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Regulatory Information

Medical Laboratory Evaluation

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MLE offers prompt, knowledgeable customer service including experienced laboratory professionals to assist you with your regulatory questions. Call MLE Customer Service 800-338-2746, ext. 4510 or 202-261-4510, or
e-mail us at, if you have any questions about laboratory regulations or other laboratory-related questions not listed below.

Clinical Laboratory Improvement Amendments (CLIA) Regulations

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing performed on humans in the U.S. through CLIA. There are about 189,000 laboratories that fall under their oversight and are subject to CLIA standards and requirements. The Division of Laboratory Services, under the Center for Medicaid and State Operations (CMSO) has the responsibility for enforcing the CLIA Program. The main goal of the CLIA program is to ensure quality laboratory testing.

Accrediting Agency Websites

Additionally, other publications or laboratory information including compliance and coding is available from MLE/ACP Services for participants and non-participants. Visit our Education Resources site for a complete list of these products.

Changes were made to the Clinical Laboratory Improvement Amendments of 1988 and the Final Rule was published January 24, 2003. 

Laboratory Related Websites