Clinical Laboratory Improvement Amendments

• About CLIA
• Eligibility for multiple-site certificate
• CLIA Waived Testing

Resources

• CLIA-116 application
• US Food and Drug Administration's CLIA Waived Only Testing
• Centers for Medicare & Medicaid Services CLIA Overview
• US Food and Drug Administration's CLIA Database

Contact Information:

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Eligibility for a
Multiple-Site Laboratory

Each location where laboratory tests are performed must file a separate application, unless it meets one of the following exceptions as outlined in 42 CFR 493.35(b), 493.43(b) and 493.55(b):

1. Laboratories that are not at a fixed location, i.e., laboratories that move from testing site to testing site, such as mobile units providing laboratory testing, health screening fairs, or other temporary testing locations may be covered under the CLIA certificate and address of the designated primary site or home base.
2. Not-for-profit or Federal, State, or local government laboratories that engage in limited (not more than a combination of 15 types of moderately complex or waived tests per certificate) public health testing may file a single application.
3. Laboratories within a hospital that are located at contiguous buildings on the same campus and under common direction may file a single application or multiple applications for CLIA certificate(s) for the laboratory sites within the same physical location or street address.

Certificate and Fees

Laboratories Performing Limited Public Health Testing (Exception 2)

• The Certificate should indicate the highest complexity level of testing performed (moderate or waived).
• No high complexity testing may be performed at any of the locations.
• The Certificate fee will be based on the total test volume of all moderate complexity tests performed at all locations.

Application for Multiple Site Status

Entities who believe they qualify for ‘Multiple Site’ status must submit their request using the CMS-116 application.

• On page 2 of the application, the laboratory should check “Yes” for the multiple site exception. The laboratory should indicate which exception applies to their situation (Exception 1, 2, or 3).
• Finally, the laboratory should fill out the bottom section of page 2 indicating the name and address of each location and the tests performed. If additional space is needed, please attach that information using the same format.