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Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management
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Biobank Quality Management in the BBMRI.be Network.

Loes Linsen1, Veronique T'Joen2, Catherine Van Der Straeten2

  • 1Biobank, University Hospitals Leuven, Leuven, Belgium.

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|July 12, 2019
PubMed
Summary

Biobanks in the BBMRI.be network have established robust quality management systems (QMS) and preanalytical standards to ensure reproducible biomarker research. Future implementation of ISO 20387 and peer-review audits will further professionalize biobanking practices.

Keywords:
BBMRI.beISO 20387QMSauditbiobankqualitysurvey

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Area of Science:

  • Biobanking and Translational Research
  • Biomarker Discovery and Validation
  • Quality Management Systems in Healthcare

Background:

  • Reproducibility in biomarker research is crucial and relies on standardized biobanking practices.
  • Guidelines and quality standards for biobanks have evolved since 2005 to address these needs.
  • The BBMRI.be Quality working group aimed to assess the current state of quality management in their network's biobanks.

Purpose of the Study:

  • To determine the status and setup of Quality Management Systems (QMS) in BBMRI.be biobanks.
  • To evaluate the evolution of QMS and related practices over a 14-month period.
  • To identify areas for improvement and future harmonization of biobanking activities.

Main Methods:

  • Two online surveys were conducted in Fall 2017 and Fall 2018, targeting biobank quality managers within the BBMRI.be network.
  • Surveys assessed the implementation of QMS, adherence to standards (e.g., ISBER, Standard Preanalytical Code), self-assessment tools, and proficiency testing.
  • Inquiries also covered policies on business/sustainability aspects and interest in peer-review audits and ISO 20387 adoption.

Main Results:

  • 85% of biobanks have implemented a QMS, primarily based on four key standards, with ISBER best practices frequently adopted.
  • The Standard Preanalytical Code was implemented in 50% of biobanks, with plans for wider adoption.
  • 62% utilized self-assessment tools, and 71% participated in proficiency testing; however, business and sustainability policies were less common.

Conclusions:

  • BBMRI.be biobanks demonstrate a strong commitment to quality, with established QMS and preanalytical procedures enhancing research reproducibility.
  • A significant interest exists in adopting ISO 20387 and implementing peer-review audits for further professionalization and harmonization.
  • The BBMRI.be Quality working group will establish an audit program to support and streamline biobank activities, bolstering their contribution to translational research.