August 27, 2020
A biobank can be termed as a biorepository or a collection of biospecimens that aid research, clinical trials, and patient care. Tracking and managing biospecimens, including the source, date of collection, clinical information, molecular and genetic information, is therefore crucial for the operation of a biobank. Rising data complexity with an increasing collection of biospecimens creates challenges for biobanks that need efficient data management to facilitate research. A Laboratory Information Management System (LIMS) has evolved to manage biospecimens throughout the life-cycle of biospecimens, right from accessioning, processing, quality testing, to disposal of specimens. For quality specimen banking and for providing fit-for-purpose specimens, biobanks also need to follow regulatory guidelines and standards, such as HIPAA, ISO 20387:2018, 21 CFR Part 11, EU GDPR, and ISBER Best Practices. Biobanks must deploy a LIMS to effectively manage specimens, automate workflows, follow regulatory guidelines, and standardize biobanking practices.
The data management requirements of present-day biobanks are not limited to managing specimens and specimen metadata. Along with the collection and storage of biospecimens, biobanks also have to associate patient demographics, medical history, specimen storage location, storage conditions, test results, with the specimens.
Controlling the temperature remains one of the most important factors while processing biospecimens to ensure proper sample quality. Any change in temperature can affect the sample recovery after storage or subsequent analysis. Hence, it is important for the biobanks to keep a record of information about the number of times a specimen has been frozen, thawed and refrozen as it influences specimen integrity. Freezer management is important to record the temperature of specimens to identify any deviation in temperature that can influence specimen integrity.
A LIMS plays an important role in freezer management, by monitoring temperature and tracking biospecimen location in freezers. A LIMS should support all types of biospecimens, storage types, and biologic properties of the specimen.
Freezer mapping helps in updating the exact location of the biospecimens and their aliquots or derivatives without even opening the door of freezers. A LIMS software for freezer management should enable biobank staff to create hierarchical storage units to mirror physical storage inventory so that they can seamlessly locate the specimen of interest. Storage conditions such as temperature and humidity need to be monitored to maintain specimen integrity. One or multiple sensors within each freezer need to be installed to track the internal conditions of the freezer which can then be recorded. When freezers malfunction, temperature rises, and the specimen quality tends to deteriorate due to exposure to high temperature and moisture. Hence, the freezers should be equipped with automatic alarms to alert the staff about the slightest deviation in the condition of specimens. An ideal LIMS software should be scalable so that all the freezers and specimens collections can be managed to cater to the growing needs of biobanks.
To track the transfer of biospecimens from one custodian to another, biobanks must maintain a chain of custody of specimens. A LIMS electronically maintains an unbroken chain of custody as specimens are transferred from one individual to another to regulate the transfer of specimens within a biobank or outside a biobank. A Biobanking LIMS also ensures the protection of patients’ sensitive information through the de-identification of patient data and maintains a read-only audit trail to track all the sequence of activities performed in a biobank. The audit trail should record the name of the person making the change, the original and the updated data, and the reason for making the change. This is one of the mandatory features for biobanks operating in regulated environments.
A LIMS also helps in scheduling instrument calibration and recording maintenance data, preventing the use of obsolete instruments for quality control testing of specimens. Furthermore, a LIMS also helps in managing various documents of a biobank, including documents on Standard Operating Procedures (SOPs), Material Transfer Agreements (MTAs), and track their revision history. It also helps in restricting the access of documents to authorized personnel only, thereby preventing misuse of confidential documents. This functionality enables biobanks to follow regulatory guidelines, such as ISO 20387:2018.
A biobank must choose a LIMS that can not only help them in managing specimens and associated data but also help them in managing freezers, anonymizing sensitive patient data, and following international regulatory standards and best practices, such as ISBER Best Practices. If you are looking for a cloud-based LIMS to automate and streamline biobanking workflows, you can sign up for FreeLIMS.