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