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Sample management: The elephant in the room?
September 2009
SHARING OPTIONS:
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.
Radi Hofstetter is CEO of Hamilton Storage Technologies
in Hopkinton, Mass. and vice president of Hamilton Robotics AG in Bonaduz,
Switzerland. He has been in the robotics industry for more than 25 years.
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