U.S. community pharmacies as CLIA-waived facilities: Prevalence, dispersion, and impact on patient access to testing

Background: The Clinical Laboratory Improvement Amendments of 1988 (CLIA) enabled greater access to low-risk tests by allowing their use in facilities with a Certificate of Waiver in the U.S. Community pharmacies are among the most accessible health professionals, and they are increasingly offering CLIA-waived tests. This manuscript aims to determine: 1) the current number of pharmacies in the United States with CLIA-waivers; 2) the uptake of CLIA-waivers by different pharmacy store types; and 3) the state-by-state differences in the percentage of pharmacies with a CLIA-waiver. Methods: Data were collected from the U.S. Centers for Disease Control and Prevention CLIA Laboratory Search website on May 3rd, 2015. The website allows for exportation of demographic data on all CLIA-waived facilities by state. Results: Pharmacies are currently the fourth highest-ranking facility of CLIA-waived laboratories with 10,838 locations. Supermarkets had the highest percentage of pharmacies with a CLIA-waiver (43.16%). States demonstrated considerable variability in the percentage of pharmacies with a CLIA-waiver, with a median percentage of 19.56% (0%-60.00% range). Conclusions: Community pharmacies are currently a leading facility for CLIA-waived laboratories. Substantial state-level variation is observed in the percentage of pharmacies with CLIA-waivers, and these differences may be driven by restrictions in state law or regulations.