Quality Management (QM) at BBMRI.at is a key competence
Activities of BBMRI.at and its partners include:
- Development of ISO standards and CEN Technical Specifications for sample-pre-analytics and overview on latest standards of this series
- Implementation of these standards
- Provide information about existing and upcoming standards relevant to biobanking
- Contribution to the development of a BBMRI Self-Assessment-Tool for pre-analytical processes
- Free access to the online Self-Assessment Surveys for testing the state-of-the-art of pre-analytical processes
- Quality Management cross audits in BBMRI.at partner biobanks
- Quality Management trainings
- Videos & presentations about the relevance of pre-analytics and ISO/CEN standards with respect to in-vitro dagnstic regulation (IVDR) and reproducibility/reliability of research results
- Publications about the relevance of pre-analytics and ISO and CEN standards with respect to IVDR and reproducibility/reliability of research
- Information on why sample quality and respective standards are essential for research and development
- Customer Satisfaction Survey Template for biobanks
Several BBMRI.at partners have QM systems in place and are ISO certified. All BBMRI.at partner biobanks have committed themselves to handling biological samples from patients and research study participants according to state-of-the-art procedures, i.e. CEN and ISO standards like those for pre-examination processes.
Standard series “Molecular in vitro diagnostics – specifications for pre-examination processes”
The European Committee for Standardization (CEN) and the international Standard Organisation (ISO) published standards for the pre-analytics of biospecimens that are intended for molecular analysis. Representatives of BBMRI.at have contributed to the deveopment of these standards, which was in part done in the context of the EU Project SPIDIA4P. They describe requirements for the pre-analytical phase and are considered as state-of-the-art for pre-analytical workflows.
These standards can be purchased at Standards Institutes like the Austrian Standards Insitute (ASI).
Quality Management System Standards
- EN ISO 20387:2020 Biotechnologie – Biobanking – Allgemeine Anforderungen an das Biobanking
- EN ISO 20387:2018 08 15 Biotechnology — Biobanking — General requirements for biobanking
ISO and CEN standards are considerted state-of-the-art and good scientific practise for basic and translational research.
Particularly the pre-analytical phase is a very critical phase of the analysis workflow. Errors can easily occur during all pre-analytical steps like labeling, sample collection, transport, processing, storage, DNA/RNA isolation etc. Pre-analytical errors have turned out to be a major cause why promising results in biomarker research fail in the process of validation, as data were not reproducible on a large scale. Also in diagnostics pre-analytical variables can lead to unreliable or wrong test results.
Therefore, pre-analytical sample quality – a pre-requisite for reliable and reproducible analyses results – is important.
ISO and CEN standards
The European Committee for Standardization (CEN) and the international Standard Organisation (ISO) have taken up this issue and published standards for the pre-analytics of biospecimens that are intended for molecular analysis. They describe requirements that are considered as state-of-the-art for pre-analytical workflows.
Does your lab meet the pre-analytical CEN/TS & ISO Standards’ requirements?
To find out use the BBMRI Self-Assessment Surveys for
- General Requirements for Biobanking; ISO 20387:2018
- Frozen tissue – Part 1: Isolated RNA; ISO 20184-1:2018
- Frozen tissue – Part 2: Isolated proteins; ISO 20184-2:2018
- FFPE tissue – Part 1: Isolated RNA; ISO 20166-1:2018
- FFPE tissue – Part 2: Isolated proteins; ISO 20166-2:2018
- FFPE tissue – Part 3: Isolated DNA; ISO 20166-3:2018
- Venous whole blood – Part 1: Isolated cellular RNA; ISO 20186-1:2019
- Venous whole blood – Part 2: Isolated genomic DNA; ISO 20186-2:2019
- Venous whole blood – Part 3: Isolated ccfDNA from plasma; ISO 20186-3:2019
- Metabolomics in urine; CEN/TS 16945:2016
Documentation of pre-analytical data is state-of-the-art and good scientific practice
Several CEN/TS and ISO standards for pre-examination processes exist that require the documentation of pre-analytical data from human specimens and samples. Also the In Vitro Diagnostics Regulation explicitly mentions pre-analytics and requires pre-analytical data in the technical documentation for in vitro diagnostic devices.
In order to support researchers in their efforts to optimize their pre-analytical workflows, BBMRI.at in collaboration with SPIDIA4P (H2020, grant no. 222916), Biobank Graz, and CyBiobank (H2020 grant no. 8571222) developed a software template for the documentation of pre-analytical data. It is based on REDCap as IT framework and on the ISO Standards (ISO 20184-1:2018; ISO 20184-2:2018) as source for pre-analytical requirements.
Download free software template for pre-analytical frozen tissue
The software can be downloaded as file and shall serve as a template that can be adapted by the users (familiar with REDCap) to local / individual needs. How the installed software and data entry mask for frozen tissue looks like is to be seen here.
Together with BBMRI-ERIC experts from BBMRI.at and many other BBMRI-ERIC National Nodes have developed a template for a Biobank User Satisfaction Survey. This survey template is now availabe for biobanks and can be accessed via the Open Science Platform Zenodo.
The BBMRI-ERIC user satisfaction survey template is intended to help biobanks to have their services evaluated by their users on a regular basis and to collect feedback regarding future needs for services as well as suggestions for improving biobank processes. In this way, they comply with the requirement to seek feedback, for example, in ISO standards 20387:2018 and ISO 9001:2015. The survey template, of which members from BBMRI.at are recognized co-authors (C Stumptner, H Haslacher), is the basis for the user survey and must be individually adapted by each biobank before it can be used to assess user satisfaction. To support this process, the document also includes an implementation guide.