I work for a small family practice, we currently have a CLIA# however it does expire soon. Do we really need it? We do the phlebotomy part, as well as other procedures in getting the other specimens/fluids, etc., but we send it to an outside lab for processing. They send us back the results. My question is, does a medical office need a CLIA license (Clinical Laboratory Improvement Amendments) from the state to perform the acquiring the said blood/fluids/etc? If the medical office does not have the said CLIA number, does it mean, the acquring of said fluids from the patient is illegal and not billable? Is there someone I can call to find out details? Would we just use a modifier indicating we only attained the specimens?

TIA