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.

Source Note: The provisions of this §558.284 adopted to be effective February 1, 2002, 26 TexReg 9159; transferred effective May 1, 2019, as published in the April 12, 2019, issue of the Texas Register, 44 TexReg 1893; amended to be effective April 25, 2021, 46 TexReg 2427