Each year, approximately two million blood components are issued annually in the United Kingdom, and the vast majority are given safely without any adverse effects or events.

The Serious Hazards of Transfusion (SHOT) hemovigilance scheme collects and analyses data regarding serious adverse events (SAE) and serious adverse reactions (SAR) of blood components transfused in the United Kingdom.

Haemovigilance is the systematic surveillance covering the whole transfusion chain from collection of blood (components) to follow-up of its recipients. It assesses information on undesirable transfusion effects to prevent their occurrence.

SHOT work collaboratively with Medicines and Healthcare Products Regulatory Agency (MHRA). Under the Blood Safety and Quality Regulations 2005 (BSQR) there is a legal requirement to report serious adverse reactions and events to the MHRA.

There is a legal requirement to report Serious Adverse Reactions (SAR) and Serious Adverse Events (SAE) to the Medicines & Healthcare Products Regulatory Agency (MHRA) via the online reporting system Serious Adverse Blood Reactions & Events (SABRE).

Incorrect Blood Component Transfused (IBCT) as defined by SHOT (2019): There are two definitions included in this reporting category: 'wrong component transfused' (WCT) and specific requirements not met (SRNM).

IBCT encompasses:

• Wrong component transfused (WCT)
• Specific requirements not met (SRNM)
• Avoidable, delayed or under/over transfusion (ADU)
• Handling and storage errors (HSE)
• Right Blood Right Patient (RBRP)
• Laboratory errors
• Anti-D errors
• Near miss events (NM)
  • A near miss is an error or deviation from standard procedures or policies that is discovered before the start of the transfusion and that could have led to a wrong transfusion or a reaction in a recipient if transfusion had taken place
• Pathological reactions
  • Examples include Febrile, allergic and hypotensive reactions (FAHR), Haemolytic Transfusion Reactions (HTR) – these may be acute or delayed, and Transfusion Associated Circulatory Overload (TACO). Most of these constitute a serious reaction which also requires to be reported to MHRA.

What is major morbidity?

Admission to ICU or HDU, life threatening reactions, or sensitisation to D or K red cell antigen.