Analysis of Body Fluids in Clinical Chemistry (C49-A); Toxicology and Drug Testing in the Clinical Laboratory (C52-A2); Enumeration of Immunologically Defined Cell Populations by Flow Cytometry (H42-A2);Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells (H43-A2); Principles and Procedures for Blood Cultures (M47-A); Molecular Methods for Bacterial Strain Typing (MM11-A)

H42-A2—Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline—Second Edition
This document provides guidance for the immunophenotypic analysis of non-neoplastic lymphocytes by immunofluorescence-based flow cytometry; sample and instrument quality control; and precautions for acquisition of data from lymphocytes.
Purchase here.

M47-A—Principles and Procedures for Blood Cultures; Approved Guideline
This document provides recommendations for the collection, transport, and processing of blood cultures as well as guidance for the recovery of pathogens from blood specimens taken from patients who are suspected of having bacteremia or fungemia.
Purchase here.

Second Notice

C49-A—Analysis of Body Fluids in Clinical Chemistry; Approved Guideline
This document provides guidance 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 fluid; 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.
Purchase here.

C52-A2—Toxicology and Drug Testing in the Clinical Laboratory; Approved Guideline—Second Edition
This guideline addresses drug testing in the clinical laboratory, both for clinical and forensic purposes, and pertains to both drugs of abuse and other drugs normally encountered and analyzed by hospital laboratories. The guideline discusses the preanalytical, analytical, and postanalytical considerations for specimen collection, methods of analysis, quality assurance,  and the reporting and interpretation of results.
Purchase here.

H43-A2—Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline—Second Edition
This document provides performance guidelines for the immunophenotypic analysis of neoplastic hematolymphoid cells using immunofluorescencebased flow cytometry; for sample and instrument quality control; and precautions for acquisition of data from neoplastic hematolymphoid cells.
Purchase here.

MM11-A—Molecular Methods for Bacterial Strain Typing; Approved Guideline
This guideline examines the biology behind molecular strain typing and the process of characterizing and validating typing systems. The prevalent methods are described with particular attention to pulsed-field gel electrophoresis (PFGE) and multilocus sequence typing (MLST).
Purchase here.

Our procedures have been designed to ensure that consensus has been achieved when a standard or guideline is published at the approved level. This means that a document has been rigorously reviewed by the authoring subcommittee, the area committee overseeing the project, the Board of Directors, and the medical-testing community that participates in the consensus process by carefully reviewing and commenting on the standard or guideline.

You may automatically receive or select approved-level documents as a member benefit.  Find out more about joining CLSI:  view membership options and benefits. [ return to top ]