Application packets are mailed upon request. Requests may be made by phone at (803) 545-4205 or by email at SC_CLIA@dph.sc.gov. Applications (CMS Form-116) are also available on the CLIA website. (Note: The application packet requested from SC DPH CLIA Program contains required documents that cannot be obtained from the CLIA website.).

CLIA certificates should be received within 30 days after the application has been processed by the SC DPH CLIA program. Payment of the certificate fee is required before certificates are issued. (Note: The above time frame is an estimate.)

All CLIA fee payments should be submitted to the CMS contractor in Portland, OR. SC DPH DOES NOT accept payment for CLIA certificates. All fees are payable to the following mailing address:

CLIA Laboratory Program
PO Box 3056
Portland, OR 97208-3056

All fees must be paid by CHECK or MONEY ORDER . Credit Card payments can now be made online by visiting www.pay.gov.

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 .

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.

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 DPH CLIA Program if you think your facility qualifies for the multi-site exception.

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.

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.

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 DPH CLIA Program within 30 days of making the change.

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 DPH office at (803) 545-4291 for more information.

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 DPH CLIA Program.

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 DPH CLIA PROGRAM for more information PRIOR to adding the test/ specialty.

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.

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.

The CLIA program is part of DPH’s Bureau of Hospitals, Community Services and Emergency Management.

Send CLIA-related documents and correspondence to SC_CLIA@dph.sc.gov or contact the CLIA Program at (803) 545-4205.