NOTE: This edition of the Guidebook was published in November 2018. The May 2019 Guidebook is the most recent version. ® ® Laboratory Information Systems Project TM TM Management: A Guidebook for International Implementations November 2018 ACKNOWLEDGMENTS This publication has been a multi-year, multi-country collaborative effort. APHL would like to thank participants 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 Jankaus- kas, Kim Lewis, Solon Kidane and Kenneth Landgraf. Second Review Team: Ava Onalaja, Sherrie Staley, Samantha Dittrich, Ralph Tim- peri, Rufus Nyaga, Fredrick Mwasekaga, Aika Mongi and Thomas Nyongesa. Final Review Team: Lucy Maryogo-Robinson, Eric Blank, Patina Zarcone and Rachelle Jones. A special thanks to APHL In-Country Informatics Staff for sharing their experiences, the APHL Com- munications Team for additions to the LIMS data provided in this publication, and Halima Jenkins for her diligence with design and layout. FUNDING This 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 are solely the responsibility of the authors and do not necessarily represent the views of CDC. CONTENTS EXECUTIVE SUMMARY ............................................................................................... 7 INTRODUCTION........................................................................................................... 8 LABORATORY INFORMATION SYSTEMS (LIS) OVERVIEW ........................................... 10 THE BASICS ................................................................................................................. 11 LIS VS. LIMS ......................................................................................................................................11 WHY LABORATORIES NEED A DEDICATED LIS ........................................................... 14 TYPES OF LIS ...................................................................................................................................14 DETERMINING NEED ..........................................................................................................................16 LIS CONCERNS, PROCESSES AND RESPONSIBILITIES ..........................................................................16 LIS BENEFITS AND CONTINUOUS QUALITY IMPROVEMENT ...................................................................17 CORE FUNCTIONS OF AN LIS ....................................................................................... 18 PRE-ANALYTICAL ..............................................................................................................................18 ANALYTICAL ......................................................................................................................................18 POST ANALYTICAL .............................................................................................................................20 UNDERSTANDING AND MANAGING DATA ........................................................................................................ 22 COLLECTING AND USING DATA ...........................................................................................................22 THREE MAIN TYPES OF DATA USE .......................................................................................................23 EXAMPLES OF VALUABLE DATA USE ...................................................................................................23 STORING DATA (OLTP & OLAP) ...........................................................................................................24 APPLICATION ARCHITECTURE .............................................................................................................24 USE OF DATA BY ROLE ............................................................................................... 25 STARTING A NATIONAL LIS PROGRAM ...................................................................... 26 VISION, MISSION AND DEFINING SUCCESS ................................................................ 27 DISCUSSION POINTS FOR DEFINING SUCCESS ...................................................................................28 BUY-IN ......................................................................................................................... 29 PROGRAM/PROJECT CHARTER ...........................................................................................................29 BUSINESS CASE ................................................................................................................................30 PROGRAM MANAGEMENT/ TEAM STRUCTURE AND ORGANIZATION ..................................................................... 31 PROJECT SPONSOR ..........................................................................................................................34 LIS TECHNICAL WORKING GROUP .......................................................................................................34 THE LIS TWG PARTICIPANTS ..............................................................................................................34 LIS PROJECT MANAGEMENT TEAM ...................................................................................................35 LIS TASK FORCE/SUBCOMMITTEE ......................................................................................................35 IMPLEMENTING PARTNER .................................................................................................................36 STRATEGIC PLANNING ............................................................................................... 37 PURPOSE .........................................................................................................................................37 SUMMARY AND EXAMPLES OF LIS STRATEGIC PLAN ...........................................................................39 IMPLEMENTATION OF LIS AS A NATIONAL PROGRAM ............................................... 40 IMPLEMENTATION APPROACH ............................................................................................................40 APPROACH TO DEVELOPMENT ...........................................................................................................44 EXPANSION .......................................................................................................................................47 MONITORING AND EVALUATION.................................................................................. 48 INDICATOR MONITORING EXAMPLE AT FOUR LABORATORIES PRE- AND POST-LIS IMPLEMENTATION ...............................................................................................49 ASSESSMENT ...................................................................................................................................50 SAMPLE ASSESSMENT SUMMARY RESULTS 6 MONTHS AND 12 MONTHS POST IMPLEMENTATION (%) ..................................................................50 USE OF DATA TO SUPPORT PUBLIC HEALTH SURVEILLANCE ................................................................................ 51 NATIONAL LAB PROGRAM CENTRAL DATABASE ..................................................................................52 CHALLENGES AND LESSONS LEARNED ..............................................................................................53 SUSTAINABILITY: ENHANCEMENTS AND EXPANSION ................................................ 54 FINANCIAL .........................................................................................................................................54 LIS COST ESTIMATES .........................................................................................................................55 DEVELOPMENT OF AN IT HUMAN RESOURCE PLAN FOR LIS DEPLOYMENT, MAINTENANCE AND SUPPORT AND BUILDING CAPACITY ...............................................57 DEVELOPMENT OF A HARDWARE MAINTENANCE PLAN: REPLACE OUTDATED AND/OR MALFUNCTIONING HARDWARE, TROUBLESHOOTING ............................................58 CREATING VALUE ..............................................................................................................................59 LIS AS A PROJECT IN A LABORATORY ...................................................................... 60 ASSESSMENTS ............................................................................................................ 61 SITE ASSESSMENTS ..........................................................................................................................61 WORKFLOW ANALYSIS .......................................................................................................................62 SCOPE ......................................................................................................................... 63 LIS FUNCTIONAL AND TECHNICAL REQUIREMENTS ................................................ 65 STANDARDIZATION ..................................................................................................... 68 INTERFACING WITH LABORATORY INSTRUMENTS ...................................................