Haipeng Shao M.D., PH.D.

(1) A clinical laboratory is 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, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered clinical laboratories. (2) Any facility that examines materials from the human body for purposes of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of, the health of human beings. Typical divisions of a clinical laboratory include hematology, cytology, bacteriology, histology, biochemistry, medical toxicology, and serology.

A pathologist deals with the causes and nature of disease and contributes to diagnosis, prognosis and treatment through knowledge gained by the laboratory application of the biologic, chemical and physical sciences. A pathologist uses information gathered from the microscopic examination of tissue specimens, cells and body fluids, and from clinical laboratory tests on body fluids and secretions for the diagnosis, exclusion and monitoring of disease.

Source: NUCC, CMS