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Bureau of Certification

Clinical Laboratory Improvement Amendments - Frequently Asked Questions

 

THIS INFORMATION IS FOR LABORATORIES OPERATING IN THE STATE OF SOUTH CAROLINA ONLY. IF YOU ARE A LABORATORY OPERATING IN A STATE OTHER THAN SOUTH CAROLINA PLEASE CONTACT THE CLIA PROGRAM IN YOUR STATE.

 

How do I apply for a CLIA certificate?
Application packets are mailed upon request. Requests may be made by phone at (803)545-4205 or by fax at (803) 545-4563. Applications (CMS Form-116) are also available on the CLIA Web site. (Note: The application packet requested from SC DHEC CLIA PROGRAM contains required documents that cannot be obtained from the CLIA Web site.)

How long does it take to receive a CLIA certificate once an application has been submitted?
CLIA certificates should be received within 30 days after the application has been processed by the SC DHEC CLIA program. Payment of the certificate fee is required before certificates are issued. (Note: The above timeframe is an estimate.)

How do we pay our CLIA certificate fees?
All CLIA fee payments should be submitted to the CMS contractor in Charlotte, NC. SC DHEC DOES NOT accept payment for CLIA certificates. All fees are payable to the following mailing address:

CLIA Laboratory Program
PO Box 530882
Atlanta, Georgia 30353-0882

All fees must be paid by CHECK or MONEY ORDER. Credit Card payments are not accepted at this time.

How do we make changes (i.e. address, Lab Director, name, ownership, etc.) to our CLIA certificate?
The CLIA program will accept changes to the CLIA certificate upon request. A request can be submitted by a faxed document to (803) 545-4563. The request must be written on your laboratory/company letterhead and include the facility’s CLIA number. Please note that requests for a change of Laboratory Director for Certificates of Provider-Performed Microscopy Procedures (PPMP) and/or Certificates of Compliance (CoC) require additional documentation of laboratory director qualifications which must be submitted with the change request. The Laboratory Director change request for PPMP or CoC cannot be processed without this information.

What kind of documentation is required to change directors? Can’t we just send a letter?

  • For Certificates of Waiver, mail or fax a written notice on company letterhead requesting the change. The written notice must include the laboratory’s CLIA number.
  • For PPMP certificates, submit an updated CMS-116 CLIA application and a copy of the director’s current SC medical license.
  • For Compliance (CoC) certificates, submit a copy of the director’s current SC medical license plus evidence of 1 year’s experience directing/ supervising a non-waived laboratory OR documentation of 20 hours’ continuing medical education (CME) credits for laboratory medicine. A resume or CV is not acceptable evidence of experience or CME training.
  • For Accreditation certificates, notify your accrediting agency and submit to CLIA an updated CMS-116 CLIA application.

Will we receive a new CLIA certificate after a change (i.e. address, Lab Director, name, ownership, etc.) has been requested?
No. The State Agency will notify you via the CLIA CHANGE FORM letter when your change has been made. Please attach the letter that you receive from the State to your current CLIA certificate as proof of the change. The renewal CLIA certificate will reflect all requested changes.

Our facility is planning to open a satellite office. Are we required to obtain a new CLIA certificate for the laboratory testing performed in the satellite office?
Yes. CLIA certificates are site-specific, meaning each site is required to have its own CLIA certificate. An exception can be made for Federal/State government facilities and Not-for-Profit organizations. Federal/State government facilities and Not-for-Profit organizations may be eligible for multi-site certificates in certain circumstances.  Contact the SC DHEC CLIA PROGRAM if you think your facility qualifies for the multi-site exception.

Our CLIA certificate will be expiring soon. Are we required to submit a renewal application?
No. All facilities with active CLIA certificates will receive a renewal billing from the CMS fee contractor prior to the actual certificate expiration date. Once the laboratory pays the certificate fee to the CMS contractor, a new CLIA certificate will be automatically generated and mailed to the laboratory’s mailing address.

My CLIA certificate doesn't expire for 6 months. Why did we receive a billing so far in advance of the expiration date?
All fees for CLIA certificates must be paid before a renewal certificate is issued. In order to assure that the laboratory has received the bill, the CMS contractor begins to bill the laboratory between 6 months to 1 year prior to the certificate expiration date. The billing cycles are as follows:

  • 6 months prior to CLIA Certificate expiration:
    Certificate of Waiver
    Certificate of Provider Performed Microscopy Procedures
    Certificate of Accreditation
  • 1 year prior to CLIA Certificate expiration (first bill - survey fees):
    Certificate of Compliance - Once the survey has been completed the facility will receive a second bill for the renewal certificate.

We paid our certificate renewal fees, but, have not received our renewal certificate yet, what should we do?
Once certificate fees have been paid, certificates are automatically generated and mailed to the laboratory’s most recent mailing address no more than one month before the actual expiration date. REMEMBER: It is the laboratory’s responsibility to report any changes to its most recent mailing address to the SC DHEC CLIA PROGRAM within 30 days of making the change.

Our lab has a Certificate of Accreditation. We want to change to another certificate type.  Do we notify CLIA?
First, you must notify your Accrediting Organization  such as CAP/COLA/JCAHO that your laboratory wishes to make this change. They will initiate the change through the CMS Regional Office in Atlanta. Contact the SC DHEC office at (803)545-4291 for more information.

How do I receive a replacement CLIA certificate?
Replacement certificates are not issued for lost or misplaced CLIA Certificates. If a laboratory experiences difficulties in receiving a new or renewal CLIA certificate, please contact the SC DHEC CLIA Program.

We want to add more tests to our menu. Do we need to upgrade our certificate to do that?
The CLIA regulations require laboratories to perform testing appropriate to their certificate type. If you wish to add more tests or specialties to your testing menu, contact the SC DHEC CLIA PROGRAM for more information PRIOR to adding the test/ specialty.

Where can I find the CLIA regulations?
All CLIA regulations and Interpretive Guidelines can be found in the State Operations Manual (SOM). The SOM and helpful links to other sites may be found on the CMS website at www.cms.hhs.gov.

Where can I find other information about CLIA?
Information regarding the CLIA program and links to helpful brochures and other information (including a downloadable CLIA application and information about laboratory director CMEs) may be found at the CLIA website, www.cms.hhs.gov/clia.

How do I contact CLIA program staff?
The CLIA program is part of DHEC's Bureau of Certification, located at 2600 Bull Street, Columbia, SC 29201. The main telephone number for the Bureau is (803) 545-4205.

You can call CLIA Section Manager Lakeisha Wright directly at (803) 545-4291 or e-mail her at WRIGHTLN@dhec.sc.gov.

Fax CLIA-related documents and correspondence to (803) 545-4563.

Revised 07.2011