08/26/2020: Lab Alert: CMS Issues New Rule for SARS-CoV-2 Laboratory Test Result Reporting
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 Rule 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:
- How to Report COVID-19 Laboratory Data
- Clinical Laboratory Improvement Amendments (CLIA)
- Information for Laboratories about Coronavirus (COVID-19)
- Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories
- CDC Coronavirus (COVID-19) Website
- CDC Laboratory Outreach Communication System (LOCS)
- Clinical Laboratory COVID-19 Response Calls
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)