A serious adverse reaction (SAR) is an unintended response or effect in a patient that is associated with the administration of a blood component, may be fatal, life-threatening, disabling or incapacitating or results in prolonged hospitalisation or morbidity.
A serious adverse event (SAE) is any untoward incident associated with the collection, testing, processing, storage and distribution of blood components that might lead to death or life-threatening, disabling or incapacitating conditions that result in prolonged hospitalisation or morbidity.
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). Serious Hazards of Transfusion (SHOT) is the UK’s independent, professionally led haemovigilance scheme, designed to support and encourage the voluntary reporting of serious adverse transfusion reactions, errors and events as well as near-miss incidents. SHOT and MHRA work closely together and have a joint reporting system known as SABRE (Serious adverse blood reactions and events).
This section focuses on the different types of reactions and events, how they can be identified and prevented in the future, as well as the guidance to follow when investigating and reporting such occurrences to conform with regulations and remain compliant.