CLSI GP2 A5 : 5ED 2006

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Definitions
4 Path of Workflow
   4.1 Preexamination Processes
   4.2 Examination Processes
   4.3 Postexamination Processes
5 Process - The Sequence of Laboratory Activities
   5.1 Key Work Processes
   5.2 Process as a Basis for Training and Competence
        Assessment
6 Procedure - How to Do It
7 Elements Common to Process and Procedure Documents
   7.1 Title
   7.2 Purpose or Principle
   7.3 Process Flowchart or Table
   7.4 Procedure Instructions
   7.5 Related Documents
   7.6 References
   7.7 Appendixes or Attachments
   7.8 Author
   7.9 Approval Signatures
8 Process Documents
   8.1 Benefits of Process Documents
   8.2 Suggested Template for Process Documents
9 Procedure Documents - Specific for the Path of Workflow
   9.1 Preexamination Procedures
   9.2 Examination Procedures
   9.3 Postexamination Procedures
10 Form Documents
11 Procedures Manuals
12 Document Management
   12.1 Document Identification
   12.2 Master File
   12.3 Review and Approval of New Documents
   12.4 Review and Approval of Changes to Approved
        Documents
   12.5 Job Aid Documents
   12.6 Periodic Review of Unchanged Documents
   12.7 Master Index
   12.8 Distribution
   12.9 Archiving, Storage, and Retention of Documents
13 Summary
References
Appendix A1 - Inpatient Blood Sample Collection Process
              Flowchart
Appendix A2 - Inpatient Blood Sample Collection Process Table
Appendix B1 - Analyzer Examination Process Flowchart
Appendix B2 - Analyzer Examination Process Table
Appendix C1 - Bacteriology Culture Process Flowchart
Appendix C2 - Bacteriology Culture Process Table
Appendix D1 - Transfusion Medicine Prenatal Examination
              Process Flowchart
Appendix D2 - Transfusion Medicine Prenatal Examination
              Process Table
Appendix E1 - Surgical Pathology Sample Process Flowchart
Appendix E2 - Surgical Pathology Sample Process Table
Appendix F - Sample Preexamination Procedure
Appendix G - Sample Analyzer Procedure
Appendix H - Sample Microbiology Procedure
Appendix I - Sample Transfusion Service Procedure
Appendix J - Sample Histology Procedure
Appendix K - Sample Computer Procedure
Appendix L - Suggested Contents of Laboratory Procedures
Appendix M1 - Attributes for a Single Analyte on the ABC
              Analyzer
Appendix M2 - Attributes for Multiple Analytes on the
              XYZ Analyzer
Appendix N - Sample Table of Contents for a Preexamination
              Procedures Manual
Appendix O - Sample Table of Contents for the ABC Analyzer
              Procedures Manual
Appendix P - Sample Table of Contents for a Computer
              Downtime Manual
Appendix Q1 - Document Creation, Review, and Approval
              Process Flowchart
Appendix Q2 - Document Creation, Review, and Approval
              Process Table
Appendix R - Sample Document Change Request Form
Appendix S - Ten Rules for Document Control
Summary of Delegate Comments and Working Group Responses
The Quality System Approach
Related CLSI/NCCLS Publications

Gives guidance on development, review, approval, management, and use of policy, process, and procedure documents in the medical laboratory community.