Laboratory Information Systems Project

NOTE: This edition of the Guidebook was published in November 2018. The May 2019 Guidebook is the most recent version.

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Laboratory Information Systems Project

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 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 and Rachelle 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 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 ..................................................... 69

MINIMUM/REQUIRED DATA ELEMENTS ...................................................................... 70

SYSTEM SPECIFICATIONS............................................................................................ 71

INFRASTRUCTURE SPECIFICATIONS..................................................................................................... 71 SOFTWARE SPECIFICATIONS .............................................................................................................. 74

QUALITY STANDARDS.................................................................................................. 76

IMPLEMENTATION........................................................................................................ 78

LIS SOFTWARE ALIGNMENT: GAP ANALYSIS AND PRIORITIZATION ........................................................ 79 LIS SOFTWARE ALIGNMENT: DEVELOP CUSTOMIZATION ...................................................................... 80 LIS SOFTWARE ALIGNMENT: CHANGE CONTROL PROCESS................................................................... 81 LIS SOFTWARE ALIGNMENT: DATA MIGRATION .................................................................................... 83 INSTALLATION: INFRASTRUCTURE ...................................................................................................... 84 INSTALLATION: LIS HARDWARE AND SYSTEM SOFTWARE .................................................................... 86 INSTALLATION: LIS SOFTWARE ........................................................................................................... 88 TESTING: FACTORY ACCEPTANCE TESTING.......................................................................................... 89 TESTING: INTEGRATION TESTING ........................................................................................................ 90 TESTING: STRESS AND PERFORMANCE TESTING ................................................................................. 91 TESTING: USER ACCEPTANCE TESTING ............................................................................................... 92 TESTING: SYSTEM RELIABILITY DEMONSTRATION (IN PARALLEL).......................................................... 93 TRAINING: COMPUTER TRAINING ........................................................................................................ 94 TRAINING: LIS USER ........................................................................................................................... 95 TRAINING: LIS ADVANCED/SUPER USER .............................................................................................. 96 TRAINING: SYSTEMS ADMINISTRATOR ................................................................................................ 97 TRAINING: PRE-SERVICE .................................................................................................................... 98 GOING LIVE: OPERATIONAL READINESS............................................................................................... 99 GOING LIVE: SUPPORTED SUPERVISION............................................................................................. 101

SUSTAINABILITY........................................................................................................ 102

OPERATIONS: USER ADMINISTRATION................................................................................................ 104 OPERATIONS: MASTER DATA MANAGEMENT...................................................................................... 105 BACKUP AND RECOVERY PROCEDURES............................................................................................. 106 PRINTING SUPPORT.......................................................................................................................... 107 EMERGENCY SHUTDOWN.................................................................................................................. 108 SUPPORT: HELP DESK....................................................................................................................... 109 SUPPORT: ISSUE/INCIDENT LOG........................................................................................................ 110 SUPPORT: LEVEL 1 ........................................................................................................................... 111 SUPPORT: LEVEL 2 ........................................................................................................................... 112 SUPPORT: LEVEL 3 ........................................................................................................................... 113 MAINTENANCE AND CHANGE MANAGEMENT PLAN ........................................................................... 114 BUDGET........................................................................................................................................... 116

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