Even though every laboratory manager knows the mostimportant articles in a lab are the samples, many are not equipped to properlymanage and protect them. Careless sample management is an accident waiting tohappen. These accidents can come with severe consequences including degradedsample integrity, reduced lab productivity and unanticipated costs.
A researcher can spend days or even weeks designing andrunning an assay, only to discover the results are invalid because the sampleshad degraded. Money and time are wasted and these costs can add up quickly ifthis happens frequently. Everyone knows that sample integrity and security maybe a problem, but most choose to ignore the issue until a mishap occursresulting from lost, mishandled or decomposed samples.
In today's environment, we are beginning to see two trendsdriving laboratories to adopt more sophisticated sample storage and managementsystems. The first is the knowledge that samples degrade every time the freezeris opened. The second factor is that government-backed projects and agencieshave now started implementing stricter requirements on sample tracking andsecurity, leaving laboratories scrambling to catch up.
A key factor that causes samples to degrade is temperaturefluctuation. Currently, most laboratories use manual cold storage freezers. Adoor that is manually opened allows warm, moist outside air to penetrate thesystem, which raises the storage temperature and causes frost. When frostbuilds up, the researcher must chip away at samples to retrieve them, whichmeans the door remains open for even longer periods of time, increasing thetemperature of the samples. Constant changes in temperature can ruin a sample'sbiological composition and lead to incorrect test results. Additionally, when afreezer door is frequently opened and closed, samples can be exposed todamaging UV light, moisture and oxygen, which can also affect a sample'scomposition.
The other factor that drives laboratories to adopt advancedsample management systems is the need for sample tracking and security. Inlaboratories with manual freezers, there are many opportunities for humanerror. Samples can be misplaced, mixed up and even lost. More serious are caseswhere samples are tampered with or when hazardous compounds are lost or stolen.
Most of us remember the anthrax scare in 2001, when severalletters were mailed to news media outlets and two United States senatorscontaining anthrax spores, killing five people and infecting 17 others. Duringthe investigation, it was revealed that records and documentation wereincomplete 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 aprominent issue.
Another environment where demand is increasing for samplesecurity is in the growing number of biobanks at hospitals and researchinstitutions. New requirements for access control and sample tracking areevolving. Last year, Dr. Carolyn Compton, director of the Office ofBiorepositories and Biospecimen Research at the National Cancer Institute(NCI), reiterated the issue of proper sample management at the NCI BiospecimenBest Practices Forum: "For NCI's biospecimen resources, the need forstandardization and quality management is critical and long overdue," shestated.
To ensure that the samples are secure and the integrityremains intact, standardized procedures must be developed to address specimencollection, freezing rates, thaw process, storage temperatures, storagetemperature validation, acceptable temperature fluctuation, along with labwarestandardization.
The good news is that there are tools available today tohelp address these challenges, from basic barcoding systems for sample trackingto robotics that eliminate error-prone manual steps and sample exposure.Automated sample storage addresses the many sample integrity issues associatedwith manual freezers by eliminating the opening and closing of the door andclosely controlling the storage environment. The integration of roboticsstreamlines and improves a number of functions. For example, picking andtracking microtubes manually is usually a difficult and time-consuming task,and it is easy to place a tube in the wrong place. Automation provides precisetube-picking functions to eliminate these errors. New systems can automatepicking, thawing and return for faster turnaround. The latest systems can evenautomatically seal and unseal microplates to prevent error and samplecontamination.
Automation software minimizes paperwork and creates an audittrail with electronic signatures, which are critical for pharmaceuticalcompanies that need to comply with 21 CFR Part 11 guidelines. Automated samplemanagement systems can monitor all hardware movements and offer many otherfunctions such as error recovery and emergency shutdown procedures. Programscan also be set up to control access to samples, designating which users areauthorized to access individual libraries.
Upgrading sample management and storage can represent asignificant initial investment, but the benefits far exceed the costs. By upgradingsample management systems, the "elephant in the room" can be exposed andremoved, saving time and money and averting a wide range of problems.