How to Apply for a CLIA Certificate, Including International Laboratories

APPLICATION FOR A CLIA CERTIFICATE:  FORM CMS-116

The Centers for Medicare & Medicaid Services (CMS) has made available the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Application for Certification Form, CMS-116.  This form should be completed and mailed to the address of the local State Agency for the state in which your laboratory resides.  Refer to the State Agency & Regional Office CLIA Contacts page located on the left navigation bar to obtain the appropriate state agency address.  The CMS-116 form and its instructions are found as a download in the Related Link Inside CMS section below and contain the following information:

• The CLIA application form, CMS-116;
• Instructions for completing the CMS-116;
• Guidelines for counting tests for CLIA; 
• Certificate fees for laboratories established under 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: If you have any questions regarding the completion of the CMS-116 form, contact the appropriate State Agency. 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 that must be met as a prerequisite to CLIA certification and thus California applicants should contact their local State Agency at (213) 620-6160. Be sure to make contact with your State Agency to ensure that you have all the necessary information that is required for the application.

NOTE: Washington State applicants should not complete the CMS-116 form. They should contact the Washington State Agency at (253) 395-6746 for guidance.

NOTE: Laboratory directors performing nonwaived testing (including PPM) must meet specific education, training and experience under subpart M of the CLIA requirements.  Proof of these requirements for the laboratory director must be provided and submitted with the application.  Information to be submitted with the application include:

• Verification of State Licensure, as applicable
• Documentation of qualifications:
  • Education (copy of Diploma, transcript from accredited institution, CMEs),
  • Credentials, and
  • Laboratory experience.

Individuals who attended foreign schools must have an evaluation of their credentials determining equivalency of their education to education obtained in the United States.  Failure to submit this information will delay the processing of your application.  

The CLIA certification process for international laboratories is outlined in the download below.