Advanced LIMS Technology: Case Studies and Business Opportunities PDF
Preview Advanced LIMS Technology: Case Studies and Business Opportunities
Advanced LIMS Technology Case Studies and Business Opportunities Advanced LIMS Technology Case Studies and Business Opportunities Edited by J.E.H. STAFFORD Consultant Fisons Instruments Cheshire SPRINGER-SCIENCE+BUSINESS MEDIA, B.V. First edition 1995 © 1995 Springer Science+Business Media Dordrecht Originally published by Chapman & Hali in 1995 Softcover reprint ofthe hardcover Ist edition 1995 Typeset in 10/12pt Times by Cambrian Typesetters, Frimley, Surrey ISBN 978-94-010-4270-3 ISBN 978-94-011-0615-3 (eBook) DOI 10.1007/978-94-011-0615-3 Apart from any fair dealing for the purposes of research or private study, or criticism or review, as permitted under the UK Copyright Designs and Patents Act, 1988, this publication may not be reproduced, stored, or transmitted, in any form or by any means, without the prior permission in writing of the publishers, or in the case of reprographic reproduction only in accordance with the terms of the licences issued by the Copyright Licensing Agency in the UK, or in accordance with the terms of licences issued by the appropriate Reproduction Rights Organization outside the UK. Enquiries conceming reproduction outside the terms stated here should be sent to the publishers at the Glasgow address printed on this page. The publisher makes no representation, express or implied, with regard to the accuracy of the information contained in this book and cannot accept any legal responsibility or liability for any errors or omissions that may be made. A catalogue record for this book is available from the British Library Library of Congress Catalog Card Number: 95-00000 e Printed on acid-free text paper, manufactured in accordance with ANSI/ NISO Z39.48-1992 (Permanence of Paper). Preface The use of Information Technology (IT) to automate business processes has had a tremendous impact upon the lives of people throughout the w<?r1d. IT has transformed the role oflaboratory managers, scientists and techniciansthroughtheapplicationofpointsolutionstobusinesschallenges. The inappropriate context of these solutions has often led to unexpected problemswithlaboratorymanagement,givingrise totheneedforaholistic approach to the use of IT in laboratory environments. One vehicle for the introduction ofIT into laboratories is a Laboratory Information Management System (LIMS). A LIMS implies a holistic approach, but in practice this has not happened because the vision for implementation has been clouded by the need to solve only local sample management issues. Part of the problem may relate to understanding the nature of a LIMS and the impact of context on the relationship between thelaboratoryandthebusinessworld. Ifthe purposeofthelaboratoryisto provideinformation, then contextmustbe partofthe laboratoryinput. As an illustration of this requirement, the application of LIMS in forensic, environmental, pharmaceutical and clinical research as well as clinical pathology laboratoriesisdiscussed. The analytical processmust beviewed as an integral part of the LIMS and not merely an addition. The use of computerised equipment and robots to automate the laboratory has important implications for the relationship between the technical and managerial staff, and new technology facilitating information generation will have further impact upon the supervisory and managerial staff. However, freedom to manage and manipulate data in order to generate information will be severely restricted unless standards are in place to facilitate the sharing ofdata. Thisbookshouldenablelaboratorymanagers,scientistsandinformation management personnel to understand the IT requirements of their colleaguesinotherdisciplines. They will discover that, to varyingdegrees, they share many requirements. Contributors Dr K.E. Blick Department of Pathology, The University of Oklahoma Health Sciences Center, PO Box 26307, Oklahoma Memorial Hospital, 800 NE 13th, Rm EB-400, Oklahoma City, Oklahoma 73126, USA Dr D.L. Clay Office of Information Resources Management, EPA (MD-34), Research Triangle Park, North Carolina 27711, USA Dr D.M. CIiDe Office of Information Resources Management, EPA (MD-34), Research Triangle Park, North Carolina 27711, USA Dr M.J. Crook Process Analysis & Automation Ltd, Falcon House, Fernhill Road, Farnborough, Hants GU14 9RX, UK Dr D.J.M. Graham Quintiles Scotland Ltd, Research Avenue South, Heriot-Watt University Research Park, Riccarton, Edinburgh EH14 4AP, UK Dr T.V. lorDs Andersen Consulting L.L.P., 100Campus Drive, PO Box 765 Florham Park, NJ 07932, USA Dr R.S. Lysakowski