Filing a complaint about a genetic testing lab

If you believe that you have been harmed by unethical behavior, unsafe business/health care practices or inaccurate results from a lab or its employees, you may file a complaint with the following agencies:

CLIA

All clinical laboratory testing performed on humans in the U.S. (except in clinical trials and basic research) is overseen by the Clinical Laboratory Improvement Amendments (CLIA).

If you have concerns or want to file a complaint against a lab that conducted genetic testing, you or your health care provider should reach out to your state CLIA contact. 

All other questions or concerns about the CLIA program should be submitted to LabExcellence@cms.hhs.gov

FDA

The Food and Drug Administration (FDA) also tracks adverse (negative) events and concerns about laboratory tests through MedWatch: the FDA Safety Information and Adverse Event Reporting Program. Patients or health care providers can report adverse events to the FDA.

• Patient Reporting Form
• Medical Provider Reporting Form