Interim Final Rule (IFC), CMS-3401-IFC, Updating Requirements for Reporting of SARS-CoV-2 Test Results by Clinical Laboratory Improvement Amendments of 1988 (CLIA) Laboratories, and Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency

Attention: Clinical Laboratories Please share this information with individuals in the following roles: Accreditation Coordinator Quality Director Medical Director – Laboratory Key points: ALL laboratories regardless of CLIA type (including those with a Certificate of Waiver and Point of Care testing) must report both positive and negative results to their state or local public health…

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Interim Final Rule: Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency

Attention: Acute Care Hospitals Critical Access Hospitals Clinical Laboratories Please share this with individuals in the following roles: Chief Nursing Officer Accreditation Coordinator Infection Control Program Leader Quality Director Medical Director – Laboratory Services Key points: On August 25, 2020, CMS announced regulatory changes. The changes were published in the Federal Register on September 2,…

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Laboratory Alert: Safety letter about the Thermo Fisher Scientific TaqPath COVID-19 Combo Kit

Attention: Clinical Laboratories Please share this announcement with: Medical Director, Laboratory Services Administrative Director and Manager(s), Laboratory Services Posted 08.18.2020 by: Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS) Center for Surveillance, Epidemiology, and Laboratory Services (CSELS) Centers for Disease Control and Prevention (CDC) On August 17, 2020, the U.S. Food and Drug…

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Laboratory Alert: new COVID antigen testing guidance

Attention: Clinical Laboratories Please share this announcement with: Medical Director, Laboratory Services Administrative Director and Manager(s), Laboratory Services Posted 08.16.2020 by: Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS) Center for Surveillance, Epidemiology, and Laboratory Services (CSELS) Centers for Disease Control and Prevention (CDC) CDC recently issued new antigen testing guidance for evaluating and…

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