Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Nebraska
- A certificate type change needs a new List of Tests Performed along with the new CMS-116.
- Pre-employment drug screens whose results are not used to send the employee to treatment do not need a CLIA certificate, according to the Nebraska CLIA FAQ.
Does Nebraska require a state lab license on top of CLIA?
Nebraska has no licensure requirement for CLIA laboratories or lab personnel. Labs operating in Nebraska, or testing Nebraska samples, follow the federal CLIA rules.
- Does not reach waived-only labs
Do labs in other states need a Nebraska license to test its specimens?
No Nebraska license is needed. Out-of-state labs testing Nebraska samples must follow federal CLIA, and an out-of-state lab running a health fair in Nebraska on its home-state certificate should tell the Nebraska CLIA Program.
Does Nebraska add a form to the CMS-116?
Nebraska asks for a CLIA Ownership Information Form and a List of Tests Performed with the CMS-116, sent with original signatures by mail or email to the Licensure Unit.
Where does a Nebraska CMS-116 go?
- Nebraska Department of Health and Human Services, Division of Public Health, Licensure Unit, Office of Acute Care Facilities
- Email: DHHS.acutecarefacilities@nebraska.gov
- Phone: (402) 471-3484
Opening a testing site in Nebraska?
We prepare the CMS-116 and any Nebraska 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.