With the dramatic growth of life science research promising more cures and treatments for disease, the volume of biological samples being stored in ultra-low temperature (ULT) biobanks around the world is growing dramatically. As is often the case, "more" is not always better when quality control processes do not keep pace. Maintaining large collections of samples has many challenges that have only intensified with ever-growing sample inventories and increasing regulation.
If your biorepository is, like many, storing more biological specimens than ever, then sample management and preservation is also a growing taskwith potential threats to your important work. The value of a precious biological sample depends on its physical preservation at ultra-low temperatures, as well as your ability to continuously track it’s whereabouts and condition. A misplaced vial represents a failure in managing the information flow and sample preservation is compromised, just as much, as when you can't locate and retrieve the right vial.
So what are the biggest threats to the integrity of your biological samples?
Sample Integrity Disruption: Inside the Freezer
The critical need to consistently maintain ultra-low temperatures inside the freezer is the most obvious and well-understood threat to the preservation of your biological samples, and the reason why ULT freezer reliability and backup systems are so important to life science research.
Sample Integrity Disruption: Outside the Freezer
Exposureof specimens to damaging temperatures,inside and outside the ULT freezer,is often the result of poor sample handling processes and human error. All too often, the process of physically verifying and removing samples from the freezer, places them at risk of damage because verifying the location of a sample generally requires that it be removed from the freezer and handled in some way. This warms the sample and compromises its integrity, which is true of the other samples that are handled in the process as well.
Typically, there is no way to know how long a sample has been out of the freezer.This is a critical sample integrity issue—searching through racks and boxes for sample vials can be a slow trial and error process. Since samples still “look cold” even if the temperature of the sample is too high, lab personnel may not immediately detect damage that occurs in this way, resulting in a heartbreaking revelation that comes later in the analysis process.
Also consider that opening a freezer door, especially for longer periods,warms up the entire freezer and all of its contents—not only the sample you are searching for. And after the door is closed, a long freezer cool down time only adds to the risks.
With the legal and privacy implications of today’s sample inventories, biobanks are subject to ever-increasing regulation that demands inventory audits. This is a growing manpower burden that requires more frequent handling of samples for verification, with increased risk to sample integrity. All of this makes efficient and error-free sample verification and retrieval a priority in biobank and biorepository operations.
Gaps and Inaccuracies in Chain of Custody
Conventional sample tracking systems are still very dependent on the attention, accuracy and proper training of the lab personnel who handle them. If your sample boxes and vials are marked with bar codes or labels, which are often frosted over in ULT storage, a human being must still read or scan it, log the transaction, record time/duration, action taken, storage location, ID of the user, etc.Misrecording any of these items, or not recording them at all in a given process, can compromise the samples.Assuming that your LIMS software provides easy management of these functions and all your lab personnel are effectively trained in these procedures, the traceability of your biological samples is still vulnerable to human error and dependent on the diligence of your lab staff.
What is the cost of a flawed process for tracking chain of custody? I hope you never have to find the answer to this question the hard way, as a critical vial comes up missing from a freezeror something is found that wasn’t supposed to be there.In a repository of any significant size,a sample that is misplaced is essentially lost. In a best case, this may cost a few hours of lab tech time searching for the missing sample. In a more serious case, it could cost a person's job or life's work, or even endanger human lives (like the Smallpox mishap in 2014 or the missing nerve agent in 2011)! Just the financial cost of time wasted on searching for a "needle in a haystack of needles" could be exorbitant.
Compromised Sample Information
Biological sample information can be compromised in any number of ways. Conventional sample tracking processes require manual entry of records for documenting where a sample is located or manual placement of the sample in a computer assigned location. Eventually, records will not reflect the true physical location of all samples due to simple human error.
On the “high tech” end, as in all information systems, electronic records are subject to security breaches, malware/viruses, corruption, accidental erasure and the like. Even with today's IT technology and backup systems, it would be nice to think these things can never happen . . . but they do happen all the time.
Then there are the "low tech" threats to the integrity of your sample information, such as adhesive labels that sometimes detach from vials and boxes,rendering specimen information useless without visual identification. Even labels that stay intact get covered with frost, and lab personal must find the "needle in a haystack" with gloves on, having little time before sample integrity is jeopardized by the thawing process.
With typical lab staffturnover, information systems can only go so far in protecting the sample management process from mishandled vials and mishandled information. With the immeasurable value ofthe samples found in biobanks, researchers should demand the most robust information and tracking systems available.
The Solution: RFID-Based “Preservation Intelligence”
At BioTillion, we're using RFID technology to revolutionize the sample management process and address these threats to biological sample integrity. To find out more about “Preservation Intelligence” and our ColdSIGHT solution, please contact us here.