Federal authorization of the use of Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived point-of-care tests for SARS-CoV-2 by pharmacists during the pandemic resulted in a dramatic rise in the number of community pharmacies that became CLIA-waived test sites. Now as we exit the pandemic, the wide-ranging expansion of the scope of practice facilitated currently by the PREP Act is set to expire in fall 2024. As a result, American pharmacists’ ability to offer CLIA-waived testing services will revert to a patchwork of state laws. This study aims to examine both the number of pharmacies in the United States with CLIA Certificates of Waiver before and after the SARS-CoV-2 pandemic and the state-by-state differences in the percentage of pharmacies with CLIA Certificates of Waiver. Data were collected from the U.S. Centers for Disease Control and Prevention CLIA Laboratory Search website on May 3rd, 2015, August 4th, 2019, November 26th, 2020, October 6th, 2021, November 23rd, 2022, and December 4th, 2023. The website allows for the exportation of demographic data on all CLIA-waived facilities by state. The total number of pharmacies with a CLIA-waiver grew from 10,626 (17.9%) locations in 2015 to 12,157 (21.4%) locations in 2019, to 15,671 (27.6%) locations in 2020, and to 29,011 (51.6%) locations in 2023. States demonstrated considerable variability in the percentage of pharmacies possessing a CLIA certificate of waiver in 2023, with a range of 10.7%–87.9%. Use of CLIA-waived tests in pharmacies has grown by 140% since 2019. The time period from 2019 to 2021 witnessed a 92.5% increase in pharmacies that possessed a certificate of waiver which was largely driven by the pandemic. Interestingly, from 2021 to 2023 the was continued growth in the market of 31.6%. This suggests that pharmacies continue to see opportunity in offering CLIA-waived testing services beyond those that had been extended as a result of the pandemic.

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美国基于药房的 CLIA 豁免测试：趋势、影响和未来之路

联邦授权药剂师在大流行期间使用 1988 年临床实验室改进修正案 (CLIA) 豁免的 SARS-CoV-2 即时护理检测，导致获得 CLIA 豁免检测的社区药房数量急剧增加网站。现在，随着疫情的结束，《PREP 法案》目前推动的执业范围的广泛扩大将于 2024 年秋季到期。因此，美国药剂师提供 CLIA 豁免测试服务的能力将恢复为各州法律的拼凑。本研究旨在调查 SARS-CoV-2 大流行前后美国拥有 CLIA 豁免证书的药房数量，以及各州拥有 CLIA 豁免证书的药房百分比差异。数据收集自美国疾病控制与预防中心CLIA实验室搜索网站，时间为2015年5月3日、2019年8月4日、2020年11月26日、2021年10月6日、2022年11月23日和2023年12月4日。该网站允许按州导出所有 CLIA 豁免设施的人口统计数据。获得 CLIA 豁免的药店总数从 2015 年的 10,626 家 (17.9%) 增加到 2019 年的 12,157 家 (21.4%)，到 2020 年增加到 15,671 家 (27.6%)，到 2023 年增加到 29,011 家 (51.6%) . 到 2023 年，各州拥有 CLIA 豁免证书的药房比例存在很大差异，范围为 10.7%–87.9%。自 2019 年以来，药房使用 CLIA 豁免测试的数量增长了 140%。从 2019 年到 2021 年，拥有豁免证书的药房增加了 92.5%，这主要是由疫情推动的。有趣的是，从2021年到2023年，市场持续增长31.6%。这表明药房继续看到机会，提供除因大流行而延长的服务外的 CLIA 豁免检测服务。