CLIA '88 greatly widened the definition of a laboratory. CLIA '88 defines a laboratory as “a place where materials derived from the human body are examined for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or assessment of the health of human beings. Laboratories may be located in hospitals, freestanding facilities or physician offices” (11). For the first time, federal laboratory regulation was site neutral. The level of regulation was determined by the complexity of the tests performed by the laboratory rather than where the laboratory was located. Physician office laboratories, dialysis units, health fairs, and nursing homes were all covered under the new law, along with