Drug or Alcohol Screening/Testing and CLIA Certification

This memorandum provides additional guidance regarding the circumstances when laboratories performing drug or alcohol screening and/or testing must be CLIA certified, and should be considered an addendum to the attached February 05, 1993 memorandum Guidance on the Applicability of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to Substance Abuse Testing. We are restating our ongoing policy that laboratories performing drug or alcohol screening and/or testing followed by individual treatment must be CLIA-certified. Facilities found to be performing such testing without CLIA certification are in violation of CLIA.