CLSI Documents with the Participation of HCSL
A. Risk Management
1. Krouwer JS, Halim A-B, Hatjimihail AT, Jacobs E, Manasterski A, Nichols, JH. Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition. CLSI document EP18-A2 (ISBN 1-56238-000-0). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2009:1-82.
Abstract
Clinical and Laboratory Standards Institute document EP18-A2 - Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition recommends a quality management system for in vitro diagnostic test systems that is based on expert opinion, is practical to implement, and is applicable to various devices and settings, so sources of failure (potential failure modes) are identified, understood, and managed. This system will assist device manufacturers, regulators, accrediting agencies, and laboratory directors in ensuring correct results. It addresses regulatory considerations (eg, principles and accountability), recommends the development of a partnership between users and manufacturers, provides a source-of-failures matrix, and suggests approaches to quality monitoring/identification of the problems.
Comment
This CLSI document is an introduction to the failure modes and effects analysis (FMEA) and to the failure reporting, analysis, and corrective action system (FRACAS), in a clinical laboratory setting.
B. Quality Control and Risk Management
1. Nichols JH, Altaie, SS, Cooper G, Glavina P, Halim A-B, Hatjimihail AT, et al. Clinical and Laboratory Standards Institute (CLSI). Laboratory Quality Control Based on Risk Management; Approved Guideline. CLSI document EP23-A (ISBN 1-56238-767-7 [Print]; ISBN 1-56238-768-5 [Electronic]). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087 USA, 2011:1-73.
Abstract
Clinical and Laboratory Standards Institute document EP23-A - Laboratory Quality Control Based on Risk Management; Approved Guideline provides guidance to laboratories on the development of quality control plans for measuring systems. Regulatory requirements, information provided by the manufacturer, information pertaining to the laboratory environment, and medical requirements for the test results are evaluated, using risk management principles, to develop a quality control plan tailored to the particular combination of measuring system, laboratory environment, and clinical application. The effectiveness of the laboratory quality control plan is monitored to detect trends, identify corrective actions, and provide continuous quality improvement. The advantages and limitations of various quality control processes are considered.
C. Diagnostic Accuracy
1. Kroll MH, Bipasa B, Budd JR, Durham P, Gorman RT, Gwise TE, Abdel-Baset H, Hatjimihail AT, Hilden J, Kyunghee S. Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition. CLSI document EP24-A2 (ISBN 1-56238-777-4 [Print]; ISBN 1-56238-778-2 [Electronic]). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2011:1-60.
Abstract
Clinical and Laboratory Standards Institute document EP24-A2 - Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition provides guidance for laboratorians and manufacturers who assess clinical test accuracy. It is not a recipe; rather, it is a set of concepts to be used to design an assessment of test performance or to interpret data generated by others. In addition to the use of ROC curves and comparison of two curves, the document emphasizes the importance of defining the question, selecting a sample group, and determining the "true" clinical state. The statistical data generated can be useful whether one is considering replacing an existing test, creating or adding a new test, or eliminating a current test.
D. Measurement Uncertainty
1. Kallner A, Boyd JC, Duewer DL, Giroud C, Hatjimihail AT, Klee GG, et al. Expression of Measurement Uncertainty in Laboratory Medicine; Approved Guideline. CLSI document C51-A (ISBN 1-56238-787-1 [Print]; ISBN 1-56238-788-X [Electronic]). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2012:1-56.
Abstract
Clinical and Laboratory Standards Institute document C51-A - Expression of Measurement Uncertainty in Laboratory Medicine; Approved Guideline describes the principles of estimating measurement uncertainty and provides guidance to clinical laboratories and in vitro diagnostic device manufacturers on the specific issues to be considered for implementation of the concept in laboratory medicine. This document illustrates the assessment of measurement uncertainty with both bottom-up and top-down approaches. The bottom-up approach suggests that all possible sources of uncertainty are identified and quantified in an uncertainty budget. A combined uncertainty is calculated using statistical propagation rules. The top-down approach directly estimates the measurement uncertainty results produced by a measuring system. Methods to estimate the imprecision and bias are presented theoretically and in worked examples.