This is the Nebraska state DHHS CLIA page. To reach the federal site, go to CMS.gov and type CLIA in the search bar.
Welcome to the Nebraska Clinical Laboratory Improvement Amendments (CLIA) Program. Our mission is to ensure that the highest quality of laboratory testing is performed in the State, through the use of education and enforcement of federal CLIA regulations.
Under CLIA, a laboratory is defined as a “facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings." This program certifies, inspects and monitors clinical labs for compliance of federal CLIA regulations, and investigates complaints received to ensure clinical laboratory testing is accurate, effective and reliable.
NOTE: The State of Nebraska does not have licensure requirements for CLIA laboratories or CLIA lab personnel. Nebraska fully participates in the Federal CLIA program and any laboratory or lab personnel operating in the State of Nebraska or testing samples from the State of Nebraska must follow the federal CLIA regulations.
Hospital Licensing Web Page
How to Obtain a CLIA CertificateHow to Obtain a CLIA Certificate of Waiver
To be initially certified as a CLIA lab in Nebraska, you must complete the following forms:
Submit these documents with original signatures to:
DHHS Public Health – Licensure Unit/CLIA Po Box 94669301 Centennial Mall South Lincoln, NE 68509-4669
Fees: CMS.gov Clinical Laboratory Fee Schedule
NOTE: The State of Nebraska does not collect CLIA user fees. You will receive a CLIA Fee Coupon which will provide you with the address/directions to pay your fees online or via mail.
Online payment can be made by credit card using the following link: https://www.pay.gov/paygov/. On the top under Search type in CLIA and click "search." It will bring up CLIA Laboratory User Fees. Click "Continue to the form" twice and then enter the laboratory name, CLIA number, address and payment amount. Continue by following the prompts.
Renewals: Renewal billing statements are automatically mailed out from the federal CLIA system beginning six months prior to the current certification expiration date for CLIA certificates of waiver, PPM and certificates of accreditation labs. For certificate of compliance labs, the renewals are mailed 12 months prior to the current certificate expiration date.
A CLIA lab must submit a new CMS-116 form for:
For Certificate of Accreditation Lab Director changes - submit directly to the accrediting organization
For certificate type changes, in addition to the CMS-116 form you must submit a new List of Tests Performed.
For Change of Ownership, in addition to the CMS-116 form you must submit the CLIA Ownership Information form.
CMS: CMS.gov Clinical Labs Center
FDA: FDA.gov Medical Devices
CDC: CDC.gov CLIA
How to Obtain a CLIA Certificate
How to Obtain a CLIA Certificate of Waiver
Regulations: CMS.gov State Operations Manual
DHHS Licensure UnitAttn: CLIA Labs
PO Box 94669Lincoln NE 68509-4669