards to be reached should be defined by the respective national experts who understand the culture and needs of their country. In respectful collaboration, we could learn from each other to finally improve transfusion in resource‐limited regions.

Revised international surveillance case definition of transfusion-associated circulatory overload: a classification agreement validation study

Transfusion-associated circulatory overload (TACO) is a major cause of transfusion-related morbidity and mortality in countries with well developed transfusion services. The International Society of Blood Transfusion, the International Haemovigilance Network, and AABB (formerly American Association of Blood Banks), have developed and validated a revised definition of TACO. International Haemovigilance Network-member haemovigilance systems (Australia, Austria, Denmark, Finland, Greece, India, Ireland, Italy, Japan, Malta, Netherlands, New Zealand, Norway, Slovenia, United Kingdom and United States) provided cases of respiratory complications categorised by their systems, including clinical parameters listed in the 2017 draft definition (part 1). Individual transfusion professionals were then invited to assess 24 case descriptions according to the draft definition (part 2). Positive and negative agreement and inter-rater agreement (κ) were calculated. Based on validation results, cases were reanalysed and slight adjustments made to yield the final 2018 TACO definition. In part 1, 16 (44%) of 36 haemovigilance systems provided 178 cases, including 126 TACO cases. By use of the 2018 definition, 96 (76%) of 126 cases of TACO were in positive agreement. 19 (37%) of 52 cases were recognised as non-TACO respiratory complications. In part 2 (47 experts from 20 countries), moderate all-case agreement (κ=0·43) and TACO-specific agreement (κ=0·54) were observed. Excluding cases missing some clinical information (eg, N terminal pro-brain natriuretic peptide, distinctive chest x-ray findings, and relationship with existing respiratory co-morbidities like pneumonia and chronic obstructive pulmonary disease) improved all-case agreement to κ=0·50 (moderate) and κ=0·65 (good) for TACO cases. The two-part validation exercise showed that the revised 2018 TACO surveillance case definition captures 76% of cases endorsed as TACO by participating haemovigilance systems. This definition can become the basis for internationally consistent surveillance reporting and contribute towards increased awareness and mitigation of TACO. Further research will require reporting more complete clinical information to haemovigilance systems and should focus on improved distinction between TACO and other transfusion respiratory complications. International Society of Blood Transfusion, International Haemovigilance Network, and AABB.

International haemovigilance: what have we learned and what do we need to do next?

The International Haemovigilance Network (IHN) defines haemovigilance as 'a set of surveillance procedures covering the whole transfusion chain (from the collection of blood and its components to the follow-up of recipients), intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent their occurrence or recurrence'. IHN, the International Society of Blood Transfusion and World Health Organization work together to support both developing and established haemovigilance systems. Haemovigilance systems provide valuable data on a range of adverse events related to blood donation and clinical transfusion, from donor syncopal events to transfusion-transmitted infections, immunological complications and the impact of human errors. Harmonised definitions for most adverse reactions have been developed and validated internationally. Definitions of pulmonary complications are again under review. Haemovigilance data have resulted in changes in policy, products and practice, and can complement and inform clinical audit and research, leading to improved blood donor safety, optimised product use and better clinical outcomes after transfusion. However, more work is needed. Not all countries have haemovigilance systems in place. More robust data and careful analysis are required to improve the understanding of the causes, occurrence and clinical outcomes of these events. Wider dissemination of results will facilitate health policy development internationally, and implementation of haemovigilance recommendations will support further important progress in blood safety.

Transfusion-Associated Circulatory Overload: Risks and Prevention

Transfusion-associated circulatory overload (TACO) is one of the leading causes of transfusion associated morbidity and mortality. It occurs in 1 in 5,932 components transfused to 1 in 28,873 components issued in passive haemovigilance systems and 1–11% of patients in active surveillance studies highlighting a significant problem with under-recognition and under-reporting. The International Society of Blood Transfusion definition of TACO is acute or worsening respiratory compromise during or up to 12 hours after transfusion with two or more of the following criteria: evidence of acute worsening pulmonary oedema; evidence of cardiovascular system changes not otherwise explained (tachycardia, hypertension, jugular venous distension, enlarged cardiac silhouette and/or peripheral oedema); evidence of fluid overload; and elevation of B type natriuretic peptide levels to greater than 1.5 times the pre-transfusion value.1 Risk factors include increased age, heart disease or pre-existing heart failure and renal insufficiency.2 The pathophysiology, although likely predominantly due to fluid overload, may also include inflammatory mediators from the transfusion itself. Strategies to mitigate TACO include minimising the volume of transfusion, slowing the rate of transfusion, and potentially the use of diuretics.3 Studies exploring the role of diuretics are underway.

