In Focus
Standing on the shoulders of giants
The origins and development of the ISBT Haemovigilance Working Party
In the early 1990s, after a decade of concern about transfusion-transmitted HIV and hepatitis, improved data collection and analysis systems were needed for such transmissions and new blood-borne infections. By the mid-1990s, haemovigilance systems were established. In France, hospitals reported every post-transfusion event, regardless of severity or transfusion-relatedness, using a network of rapporteurs and a hierarchical reporting structure
However, public dissemination was limited, and formal recommendations were rare. In contrast, the UK introduced the Serious Hazards of Transfusion (SHOT) scheme in 1996, anticipating the EU Blood Directives. SHOT was clinician-led and aligned with other national confidential reporting systems for peri-operative and obstetric mortality. It focused on major patient events, including immunological and infectious complications, and included “wrong blood to patient” incidents due to errors in the transfusion pathway. The scheme aimed to publish annual reports with data analyses, case vignettes, and practice improvement recommendations.
These contrasting models demonstrated that haemovigilance systems inevitably reflect national governmental requirements and must integrate with existing regulatory frameworks and healthcare structures. Consequently, global haemovigilance systems were likely to evolve in diverse forms, complicating international comparisons and potentially leading to incomplete coverage.
Recognizing this, the ISBT established a haemovigilance working group composed of transfusion specialists worldwide to provide professional guidance for countries developing their own systems.
The group’s objectives included:
- Defining a minimum set of transfusion complications to be monitored. Initial priorities focused on major recipient complications in three categories: infections, errors, and immune reactions such as transfusion-related acute lung injury (TRALI) and transfusion-associated graft-versus-host disease (TA-GvHD). Monitoring of donor complications was often introduced later as systems matured.
- Advising on investigative criteria to establish diagnoses and attribute complications to transfusion, including evidence required to confirm transfusion-transmitted infection (TTI), clinical and radiological indicators for TRALI, and whether reporting should include near-miss events.
- Promoting awareness among clinicians involved in prescribing and administering transfusions and encouraging a no-blame culture to maximize reporting.
- Supporting the development of safety recommendations based on collected evidence to enhance protection for both patients and donors.
The involvement of ISBT at this formative stage ensured that clinicians played a central role in shaping national haemovigilance arrangements, helping to keep patient and donor safety as the primary focus of haemovigilance activities.
Pierre Robillard
Pierre served as chair of the Working Party from 2004 to 2011. During this time, he strongly promoted the development of standardized definitions for transfusion reactions. This effort culminated at the Cape Town meeting in 2006, when — partly in jest — he remarked that no one would leave the room until consensus had been reached (a comment that was taken rather seriously by some of our European colleagues).
Over this period, he also established close collaborations with the ISBT TTI Working Party, joining it as a member in 2005, and with the European Haemovigilance Network — later the International Haemovigilance Network (IHN) — to support the harmonization of definitions.
Jo Wiersum
Jo became active in the Working Party in 2006. During the Cape Town meeting, she spent an entire day working to clarify the distinctions between near misses, events, incidents, and reactions, ultimately producing the diagram that remains part of the non-infectious transfusion reaction document today. She later served as secretary before taking over as chair at the Lisbon ISBT meeting in 2011.
Serving as chair was both rewarding and demanding. It was an adventure because of the many outstanding colleagues Jo had the opportunity to engage with, but maintaining momentum in the group’s activities required considerable effort. In one of documents — the definitions and tools framework — she strongly recommended that definitions should be reviewed every few years. However, after tackling a single definition (TACO) and spending five years on it, we would now phrase that recommendation more cautiously.
Kevin Land
When Kevin assumed the role of Chair of the ISBT Haemovigilance Working Party in 2015, the group had already established strong foundations in defining and classifying transfusion-related adverse events. His focus was to build on this work by extending international harmonization into donor haemovigilance, where differences in terminology and classification continued to limit the ability of individual systems to learn effectively from one another.
During his tenure (2015–2020), the Working Party completed and validated the first internationally harmonized set of donors haemovigilance definitions. A central aim of this effort was to promote the use of shared terminology, recognizing that consistent language enables haemovigilance systems not only to compare data, but also to interpret experiences, identify patterns, and apply lessons learned across borders.
He collaborated closely with organizations like AABB, ICCBBA, SHOT, WHO, and IHN to promote these standards and support national haemovigilance programme development. He was particularly impressed by the global response during validation, as haemovigilance systems submitted standardized case studies and detailed feedback. Their willingness to share real-world experience was invaluable, strengthening the definitions and ensuring they were practical, relevant, and widely applicable.
As donor definitions were validated across various haemovigilance systems, the Working Party identified key areas needing further harmonisation. Notably, the experience emphasised the need for more consistent approaches to severity scoring and imputability determination. These insights, derived from the validation process and extensive case-based feedback from participating programmes, guided the Working Party’s focus and informed the priorities of the next chair, Mary Townsend.
He also focused on education and capacity building, organising workshops and training in Africa and Asia, and publishing information on donor and recipient safety. This period saw a shift from defining measurement to strengthening international haemovigilance system learning. The progress made was a collective effort, built on previous chairs’ work, to support future efforts.
Mary Townsend
I assumed the role of Chair in 2020 following Kevin Land. Throughout my term, my aim was to build on Kevin’s work by advancing efforts related to the Definitions while also supporting the development of new haemovigilance initiatives.
A key foundation for this work was the 2014 Standard for Surveillance of Complications Related to Blood Donation, developed collaboratively by AABB, ISBT, and the IHN, and adopted by those organizations as well as the European Blood Alliance (EBA). Building on this framework, a joint initiative began in 2018 to develop a Severity Grading Tool for Adverse Donor Events. The ISBT HV WP reviewed the proposed tool for adoption as an addendum to the 2014 standard, and it was ultimately approved by all participating organizations. This work culminated in the publication by Townsend et al., Development and validation of donor adverse reaction severity grading tool: enhancing objective grade assignment to donor adverse events.
Another significant initiative arose from international collaboration inspired by the WHO Aide-Mémoire supporting countries implementing haemovigilance programmes. In December 2020, more than 20 experts from IHN, ISBT, WHO, and partner organisations formed a working group that met weekly over several months to review existing materials and compile a consolidated resource set.
This effort resulted in the publication of the WHO User Guide for Navigating Resources on Stepwise Implementation of Haemovigilance Systems in 2022. The associated materials were assembled on the ISBT HV WP webpage and made freely accessible to support capacity building. To maintain and expand this repository, the Working Party established a dedicated HV Tools Management Group responsible for ongoing review and updates — now a routine element of its activities. Several additional initiatives were launched during my term as chair:
- Regular Working Party newsletters (approximately quarterly).
- The Imputability Project, led by then-Secretary (now Chair) Gopal Patidar, aiming to standardise the assessment of imputability for adverse events.
- Development of a short educational video (approximately five minutes), jointly sponsored and branded by ISBT, IHN, and AABB.
- Collaboration with the Paediatrics Working Party to define approaches to TACO risk assessment.
- Contribution of multiple articles to the April 2022 issue of Transfusion Today.
Serving as Chair of the ISBT HV WP was a highlight of my career. I had the privilege of working with exceptional colleagues, collaborating across organisations and regions, and contributing to the advancement of haemovigilance globally. I hope that the work undertaken during this period continues to strengthen haemovigilance systems worldwide. I know I leave the WP the capable hands of Gopal Patidar.
