Download report (pdf)
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.
A copy of the NHS Operational Impact Group report which includes recommendations for consideration by DH and MHRA is available here.