CLSI GP2 A5 : 5ED 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL
02-28-2013
01-12-2013
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
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