Blood Quality Management Programme
- Claudia Pecoraro
European Programme Open to European Blood Establishments Implementation of a Quality Management System (QMS) in European blood establishments is required by EU Directives 2002/98/EC, 2005/62/EC and is prescribed in the Council of Europe's Guide to the Preparation, Use and Quality Assurance of Blood Components. Nevertheless, implementation of a QMS is often regarded as a burden and the concept is not entirely understood, as a consequence of a lack of appropriate on-site support. This was confirmed in a survey performed by the EDQM in 2012. Data collected from 186 blood establishments (33 countries), together with observations during on-site visits, provided evidence of the difficulties encountered in understanding the quality concepts and in implementing requirements and developing an integrated QMS. It also highlighted that the systems being used were mostly blood product quality-oriented. In addition, the use of existing standards and guidelines varies between countries and even within countries. Hence, the development of a Blood Quality Management (B-QM) programme. The B-QM programme started with a pilot phase in April 2012, that was completed in December 2013. Through this pilot, the programme was assessed before moving to a fully-fledged programme. The B-QM programme is aimed at supporting European blood establishments in developing, implementing and improving their QMS and takes into account the specificities of the blood transfusion field. The B-QM Programme is an assistance and educational programme.