CLSI H26 P2 : 2ED 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS
25-06-2010
12-01-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Validation (Manufacture)
6 Verification (End-User Laboratory)
7 Quality Assurance and Quality Control
References
Appendix A - Plasma Interferent Correction
Appendix B - Whole Blood Concentration and Dilution
Appendix C - Calibrators
Appendix D - Within-Run Imprecision Data Recording
Appendix E - Establishing Laboratory-Specific Quality Control
Means and Ranges
The Quality Management System Approach
Related CLSI Reference Materials
Specifies guidance for the validation, verification, calibration, quality assurance (QA), and quality control (QC) of automated multichannel hematology analyzers for manufacturers, end-user clinical laboratories, accrediting organizations, and regulatory bodies.
| DevelopmentNote |
Supersedes NCCLS H26 A. (09/2009)
|
| DocumentType |
Miscellaneous Product
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy |
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| CLSI EP21 A : 1ED 2003 | ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS |
| CLSI EP5 A2 : 2ED 2004 | EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS |
| CLSI EP31 A : 1ED 2008 | VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM |
| CLSI EP6 A : 1ED 2003 | EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH |
| CLSI EP15 A2 : 2ED 2006 | USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS |
| CLSI GP41 A6 : 6ED 2007 | PROCEDURES FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY VENIPUNCTURE |
| CLSI EP17 A : 1ED 2004 | PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION |
| CLSI C24 A3 : 3ED 2006 | STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS |
| CLSI EP9 A2 : 2ED 2002 | METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES |
| CLSI EP10 A3 : 2006 + A1 2014 | PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES |
| CLSI GP2 A5 : 5ED 2006 | LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL |
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