CLIA Laboratories - Compliance with Civil Rights Requirement

6034 - CLIA Laboratories - Compliance with Civil Rights Requirement (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) CLIA laboratories are required to comply with certain requirements enforced by the Office for Civil Rights (OCR), including the Americans with Disabilities Act, but are not subject to traditional pre-certification assurance investigations. These requirements are enforced only on the basis of complaints. The OCR makes any necessary investigations and determinations related to compliance with civil rights requirements. The SA forwards complaints concerning a CLIA laboratory’s noncompliance with Federal civil rights requirements to CMS. CMS must not assess the validity of such complaints. Rather, it must forward such complaints to OCR for review and investigation. As necessary, OCR forwards the complaint to the Department of Justice (DOJ) for evaluation, investigation, and disposition. CMS does not investigate Federal civil rights complaints under any circumstances. OCR or the DOJ is responsible for investigating Federal civil rights complaints. CMS is not authorized to bill the laboratory for the cost of a complaint survey for noncompliance with civil rights as part of the laboratory’s user fee obligation.