What we regulate: Blood

The Regulations set the standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components.

The Principal Regulations require and provide for:

• Blood establishments (primarily the national blood services of England, Wales, Scotland and Northern Ireland - the “UK Blood Service”) to be authorised and inspected, a process very similar to the existing arrangements operated by the MHRA under the Medicines Act.  The Regulations define a blood establishment as an organisation which collects and tests blood and blood components, whatever their intended purpose; and processes, stores and distributes blood and blood components when they are intended for transfusion.
• Hospital blood banks to establish systems for quality management and haemovigilance1 and the MHRA to have powers to monitor compliance.
  A hospital blood bank is defined in the Regulations as any unit within a hospital which stores and distributes and may perform compatibility tests on, blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities. The Regulations do not require authorisation or routine inspection of blood banks. However, inspections of blood banks “for cause” may be carried out by the MHRA. Blood banks or blood establishments that are operating as blood banks are required to submit an annual return to the department setting out how they comply with the requirements of the Regulations.
• Blood establishments and hospital blood banks to report to the MHRA  any serious adverse events or serious adverse reactions related to blood and blood components.

1 Haemovigilance comprises a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients and the epidemiological follow-up of donors.