Information for hospital blood banks during the coronavirus (COVID-19) outbreak
Guidance to hospital blood banks (HBBs) on flexible approaches to requirements
We are working to support hospital blood banks to focus on service continuity during the COVID-19 outbreak, by offering to provide temporary regulatory flexibility in exceptional circumstances.
Blood compliance report
The submission of your blood compliance report is required by 30 April following the reporting year which ended on 31 March 2020.
The reporting period will remain the same i.e. 1 April 2019 to 31 March 2020.
We will apply some flexibility for HBBs that require extra time to submit.
HBBs should email bcr@mhra.gov.uk before 30 April 2020 stating their reason for late submission and proposed target date.
Traceability
HBBs may alter the process and timelines that they currently use to achieve traceability particularly in the follow-up of missing traceability tags. Reliance on NHS Trust non-conformance reporting mechanisms such as Datix may be reduced due to changes in the prioritisation of investigations.
HBBs should risk assess and document any changes in procedure, ensuring that action is taken in response to any identified trend to ensure no adverse impact on traceability.
SABRE
Notification of serious adverse reactions (SAR) and serious adverse events (SAE) via SABRE is expected to take place as soon as possible after their discovery. The safety critical nature of this requirement means that it must remain a priority.
We will take a pragmatic approach to the timelines associated with follow-up investigations and reports where there is no critical need for a prompt follow-up.
However, there must be a mechanism in place to ensure that the investigation of critical issues is prioritised Particular attention should be paid to adverse reactions that may be associated with infection transmission.
Based on the evolving situation with the coronavirus outbreak, this guidance may be subject to further changes.
Send any enquiries to gmpinspectorate@mhra.gov.uk.