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What you need to know

What you need to know

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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.

FAQs

CMS Website

Complaints

Hospital Licensing Web Page

Workplace COVID-19 Testing

In an effort to provide support to workplaces that may be doing COVID-19 testing, CMS has prepared materials to outline the simple steps necessary to do this. Generally, a CLIA certificate of waiver is necessary for a workplace to do testing. For information regarding CLIA requirements and the application process for workplace COVID-19 testing, please see the Quick Start Guide for COVID-10 Testing in the Workplace and the Workplace COVID-19 Testing Fact Sheet​.
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How to get certification for in-school COVID-19 testing

​Click here for the COVID School Testing Factsheet​.
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Certification & Fees

FAQs

How to Obtain a CLIA Certificate
How 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 94669
301 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.

Changes

FAQs

A CLIA lab must submit a new CMS-116 form for:

  • Initial application
  • Survey, initial or recertification
  • Certificate type changes
  • Reinstatement of a CLIA certificate
  • Director changes
    • PPM (Provider-performed Microscopy) lab
    • Certificate of Compliance labs
    • Certificate of Waiver labs

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.

Resources & Regulations

FAQs

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

CLIA - Clinical Laboratories
Department of Health & Human Services/Public Health/Licensure Unit
Phone Number
(402) 471-4363
 
Fax Number
(402) 742-8319
Mailing Address

DHHS Licensure Unit
Attn: CLIA Labs

PO Box 94669
Lincoln NE 68509-4669