COVID Tests for Patients

You are authorized to resell COVID-19 testing kits if you have CLIA Certificate of Waiver. We recommend that you administer the test on behalf of the patient in your practice as this ensures the highest level of scientific compliance and accuracy.

What is CLIA?

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) establish quality standards for laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results. CLIA requires that any facility examining human specimens for diagnosis, prevention, treatment of a disease or for assessment of health must register with the federal Centers for Medicare & Medicaid Services (CMS) and obtain CLIA certification.

Are dentists eligible to administer COVID-19 tests?

Licensed dentists are eligible to administer COVID-19 diagnostic tests within their scope of practice, provided they obtain (or already have) a Certificate of Waiver from the Centers for Medicare & Medicaid Services, as may be needed. Like physicians, dentists may need the certificate to administer FDA-waived COVID-19 diagnostic tests, as required by the Clinical Laboratory Improvement Amendments (CLIA) regulation.

To obtain a CLIA waiver, dentists must

  • Submit an application – Clinical Laboratory Improvement Amendments (CLIA) Application for Certification with Waiver (CMS116)
  • Pay a $150 application fee

What is the process?

According to a DentistryiQ article “How to get approval for fast COVID-19 testing in your dental practice” (written by Dr Pat Cassidy for ) the process is relatively simple:

  • The application is long, but you will only need to complete Sections I–VI, IX, and X. A waived test is categorized by CLIA as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.”
  • For “Estimated Annual Test Volume,” I entered the following: “Testing volume as appropriate and necessary to assist patients in my community, and my office personnel, during the COVID-19 pandemic. Estimated total annual test volume approximately [my patient count].” The application is only $150 and is not payable until your office is certified.

 

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