Biobanking is the process of collecting, storing, managing, and sharing biological samples (such as blood, tissue, and DNA) along with associated data (like clinical information) for use in research and clinical care. At first glance, biobanking could seem simple enough to handle with an Excel spreadsheet. However, managing and accurately tracking these samples and their data can be challenging. In this blog, we’ll explore how a Laboratory Information Management System (LIMS) specifically tailored for biobanking can help overcome these challenges, paving the way to success for your biobanking facility.
Biobanks often store hundreds of thousands, or even millions, of samples at one time. They consist of a wide range of biological sample types, each requiring defined storage conditions. The datasets associated with specimens in a biobank can be large and diverse, including clinical information about the donor, genetic data from the specimens, information about how the specimens have been processed and stored, and data on how they’ve been used in research. For instance, some samples need to be stored at very low temperatures, while others might require specific environmental conditions (humidity, air quality, etc.) to retain their viability. The sheer volume of samples and their intricate storage requirements make managing and maintaining them under the correct conditions, indefinitely, a massive challenge.
Documenting such large quantities and types of samples and the appropriate storage conditions is just half the battle because samples don’t always stay in a single location. Following their movements, subdivisions, and related tests and assuring the associated clinical data stays with each is the next challenge. Every sample in a biobank is linked with a wealth of information, including clinical data about the donor and data on how the sample has been processed and stored. Tracking all this information, and managing the relationships between various types of information, like sample, collection, or (if relevant) study information, is a complex task. Mislabeling or misplacing a sample, or losing associated data, can significantly affect the usability of the sample in research.
A LIMS designed for biobanking can automate many aspects of storage and tracking. For example, a LIMS enables the use of barcodes to label and locate samples and databases to manage associated data. A LIMS can even alert users to conditions like a freezer that’s gotten above the maximum temperature specified, or a sample that has exceeded its optimum number of freeze–thaw cycles. But even with a LIMS, biobanks need to have good procedures in place to prevent errors. It’s important to integrate the LIMS into your processes rather than making LIMS data entry an afterthought or separate process.
Biobanks are responsible for satisfying regulatory requirements. Each step in the sample lifecycle must be accurately documented from the point of collection to the sample’s use in research and eventual disposal. This includes information about who handled the sample, when and where it was stored, the conditions under which it was kept, and how it was used in research.
Biobanks are also responsible for ensuring that informed patient consent follows the samples from trial or study participants. Informed consent refers to the permission given by donors for the use of their samples in research. Consent forms usually specify the types of research the samples will be used for and any associated data that will be shared. In the rapidly evolving field of biomedical research, the future uses of a biospecimen may not be fully known at the time of collection, making it challenging to obtain fully informed consent. There is also the issue of tracking which samples have consent for specific types of research.
A well-designed LIMS can automate the tracking of the chain of custody and can keep an accurate record of patient consent. CSols recommends implementing electronic signatures and audit trails in your LIMS to further ensure chain of custody completeness and enable compliance with 21 CFR Part 11 and HIPAA. Supporting your LIMS with clear policies and procedures, regular audits, and staff training will ensure it is used effectively and ethically.
Managing these large data sets effectively is crucial to ensure the quality and usability of the biospecimens, but it’s a complex task. Biobanks need robust systems to ensure data accuracy, completeness, security, and confidentiality. They also need to have procedures in place for data backup and recovery, to prevent data loss.
There’s also the challenge of making biobanking data available to other laboratory systems. Biobanking LIMS are most often interfaced with the following:
Integrating a biobanking LIMS with these systems can greatly increase efficiency, reduce manual errors, improve data integrity, and enhance the overall workflow in the biobank. However, the integration process can be complex and requires careful planning and execution to ensure compatibility and secure data exchange.
While the road to seamless biobanking has many challenges, they can be overcome with the help of the right technology configured for your unique needs. CSols has domain expertise in configuring LIMS biobanking solutions that support your organization’s success. Through efficient sample tracking, solid methods to comply with regulatory requirements, and effective data management, together we can navigate obstacles and continue to enhance the vital role of biobanks in biomedical research.
What aspect of your biobanking data management could use an upgrade?