08/26/2020: Lab Alert: CMS Issues New Rule for SARS-CoV-2 Laboratory Test Result Reporting

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Subject: Laboratory Alert: CMS Issues New Rule for SARS-CoV-2 Laboratory Test Result Reporting

Level: Laboratory Alert

On August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) released a new Interim Final Rulepdf iconexternal icon with a Comment Period (CMS-3401-IFC). The new rule describes:

  • Modifications to the Clinical Laboratory Improvement Amendments (CLIA) regulations to require all CLIA-certified laboratories to report positive and negative test results for SARS-CoV-2
  • Failure to report test results will result in a condition-level noncompliance with CLIA regulations and a civil monetary penalty may be imposed
  • Long-term care facilities must offer SARS-CoV-2 testing to staff and residents

Healthcare facilities (including nursing homes, pharmacies, or other settings) using point-of-care COVID-19 testing devices under a CLIA Certificate of Waiver will be required to report test results under this regulation.

Online Resources:

If you have any questions, please contact us at LOCS@cdc.gov.

Thank you,

The Laboratory Outreach Communication System

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)

LOCS@cdc.gov

www.cdc.gov/csels/dls/locs

Page last reviewed: August 18, 2020