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.

Activities

• On-site Schemes

Blood Training Visits (B-TVs)

An on-site visit is performed. Training sessions then take place on technical and QMS issues, based on the observed non-compliances.

Blood Mutual Joint Visits (B-MJVs)

These are intended to advise blood establishments and help them implement and/or improve their QMS.

Blood Mutual Joint Audits (B-MJAs)

These check that the implemented QMS complies with the requirements of the standards and regulations to be followed by the blood establishment (minimum standards to be implemented: EU Blood Directives and Council of Europe’s Guide to the Preparation, Use and Quality Assurance of Blood Components).

The B-TVs, B-MJVs and B-MJAs are performed by peers, experts in European blood establishments, who provide and share their experience and knowledge. Four to five schemes are organised each year.

• Training Course and workshops on Quality Management

Training Courses and workshops with the aim to share best practices in the field are organised by the EDQM.

• Quality Management Manual

The EDQM is currently developing a manual on Quality Management Systems for blood establishments. More information will be available in 2020.

Achievements

Since the beginning of the B-QM Programme (April 2012) 28 on-site schemes have been carried out to train Blood Establishment personnel and support the development of Quality Management Systems. It is an encouraging sign that an increasing number of European Blood Establishments are willing to participate in the schemes.

Moreover, several European training courses and conferences have been organised since 2015, in particular:

• European Training Course on Quality Management for European Blood Establishments, 14-17 April 2015, Strasbourg, France
• European Training Course on Quality Management, 27-30 September 2016, Skopje, North Macedonia
• European Conference on Sharing best practices: quality risk management, change control, validation and qualification in Blood Establishments, 17-19 October 2017, Strasbourg, France
• European Training Course on Statistical Process Control (SPC) for Blood Establishments, 23-24 October 2018, Strasbourg, France