Center of Medicare and Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance during COVID-19 Public Health Emergency

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Division of Quality Assurance: Notifications & Updates

Attn: All Wisconsin Providers Performing Laboratory Testing

Center of Medicare and Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance during COVID-19 Public Health EmergencyEnter your message here. 

CMS has issued this memorandum to provide important guidance for CLIA laboratories regarding the review of pathology slides, proficiency testing, alternate collection devices, and requirements for a CLIA certificate during the COVID-19 public health emergency.

All guidance in this memorandum is applicable only during the COVID-19 public health emergency. CMS has also issued a CLIA Frequently Asked Questions (FAQs) document for further guidance during the COVID-19 emergency:

Laboratories that are accredited must follow Accrediting Organization (AO) requirements. All laboratories need to also follow any State laws governing laboratories, which may be more stringent than CLIA.

For regulatory questions about these documents please contact CMS at LabExcellence@cms.hhs.gov.