TABLE 6-1CLIA Categories of Laboratories

LABORATORY TYPECLIA DEFINITIONaCLIA CERTIFICATION REQUIRED?
Regulated by CLIA“[F]acilit[ies] for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.”Yes
“CLIA-exempt”Laboratories licensed by states that have “enacted laws relating to laboratory requirements that are equal to or more stringent than CLIA requirements” and CMS has approved the licensure program.No, but subject to CMS-approved, state regulations
ResearchFacilities “that test humans but do not report patient specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of individual patients.”No
a

42 C.F.R. § 493.2.

From: 6, Reshaping the Legal and Regulatory Landscape to Support Return of Individual Research Results

Cover of Returning Individual Research Results to Participants
Returning Individual Research Results to Participants: Guidance for a New Research Paradigm.
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories; Downey AS, Busta ER, Mancher M, et al., editors.
Washington (DC): National Academies Press (US); 2018 Jul 10.
Copyright 2018 by the National Academy of Sciences. All rights reserved.

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