Click here to download (pdf) report
The EU directive has now become law and the deadline for implementation is the 8th November 2005. Organisations, including hospital, not complying with the directive by then could face fines or criminal charges.
This directive sets standards for quality and safety for collection, testing, processing, storage and distribution of human blood and blood components. This directive specifies certain technical requirements for blood and blood components and for quality management systems, traceability and notification of adverse events.
The key areas are of impact for hospitals are:
To comply with this directive is going to require hospitals to invest resource and start addressing all the areas of the law immediately – the 8th November is not far away. Organisations can not opt in or out of the law, compliance is compulsory and will be monitored by the MHRA.
Hospitals must have total traceability of the fate of each unit of blood and retain that information for 30 years.
- Quality systems
Hospital Transfusion Laboratories must have a comprehensive quality system in place.
- Processing activities
Some activities currently conducted by Hospital Transfusion Laboratories are regarded as ‘processing activities’ under the new regulations and can only be done by licensed Blood Establishments.
- Training, education and communication
The regulations requires the provision of training for Hospital Transfusion Laboratory staff.
The MHRA is chairing a group that is working on serious adverse event/reaction reporting, and separate guidance will be issued in due course.
A copy of the NHS Operational Impact Group report which includes recommendations for consideration by DH and MHRA is available here