Quality Control Proficiency Testing Scheme (QCPTS-WG)

Biological parameters of blood products are very different compared to the physiology, making it challenging to find suitable quality controls. The aim of the working group is to lead and co-ordinate a collaborative scheme of inter-laboratory testing to demonstrate the equivalence of the procedures between laboratories. The group also aims to compare new or established analytical procedures and to highlight difficulties or deficiencies in their performance.

Objectives and activities

In 2020, the French National Blood Service (EFS) initiated a four-stage pilot phase to evaluate the logistical coordination and financial viability. Each stage featured a single lab preparing and sending samples to fellow participants. To further refine the process, a second phase took place in 2022, featuring four new stages organized by various labs from Belgium, Luxembourg, and France.

Key factors, such as hemoglobin, hematocrit, red blood cell hemolysis, and platelet concentration in platelet concentrates, were examined. Detailed reports were generated for each stage, with a thorough statistical analysis of the results, including robust mean estimation, Z-score calculation, and bias evaluation.

Remarkably, even with differing transport conditions across countries, the inter-laboratory testing proved feasible. In 2022, 21 quality control labs from 11 countries participated in four stages, with three countries coordinating the exchanges. Four assessment reports were published by the organizing parties.

The inter-laboratory testing scheme’s success highlights its potential to enhance blood product quality control methods. For 2023, the plan is to explore additional parameters and pursue long-term goals, such as benchmarking through surveys on diverse subjects, including sampling methods and statistical process control monitoring of production processes.