When former President Obama’s team released the paperwork for what’s become the All of Us Research Program, in the part about biobanking, the wording specified that the biobanks applying for the grants be “CLIA compliant.”
“They didn’t put quotes around it, but whenever I say it, I put quotes around it. “CLIA compliant”—it's not a thing,” says today’s guest Shannon McCall, one of our country’s leading experts in the field of biobanking and biospecimen science. Shannon leads the Precision Cancer Medicine Initiative with her team at the Biorepository and Precision Pathology Center at Duke University.
What Shannon is getting at is that biobanks are not currently required to be CLIA compliant the way labs are required to be. And they never have. Biobanks are unregulated, and many in the field argue standards, and therefore, biomedical research, is suffering as a result.
This is the second in a series of interviews on the topic of biospecimen quality, and today we focus solely on storage and the biobank.
Shannon is also the Vice Chair of the College of American Pathologists (CAP’s) Biorepository Accreditation Program, the country’s only program of its kind to offer such accreditation. This year CAP is celebrating their 50th anniversary of offering laboratory accreditation. They're widely seen as the leader in lab quality assurance.
Biobanking is a relatively new industry, it's true. Time Magazine made it one of their 10 ideas changing the world in 2009. So is it nigh on time for biobanks to come under one regulatory agency such as CMS and the CLIA program? Some international biobanks, many of which were built in Europe based originally on American models, now serve already as standards of excellence back here across the pond.
Has Shannon heard pushback from the community against coming under CLIA? Why are biobanks going for CAP accreditation in the first place?
What is the biggest issue for storing samples? Why do biobanks struggle with sustainability?
We come in at around 28 minutes.