Clinical Laboratory Improvement Amendments Laboratory Certification

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing minimum quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. A laboratory is defined as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.

The Centers for Medicare and Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total CLIA covers approximately 171,000 laboratory entities. The Division of Laboratories and Acute Care Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations has the responsibility for implementing the CLIA Program. In Kansas, the CLIA program is administered by the Laboratory Improvement Program Office of the Kansas Health and Environment Laboratories. There are approximately 2,200 certified laboratories in the state of Kansas.

Questions concerning laboratory certification or testing can be found on the "CLIA Lab demographic information" webpage. For any additional questions or concerns, please contact us by email. We have eliminated our CLIA Certificate Change Form. All CLIA changes will need to be completed on the Federal CLIA Application Form CMS 116 and signed by the laboratory director. Applications and documents may be submitted by email or faxed to 785-559-5207.