Klepser Nicklas S, Klepser Donald G, Adams Jennifer L, Adams Alex J, Klepser Michael E
Kalamazoo College, 1200 Academy St. Kalamazoo, MI, 49006, USA.
University of Nebraska Medical Center, College of Pharmacy, 981620 Nebraska Medical Center, Omaha, NE, 98198-6120, USA.
Res Social Adm Pharm. 2021 Sep;17(9):1574-1578. doi: 10.1016/j.sapharm.2020.12.003. Epub 2020 Dec 15.
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. Recently, the 2019 novel coronavirus (COVID-19) pandemic has shined a spotlight on CLIA-waived diagnostic testing. To meet this increased patient demand for diagnostic testing, the U.S. Department of Health and Human Services (HHS) authorized licensed pharmacists to order and administer FDA authorized COVID-19 tests.
This study aims to update the previous national benching report and 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 May 3rd, 2015, August 4th, 2019 and November 26th, 2020. The website allows for exportation of demographic data on all CLIA-waived facilities by state.
Pharmacies exhibited the largest growth both in number (4865 new locations) and by percent (45%) of CLIA-waived facilities between 2015 and 2020. The total number of pharmacies with a CLIA-waiver grew from 10,626 (17.94%) locations in 2015 to 12,157 (21.43%) locations in 2019, to 15,671 (27.63%) locations in 2020. States demonstrated considerable variability in the percentage of pharmacies with a CLIA-waiver, with a range of 2.92%-56.52%.
Pharmacies have become an increasingly important location for patients to access CLIA-waived tests in the United States, now serving as the second largest provider of CLIA-waived tests by the total number of locations. Most of this growth occurred between 2019 and 2020 due to the COVID-19 pandemic, and concentrated efforts will be necessary to sustain this momentum.
1988年的《临床实验室改进修正案》（CLIA）通过允许在美国拥有豁免证书的机构使用低风险检测，使更多人能够进行此类检测。最近，2019年新型冠状病毒（COVID-19）大流行让CLIA豁免诊断检测受到关注。为满足患者对诊断检测日益增长的需求，美国卫生与公众服务部（HHS）授权持牌药剂师订购和管理FDA授权的COVID-19检测。
本研究旨在更新之前的全国基准报告，调查在严重急性呼吸综合征冠状病毒2（SARS-CoV-2）大流行之前和之后美国拥有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，时间分别为2015年5月3日、2019年8月4日和2020年11月26日。该网站允许按州导出所有CLIA豁免机构的人口统计数据。
在2015年至2020年期间，药房在CLIA豁免机构数量（新增4865个地点）和百分比（45%）方面增长幅度最大。拥有CLIA豁免的药房总数从2015年的10626个地点（17.94%）增至2019年的12157个地点（21.43%），再到2020年的15671个地点（27.63%）。各州拥有CLIA豁免的药房百分比差异很大，范围在2.92%至56.52%之间。
在美国，药房已成为患者获取CLIA豁免检测的一个越来越重要的场所，目前按地点总数计算是CLIA豁免检测的第二大提供者。这种增长大多发生在2019年至2020年期间，原因是COVID-19大流行，需要集中努力来维持这一势头。
