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

Acute Care Hospital Program, Clinical Laboratory Program, Critical Access Hospital Program

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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No FDA pre-market review or review of EUA requests for LDTs for SARS-CoV-2

Acute Care Hospital Program, Clinical Laboratory Program, Critical Access Hospital Program

Attention: Clinical Laboratory Professionals Please share the following with: Medical Director, Laboratory Services Lab Manager(s) The U.S. Department of Health and Human Services (HHS) recently announced that the U.S. Food and Drug Administration (FDA) will not require premarket review of Laboratory-Developed Tests (LDTs) for SARS-CoV-2. In alignment with this announcement, FDA will not review Emergency…

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Laboratory Alert: Reporting Non-EUA test results

Acute Care Hospital Program, Clinical Laboratory Program, Critical Access Hospital Program

Attention: Clinical Laboratories Please share this information with: Medical Director, Laboratory Services Laboratory Manager(s) For laboratories and testing sites that are using a Laboratory-Developed Test (LDT) that has not received a U.S. Food and Drug Administration Emergency Use Authorization (EUA), refer to these tips and links when selecting codes to report test results to public health agencies: LOINC and SNOMED-CT codes…

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COLLABORATION LEADS TO STANDARDIZED ELR FOR REPORTING COVID-19 LABORATORY DATA ELEMENTS TO STATE HEALTH DEPARTMENTS

Acute Care Hospital Program, Clinical Laboratory Program, Critical Access Hospital Program

Attention: Clinical Laboratories Please share this announcement with: Medical Director, Laboratory Services Administrative Director and Manager(s), Laboratory Services The CDC, the Association of Public Health Laboratories (APHL), and the Council of State and Territorial Epidemiologists (CSTE) collaborated with federal and private sector partners to create a standardized electronic laboratory reporting (ELR) flat file as an…

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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

Clinical Laboratory Program

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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