The federal Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). Any entity or facility performing drug or alcohol testing or screening on specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings is considered a laboratory and must obtain an appropriate CLIA certificate and meet the applicable CLIA standards or cease testing.
For information about CLIA, see: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html. To obtain an application for CLIA certification contact the Wisconsin Department of Health Services Division of Quality Assurance at: DHSDQACLIA@dhs.wisconsin.gov.
Wis. Admin. Code Department of Children and Families DCF 154.05