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CLIA Program
Clinical Laboratory Improvement Amendments

The federal government requires that all entities performing laboratory testing (except for research purposes) on humans be certified and in compliance with the regulations for Clinical Laboratory Improvement Amendments (CLIA) to ensure quality laboratory testing.

For assistance with answering your questions or completing your CLIA Application contact our office:

Information on the CLIA Program is available on the internet.  The web address is: www.cms.hhs.gov/clia/

SCROLL DOWN TO FIND:

1. Regulations are titled "CLIA Regulations Part 493--Most current – Includes all changes through 1/24/03 (CDC Site)
2. Interpretive Guidelines are titled "New Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services

FDA CLIA Home Page http://www.fda.gov/cdrh/clia/index.html

INITIAL CERTIFICATION

The CLIA Application for Certification form CMS-116 is available on the internet.  The web address is:  http://www.cms.hhs.gov/cmsforms/downloads/cms116.pdf

The State of Nebraska requires that two additional forms be completed along with the CMS-116 Application for Certification Form: 

CLIA Ownership Information Form

List of Tests Performed

STATE LICENSURE

The State of Nebraska does not have licensure requirements for laboratory personnel or laboratories.   The State of Nebraska fully participates in the Federal CLIA program and any laboratory or laboratory personnel operating in the State of Nebraska or testing samples from the State of Nebraska must follow the Federal CLIA regulations.

WAIVED TESTING

A current listing of the FDA CLIA Waived Test List is available from the internet at the following websites:

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/testswaived.cfm

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

If you want to check a test’s complexity, go to this website:

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm

CLIA CHANGE FORMS

Laboratories certified under the CLIA program must meet the following conditions:

(a) Notify HHS or its designee within 30 days of any change in--

1. Ownership;
2. Name;
3. Location;
4. Director; or
5. Technical supervisor (laboratories performing high complexity only).

New-Laboratory Changes that Require Submitting a New Form CMS-116

A new form CMS-116 MUST be obtained when any of the following laboratory changes takes place:

• Initial application
• Survey, initial or recertification
• Status changes other than to a Certificate of Waiver
• Reinstatement of CLIA certificate
• Director change (Provider-Performed Microscopy (PPM) Certificate or Certificate of Compliance)

For ownership changes - also complete the CLIA Ownership Information Form.

For certificate type changes - also complete the List of Tests Performed.

CLIA Change form

CLIA Ownership Information Form

Lists of Tests Performed

Guidelines for Counting Tests

CLIA CMS-116 Form- Clinical Laboratory Improvement Amendments Application for Certification

Documents in PDF format require the use of Adobe Acrobat Reader which can be downloaded for free from Adobe Systems, Inc. 

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