Internal quality control: planning and implementation strategies.
The first essential in setting up internal quality control (IQC) of a test procedure in the clinical laboratory is to select the proper IQC procedure to implement, i.e. choosing the statistical criteria or control rules, and the number of control measurements, according to the quality required for the test and the observed performance of the method. Then the right IQC procedure must be properly implemented. This review focuses on strategies for planning and implementing IQC procedures in order to improve the quality of the IQC. A quantitative planning process is described that can be implemented with graphical tools such as power function or critical-error graphs and charts of operating specifications. Finally, a total QC strategy is formulated to minimize cost and maximize quality. A general strategy for IQC implementation is recommended that employs a three-stage design in which the first stage provides high error detection, the second stage low false rejection and the third stage prescribes the length of the analytical run, making use of an algorithm involving the average of normal patients' data.
Westgard
James O
JO
University of Wisconsin Medical School, 1300 University Avenue, Madison, WI 53706, USA. jowestgard@med.wisc.edu
D015982:Bias; D019411:Clinical Laboratory Techniques / Q000592:standards*; D003627:Data Interpretation, Statistical; D009937:Organizational Objectives; D010934:Planning Techniques; D011786:Quality Control; D012015:Reference Standards; D012680:Sensitivity and Specificity; D009626:Terminology as Topic; D017749:Total Quality Management / Q000379:methods*