Idaho Admin. Code r. 16.02.06.010

Current through September 2, 2024
Section 16.02.06.010 - DEFINITIONS
01.Board. The Idaho Board of Health and Welfare.
02.Department. The Idaho Department of Health and Welfare, or its designee.
03.Clinical Laboratory. A facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examinations of material derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease, or the impairment or assessment of human health.
04.Laboratory Director. The person under whose supervision the laboratory is operating.
05.Nonwaived Test. A moderate or high complexity test system, assay, or examination that does not meet the criteria for a waiver as specified under Title 42 USC, Section 263a (3).
06.Proficiency Testing. Evaluation of a laboratory's ability to perform laboratory procedures within acceptable limits of accuracy through analysis of unknown specimens distributed at periodic intervals.
07.Quality Control. Analysis of reference materials to ensure reproducibility and accuracy of laboratory results and an acceptable system to assure proper functioning of instruments, equipment, and reagents.
08.Reviewer. The Department's representative who is knowledgeable and experienced in clinical laboratory methods and procedures.
09.Waived Test. A low complexity test system, assay, or examination that meets the criteria for waiver specified under Title 42 USC, Section 263a (3).

Idaho Admin. Code r. 16.02.06.010

Effective July 1, 2024