Wednesday, October 21, 2015

The woman with the (specimen) solution

After nearly three decades with the Centers for Disease Control & Prevention, Elaine Gunter was looking for a change. Since 1978, her role in the central laboratory for the National Health and Nutrition Examination Survey included designing specimen collections for various field studies, managing personnel, and developing assays.

In 2001, she was promoted to a the deputy director position of the Division of Laboratory Sciences at CDC. While working in the management and operations realm, she found she was dealing with the “suits” of Washington, D.C., who were trying to run science agencies as a business.

That’s when she took the leap.

“My older daughter, Christie, was about to have what has turned out to be our only grandchild, and I thought, ‘OK I’ve got enough time in, I’m going to retire and I’ll think about doing something after the fact,” Gunter said. “And before I could even think about getting retired, I had people calling me saying, ‘Could you help with this?’”

The solution for your biobank

Gunter, whose professional network was 3,000 strong at this point in her career, created her biorepository and laboratory consulting business, Specimen Solutions, LLC, which assists clients in repository operation, quality assurance and laboratory management. Gunter said specimen banking (or biorepositories) is essentially like having a warehouse of sorts for materials. These materials could be human, animal, environmental, or whatever is needed for research.

“It’s taking care of anything that would be stored in a biological or environmental repository, and it can be stored at temperatures from ambient or room temperature all the way down to cryogenic storage by immersion in liquid nitrogen,” she said.

But Gunter has found while working with collections in the public sector or as a business owner, that there are now multiple challenges facing repositories. Among funding difficulties, the high cost of operations, human subject issues and storage and preservation of collections and samples, Gunter stressed management is a huge challenge for facilities.

“Biobankers have to have very careful management of collections, and if they are holding 2 million samples that nobody has asked for in 20 years, then it’s time to exercise a little bit of a value assessment there,” she said. “They must look at the quality of the stored specimens and at the amount of associated data available.  If there’s not enough potential value there, it’s time to significantly trim or even purge the collection.”

Biobanks and other repositories are part of the clientele that
Gunter works with. (Credit: MilitaryHealth)
Gunter cited the National Heart, Lung and Blood Institute’s (NHLBI) collections from past coronary drug trials when they had collected large volumes of blood, primarily from men. And they stored aliquots of serum in large volumes. Over several decades, however, they had given away only a small percentage of their collections and storage costs were increasing.

“Nowadays,” Gunter said, “people are asking for 0.5-mL aliquots, so NHLBI worked very carefully with their repository contractor and advisory panel, and decided to pare down their collection size considerably.”

Best practices for all 

In Gunter’s experience, setting standards allows for better operations and management. Whether it’s the Clinical Laboratory Improvement Act (CLIA), the International Standards Organization (ISO), a combination of the two, or internal guidelines, she helps laboratories and repositories incorporate the highest quality standards.

So when the International Society for Biological and Environmental Repositories (ISBER) was established in 2000, with the help many others interested in improving biorepository science, Gunter was appointed as its first president, and the organization got to work on what is important for its members: best practices.

Gunter said the group is currently working on its fourth iteration of ISBER Best Practices, and in the 15 years since ISBER’s inception, members have seen the first three guidelines change for various reasons. One component that has largely changed their practices: an increasingly digital world.

“All of the things like software to manage the inventory, barcodes — we were happy at first to get the one-dimensional barcodes, and now everybody is incorporating two-dimensional barcodes,” Gunter said. “And then there are ... the radio frequency identification (RFID) chips that can actually go into specimen vials for very valuable collections, like special pathogens that you have to track down to chain of custody level.”

And as the group’s best practices change and grow, so does the society. Since 2000, the group has grown from 125 attendees at its first annual meeting to 1,300 institutional and individual members. ISBER now has additional  affiliate and associate partnerships, such as the European, Middle Eastern, & African Society for Biopreservation & Biobanking (ESBB) to expand awareness about management and preservation to biorepositories worldwide. ISBER also has an official journal called Biopreservation & Biobanking.

Gunter doesn’t go to a lab every day anymore. Her commute means crossing the hallway from her bedroom to her office. But she remains as busy as ever. She travels when she has to and remains an active member in ISBER, the society that she co-founded, proselytizing for members who feel the same way she does about quality and management of collections.

“The organization has succeeded beyond my wildest dreams, and I’m still learning tons of new stuff every day.”


Testing of a metal or ore to determine ingredients and/or quality
A portion of a larger whole
In blood, it is the plasma not including the fibrinogen, which helps in forming clots

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