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Transfusion Serious Hazards of Transfusion Haemovigilance – The UK Experience Paula HB Bolton-Maggs 1 and Hannah Cohen 2 on behalf of the Serious Hazards of Transfusion Steering Group 1. Consultant Haematologist and Honorary Senior Lecturer, University of Manchester; 2. Consultant Haematologist and Honorary Senior Lecturer, Department of Haematology, University College London Hospitals NHS Foundation Trust and University College London, UK Abstract Haemovigilance is an important method for the surveillance of adverse events. The UK Serious Hazards of Transfusion (SHOT) scheme was set up in 1996 and collects adverse events resulting from the transfusion of blood and its components. The information collected is presented at an annual symposium and published in report form, and has resulted in several changes in blood transfusion practices – in the blood services at donor collection, within hospital laboratories and at the patient’s bedside – resulting in improved safety and a reduction in serious events and deaths. SHOT reporting has stimulated many other initiatives, such as national transfusion audit and education strategies, endorsed by the government in order to reduce harm and increase transfusion safety. Keywords Serious Hazards of Transfusion (SHOT), haemovigilance, transfusion safety Disclosure: The authors have no conflicts of interest to declare. Received: 29 February 2012 Accepted: 28 March 2012 Citation: European Oncology & Haematology, 2012;8(2):127–9 Correspondence: Paula HB Bolton-Maggs, SHOT Office, Manchester Blood Centre, Plymouth Grove, Manchester M13 9LL, UK. E: paula.bolton-maggs@nhsbt.nhs.uk ‘Haemovigilance’ is defined by the International Haemovigilance Network (IHN) 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’. 1 An international agreement on the definition of non-infectious adverse transfusion reactions was reached in 2006, and proposals have recently been published. 2 About three million blood components are issued each year to hospitals from the UK transfusion services. Haematologists and other clinicians require reliable information about adverse events to provide an assessment of risk and to develop guidelines. The emergence of serious infectious complications (particularly HIV) in the 1980s and 1990s and anxiety about the possible transmission of variant Creutzfeld–Jacob disease (vCJD) by blood transfusion, together with a suspicion that identification errors were occurring at hospital level (isolated case reports), prompted action. A working group was set up in the UK in 1994 to plan for a UK-wide haemovigilance system, additionally as part of the preparations for the new EU Blood Directive, which would set some standards in EU law (in 2005) for the provision of blood supplies. The working group modelled the new reporting system on other UK confidential enquiries and worked in close cooperation with the Health Protection Agency (HPA), which had started collaborating with the National Blood Services to collect information on viral infections and their transmission by transfusion. The Serious Hazards of Transfusion (SHOT) scheme was introduced in the UK as a confidential haemovigilance scheme in 1996. Many different groups and organisations have some part in the transfusion process, and SHOT reporting has stimulated both new initiatives from and © TOUCH BRIEFINGS 2012 increased collaboration between these partner groups. SHOT is affiliated to the Royal College of Pathologists and is overseen by a steering group, which has wide representation from the UK Royal Colleges and professional bodies as well as from speciality groups involved in blood transfusion. SHOT is independent and professionally led. SHOT analyses data collected over 12-month periods, presenting the results at a national symposium and publishing annual reports (available at www.shotuk.org). The scheme is funded by the four UK blood services (England, Scotland, Wales and Northern Ireland) and is now managed by a team based in Manchester. Initially, hospital haematologists and blood banks participating in the UK national quality assurance scheme for serology were invited to cooperate. When events were reported, a detailed questionnaire was sent out. Since January 2010, the reporters use a web-based system, which is easier for both users and analysts. Reports are reviewed by a clinical incidents specialist or a laboratory incidents specialist, who can then make further enquiries as indicated to ensure that the events are fully reported and appropriately classified. The focus at SHOT has always been on patient safety, therefore report categories include events that put the patient most at risk, particularly ABO-incompatible transfusions. The reported events can be broadly divided into those that are physiological (or pathological) reactions to transfusion (such as acute transfusion reactions or transfusion-related acute lung injury [TRALI]) and those resulting from one or more errors in the transfusion process. Over the years, some categories have been modified; for example, it has been recognised that not all cases with pulmonary symptoms after transfusion have TRALI or transfusion-associated cardiac overload (TACO), but that there is another category for analysis from which we may learn more, i.e., ‘transfusion-associated dyspnoea’ (TAD). Information about cases of TACO has been collected since 2008. In the early years, we did not seek to report events occurring with the administration of anti-D 127