The WV BOP is aware of the HHS Advisory Opinion the came out today regarding pharmacist COVID-19 testing.  The WV BOP has worked with WV DHHR Bureau for Public Health and the State Health Officer to provide Guidance with the appropriate contacts and pathways to follow for a pharmacist/pharmacy who decides to undertake the provision of COVID-19 testing at his/her pharmacy.  

On April 8, 2020, the United States Department of Health and Human Services (HHS) published a guidance to authorize licensed pharmacists to order and administer COVID-19 tests, including serology authorized by the Food and Drug Administration (FDA).  A current list of the FDA authorized tests under the Emergency Use Authorization (EUA) to diagnose and respond to public health emergencies are available here under In Vitro Diagnostic EUAs.

The FDA specifies which point-of-care tests for COVID-19 are considered CLIA-waived according to an EUA. As defined, CLIA-waived tests are “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.”  The FDA determines which tests meet these criteria when it reviews the manufacturer’s application for a waiver.

May CLIA-waived tests be performed at a pharmacy in WV?

The long standing position of the WV Board of Pharmacy is that the performance of CLIA-waived tests is within the scope of the practice of pharmacist care provided they are administered in accordance with the FDA’s CLIA requirements.

Who may perform the CLIA-waived tests in WV?

Pharmacists, along with pharmacy interns under the supervision of a pharmacist, may perform CLIA-waived tests.  Training for how to collect the sample and perform the specific CLIA-waived test must be documented per CLIA requirements.

How can a pharmacy obtain a CLIA Certificate of Waiver?

All sites where a pharmacy is performing FDA-authorized COVID-19 testing must have a CLIA certificate for the appropriate type of testing that will be performed.  Refer to the CMS document How to Apply for a CLIA Certificate of Waiver.  The WV Department of Health and Human Resources Office of Laboratory Services is the state agency that will process new CLIA Certificates of Waiver and is processing these applications as they are submitted online. When completing the CLIA Certificate of Waiver application on Page 3, Section VI, Waived Testing, the pharmacy must list the specific test(s) the pharmacy will be performing.  It is necessary to be specific to the level of name of the test/kit and manufacturer (e.g. Abbott ID Now, Quidel Sofia SARS antigen, etc.)

Which of the COVID-19 Tests are CLIA-waived for Point-of-Care testing?

As previously mentioned, the FDA has clarified that when an EUA is granted for a COVID-19 point-of-care test, the test is considered to be CLIA-waived.

Please be aware that there are availability concerns for these tests and the supplies required for testing.  Additionally, be aware that some of these tests recommend the test itself be run in a biosafety cabinet because the well is open and there are concerns for the safety of the individual performing the test.  Be well educated on the test parameters, requirements, and reliability. 

Point-of-care testing that is CLIA-waived by definition does not require a medical order, and can be identified using the following steps:

1. Access the FDA’s EUA website.
2. Scroll down to find the “In Vitro Diagnostic EUAs” on the FDA’s website.
3. Tests that are indicates with a “W” under the “Authorized Setting(s)” section of the list are considered CLIA-waived point-of-care tests.

Is a prescriber’s Order Required to Perform a CLIA-waived COVID-19 Test?

No. The point-of-care tests authorized under an EUA are deemed CLIA-waived and do not require a prescriber’s order prior to administration.  However, testing should be performed in accordance with CDC and WV DHHR testing priorities and therefore, patients should be screened for testing.

Pathways for pharmacies to perform COVID-19 tests

There are two possible pathways for a pharmacy to participate in COVID-19 testing in the community.  The process is explained in a detailed checklist and is available here.

Must test results be reported to WV DHHR?

Yes. If the pharmacy is performing the test, then the pharmacy must electronically report the test results to the WVDHHR in accordance with the emergency provisions of 64 CSR 7.

If the pharmacy is only collecting the specimen sample and partnering with a lab that will perform the test,  the pharmacy should only partner with a lab that reports results electronically to WVDHHR in accordance with the emergency provisions of 64 CSR 7.

If a pharmacy is interested in working with a lab that does not electronically report to WVDHHR, they should have the lab contact the WVDHHR, Division of Infectious Disease Epidemiology at 1-800-423-1271 or 304-558-5358 to learn how to get electronic reporting set up.

Must test results be reported to the Local Health Department?

Positive test results must be immediately reported to the local health department. If the pharmacy is performing the test, it must immediately report all positive test results to the local health department.

If the pharmacy is partnering with a lab, the pharmacist should confirm that the lab will immediately report all positive test results to the local health department. Additionally, the pharmacist must contact the patient’s primary care provider to notify of any test result.  If the pharmacist has questions about reporting he/she should contact the local health department.

How must patients be notified?

The pharmacist must notify all patients of their test results in a timely manner that maintains patient privacy in accordance with state and federal laws and regulations. The local health department will implement contact tracing upon notification of a positive test result.

Is training required for collecting and performing tests?

The pharmacy must ensure that all pharmacists and pharmacy interns have received appropriate training to collect specimen samples and perform COVID-19 tests in a safe an effective manner and document the training.  The pharmacy must adhere completely to the manufacturer’s instructions.

PPE

All COVID-19 testing must be conducted while wearing appropriate PPE.  Guidance for this can be found at the CDC’s website.