West Virginia Office
of Laboratory Services
167 11th Ave
South Charleston, WV 25303
[NEW - 08/02/2022] CMS and CDC issued a proposed rule (CMS-3326-P) to update CLIA fees, histocompatibility and personnel requirements, and alternative sanctions for Certificate of Waiver laboratories.
CMS is issuing this proposed rule to update the CLIA fees and to clarify the CLIA fee regulations. The rule includes a proposal to provide sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees. OLS is proposing to incorporate limited/specific fees for laboratories, including fees for follow-up surveys, substantiated complaint surveys, and revised certificates.
This proposed rule would also ammend histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate changes in technology. In addition, this proposed rule would update alternative sanctions that include civil money penalties, a directed plan of correction, a portion of a plan of correction, and onsite state monitoring, allowing for these sanctions to be applied to Certificate of Waiver laboratories.
There will be a 30-day public comment period, which ends on August 25, 2022. To submit a comment, follow the link to the proposed rule and click the green box near the top of the page that says "submit a formal comment".
A fact sheet can be found on the CLIA website in the "downloads" section HERE.
Any questions related to the proposed rule can be sent to email@example.com.
U.S. Food and Drug Administration (FDA) recently clarified that when it grants
an Emergency Use Authorization (EUA) for a point-of-care test, that test is
deemed to be CLIA-waived. For the duration of the national emergency
declaration for COVID-19, such tests can be performed in any patient care
setting that operates under a CLIA Certificate of Waiver or
Certificate of Compliance/Certificate of Accreditation.
addition, FDA clarified that tests for SARS-CoV-2 that are offered prior to or
without an EUA have not been reviewed by FDA, are not FDA authorized, and have
not received a CLIA categorization. Thus, those tests are
considered high complexity by default until they receive an EUA or other FDA
approval that indicates they may be performed as moderate complexity or waived
list of tests with an EUA, visit https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.
For a list of serology assays in
which the manufacturer has notified FDA that it will be distributing for use,
but has not sought an EUA, visit https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2. The list is currently
in the last question of the first block of Q&A on the page. These
are the tests that default to high complexity and may only be used in the
The Centers for Medicare and Medicaid Services (CMS) has released guidance for consumers who wish to submit a complaint against any entity who is performing COVID-19 testing, whether it is in a single permanent building or at a temporary location (like a health fair or community screening event). For more information on consumer complaints, visit https://www.cms.gov/files/document/consumer-complaints-faq.pdf. For more information on temporary testing quality and safety, visit https://www.cms.gov/files/document/temporary-covid-19-testing-sites.pdf.
In an effort to provide support to workplaces who may be doing COVID-19 testing, CMS has prepared materials to outline the simple steps necessary to do this. Generally, a CLIA certificate of waiver is necessary for a workplace to do testing. For information regarding CLIA requirements and the application process for workplace COVID-19 testing, please see the Quick Start Guide for COVID-19 Testing in the Workplace and the Workplace COVID-19 Testing Fact Sheet.
Please Note: CMS is temporarily exercising enforcement discretion and allowing employers to start waived SARS-CoV-2 Point of Care testing after a facility has submitted a CMS-116 application.
Please do not hesitate to contact
us with any questions you have regarding SARS-CoV-2 (COVID-19) testing at 304-558-3530 or by email at firstname.lastname@example.org.