What's New in Laboratory Statistical Quality Control Guidance? The 4th Edition of CLSI C24, Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions

Abstract

In laboratory medicine, our main goal is to improve patient health by providing laboratory results that support medical decisions. To meet this goal, the laboratory needs to report accurate results that enhance care and minimize patient risk. Analytical goal setting helps the laboratory assure that when their measurement procedures are operating in their stable, in-control state, the patient results they report will be fit for their intended use. The laboratory's QC plan is designed to assure that even when test system failures occur, the risk of patient harm due to erroneous reported results is kept to acceptable levels. The CLSI C24 document first published as an approved guideline in 1991 has been a popular and useful resource to help laboratories design, implement, and assess their QC practices. The 4th edition of CLSI C24 titled Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions has just been completed (1). As chair of the C24, 4th edition, document development committee, my goal, as I expressed it to the committee at our first meeting, was to keep the content that was still applicable and relevant to the modern laboratory, modify or enhance content where necessary to bring it in line with current laboratory …