CLIA-Waived Testing
Rachel Balick
Lots of pharmacists already perform CLIA-waived tests, but with COVID-19 testing expected to become available in many pharmacies, we’re hearing CLIA-related terms more than ever. While there’s a general understanding that CLIA-waived tests are those that are simple to perform and involve minimal chance of false positives or negatives, the finer details are a bit hazier.
What’s CLIA anyway?
CLIA stands for Clinical Laboratory Improvement Amendments of 1988. CLIA gives CMS regulatory authority over all laboratory tests performed on humans, excluding those performed for clinical trials or other research purposes. CLIA’s regulatory standards are aimed at ensuring high-quality laboratory testing.
The U.S. Congress passed CLIA in 1988 after public outcry about a series of false negatives on Pap tests, leading to several deaths. The inaccurate readings had originated in federal labs, but Congress ultimately passed legislation—CLIA—that regulates tests performed in any setting.
According to CMS, CLIA covers approximately 260,000 laboratory entities.
What is a laboratory under CLIA?
Any facility that collects human specimens to perform lab tests that provide information used for health assessments or the diagnosis, prevention, or treatment of disease or impairment qualifies as a laboratory under CLIA.
But that’s not necessarily helpful information for a pharmacist. The question really is, “Does a pharmacy count as a laboratory under CLIA?” And the answer is, “It can, if it has one or more CLIA Certificates of Waiver.” According to a 2016 study published in Clinical Chemistry, approximately 18% of community pharmacies had obtained a CLIA Certificate of Waiver.
The U.S. Department of Health and Human Services has released guidance empowering pharmacists to perform COVID-19 testing regardless of state scope of practice, but pharmacies still require a CLIA Certificate of Waiver before they can perform CLIA-waived COVID-19 diagnostic or antibody tests at point of care.
What is CLIA Certificate of Waiver and how do I apply for one?
CLIA terminology can be confusing—only tests can be CLIA-waived, but for pharmacies or other sites to be permitted to perform these tests, they must complete the CMS-116 form and receive a CLIA Certificate of Waiver. You can find the CMS-116 application form at https://apha.us/WaiverApp.
Applications must then be submitted to the appropriate state agency, which you can find at https://apha.us/StateAgencies.
On the CMS-116 form, it is typical to name the pharmacist in charge as lab director, but pharmacies can use their discretion. Pharmacies can select “pharmacy” as type of lab in section III, but check with your state to see if it requires something more specific.
Pharmacies with multiple locations can select “multiple sites” and answer the associated questions in section V of the form, but it is typically better to submit separate applications for each location.
Section VI asks for the specific CLIA-waived tests that will be performed; applicants should include manufacturers and the names of the tests in this section.
Even if a pharmacy only intends to perform CLIA-waived COVID-19 tests that have been FDA-approved through emergency use authorization, it can also list other CLIA-waived tests it might want to offer in the future, such as rapid strep tests or glucose testing.
Applicants must list the number of CLIA-waived tests that will be performed in a 12-month period. Use your best guess, and don’t forget to figure in non-COVID-19 CLIA-waived tests, if you have listed any.
You can find more information about applying for CLIA Certificates of Waiver at https://apha.us/COW_Instructions.
What kind of tests are CLIA-waived?
A CLIA-waived test is one that is not subject to CLIA regulatory standards. FDA reviews applications by test manufacturers to determine if a test qualifies as CLIA-waived. Tests that meet the following three criteria are classified as CLIA-waived:
Cleared by FDA for home use
Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible
Pose no reasonable risk of harm to the patient if the test is performed incorrectly.
You can find a list of CLIA-waived tests at https://apha.us/CLIAWaivedTests.
What else should I know?
Laboratories that only perform CLIA-waived tests, in addition to enrolling in the program by obtaining a Certificate of Waiver, must pay a certificate fee every 2 years; follow the manufacturer’s instructions for the waived tests being performed; and notify the appropriate state agency of any changes in ownership, name, address, or laboratory director within 30 days.