What are the objectives of 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 254,000 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 objectives of 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, these downloads/links listed below can be referred:
- For additional information about a particular laboratory, the appropriateState Agency or Regional Office CLIA contact must be contacted;
- 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”;
- CMS Blog – FDA & CMS Form Task Force on LDT Quality Requirements;
- 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;
- 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);
- FDA Safety Tip for laboratories on how workload should be calculated when using currently FDA-approved semi-automated gynecologic cytology screening devices; and
- CDC educational booklet, “PROVIDER-PERFORMED MICROSCOPY PROCEDURES – A Focus on Quality Practices” (In the Related Links section.).
Complaint Reporting.
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 must be contacted, in case of a complaint to be reported about a laboratory.