Abstract:

Experts design and establish quality control methods,like sigma（σ） multi-rule quality control method by Westgard,in order to meet the requirements of clinical laboratories. In this process,besides clear clinical quality objectives,the concept of determination system should be available and must be strengthened,the analysis performance of determination system should be verified or confirmed,and whether determination systems meet the requirements or not also should be verified. Determination report is issued after each item determined just for 1 time. Therefore,quality control methods with complete description and theory,such as using error and total error,not using uncertainty,are suitable for single-time determination.

Key words: Total analysis error, Allowable total error, Uncertainty, Determination system, Precision