CLSI MM14 A2 : 2ED 2013
Current
The latest, up-to-date edition.
DESIGN OF MOLECULAR PROFICIENCY TESTING/EXTERNAL QUALITY ASSESSMENT
Hardcopy , PDF
English
23-05-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Survey of Regulatory and Guidance Documents
Regarding Proficiency Testing
6 Design
7 Material Sourcing/Collection
8 Production/Manufacture
9 Transportation of Samples for Proficiency
Testing Programs
10 Documentation to Exchange Information
11 Provider Results Review and Evaluation
12 Complementary and Supplementary Approaches to
Proficiency Testing/External Quality Assessment Programs
References
Appendix A - Globally Influential Documents Addressing
Proficiency Testing: Relevance to and impact
on Stakeholders
Appendix B - Process Checklist Example
Appendix C - Useful Websites for Information in Shipping
Proficiency Testing/External Quality
Assessment Samples
Appendix D - Example Registration Form for Proficiency
Testing/External Quality Assessment
Challenge/Scheme
Appendix E - Example Instructions Manual
Appendix F - Example of Clinical Information Related to
the Proficiency Testing/External Quality
Assessment Sample
Appendix G - Example sections From a Proficiency
Testing/External Quality Assessment Result
Reporting Form
Appendix H - Example Confidentiality Form
Appendix I - Example Data From a Participant Summary Report
The Quality Management System Approach
Related CLSI Reference Materials
Specifies guidelines for a quality proficiency testing/external quality assessment program, including reliable databases; design control in the choice of materials and measurands; good manufacturing processes; documentation procedures; complaint handling; corrective and preventive action plans; and responsive timing of reports.
DevelopmentNote |
Supersedes CLSI MM14 A. (06/2013)
|
DocumentType |
Standard
|
ISBN |
1-56238-873-8
|
Pages |
84
|
PublisherName |
Clinical Laboratory Standards Institute
|
Status |
Current
|
Supersedes |
CLSI MM9 A2 : 2ED 2014 | NUCLEIC ACID SEQUENCING METHODS IN DIAGNOSTIC LABORATORY MEDICINE |
CLSI MM3 A3 : 3ED 2015 | MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES |
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