A room or building equipped for scientific experimentation, research, testing, or clinical studies of materials, fluids, or tissues obtained from patients.
(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.Backup to top
A commercial laboratory specializing in the construction of dental appliances that conform to a dentist?s specifications including the construction of dentures (complete or partial), orthodontic appliances, bridgework, crowns, and inlays.Backup to top
A Department of Defense (DoD) medical clinical reference laboratory not associated with a DoD Hospital or DoD Clinic. An example is the Armed Forces Institute of Pathology.Backup to top
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.Backup to top