The College of American Pathologists Biorepository Accreditation Program: Results from the First 10 Years.

The College of American Pathologists (CAP) Biorepository Accreditation Program (BAP) was established in 2012 with the goal of providing standardized requirements that ensure high quality for procuring, processing, storing, distributing, and computerizing information of biospecimens for scientific investigations. CAP BAP was the first biorepository accreditation program, and, since the program started in 2012, the world's second biorepository accreditation standard was issued by the International Organization for Standardization (ISO) as ISO 20387 in 2018. CAP BAP serves as an interface between several programs and draws best practices from renowned organizations. This elective program is based on a peer-inspection model to ensure that the inspectors have proper expertise and to promote educational efforts through information sharing. On-site inspections occur every 2 years, like other CAP Accreditation Programs, with an interim self-inspection in the off year. The program compliance is assessed based on CAP Accreditation Checklists, which are regularly revised. This article reviews the accomplishments of the first 10 years of the CAP Biorepository Accreditation Program. As of December 2024, 104 biorepositories are CAP BAP accredited, which increased from 53 accredited biorepositories in 2018. Accreditation of 10 additional biorepositories is underway. A total of 88 inspections were completed between January 2017 and December 2022; 16 were initial inspections and 72 were reinspections. Deficiencies, defined as insufficient or lack of evidence of compliance with a checklist item, were mainly related to equipment/instrumentation (24%), quality management (15%), safety (14%), information technology (13%), personnel (13%), specimen handling and quality control (9%), facilities (6%), and regulatory (6%) issues. The proportion of deficiencies between categories was like the first 5 years. The increased number of accredited biorepositories, in both academic and commercial settings, highlights the continued success of the program and its applicability to maintaining high standards for biorepositories.