CAP laboratory accreditation is the College of American Pathologists' Laboratory Accreditation Program, which CMS has granted deeming authority so that a CAP inspection can stand in for a CMS inspection under CLIA. This page is for clinical laboratory directors and quality managers choosing CAP accreditation, or CAP 15189 accreditation to ISO 15189, and building the quality system to meet it. Integral Healthcare Solutions (IHS) builds the laboratory's quality-system documents and evidence structure for CAP or ISO 15189; your director and scientists own the testing.
Last reviewed: October 2026.
What is CAP laboratory accreditation?
CAP states: "The Centers for Medicare & Medicaid Services (CMS) granted the CAP Laboratory Accreditation Program deeming authority, which allows for a CAP inspection in lieu of a CMS inspection" (CAP Laboratory Accreditation Program). Its scope: "The CAP accredits laboratories that perform testing on specimens from human beings or animals, using methodologies and clinical applications within the expertise of the program" (same page). Accredited labs must "Meet required standards from CLIA, FDA, and OSHA" (same page).
The governing texts are the CAP Accreditation Checklists, the discipline-specific checklists plus the Laboratory General and All Common checklists, which CAP delivers to participants; the edition you hold is the version of record. They are read with CLIA at 42 CFR Part 493, which "sets forth the conditions that all laboratories must meet to be certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)" (42 CFR 493.1). The accreditation route is in 42 CFR 493.551: "CMS may deem a laboratory to meet all applicable CLIA program requirements through accreditation by a private nonprofit accreditation program (that is, grant deemed status)" (42 CFR 493.551(a)).
CAP inspects on a two-year cycle: "On-site inspections occur every two years, using the CAP Accreditation Checklists to assess compliance with program requirements" (CAP).
CAP 15189 is an optional second layer. CAP says it "provides accreditation to the ISO 15189 standard, an international standard to recognize the competence of medical laboratories," specifically "ISO 15189:2022 Standard Medical Laboratories—Requirements for quality and competency," and that "The CAP's Laboratory accreditation program is a prerequisite" (CAP 15189).
Who needs it and what triggers it
The buyer is a clinical laboratory that must meet CLIA and is deciding how. Under 42 CFR 493.551(b), a laboratory meeting CLIA through an approved accreditation organization must "(1) Obtain a certificate of accreditation as required in subpart D of this part. (2) Pay the applicable fees as required in subpart F of this part. (3) Meet the proficiency testing (PT) requirements in subpart H of this part" (42 CFR 493.551(b)). Typical triggers:
- Choosing an accreditation organization for deemed status. CMS lists ACHC, A2LA, ASHI, AABB, CAP, COLA and The Joint Commission as approved CLIA accreditation organizations, with specialty coverage that differs by organization (CMS list).
- Moving from CAP accreditation to a quality-management framework as well, through CAP 15189, for which CAP accreditation is the prerequisite (CAP 15189).
- Preparing for the next biennial CAP inspection, or answering deficiencies, for which CAP's general accreditation process says "Respond to deficiencies within 30 days" (CAP accreditation process).
How IHS helps
IHS markets a process, applied to the CAP checklists your laboratory holds:
- Gap assessment of the quality system against the checklists, and against ISO 15189:2022 where you have chosen CAP 15189.
- Questionnaires on personnel, proficiency testing oversight, document control and nonconformities.
- Document and evidence mapping: a crosswalk from each checklist requirement to the policy, record or log that shows it is met.
- Drafting quality-system policies, document-control and nonconformity procedures, and management-review records for your laboratory director to review and approve.
- Mock inspection document review against the same checklists before CAP arrives.
- Readiness support through the inspection and the 30-day deficiency response.
What you supply: the checklists, your SOPs, proficiency testing records, and your laboratory director and scientists.
The limit: method validation and test performance are scientific and technical. IHS works only on the quality-system and documentation layer. Your laboratory applies to CAP and hosts the inspection; IHS does not apply on your behalf.
If your laboratory is weighing ACHC instead, see ACHC clinical laboratory accreditation.
What to have ready
- Your current CAP Accreditation Checklists, discipline-specific plus Laboratory General and All Common, with the edition noted (CAP).
- Your current CLIA certificate, and a plan for the "certificate of accreditation as required in subpart D" (42 CFR 493.551(b)(1)).
- Proficiency testing enrollment and results, since an accredited lab must "Meet the proficiency testing (PT) requirements in subpart H" (42 CFR 493.551(b)(3)).
- A list of every test method and specimen type, checked against CAP's scope: testing "using methodologies and clinical applications within the expertise of the program" (CAP).
- Your document-control procedure and the current controlled-document list.
- Nonconformity and corrective action records for the last cycle.
- Evidence for the CLIA, FDA and OSHA standards CAP says accredited labs must meet (CAP).
