Which Laboratories Require CLIA Certification for Covid-19 Testing?
With the push to reopen the economy across the country, it is imperative that testing for COVID-19 is readily available, not only so that infected individuals can be isolated, but also for contact tracing. Identifying areas where the new coronavirus that causes the disease is spreading is a key tool used for bringing it under control.
The Department of Health and Human Services (HHS) is releasing $11 billion to support COVID-19 testing, and the intention is to increase testing as quickly as possible. This makes it important for labs to be able to perform the tests, and since the tests themselves are new, labs need to know how to get approved to do them.
CLIA Certification Is Still Required for Moderate or High Complexity Testing
The Clinical Laboratory Improvement Amendments, collectively referred to as CLIA, require laboratories to be certified to perform testing unless the test has been designated as waived. Waivers are only available for tests that are very simple, such as those that are approved for home use. Only a few COVID-19 tests have received that designation.
Even though many tests for COVID-19 have been allowed without the usual stringent validation under Emergency Use Authorizations (EUAs), those tests must still be performed by labs that are CLIA certified and meet all requirements set out in the applicable regulations.
Obtaining CLIA Certification Now
State agencies carry out licensing and oversight of laboratories, and each state may also have regulations of its own, so any lab performing COVID-19 testing must be in compliance with both federal and state regulations. Labs that wish to get CLIA certified should submit a CLIA Application Form to the state where the laboratory is located (not where the corporate headquarters are if they differ).
The lab has to have a qualified laboratory director and provide all the information that the CMS-116 application asks for. A CLIA number will then be assigned and as soon as the lab meets the requirements specified by CLIA, they can begin testing.
Almost all existing EUA authorizations for COVID-19 testing include FDA authorization for labs that meet the CLIA requirements for either moderate or high complexity testing. Additionally, the testing personnel must have qualifications matching the level of the test in use.
In addition to the guidance provided by CMS and FDA, a CMS document titled Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency provides additional information.
Drive-Through and Other Outdoor Testing
Because of the need for social distancing and contact with the fewest medical personnel as possible when testing is being done, collecting specimens from patients who are still in their vehicles has been implemented throughout the nation.
The volume of needed tests has exceeded the space available in many labs and outdoor areas are being used for overflow. This is acceptable as long as the facility has the appropriate CLIA certificates for the tests and follows the applicable state and CLIA regulations and guidelines.
States May Authorize CLIA-Certified Labs to Perform COVID-19 Testing
With many different entities working to develop effective and fast testing for COVID-19, the FDA is allowing states to authorize labs to develop and perform tests that are used to identify the disease.
The language FDA uses is “FDA does not intend to object,” rather than granting any particular authority and specifies that they request that the state notify FDA if they choose to “use this flexibility to expedite COVID-19 testing.”
Each state that elects to authorize testing will be responsible for developing its own process, which will not be reviewed by FDA. They do however expect states to design an oversight process that requires labs to validate COVID-19 tests prior to their use. They also request that labs that are developing and performing any of these tests send FDA an email notification that they are doing so.
Further information from FDA is available in the downloadable Policy for Coronavirus Disease-2019, Tests During the Public Health Emergency (Revised), which was issued on May 11, 2020 on the internet.