Does Your Biorepository Follow ISBER Best Practices Recommendations?
Biorepositories provide essential support to biomedical researchers by collecting, processing, storing and distributing millions of biospecimens every year. Biorepository staff must navigate complex international regulatory rules governing the use of biospecimens and protected health information. The International Society for Biological and Environmental Repositories (ISBER) aims to make this easier with it’s comprehensive Best Practices Recommendations for Biorepositories.
While ISBER Best Practices are voluntary, these guidelines help biorepositories comply with regulatory rules and accreditation requirements. More importantly, ISBER Best Practices help biorepositories maintain high-quality biospecimens and data that is fit for the specific purpose.
ISBER’s Best Practice: Repositories should develop a complete records management system to track all repository operations.
Comprehensive biobanking management software, such as laboratory informatics Management Systems (LIMS), can help biorepositories implement best practices and ensure they comply with international regulatory guidelines such as HIPAA, 21 CFR Part 11, GDPR and ISO 20387:2018.
Quality Management
Any variation in biospecimen quality can negatively affect experimental results. Therefore, biorepositories face the challenge of maintaining biospecimen integrity and quality, often over long time periods. A robust quality management system, including quality assurance (QA) and quality control (QC) will allow biorepositories to preserve biospecimen quality.
ISBER’s Best Practice: Tissue quality is fundamentally tied to processing conditions (e.g., ischemia times, time to processing, fixation type/duration, time to storage) which may impact downstream applications and should be closely monitored and recorded as part of the quality management program.
Standard Operating Procedures (SOPs) are a central part of any quality management system. ISBER Best Practices that biorepositories write SOPs for all processes, train staff on those SOPs and review documents periodically. Biorepositories can use SOPs to standardize biobanking methods and minimize any variation in biospecimen quality.
A biobanking LIMS provides a central platform to store, update and access SOPs. Biobanking LIMS also allow biorepositories to track and document staff training.
Quality Assurance and Quality Control
QA and QC include validating and qualifying all instruments, reagents, and methods to ensure they perform to an acceptable standard. Once equipment and protocols are validated, biorepository staff should make regular and standardized QC measurements, for example measuring a set of analytes to test the quality of fluid samples, or assessing cell viability in cell lines. Staff should also report any protocol or quality deviations.
ISBER’s Best Practice: The repository should have a procedure for periodic verification of the inventory and associated data. Random sampling from each storage unit using a predefined acceptable quality level can be used for QC purposes.
Documentation of QA/QC processes is a regulatory requirement in certain countries. A fully compliant biobanking LIMS allows staff to easily document all aspects of quality management and facilitate internal and external audits.
Biospecimen and Data Security
Biorepositories are required by law to maintain strict security when storing human biospecimens and associated data.
Best practices for biospecimen security include using barcodes to uniquely identify biospecimens, track location by saving their storage locations as well as freeze-thaw cycles, implementing 24/7 facility monitoring and alarm systems, and having controlled or tiered access to biospecimens and data.
ISBER’s Best Practice: Arrangements should be made to store all critical records at a remote location, potentially with an off-site data security company.
Data security best practices include backing up data on a remote secure server and controlling user and role based access to records.
ISBER’s Best Practice: Physical and electronic access to records and documents should be restricted and assigned based on roles; authorizations for access should be documented and available for audit.
Secure, cloud-based biobanking LIMS platforms ensure privacy and complete data security with user authorization and tiered access, built-in firewalls and encrypted data storage and transmission.
Safety and Training
Ensuring staff safety is a very important part of managing a biorepository. Safety measures include appropriate infrastructure, staff training, use of personal protective equipment (PPE), risk assessments, and SOPs. Best practices include training staff in all procedures and maintaining a training file for each staff member. Training can also minimize any protocol deviations or variations in biospecimen quality.
ISBER’s Best Practice: Training associated with SOPs should be maintained in a training record.
Biorepositories can easily document all training and safety programs using biobanking LIMS.
Conclusion
Comprehensive documentation allows biorepositories to run effective quality management systems, maintain biospecimen quality, and comply with regulatory requirements. To meet regulatory and accreditation requirements, biorepositories must utilize many different types of documents including training documents, informed consent forms, material transfer agreements and other procurement records, equipment maintenance records, and notes on sample handling and storage conditions.
ISBER’s Best Practice: Follow Good Documentation Practices as per the appropriate Quality Management System and regulatory requirements.
Biobanking LIMS offers a convenient, centralized platform to store and manage all biorepository documents. Compliant LIMS also make it easy for clients to follow Good Documentation Practices.
References
- 10 Largest Biobanks in the World. Biobanking.com. 2018
- EU Regulations for Biobanks. CloudLIMS. 2020
- Regulatory Requirements for Biobanks. CloudLIMS. 2020
- Biobanking Science: ISBER Best Practices for Biobanks. Biobanking.com. 2018
- Campbell et al. The 2018 Revision of the ISBER Best Practices: Summary of Changes and the Editorial Team’s Development Process. Biopreserv and Biobank. 2018
- National Cancer Institute Best Practices for Biospecimen Resources (Online) Available at: https://biospecimens.cancer.gov/bestpractices/
- https://freelims.org/industries/biobanking-lims-software.html
Note: Shonali contributed this article from her professional capacity. The views expressed do not necessarily represent the views of ISBER and do not imply endorsement of any product or service.
