Quality Standards and Global Compliance
Because reference labs provide critical data that determines life-saving treatments, they are the most heavily regulated entities in healthcare.
CLIA (Clinical Laboratory Improvement Amendments): In the U.S., labs must meet strict federal standards for accuracy and reliability. By March 2026, the transition to fully digital, paperless CLIA certification is mandatory.
ISO 15189: This is the international "gold standard" for medical lab quality. It ensures that a test result from a lab in Milan is just as reliable as one from a lab in New York.
CAP Accreditation: The College of American Pathologists (CAP) conducts "peer-review" inspections to ensure the highest level of technical proficiency.
1 View