Navigate Exceptions for CLIA Certificate Locations
Question: Our practice has multiple locations, and our providers perform tests that are considered waived under the Clinical Laboratory Improvement Amendments (CLIA) regulations. Do we need to have a CLIA certificate for each location or will one suffice for our practice? Arkansas Subscriber Answer: According to the Centers for Medicare & Medicaid Services (CMS), each laboratory location requires its own certificate, with three exceptions. Laboratories that are mobile or at an otherwise unfixed location, like labs that perform tests at health screening fairs or other temporary testing sites, can consider themselves covered under the certificate for their designated primary address. Laboratories that perform public health testing — which is defined as nonprofit or federal, state, or local government laboratories that perform, in combination, 15 or fewer moderately complex or waived tests per certificate — can be covered under a single certificate even if performed across multiple locations. Laboratories within a hospital but on the same campus and under the same laboratory director can be covered under a designated primary address/site. So if your practice’s laboratories do not fit within these circumstances, you probably need a separate certificate for each location. Rachel Dorrell, MA, MS, CPC-A, CPPM, Production Editor, AAPC
