Definitions in haemovigilance: guiding principles and current state of development of international reference definitions

Abstract

Background Haemovigilance systems capture data on adverse reactions and infections in recipients of blood transfusions as well as on errors and incidents in the transfusion chain. The objective is to analyse them and make recommendations for improving transfusion safety. Many haemovigilance systems also collect data on complications in blood donors with a view to monitoring and improving blood donor safety. Standardized definitions are necessary for classifying and comparing data in all these domains and at all levels.Method Since 2004, at international meetings of blood transfusion professionals, members the International Haemovigilance Network (IHN) and the haemovigilance working party of the International Society for Blood Transfusion (ISBT) have collaborated in developing and validating definitions for non-infectious transfusion complications, errors and incidents in the transfusion chain as well as adverse reactions in blood donors. From 2012, contacts with other groups including the World Health Organisation (WHO) have been put in place to ensure wide consultation as well as awareness and use of the definitions. ResultsStandardized definitions have been published for recipient adverse reactions, for complications of blood donation and for a limited number of types of incident in the transfusion chain. The ISBT haemovigilance working party and IHN are committed to ensuring that the definitions remain up-to-date and that revisions and improvements are conducted with wide consultation of professionals in relevant organizations worldwide. The haemovigilance working party and working party on transfusion-transmitted infections are collaborating on the development of definitions and criteria for assessing suspected transfusion-transmitted infections.Conclusion Internationally agreed definitions are available for registration and surveillance of complications of blood donation and most types of adverse reaction in patients receiving blood transfusions. For errors and incidents in the transfusion chain, further work is necessary to improve comparability of data between haemovigilance systems.

Adverse transfusion reactions in patients with aplastic anaemia or myelodysplastic syndromes

“…Lastly, its imputability was evaluated as definite (certain), probable (likely), possible, unlikely (doubtful) or excluded. Using standardized definitions , it was possible to obtain comprehensible and relevant comparisons from different haemovigilance systems . These definitions were used in this study.…”

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

“…It is also clear that there is substantial under‐reporting. For over a decade, international collaborative activities have been underway to develop and validate robust, practical and internationally recognised definitions (Wiersum‐Osselton et al, ; Goldman et al, ). These are now widely used by professional, policy and regulatory authorities internationally, as well as haemovigilance systems.…”

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

“…Collaboration in haemovigilance has been achieved by networking systems and experts in new or existing organizations, such us the IHN, the ISBT Working Party on Haemovigilance and the WHO. With the concerted and tremendous efforts of all sides, standard definitions of ‘recipient adverse reactions’, ‘complications of blood donation’, ‘a limited number of types of incident in the transfusion chain’, ‘noninfectious hazards’ and the international haemovigilance database (ISTARE project) have been developed .…”

“…There are several challenges that can affect the implementation of haemovigilance such as (1) variation in terminology and definitions: the umbrella term ‘adverse event’ is problematic , the variant definition of the term between different systems is disadvantageous to standardization of definition and its usage, it is very necessary to find an alternative umbrella term. The term of ‘side‐effect’ is suggested and used in our haemovigilance system, thus the definition of ‘side‐effect’ contains ‘adverse event’ and ‘adverse reaction’, while ‘adverse reaction’ defines as an unintended response in donor or in patient associated with the collection or transfusion of blood or blood components, but ‘adverse event’ defines as any untoward occurrence of transfusion chain unrelated to human response/injury, which contain incident, error and near miss.…”