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MANAGING AND VALIDATING LABORATORY INFORMATION SYSTEMS
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Available format(s): Hardcopy, PDF
Language(s): English
Published date: 15-12-2006
Publisher: Clinical Laboratory Standards Institute
Abstract Committee MembershipForeword 1 Scope2 Introduction3 Terminology 3.1 Definitions 3.2 Acronyms4 Computer System Facilities 4.1 Environmental Conditions and Safeguards for Proper System Operations 4.2 Preventive Maintenance for Computer Systems 4.3 Disaster Recovery 5 Systems Programs 5.1 Laboratory Accreditation/Regulatory Requirements 5.2 Security/Access 5.3 Changes to Existing Programs or Validation of New Programs6 Data 6.1 Registration and Requisition Information 6.2 Data Entry 6.3 Computer Calculations 6.4 Autoverification of Transmitted Results 6.5 Generated Reports7 Quality Assurance Standards/CQI 7.1 User Responsibilities 7.2 Database Maintenance 7.3 Certification of Interfaces 7.4 Problem Reporting and Tracking 7.5 Train Staff 7.6 Postimplementation Monitoring 7.7 Documentation and Record RetentionReferencesAdditional ReferencesAppendix A - Sample Change/Addition Request FormAppendix B - Example of Change/Addition Request Appendix C - Validation ScriptSummary of Consensus Comments and Committee Responses
Provides guidance for developing a protocol for validation of the laboratory information system (LIS), as well as protocols for assessing the dependability of the LIS when storing, retrieving, and transmitting data.
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