Statistical analysis of data in cervical cytology from the viewpoint of total quality management

As a consequence of widespread dissatisfaction with the high incidence of false negatives in cytologic smear screening, the Clinical Laboratory Improvement Amendments of 1988 were enacted by Congress with specific requirements for quality assurance in the screening of cytologic smears for cervical cancer. This paper examines the process of cervical cytologic screening from a total quality management perspective and suggests the use of several statistical techniques from industrial total quality management for describing and monitoring the process of cytologic smear screening. Several examples are included, and a general approach to implementing these techniques is suggested.