CAP biorepository accreditation is the College of American Pathologists' accreditation of a biorepository that receives, stores, processes and distributes biospecimens and data for research, inspected on site every two years against CAP checklists. This page is for research and healthcare organizations that are setting up a repository or preparing for a first CAP inspection. Integral Healthcare Solutions (IHS) drafts the repository's governance and documentation procedures for CAP accreditation; your scientists own preservation methods and biosafety.
Last reviewed: October 2026.
What is CAP biorepository accreditation?
CAP describes the program this way: "The Biorepository Accreditation Program, established in 2012 by the College of American Pathologists (CAP) was the first accreditation program to improve the quality and consistency of biorepositories" (CAP Biorepository Accreditation Program). It is one of several CAP programs, alongside the Laboratory Accreditation Program, CAP 15189, Forensic Drug Testing and Reproductive programs (CAP accreditation).
The governing text is the CAP checklist set for the program. CAP states: "Participants have access to the CAP's Biorepository, Laboratory General, Director Assessment, and All Common Checklists through our customer portal, e-LAB Solutions Suite" (CAP). Checklists sit behind that portal, so the checklist edition you purchase is the version of record for your preparation. IHS works from your copy.
The inspection cycle is set out on the program page: "On-site inspections occur every two years using the CAP Accreditation Checklists to assess compliance with program requirements, with an interim self-inspection required during the off-year" (CAP). CAP's general accreditation page describes its inspections as "educational peer inspections" built on "customized, discipline-specific checklists" (CAP accreditation).
Who needs it and what triggers it
CAP's eligibility wording, as published: "A biorepository receives, stores, processes, and disseminates biospecimens, their derivatives, and relevant data for research purposes qualify" (CAP). The work usually starts with one of these events:
- A repository is being established and needs written governance, custody and inventory procedures from the start.
- The organization has decided to apply to CAP. The biorepository program page says to: "Submit the Accreditation Request for Application form (PDF) and a one-time, non-refundable application fee" (CAP).
- An accredited repository is approaching its off-year self-inspection or its next biennial on-site inspection (CAP).
CLIA is a separate question. CLIA's rules exclude "Research laboratories that test human specimens but do not report patient specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of individual patients" (42 CFR 493.3(b)(2)). IHS's reading, as of October 2026: a repository that only stores and distributes specimens for research, and reports no patient-specific results, will often fall outside CLIA, which makes CAP biorepository accreditation a voluntary quality credential rather than a federal certificate. Whether your repository is inside or outside CLIA depends on what it does, and this page does not decide that for you.
How IHS helps
IHS markets a process, applied to the CAP biorepository checklist set you hold:
- Gap assessment against the Biorepository, Laboratory General, Director Assessment and All Common checklists.
- Questionnaires on specimen receipt, transfer, inventory and deviations, so the gaps are found in your own words and records.
- Document and evidence mapping: a crosswalk from each checklist requirement to the procedure, record or log that shows it is met.
- Drafting the specimen governance, chain-of-custody, inventory and deviation procedures for your repository scientists to review and approve.
- Mock inspection document review before the CAP inspection, using the same checklists.
- Readiness support while you prepare your application, through the inspection and during the response to any deficiencies. You submit the application and the response.
What you supply: the purchased checklists, your current SOPs, access to your inventory systems, and the repository scientists who own preservation methods and biosafety.
The limit: preservation methods, biosafety and specimen fitness for use are scientific judgments. They stay with your scientists. IHS covers governance and documentation. Your organization applies to CAP and hosts the inspection; IHS does not apply on your behalf.
What to have ready
- Your purchased CAP checklist set: "Biorepository, Laboratory General, Director Assessment, and All Common Checklists" (CAP), with the edition noted.
- A written description of what the repository does, matched to CAP's eligibility wording: it "receives, stores, processes, and disseminates biospecimens, their derivatives, and relevant data for research purposes" (CAP).
- Your specimen receipt, transfer and inventory procedures as they exist today, for the gap assessment against the Biorepository checklist.
- Your deviation records and the procedure that governs them.
- A named person to complete the Director Assessment Checklist, one of the checklists CAP lists for the program (CAP).
- A signer and budget for the "Accreditation Request for Application form (PDF) and a one-time, non-refundable application fee" (CAP).
- Someone to complete the "online Organizational Profile, which you must complete to finalize the accreditation application" (CAP).
- A plan for the "interim self-inspection required during the off-year" (CAP).
- An owner and calendar time for deficiency responses: CAP's general accreditation process says "Respond to deficiencies within 30 days" (CAP accreditation process).
To go through the list with IHS, book the introductory call below.
