CLSI MM20 A : 1ED 2012

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Overview of the Process for Providing Molecular Genetic
  Testing Services and Path of Workflow
6 Application of Quality System Essentials to Molecular
  Genetic Testing
7 Technical Processes of Molecular Genetic Testing
8 Personnel Qualifications, Responsibilities, and Competency
References
Appendix A - Example of a Laboratory Quality Manual
Appendix B - A Crosswalk of Quality Standards of ISO 15189
             and Clinical Laboratory Improvement Amendment
             Regulations in Relation to Quality System
             Essentials
Appendix C - Example Molecular genetic Test XYZ Training Form
Appendix D - Sample Training Grid
Appendix E - Quality Management Documents and Records for
             the Path of Workflow of Molecular Genetic Testing
Appendix F - Required or Recommended Retention Practices
             Related to Records and Reports of Molecular
             Genetic Testing
Appendix G - Example of a Completed Nonconforming Event Record
Appendix H - sample Process for Corrective and Preventive
             Action Activities/Review
Appendix I - Recommended or Required Test Report Content
Appendix J - Sample Failure Modes and Effects Analysis
Appendix K - Informed Consent for Molecular Genetic Testing
Appendix L - Example of a Molecular Genetic Test Requisition Form
Appendix M - Examples of Molecular Genetic Test Reports
Appendix N - Recommended Practices for Retention of Residual
             Patient Samples
Appendix O - Competency Assessment Examples
The Quality Management System Approach
Related CLSI Reference Materials

Specifies guidance for implementing international quality management system standards in laboratories that perform human molecular genetic testing for inherited or acquired conditions.

This guideline addresses quality management activities for nucleic acid–based human molecular genetic testing, including the development and maintenance of a QMS for improving the quality of molecular genetic laboratory services.