Which statement describes a Certificate of Accreditation (COA) under CLIA?

• A. The COA Is Issued By CMS After On-Site State Survey
• B. The COA Is Issued To Labs After Accreditation By CMS-Approved Accrediting Organization
• C. The COA Is The Same As The Certificate Of Compliance
• D. The COA Is Issued To Labs Without Accreditation

Answer: (B)

Under CLIA, a laboratory can demonstrate compliance either through a direct CMS survey that leads to a Certificate of Compliance, or through accreditation by a CMS-approved accrediting organization that leads to a Certificate of Accreditation. The Certificate of Accreditation is issued only after the lab has been accredited by one of these CMS-approved bodies, which means the lab met CLIA standards as evaluated by an independent accrediting organization. It isn’t issued by CMS after an on-site CMS survey, and it isn’t the same document as a Certificate of Compliance. It also isn’t given to labs that aren’t accredited.