The Mayo Clinic Center for Individualized Medicine's biorepository has earned the College of American Pathologists (CAP) biorepository accreditation, an internationally recognized gold standard of operational excellence. CAP accreditation requires proof of the highest level of accuracy in collecting, processing and storing blood and tissue samples used in research to improve patient care. Biorepositories also must meet scientifically endorsed standards of quality, efficiency, consistent process and best practices.
"This is a further demonstration that the biomedical community can trust us to provide quality samples preserved through methods that meet or exceed industry standards," says Stephen Thibodeau, Ph.D., program director of the Mayo Clinic Biorepository. "Rigorous processes in handling samples lead to solid studies with valid results. This will help us meet the growing need for qualified biospecimens crucial to developing targeted, personalized diagnostics and therapies."
CAP accreditation ensures that Mayo Clinic's biorepository is in line with international best practice guidelines for handling human blood and tissue samples. This peer-based inspection model includes an on-site inspection and meeting a comprehensive checklist of requirements aimed at reducing errors and ensuring quality.
"This accreditation is validation from an external body that we have superior management of our biorepository," says Mine Cicek, Ph.D., assistant professor of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine, and director of the Biospecimens Accessioning and Processing lab, which processes and stores blood and other liquid samples. "This tells us that we haven't missed anything in our own oversight. We've gone through a very rigorous process that finds we are complying with standardized criteria and following best practices."
Biorepositories play an important role in studying health and disease. Biospecimens are used in research to advance patient care in many ways, such as finding genomic links to disease, testing new drugs or developing new therapies. The samples are especially helpful in research on rare diseases in which it is difficult to collect samples from patients who come from different parts of the globe.
"The biorepository quality team did a wonderful job to bring together all of the elements to obtain this accreditation," says Thomas Flotte, M.D., professor of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine, and director of the Pathology Research Core, which provides advanced services for research tissue samples. "It was a team effort involving all of the staff of the biorepository."
Once accredited, biorepositories must maintain high-quality operations with an eye on continuous improvements. Inspections will be done every three years to ensure compliance.
Biorepository staff members on Mayo Clinic's Arizona and Florida campuses are preparing for CAP inspection and accreditation in 2017.