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Louisiana CLIA and State Lab Requirements

The state lab license or registration, exemptions, fees and where the CMS-116 goes, with citations.

Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states

What testing sites miss in Louisiana

Does Louisiana require a state lab license on top of CLIA?

The Louisiana Department of Health's CLIA pages describe only federal CLIA certification, which LDH's Health Standards Section administers for CMS. No separate state laboratory facility license is described.

  • Does not reach waived-only labs

What does Louisiana charge?

No state laboratory fee; the lab pays only the CMS certificate fee.

Do labs in other states need a Louisiana license to test its specimens?

No state laboratory license was found, so a lab in another state needs nothing from this state to test its specimens beyond its own CLIA certificate.

Where does a Louisiana CMS-116 go?

  • Louisiana Department of Health, Health Standards Section, CLIA Program
  • Email: LDH.CLIA@la.gov
  • Phone: (225) 342-9324

Opening a testing site in Louisiana?

We prepare the CMS-116 and any Louisiana filing for your owner or director to sign, and track both to approval. You pay CMS and the state directly. A Certificate of Waiver application is $399 per site.

Sources

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