Complaints Involving Laboratories

6140.5 - Complaints Involving Laboratories (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) The SA/CMS investigates allegations of non-compliance that are related to CLIA requirements in laboratories. A complaint about a laboratory should be reported to the appropriate SA or CMS contact. The complete list of SA/CMS contacts can be found on the CLIA website at: https://www.cms.gov/Regulations-and- Guidance/Legislation/CLIA/index.html. CMS is responsible for coordinating the responses to all complaints. (See SOM Chapter 5, sections 5500-5590, “Complaint Procedures” for guidance regarding complaint investigations). Sample Validation Surveys of Accredited Laboratories