Skip to Main Content

COVID-19 INFORMATION
Information from TN Dept of Health about the Ongoing Novel Coronavirus Outbreak

COVID-19 Resources and Links

In an effort to provide support to workplaces who may be doing COVID-19 testing, CMS has prepared materials to outline the simple steps necessary to do this.

Generally, a CLIA certificate of waiver is necessary for a workplace to do testing. For information regarding CLIA requirements and the application process for workplace COVID-19 testing, please see the Quick Start Guide for COVID-19 Testing in the Workplace and the Workplace COVID-19 Testing Fact Sheet.

TN Department of Health

•    Information  from the TN Dept of Health about the ongoing Novel Coronavirus outbreak

https://www.tn.gov/health/cedep/ncov.html

•    Laboratories seeking to add COVID-19 testing to their CLIA certificate should submit a CMS-116 to their State Agency. The required information should include the specific name and manufacturer of the COVID-19 test as well as the location where the test will be administered (office, parking lot, mobile unit, etc.)

https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS116.pdf

Centers For Disease Control And Prevention

•    CDC convenes a weekly call with clinical laboratories to discuss the nation’s clinical laboratory response to coronavirus disease (COVID-19). These Clinical Laboratory COVID-19 Response Calls take place every Monday at 3:00 PM EDT. Audio and transcripts are posted online after each call.

https://www.cdc.gov/safelabs/resources-tools/covid-19-weekly-clinical-calls.html

U.S. Food & Drug Administration

•  FDA Emergency Use Authorization (EUA) information, and list of all current EUAs

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization  

•   FAQs on Diagnostic Testing for SARS-CoV-2 Serology IgG/IgM tests

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2

Centers For Medicare  & Medicaid Services

•    Admin Info: 20-06-CLIA  Memo  from CMS provides  clarity on the types of SARS-CoV-2 testing, whether the tests are being offered under an EUA issued by FDA  and information for Medicare beneficiaries on testing services and coverage.

https://www.cms.gov/files/document/admin-info-20-06-clia.pdf

• FAQs on CLIA Guidance during the COVID-19 Emergency 

https://www.cms.gov/files/document/clia-laboratory-covid-19-emergency-frequently-asked-questions.pdf

• FAQs regarding IQCP Clarification for EUA Tests 

https://www.cms.gov/files/document/frequently-asked-questions-faqs-clia-guidance-during-covid-19-emergency.pdf