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