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Sample management: The elephant in the room?
Even though every laboratory manager knows the most important articles in a lab are the samples, many are not equipped to properly manage and protect them. Careless sample management is an accident waiting to happen. These accidents can come with severe consequences including degraded sample integrity, reduced lab productivity and unanticipated costs.
A researcher can spend days or even weeks designing and running an assay, only to discover the results are invalid because the samples had degraded. Money and time are wasted and these costs can add up quickly if this happens frequently. Everyone knows that sample integrity and security may be a problem, but most choose to ignore the issue until a mishap occurs resulting from lost, mishandled or decomposed samples.
In today's environment, we are beginning to see two trends driving laboratories to adopt more sophisticated sample storage and management systems. The first is the knowledge that samples degrade every time the freezer is opened. The second factor is that government-backed projects and agencies have now started implementing stricter requirements on sample tracking and security, leaving laboratories scrambling to catch up.
A key factor that causes samples to degrade is temperature fluctuation. Currently, most laboratories use manual cold storage freezers. A door that is manually opened allows warm, moist outside air to penetrate the system, which raises the storage temperature and causes frost. When frost builds up, the researcher must chip away at samples to retrieve them, which means the door remains open for even longer periods of time, increasing the temperature of the samples. Constant changes in temperature can ruin a sample's biological composition and lead to incorrect test results. Additionally, when a freezer door is frequently opened and closed, samples can be exposed to damaging UV light, moisture and oxygen, which can also affect a sample's composition.
The other factor that drives laboratories to adopt advanced sample management systems is the need for sample tracking and security. In laboratories with manual freezers, there are many opportunities for human error. Samples can be misplaced, mixed up and even lost. More serious are cases where samples are tampered with or when hazardous compounds are lost or stolen.
Most of us remember the anthrax scare in 2001, when several letters were mailed to news media outlets and two United States senators containing anthrax spores, killing five people and infecting 17 others. During the investigation, it was revealed that records and documentation were incomplete as to who had access to the deadly material and where it had been. In response to this debacle, the importance of sample security has become a prominent issue.
Another environment where demand is increasing for sample security is in the growing number of biobanks at hospitals and research institutions. New requirements for access control and sample tracking are evolving. Last year, Dr. Carolyn Compton, director of the Office of Biorepositories and Biospecimen Research at the National Cancer Institute (NCI), reiterated the issue of proper sample management at the NCI Biospecimen Best Practices Forum: "For NCI's biospecimen resources, the need for standardization and quality management is critical and long overdue," she stated.
To ensure that the samples are secure and the integrity remains intact, standardized procedures must be developed to address specimen collection, freezing rates, thaw process, storage temperatures, storage temperature validation, acceptable temperature fluctuation, along with labware standardization.
The good news is that there are tools available today to help address these challenges, from basic barcoding systems for sample tracking to robotics that eliminate error-prone manual steps and sample exposure. Automated sample storage addresses the many sample integrity issues associated with manual freezers by eliminating the opening and closing of the door and closely controlling the storage environment. The integration of robotics streamlines and improves a number of functions. For example, picking and tracking microtubes manually is usually a difficult and time-consuming task, and it is easy to place a tube in the wrong place. Automation provides precise tube-picking functions to eliminate these errors. New systems can automate picking, thawing and return for faster turnaround. The latest systems can even automatically seal and unseal microplates to prevent error and sample contamination.
Automation software minimizes paperwork and creates an audit trail with electronic signatures, which are critical for pharmaceutical companies that need to comply with 21 CFR Part 11 guidelines. Automated sample management systems can monitor all hardware movements and offer many other functions such as error recovery and emergency shutdown procedures. Programs can also be set up to control access to samples, designating which users are authorized to access individual libraries.
Upgrading sample management and storage can represent a significant initial investment, but the benefits far exceed the costs. By upgrading sample management systems, the "elephant in the room" can be exposed and removed, saving time and money and averting a wide range of problems.