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December 2016 Texas Medicaid Provider Procedures Manual

Radiology and Laboratory Services Handbook : 2 Independent Laboratory : 2.1 Enrollment : 2.1.1 Clinical Laboratory Improvement Amendments (CLIA)

2.1.1
CLIA regulations set standards that are designed to improve quality in all laboratory testing and include specifications for quality control (QC), quality assurance (QA), patient test management, personnel, and proficiency testing.
The regulations concern all laboratory testing that is used for the assessment of human health or the diagnosis, prevention, or treatment of disease. Under CLIA 88, all clinical laboratory providers (including those located in physicians’ offices), regardless of location, size, or type of laboratory, must meet certain standards based on the complexity of the tests they perform.
Providers must hold the appropriate CLIA certificates to perform certain tests as indicated in this handbook.
Refer to:
The Centers for Medicare & Medicaid Services (CMS) website at www.cms.gov for the CLIA rules and regulations. The regulations are found at Title 42 Code of Federal Regulations, Part 493.

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