CLSI EP23 A : 1ED 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
LABORATORY QUALITY CONTROL BASED ON RISK MANAGEMENT
Hardcopy , PDF
19-08-2023
English
25-10-2011
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Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Quality Control Toolbox
6 Information Gathering for Risk Assessment
7 Developing the Quality Control Plan
8 Postimplementation Monitoring of the
Quality Control Plan
References
Appendix A - Quick Guide Checklist for Establishing a
Quality Control Plan Based on Risk Management
Appendix B - The Laboratory Risk Assessment: Example
Glucose Measurement Using an Automated
Measuring System
Appendix C - Summary of Laboratory Risk Assessment Table -
Example: Glucose Measurement on an Automated
Measuring System
Appendix D - The Quality Control Plan Developed From the
Individual Components of the Quality Control
Strategies From Appendixes B and C - Example:
Glucose Measurement on an Automated Measuring
System
Appendix E - Example of Failure Investigation and Corrective
Action for Glucose Measurement on an Automated
Measuring System
The Quality Management System Approach
Related CLSI Reference Materials
Specifies guidance based on risk management for laboratories to develop quality control plans tailored to the particular combination of measuring system, laboratory setting, and clinical application of the test.
| DevelopmentNote |
Supersedes CLSI EP23 P. (11/2011)
|
| DocumentType |
Miscellaneous Product
|
| ISBN |
1-56238-767-7
|
| Pages |
84
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| CLSI M100 S25 : 25ED 2015 | PERFORMANCE STANDARDS FOR ANTIMICROBIAL DISK SUSCEPTIBILITY TESTS |
| CLSI EP19 : 2ED 2015 | A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES |
| CLSI M52:2010(R2020) | Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems |
| PD ISO/TS 17822-1:2014 | <i>In</i> <i>vitro</i> diagnostic test systems. Qualitative nucleic acid-based <i>in</i> <i>vitro</i> examination procedures for detection and identification of microbial pathogens General requirements, terms and definitions |
| CLSI C24 : 4ED 2016 | STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS |
| CLSI M100 S23 : 23ED 2013 | PERFORMANCE STANDARDS FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING |
| CLSI M52 : 1ED 2015 | Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems, 1st Edition |
| CLSI C57 : 1ED 2015 | MASS SPECTROMETRY FOR ANDROGEN AND ESTROGEN MEASUREMENTS IN SERUM |
| CLSI M100 S24 : 24ED 2014 | PERFORMANCE STANDARDS FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING |
| CLSI POCT4 : 3ED 2016 | ESSENTIAL TOOLS FOR IMPLEMENTATION AND MANAGEMENT OF A POINT-OF-CARE TESTING PROGRAM |
| CLSI MM20 A : 1ED 2012 | QUALITY MANAGEMENT FOR MOLECULAR GENETIC TESTING |
| CLSI MM3 A3 : 3ED 2015 | MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES |
| CLSI M2 A12 : 12ED 2015 | PERFORMANCE STANDARDS FOR ANTIMICROBIAL DISK SUSCEPTIBILITY TESTS |
| CLSI M7 A10 : 10ED 2015 | METHODS FOR DILUTION ANTIMICROBIAL SUSCEPTIBILITY TESTS FOR BACTERIA THAT GROW AEROBICALLY |
| CLSI GP47 : 1ED 2015 | MANAGEMENT OF CRITICAL- AND SIGNIFICANT-RISK RESULTS |
| ISO/TS 17822-1:2014 | In vitro diagnostic test systems Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens Part 1: General requirements, terms and definitions |
| CLSI M100 S26 : 26ED 2015 | PERFORMANCE STANDARDS FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING |
| CLSI POCT12 A3 : 3ED 2013 | Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition<br> |
| CLSI M29 A3 : 3ED 2005 | ACQUIRED INFECTIONS; APPROVED GUIDELINE |
| CLSI C24 A3 : 3ED 2006 | STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS |
| CLSI GP2 A5 : 5ED 2006 | LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL |
| CLSI EP18 A2 : 2ED 2009 | RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES |
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