CSHCN 2008 > Provider Enrollment and Responsibilities > Provider Responsibilities

3.2.10.2 CLIA Regulations

CLIA regulations set standards designed to improve quality in all laboratory testing and include specifications for quality control, quality assurance, 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, 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.

CLIA Federal regulations, categorization listings, and survey procedures and interpretive guidelines for laboratories and laboratory services are available on the CMS website at www.cms.hhs.gov (click on the Medicare, then Clinical Laboratory Fee Schedule link. For more information, click on the CLIA Certificate Fee Schedule link). For help researching Regulations or the Federal Register call 1-866-272-6272.