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    Sep 2018

    Control Inspections of Hospital Blood Banks

    Hospital blood banks (HBBs) must send a blood compliance report (BCR) to MHRA every year during April. The BCR is the main tool that is used to assess organisations for risk and to trigger ‘for-cause’ inspections. A list of HBBs to be inspected is produced after assessment of all BCRs and each site selected is given a maximum notice period of 7 days before inspection. The fee for this inspection is currently £2583 per site.

    MHRA also performs control inspections of HBBs to validate the BCR process and to verify that the information provided on the BCR was accurate. An inspection fee is not normally raised for a control inspection. Information will be reviewed during the inspection from the BCR reporting period; if it is found that the BCR did not reflect the true compliance level of the site, then the inspection will be converted to a ‘for-cause’ inspection and a normal inspection fee will be charged.

    HBBs that have been selected as control inspection sites will be informed of this fact during the inspection opening meeting. Where a site has the potential for conversion to a ‘for-cause’ inspection this will be indicated during the closing meeting and confirmed in the Post-Inspection Letter.
    Last edited by Shirley-Stagg; 22nd Oct 2019 at 02:09 PM.

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