title: Clinically useful limits (CUL) criteria as a basis for quality control including minimal and optimal goals for quality control.
abstract: Quality control goals for quantitative clinical chemistry assays are reviewed. Recommendations for clinically useful limits (CUL) criteria as minimally acceptable +/- 2 SD for run-to-run and/or day-to-day technical reliability are presented in terms of biologic variations for different levels and clinical applications. A review of the literature and the questionnaire response of a medical school staff presented in this study reveal striking agreement of acceptable analytic goals based on physicians' opinions, biologic variation, and practical analytic feasibility. The current state-of-the-art in clinical laboratories can approach excellence because actual within-laboratory 2-SD variability estimates are somewhere between acceptable CUL criteria and twice as good. Assessing the reliability of laboratory reports based on accuracy and precision or total analytic error is also discussed.
authors.affiliation: Department of Pathology, University of Texas Medical Branch, Galveston 77550.
authors.forename: I
authors.initials: I
authors.lastname: Schoen
authors.forename: G A
authors.initials: GA
authors.lastname: Graham
authors.forename: E
authors.initials: E
authors.lastname: Custer
authors.forename: Z
authors.initials: Z
authors.lastname: Bandi
authors.forename: D
authors.initials: D
authors.lastname: Georgewill
mesh_terms: D001774:Blood Chemical Analysis / Q000592:standards*; D005180:Faculty, Medical; D006040:Goals; D006801:Humans; D011786:Quality Control; D011795:Surveys and Questionnaires