Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Rhode Island
- A waived-only site in Rhode Island needs its CLIA Certificate of Waiver but no state lab license, while a PPM or nonwaived site outside the physician exemption needs both.
- Health fairs and other temporary public screening programs need a Department of Health screening permit.
Does Rhode Island require a state lab license on top of CLIA?
Rhode Island licenses clinical laboratories and collection stations, including out-of-state labs testing specimens collected there. The law exempts anyone performing only limited-function tests, which the rules define as CLIA-waived tests, and pharmacists performing them, so a waived-only site needs no state license.
- Clinical laboratory license (and station license for collection sites)
- Issued by Rhode Island Department of Health
- Does not reach waived-only labs
Citation: R.I. Gen. Laws 23-16.2-3, 23-16.2-4; 216-RICR-60-05-4
Who is exempt in Rhode Island?
Hospital labs; physicians testing personally and solely for their own patients (an independent lab testing for them is covered); permitted health promotion screening programs; anyone performing only CLIA-waived tests; pharmacists performing waived tests.
Citation: R.I. Gen. Laws 23-16.2-3; 216-RICR-60-05-4.2, 4.3
What does Rhode Island charge?
Station license $650 biennial; screening program permit $70 (as of October 2026).
- PPM: $650 per approved specialty for a biennial license, unless exempt (as of October 2026)
Citation: 216-RICR-10-05-2
How often does a Rhode Island lab registration renew?
- Renews every two years
- Due Licenses expire December 30 of every other year; file the renewal one month before expiration.
Do labs in other states need a Rhode Island license to test its specimens?
Any out-of-state lab testing specimens collected in Rhode Island must hold a Rhode Island license, at $650 per specialty every 2 years. The Department reviews its CLIA certification and home-state license first.
Citation: 216-RICR-60-05-4.5(F); 216-RICR-10-05-2
Where does a Rhode Island CMS-116 go?
- Rhode Island Department of Health, Division of Facilities Regulation
- Email: DOH.OFR@health.ri.gov
- Phone: (401) 222-2721
Opening a testing site in Rhode Island?
We prepare the CMS-116 and any Rhode Island 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.