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,…

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…

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…

Laboratory Alert: COVID testing false negative/false positive results

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) For laboratories using any Emergency Use Authorization (EUA)…

CMS QSO Memo 20-35-ALL: Enforcement Cases Held during the Prioritization Period and Revised Survey Prioritization

Attention: Acute Care Hospitals Critical Access Hospitals Ambulatory Surgery Centers Clinical Laboratories Please share this with individuals in the following roles: Accreditation Coordinator Quality Director Medical Director – Laboratory services Key points: CMS has issued guidance to the state agencies for conducting resuming state surveys and prioritizing the backlog of surveys. For all surveys, CMS…

Update on COVID-19 Laboratory Reporting Requirements

Attention: Clinical Laboratories Please share this announcement with: Medical Director, Laboratory Services Administrative Director and Manager(s), Laboratory Services The Coronavirus Aid, Relief, and Economic Security (CARES) Act and the HHS Lab Data Reporting Guidance released on June 4, 2020 require every COVID-19 testing site to report specific data elements for every test (e.g., molecular, antigen,…

CDC updates the LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests

Attention: Clinical Laboratories Please share this announcement with: Medical Director, Laboratory Services Administrative Director and Manager(s), Laboratory Services On Friday, July 24, the CDC updated the LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests to include new data elements in the “LOINC Mapping” tab: Testkit Name ID Testkit Name ID Type LOINC…

CDC publishes new interim guidance for use of pooling procedures for SARS-CoV-2 diagnostic, screening, and surveillance testing

Attention: Clinical Laboratories Please share this announcement with: Medical Director, Laboratory Services Administrative Director and Manager(s), Laboratory Services View the guidance here. Online resources: Frequently Asked Questions about Coronavirus for Laboratories Clinical Laboratory COVID-19 Response Weekly Calls CDC’s Laboratory Outreach Communication System (LOCS) COVID-19 Information for Laboratories CDC COVID-19 website Register for CDC Health Alert…