A reminder of what information hospital blood banks need to provide to the MHRA

[Shirley-Stagg]

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.

[I.Sullivan]

Hi Shirley

To confirm "Changes to key personnel e.g. blood bank manager, quality manager" report only on the annual BCR form as a significant change? This form only records the numbers and doesn't ask for details. Is this sufficient?

Thanks
Ian

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.

[Shirley-Stagg]

Hi Ian

The BCR does record the blood bank manager (Section E1) and the quality manager (Section G1.1). Any other clarifications of changes that you want to highlight could be described in section U of the form. One of these roles is commonly the main contact for the BCR - where this is the case it would be helpful to advise us of the change by email via bcr@mhra.gov.uk so that we can send you information concerning eg the next BCR.

Regards

Shirley