European Blood Safety Directives
The following extract is taken from the UK Blood Transfusion and Tissue Transplantation Guidelines website:
Two
EU Directives - 2002/98/EC and 2004/33/EC have been transposed into UK law through the Blood
Safety and Quality Regulations 2005 (Statutory Instrument 2005/50 and Statutory
Instrument 2005/1098). The regulations came into force on 8 February 2005 and
have to be implemented by 8 November 2005. An amendment to the regulations came
into force on 8 April 2005. The regulations set standards for quality and safety
for the collection, testing, processing, storage and distribution of human blood
and blood components, aspects of the regulations apply to ‘blood establishments’ (the
UK Blood Services) and Hospital Blood Banks.
Appropriate records are maintained
within Health Boards / Health Authorities / Trusts. With regard to records which
permit the traceability of blood from donor to patient (or final fate if not
transfused) the following data items need to be available and accessible for
30 years:
- Donation number
- Component type
- Blood establishment which provided the blood component
- Date provided
- Identity of patient who received the blood component or final fate if not transfused.
Health Boards / Health Authorities / Trusts shall determine how this
requirement is met e.g; by entry into a computer database at ward or in the blood
bank or by making a record available which is stored separately from the patients
notes, possibly in the blood bank, to facilitate storage for 30 years.
The following extract is taken from the NHS Operational Impact
Group (OIG) Report on the impact of the EU Blood Safety and Quality regulations
2005 on Hospital transfusion Laboratories:
We believe that only electronic blood tracking systems that support data retrieval and improve the clinical transfusion process will provide total assurance on traceability.
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