CAP Biorepository Accreditation Program (CAP-BAP)

What CAP-BAP is

The Biorepository Accreditation Program (CAP-BAP) is run by the College of American Pathologists (CAP), a US-based medical society and accrediting body long established as an accreditor of clinical and anatomic pathology laboratories. CAP launched the program in 2012, describing it as the first accreditation program created specifically for biorepositories. It applies to facilities that receive, store, process, and distribute human biospecimens and associated genetic material for research, drug discovery, and precision-medicine use — it explicitly excludes tissue banked for transplant purposes and retained clinical specimens that are not intended for research.

How accreditation works

CAP-BAP accreditation is assessed against a defined set of CAP accreditation checklists: a Biorepository-specific checklist alongside the Laboratory General, Director Assessment, and All Common checklists that CAP also uses across its broader laboratory-accreditation programs. Together these run to several hundred discrete requirements covering informed-consent documentation and protection of research participants, specimen collection and chain-of-custody handling, institutional governance instruments such as material transfer agreements, and long-term preservation infrastructure — equipment preventive maintenance, temperature monitoring, and backup systems for stored specimens. A biorepository seeking accreditation undergoes an on-site peer inspection by CAP against these checklists, is re-inspected on-site every two years to maintain accredited status, and completes a self-inspection against the same checklists in the intervening off-year.

CAP-BAP compared to ISO 20387 and to ISBER/NCI guidance

CAP-BAP sits alongside, and is regularly compared directly to, ISO 20387 as one of two formal, third-party accreditation pathways available to a biorepository — both result in a public, auditable accreditation status verified by an independent assessment, rather than a self-declared claim of conformance. The two programs differ in structure and origin: ISO 20387 is an international standard, and accreditation against it is delivered through national accreditation bodies operating in the ISO/IEC 17025-aligned accreditation infrastructure (for example UKAS or ANAB); CAP-BAP is a single accrediting organisation’s own program, built on CAP’s long-standing laboratory-inspection model and checklist system. CAP-BAP is distinct in a different way from the two leading biobanking best-practice documents, the ISBER Best Practices for Repositories and the NCI Best Practices for Biospecimen Resources: those are voluntary guidance documents that a biobank can adopt internally without any external verification, while CAP-BAP requires the same kind of formal, on-site, third-party inspection that ISO 20387 does. CAP-BAP’s own checklists draw on ISBER, NCI, and OECD guidance in their construction, so a biorepository already aligned with ISBER or NCI best practices is typically better positioned to pass a CAP-BAP inspection, but adherence to that guidance alone is not equivalent to holding CAP-BAP accreditation.

Why the distinction matters

For funders, research consortia, and biospecimen users deciding how much independent assurance to require of a biorepository, the practical question is usually whether a given credential reflects formal third-party assessment or self-reported conformance to guidance. CAP-BAP and ISO 20387 both answer that question the same way — an independent inspection body examined the biorepository’s quality management system, specimen handling, traceability, and (for CAP-BAP specifically) research-participant protections, and issued an accreditation that can be checked. ISBER and NCI best-practice adherence, by contrast, is a useful and widely used quality signal, but not itself a verifiable credential in the same sense. A given biorepository may pursue CAP-BAP, ISO 20387, both, or neither, depending on its funders’ requirements, its geography (CAP-BAP originated in, and is most commonly held by, US biorepositories, while ISO 20387 accreditation is available through national accreditation bodies internationally), and whether its stakeholders specifically require CAP’s inspection model.

Related terms

See also ISO 20387 (Biobanking), Biobank, and Biorepository for the underlying entities CAP-BAP accredits, and the ISBER vs. NCI Best Practices for Biorepositories guide for how the two leading voluntary best-practice documents CAP-BAP draws on compare to each other.

References

• College of American Pathologists, ‘Biorepository Accreditation Program’ (cap.org/laboratory-improvement/accreditation/biorepository-accreditation-program).