Definition: CLIA certified? CAP accredited? What does this mean?

In simple terms, being CLIA certified and CAP accredited ensures your test results are meeting and exceeding industry standards for clinical laboratory testing.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) are federal regulations for United States based clinical laboratories to provide industry standards for testing of human samples for diagnostic purposes. These amendments were added to the laboratory requirements outlined in the Code of Federal Regulations, 42 CFR 493. Three federal agencies are responsible for ensuring compliance of laboratories to CLIA: the Food and Drug Administration (FDA), Center for Medicaid Services (CMS), and the Center for Disease Control (CDC). Having a CLIA certificate demonstrates that OralDNA® Labs meets the federal regulations for clinical diagnostic testing, ensuring quality and safety in the laboratory and laboratory results.

Further, a laboratory can pursue a higher level of quality by becoming accredited by a recognized accreditation agency. The College of American Pathologists (CAP) is such an agency. The CAP releases its own requirements building upon CLIA ’88 regulations. Compliance is assessed by a peer group site inspection every two years. Meeting these criteria ensures that industry specific standards for laboratory operation are upheld in the lab. These requirements can also point out areas for improvement in order to reach the highest level of quality.  Being able to show our clients that OralDNA® Labs has maintained CAP accreditation for years, only attests to our commitment to laboratory quality.

If you have any questions, please contact us by phone 855.ORALDNA (672.5362) or email support@oraldna.com.  To learn more about becoming an OralDNA® Labs Provider TEXT “OralDNA” to 31996!

Dana Willard

Dana Willard

Dana’s strong interest in seeing scientific research applied to molecular diagnostics lead her to complete her B.S in Biotechnology. Her Master of Science thesis involved the interaction of nuclear proteins with RNA processing. Dana shifted career direction from an academic setting to clinical laboratory work where she eventually joined Access Genetics. Her many skills include serving as a clinical lab supervisor, quality/regulatory roles and fulfilling CAP requirements as Technical Supervisor for Access Genetics/OralDNA® Labs.
Dana Willard

7 thoughts on “Definition: CLIA certified? CAP accredited? What does this mean?

  1. Is there a capacity level for CLIA and CAP certification or accredited? Are the number of tests limited by size or is it just a blanket approval?

    1. Ron McGlennen MD says:

      Licensure by CLIA, with the presumption of that lab being high-complexity, has only the requirement that there is at least one test offered for patient care. That application for care could be either for research or for conventional care. So, when a lab issues a test report for a patient, they need to be CLIA licensed. Accreditation by College of American Pathologists is a value-added credential.

      There are no volume limits to a CLIA licensed laboratory. The more testing, presumably, the better- for the laboratory.

  2. Mary Williams says:

    Is a CAP required (regulatory purposes) if a site has a CLIA and COLA ?

    1. Ron McGlennen MD says:

      Only CLIA is required, and in addition to the credentialing, they are a licensing agency. The choice of CAP or COLA and for that matter, AABB is often preference of the institution and sometimes geography. For example, COLA is preferred by labs that do forensic testing. AABB, another credentialing organization is favored by labs that do chemical analysis. CAP is by far and away preferred by labs that serve physicians and do diagnostic testing. Beyond that there is no objective way to say one credentialing agency is better than another. CAP is most popular.

  3. Ana Victoria Cruz says:

    My laboratory has a CLIA certification, butt not CAP accreditation.
    Do you think we need it, due any time soon we will be using GeneXpert machine?
    Thank Yo u

  4. Ron McGlennen MD says:

    Dear Sir/Madam;

    Thank you for your questions regarding accreditation of your laboratory.

    In the United States, licensing by CLIA is required by all laboratories offering testing for patient care. The absence of the appropriate level of CLIA certification is illegal. The additional credentialing by the College of American Pathologists, or any of several other “deemed status” organization is not required, but is a mark of quality and accountability.

    If your laboratory is offering only a single test, or if your volumes are small or dedicated to an exclusive number of patients, ie. associated with a single practice, the effort and expense to maintain CAP accreditation may be a consideration. On the other hand, the work and the associated status of obtaining CAP accreditation is a benefit to all patients. In specific to your laboratory, the use of the GeneXpert requires a high complexity CLIA certification and as such requires a level of expertise in the operating and support of testing from that platform that would be expected of any CAP accredited laboratory. For that reason, I would support a decision to seek CAP accreditation.

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