BELLA CLINICAL CARE

(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 laboratory that operates independently of a hospital and physician's office to furnish physiological diagnostic services (e.g. EEG's , EKG's, scans, etc.). Facilities offering ONLY physiological services are not certified as independent laboratories. If an independent laboratory offers physiological services IN ADDITION to clinical laboratory services, they are surveyed only for compliance with the clinical laboratory regulations because there are no health and safety regulations for physiological services.

Source: NUCC, CMS