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Information about the ongoing novel coronavirus outbreak.

Frequently Asked Questions

Application Process

To apply for a CLIA certificate you must determine the appropriate Certificate Type and complete a CLIA
Application for Certification, Form CMS-116
. It is the facility’s responsibility to make sure the certificate
type applied for matches the level of testing performed. Non-waived certificate types require additional
documentation.

See also How to Apply for a CLIA Certificate.

You can find the application at www.cms.gov/clia. Once at the site, click on the top link “How to Apply for
a CLIA Certificate.” Scroll down to the bottom of the page and you will find a PDF file labeled “CMS 116.”
Clicking on the PDF file will open the application.

Certificates

Generally, if we receive all the required paperwork and it is properly filled out, it will take 4-6 weeks for a
facility to receive its CLIA certificate.

In most cases, yes. CLIA certificates are location specific. Therefore, you must have a separate CLIA number
for each separate physical location of testing. There are certain exceptions in which one CLIA certificate can
cover multiple sites. You would need to meet the requirements for one of these exceptions included on
the CLIA application in order to qualify.  See Lab Situations.

Yes, if your lab qualifies for a multiple site exception. Laboratories with temporary testing sites,
governmental or not-for-profit facilities, and hospitals with multiple labs may qualify.
See also Lab Situations.

No. The State Agency will notify you via a confirmation letter when your changes have been entered into
the CLIA data system. Retain this letter as proof of the change. These changes will be reflected on your
next renewed CLIA certificate.

No. Facilities with an active CLIA certificate will automatically receive a renewal fee coupon biennially from
CMS prior to the certificate expiration date. The time frame for when the fee coupon is mailed varies by
certificate type. Once the laboratory pays the certificate fee, the new CLIA certificate will be generated and
mailed approximately one month prior to the current certificate’s expiration date.

Replacement certificates are not issued for lost or misplaced CLIA certificates. If a facility experiences
difficulty in receiving their new or renewal CLIA certificate they should contact the TN CLIA State Agency (SA)
at (615) 741-7023 or CLIA.Health@tn.gov

A facility that has lost or misplaced a CLIA certificate can request a verification letter. The request should be
in writing and should include the facility’s CLIA ID number and signed by the Laboratory Director or Owner,
or an authorized representative of the facility. The verification letter can be used as proof that the
certificate is valid and active.

Yes, but first you must contact your Accrediting Organization (AO) and notify them that your laboratory
wishes to make this change. The AO should inform you in writing once your lab has been withdrawn from
the organization. We require a copy of the written verification of withdrawal from the AO when you submit
a new application to change your certificate type.

Certificate Changes

It depends on the kind of changes being requested and the type of certificate that the changes are being made to:

  • For all demographic information made to all certificate types, and laboratory director changes made to a waived certificate, any written format is acceptable such as fax, email, or regular mail.

  • If reporting a new laboratory director for all other certificate types other than a waived certificate, the laboratory must complete Form CMS-116 and submit acceptable documentation of the laboratory director’s qualifications.

  • Changes in ownership require a Disclosure of Ownership form.

When reporting changes always include the facility’s CLIA ID number and signature of the Laboratory Director or Owner, or an authorized representative of the facility.

See also How to Make Changes to a CLIA Certificate.

The State Agency will notify you via a confirmation letter when your changes have been entered into the
CLIA data system.

You will need to complete a Disclosure of Ownership form. This form is also required for a name change
to the facility even if the ownership is not changing.

Lab Director/Lab Personnel

For laboratories performing moderate and/or high complexity testing the credentials of the Laboratory
Director must be verified. In addition to the director’s current TN state license, the information needed to
qualify medical doctors or doctors of osteopathy include:

  • For moderate complexity testing, evidence of 1 year’s experience directing/supervising a nonwaived laboratory; or completion of 20 hours’ continuing medical education (CME) credits for laboratory directors of moderate complexity laboratories as listed on the CMS website; or documentation of lab training equivalent to 20 CME credit hours in lab practice during medical residency is required.
  • For high complexity testing, documentation of board certification in Anatomic and/or Clinical Pathology; or documentation of 1 year of high complexity lab experience during residency; or documentation of 2 year’s experience directing/supervising high complexity lab testing is required.

For Ph.D. applicants the following documentation is required:

  • A copy of the doctoral degree (in a chemical, physical, biological, or clinical laboratory science) indicating specialty; or a copy of transcripts indicating specialty; and
  • A copy of a current board certification approved by HHS.

A resume or CV is not acceptable evidence of experience, nor does a copy of a CLIA certificate from another non-waived laboratory showing the applicant as director verify the required years of experience.

The requirements for changing a laboratory director vary according to certificate type:

  • For a Certificate of Waiver, written notification signed by the new director must be submitted. The laboratory’s CLIA ID number must be included.
  • For PPMP certificates, a CMS-116 CLIA application and a copy of the new director’s current TN state license must be submitted.
  • For Certificates of Compliance/Accreditation, a CMS-116 CLIA application, a copy of the new director’s current TN state license, and acceptable documentation qualifying the director must be submitted.

The personnel credentials of the laboratory’s testing staff are verified by the surveyor during onsite
inspections for laboratories with a Certificate of Compliance or Certificate of Accreditation. For state
licensure personnel questions please contact the Tennessee Medical Laboratory Board Administrative Office.

Payment

No. Do not send your payment to the TN CLIA State Agency (SA) with your application. Once the
application is entered into the CMS data system, CMS will bill you for the appropriate amount based on the
certificate type you requested.
See also What to Expect After Submitting an Application.

Yes. CMS is now accepting credit card payments online. For more information, please contact the TN CLIA
State Agency (SA) at (615) 741-7023 or CLIA.Health@tn.gov., or see instructions on how to pay online.

Surveys

All facilities performing laboratory testing may be subject to an inspection. Laboratories having a Certificate
of Compliance or Certificate of Accreditation are required to have routine biennial inspections. A waived
facility may receive an educational survey to ensure quality patient testing. Complaint investigations can be
performed on laboratories regardless of certificate type and are performed as needed.

The surveyor will schedule routine surveys six months prior to the certificate expiration date.
Complaints and follow-up surveys are always unannounced. The surveyor will review all documents related
to laboratory testing including but not limited to: procedure manuals, test records, personnel files, and
patient records. Failure to voluntarily provide this information may result in termination of your CLIA
certificate and Medicare reimbursements. If deficiencies are cited the laboratory will be given the
opportunity to submit a plan of action outlining how they will correct the deficient practice.

Testing

No. If your laboratory is performing CBCs, you will need to apply for a Certificate of Compliance.

No. A CLIA certificate is only required for facilities that perform diagnostic testing onsite. However, if you do any diagnostic testing, you are required to have a CLIA certificate.

see also Who Needs a CLIA Certificate?

Miscellaneous

Complaints can be submitted via telephone to the Complaint Hotline at 1-877-287-0010. You should
provide as much specific information to the Complaint Intake Representative as you can, including the
name and address of the facility, date and time of the incident, and a complete description of what
occurred. You may remain anonymous; however, if you do not provide your name and contact
information, you will not be informed of the outcome of the investigation.

You can contact the TN CLIA State Agency (SA) in a number of ways:

  • Write: Office of Health Care Facilities, CLIA Certification, 665 Mainstream Drive, 2nd Floor, Nashville, TN 37243

  • Phone: (615) 741-7023
  • Fax: (615) 532-2700
  • Main Email: CLIA.Health@tn.gov

See also Contact Information.