Clinical Laboratory Improvement Amendments (CLIA)


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.


CMS CLIA Testing Requirments for SARS-CoV-2 [NEW]


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 use the link below to ensure you are using 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 Support

Ernie Barger
Phone: 304-558-3530 extension 2103
  • 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
  • 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 2106
  • Laboratory Testing Technical Questions
  • Complaints / Concerns
  • Questions About Your Recent CLIA Inspection
  • Test Complexity
  • Personnel Licensure Questions