Accreditation processes are evaluated with special emphasis on standards established by agencies and organizations such as JCAHO, CAP, FDA, NCCLS (FCC). The continuing quality control demands of the Clinical Laboratory Improvement Act of 1988 (CLIA '88) and the various accrediting bodies are addressed through a statistical approach that examines descriptive and inferential analysis to include hypothesis testing (t-test), power and confidence intervals, OVA-testing and regression analysis, TEA algorithms, reference range establishment, interference studies, bias studies, method comparison, validation studies, and, unstable error studies. Performance and utilization management systems, standard compliance issued related to Medicare laboratory fee schedules, CPT and ICD coding, reimbursement strategies and other billing practices are presented. The course concludes with a unit on OSHA that delineates chemical and infectious hazards and safety in the laboratory.