What FDA expects is that each clini

What FDA expects is that each clinical study site use a clinical laboratory that is qualified to do the clinical testing specified in the protocol. In the US, this will usually be a CLIA certified laboratory. For some highly specialized tests, only a few laboratories may actually be qualified to perform the test, some based at academia or private laboratories that only do the test in question and therefore have no reason to hold a CLIA certification. Other documentation of their qualification to perform the specific test(s) would then be necessary.