Clinical Laboratory Improvement Amendments (CLIA)

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 244,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification 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. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.

For the following information, refer to the downloads/links listed below:

• For additional information about a particular laboratory, contact the appropriate State Agency or Regional Office CLIA contact (refer to State Agency or Regional Office CLIA link found on the left-hand navigation pane);
• Information about what is CMS’ authority regarding Laboratory Developed Tests (LDTs) and how does it differ from FDA’s authority is found in the downloads section in the file called "LDT and CLIA FAQs";
• Information on research testing and CLIA is found in the file called "Research Testing and CLIA";
• Information about direct access testing (DAT) and the CLIA regulations is included in the Direct Access Testing download;
• OIG reports relating to CLIA;
• Guidance for Coordination of CLIA Activities Among CMS Central Office, CMS Regional Offices, State Agencies (including State with Licensure Requirements), Accreditation Organizations and States with CMS Approved State Laboratory Programs is contained in the Partners in Laboratory Oversight download;
• Quality control (QC) highlights from the regulations published in the Federal Register on January 24, 2003 are listed under the QC Highlights download;
• Micro sample pipetting information for laboratories;
• Information on alternative (non-traditional) laboratory is contained in the Special Alert download;
• Identifying Best Practices in Laboratory Medicine - a Battelle Project for the Centers for Disease Control and Prevention (CDC); and
• FDA Safety Tip for laboratories on how workload should be calculated when using currently FDA-approved semi-automated gynecologic cytology screening devices.

For specific information about the quality assurance guidelines for testing using the rapid HIV-1 antibody tests waived under CLIA, refer to the CDC Division of Laboratory Systems website listed under the related links outside CMS section below.

Complaint Reporting

To report a complaint about a laboratory, contact the appropriate State Agency that is found on the State Agency & Regional Office CLIA Contacts page located in the left-hand navigation pane in this section.