Source: Government Printing Office (GPO) Federal Digital System.
The section of the federal regulations titled "Standards and Certification: Laboratory Requirements" is issued by the Centers for Medicare & Medicaid Services (CMS) to enact the CLIA law passed by Congress (see below). In general terms, the CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health. The final CLIA'88 regulations were first published in 1992, phased in through 1994, and amended in 1993, 1995, and 2003. Please visit the CLIA History page to search and view the Federal Register Notices and former editions of the Code of Federal Regulations (published annually in October).