Laboratory Quality Control Based on Risk Management

Risk management is the systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling and monitoring risk (the effect of uncertainty on objectives). Clinical laboratories conduct a number of activities that could be considered risk management including verification of performance of new tests, troubleshooting instrument problems and responding to physician complaints. Development of a quality control plan for a laboratory test requires a process map of the testing process with consideration for weak steps in the preanalytic, analytic and postanalytic phases of testing where there is an increased probability of errors. Control processes that either prevent or improve the detection of errors can be implemented at these weak points in the testing process to enhance the overall quality of the test result. This manuscript is based on a presentation at the 2nd International Symposium on Point of Care Testing held at King Faisal Specialist Hospital in Riyadh, Saudi Arabia on October 12-13, 2010. Risk management principles will be reviewed and progress towards adopting a new Clinical and Laboratory Standards Institute Guideline for developing laboratory quality control plans based on risk management will be discussed.