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)
- New Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services
- S&C 04-16, Clinical Laboratory Improvements (CLIA) Policy and Data Reporting Guidance for First Survey Cycle Following the Effective Date of CMS-2226-F - (PDF 81K)
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- Attachment 1 - (PDF 82K)
- Attachment 2 - (PDF 32K)
- Attachment 3 - (PDF 544K)
- Attachment 4 - (PDF 1.4M)
- Attachment 5 - (Excel Zipped
5K)
- CLIA Updated Regulations Brochures
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- Brochure #1 - How do they affect my laboratory? - (PDF 542K)
- Brochure #2 - Verification of Performance Specifications - (PDF 192K)
- Brochure #3 - Calibration and Calibration Verification - (PDF 1.7M)
- Brochure #4 - Equivalent Quality Control
Procedures - (PDF 724K)
- Direct Access Testing (DAT) and the CLIA Regulations - (PDF 18K)
- Quality Assurance Guidelines for Testing Using the OraQuick® Rapid HIV-1 Antibody Test (CDC Site)
- January 24, 2003 Regulation - Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule (CMS-2226-F)
How to Apply for a CLIA Certificate: Form CMS-116
Program Description/Projects
- General Program Description
- Certificate Types
- Alternative Quality Assessment Survey
- Outcome Oriented Survey Process
- CLIA Performance Measures
- CMS CLIA Waived/PPMP Laboratory Project
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.
- CLIA Regulations Part 493--Most current - Includes all changes through 1/24/03 (CDC Site)
- CLIA Regulations Part 493--Revised as of October 1, 2000 (CDC Site)
- CLIA Regulations Part 493--Revised as of October 1, 1999 (CDC Site)
- CLIA Regulations Part 493--Revised as of October 1, 1998 (CDC Site)
- List of Published CLIA Rules/Notices/PDF Federal Register Documents (CDC Site)
- Search the Code of Federal Regulations (GPO Access Site)
- Search the Federal Register (GPO Access Site)
Categorization of Tests Under CLIA
- List of Waived Tests (PDF 265K)
- List of Provider-Performed Microscopy Procedures
- Test Complexity Database--All Complexities (FDA Site)
- Tests (CPT-4 and HCPCS Codes) Subject to CLIA
Edits (PDF 1.1M)
- Laboratory Certification (LC) Codes--CLIA Specialty and Subspecialty Information (for information purposes only) (PDF 44K) - Tests (CPT-4) Excluded From CLIA Edits (PDF 51K)
State Survey Agencies (CLIA Contact List)
CMS Regional Offices (CLIA Contact List)
List of Accrediting Organizations
List of States/Territories With Laboratory Licensure Programs
List of Proficiency Testing (PT) Providers (PDF 424K)
Certification Boards for Clinical Consultants and Directors of High Complexity Testing
Clinical Laboratory Information Resource for Medicare
CLIA Program Statistical Tables/Graphs
From CMS CLIA Data Base (August 2004)
- Total CLIA Laboratories Registered (PDF 22K)
- Percent of CLIA Laboratories By Certificate Type (PDF 18K)
- Physician Office Laboratories Under CLIA (PDF 15K)
- CLIA Accredited Laboratories (PDF 15K)
- Top Four CLIA Deficiencies Cited (PDF 50K)
- CLIA Update Statistics (PDF 23K)
- Overview of CLIA Statistics for the Last Decade (PDF 180K)
- Laboratories By Facility Type Under CLIA (PDF 29K)
- Laboratories By Certificate Type Under CLIA (PDF 91K)
- Certificate Of Compliance Laboratories By Certificate Schedule Under CLIA (PDF 28K)
CLIA-Related Hearing Decisions
Laboratory Registry (status of laboratory's compliance with CLIA requirements)
- 2003 Laboratory Registry (PDF 214K)
- 2002 Laboratory Registry (PDF 386K)
- 2001 Laboratory Registry (PDF 531K)
- 2000 Laboratory Registry (PDF 545K)
- 1999 Laboratory Registry (PDF 338K)
- 1998 Laboratory Registry
- 1997 Laboratory Registry
- 1996 Laboratory Registry
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