Mississippi State Department of Health

CLIA Requirements for Mississippi COVID-19 Collection and Testing Facilities
March 27, 2020

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Mississippi facilities who wish to collect and/or test for COVID-19 (and other screening tests) should follow the procedures below.

Facilities in other states: If you are not located in Mississippi, please see the State Agency contact list at cms.gov to find the contact information for your state.

Collection Site Only

Requirements: There are no CLIA (Clinical Laboratory Improvement Act) requirements to collect swabs for COVID-19. However, the samples must be sent to a CLIA-certified lab for testing.

Training: Collection personnel should be trained in the proper collection procedure. For COVID-19, a Nasopharyngeal (NP) swab is the specimen of choice.

Testing Site (waived testing included as part of the screen)

If a Mississippi facility wishes to perform waived testing as part of the COVID-19 screen (flu tests, strep A tests), there must be an appropriate CLIA Certificate of Waiver (or greater) for that site. CLIA certificates are site specific. For example, if a clinic is going to sponsor a "drive-through" testing site on the premises, the CLIA certificate at that site will cover the testing. If the testing site is not on the premises, the entity will need to apply for a CLIA certificate for that site. Please call the Mississippi State Department of Health's CLIA office at 601-364-1115 or email at clia-msdh@msdh.ms.gov for specific situations and help.

Mississippi COVID-19 Testing

To perform COVID-19 testing (moderate or high complexity testing) in Mississippi, the facility must have a CLIA Certificate of Compliance or Certificate of Accreditation. There must be a qualified Lab Director, along with testing personnel and other required positions.

To apply for a COC/COA submit a CMS-116 application along with the Lab Director qualifications and complete testing information:

Return the application via email to clia-msdh@msdh.ms.gov.

Important: Per new guidance from CMS-CLIA, the entity may begin testing for COVID-19 as soon as a CLIA number is generated. This will occur after a complete application is received and entered. If a complete application is received via email by 4:30 p.m., the application will be entered the same day, and a return email will contain the CLIA number required to begin testing. This only applies to labs who are testing for COVID-19.

If there are questions about the application, please call the Mississippi State Department of Health's CLIA office at 601-364-1115 or email the above address.

Reporting requirement: All COVID-19 results must be reported to the Mississippi State Department of Health at this time. More about submitting samples

Sample submission: All samples must be sent to a CLIA-certified lab for testing. If you have questions, please call the CLIA office at 601-364-1115 to verify laboratory status.



Links referenced
State Agency contact list    https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf
cms.gov    https://www.cms.gov/clia
clia-msdh@msdh.ms.gov    mailto:clia-msdh@msdh.ms.gov
CMS-116 application    https://www.cms.gov/medicare/cms-forms/cms-forms/downloads/cms116.pdf
clia-msdh@msdh.ms.gov    mailto:clia-msdh@msdh.ms.gov
More about submitting samples    http://msdh.ms.gov/msdhsite/index.cfm/14,0,420,694,html

Find this page at http://msdh.ms.gov/msdhsite/index.cfm/index.cfm

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