Blood Proficiency Testing Scheme (B-PTS)
The purpose of the Blood Proficiency Testing Scheme (or B-PTS) programme is to improve the safety of blood components, plasma-derived medicinal products, organs and tissues and cells, and therefore protect patients receiving blood transfusions, undergoing a transplant or benefitting from medically assisted reproduction.
European Union legislation and the Good Practice Guidelines (GPG) in the Council of Europe’s Guide to the preparation, use and quality assurance of blood components and Guide to the quality and safety of tissues and cells for human application require blood testing laboratories to participate in external quality assessment (EQA) initiatives such as PTS programmes, which are also recognised as an important aspect of any quality management system (QMS).
Seven B-PTS studies are organised every year.
The EDQM designs and organises B-PTS studies according to the principles laid out in ISO/IEC 17043:2023 Conformity assessment – General requirements for the competence of proficiency testing providers.
The B-PTS programme is set up and implemented by the European Directorate for the Quality of Medicines & HealthCare (EDQM), the Council of Europe directorate responsible for numerous essential healthcare programmes, this initiative has been assisting European blood establishments since 2010 and, since 2025, laboratories performing testing on living organ, tissue and cell donors. It is co-funded by the EDQM and the European Commission.
All European blood establishments and laboratories performing testing on living organ, tissue and cell donors from European Union and Council of Europe member states may participate in B-PTS studies.
Note: The four serology studies, as well as the NAT study, are open to laboratories performing testing on living organ, tissue and cell donors.
In 2025, an average of 68 laboratories participated in each B-PTS study, covering 29 countries from the Council of Europe and European Union. The 7 B-PTS studies carried out in 2025 were:
- B-PTS081 Bacterial testing of platelet components
- B-PTS082 HBV/HCV/HIV NAT
- B-PTS083 Anti-HCV
- B-PTS084 HBsAg/Anti-HBc
- B-PTS085 Anti-Treponema
- B-PTS086 Anti-HIV/p24
- B-PTS087 ABO Rhesus, extended phenotyping and irregular antibodies
More information about ordering and shipments here.
Inscriptions HERE
Practical implementation guidance document
Root Cause Analysis of non-Satisfactory quality assessment results (2017)
The electronic version of this Guide can be downloaded for free online.
Leaflet
