A clinical laboratory is a facility for the examination of materials taken from the human body, to help diagnose, prevent, or treat a human disease or condition. CLIA requires all entities that perform even one test, including waived tests on ... "materials derived from the human body" to meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory. For CLIA's definition of a clinical laboratory, see 493.257 FR 7139, Section 493.2 Definitions. http://www.phppo.cdc.gov/clia/regs/subpart_a.aspx#493.2 | 
