TMPPM 2008 > Texas Medicaid Services > Independent Laboratory > Clinical Laboratory Improvement Amendments (CLIA)

26.2.2 CLIA Regulations

CMS implemented CLIA rules and regulations. The CLIA regulations were published in the February 28, 1992, Federal Register and have been amended several times since. The regulations are found at Title 42 Code of Federal Regulations, Part 493.

The CLIA rules and regulations are available on the CMS website at www.cms.gov.

CLIA regulations set standards 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. These regulations concern all laboratory testing used for the assessment of human health or the diagnosis, prevention, or treatment of disease. Under CLIA 88, all clinical laboratories (including those located in physicians' offices), regardless of location, size, or type of laboratory, must meet standards based on the complexity of the test(s) they perform.