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Frequently Asked Questions

Frequently Asked Questions1. How do I know if I need CLIA certification?CLIA certification is required for facilities thattest clinical specimens for the purpose ofdiagnosis, treatment, or prevention of disease. Ifyour facility only collects specimens tobe sent out for testing at another facility, thenCLIA certification is not required for yourfacility. Laboratories performing research only testing,laboratories operated directly bythe Federal Government (for example VA, DOD), or laboratorytesting for the hiring ortermination of employees are CLIA-exempt and do notrequire CLIA certification. Thereare four certification types, depending on the typeof testing performed: Certificate ofWaiver, Certificate of PPM, Certificate of Complianceor Certificate of Accreditation. Allcertifications are valid for a 2 year Where do I get the CLIA application?

Once the laboratory receives the invoice from CMS,there are 2 ways to make a payment. The facility may mail a check to the PO Boxaddress listed on the fee coupon: CLIA Laboratory Program P.O. Box 530882 Atlanta, GA 30353-0882 or pay online atwww.pay.gov(enter “CLIA” in thesearch area).Do not send payment 5. How do I tmoatkhee ...

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