14/15 December 2021
This new guidance for blood establishments, should support the establishments in the root-cause analysis in case of non-satisfactory external quality assessment results. In this case, blood establishments means, "Any structure or body that is responsible for any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage and distribution if intended for transfusion. This does not include hospital blood banks." Participating in External Quality Assessments (EQA) programmes plays an important role in line with an effective Quality Management. That such EQAs are more or less mandatory components of the QMS is shown in different directives and state-of-the-art publications like the European Union Commission directive 2005/62/EC (which implements the directive 2002/98/EC (defining the community standards and specifications to a quality system for blood establishments)), EDQM's Good Practice Guidelines for blood establishments and hospital blood banks from 2017 or the European Directorate for Quality of Medicines and HealthCare (EDQM)/Council of Europe's Guide to the preparation, use and quality assurance of blood components, 19th ed. 2017.
In the introduction of the new guidance, the Proficiency Testing Scheme (PTS) was introduced as suitable programme for the measurement of the laboratory performance: "Participation in PTS provides laboratories with an objective means of assessing and demonstrating
the reliability of the data they are producing. Thus for PTS studies the participants are asked to use their routine methods, rather than being prescribed the use of a common method, as is done in certain collaborative studies. Proficiency testing covers the overall performance of a laboratory. This includes the whole process from receipt and storage of the samples, to the experimental work in the laboratory, the interpretation and the transcription of the data and conclusions onto the reporting sheet. Failure at any stage of this process affects the proficiency of the laboratory."
The guidance document includes the following parts:
The target of the presented document is defined by the authors as followed: "Although the present document provides information on the
general management of a Non-Conformity (NC), , it primarily aims at guiding laboratories of blood establishments on root-cause analysis of an unsatisfactory result and/or performance that may occur in a PTS study."
More details about the background and for guidance can be found directly in the "Guidance for root-cause analysis of non-satisfactory external quality assessment results".