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Press Releases
Reagent Water in Clinical Laboratories (C3-A4); Statistical Quality Control Procedures (C24-A3); Analysis of Body Fluids (C49-P); Aquatic Veterinary Microbiology Guidelines (M42-A), (M49-A); Molecular Diagnostic Methods for Genetic Diseases (MM1-A2); CDC Announcement: Important Laboratory Diagnosis Information Concerning Mumps Specimen Collection and Storage and Testing
CLSI Publishes New Guideline for Preparation and Testing of Reagent Water in Clinical Laboratories
Wayne, Pennsylvania, USA—July 2006—Purified water constitutes the major component of many reagents, buffers, and diluents used in clinical laboratory testing. It can also become an indirect component of tests when it is used for washing and sanitizing instruments and laboratory ware, generating autoclave steam, etc. Inadequate control of contamination in purified water is an important potential cause of laboratory error.
The newly published edition of Clinical and Laboratory Standards Institute’s (CLSI, formerly NCCLS) document, Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline—Fourth Edition (C3-A4), 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.
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CLSI Publishes New Document for Practical Guidance on Planning Statistical Quality Control Procedures
Wayne, Pennsylvania, USA—July 2006—Statistical quality control (QC) is critically important in laboratories today to ensure the quality of the test results produced by any measurement procedure. The almost universal applicability of statistical QC to quantitative measurement procedures provides laboratories with a quality management tool that can be deployed whenever and wherever needed. It also allows laboratories to independently verify and validate the ongoing performance of in vitro diagnostic device manufacturers’ built-in quality control measures and monitors.
Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published a new edition of the document, Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline—Third Edition (C24-A3). This guideline addresses the purpose of statistical quality control for quantitative measurement procedures; describes an approach for planning quality control for a particular measurement procedure; addresses the use of quality control material and quality control data, including the use of the data in quality assurance and interpretation; and provides detailed examples that demonstrate a practical QC planning process for clinical laboratories.
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CLSI Publishes New Guideline for Analysis of Body Fluids
Wayne, Pennsylvania, USA—July 2006—Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published a new document, Analysis of Body Fluids in Clinical Chemistry; Proposed Guideline (C49-P). This document provides guidance for clinical diagnostic laboratories to apply widely available measurement procedures to body fluids, as well as for reporting and interpreting those results. Emphasis is placed on:
• 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;
• variability in comparing results between different instrument manufacturers; and,
• recommended reporting format.
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CLSI Releases New Aquatic Veterinary Microbiology Guidelines
A Global Approach to Improve Quality and Efficiency in Aquatic Animal Diagnostic Laboratories
Wayne, Pennsylvania, USA—July 2006—Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has released guidelines for performing susceptibility testing on bacteria isolated from aquatic animals. Representing the collective efforts of a global, multilaboratory trial, the new CLSI guidance documents contain standardized methods to help scientists around the world monitor the epidemiology of resistance in the aquatic environment.
CLSI document Methods for Antimicrobial Disk Susceptibility Testing of Bacteria Isolated from Aquatic Animals; Approved Guideline (M42-A) provides the most up-to-date techniques for disk diffusion susceptibility testing of aquatic species isolates. Methods for Broth Dilution Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Approved Guideline (M49-A) provides methods for determining minimal inhibitory concentrations (MICs) of aquatic bacteria by broth micro- and macrodilution.
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New CLSI Guideline Covers Molecular Diagnostic Methods for Genetic Disease
Principles to Optimize the Provision of Accurate Genetic Information
Wayne, Pennsylvania, USA—July 2006—Molecular genetics has now become firmly entrenched as the third major subdiscipline of clinical laboratory medical genetics, emerging more recently than the other subspecialties, biochemical genetics and cytogenetics. As with any diagnostic method or test, in order to fully benefit the patient, it must be developed and practiced under appropriate conditions.
Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published a new edition of its document, Molecular Diagnostic Methods for Genetic Diseases; Approved Guideline—Second Edition (MM1-A2), which provides general recommendations for all phases of the operation of a molecular genetics diagnostic laboratory. The recommendations cover nomenclature for human pedigrees and the designation of mutations; laboratory safety; and “front end” activities, such as intake information, specimen identification and accessioning, and sample preparation. Other topics addressed are molecular analytical techniques, test validation and characterization, quality assurance, results reporting, and selection of referral laboratories. The guideline also includes definitions of selected terms commonly used in the theory and practice of molecular genetics.
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Special Announcements from the Centers for Disease Control and Prevention (CDC)
Important laboratory diagnosis information concerning mumps specimen collection and storage and testing
National Immunization Program’s Website
Information for Healthcare Professionals
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