Frequently Asked Questions for Pharmacists on Pharmacies' Use of CLIA-Waived Rapid Diagnostic Tests
Q: What is the Board’s position on pharmacies performing “rapid diagnostic” and other “CLIA-waived” tests?
A: Board staff have received numerous questions about pharmacies' ability to perform "rapid diagnostic" and other "CLIA-waived" tests.
Some point-of-care tests for things like streptococcus infection, blood glucose levels, and cholesterol levels are approved by the FDA as so-called “CLIA-waived” tests. CLIA refers to the Clinical Laboratory Improvement Amendments Act, a federal statute that, as the name suggests, governs clinical laboratories.
When FDA approves an in vitro diagnostic device, it may designate the device as approved “for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that . . . employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or . . . the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly.” 42 USC § 263a(d)(3). If so deemed by the FDA, these tests may be performed in a laboratory that has applied for a waiver of CLIA requirements. Id. § 263(a)(d)(2). CLIA-waived tests don’t require, as a condition of FDA approval, any sort of “prescription” or medical order.
Unlike some states, North Carolina law does not impose a separate layer of regulations on top of CLIA. If a facility – including a pharmacy – meets the criteria to perform CLIA-waived tests, and obtains from the federal Centers for Medicare and Medicaid Services a CLIA waiver, then that facility may perform any CLIA-waived tests. More information about the CLIA waiver process may be found here: https://www2.ncdhhs.gov/DHSR/ahc/clia/cliafaq.html
Staff is of the opinion that there is nothing in the law that would prevent a pharmacy that applies for, and obtains, a CLIA waiver from performing CLIA-waived tests. Of course, a pharmacy performing a CLIA-waived test cannot allow its pharmacists to use the results of a CLIA-waived test to prescribe drug therapy independently, or to do anything with the test results besides provide them to the patient and/or communicate them to the patient’s provider of choice. (The exception would be a CPP whose agreement with the supervising physician authorizes the CPP to act on test results.)