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. For more information, visit
www.cms.gov/clia.
APHL develops educational sessions, materials and resources to assist members with CLIA certification:
• Education sessions are held each year at the APHL annual meeting to update members and staff on current CLIA issues.
• Three sets of bench aids have been developed to assist laboratories in understanding the CLIA regulations (see CLIA Guidelines Bench Aids), to obtain the proper specimens for testing (see Sample Collection Bench Aids) and to 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 (see Testing Instructions Bench Aid). All are available to download and print as needed. If you have suggestions for additional bench aids, please contact Karen Breckenridge at
karen.breckenridge@aphl.org.
Checklists
Sample Collection Bench Aids
CLIA Guidelines Bench Aids
Testing Instructions Bench Aid
Other CLIA Related Resources
For more information contact, Karen Breckenridge, MBA, MT(ASCP), Director of Quality Systems, 240.485.2756,
karen.breckenridge@aphl.org