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NOTE: This edition of the Guidebook was published in November 2018.The May 2019 Guidebook is the most recent version.Laboratory InformationSystems ProjectManagement: TMA Guidebook for InternationalImplementationsNovember 2018

ACKNOWLEDGMENTSThis publication has been a multi-year, multi-country collaborative effort. APHL would like to thankparticipants at LIS trainings in South Africa and Uganda for their feedback.Multiple teams developed and reviewed this Guidebook over several months:Core Development Team: The St. John Group/Srinath Remala, Reshma Kakkar,Michelle Meigs, Patina Zarcone and Bob Bostrom.Core Review Team: Michelle Meigs, Jan Flowers, Garrett Peterson, Paul Jankauskas, Kim Lewis, Solon Kidane and Kenneth Landgraf.Second Review Team: Ava Onalaja, Sherrie Staley, Samantha Dittrich, Ralph Timperi, Rufus Nyaga, Fredrick Mwasekaga, Aika Mongi and Thomas Nyongesa.Final Review Team: Lucy Maryogo-Robinson, Eric Blank, Patina Zarcone andRachelle Jones.A special thanks to APHL In-Country Informatics Staff for sharing their experiences, the APHL Communications Team for additions to the LIMS data provided in this publication, and Halima Jenkinsfor her diligence with design and layout.FUNDINGThis publication was 100% funded with federal funds and supported by Cooperative Agreement#NU60OE000103 from the US Centers for Disease Control and Prevention (CDC).Its contents aresolely the responsibility of the authors and do not necessarily represent the views of CDC.

CONTENTSEXECUTIVE SUMMARY. 7INTRODUCTION. 8LABORATORY INFORMATION SYSTEMS (LIS) OVERVIEW. 10THE BASICS. 11LIS VS. LIMS. 11WHY LABORATORIES NEED A DEDICATED LIS . 14TYPES OF LIS . 14DETERMINING NEED. 16LIS CONCERNS, PROCESSES AND RESPONSIBILITIES. 16LIS BENEFITS AND CONTINUOUS QUALITY IMPROVEMENT. 17CORE FUNCTIONS OF AN LIS. 18PRE-ANALYTICAL . 18ANALYTICAL. 18POST ANALYTICAL. 20UNDERSTANDING ANDMANAGING DATA . 22COLLECTING AND USING DATA. 22THREE MAIN TYPES OF DATA USE. 23EXAMPLES OF VALUABLE DATA USE. 23STORING DATA (OLTP & OLAP). 24APPLICATION ARCHITECTURE. 24USE OF DATA BY ROLE . 25

STARTING A NATIONAL LIS PROGRAM. 26VISION, MISSION AND DEFINING SUCCESS. 27DISCUSSION POINTS FOR DEFINING SUCCESS . 28BUY-IN. 29PROGRAM/PROJECT CHARTER. 29BUSINESS CASE. 30PROGRAM MANAGEMENT/TEAM STRUCTURE AND ORGANIZATION. 31PROJECT SPONSOR . 34LIS TECHNICAL WORKING GROUP. 34THE LIS TWG PARTICIPANTS . 34LIS PROJECT MANAGEMENT TEAM . 35LIS TASK FORCE/SUBCOMMITTEE . 35IMPLEMENTING PARTNER . 36STRATEGIC PLANNING . 37PURPOSE . 37SUMMARY AND EXAMPLES OF LIS STRATEGIC PLAN. 39IMPLEMENTATION OF LIS AS A NATIONAL PROGRAM. 40IMPLEMENTATION APPROACH. 40APPROACH TO DEVELOPMENT. 44EXPANSION. 47MONITORING AND EVALUATION. 48INDICATOR MONITORING EXAMPLE AT FOUR LABORATORIESPRE- AND POST-LIS IMPLEMENTATION. 49ASSESSMENT . 50SAMPLE ASSESSMENT SUMMARY RESULTS6 MONTHS AND 12 MONTHS POST IMPLEMENTATION (%). 50USE OF DATA TO SUPPORTPUBLIC HEALTH SURVEILLANCE . 51NATIONAL LAB PROGRAM CENTRAL DATABASE. 52CHALLENGES AND LESSONS LEARNED . 53SUSTAINABILITY: ENHANCEMENTS AND EXPANSION. 54FINANCIAL. 54LIS COST ESTIMATES. 55DEVELOPMENT OF AN IT HUMAN RESOURCE PLAN FOR LISDEPLOYMENT, MAINTENANCE AND SUPPORT AND BUILDING CAPACITY. 57DEVELOPMENT OF A HARDWARE MAINTENANCE PLAN: REPLACEOUTDATED AND/OR MALFUNCTIONING HARDWARE, TROUBLESHOOTING . 58CREATING VALUE . 59

LIS AS A PROJECT IN A LABORATORY . 60ASSESSMENTS. 61SITE ASSESSMENTS. 61WORKFLOW ANALYSIS. 62SCOPE. 63LIS FUNCTIONAL AND TECHNICAL REQUIREMENTS . 65STANDARDIZATION. 68INTERFACING WITH LABORATORY INSTRUMENTS . 69MINIMUM/REQUIRED DATA ELEMENTS . 70SYSTEM SPECIFICATIONS. 71INFRASTRUCTURE SPECIFICATIONS. 71SOFTWARE SPECIFICATIONS . 74QUALITY STANDARDS. 76IMPLEMENTATION. 78LIS SOFTWARE ALIGNMENT: GAP ANALYSIS AND PRIORITIZATION . 79LIS SOFTWARE ALIGNMENT: DEVELOP CUSTOMIZATION . 80LIS SOFTWARE ALIGNMENT: CHANGE CONTROL PROCESS. 81LIS SOFTWARE ALIGNMENT: DATA MIGRATION . 83INSTALLATION: INFRASTRUCTURE . 84INSTALLATION: LIS HARDWARE AND SYSTEM SOFTWARE . 86INSTALLATION: LIS SOFTWARE . 88TESTING: FACTORY ACCEPTANCE TESTING. 89TESTING: INTEGRATION TESTING . 90TESTING: STRESS AND PERFORMANCE TESTING . 91TESTING: USER ACCEPTANCE TESTING . 92TESTING: SYSTEM RELIABILITY DEMONSTRATION (IN PARALLEL). 93TRAINING: COMPUTER TRAINING . 94TRAINING: LIS USER . 95TRAINING: LIS ADVANCED/SUPER USER . 96TRAINING: SYSTEMS ADMINISTRATOR . 97TRAINING: PRE-SERVICE . 98GOING LIVE: OPERATIONAL READINESS. 99GOING LIVE: SUPPORTED SUPERVISION. 101SUSTAINABILITY. 102OPERATIONS: USER ADMINISTRATION. 104OPERATIONS: MASTER DATA MANAGEMENT. 105BACKUP AND RECOVERY PROCEDURES. 106PRINTING SUPPORT. 107EMERGENCY SHUTDOWN. 108SUPPORT: HELP DESK. 109SUPPORT: ISSUE/INCIDENT LOG. 110SUPPORT: LEVEL 1 . 111SUPPORT: LEVEL 2 .