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

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

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

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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