CLSI H43 A2 : 2ED 2007

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Overview
   4.1 Goals
   4.2 Quality Control Procedures
   4.3 Sample Preparation
   4.4 Reagents
   4.5 Data Acquisition
   4.6 Data Analysis and Interpretation
5 Terminology
   5.1 Definitions
   5.2 Acronyms and Abbreviations
6 Safety
   6.1 Specimen Collection
   6.2 Safety Attire
   6.3 Biological Safety Cabinets
   6.4 Sample Containers
   6.5 Centrifugation
   6.6 Pipetting
   6.7 Sharp Devices
   6.8 Blood Spills
   6.9 Waste Disposal and Specimen Inactivation
   6.10 Specimen Storage
   6.11 Unfixed Specimens
   6.12 Equipment Disinfection
7 Specimen Collection
   7.1 Labeling of Specimen and Test Requisition
   7.2 Sample Collection Techniques
   7.3 Anticoagulants
8 Specimen Transport
   8.1 Specimen Handling and Packaging
   8.2 Specimen Integrity
9 Sample Preparation
   9.1 Visual Inspection
   9.2 Selection of a Sample Preparation Procedure
   9.3 Adjustment of Cell Counts
   9.4 Evaluation of Sample Viability
   9.5 Sample Preparation for Immunoglobulin Staining
   9.6 Intracellular Sample Preparation
10 Immunofluorescence Staining of Surface and Intracellular
   Antigens in Neoplastic Hematolymphoid Specimens
   10.1 Reagents
   10.2 Optimization of Staining Protocol
11 Sample Quality Control
   11.1 Verification of a Neoplastic Hematolymphoid Population
   11.2 Negative Controls
   11.3 Positive Controls
12 Data Acquisition
   12.1 Instrument Configuration
   12.2 Enrichment for Cells of Interest
   12.3 Analysis of Negative Control Sample(s)
   12.4 Data Management
   12.5 Consistency in Data
13 Data Analysis
   13.1 Goals
   13.2 Identification and Analysis of Populations in
        Specimens
   13.3 Quantification of Antigen Expression
   13.4 Multiparametric Analysis
14 Data Reporting and Interpretation
   14.1 Introduction
   14.2 Acute Leukemia
   14.3 Mature Lymphoid Neoplasms
   14.4 Myelodysplastic Syndrome (MDS)
   14.5 Data Reporting
   14.6 Regulatory Statement
15 Data Storage
   15.1 Information Stored
   15.2 Types of Data Storage
References
Additional References
Appendix A. Instrument Setup and Quality Control of
            Instrument Performance
References for Appendix A
Summary of Delegate Comments and Subcommittee Responses
The Quality Management System Approach
Related CLSI/NCCLS Publications

Provides performance guidelines for the immunophenotypic analysis of neoplastic hematolymphoid cells using immunofluorescence-based flow cytometry; for sample and instrument quality control; and precautions for acquisition of data from neoplastic hematolymphoid cells.