From 01 April 2018, MHRA will be changing its approach to inspection notification for hospital blood banks (HBBs).

Following submission of the annual blood compliance report, HBBs will be provided with a letter to confirm that assessment has been completed, without indicating the outcome (i.e. inspection or no inspection). All inspections will be performed with a maximum of 7 daysí notice.

This action is being taken because several MHRA hospital blood bank inspections during 2016 and 2017 identified good practice failures resulting in compliance management escalation, or regulatory action. Failures were often linked to lack of resources and/or failure of management oversight. Indicators suggest that organisations may reduce focus on regulatory compliance until an inspection notification is received.
Performing inspections with a shortened notice period will encourage senior management to focus on maintaining compliance, rather than waiting until notified of an inspection date.

MHRA also plans to publish the outcomes from hospital blood bank inspections. This will act as an educational tool for others, and further highlight the importance of on-going compliance.

Compliance reports and inspections are used to determine an organisationís compliance with the Blood Safety and Quality Regulations 2005 (SI 2005/50, as amended). The Chief Executive of a hospital managed by a health service body (or in the case of an independent hospital the Registered Person) is responsible for compliance. Transfusion laboratory managers are requested to make their Chief Executive / Registered Person aware of this change in practice.