CDC includes new information on cycle threshold values for RT-PCR tests for SARS-CoV-2 in Laboratory FAQ

Attention: Clinical Laboratory Professionals Please share this information with: Medical Director(s), Laboratory Services Lab Manager(s) The CDC recently updated the Frequently Asked Questions (FAQs) about COVID-19 for Laboratories to include new information on cycle threshold (Ct) values for reverse transcriptase – polymerase chain reaction (RT-PCR) tests for SARS-CoV-2. Click here to view the updated FAQs.…

CMS Issues Statement Regarding Quality Control for Tests with FDA EUA

Attention: Clinical Laboratory Professionals Please share the following with: Medical Director, Laboratory Services Lab Manager(s) The Centers for Medicare & Medicaid Services (CMS) has issued a statement in response to recent confusion regarding quality control for tests with FDA emergency use authorization (EUA). See below for the statement from CMS: “The manufacturer’s instructions for all…

FDA Safety Letter about Potential False Positives with Antigen Tests for Rapid Detection of SARS-CoV-2

Attention: Clinical Laboratory Professionals Please share the following with: Medical Director, Laboratory Services Lab Manager(s) On November 3, 2020, the U.S. Food and Drug Administration (FDA) issued a Letter to Clinical Laboratory Staff and Health Care Providers as an alert that false positive results can occur with antigen tests, including when users do not follow…

HFAP Joins ACHC

Combined Nonprofit Organization Meets Accreditation Needs of Healthcare Providers Across the Entire Continuum of Care CARY, N.C. (Oct. 20, 2020) – In a historic move, Accreditation Commission for Health Care (ACHC) and Healthcare Facilities Accreditation Program (HFAP) are joining to form a single company with the programs, knowledge and resources to provide complete, quality accreditation…

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…

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…

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…

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…

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…

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,…