Clinical Laboratory Improvement Amendments (CLIA)

COVID-19 INFORMATION

COVID-19 (SARS-CoV-2) reporting is still required by the State of West Virginia. This includes all nucleic acid amplification (NAAT) results and positive results for all other tests.

A test may continue to be used pursuant to the EUA in the following circumstances:

The manufacturer provided a marketing submission to the FDA before May 11, 2023 and
FDA accepted the application but has not yet made a decision.

For a list of tests with an EUA, visit https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas.

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 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.

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.

Laboratory Quick Guide to CMS CLIA Certification

Initial CLIA Applications

All initial CLIA applications for laboratories physically located in WV are processed by the Office of Laboratory Services. Applications for all certificate types except Certificate of Waiver must include documents that prove Director qualifications. A list of supporting documents and Director qualifications can be found HERE. The CMS-116 application must be completed in its entirety or it will not be processed. Applications, letters, and documents may be submitted via email, fax, or mail. Our contact information can be found at the bottom of this page.

Notification of Changes

All laboratories are required to notify our office within 30 days of any change to the facility name, location, contact information, or ownership. All laboratories, except those with a Certificate of Accreditation, are required to notify our office within 30 days of any change to the Laboratory Director. Change notification can be made via the CMS-116 form or letter as explained below. Refer to CMS Memo 23-05-CLIA for more information.

A new CMS-116 form is required to add a multiple site exception or make changes to the certificate type, ownership, or nonwaived Laboratory Director. The form must be filled out in its entirety, regardless of whether the other information is changing, or it will not be processed. Please be sure to include supporting documentation for a change to Laboratory Director. Laboratories with a Certificate of Waiver do not need to provide any extra documentation and may request a Director change via letter.
An official letter is acceptable for requesting changes to existing multiple sites, facility name, tax ID, location, contact information, Technical Supervisor, or waived Laboratory Director and must include the date, facility name, CLIA number, a description of the requested change(s), and the signature of the Laboratory Director or designee.

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.

https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms116.pdf

Obtaining a Certificate or Replacement Certificate

How do I get a replacement CLIA certificate (labs in WV)?

How do I get a replacement CLIA certificate (labs outside WV)?
How long will it take to get my initial CLIA certificate?
How long will it take to get my updated CLIA certificate after I request one or make a certificate change?
When is my renewal certificate going to arrive? I already paid and the current certificate will expire soon.

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

Certificates of Waiver, PPMP, Registration, Compliance, and Accreditation 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.

Waived Initial CLIA-116 Application Example

Waived Change CLIA-116 Application Example

Waived Change CLIA-116 Formal Letter Examples (Only Used for Minimal Changes)

PPM Initial CLIA-116 Application Example

PPM Change CLIA-116 Application Example

Compliance Initial CLIA-116 Application Example

Compliance Change CLIA-116 Application Example

Accreditation Initial CLIA-116 Application Example

Accreditation Change CLIA-116 Application Example

Change of CLIA Certificate Type

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.

Completed CMS-209 Example

Completed OLS Survey Test Volume Sheet Example

Guidelines for Counting Tests Volumes