|
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 200,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO) 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 plane);
- CMS initiatives to improve quality of laboratory testing under the CLIA program;
- Updated FYI CLIA information is contained in the Current CLIA News download;
- 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;
- CLIA presentation at NIAID/CMCR Workshop on the FDA Pre-Market Regulatory Process: Applications to Technologies for Radiation Biodosimetry After a Large-Scale Radiological Incident, March 27th, 2006, Bethesda, MD;
- Information on alternative (non-traditional) laboratory is contained in the Special Alert download;
- Survey and Certification memorandum entitled "Doctors of Optometry Serving as Directors and/or Technical Consultants for Laboratories Performing Moderate Complexity Testing"; and
- Identifying Best Practices in Laboratory Medicine - a Battelle Project for the Centers for Disease Control and Prevention (CDC).
For specific information about the quality assurance guidelines for testing using the OraQuick® Rapid HIV-1 Antibody Test, 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 navigation bar in this section.
Page Last Modified: 09/08/2008 3:21:37 PM
Help with File Formats and Plug-Ins
Submit Feedback
|
Email
Print