Developing risk-based quality control plans: an overview of CLSI EP23-A.

What constitutes quality control (QC) in the clinical laboratory has expanded from being focused on the testing of QC samples to managing the risks of reporting incorrect patient results. To effectively implement this expanded vision of QC, the techniques of risk management are important tools. In 2011, the Clinical and Laboratory Standards Institute published EP23-A, Laboratory Quality Control Based on Risk Management, providing an introduction to risk management techniques and guidance on developing a risk-based QC plan. This article outlines the steps in developing and using a risk based QC plan based on the EP23 model.