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
Note:
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Last Modified on Tuesday, October 05, 2004
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