A reminder of whatinformation hospital blood banks need to provide to the MHRA

Hospital Blood Banks arerequired to report any changes that might affect their compliance with the requirements of the Blood safety and Quality Regulations 2005 (As amended).These should be reported immediately via gmpinspectorate@mhra.gov.uk.

It would be helpful if the following changes were reported to bcr@mhra.gov.uk :

  • Changes to company or NHS Trust (where the blood bank is sited), e.g. a merger of Trusts
  • Changes to main contact for the BCR
  • Changes to the organisation that manages the hospital blood bank, e.g. the formation of a pathology partnership

Other significant changes should be noted on the annual bcr:

  • Changes to laboratory systems e.g. analysers or LIMS
  • Changes to key personnel e.g. blood bank manager, quality manager

All changes must of course be introduced via a formal change control process.