Perspectives on quality control, risk management, and analytical quality management.

Quality control (QC) practices are changing in US laboratories as Centers for Medicare and Medicaid Services adopts individualized QC plans as a new option for compliance with the Clinical Laboratory Improvement Amendments regulations. The Joint Commission provides general guidance for applying risk management in health care organizations. The EP23A (Evaluation Protocol 23A) document from the Clinical and Laboratory Standards Institute provides specific guidance on the use of risk management for developing analytical QC plans. Medical laboratories should integrate risk management tools with existing quality management techniques and activities to provide an overall plan for analytical quality management.