Planning Risk-Based Statistical Quality Control Strategies: Graphical Tools to Support the New Clinical and Laboratory Standards Institute C24-Ed4 Guidance
نویسنده :
تاریخ انتشار : 1396/10/03
Clinical and Laboratory Standards Institute (CLSI)'s new guideline for statistical quality control
(SQC; C24-Ed4) (CLSI C24-Ed4, 2016; Parvin CA, 2017) recommends the implementation of risk-based SQC strategies.
Important changes from earlier editions include alignment of principles and concepts with the general patient
risk model in CLSI EP23A (CLSI EP23A, 2011) and a recommendation for optimizing the frequency of SQC (number
of patients included in a run, or run size) on the basis of the expected number of unreliable final patient results. The
guideline outlines a planning process for risk-based SQC strategies and describes 2 applications for examination
procedures that provide 9-σ and 4-σ quality. A serious limitation is that there are no practical tools to help
laboratories verify the results of these examples or perform their own applications.