Friday, November 19, 2004

TraQ has been following the UK's response to the EU Blood Directive, which extends regulation of the blood system from blood suppliers to hospital blood banks. This is similar to the situation in Canada, in which CSA Z902-04 Standards will eventually become government regulations that impact hospital transfusion services.

The UK Dept. of Health has now called for Public consultation on The Blood Safety and Quality Regulations 2005

Although the EU Directive does not specifically require accreditation, licensing or inspection of hospital blood banks, it does make them subject to several articles, including those concerning

  • PersonnelQuality Management
  • Quality system and DocumentationHaemovigilance - Traceability & Notification of serious adverse events and reactions
  • Quality and Safety of Blood and Blood Components - Storage, transport and distribution conditions
  • Data protection and confidentiality

In Canada, we do not yet know which Z902-04 clauses will become government regulations but it will be interesting see how closely they mirror the EU Directive approach. For more information, see TraQ's backgrounder on the EU Directive


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