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.
• An APHL series of bench aids is under development 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. Download the first of the series to review proper urine dipstick testing techniques and to train staff new to the test.
• An issue brief details best practices in filing for and maintaining a single application to comply with CLIA, and benefit from the exemption from multiple filings to which laboratories are eligible if they perform limited public health diagnostic testing.
• After a CLIA survey, CMS welcomes your feedback. Please complete the Post Clinical Laboratory Survey Questionnaire.