The European testing scheme open to European Blood Transfusion Laboratories
The Blood Proficiency Testing Scheme (B-PTS) is a form of External Quality Assessment (EQA) that uses inter-laboratory comparisons to determine the performance of Blood Establishments laboratories responsible for the testing of individual blood donations. This scheme supplements each laboratory's own internal quality control procedures by providing an external measure of their testing capabilities.
Participation in EQA programmes such as proficiency testing studies, has been recognised as an important factor in Quality Assurance. This principle is laid down in EU blood legislation (Directive 2002/98/EC and Directive 2005/62/EC), more recently in the Good Practice Guidelines (GPG) and the CoE’s Guide to the Preparation, Use and Quality Assurance of Blood Components.
Participation in the scheme provides laboratories with an objective means to assess and demonstrate the reliability of their data. This helps to build mutual trust between European Blood Establishments, which is an important element of an effective common system for the testing of blood donations.
Six B-PTS studies are organised each year.
Who organises the Scheme?
The EDQM organises, co-ordinates and manages the scheme. The EDQM designs and organises the activity according to "ISO/IEC 17043:2010 Conformity Assessment - General Requirements for proficiency testing".
The B-PTS Advisory Group (B-PTS AG), who is composed of experts in the field, is supporting and advising the EDQM in several steps of the activity. The activity is run under the aegis of the European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS).
The activity is funded both by the Council of Europe/EDQM and the European Union and implemented by the Council of Europe/EDQM.
Who can participate?
Following registration, any European Blood Establishment (BE) laboratories of member countries and observers countries to the CD-P-TS in charge of the testing of individual blood donation can participate.
Achievements in 2019
In 2019, an average of 56 laboratories participated in each B-PTS study, covering 29 countries from the Council of Europe and European Union. The 6 B-PTS studies carried out in 2019 were:
- B-PTS043 HBV/HCV/HIV NAT
- B-PTS045 Anti-HCV
- B-PTS046 Anti HIV/p24
- B-PTS047 Anti-Treponema
- B-PTS048 HBsAg/Anti-HBc
- B-PTS049 ABO Rhesus, extended phenotyping and irregular antibodies