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CLIA Program
Clinical Laboratory Improvement Amendments


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 175,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations 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. Here are helpful sites related to the Medicare and Medicaid programs.

Current CLIA News - (PDF 95K)

Special Alert

How to Apply for a CLIA Certificate: Form CMS-116

Program Description/Projects

CLIA Regulations and Federal Register Documents

Note: For help in searching Regulations or the Federal Register, call 1-202-512-1530 or 1-888-293-6498.

Categorization of Tests Under CLIA

CLIA Certificate Fee Schedule

State Survey Agencies (CLIA Contact List)

CMS Regional Offices (CLIA Contact List)

List of Accrediting Organizations

List of Exempt States

List of States/Territories With Laboratory Licensure Programs

List of Proficiency Testing (PT) Providers (PDF 424K)

20 Hour Continuing Medical Education (CME) Courses for Laboratory Directors of Moderate Complexity Laboratories (PDF 72K)

Certification Boards for Clinical Consultants and Directors of High Complexity Testing

Frequently Asked Questions

Clinical Laboratory Information Resource for Medicare

CLIA Program Statistical Tables/Graphs
From CMS CLIA Data Base (August 2004)

CLIA-Related Hearing Decisions

Laboratory Registry (status of laboratory's compliance with CLIA requirements)

OIG Reports Relating to CLIA

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Last Modified on Tuesday, October 05, 2004