CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Dr. Jewell
Dr. Jewell co-wrote (with David Chesla of Universal Biorepository, Spectrum Health, and Daniel Rohrer of Van Andel) the book’s chapter on establishing a flow for biospecimens. They cover, among other things, standardization of collection using biospecimen kits (see book excerpt, page 48), participant identification and informed consent, tissue collection policies, storage, and distribution.
“Better biorepositories better serve research and, hopefully, better serve clinical care,” Dr. Jewell says.
Having consistent protocols and carefully documenting biospecimen handling are essential to providing researchers with usable samples, says Sarah M. Dry, MD, who co-wrote (with Clara Magyar, PhD, of UCLA) the book’s chapter on specimen quality control. Researchers need to know how a sample was handled to know if it will be appropriate for their study.
Dr. Dry
Dr. Dry, co-director of the Translational Pathology Core Laboratory at UCLA, says if a sample had thawed or thawed partially during a freezer failure, for example, it could affect the levels of specific analytes in serum or plasma, particularly if the biosample experienced more than one freeze-thaw cycle. But this same sample may be acceptable for another project. The key is making sure the documentation is available to allow researchers to make the best choices about whether the samples are suitable for their studies, she explains.
“Pathologists must understand that the ‘best’ collection, processing, preservation, and storage method for a sample depends on its intended use,” she says.
Formalin fixation with paraffin embedding (FFPE) and sectioning would be recommended for “best” tumor tissue histology. But for RNA studies, Dr. Dry says, FFPE tissue may be “suboptimal or unacceptable depending on the specific use, while rapidly snap frozen tissue is optimal.” In setting up a biorepository, she says, “pathologists must understand the intended end uses by researchers and put appropriate protocols in place that span the full lifespan of the biosample.” If the intended use is unknown, Dr. Dry recommends that pathologists set up protocols suited to the most likely uses of the specimens.
Pathologists must have “well-written, internally consistent protocols, good documentation, well-trained staff, and a strong quality management program” to maintain high-quality samples in their biobanks, she says.
Consistency across institutions is also important. While the National Cancer Institute was working to develop The Cancer Genome Atlas, Carolyn Compton, MD, PhD, former director of the NCI Office of Biorepositories and Biospecimen Research, contacted biorepositories across the country to find suitable tissues for the project. But she discovered that the processes used to collect the samples and the data associated with them were not standardized across institutions. There were important variations in the time between tissue collection and fixation. Quality control checks for RNA degradation in samples also varied. So, too, did the specimen-associated consents for research, which Dr. Compton tells CAP TODAY precluded the use of many samples for The Cancer Genome Atlas.
The right kind of specimen sets were another problem. “For TCGA, we needed a sample of normal tissue as well as the cancer from the patient,” she says. “Otherwise mutation calling was impossible.” But she says many institutions or biospecimen collections had no stored blood or other normal tissue from the same patient.
Finding biobank staff with the right expertise can be difficult. Dr. Ramirez says those who have been working in hospital laboratories may not be familiar with some of the unique requirements of biorepositories. They may not be familiar, for example, with material use agreements, research regulations, or bioinformatics. The book’s descriptions of the personnel needed for a biorepository and the experience they should have, she says, will help biorepository directors train their staff or even “discover” existing staff with the relevant skills.
The book was designed, Dr. Jewell says, to aid biorepositories in following the guidelines set out by the Office of Biorepositories and Biospecimen Research (NCI Best Practices for Biospecimen Resources, http://biospecimens.cancer.gov/bestpractices) and the International Society for Biological and Environmental Repositories (www.isber.org/?page=BPR).
It will also be useful to those pursuing CAP accreditation through the Biorepository Accreditation Program, launched in 2012. Dr. Jewell, a member of the BAP committee, says the program leverages the CAP’s experience with laboratory accreditation to help biorepositories meet the highest operational standards. Peer reviewers help assess each participating site and make recommendations for improvement. To date, 55 biorepositories have applied to the accreditation program and 29 have been accredited. Dr. Jewell expects that more institutions will seek accreditation for their biorepositories because it gives them an edge when seeking funding and research partners.
Dr. Hansel says the book will be equally useful to small biobanks and large, centralized repositories. She adds, “This is basically a companion guide that can help people navigate the CAP accreditation program.”
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Bridget Kuehn is a writer in Chicago. To purchase a print book (PUB314), go to www.cap.org (“Shop” tab). To purchase an ebook, go to ebooks.cap.org. Or call 800-323-4040 option 1. List price: $90. CAP member price: $72. Ebook price: $63.
