R444-1-1. Definitions

(1) "Department" means the Department of Health.

(2) "Facility" means a place physically equipped to be a laboratory, but not yet approved to operate as a laboratory for a particular specialty or subspecialty.

(3) "Laboratory" means an approved facility that conducts 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 the health 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.

(4) "Review" means an evaluation of a laboratory or a facility by an authorized department representative to determine compliance with R444-1.