Clinical Chemistry
Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline—Fourth Edition. CLSI document C3-A4 (ISBN 1-56238-610-7). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2006.
Abstract: CLSI document C3-A4—Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline—Fourth Edition provides information on water purity requirements for clinical laboratory testing, validation of specifications, technology available for water purification, and test procedures to monitor and trend water purity parameters.
Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline—Third Edition. CLSI document C24-A3 (ISBN 1-56238-613-1). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2006.
Abstract: CLSI document C24-A3—Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline—Third Edition addresses the principles of statistical quality control (QC), with particular attention to the planning of a QC strategy, the definition of an analytical run, and the application of statistical QC in a healthcare laboratory. While these principles are of interest to manufacturers, this guideline is intended for use by a healthcare laboratory to provide a QC procedure that employs control materials that are independent and external to a reagent kit, an instrument, or analytical system. This guideline is a revision of an earlier guideline and includes the original definition for user-defined run length. Changes in the second edition included a strong emphasis on defining quality up front to guide the selection of control rules and the number of control measurements. The third edition adds example applications that make use of a simple sigma-metrics QC planning tool.
Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline—Second Edition. NCCLS document C31-A2 (ISBN 1-56238-436-8). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2001
Abstract: Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline—Second Edition (CLSI document C31-A2) is a guideline for specimen collection for ionized calcium determinations. The primary audience for this publication is personnel responsible for ionized calcium determinations. This document discusses the reasons for in vivo (nonpathologic) and in vitro changes in ionized calcium concentrations, and it presents recommendations for avoiding or minimizing these effects.
Control of Preanalytical Variation in Trace Element Determinations; Approved Guideline. NCCLS document C38-A (ISBN 1-56238-332-9). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087 USA, 1997.
Abstract: Control of Preanalytical Variation in Trace Element Determinations; Approved Guideline (CLSI document C38-A) is intended for persons responsible for the collection and processing of samples used for trace element determinations. The guideline addresses patient preparation, as well as considerations for collection, transport, and processing of specimens by element. Contamination control and quality assurance programs are also discussed.
Blood Gas and pH Analysis and Related Measurements; Approved Guideline - Second Edition. CLSI document C46-A2 (ISBN 1-56238-694-8). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2009.
Abstract: This guideline is a consolidation of six CLSI documents and projects. The Area Committee on Clinical Chemistry and Toxicology concluded that CLSI’s constituencies (professions, government, and industry) would be better served with the production of a single document that retains the essential information from the six original documents while making it even more relevant and useful. It addresses blood gas, pH, and related measurements (e.g., fractional oxyhemoglobin, oxygen content, hemoglobinoxygen saturation, and selected electrolytes) as measured in blood. It defines terminology and discusses performance characteristics as well as preanalytical variables and analytical considerations. It also addresses quality control issues.
Analysis of Body Fluids in Clinical Chemistry; Approved Guideline. CLSI document C49-A (ISBN 1-56238-638-7). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2007.
Abstract: CLSI document C49-A, Analysis of Body Fluids in Clinical Chemistry; Approved Guideline provides guidance to the clinical laboratory director for the application of widely available measurement procedures for testing body fluids and for reporting and interpreting those results. It emphasizes defining the common clinical situations for this use; acceptable practice for measuring analytes without extended method verification for abnormal body fluids; influence of biologic and analytic variation on interpretation of results; and variability in comparing results between different instrument manufacturers. This document does not consider serum, plasma, whole blood, or fluids for which assays typically have performance claims in the measurement procedure documentation.
SIMEL Italian Society Guidelines. (In Italian Language)
Abstract: SIMEL is the Italian Society of Laboratory Medicine for the progress of the laboratory science and its practical clinical application. The unit of diagnostic with clinical pathology and the cure of the patient constitutes the foundation of this multidisciplinary society. Please visit its website to find approved guidelines by SIMEL.
SIBIOC Italian Society Guidelines. (In Italian Language)
Abstract: SIBIOC is the Italian Society of Clinical Biochemistry and Clinical Molecular Biology. Please visit its website to find the approved and sponsored guidelines by SIBIOC.
GBM - Germany Society for Biochemistry and Molecular Biology Guidelines. (In German Language)
Abstract: The aim of the GBM is to promote basic and applied research as well as education in the fields of biochemistry, molecular biology and molecular medicine. Please visit its website to download the guidelines from the website.
