I perform Point-of-Care tests at multiple locations. Do I need a CLIA Certificate of Waiver for each location?
Yes. A CLIA Certificate of Waiver is required for each location unless the following regulatory exemptions apply:
The location isn't fixed (e.g. mobile unit, health screen fairs, or other temporary testing locations) and it may be covered under the certificate of the designated primary site or home base.
Is a not-for-profit, or a Federal, State, or local government laboratory engaged in limited (not more than a combination of 15 waived tests per certificate) public health testing and filing for a single certificate for multiple sites.
Is a hospital with several laboratories located at contiguous buildings on the same campus within the same physical location or street address and under common direction.
The location isn't fixed (e.g. mobile unit, health screen fairs, or other temporary testing locations) and it may be covered under the certificate of the designated primary site or home base.
Is a not-for-profit, or a Federal, State, or local government laboratory engaged in limited (not more than a combination of 15 waived tests per certificate) public health testing and filing for a single certificate for multiple sites.
Is a hospital with several laboratories located at contiguous buildings on the same campus within the same physical location or street address and under common direction.