Regulations & Implementation

European Blood Safety Directives / Blood Safety and Quality Regulations (BSQR)

Two EU Directives - 2002/98/EC and 2004/33/EC have been transposed into UK law through the Blood Safety and Quality Regulations 2005 (Statutory Instruments 2005/50, 2005/1098 and 2006/2013). The regulations came into force on 8 February 2005 and where implemented on 8 November 2005. An amendment to the regulations came into force on 8 April 2005.

The regulations set standards for quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, aspects of the regulations apply to 'blood establishments' (the UK Blood Services) and Hospital Blood Banks.

The Blood Safety and Quality (amendment) Regulations 2006/2013 further amend the BSQR 2005 (SI 2005/50) ("the principal regulations") to make a number of changes to the provisions governing the operation of blood establishments (establishments which collect, process and test human blood and blood components) and hospital blood banks (hospital units which store, distribute, and perform compatibility tests on, blood and blood components for use in hospitals). These changes relate specifically to traceability requirements and notification of adverse reactions and events and introduce Community standards and specifications relating to a quality system for blood establishments.

All links to the EU Directives and the UK Blood and Quality Regulations (BSQR) can now be found in the UKBTS Document Library.

Since producing the report on the impact of the Blood Safety and Quality Regulations 2005 the NHS Operational Impact Group is continuing their work by:

  • Reviewing clarification issues with the MHRA. The results of these are available under 'Clarifications'

  • Providing support to hospital transfusion laboratories with information being posted on the "toolkit"

  • Providing feedback from sites that have been inspected by the MHRA. Click here to follow link.