Established in 1988 and finalized in 1992, the
Clinical Laboratory Improvement Amendments, or “CLIA,” sets quality standards for laboratory testing of clinical specimens for patient diagnosis and treatment. CLIA aims to ensure accurate, reliable and timely diagnostic test results, no matter where testing is performed.
Most APHL member laboratories perform testing regulated under CLIA. Sites that conduct testing of clinical specimens for diagnosis, treatment or prevention of disease must obtain a CLIA certificate corresponding to the complexity of the tests performed. APHL holds educational sessions each year at the APHL annual meeting to update members and staff on current CLIA issues and also develops resources to assist members with CLIA certification.
CLIA Certification Checklists
Obtain proper specimens for testing:
Reinforce basic steps to obtain an accurate and quality result from tests that the Food and Drug Administration classifies as waived for low risk of error and ease to perform, even by non-laboratory personnel:
Clinical Laboratory Improvement Advisory Committee (CLIAC)
The Clinical Laboratory Improvement Advisory Committee (CLIAC), managed by the US Centers for Disease Control and Prevention (CDC), provides scientific and technical advice and guidance to the Department of Health and Human Services (HHS). The Committee includes diverse membership across laboratory specialties, professional roles, (laboratory management, technical, physicians, nurses) and practice settings (academic, clinical, public health), and includes a consumer representative.
Quality Improvement Forum Audio Files
APHL CLIA Policy
APHL Reports and Briefs
For more information, contact Tina Su, MPH, manager, Quality Systems, 240.485.2729,