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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Laboratory Alert: Reporting Non-EUA test results

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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CMS RELEASES QSO-20-40-LSC CATEGORICAL WAIVER – CORRUGATED MEDICAL TUBING (COPPER)

Attention: Acute Care Hospitals, Critical access Hospitals, ASCs Please share this announcement with: Facilities managers The Centers for Medicare & Medicaid Services (CMS) has released a memo stating it will allow a Categorical Waiver to allow Corrugated Medical Tubing (CMT) meeting the copper standard under NFPA 99, 2018 edition, section 5.1.10 for Category 1; 5.2.10…

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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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