| Series Preface | 5 |
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| Preface | 6 |
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| Contents | 8 |
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| Contributors | 10 |
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| Laboratory Informatics and the Laboratory Information System | 12 |
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| Business of Pathology | 14 |
| Information Product of the Laboratory | 14 |
| Pathologist as Information Manager | 15 |
| Information Management in the Laboratory Organization | 16 |
| What Is Information? | 17 |
| Information Technology in the Laboratory | 18 |
| Evolving Role of the Computer | 18 |
| Cost, Quality, and Efficiency Considerations | 19 |
| Study of Information | 20 |
| Laboratory Information Management | 21 |
| Responsiveness to Needs | 22 |
| Confidentiality, Security, and Integrity of Records | 22 |
| Uniform Data Definitions and Data Capture Methods | 23 |
| Defining, Capturing, Analyzing, Transforming, Transmitting, and Reporting of Patient- Specific Data and Information | 24 |
| Laboratory Information System | 24 |
| Database | 25 |
| Electronic Data Processing | 26 |
| Summary | 28 |
| Chapter Glossary | 29 |
| References | 30 |
| Developing the Laboratory Information System | 32 |
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| Planning for Purchase of a Vendor- Supplied System | 33 |
| Request for Proposal | 34 |
| Questions to Be Asked in the RFP | 36 |
| User Definability vs. Customization | 38 |
| Functional Requirements of the System | 38 |
| Structure of the Database | 39 |
| Transaction Logging ( Event- Level Processing) | 40 |
| Evolution of the Database | 42 |
| Encoding | 44 |
| Security and Confidentiality | 44 |
| Site Visit | 45 |
| Developing a Contract | 45 |
| Problem Resolution | 47 |
| Build or Buy? | 49 |
| Application Service Providers ( ASP) | 49 |
| Risks of Using an ASP | 50 |
| Benefits of Using an ASP | 50 |
| Types of ASP | 51 |
| Summary | 51 |
| Chapter Glossary | 52 |
| References | 53 |
| Validation of the Laboratory Information System | 54 |
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| General Validation Issues | 55 |
| Validation for Quality Assurance and Improvement | 55 |
| Vendor Validation Testing | 57 |
| General Process of User Validation | 58 |
| Identification and Description of the System to be Validated | 58 |
| Specification of the Stage in the System Life Cycle | 58 |
| Formalization of the Process for Prioritizing and Deciding | 59 |
| Development of Hazard Analyses | 59 |
| Identification of Regulatory Concerns | 59 |
| Documentation | 59 |
| Validation Plan | 60 |
| Initial Validation Program | 60 |
| Continuing Validation Plan | 65 |
| Chapter Glossary | 67 |
| References | 68 |
| Security and Confidentiality on Laboratory Computer Systems | 70 |
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| Objectives of a Security System for Patient Records | 70 |
| Security Interests | 71 |
| Protecting Data and Information | 71 |
| Sensitive Data | 71 |
| Risks Associated with Computerization of Records | 72 |
| Limits of Security | 72 |
| Security in Systems and Networks | 73 |
| Practical Security Measures | 74 |
| General Security Responsibilities for the User | 74 |
| Security and Control Guidelines | 76 |
| Types of Security Deficiencies or “ Holes” | 77 |
| Selecting Good Passwords | 78 |
| Summary | 79 |
| Laboratory Information System Security at UTMB | 80 |
| Confidentiality: Patient Privacy | 81 |
| Access to the Laboratory Record | 82 |
| Medical Information on the Internet | 84 |
| Legal Protection of Information on the Internet | 84 |
| Security Considerations for the Internet | 89 |
| E- Mail Communication of Health Information | 90 |
| Computer Viruses | 91 |
| WEB Crackers | 94 |
| Chapter Glossary | 95 |
| References | 97 |
| Total Cost of Ownership | 98 |
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| Types of Costs | 99 |
| Direct and Indirect Costs | 99 |
| Selection | 101 |
| Purchase and Installation | 102 |
| Operation | 103 |
| Ways to Manage TCO | 104 |
| Standardize | 104 |
| Maintain and Upgrade | 105 |
| Plan Support Carefully | 106 |
| Systematically Replace Manual Systems | 106 |
| Maintain Openness | 106 |
| Exercise Good Routine Business Practices | 106 |
| Justifications Based on Value Added | 107 |
| Chapter Glossary | 108 |
| References | 108 |
| Computer Basics | 109 |
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| Definitions and Descriptions | 109 |
| Bits and Bytes | 113 |
| Memory | 114 |
| Codes | 114 |
| Chips | 115 |
| Hardware | 117 |
| Operating Systems | 122 |
| Microcomputer Operating Systems | 123 |
| Adding Memory | 124 |
| Cache | 125 |
| Minicomputers and Mainframes | 126 |
| Distributed vs. Central Processing | 128 |
| Chapter Glossary | 132 |
| References | 135 |
| Computer Networks | 136 |
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| Physical Topology | 138 |
| “ Logical Topology”—The Communications Protocol | 144 |
| Network Manager | 146 |
| The Internet | 151 |
| Chapter Glossary | 152 |
| References | 154 |
| Interfaces | 155 |
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| Interface Protocols | 157 |
| Health Level 7 ( HL7) | 157 |
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