The CLIA'88 standards requires clinical laboratories to obtain one of four certificates--certificate of waiver; certificate of provider-performed microscopy; certificate of compliance or certificate of accreditation--to perform laboratory testing. The first three certificates can be obtained from the Centers for Medicare and Medicaid Services . The last certificate can be obtained from a listing of CLIA-approved accrediting organizations .
The laboratory regulations also require moderate and high complexity laboratories to conduct proficiency testing (PT) on each analyte they offer at least three times a year. The laboratory must contract with one of the CLIA-approved proficiency testing providers selected by CMS.