Experience of haemovigilance in Japan

A haemovigilance system was established in Japan in 1993 by the Japanese Red Cross (JRC) headquarters, with the initial purpose of collecting reports of adverse transfusion reactions from medical facilities. Although this is a voluntary reporting system, the JRC, in co‐operation with medical facilities, collects almost all serious adverse reactions caused by blood transfusion. Non‐haemolytic transfusion reactions account for >90% of all reported events and transfusion‐transmitted infection (TTI) account for 5–6%. The JRC haemovigilance system is supported by laboratory analyses conducted in the JRC Central Blood Institute and other laboratories. The JRC collects pre‐ and post‐transfusion blood samples from patients who have experienced adverse reactions. These samples together with repository blood samples obtained from corresponding blood donations are analysed to investigate the pathogenesis of adverse events. Data obtained using these samples are helpful in increasing our understanding of transfusion‐related events such as TTI, transfusion‐related anaphylaxis and transfusion‐related acute lung injury (TRALI). Each country has its own history of establishing blood programmes. The relationship between government, blood facilities, transfusion societies and physicians or clinical fields may differ greatly between countries, and the structure of national haemovigilance systems will differ according to these relationships. Whatever haemovigilance system is established, extensive collaboration and adequate information exchange are essential among stakeholders. Strong leadership by a national transfusion society in addition to legislative measures is required if a comprehensive national haemovigilance system is to be established.

Haemovigilance in China: experiences, challenges and strategies

Haemovigilance (HV) plays an essential role in ensuring the safety of donors and recipients with regard to blood transfusions. China now has annually survey on blood collection and supply, but no national reporting system of AR/AE related to blood transfusion. By 2013, the first guideline on HV in China was released by the Blood Quality Management Committee of Chinese Society of Blood Transfusion (CSBT) and revised in 2015. For blood establishments and hospitals looking for help with setting up new plans or further improving blood transfusion safety, the guideline provides ample information on definitions, methodology and documentation protocols. Based on the guideline, a series of education and promoting programmes was developed in Shanghai and other regions. With the integration of HV into the existing expert symposiums and education courses in the past few years, hundreds and thousands of clinicians and blood bank practitioners got training and the importance of HV were recognized widely, and the principles of nonpunitive principle and learning from errors. In 2017, the working party on haemovigilance of CSBT was set up, which is a milestone for the progress of HV in China. Through the working party, we can study the practices of antecedence countries and learning their experiences, by formulating policies, evaluating modes and mechanisms, compiling standards and guidelines, improving information management and standardization from one region to the other, to establish a national HV systems step by step in China.

The haemovigilance: the best quality management system of the transfusion chain?

Background and ObjectivesHaemovigilance is an integral part of blood safety worldwide. Many haemovigilance systems are already in place or are developing, and national or regional haemovigilance systems have been implemented in several countries. In 2016, the WHO Global Database on Blood Safety reported that national haemovigilance system had been established in 70 countries, among which 38 countries were members of the International Haemovigilance Network by the end of August 2017. In this review, we retrospect the development and current status of haemovigilance to outline its function in transfusion chain.Materials and MethodsThrough contrasting the evolution of haemovigilance definition in different periods, by analysing its scope and breadth, and with the illustrating its achievements and challenges, we retrospect the development and current status of haemovigilance to outline its function in transfusion chain.ResultsHaemovigilance is becoming an important aspect of transfusion medicine,could be used as quality indicator for monitoring the blood transfusion safety, contribute significantly to evidence‐based transfusion medicine and results in improved policies, procedures and practices in the blood transfusion chain.ConclusionsThe scope of haemovigilance may cover the whole transfusion chain, from collection of blood and its components to follow‐up of recipients. Haemovigilance is an essential component of quality management in a blood system and haemovigilance is the best quality management system of the transfusion chain.

Establishment of the Korean haemovigilance system

BackgroundThe first regulation on haemovigilance in South Korea was first established in 1999 by the Blood Management Act. The purpose of this act was mainly focused on management of transfusion‐transmitted infections.AimsA more general form of haemovigilance system was needed for surveillance on the transfusion chain.Materials & MethodsA research funded by the government was initiated in 2007 for development of a haemovigilance system. Review on haemovigilance systems of other countries and development of draft report forms were proceeded on the first year. Pilot operation of the system with 46 voluntary participating institutions was conducted during 2008‐2009 including development of an online reporting system via the website.ResultsThe system was formally launched in a nationwide scale in 2010, financially supported continuously by the government but independently operated by the Korean Society of Blood Transfusion. The program is a centralized, stand‐alone, voluntary reporting, non‐punitive, anonymized, comprehensive system. The number of reporting hospitals and reports submitted has grown every year, with a significant increase after several administrative changes regarding financial incentives and institutional accreditation programs which requested the participation of haemovigilance. Workshops are held for participants every year, and the annual reports can be accessed on the website. Among 215 participating hospitals, 169 reported 3,375 adverse events during the fiscal year 2016.ConclusionWe have successfully operated the program for ten years, including a two‐year pilot study. We hope to further enhance the system qualitatively regarding case validation and standardization of case reporting.