Are there any concerns practices need to be aware of related to testing patients for COVID-19?

Yes, patients need to understand what COVID-19 testing is for and what to do if they test positive. Here are some steps practices can follow:

• Ask the patient to sign an acknowledgement form for COVID-19 testing.
• Report positive test results to your local health department. COVID-19 tests are required to be reported as communicable disease cases.
• Plan with the patient for what to do if they test positive. The following should be discussed with the patient prior to testing:
  • Address treatment options and actions they need to take, depending on their symptoms and disposition. Refer to the CDC for the latest updates on clinical management of patients.
  • Discuss self-quarantine vs. isolation (separating from others) until their test comes back negative or they are cleared of being infectious.

• Provide work notices for patients who need to be absent from work due to illness or return to work once they are no longer infectious. See the CDC’s criteria for when patients can be around others and return to work.
  • • CDC clearance criteria for patients with COVID-19:
      • Fever free for 24 hours without the use of fever-reducing medication;
      • Improvement in symptoms; and
      • Minimum of 10 days post onset of symptoms;

CLIA Waived Testing and COVID-19 Testing Systems:

Physician offices that are certified for CLIA Waived Testing need to exercise caution when selecting COVID-19 testing kits or systems. Not all COVID-19 testing kits are approved as CLIA Waived Tests.  There are some COVID-19 testing systems which have not been granted an Emergency Use Authorization (EUA) from the Food & Drug Administration (FDA) and therefore are categorized as a test requiring high complexity testing certification. Use caution, as we are seeing CLIA investigations and the issuance of threatening letters from CMS due to improper CLIA licensure.

The advice to practices is that if their laboratory currently has a Certificate of Waiver, they must use a COVID-19 test system that is waived or has been granted an EUA from the FDA. Do not rely on the information from a vendor or the company who made the test. Check the FDA website for the latest information and do your own due diligence. COVID-19 test systems that have not been granted an EUA from the FDA are categorized as a high complexity. In order to do high complexity testing, a physician laboratory must meet the CLIA requirements to perform high complexity testing under 42 C.F.R. §§ 493.1441 through 493.1495.

To stay up to date on the most current information for testing refer to CDC testing page.

Resources:

• Labcorp: How to collect the sample and send for testing
• Labcorp: FAQ document addressing many questions on testing
• Labcorp: Specimen collection guide
• FDA: FAQs on testing