Quality assurance programs to meet CLIA requirements.
CLIA '88 delineates specific quality assurance (QA) practices for cytology laboratories in the United States. In addition, there are general requirements that all types of clinical laboratories must meet to satisfy the CLIA law and regulations. This paper describes the origins and objectives of CLIA and it outlines the major sections of the legislation. To satisfy the regulations, every laboratory must develop its own quality assurance plan that addresses each of the specific conditions and standards. Furthermore, the laboratory must monitor its performance and document that, indeed, the QA systems are operating effectively. The article then describes the quality assurance plan of the Cytology Department of the Wisconsin State Laboratory of Hygiene. The department uses 28 monitors to determine compliance with the criteria and standards and to prevent problems in its day-to-day operation. When standards are not met or are exceeded, action steps are specified.
Inhorn
S L
SL
Department of Pathology and Laboratory Medicine, University of Wisconsin, Madison.
Shalkham
J E
JE
Mueller
G B
GB
D003585:Cell Biology / Q000592:standards*; D007753:Laboratories / Q000592:standards; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence*; D014481:United States