Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Utah
- Approved Utah labs must report changes to the program within 30 calendar days and keep a valid CLIA certificate for each approved specialty.
Does Utah require a state lab license on top of CLIA?
Utah rule R444-1 says a facility may not operate as a laboratory for a specialty or subspecialty until the Department approves it, and approval requires a valid CLIA certificate plus the location, director, CLIA number and specialties. Whether this is a filing separate from the CMS-116, and whether it reaches waived-only sites, was not confirmed.
- Department approval of a laboratory by specialty (Rule R444-1)
- Issued by Utah Department of Health and Human Services, Clinical Lab Certification Program
Citation: Utah Admin. Code R444-1-1, R444-1-3
Who is exempt in Utah?
Entities that only collect or prepare specimens, or only serve as a mailing service, are exempt from the approval rule.
Citation: Utah Admin. Code R444-1-1(3)
Where does a Utah CMS-116 go?
- Utah Unified State Laboratories: Public Health, Bureau of Laboratory Improvement
- Email: labimprovement@utah.gov
- Phone: (801) 538-4151
Opening a testing site in Utah?
We prepare the CMS-116 and any Utah 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.