How it compares
The routes below come from the sources' own pages. Which one fits depends on what your sponsors, collaborators and leadership expect.
| Route | What the sources say |
|---|---|
| CAP Biorepository Accreditation Program | On-site inspection every two years against CAP checklists, with an off-year self-inspection (CAP). |
| ISO 20387 accreditation through A2LA | "The A2LA Biobanking Accreditation Program uses the ISO 20387 standard to promote confidence in biobanking." ISO 20387 "contains requirements designed to demonstrate the competence of a biobank's operation and the ability to provide biological material and associated data for research and development" (A2LA). |
| CAP readiness options | A repository "not confident in its readiness may purchase a set of checklists and perform a self-inspection," and CAP offers a CAP Accreditation Readiness Assessment (CARA) that "provides a high-level evaluation of the biorepository's processes using an educational approach" (CAP). |
| No accreditation | IHS's reading (October 2026): available to a research-only repository outside CLIA under 42 CFR 493.3(b)(2), with no external quality credential to show sponsors or collaborators. |
| IHS gap assessment and drafting | A crosswalk, drafted procedures and a mock document review against the checklists you hold. It does not replace your scientists or CAP's decision. |
What it costs
CAP does not publish a fee schedule on the pages we reviewed; fees depend on scope. CAP names "a one-time, non-refundable application fee" without an amount (CAP) and offers a fee estimate form: "Submit a fee estimate form to receive more information about cost and next steps to become CAP accredited" (CAP accreditation). CAP also states: "If you purchase the checklists and apply for accreditation within six months, we will waive the application fee" (CAP accreditation process, read October 2, 2026). Verify current fees with CAP. IHS scopes each engagement after a free introductory call.
What this is not
- IHS is not CAP and does not grant, predict or influence an accreditation decision.
- IHS does not contact, apply to or speak for your organization to CAP. IHS drafts; your organization applies and hosts the inspection.
- IHS does not set preservation methods, biosafety practice or specimen acceptance criteria, and this page is not legal or scientific advice.
Frequently asked questions
What is CAP biorepository accreditation?
It is the College of American Pathologists' accreditation program for biorepositories, established in 2012. A biorepository that receives, stores, processes and disseminates biospecimens, their derivatives and related data for research is eligible. CAP inspects on site every two years against its checklists.
Does a research biobank need CAP accreditation, or is it voluntary?
IHS's reading, as of October 2026, is that CAP presents the program as an accreditation a repository may seek, and the pages we reviewed do not say a repository must hold it. IHS's reading, as of October 2026, is that a research-only repository that reports no patient-specific results will often fall outside CLIA, which would make CAP accreditation voluntary for it. Whether that holds depends on what your repository does.
Is a research-only biorepository subject to CLIA?
CLIA's rules at 42 CFR 493.3(b)(2) exclude research laboratories that test human specimens but do not report patient-specific results for diagnosis, prevention, treatment or the assessment of an individual patient's health. A repository that does report such results is a different case. This page does not decide which side your repository is on.
What checklists does CAP use to inspect a biorepository?
CAP gives participants the Biorepository, Laboratory General, Director Assessment and All Common Checklists through its customer portal, e-LAB Solutions Suite. The edition you purchase is the one to prepare against.
How long does it take to get CAP biorepository accreditation after applying?
CAP's general accreditation process page shows a timeframe of 13 to 24 weeks beside its application-to-inspection steps. That page does not say whether the range applies to the biorepository program specifically, so confirm it with CAP for your application.
How often is a CAP-accredited biorepository inspected?
CAP inspects on site every two years, using the CAP Accreditation Checklists. An interim self-inspection is required during the off-year.
How much does CAP biorepository accreditation cost?
CAP names a one-time, non-refundable application fee but does not publish the amount on the pages we reviewed, and it offers a fee estimate form. CAP states it will waive the application fee if you purchase the checklists and apply within six months. Verify current fees with CAP; IHS scopes its own work after a free introductory call.
Should a biobank choose CAP accreditation or ISO 20387?
Both exist. A2LA accredits biobanks to ISO 20387, which it describes as containing requirements to demonstrate the competence of a biobank's operation. CAP inspects against its own checklists every two years. The choice depends on what your sponsors, collaborators and leadership expect, and IHS does not make it for you.
Can we do a mock inspection or readiness assessment before applying?
Yes. CAP says a repository not confident in its readiness may purchase the checklists and perform a self-inspection, and CAP offers its own CAP Accreditation Readiness Assessment (CARA). IHS runs a mock inspection document review against the checklists you hold.
Does IHS write our scientific procedures or apply to CAP for us?
No. IHS drafts governance, chain-of-custody, inventory and deviation procedures for your repository scientists to approve. Preservation methods, biosafety and specimen fitness stay with your scientists, and your organization applies to CAP and hosts the inspection.