January 1, 1970 (Vol. , No. )

Gregg A. Faulconer Quest Diagnostics Clinical Trials
Marjorie R. Powell Quest Diagnostics Clinical Trials

Here are four basic steps that can help improve the quality of biospecimen management.

Poorly implemented lab collection, processing and storage can foster conditions that erode specimen quality—particularly for molecular materials—and potentially impact the quality of research based on materials stored in biorepositories. Whether for clinical trials or academic research, scientists and biorepository managers can take basic steps that will improve the quality of biospecimen management:

Whether for clinical trials or academic research, scientists and biorepository managers can use these tips to improve biospecimen management. [© pp77 – Fotolia.com]

#1: Work with collaborators to develop protocol-specific specimen collection kits and clear, consistent sample and transport requirements.

Most samples are collected at a broad variety of inventory sites and under variable conditions. Biorepository managers should work directly with collaborators to understand sampling needs and develop specimen collection kits that support the study design, including sample volume, required number of time points, and any anticoagulant or stabilizing additive needed. Organizations and individuals at the point of collection must be given detailed written instructions for sample collection, temporary storage, and shipping so that the sample and supporting documentation coincide with the study protocol, and is not compromised on the way to the lab.

#2: Keep maintenance of the “primary identifier” at the forefront of the chain of custody.

After original informed consent is given and the sample is collected, the most important part of the process is ensuring that all attributes follow the de-identified sample via a unique identifier. Samples that lose their “primary identifier” are useless for the purpose of medical research. Therefore, samples must be labeled with a customized barcoded cryolabel that is interfaced to a tracking/manifesting system so that every “hand off” is tracked electronically. Labs that do not utilize electronic tracking should follow samples via a manifest that includes information on the sample label, collection date, sample type, number of samples (for cases of multiple samples), and storage temperature. Both systems should incorporate accountability in each step in order to guard the identity of specimens and support quality improvement.

Similarly, the patient consent authorization is a critical piece of information that must be carefully tracked from collection to storage and eventual testing. And in the event the subject takes back their consent, there needs to be a documented process to show the specimen has been discarded.

#3: Manage storage conditions by maintaining the best, but don’t forget to prepare for the worst.

The maintenance of stable storage conditions is the primary function of a biorepository lab. This is especially critical when storing molecular material, including DNA, RNA and proteins, which are particularly vulnerable to degradation from temperature fluctuations. But equally important is preparing for catastrophic occurrence such as a hurricane that might cause a loss of power at a storage facility. Each facility should have a written and tested disaster recovery plan that includes a backup generator to support temperature stability and maintain sample integrity in the event of power outage. Similarly, electronic sample inventories must be protected from surges in power and similar outages and regular back-up of inventory systems to ensure no data is lost. Facility managers must maintain at least 5% additional storage units at each temperature range so that samples can be moved quickly from one unit to another in the event of a unit’s failure.

#4: Prioritize a broad inventory system that allows numerous attributes to be linked to the sample.

The largest and most high-quality biobank is only as good as the data it yields. Biorepository executives must maintain robust and reliable inventory systems that permit attributes to be easily accessed and linked to the specimen, and the information needs to be provided to sponsors in real-time. This requires maintaining all information that is critical to the Sponsor’s protocol. This may include time of collection, subject gender, age and testing results associated with the individual providing the specimen, and even the number of slides cut from tissue samples or the type of stain used to enhance contrast in a microscopic examination.

Gregg A. Faulconer and Marjorie R. Powell work for Quest Diagnostics Clinical Trials, a business of Quest Diagnostics.

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