Implementing new blood safety regulations in the UK

In the UK the NHS Operational Impact Group (OIG) has released its final report on implications of the new regulations on transfusion services, including financial implications. It's fascinating and it's now on TraQ.

For example, they have decided that some activities currently done by hospital transfusion labs might be classified as "processing" under the new regulations and therefore can only be carried out by licensed "Blood Establishments" (blood suppliers - their National Blood Service) after 8 Nov. 2005. Processing includes pooling cryoprecipitate, irradiating components, splitting components, and washing red cells.

The result is that either hospital transfusion services will need to get licensed (like the blood supplier) or else the NBS has to do all the processing for them. There are also other implication for traceability, quality systems, training, and hemovigilance.

TraQ has been following events in the UK related to implementing the EU blood directive because Canada is in a somewhat similar situation. The main difference is that the Canadian standard that affects transfusion services (CSA Standard Z902-04) is not yet regulation. The Canadian Society for Transfusion Medicine (CSTM) has also revised its standards for hospital transfusion services to provide a user friendly equivalent of the CSA standards.

Resources:

• TraQ's backgrounder on the EU directive

• UK OIG report
  
  

• Backgrounder on Canadian standard (CSA Z902-04) (pdf)
  

Cheers, Pat

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