Increases in CLIA-Waived Testing Sites Since the Start of the COVID-19 Pandemic

Yang Xia; Nancy Anderson

doi:10.1093/labmed/lmac154

Increases in CLIA-Waived Testing Sites Since the Start of the COVID-19 Pandemic

Lab Med. 2023 Mar 7;54(2):126-129. doi: 10.1093/labmed/lmac154.

Authors

Yang Xia¹, Nancy Anderson¹

Affiliation

¹ Division of Laboratory Systems, Center for Surveillance, Epidemiology, and Laboratory Services, Centers for Disease Control and Prevention, Atlanta, GA, USA.

PMID: 36638188
DOI: 10.1093/labmed/lmac154

Abstract

The number of testing sites receiving their first Certificate of Waiver (CoW) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) increased significantly after the start of the COVID-19 pandemic. We compared the first-time CoWs in 2020-2021 to those in 2018-2019. The total number of first-time CoWs during 2020-2021 was more than twice what it was in 2018-2019, corresponding to population testing needs during the COVID-19 pandemic, especially in assisted living facility, pharmacy, physician office, and school/student health service settings. This study highlighted the need to strengthen clinical testing strategies to be better prepared for future public health emergencies.

Keywords: CLIA laboratory; COVID-19; certificate of waiver; laboratory facility type; public health emergency; test volume.

Published by Oxford University Press on behalf of American Society for Clinical Pathology 2023.

MeSH terms

COVID-19* / epidemiology
Clinical Laboratory Services*
Humans
Laboratories, Clinical
Pandemics