The 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). In total, CLIA covers approximately 260,000 laboratory entities. The Division of Clinical Laboratory Improvement & Quality, within the Quality, Safety & Oversight Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program. The objective of the CLIA program is to ensure quality laboratory testing. 

The College of American Pathologists (CAP) Laboratory Accreditation Program is an on-site, peer-inspection program that occurs every two years to assess the site’s compliance with CAP program requirements. The criteria checklist is updated annually, developed with input from more than 500 pathologists. CAP Laboratory Accreditation helps laboratories maintain accuracy of test results, ensure accurate patient diagnosis, exchange ideas and best practices among pathology and laboratory medicine peers, and manage rapidly evolving changes in laboratory medicine and technology.

A SAMHSA-certified laboratory is a clinical facility that administers drug screen procedures for employment purposes recognized federally by the Substance Abuse Mental Health Services Administration (SAMHSA), a division of the Department of Health and Human Services (DHHS). SAMHSA certification means a laboratory is authorized to perform forensic testing for regulated industries and federal agencies under federal regulation. This statute acts as both a deterrent and preventive measure against drug abuse in the workplace.