Quality management

The quality of biospecimens is crucial for the success of biomedical research.

The comprehensive quality programme of the German Biobank Node (GBN) supports biobanks on their way to an accreditation according to the biobanking standard DIN EN ISO 20387.

Quality assurance

In cooperation with the BioMaterialBank Heidelberg (BMBH), the Integrated Biobank Jena (IBBJ) and the BioBank Dresden (BBD), GBN regularly conducts proficiency tests with partner biobanks of the German Biobank Alliance (GBA). Both tissue and liquid biosamples are analysed. With proficiency tests, the biobanks check the quality of their samples and thus their processes – from sample receipt and storage to derivative preparation and analysis.

Proficiency tests

with different sample types

Schritt 1: Preparation and shipping

The organisers send biosamples to all participating biobanks
of the German Biobank Alliance (GBA).

Schritt 2: Processing

The biobanks process the samples according to their standard operating procedures and in accordance with the specifications in the proficiency test.

Schritt 3: Packing and return shipment

Afterwards, they send the samples back again - as instructed.

Schritt 4: Evaluation

The organisers check the samples and evaluate the corresponding data.

Schritt 5: Feedback

They discuss the results individually with the biobanks and suggest improvements to them.

The results of the proficiency tests allow a cross-network learning process: methodological competence at the local level is strengthened and at the same time an optimisation of processes is achieved.

Tissue proficiency tests

In order to minimise or ideally eliminate the influence of preanalytical processes on the quality of human tissue samples, GBN established tissue proficiency tests for GBA biobanks in close cooperation with its Heidelberg partner in 2017. Both fresh and frozen tissue samples are used for this purpose. The focus is on sample acceptance, freezing of fresh tissue, sectioning and staining techniques, as well as extraction and analysis of nucleic acids. An independent reference laboratory verifies the measured parameters. 

The proficiency tests allow to objectively assess the process-related performance of the participating biobanks, uncover potential for improvement and harmonise the corresponding processes. For example, an increase of the RNA yield from cryogenic tissue has been achieved across all partner sites. The concept of the GBA tissue proficiency tests consists of consistent modules for quality assurance and a variable module that takes results from the previous proficiency test into account.

PBMC proficiency test

In light of the Corona pandemic, peripheral blood mononuclear cells (PBMCs) have become highly relevant for biobanks. In order to assess the viability and functionality of PBMCs, GBN organised a  proficiency test for 12 GBA biobanks in collaboration with the Integrated Biobank of Luxembourg (IBBL) in 2020. The workflow was defined by GBN in cooperation with the BioBank Dresden (BBD). The results have enabled the participating biobanks to improve their processes. 

Biomarkers for quality assurance

The Integrated Biobank Jena (IBBJ) conducted a systematic review to select promising quality indicators (QIs) reflecting the variation of preanalytics in human blood (serum, EDTA plasma). To verify the selected QIs, IBBJ investigated the impact of critical preanalytical parameters, such as the time to centrifugation (TTC) or the time to freeze (TTF) of biospecimens, in a multicentere pilot  proficiency test. In order to be able to assess sample quality in existing and new sample collections, a suitable QI panel was compiled on the basis of these results, which is now being validated and applied within  proficiency tests.

The first proficiency test using this QI panel to assess sample quality took place in 2021.

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