Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Oregon
- Health screen testing means testing to identify health risks and refer people to care. The permit allows 9 specified screening tests without a practitioner's order at a health fair; other clinical testing in Oregon needs an order from someone Oregon allows to order tests.
- The Oregon rules on the state website still print the pre-2025 annual license fees ($75 waived, $100 PPM), but the statutes that imposed the license were repealed.
Does Oregon require a state lab license on top of CLIA?
Oregon no longer issues a separate clinical laboratory license: a 2025 law repealed the old licensing sections, and ORS 438.040 now requires only a CLIA certificate issued by the state or federal government. Separate state permits remain for health screen testing and non-medical substance of abuse screening.
- Does not reach waived-only labs
Citation: ORS 438.040 (as amended by Oregon Laws 2025, chapter 624)
What does Oregon charge?
Health screen testing permit: $150 biennial, expiring June 30 of even-numbered years (as of October 2026).
Citation: OAR 333-024-0380
Do labs in other states need a Oregon license to test its specimens?
An out-of-state lab testing Oregon specimens needs only a current CLIA certificate for its level of testing. A lab in or out of Oregon does need an Oregon permit to run health screen testing in Oregon, such as health fair testing.
Citation: ORS 438.060; OAR 333-024-0380(3)
Does Oregon add a form to the CMS-116?
Address, phone and name changes go on Oregon's own Change Request form; the CMS-116 is still used for initial applications, certificate type changes and PPM or Compliance director changes.
Where does a Oregon CMS-116 go?
- Oregon Health Authority, Oregon State Public Health Laboratory, Laboratory Compliance Section
- Email: LC.info@odhsoha.oregon.gov
- Phone: (503) 693-4125
Opening a testing site in Oregon?
We prepare the CMS-116 and any Oregon 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
- stateAgency (CMS list updated May 2026)
- stateLicense (438.040; license sections repealed by 2025 c.624), outOfStateLabs (438.060), notes (health screen testing definition, 438.010)
- stateLicense (state programs: SOA registration, health screen testing permit), supplement
- fees.other, outOfStateLabs, notes (office exemption)
- outOfStateLabs (CLIA certificate only), notes (Oregon regulates who may order tests; 9 health fair tests without an order)
- notes (fee table still printed in the rule)