An agency that provides laboratory services must adopt and enforce a written policy to ensure that the agency meets applicable requirements of 42 United States Code (USC) §263a, concerning certification and certificates of waiver of a clinical laboratory (CLIA 1988). The section 42 USC § 263a applies to all agencies with laboratories that examine human specimens to provide information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.
26 Tex. Admin. Code § 558.284