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CLSI C54 P : 1ED 2007

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM

Superseded date

30-05-2008

Superseded by

CLSI EP31 A : 1ED 2008

Published date

12-01-2013

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Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Definitions
5 Practical Considerations for Designing a Comparability
   Monitoring Protocol
   5.1 Causes of Noncomparability of Results
   5.2 Scope of Comparisons
   5.3 Risk Assessment for Noncomparable Results
   5.4 Frequency and Complexity of Comparability Assessment
         Protocols
   5.5 General Approaches to Comparability Testing
   5.6 Triggers for Special Cause Comparability Testing
6 Samples for Comparability Testing
   6.1 Commutability
   6.2 Analyte Concentrations for Testing
   6.3 Storage and Transport
7 Acceptance Criteria for Comparability Testing of Patient
   Results
   7.1 Evaluation of Comparability Based on Clinical Outcomes
   7.2 Evaluation of Comparability Based on Clinician's
         Questionnaire
   7.3 Evaluation of Comparability Based on Biological Variability
   7.4 Evaluation of Analytical Performance Based on Published
         Professional Recommendations
   7.5 Evaluation of Analytical Performance Based on Goals Set
         by Accrediting Agencies
   7.6 Evaluation of Analytical Performance Based on the General
         Capability
8 Statistical Evaluation of Comparability Data
   8.1 Hypothesis Testing
   8.2 Statistical Analysis of Comparability Data
   8.3 Fixed Limit Evaluation
9 Point-of-Care Testing (POCT)
   9.1 Specimen Selection
   9.2 Specimen Acquisition
   9.3 Range of Specimen Values
   9.4 Multiple Devices of the Same Make and Model
   9.5 Statistical Considerations for POCT Comparability
         Testing
10 Range Test Comparability Protocol
   10.1 Select an Analyte for Comparison
   10.2 Select the Instruments to Be Compared
   10.3 Identify an Approximate Analyte Concentration for
         Comparison Testing
   10.4 Calculate the Desired Concentration or Activity to
         Be Used for Comparison Sample Selection
   10.5 Select a Sample for Comparison Testing
   10.6 Select the Appropriate Level of Acceptance Criteria
         That Can Be Applied to the Comparison Test (from
         Section 7)
   10.7 Set the Critical Difference for the Comparability Test
         at the Recommended Total Error or Bias Limit Determined
         in Section 10.6
   10.8 Determine the Number of Replicates to Be Run
   10.9 Perform the Comparison
   10.10 Evaluate the Clinical Relevance of the Comparison
         Results
   10.11 Troubleshooting Noncomparability
References
Appendix A. Worked Examples
Appendix B. Table of Critical Differences (%) for the Range Test
Appendix C. Statistical Concepts
Appendix D. Biological Variation
The Quality Management System Approach
Related CLSI Reference Materials

Provides guidance on how to verify comparability of quantitative laboratory results for individual patients within a health care system.

DocumentType
Proposed Guideline
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy

BIS IS/ISO 15189 : 2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE

CLSI EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
CLSI C30 A2 : 2ED 2002 POINT-OF-CARE BLOOD GLUCOSE TESTING IN ACUTE AND CHRONIC CARE FACILITIES
CLSI C24 A3 : 3ED 2006 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS

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