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Changes/Renewal Process

How to Make Changes to a CLIA Certificate

All changes made to the information pertaining to your CLIA certificate should be submitted in writing within 30 days of the change. If changes are not reported in a timely manner the CLIA certificate may be issued with incorrect information, mailed to the wrong address, or terminated for non-payment of fees if the renewal fee coupon cannot reach your facility. Furthermore, the Centers for Medicare & Medicaid Services (CMS) will not reissue a CLIA certificate for changes in demographic information, such as facility name, physical address or laboratory director. These changes will appear on the next renewed certificate.

A written request submitted for a change should include the facility’s CLIA ID number and be signed by the Laboratory Director or Owner, or an authorized representative of the facility. Changes can be submitted by email, fax or regular mail to the Tennessee CLIA State Agency (SA).

Use the following table to determine what written documentation is required based on the certificate type and type of change requested:

CertificateType

ChangeType

DocumentationRequired

Waiver

  • telephone number, fax number
  • email address
  • physical address, mailing address
  • laboratory director
  • voluntary closure/termination

 

written*

  • facility name

  • tax number

  • ownership

 

Disclosure of Ownership

  • certificate type change to Waiver

CMS-116 application

PPMP

  • telephone number, fax number

  • email address

  • physical address, mailing address

  • voluntary closure/termination

 

written*

  • facility name

  • tax number

  • ownership

 

Disclosure of Ownership

  • laboratory director

  • certificate type change to PPMP

Compliance
  • Telephone number, fax number
  • email address
  • physical address, mailing address
  • voluntary closure/termination
written*
  • facility name
  • tax number
  • ownership
Disclosure of Ownership
  • laboratory director
  • certificate type change to Compliance
Accreditation
  • Telephone number, fax number
  • email address
  • physical address, mailing address
  • voluntary closure/termination
written*
  • facility name
  • tax number
  • ownership
Disclosure of Ownership

  • certificate type change to Compliance
  • accrediting organization (AO)
  • NOTE: changes to laboratory director, specialties and volumes must be directed
    to the accrediting organization
  • proof of termination from old AO
  • proof of enrollment with new AO

*Written documentation can include a letter, fax , or email. When submitting written documentation always provide the CLIA ID number and signature of the Laboratory Director or Owner, or an authorized representative of the facility.

How to Reactivate/Terminate a CLIA Certificate

Reactivation
If you have allowed your certificate to expire your certificate can be reactivated. The reactivation process is based on the amount of time the certificate has been inactive. If reactivation occurs before 6 months has lapsed since the certificate’s expiration date, the lab may be reactivated without a gap in the certificate cycle. Payment for the past due user fee should immediately be mailed to CMS.

If you wish to make changes to your certificate while in the process of reactivation you will need to submit an application to the Tennessee CLIA State Agency (SA).

If reactivation occurs after 6 months has elapsed, there must be a gap in the certificate cycle. Payment for the past due user fee must immediately be paid and an application submitted to the Tennessee CLIA State Agency (SA).

ExpirationTimeframe

Gap?

DocumentationRequired

Up to 6 months

No

6 months and greater

Yes

Termination

Facilities that wish to terminate their CLIA certificate should do so by written request. The request should include the CLIA ID number, the reason for termination, the effective date of the termination, and the signature of the Laboratory Director or Owner, or an authorized representative of the facility. Accredited laboratories that wish to terminate must additionally submit a letter of withdrawal from their accrediting organization. A letter from the Tennessee CLIA State Agency (SA) will be sent notifying the facility of the termination.

How to Renew a CLIA Certificate

Renewal of CLIA Certificates is an automated process initiated by the Centers for Medicare & Medicaid Services (CMS) in Baltimore. Unless a certificate has been allowed to expire, it is not necessary for facilities to complete an application to renew their certificate. User fee coupons are generated biennially according to certificate type using the following time frame:

CertificateType

FeeTimeframe

 

Waiver

6 months before the expiration date

 

PPMP

6 months before the expiration date

 

Accreditation

6 months before the expiration date

 

Compliance

Survey fee: 12 months before expiration date
Certificate fee: after the survey has been completed

 

 

Because the renewal process is automated it is important that facilities keep their address up to date. Please notify the Tennessee CLIA State Agency (SA) immediately of a change of address.

Once the renewal fee has been paid, CMS will mail the new certificate approximately one month prior to the expiration date of the current certificate. If the facility has not received its certificate within two weeks of the certificate’s expiration date, the facility should contact the Tennessee CLIA State Agency (SA) to inquire about the status of their certificate.

How to Request a Replacement CLIA Certificate

If a facility has changed its address or other demographic information, a new certificate will not be issued. Instead, the facility should submit a written request for a verification letter. The request 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.

The Tennessee CLIA State Agency does not keep copies of certificates and cannot issue replacement certificates. However, if a facility has renewed its certificate but has not received it by their current certificate’s expiration date, a replacement certificate can be requested from CMS. The facility should verify in writing that their physical and/or mailing address, tax ID number, laboratory director and certificate type are correct and has not been changed at the time of renewal. The Tennessee CLIA State Agency (SA) will forward the request to CMS for issuance of the replacement certificate.

Replacement certificates are not issued for lost or misplaced CLIA certificates. In such cases, a verification letter should be requested.

Overview Quick Guide    
  • Notify the Tennessee CLIA State Agency (SA) in writing within 30 days of changes to your certificate.
  • Always provide the CLIA ID number and signature of the Laboratory Director or Owner when submitting written notification.
  • CLIA certificates are renewed every two years. CMS will automatically begin the process by mailing out a fee coupon 12 months before the expiration date for a Certificate of Compliance and 6 months before the expiration date for all other certificate types.
  • A renewed certificate that has been paid for will be mailed approximately one month prior to the expiration date of the current certificate.
  • Reactivating an expired certificate involves paying the past due user fee and submitting an application if it has been expired for over 6 months.
  • A replacement certificate will not be issued for changes to demographic information, or certificates that are lost or misplaced. A verification letter should be requested instead.