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LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL
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Superseded date: 28-02-2013
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Published date: 12-01-2013
Publisher: Clinical Laboratory Standards Institute
AbstractCommittee MembershipForeword1 Scope2 Introduction3 Definitions4 Path of Workflow 4.1 Preexamination Processes 4.2 Examination Processes 4.3 Postexamination Processes5 Process - The Sequence of Laboratory Activities 5.1 Key Work Processes 5.2 Process as a Basis for Training and Competence Assessment6 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 Signatures8 Process Documents 8.1 Benefits of Process Documents 8.2 Suggested Template for Process Documents9 Procedure Documents - Specific for the Path of Workflow 9.1 Preexamination Procedures 9.2 Examination Procedures 9.3 Postexamination Procedures10 Form Documents11 Procedures Manuals12 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 Documents13 SummaryReferencesAppendix A1 - Inpatient Blood Sample Collection Process FlowchartAppendix A2 - Inpatient Blood Sample Collection Process TableAppendix B1 - Analyzer Examination Process FlowchartAppendix B2 - Analyzer Examination Process TableAppendix C1 - Bacteriology Culture Process FlowchartAppendix C2 - Bacteriology Culture Process TableAppendix D1 - Transfusion Medicine Prenatal Examination Process FlowchartAppendix D2 - Transfusion Medicine Prenatal Examination Process TableAppendix E1 - Surgical Pathology Sample Process FlowchartAppendix E2 - Surgical Pathology Sample Process TableAppendix F - Sample Preexamination ProcedureAppendix G - Sample Analyzer ProcedureAppendix H - Sample Microbiology ProcedureAppendix I - Sample Transfusion Service ProcedureAppendix J - Sample Histology ProcedureAppendix K - Sample Computer ProcedureAppendix L - Suggested Contents of Laboratory ProceduresAppendix M1 - Attributes for a Single Analyte on the ABC AnalyzerAppendix M2 - Attributes for Multiple Analytes on the XYZ AnalyzerAppendix N - Sample Table of Contents for a Preexamination Procedures ManualAppendix O - Sample Table of Contents for the ABC Analyzer Procedures ManualAppendix P - Sample Table of Contents for a Computer Downtime ManualAppendix Q1 - Document Creation, Review, and Approval Process FlowchartAppendix Q2 - Document Creation, Review, and Approval Process TableAppendix R - Sample Document Change Request FormAppendix S - Ten Rules for Document ControlSummary of Delegate Comments and Working Group ResponsesThe Quality System ApproachRelated CLSI/NCCLS Publications
Gives guidance on development, review, approval, management, and use of policy, process, and procedure documents in the medical laboratory community.
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