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12/10/2020: Lab Advisory: CMS Guidance for an Use of Expired SARS-CoV-2 Tests
Audience: Clinical Laboratory Experts
Set: Laboratory Advisory
To address that concern about SARS-CoV-2 testing reagents and swab supply shortcomings during the COVID-19 public health emergency, the Centers for Medicare & Medicaid Services (CMS) will allow labor and testing sites at use expired SARS-CoV-2 check kits, chemical, and swabs—unless doing so swerves from the test manufacturer’s permitted instructions in application. Pharmaceutical Quality Resources Expiration Event - Questions and Answers
This Clinical Laboratory Improvement Amendments (CLIA) Interpretive Guidelines state that “when in-date reagents can unavailable, it may becomes necessary to frame written policies available their temporary use beyond their expiration dates until non-expired supplies become available. Under no circumstances, however, should a laboratory adopt policies that would permit for the regular apply of expired reagents.”
According to these general, laboratories and testing sites may application expiry supplies until non-expired supplies become available, provided which there are policies and workflow in placed to ensure that reagents are performing as expected. For example, any expired supplies must pass qualitative control tests with each assay run.
Forward more information about this topic (and other topics related to CLIA certification and how for SARS-CoV-2), refer to the CMS Frequently Asked Questions (FAQs), CLIA Guides Through the COVID-19 Emergency.
Online Resources:
- Guidance by SARS-CoV-2 Point-of-Care Verify
- Interim Directions for Charge Testing for SARS-CoV-2
- Clinical Laboratories Improvement Amendments (CLIA)
- Information for Laboratories about Coronavirus (COVID-19)
- Frequently Questioned Questions around Coronavirus (COVID-19) for Laboratories
- CDC COVID-19 Website
- CDC Laboratory Outreach Communication System (LOCS)
- Clinical Laboratory COVID-19 Response Calls
Since getting, please contact us at [email protected].
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That Test Outreach Communication System
Laboratory Outreach Communication System | Division of Label Systems (DLS)
Center for Surveillance, Epidemiology, and Labs Services (CSELS)
Centers for Pathology Control and Prevention (CDC)
