Biobanks play a valuable role in maintaining research integrity through provision of high-quality biospecimens and data to investigators. Grizzle et al. (2015) explore the aspects of a robust quality management system (QMS) that need to be in place, using experience gained at two institutions to show how this approach adds to biobank value.1
A QMS is a managerial tool that includes quality control with other operational procedures, such as standard operating policies (SOPs), to ensure consistent operations. It is similar to procedures in place at analytical laboratories where regular audits and benchmarking ensure that assays and other procedures present valid quantitative data. In these cases, laboratory managers have a system for regular calibration of instruments, assay performance monitoring and participation in recognized standards schemes for external verification.
Grizzle et al. present QMS protocols in place at the University of Alabama at Birmingham Tissue Collection and Biobanking Facility (UAB TCBF) and at a government institute, the Centers for Disease Control (CDC). Both facilities operate biobanks, with UAB TCBF holding primarily solid human biosamples and the CDC banking and analyzing human biofluids. As biobanks, they ensure access to high-quality research materials by paying close attention to key areas such as biospecimen collection and storage, processing, sample quality control, data recording, and labeling through SOPs, staff training and facilities monitoring.
Having noted in previous studies that solid tissue biospecimens may not adequately reflect research needs through misdiagnosis, poor sampling and other processing errors, the study authors advise verifying submissions before inclusion. This is especially required for rare tumors that are difficult to diagnose. Other measures available include DNA/RNA analysis for tissue quality and analysis of mirror image sections for appropriate architecture, cell infiltrates and interpretation.
Grizzle et al. advise standardizing collection with SOPs created for specific tissues, covering duration of cold ischemia, collection vessel, time to storage and other important factors that can affect sample integrity. SOPs for this and other areas of biobanking should be updated regularly. However, managers should keep archives so that reference can be made to all stages of a biosample’s storage within the facility.
The authors also note that planning sample collection avoids haphazard and random tissue storage. In this way, biobankers will collect relevant tissues for research use and match these with appropriate controls from age- and population-matched controls. Using this approach minimizes the influence of bias on analysis of results.
Staff training is also an important part of a robust QMS to ensure compliance with SOPs and best practices for consistency. Training covers all aspects of biobank activity, including sample collection, animal care where appropriate, environmental monitoring and so on. Daily, weekly and monthly systems for recording these variables form an important history of biobank integrity that is available if users identify inconsistencies in subsequent studies.
Associations and groups such as ISBER (International Society of Biological and Environmental Repositories), NCI (National Cancer Institute) and CTRNet (Canadian Tumor Research Network) offer guidelines on developing a QMS with advice and templates available online for managers. Biobanks can also gain appropriate accreditation, thus improving trust from the research community. Grizzle et al. believe that having an effective QMS in place is necessary for biobanks to provide high-quality research materials and data.
1. Grizzle, W.E., at al. (2015) “Quality management of biorepositories,” Biopreservation and Biobanking, 13 (pp.183–94). doi: 10.1089/bio.2014.0105.