COVID-19 TESTING
The U.S. Department of Health and Human Services (HHS) recently released a statement authorizing licensed pharmacists to order and administer COVID-19 testing. As recognized by HHS, pharmacists have been on the frontline in providing patient care during this unprecedented pandemic. HHS' authorization provides another tool for protecting Missouri patients.
Pharmacists ordering/administering COVID-19 testing pursuant to HHS' authorization should be appropriately educated/trained to perform the services provided and comply with professional standards of practice. To ensure patient safety, licensees should take necessary precautions to ensure proper sanitation and prevent unnecessary exposure when testing. Permit holders should also ensure testing services comply with all applicable law and practice standards.
Pharmacies performing COVID-19 testing must have the appropriate Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver/certificate. A CLIA waiver is required for pharmacies providing CLIA-waiver testing; A CLIA certificate is required for pharmacies providing diagnostic/non-CLIA waived testing.
The Missouri Department of Health and Senior Services (DHSS) administers the CLIA program in the state of Missouri. Information on applying for a CLIA certificate is available on DHSS' website at Information on applying for a CLIA certificate. The Missouri CLIA Program can also be contacted at: CLIA@health.mo.gov or by telephone at 573-751-6318.
- How to Obtain a CLIA Certificate of Waiver
- Test or Not to Test? Considerations for Waived Testing
- Board general informational statement (4-13-20)
- New: Board/DHSS guidance statement
- DHSS statement on mandatory reporting of positive COVID-19 testing
- CMS comparison of COVID-19 testing & testing requirements chart
- FDA guidance for pharmacists & COVID-19 testing (4-8-20)
- FDA advisory opinion on pharmacist testing (5-19-20)
- Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19)
- Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons with Coronavirus Disease 2019 (COVID-19)
- CDC Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings
- PPE Recommendations
- Considerations for Pharmacies during the COVID-19 Pandemic
