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The Application Process

How to Apply for a CLIA Certificate

To receive a CLIA certificate for laboratory testing, you must first complete the CLIA Application for Certification, Form CMS-116. The application can be filled out online but ultimately must be printed, then signed and dated by the Laboratory Director or Owner, or an authorized representative of the facility. The original application and any requested qualifying documentation must be mailed to the Tennessee CLIA State Agency (SA). It is a good idea to keep a copy of the application should the Tennessee CLIA State Agency (SA) need to contact you for additional information or documentation. Instructions for completing the application are provided at the end of the application file. These instructions are provided to assist you in completing the application. It is not necessary for you to include them with your application.

Filling Out the CMS-116

All requested information (except for the CLIA Identification Number, which should be left blank) must be completed in Section I. General Information. It is especially important to include contact information should it be necessary to contact you regarding a discrepancy in your application. A telephone number is mandatory; additional contact fields such as a fax number or email address are recommended as additional methods of contact.

Once you choose a Certificate Type in Section II of the application, instructions are provided within the parentheses () to indicate which remaining sections of the application you should complete. DO NOT leave any section that is requested blank. Doing so will only delay the processing of your application.

Providing Additional Documentation

Laboratory Director Qualification. If you are applying for a Certificate of Provider Performed Microscopy Procedures (PPM), a Certificate of Compliance, or a Certificate of Accreditation, your laboratory director must be qualified to oversee non-waived testing. The documentation required for director qualification is dependent on the type of certificate that is being applied for:

CertificateType

QualificationRequirements

 

Waiver

No additional documentation required

 

PPMP

A copy of the current TN state license

 

Compliance, Accreditation

  1. A copy of the current TN state license; and

  2. One of the following based on the level of complexity testing:
    For a laboratory performing moderate complexity testing:

    • Documentation of at least one (1) year directing or supervising non-waived testing;
      or
    • Completion of 20 CME credit hours from one (1) of the CME courses for Laboratory Directors of Moderate Complexity Laboratories listed on the CMS web site;
      or
    • Documentation of lab training equivalent to 20 CME credit hours in lab practice during medical residency.  

For a more detailed list consult §493.1405 of the Code of Federal Regulations

  1. For a laboratory performing high complexity testing
     
    • Documentation of board certification in Anatomic and/or Clinical Pathology;
      or
    • Documentation of one (1) year of high complexity lab experience during residency;
      or
    • Documentation of two (2) years directing or supervising high complexity lab testing.

For more detailed list consult §493.1443 of the Code of Federal Regulations

EXCEPTIONS
For Ph. D. Applicants:  In lieu of a state license the following documentation is required:

  • A 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.

For Mohs applicants: The following documentation is required:

  • A copy of the current TN state license
    and
  • A Mohs certificate verifying at least one (1) year of training.
 

Accreditation Enrollment. Applicants for a Certificate of Accreditation should provide evidence of enrollment with one of the seven CMS approved accreditation organizations. If a laboratory has not yet enrolled with one of these organizations by the time they submit their application to CLIA, then they must provide evidence of application for accreditation with an accrediting organization within 11 months after receipt of the Certificate of Registration. If a facility wants to change or terminate their accreditation, they must submit evidence of termination from their current accrediting organization to the Tennessee CLIA State Agency (SA).

Submitting Your Application

After completing your application, you should submit the original application by mail to the Tennessee CLIA State Agency (SA).

All additional documentation regarding director qualification and/or accreditation enrollment should be included. DO NOT send payment with your application; all checks sent with the application will be returned.

If the application is incomplete or inaccurate you will be notified by phone, fax, email or mail. For this reason please verify that all contact information on page one of the application is legible and correct.

What to Expect After Submitting an Application

Approximately 2-4 weeks after submitting your application (provided you were not contacted by the SA for corrections to your application) you will receive a user fee coupon from the Centers for Medicare & Medicaid Services (CMS). The user fee coupon contains the correct fee amount of the certificate based on the type of certificate , the mailing address of the facility, the facility’s CLIA ID number, and instructions on where and how to send in the payment. If at all possible, CLIA payments should be submitted with the fee coupon. If you do not have a copy of the fee coupon then please include your CLIA ID number on your check, make your check payable to CLIA LABORATORY PROGRAM and mail it to CMS. You can also choose to pay your bill electronically.  

In order to prevent your payment from being posted to the wrong CLIA account, NEVER USE ANOTHER FACILITY’S FEE COUPON.

Upon receipt of payment, Your CLIA account will be activated and your CLIA certificate mailed to the mailing address provided on the application. If you did not provide a mailing address, the certificate will be mailed to the facility’s physical address. If you have not received your certificate 30 days prior to the certificate’s expiration date but you have submitted payment please contact your State Agency for instructions on obtaining a replacement certificate.

Overview Quick Guide    
   
App Recap: What to Submit  
If applying for a Certificate of… you must submit…*  
Waiver
  • an original application
 
PPMP
  • an original application
  • a copy of the lab director’s current TN state license
 
Compliance
  • an original application
  • a copy of the lab director’s current TN state license
  • qualifying documentation for your lab director
 
Accreditation
  • an original application
  • a copy of the lab director’s current TN state license
  • qualifying documentation for your lab director
  • enrollment letter from an approved accrediting agency
 
*All documentation for an initial CLIA must be mailed to the Tennessee CLIA State Agency (SA)