- If you plan CAP 15189: your copy of ISO 15189:2022 and a plan for CAP's "Three-year accreditation cycle includes Year One accreditation assessment, Year Two surveillance assessment (management standards), and Year Three surveillance assessment (technical standards)" (CAP 15189).
- An owner and calendar time for the 30-day deficiency response (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 your test menu, your specialties and what your customers and payers ask for.
| Route | What the sources say |
|---|---|
| CAP Laboratory Accreditation Program | CMS deeming authority; a CAP inspection in lieu of a CMS inspection; on-site inspection every two years (CAP). |
| CAP 15189 (ISO 15189:2022) | An add-on with CAP laboratory accreditation as the prerequisite; a three-year cycle of an accreditation assessment and two surveillance assessments (CAP 15189). |
| COLA | "COLA is approved by CMS to accredit these CLIA Specialties"; "Your laboratory receives the COLA Accreditation Certificate for your two-year cycle" (COLA). |
| The Joint Commission, A2LA, ACHC, AABB, ASHI | Listed by CMS as approved CLIA accreditation organizations; specialty coverage differs by organization (CMS list). For ACHC, see our ACHC page. |
| No accreditation | IHS's reading (October 2026): a laboratory that is not accredited meets CLIA through a CMS or state certificate, and which certificate type and survey applies depends on the testing it performs (certificate of waiver laboratories are a separate case that IHS has not reviewed). CLIA's certificate types are named in 42 CFR 493.3(a)(1). |
What it costs
CAP does not publish a fee schedule on the pages we reviewed; fees depend on scope. The Laboratory Accreditation Program page invites laboratories to submit a fee estimate form (CAP), and CAP's process page 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). CLIA certificate fees are set under 42 CFR Part 493, subpart F (42 CFR 493.551(b)(2)). Verify current fees with CAP and CMS. IHS scopes each engagement after a free introductory call.
What this is not
- IHS is not CAP or CMS and does not grant, predict or influence an accreditation or certification decision.
- IHS does not contact, apply to or speak for your laboratory to CAP or CMS. IHS drafts; your laboratory applies and hosts the inspection.
- IHS does not validate methods or judge test performance, and this page is not legal or scientific advice.
Frequently asked questions
What is CAP accreditation for a clinical laboratory?
It is the College of American Pathologists' Laboratory Accreditation Program, which accredits laboratories testing human or animal specimens within the program's expertise. CMS has granted the program deeming authority, and CAP inspects on site every two years against its Accreditation Checklists.
Does CAP accreditation replace a CMS or state CLIA survey?
CAP states that CMS granted its Laboratory Accreditation Program deeming authority, which allows for a CAP inspection in lieu of a CMS inspection. Under 42 CFR 493.551(b), the laboratory must still obtain a certificate of accreditation, pay the applicable CLIA fees and meet the proficiency testing requirements.
Which organizations can accredit a lab for CLIA purposes?
CMS lists ACHC, A2LA, ASHI, AABB, CAP, COLA and The Joint Commission as approved accreditation organizations. Specialty coverage differs by organization, so check the CMS table against your test menu.
How is CAP different from COLA?
Both are on CMS's approved list. CAP inspects on site every two years against its Accreditation Checklists, and CAP accreditation is the prerequisite for CAP 15189. COLA says it is approved by CMS to accredit listed CLIA specialties and issues its certificate for a two-year cycle.
What is the difference between CAP and ISO 15189, and do we need both?
CAP laboratory accreditation is inspected against CAP's checklists, and CMS has granted CAP deeming authority under CLIA. CAP 15189 accredits to ISO 15189:2022, Medical Laboratories—Requirements for quality and competency, on a three-year cycle. Whether you need both depends on your own goals; IHS does not decide that for you.
Is CAP Laboratory Accreditation a prerequisite for CAP 15189?
Yes. CAP's 15189 page states that the CAP's Laboratory accreditation program is a prerequisite.
How long does it take to get CAP accredited?
CAP's general accreditation process page shows a timeframe of 13 to 24 weeks beside its application-to-inspection steps. Confirm with CAP how that range applies to your laboratory's application.
What happens after a CAP inspection finds deficiencies?
CAP's published process says to respond to deficiencies within 30 days, after which CAP reviews the responses before issuing the certificate of accreditation. IHS can help draft the corrective documents; your laboratory submits the response.
How much does CAP accreditation cost?
CAP does not publish a fee schedule on the pages we reviewed and asks laboratories to submit 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.
Can we get a mock CAP inspection before the real one?
IHS runs a mock inspection document review against the CAP checklists your laboratory holds, after drafting the quality-system documents your director approves. It is a review of documents and evidence, not a CAP inspection, and it does not predict CAP's findings.