JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

5.1: Haemovigilance

Haemovigilance is the ‘systematic surveillance of adverse reactions and adverse events related to transfusion’ with the aim of improving transfusion safety. Transfusion reactions and adverse events should be investigated by the clinical team and hospital transfusion team and reviewed by the hospital transfusion committee. SHOT invites voluntary reporting of serious adverse transfusion reactions, errors and events as well as near-miss incidents. Under the Blood Safety and Quality Regulations 2005 (BSQR) there is a legal requirement to report serious adverse reactions and events to the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA also inspects blood establishments (transfusion centres) and hospital transfusion laboratories to ensure their processes and quality standards comply with the BSQR. SHOT and MHRA work closely together and have a joint reporting system through the SABRE IT system (http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyproblems/Blood/).

Haemovigilance can identify transfusion hazards and demonstrate the effectiveness of interventions. SHOT reporting highlighted the importance of transfusion-related acute lung injury (TRALI) as a potentially lethal risk of transfusion and confirmed the benefit of sourcing fresh frozen plasma (FFP) from male donors. More recently, transfusion-associated circulatory overload (TACO) has been identified as an important preventable cause of death or major morbidity. Incidents of avoidable, delayed or under-transfusion are increasingly reported, leading to initiatives to improve the knowledge base of clinical staff and awareness of evidence-based guidelines.

Adverse effects of transfusion are commonly classified as infectious or non-infectious; acute or delayed; caused by errors or pathological reactions; and by their severity (mild, moderate or severe).