AI Article Synopsis
- The Clinical Laboratory Improvement Amendments (CLIA) of 1988 allowed for more access to low-risk tests through CLIA-waived facilities, with recent focus on COVID-19 testing capabilities within pharmacies.
- As of 2020, the number of pharmacies with CLIA Certificates of Waiver increased significantly, with a growth of 4,865 new locations (45%) compared to previous years, reaching over 15,600 total locations.
- Variability exists among states in the percentage of pharmacies holding a CLIA-waiver, ranging from about 3% to over 56%, indicating differing access levels across the country.
Article Abstract
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. 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.
Objective: 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.
Methods: 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.
Results: 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%.
Conclusions: 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.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7737532 | PMC |
| http://dx.doi.org/10.1016/j.sapharm.2020.12.003 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Pharmacy-based CLIA-waived testing in the United States: Trends, impact, and the road ahead.
Res Social Adm Pharm
June 2024
Ferris State University College of Pharmacy, 25 Michigan Street NE Suite 7000, Grand Rapids, MI 49503, USA. Electronic address:
Background: 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.
View Article and Find Full Text PDFRapid, sensitive, and specific lateral-flow immunochromatographic point-of-care device for detection of varicella-zoster virus immunoglobulin G antibodies in fingerstick blood.
J Immunol Methods
March 2023
Viro Research, 2326 Wisteria Drive, Suite 220, Snellville, GA 30078, United States of America.
Varicella zoster virus (VZV) causes childhood chickenpox, becomes latent in sensory ganglia and reactivates years later to cause shingles (Zoster) and postherpetic neuralgia in the elderly and immunosuppressed individuals. Serologic IgG tests can be used to determine if a person has antibodies to VZV from past varicella infection or had received varicella or zoster (shingles) vaccination. Commercial enzyme-linked immunosorbent assays (ELISAs) are currently used for the detection of VZV IgG antibodies in patient serum samples.
View Article and Find Full Text PDFIncreases in CLIA-Waived Testing Sites Since the Start of the COVID-19 Pandemic.
Lab Med
March 2023
Division of Laboratory Systems, Center for Surveillance, Epidemiology, and Laboratory Services, Centers for Disease Control and Prevention, Atlanta, GA, USA.
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.
View Article and Find Full Text PDFImpact of COVID-19 on prevalence of community pharmacies as CLIA-Waived facilities.
Res Social Adm Pharm
September 2021
Ferris State University, College of Pharmacy, 1000 Oakland St, Kalamazoo, MI, 49009, USA.
Article Synopsis
- The Clinical Laboratory Improvement Amendments (CLIA) of 1988 allowed for more access to low-risk tests through CLIA-waived facilities, with recent focus on COVID-19 testing capabilities within pharmacies.
- As of 2020, the number of pharmacies with CLIA Certificates of Waiver increased significantly, with a growth of 4,865 new locations (45%) compared to previous years, reaching over 15,600 total locations.
- Variability exists among states in the percentage of pharmacies holding a CLIA-waiver, ranging from about 3% to over 56%, indicating differing access levels across the country.
CLIA-waived molecular influenza testing in the emergency department and outpatient settings.
J Clin Virol
July 2019
RBM Consulting, LLC, San Leandro, CA, United States.
Respiratory tract infections are a common cause of visits to emergency departments and outpatient settings. Infections with influenza viruses A and B in particular, are responsible for significant morbidity and mortality in both pediatric and adult populations worldwide. A significant number of influenza diagnoses occur in the emergency departments with many being performed using rapid influenza diagnostic tests (RIDT) which have sensitivities as low as 30% depending on the specific RIDT and patient population.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!