Which statement about CLIA certificates is true?

• A. They Are Issued By The CMS Only After Labs Pass A Proficiency Test
• B. They Are Not Required For Labs That Perform Only Research Testing
• C. They Can Be Issued After A Lab Is Accredited By A CMS-Approved Accrediting Organization
• D. They Guarantee Universal Coverage

Answer: (C)

CLIA certificates confirm that a laboratory meets federal quality standards for testing human specimens. A lab can receive a certificate in one of two ways: either CMS surveys the lab and issues a Certificate of Compliance, or the lab is accredited by a CMS-approved accrediting organization (such as CAP, Joint Commission, COLA, or AABB), which leads to a Certificate of Accreditation. This route—accreditation by a CMS-approved organization—is why the statement is true. Proficiency testing is an important ongoing requirement for many tests, but it does not by itself determine when the certificate is issued. The certificate does not guarantee universal coverage.