Frequently Asked Questions

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FAQ

Is a separate CLIA certificate need for each physical building that is under the same name?

In general under CLIA, a separate CLIA certificate is needed for each laboratory location. However the following exceptions exist:

  • Laboratories that are not at a fixed location, that is, 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 certificate of the designated primary site or home base, using its address.
  • Not-for-profit or Federal, State, or local government laboratories that engage in limited (not more than a combination of 15 moderately complex or waived tests per certificate) public health testing may file a single application.
  • 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 the laboratory sites within the same physical location or street address

(FAQ12558)

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