The compliance report and declaration forms for Hospital Blood Banks and Blood Facilities (01st April 2018 to 31st March 2019) are now available on the MHRA website as below and must be completed and submitted by 30th April 2019.

Please note that late submissions increase the risk score applied to the site.

Changes have been made to the submission process for 2019 BCR and Blood Facility Declaration Form to have separate mailboxes. Please read below.

For hospital blood banks, it is a requirement to complete the compliance report and the declaration form. A change in approach to blood compliance report assessment was introduced during 2015 which saw a removal of the majority of questions requiring free-text responses. You will note that some sections are not available or some question numbers do not appear to be in order in some sections. Please ensure all the available questions on the BCR are answered and submit your completed BCR as outlined in the 2019 Hospital Blood Bank Compliance Report Guidance Notes. The guidance notes have been revised to include detailed instructions and clarification to some of the questions. Please read the guidance note prior to completing the BCR.
Hospital blood banks should submit their completed BCR and Hospital Blood Bank Declaration Form to with email subject heading ‘Full Hospital Name – BCR 2019’.
(Please ensure the email includes 1 BCR and the declaration form for that hospital name, with additional information related to the blood bank ONLY. Do not send multiple BCR and declaration forms within the same trust in one email)

For blood facilities, the blood facility declaration form must be completed and sent to the MHRA at a separate mailbox with email subject heading ‘Full facility name – DEC 2019’.
(Please ensure the email only includes 1 Blood Facility Declaration Form for that facility name. The Declaration Form should be signed and dated, and submitted after 01 April. This is to confirm the reporting year of 01st April 2018 to 31st March 2019 is covered. Any declaration form submitted before 01 April will be deleted, resulting in no submission.)

Following the BCR assessment, Hospital Blood Banks will be provided with a BCR Assessment Confirmation Letter to confirm that assessment has been completed, without indicating the outcome (i.e. inspection or no inspection). The level of compliance determined will be used to inform the inspection programme for 2019/2020. The Hospital Blood Banks selected for inspection will be contacted by the inspectors to arrange a date. All inspections will be performed with a maximum of 7 days’ notice.

A compliance letter, confirming the operations are accepted as in general compliance with the requirements of the BLOOD SAFETY AND QUALITY REGULATIONS 2005/50 as amended, will be sent to the “no inspection” sites in April 2020.