Lab Compliance Guide

CLIA Waiver Guide

Understand when CLIA applies, how testing purpose affects certification, and when collection-only activities fall outside CLIA.

Start with these two questions.
State requirements and specific testing arrangements can still affect the final answer.

Do you perform the test onsite?

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No — we only collect and send the specimen to a laboratory

No CLIA certificate is required for the collection itself. 42 CFR § 493.2

End

Yes — we perform the test onsite

How will the result be used?

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Solely for an employment decision — not for health assessment, diagnosis, prevention or treatment

Federal CLIA requirements generally do not apply when testing is performed solely for an employment decision and the result is not used to assess health or diagnose, prevent or treat a disease or impairment. CMS specifically identifies pre-employment drug screening as an example that may not require a CLIA certificate. Check applicable state requirements.

To assess someone’s health or help diagnose, prevent or treat a disease or impairment

The testing site needs the appropriate CLIA certificate before performing testing used to assess someone’s health or to diagnose, prevent or treat a disease or impairment. 42 CFR §§ 493.2 and 493.3(a)

Is it a CLIA-waived test?

“Waived” means the test is considered simple and has a low risk of an incorrect result when performed properly. It does not mean the testing site is exempt. The testing site still needs a CLIA certificate that permits waived testing when the test is performed for clinical purposes.

The bottom line

Collecting a specimen is not the same as performing clinical testing. What matters is why the test is performed and how the result will be used.

General educational information, not legal advice. Confirm your situation against current federal regulations, CMS guidance and your state’s requirements.

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