CLSI C54 P : 1ED 2007
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
30-05-2008
12-01-2013
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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