Clinical Laboratory Improvement Amendments (CLIA)

PROPOSED CMS RULE CHANGE

[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 labexcellence@cms.hhs.gov.



COVID-19 INFORMATION

The 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.

In 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 tests.

For a 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 appropriate setting.

COVID TESTING COMPLAINTS

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.


CMS CLIA Testing Requirments for SARS-CoV-2

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 dhhrolsclia@wv.gov.



The Law

Congress passed CLIA in 1988 establishing quality standards for all laboratory testing performed on clinical samples to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed.  The Centers for Medicare and Medicaid Services (CMS) is the federal agency given oversight of the CLIA program.  The OLS is the State Agency for WV and administers the CLIA program following the federal guidelines.

 

CLIA Certificate Applications and Changes

Initial CLIA certificate requests and certificate changes for WV clinical laboratories are processed by this office.  A completed CMS-116 and any required supporting documents must be submitted to the OLS CLIA Section via email, mail or fax. Our mailing address, email, and fax are listed in the "Contact Information" section of this page.  Allow a minimum of 2 weeks for us to process completed 116 applications.  Certificate changes must be submitted to this office within 30 days of the change. 
 

CLIA 116 Application Form

PLEASE NOTE:  CMS has recently released a new version of the CLIA application.  The link below will direct you to the most current form.  Please discard any previous versions of this form as we are unable to process obsolete forms.

Use the link below to ensure you are accessing the most recent CMS-116 application form.  The "Examples of How to Complete a CLIA 116 Form" section below contains information on how to properly complete a CMS-116 application.

CLIA Fees

All CLIA fees must be submitted directly to CMS through their payment website, Pay.gov, or via mail to:

CLIA Laboratory Program
PO Box 3056
Portland, OR  97208-3056

OLS cannot accept any type of payment for CLIA fees.
The amount that you are charged for your CLIA Certificate is based on the CLIA Fee Schedule. 
 

WV Medicare/Medicaid

We do not handle and can’t advise on what billing/payment codes to use.  If your WV Medicare/Medicaid reimbursement application asks for a “CLIA level” for your certificate type, those numbers are listed below: 
  • Certificate of Compliance = Level 1
  • Certificate of Waiver = Level 2
  • Certificate of Accreditation = Level 3
  • Certificate for Provider Performed Microscopy Procedures = Level 4
 

Types of CLIA Certificates Explained

 

Examples of How to Complete a CLIA 116 Form

These examples show the correct way to complete a CMS-116 application.  The highlighted fields indicate where you need to add your information.  The examples aren't inclusive of every situation, but cover most.  The CMS-116 application is a legal document and must be completed in its entirety for this office to process it.



 

CLIA Compliance Survey Document Examples

The OLS CLIA Section performs inspections for Certificate of Compliance laboratories/facilities.  As part of the pre-survey packet, these facilities are sent a CMS-209 and a survey sheet to complete.  Examples of how to properly complete these forms are below.

 

How to Complete a Compliance Survey Plan of Correction

 

Resource Links

 

CONTACT INFORMATION

WV Office of Laboratory Services
ATTN: CLIA Section
167 Eleventh Avenue
South Charleston, WV  25303
 
Phone: 304-558-3530
Fax: 304-746-0658
 

CLIA Administration

Ernie Barger
Phone: 304-558-3530 extension 58913
  • CLIA Initial Applications
  • CLIA Application Changes
  • Pre-Survey Documentation Questions
  • General CMS 116 CLIA Application Questions
  • Facility Complaint
 

CLIA Surveyor

Jennifer Law, MLT(ASCP)CM
Phone: 304-558-3530 extension 20127
  • Questions About Your Recent CLIA Inspection
  • Laboratory Testing Technical Questions
  • Complaints
  • Test Complexity
 

Training and Evaluation/CLIA Supervisor

Dana Stillwagon, MLS(ASCP)CM
Phone: 304-558-3530 extension 58916
  • Laboratory Testing Technical Questions
  • Complaints / Concerns
  • Questions About Your Recent CLIA Inspection
  • Test Complexity
  • Personnel Licensure Questions