The Food & Drug Administration (FDA)
The Center for Disease Control and Prevention (CDC)
The Center for Medicare and Medicaid Services (CMS)
Accredited by the College of American Pathologists (CAP)
State licensed in New Jersey and Georgia
Compliant with HIPPA privacy guidelines & regulations
FDA – Categorizes tests based on complexity AND Develops rules/guidance for CLIA complexity categorization
CDC – Provides analysis, research, and technical assistance … Develops technical standards and laboratory practice guidelines, including standards and guidelines for cytology … Conducts laboratory quality improvement studies … Monitors proficiency testing practices
CMS – Conducts inspections and enforces regulatory compliance and Monitors laboratory performance on Proficiency Testing (PT) and approves PT programs
Diagnostic testing helps health care providers screen for or monitor specific diseases or conditions. It also helps assess patient health to make clinical decisions for patient care. The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct.
Three federal agencies are responsible for CLIA: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS) and the Center for Disease Control (CDC). Each agency has a unique role in assuring quality laboratory testing.