Quality management at the national biobanking level – establishing a culture of mutual trust and support: the BBMRI.at example

Helmuth Haslacher; Michaela Bayer; Heidelinde Fiegl; Marlene Gerner; Philipp Hofer; Melanie Korb; Sabrina Neururer; Thomas Perkmann; Katharina Plattner; Karine Sargsyan; Eberhard Steiner; Cornelia Stumptner; Ingrid Walter; Monika Wieser; Andrea Wutte; Oswald Wagner; Kurt Zatloukal

doi:10.1515/cclm-2019-0491

Published by De Gruyter June 7, 2019

Quality management at the national biobanking level – establishing a culture of mutual trust and support: the BBMRI.at example

Helmuth Haslacher , Michaela Bayer , Heidelinde Fiegl , Marlene Gerner , Philipp Hofer , Melanie Korb , Sabrina Neururer , Thomas Perkmann , Katharina Plattner , Karine Sargsyan , Eberhard Steiner , Cornelia Stumptner , Ingrid Walter , Monika Wieser , Andrea Wutte , Oswald Wagner and Kurt Zatloukal

From the journal Clinical Chemistry and Laboratory Medicine (CCLM)

https://doi.org/10.1515/cclm-2019-0491

Showing a limited preview of this publication:

Keywords: audit; biobank; harmonization; pre-analytical phase; quality management system

Corresponding author: Helmuth Haslacher, MD, PhD, MSc, BSc, BA, Department of Laboratory Medicine, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria, Phone: +43 1 40400 53190, Fax: +43 1 40495 15547

Acknowledgments

This work was supported by the Austrian BMWFW (GZ 10.470/0016-II/3/2013, BBMRI.at). We would like to thank all members and supporters of BBMRI.at for their valuable contribution. The authors declare that they have no conflict of interest.

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

References

1. Freedman LP, Cockburn IM, Simcoe TS. The economics of reproducibility in preclinical research. PLoS Biol 2015;13:e1002165.10.1371/journal.pbio.1002165Search in Google Scholar PubMed PubMed Central

2. Lippi G, Betsou F, Cadamuro J, Cornes M, Fleischhacker M, Fruekilde P, et al. Preanalytical challenges – time for solutions. Clin Chem Lab Med 2019;57:974–81.10.1515/cclm-2018-1334Search in Google Scholar PubMed

3. Davis E, Hampson K, Bray C, Dixon K, Ollier W, Yuille M. Selection and implementation of the ISO9001 standard to support biobanking research infrastructure development. Biopreserv Biobank 2012;10:162–7.10.1089/bio.2011.0044Search in Google Scholar PubMed

4. Lyon HO. News from the Biological Stain Commission, no. 16. Biotech Histochem 2015;90:231–8.10.3109/10520295.2014.1000969Search in Google Scholar PubMed

5. Seemann TL, Nybo M. Continuous quality control of the blood sampling procedure using a structured observation scheme. Biochem Med (Zagreb) 2016;26:337–45.10.11613/BM.2016.037Search in Google Scholar PubMed PubMed Central

6. International Organization for Standardization. Standards catalogue 11.100.10 – in vitro diagnostic test systems. Available at: https://www.iso.org/ics/11.100.10/x/. Accessed: 13 May 2019.Search in Google Scholar

7. Neururer SB, Hofer P, Gobel G. An IT-supported evaluation tool for biobanks based on international guidelines to improve the biosample quality. Stud Health Technol Inform 2016;223: 46–53.Search in Google Scholar

8. Zatloukal K, Stumptner C, Kungl P, Mueller H. Biobanks in personalized medicine. Expert Rev Precis Med Drug Dev 2018;3:265–73.10.1080/23808993.2018.1493921Search in Google Scholar

9. Holub P, Swertz M, Reihs R, van Enckevort D, Muller H, Litton JE. BBMRI-ERIC Directory: 515 biobanks with over 60 million biological samples. Biopreserv Biobank 2016;14:559–62.10.1089/bio.2016.0088Search in Google Scholar PubMed PubMed Central

10. International Organization for Standardization. ISO 20387:2018 Biotechnology – Biobanking – general requirements for biobanking. Geneva: ISO; 2018.Search in Google Scholar

Received: 2019-05-13

Accepted: 2019-05-14

Published Online: 2019-06-07

Published in Print: 2019-11-26

Quality management at the national biobanking level – establishing a culture of mutual trust and support: the BBMRI.at example

Acknowledgments

References

Journal and Issue

Articles in the same Issue