CLIA Requirements
Definition
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are federal regulatory standards that apply to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. The CLIA program applies to entities ranging from physician office laboratories to large commercial laboratories. CLIA certificates vary based on the complexity and risk of the tests performed. Types include Certificate of Waiver, Certificate for Provider-Performed Microscopy Procedures (PPMP), Certificate of Registration, Certificate of Compliance, and Certificate of Accreditation. Each certification corresponds to different testing complexities, from simple tests with a low risk of error to highly complex analyses.