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. 2018 Feb;16(1):16-22.
doi: 10.1089/bio.2017.0108. Epub 2018 Feb 2.

The College of American Pathologists Biorepository Accreditation Program: Results from the First 5 Years

Shannon J McCall  1 , Philip A Branton  2 , Victoria M Blanc  3 , Sarah M Dry  4 , Julie M Gastier-Foster  5 , James H Harrison  6   7 , Scott D Jewell  8 , Rajesh C Dash  1 , Rebecca C Obeng  9 , Joan Rose  10 , Dawna L Mateski  10 , Albi Liubinskas  10 , James A Robb  11 , Nilsa C Ramirez  5 , Kathi Shea  12
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The College of American Pathologists Biorepository Accreditation Program: Results from the First 5 Years

Shannon J McCall et al. Biopreserv Biobank. 2018 Feb.

Abstract

The College of American Pathologists (CAP) developed the Biorepository Accreditation Program (BAP) in 2012. This program integrates best practices from the International Society for Biological and Environmental Biorepositories, the National Cancer Institute, the Organisation for Economic Cooperation and Development, the Center for Medicare and Medicaid Services, and the CAP Laboratory Accreditation Program. The goal of this elective program is to provide requirements for standardization in biorepository processes that will result in high-quality specimens that can be used to support research, drug discovery, and personalized medicine. CAP uses a peer inspection model to ensure the inspectors have proper expertise and to promote educational efforts through information sharing. Lead inspectors are comprised of pathologists, PhDs, and managers of biorepositories and they are often supported by CAP staff inspectors. Accreditation is a 3-year continuous cycle of quality with a peer inspection occurring at the start of year 1 and a self-inspection and CAP desk assessment at the start of year 2 and 3. At this time 53 biorepositories are fully CAP BAP accredited and 13 are in the process of obtaining accreditation. There are currently 273 established standards with requirement lists customized based on the scope of activities performed by a biorepository. A total of 90 inspections were completed between May 2012 and December 2016. Sixty-one were initial inspections and 29 were reinspections. A total of 527 deficiencies were identified in the areas of Equipment/Instrumentation (22%), Information Technology (18%), Specimen Handling and QC (15%), Quality Management (16%), Personnel (11%), Safety (10%), Facilities (6%), and Regulatory (2%). Assessment of common deficiencies identifies areas of focus for continuous improvement and educational opportunities. Overall success of the program is high based on the current enrollment of 66 biorepositories, anecdotal participant feedback and increasing national recognition of the BAP in federal documents.

Keywords: CAP accreditation; CLIA accreditation; biobank; biorepository; preanalytic variables; quality management.

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Conflict of interest statement

No conflicting financial interests exist.

Figures

<b>FIG. 1.</b>
FIG. 1.
The three-year cycle of the CAP Biorepository Accreditation Program. CAP, College of American Pathologists.
<b>FIG. 2.</b>
FIG. 2.
Demographics of biorepositories enrolled in the CAP Biorepository Accreditation Program.
<b>FIG. 3.</b>
FIG. 3.
Breakdown of cited deficiency type by year of inspection.
See this image and copyright information in PMC

References

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