Blood products
What is a blood product?
A blood product is any therapeutic substance derived from human blood and plasma-derived medicinal products (PDMPs). These are regulated under the Human Medicines Regulation 2012. Incidents involving Blood Products are reported through the YC system. Blood and blood components are defined as transfusable components that can be derived from donated blood and include red cell concentrates, Platelets, plasma, cryoprecipitate, and granulocytes and are regulated under the Blood Safety and Quality Regulations (BSQR) (2005 as amended)/. Blood, blood components and blood products are therefore regulated under completely different regulations.
Incidents related to blood products
Incidents involving the transfusion of blood and blood components and issues regarding blood donations are regulated to be reported under the Blood Safety and Quality Regulations (BSQR) and not the Yellow Card system.
As part of this regulated process NHS Trusts and Health Boards are mandated to report these incidents to the Medicines and Healthcare products Regulatory Authority (MHRA). To ensure that the Trusts and Health Boards follow their regulatory responsibility please raise this incident through the Trust or Health Board complaints process. If your incident occurred during a blood donation, please raise a complaint through the local blood services complaints process.
For blood, blood component transfusions please raise a complaint with your local Trust or Health Board. Information on how to do this is on the local hospitals website.
How to report blood donation incidents
To report an incident related to blood donation, please use the appropriate link for the country of incident below: