Clinical Laboratory Improvement Amendments
(CLIA)
Any facility performing laboratory testing in the state of Montana is subject to the federal regulations of the Clinical Laboratory Improvement Amendments
(CLIA).
A laboratory is defined by CMS as a facility for the biological, microbiological, serological, chemical, immunohematological, 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 health of, human beings.
Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered laboratories.