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CMS has made available the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Application for Certification, Form CMS-116. This form should be mailed to the address of the local State Agency for the State in which your laboratory resides. (The form is in an Adobe Acrobat file (form116.pdf) and requires the Adobe Acrobat reader software to view. The file contains the following-- Form CMS-116 (PDF 33K), Instructions for Completion, Guidelines for Counting Tests for CLIA and Tests Commonly Performed and Their Corresponding Laboratory Specialties/Subspecialties.

CLIA requires all entities that perform even one test, including waived test on ... "materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings" to meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program.

The CLIA application collects information about a laboratory's operation, which is necessary to determine the type of certificate to be issued and the fees to be assessed.

NOTE: Your completed application should be forwarded to the address of the local State Agency for the State in which your laboratory resides. If you have any questions regarding the completion of the Form CMS-116, contact the appropriate State Agency as noted above. You should also contact this State agency for additional forms that may be necessary to complete the registration process or for any additional questions. For example, the State of California has additional licensure requirements and thus California applicants should be sure to contact their local State Agency --(213) 833-6000. Be sure to make contact with your State Agency to ensure that you have all the necessary information that is required for application.