Ferris State University College of Pharmacy, 25 Michigan Street NE Suite 7000, Grand Rapids, MI 49503, USA.
University of Nebraska Medical Center College of Pharmacy, 986145 Nebraska Medical Center, Omaha, NE 68198-6145, USA.
Res Social Adm Pharm. 2024 Jun;20(6):146-151. doi: 10.1016/j.sapharm.2024.03.003. Epub 2024 Mar 15.
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.
在大流行期间，联邦授权药剂师使用临床实验室改进修正案 1988 年（CLIA）豁免了 SARS-CoV-2 的即时护理检测，这导致了大量社区药房成为 CLIA 豁免检测点。现在，随着我们走出大流行，目前由 PREP 法案促成的广泛扩大实践范围将在 2024 年秋季到期。因此，美国药剂师提供 CLIA 豁免检测服务的能力将恢复到各州法律拼凑的状态。
本研究旨在检查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的差异。
数据于 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 日从美国疾病控制与预防中心 CLIA 实验室搜索网站收集。该网站允许按州导出所有 CLIA 豁免设施的人口统计数据。
拥有 CLIA 豁免权的药房总数从 2015 年的 10,626 个（17.9%）增加到 2019 年的 12,157 个（21.4%），到 2020 年的 15,671 个（27.6%），到 2023 年的 29,011 个（51.6%）。2023 年，各州拥有 CLIA 证书的药房百分比差异很大，范围为 10.7%-87.9%。
自 2019 年以来，药房使用 CLIA 豁免测试增加了 140%。从 2019 年到 2021 年，拥有豁免证书的药房数量增加了 92.5%，这主要是大流行的结果。有趣的是，从 2021 年到 2023 年，市场继续增长了 31.6%。这表明，除了因大流行而延长的服务之外，药房继续看到提供 CLIA 豁免检测服务的机会。
