Biobank Quality Management in the BBMRI.be Network

Abstract

From as early as 2005, different guidelines and quality standards covering biobank activities and sample handling methods have been developed to improve and guarantee the reproducibility of biomarker research. Ten years on, the BBMRI.be Quality working group wanted to gauge the current situation of these aspects in the biobanks of the BBMRI.be network. To this end, two online surveys were launched (fall 2017 and fall 2018) to the biobank quality managers in the BBMRI.be network to determine the status and setup of their current quality management system (QMS) and how their QMS and related practices have evolved over a 14 month time period. All biobanks addressed by the two surveys provided a complete response (12 and 13, respectively). A QMS was implemented in 85% of biobanks, with 4 standards emerging as primary basis. Supplementary guidelines were used, with a strong preference for the ISBER best practices for biobanks. The Standard Preanalytical Code-an indicator of the preanalytical lifecycle of a biospecimen impacting the downstream analysis results-was already implemented in 50% of the biobanks while the other half intends future implementation. To assess and maintain the quality of their QMS, 62% of biobanks used self-assessment tools and 71% participated in proficiency testing schemes. The majority of biobanks had implemented procedures for general and biobank specific activities. However, policies regarding the business and sustainability aspect of biobank were only implemented in a limited number of biobanks. A clear desire for a peer-review audit was expressed by 69% of biobanks, with over half of them intending to implement the recently published biobank standard ISO20387. Overall, the biobanks of the BBMRI.be network have actively implemented a solid quality approach in their practices. The implementation of ISO 20387 may bring further professionalization of activities. Based on the needs expressed in this survey, the Quality working group will be setting up an audit program for the BBMRI.be biobanks, to enhance, harmonize and streamline their activities. On the whole, the biobanks in the BBMRI.be network are able to substantially contribute to translational research, as a primary facilitator guaranteeing high quality standards and reproducibility.

Keywords: BBMRI.be; ISO 20387; QMS; audit; biobank; quality; survey.

Figure 1

The set-up and composition of human body material collections in biobanks of the BBMRI.be network. Responses were divided by the nature of the human body material collection (collection with a disease orientation, population-based or on environmental ground), by the method of collection of the material (systematic i.e., by sampling at occasions within the clinical path of the patient or project-based i.e., by sampling in the framework of a specific study/project at pre-defined and study-based time points) and by the type of use as defined in the Belgian legislation (primary use: the use to which the donor has explicitly consented to at the time of collection; secondary use: any other use than the one consented to at the time of collection; residuary material: the portion of human bodily material that has been taken from the donor for diagnostic or treatment purposes which, when a sufficient sample is safeguarded for refinement or completion of these purposes, is superfluous to these purposes and as such could be destroyed—presumed consent applies).

Figure 2

Quality standards or guidelines used as primary basis for the quality management system of the biobanks in the BBMRI.be network. Participants were asked to select the standard or guideline used as primary basis for their QMS from a list of nine standards/guidelines (ISO 9001, ISO 15189, ISO 17025, ISO 20387, CMI QMS Guidelines, BWB QMS Guidelines, ISBER Best Practices, OECD Recommendations for Biorepositories, French Biobanking standard NF S96-900). Only one option could be selected. Only four standards/guidelines were indicated by the responders to be used as primary basis for QMS systems, as displayed in the figure. QMS, quality management system.

Figure 3

Use of self-assessment tools in biobanks in the BBMRI.be network in 2017 and 2018. Participants were asked to indicate from a list which self-assessment survey (SAS) tools were used in their biobank to assess the status of the overall quality management system (BBMRI-ERIC QMS—general requirements and ISBER SAS), the compliance to standard specifications for pre-examination processes (CEN/TS aggregated: 10 individual SAS tools developed by BBMRI-ERIC, participation in one or more of these SAS tools was considered as 1 positive reply), the overall quality status of the pre-analytical processes (ISBER EQAS) or awareness of factors in tissue collection, processing and storage that may impact sample quality (CM Path Biobanking SQIT). Black bars indicate participants' responses in 2017, gray bars indicate participants' responses in 2018. CEN/TS, European Committee for Standardization Technical Standards; EQAS, pre-analytical external quality assessment survey; SQIT, CM-Path Biobanking Sample Quality Improvement Tool.

Figure 4

Implementation status of general procedures in the quality management system in biobanks in the BBMRI.be network. Participants were requested to indicate for each item in a list of general procedures/items whether these were fully implemented (brown), in preparation (orange) or not available (lime-green). The items listed were collected and aggregated from the ISBER best practices for biorepositories, the ISO 20387 and ISO 9001 standards. All participants responded to all items listed. The list of items asked is displayed in the X-axis.

Figure 5

Implementation status of biobank specific procedures in biobanks in the BBMRI.be network. Participants were requested to indicate for each item in a list of specific procedures/items whether these were fully implemented (brown), in preparation (orange), not available (lime-green), or not applicable (dark green). The items listed were collected and aggregated from the ISBER best practices for biorepositories, the ISO 20387 and ISO 9001 standards. All participants responded to all items listed. The list of items asked is displayed in the X-axis.

Figure 6

Overview of systems used to support activities in biobanks in the BBMRI.be network. Participants were asked to indicate in a list for which supportive tools for the QMS an electronic system was implemented (brown), a paper-based system was implemented (orange), an electronic system was in preparation (lime-green), a paper-based system was in preparation (dark green), or no system was available (petrol blue). All participants responded to all items listed. The list of items asked is displayed in the X-axis.

Figure 7

Certification intentions biobanks in the BBMRI.be network. Participants were asked to indicate which if any certification/accreditation they intended to acquire within 2 years. Black bars show participants' responses in 2017, gray bars show participants' responses in 2018. All participants responded to all items listed.