Part Two of our Protecting Complete Chain of Custody Series
As we discussed in our last post, the Role of Biobanking in Protecting Sample Chain of Custody, biobanks serve as biospecimen libraries as well as sample data, validation, and reference sources for both research and clinical labs. Like any part of a controlled process, establishment of a quality management system (QMS) ensures congruency between different sites so that users can have confidence in a uniform standard. Proper control and documentation of sample and data chain of custody are central to these technical standards.
What challenges does a biobank face?
Biobanks are often embedded in clinical biology labs that receive samples from a wide variety of sources outside of the lab. Variability in the packaging and nature of these samples, as well as the way they were collected, is common. Containers used for collection may not be compatible with processing/analysis techniques or in-lab automation which increases the possibility of handling errors.
After sample acceptance, workflow uncertainty increases as the clinician must now choose a processing technique. Novel biospecimens require exploratory methods that may have never been performed at the specific biobank or may have been adapted from an existing method to fit sample needs; neither scenario provides validation for the method unless there are also quality control (QC) materials to assess processing consistency and acceptable analytical data ranges for reporting.
Finally, proper conditions for storage must be determined to ensure that samples remain as close as possible to their native (in vivo) state. Throughout the sample lifecycle there are many challenges to quality and integrity.
Additionally, as genomics technology improves, experiments tend to require increased analytical resolution. Biospecimens that are valuable due to a rare collection population or pathology may become obsolete if they do not meet the integrity or quality requirements of these future experiments. We’ll take a closer look at “future-proofing” samples in our final post. For the scope of this discussion, QMS based on technical standards and experientially-based best practices promote harmonization and mitigate total risk to biospecimens and data provided by biobanks.
What technical standards apply to biobanks?
There are numerous national and international regulatory and professional organizations that have established standards governing different aspects of biobanking. While there is no one universally agreed upon accreditation or QMS, compliance with the below standards is generally accepted to establish credibility for biobanks:
- For consistency and competence of the biobank:
- ISO 20387:2018 Biotechnology-Biobanking-General requirements for biobanking
- For critical preanalytical steps:
- CEN/TS 16826-1:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue. Isolated RNA.
- CEN/TS 16826-2:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue. Isolated proteins.
- CEN/TS 16826-3:2018 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue. Isolated DNA.
- For traceability:
- SPREC (Standard PREanalytical Code Version 3.0) published by the International Society for Biological and Environmental Repositories (ISBER)
- For methods:
- ISO/CD 21899 Biotechnology-Biobanking-General requirements for the validation and verification of processing methods in biobanks
Whether you want to store samples with a biobank or give users confidence in the samples that you store, the above standards represent key advisory elements protecting complete chain of custody.
What are some best practices to improve biospecimen chain of custody?
In addition to compliance with the above QMS, there are additional practices that biobank site managers can implement to optimize the repository functions over the progressive sample lifecycle of collection, extraction, and storage:
- 1. Collection
- Consider maximal use of primary samples, considering even undefined applications for downstream analysis
- Ensure proper management of temperatures and timelines for sample transport
- 2. Extraction
- Utilize efficient processing/extraction technologies to improve yield and quality
- Establish protocols for nucleic acid amplification/cell line establishment to create a renewable resource and preserve primary sample and/or precious collections
- 3. Storage
- Define storage formats and temperatures to maximize storage infrastructure (tubes and automation for better handling)
- Determine needs for appropriate distribution guidelines based on specific downstream applications to preserve sample resources
Use of automated processes spans the entire sample lifecycle and ensures the highest confidence in both control and documentation. Use of 2D or tri-coded barcode tubes in conjunction with scan-in/scan-out tracking and validation simplifies the handling of thousands of samples through a laboratory information management system (LIMS). These identifiers are carried throughout the lifecycle of a sample to maintain high sample quality.
Quality management systems and best practices enable harmonization of data as well as reduce batch and temporal effects to samples. Controlling and documenting the influx and storage of thousands of biobank samples is best achieved through automated technologies for sample collection, extraction, and storage.
In our final post, we’ll take a look at how to effectively Store Biospecimens for the Future even if those needs are as yet unknown
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