CLSI EP19 : 2ED 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES
09-04-2020
25-08-2018
Abstract
Committee Membership
Foreword
Chapter 1: Introduction
Chapter 2: Introduction of Measurement Procedure Lifecycle
Chapter 3: Establishment
Chapter 4: Implementation
Chapter 5: Special Cases
Chapter 6: Conclusion
Chapter 7: Supplemental Information
References
Appendix A - Basic Statistical Concepts in the Evaluation of
Measurement Procedure Performance Characteristics
Appendix B - Checklists for Laboratory Use With the Evaluation
Protocols Documents
The Quality Management System Approach
Related CLSI References Materials
Defines the 'measurement procedure lifecycle' framework to aid users of CLSI evaluation protocols documents during establishment and implementation of measurement procedures developed by both commercial manufactures and clinical laboratories, ie, for laboratory-developed tests.
| DevelopmentNote |
Supersedes CLSI EP19 R. (06/2015)
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| DocumentType |
Miscellaneous Product
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| PublisherName |
Clinical Laboratory Standards Institute
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| CLSI C52 : 3ED 2017 | TOXICOLOGY AND DRUG TESTING IN THE MEDICAL LABORATORY |
| CLSI C49:2018(R2023) | Analysis of Body Fluids in Clinical Chemistry |
| CLSI GP27 A2 : 2ED 2007 | USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY |
| CLSI GP29 A : 1ED 2002 | VALIDATION OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE |
| CLSI AUTO13 A2 : 2ED 2003 | LABORATORY INSTRUMENTS AND DATA MANAGEMENT SYSTEMS: DESIGN OF SOFTWARE USER INTERFACES AND END-USER SOFTWARE SYSTEMS VALIDATION, OPERATION, AND MONITORING |
| CLSI EP27 A : 1ED 2012 | HOW TO CONSTRUCT AND INTERPRET AN ERROR GRID FOR QUANTITATIVE DIAGNOSTIC ASSAYS |
| CLSI QMS13 A : 1ED 2011 | QUALITY MANAGEMENT SYSTEM: EQUIPMENT |
| CLSI EP23 A : 1ED 2011 | LABORATORY QUALITY CONTROL BASED ON RISK MANAGEMENT |
| CLSI EP17 A2 : 2ED 2012 | EVALUATION OF DETECTION CAPABILITY FOR CLINICAL LABORATORY MEASUREMENT PROCEDURES |
| CLSI EP5 A3 : 3ED 2014 | Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition<br> |
| CLSI AUTO3 A2 : 2ED 2009 | LABORATORY AUTOMATION: COMMUNICATIONS WITH AUTOMATED CLINICAL LABORATORY SYSTEMS, INSTRUMENTS, DEVICES, AND INFORMATION SYSTEMS |
| CLSI QMS01 A4 : 4ED 2011 | QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES |
| CLSI MM17 A : 1ED 2008 | VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS |
| CLSI EP21 A : 1ED 2003 | ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS |
| CLSI EP26 A : 1ED 2013 | USER EVALUATION OF BETWEEN-REAGENT LOT VARIATION |
| CLSI EP31 A : 1ED 2008 | VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM |
| CLSI EP12 A2 : 2ED 2008 | USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE |
| CLSI EP24 A2 : 2ED 2011 | ASSESSMENT OF THE DIAGNOSTIC ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC CURVES |
| CLSI EP9 A3 : 3ED 2013 | MEASUREMENT PROCEDURE COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES |
| CLSI EP6 A : 1ED 2003 | EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH |
| CLSI M28 A2 : 2ED 2005 | PROCEDURES FOR THE RECOVERY AND IDENTIFICATION OF PARASITES FROM THE INTESTINAL TRACT |
| CLSI AUTO7 A : 1ED 2004 | LABORATORY AUTOMATION: DATA CONTENT FOR SPECIMEN IDENTIFICATION |
| CLSI M27 A3 : 3ED 2008 | REFERENCE METHOD FOR BROTH DILUTION ANTIFUNGAL SUSCEPTIBILITY TESTING OF YEASTS |
| CLSI M50 A : 1ED 2008 | QUALITY CONTROL FOR COMMERCIAL MICROBIAL IDENTIFICATION SYSTEMS |
| CLSI AUTO10 A : 1ED 2006 | AUTOVERIFICATION OF CLINICAL LABORATORY TEST RESULTS |
| CLSI EP14 A3 : 2014 | EVALUATION OF COMMUTABILITY OF PROCESSED SAMPLES |
| CLSI M40 A2 : 2014 | QUALITY CONTROL OF MICROBIOLOGICAL TRANSPORT SYSTEMS |
| CLSI M22 A3 : 3ED 2004 | QUALITY CONTROL FOR COMMERCIALLY PREPARED MICROBIOLOGICAL CULTURE MEDIA |
| CLSI M11 A8 : 8ED 2012 | METHODS FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ANAEROBIC BACTERIA |
| CLSI EP15 A3 : 3ED 2014 | USER VERIFICATION OF PRECISION AND ESTIMATION OF BIAS |
| CLSI M23 A3 : 3ED 2008 | DEVELOPMENT OF IN VITRO SUSCEPTIBILITY TESTING CRITERIA AND QUALITY CONTROL PARAMETERS |
| CLSI M100 S25 : 25ED 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 EP25 A : 1ED 2009 | EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS |
| CLSI C24 A3 : 3ED 2006 | STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS |
| CLSI EP7 A2 : 2ED 2005 | INTERFERENCE TESTING IN CLINICAL CHEMISTRY |
| CLSI MM3 A2 : 2ED 2006 | MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES |
| CLSI EP10 A3 : 2006 + A1 2014 | PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES |
| CLSI QMS02 A6 : 6ED 2013 | QUALITY MANAGEMENT SYSTEM: DEVELOPMENT AND MANAGEMENT OF LABORATORY DOCUMENTS |
| CLSI AUTO8 A : 1ED 2006 | MANAGING AND VALIDATING LABORATORY INFORMATION SYSTEMS |
| CLSI C56 A : 1ED 2012 | HEMOLYSIS, ICTERUS, AND LIPEMIA/TURBIDITY INDICES AS INDICATORS OF INTERFERENCE IN CLINICAL LABORATORY ANALYSIS |
| CLSI M29 A4 : 4ED 2014 | Protection of Laboratory Workers From Occupationally Acquired Infections<br> |
| CLSI EP30 A : 1ED 2010 | CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE |
| CLSI EP18 A2 : 2ED 2009 | RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES |
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