Optimize Technologies, 8 Pheasant Avenue, Sudbury, MA 01776, USA Dr R.D. McDowall McDowall Consulting, 73 Murray Avenue, Bromley, Kent BRI 3DJ, UK Dr F.D. Morrow Quintiles Laboratories Ltd., 5500 Highlands Parkway, Suite 600, Smyrna, GA 30082, USA Dr W.M. Shackelford Office of Information Resources Management, EPA (MD-34), Research Triangle Park, North Carolina 27711, USA Mr T. De Silva Horseracing Forensic Laboratory Ltd, PO Box 15, Snailwall Road, Newmarket, Suffolk CB8 7DT, UK VIll CONTRIBUTORS Dr J.E.H. Stafford Fisons Instruments, LabSystems,-Number 1, St George's Court, Hanover Business Park, Altrincham, Cheshire WA14 5TP, UK Dr I.R. Storr PA Consulting Group, 123 Buckingham Palace Road, London SW1W 9SR, UK Mr R. Yuille North West Water Ltd., Thornton Road, Great Sankey, Warrington WA5 2SL, UK Contents 1 LIMS:Anautomatingorinformatingtechnology? 1 J.E.H. STAFFORD 1.1 Introduction 1 1.2 CurrentLIMSfailtomeetbusinessrequirements 1 1.2 1 Newcustomers 1 1.2.2 Derivinginformationfromdata 2 1.2.3 Increaseddatavisibility 5 1.2.4 Datafitforpurpose 5 1.3 CurrentLIMSautomatedatamanagementfunctions 5 1.3.1 Controlofdata 6 1.3.2 Dataquality 7 1.3.3 Consolidationofexecutivecontrol 8 1.4 NewLIMSwillinformate,notautomate 8 1.4.1 Thehumanelementinthelaboratoryprocess 9 1.4.2 Improvingthequalityofdatacaptureandanalysis 9 1.4.3 Increasedcontroloversamplegathering 11 1.5 Architectureofaninformatingsystem 11 1.5.1 Applicationlayer 11 1.5.2 Humaninterface 12 1.6 MakingIThappen 13 References 13 2 AmodelforacomprehensiveLIMS 15 R.D. McDOWALL 2.1 Introduction 15 2.2 StrategicdesignofaLIMS 16 2.2.1 TheDataandInformationDomainsofaLIMS 16 2.2.2 LaboratorybusinessobjectivesandtheroleofaLIMS 17 2.3 WhatisaLIMS? 18 2.4 AnarchitectureforacomprehensiveLIMS 20 2.4.1 Architecturalviewsandcommunication 20 2.5 ALIMSmodel 21 2.5.1 LIMSfunctionalareas 22 2.5.2 Functionallevels 23 2.5.3 Communicationwiththedatabase 23 2.5.4 LIMSarchitecture 24 2.5.5 Modelorganization 24 2.6 DefinitionofaLIMS 24 2.6.1 Promotinginterdisciplinarycommunication 25 2.6.2 Technology-independentmodel 25 2.6.3 Futureexpansionofthemodel 25 2.7 DetailedclassificationofLIMSfunctions 26 2.7.1 GroupOne:Datacapture 26 2.7.2 GroupTwo:Analysisofdata 28 x CONTENTS 2.7.3 GroupThree:Reporting 29 2.7.4 GroupFour:Managingdataandthelaboratory 29 2.7.5 CommentsonfunctionsinLevels 30 2.8 ApplyingtheLIMSmodel: theselectionofacommercialLIMS 31 2.8.1 ConstructingaLIMSmodelforeachsupplier 31 2.8.2 Evaluatingpotentialsuppliers 32 2.8.3 TheroleoftheLIMSmodelinevaluation 33 2.9 LIMSstandards 34 2.9.1 Systemmanagement 35 2.10 Summary 36 References 36 3 LIMSinaforensiclaboratory 37 T. DE SILVA 3.1 Introduction 37 3.1.1 Theroleofaforensiclaboratory 37 3.1.2 Automation 39 3.1.3 Analyticaldata 40 3.2 ObjectivesofaLIMS 40 3.2.1 Efficientinteractivesamplelog-in 41 3.2.2 Sampletracking 41 3.2.3 Utilisationofbarcodes 41 3.2.4 Automaticanalyticaldatatransferandresultentry 41 3.2.5 Lessclericalworkforscientists 41 3.2.6 ApplicationofGLPprinciples 42 3.2.7 Laboratoryperformancestatistics 42 3.2.8 Notypingdelays 42 3.3 Thesystem 42 3.3.1 Samplereceipt 45 3.3.2 Sampleanalysis 47 3.3.3 Analyticalresultreview 48 3.3.4 Reporting 49 3.3.5 Generalmanagement 50 3.4 Thefuture 51 3.5 Conclusions 52 Acknowledgement 53 4 Application ofa LIMS in a pharmaceutical drug metabolism andpharmacokineticslaboratory 54 D.J.M. GRAHAM 4.1 Introduction 54 4.2 Studyobjectivesindrugmetabolismandpharmacokinetics 55 4.2.1 Pharmacokineticstudies 56 4.2.2 Drugmetabolismstudies 56 4.2.3 Outlinestudydesign 58 4.3 Configurationofthedatabase 60 4.3.1 Thesampledatabase 60 4.3.2 Sampleidentifier(SID)(fivefields) 61 4.3.3 Timefields(eightfields) 61 4.3.4 Samplestatus 62 4.3.5 Whodunitfields(sixfields) 64 4.3.6 Miscellaneousfields 64 4.3.7 Test-relatedinformation 64 xi CONTENTS 4.4 LabManagerinuse 64 4.4.1 Definingthesamplematrix 64 4.4.2 Multisampleprocessing 66 4.4.3 Processingsampletimedata 66 4.4.4 Sampletesting 67 4.4.5 QualityControl 68 4.4.6 Security 68 4.4.7 Informationmanagement 69 4.5 Thefuture 69 References 70 5 Use ofprotocol-synchronous LIMS structures to expand the role ofthe centralized clinical trial laboratory in pharmaceuticalresearch 71 F.D. MORROW 5.1 Introduction 71 5.2 Theexpanding role ofthe central laboratoryin pharmaceutical research 71 5.3 Comparingtraditional and protocol-synchronous LIMSstructures intheclinicaltriallaboratory 75 5.3.1 LIMSstructuresinthetraditionalclinicallaboratoryenvironment 76 5.3.2 LIMSstructuresintheclinicaltriallaboratoryenvironment 78 5.4 Definingprotocol-driven time and events using amultidimensional matrix 80 5.4.1 Using the accession number asadiscrete addressin a multidimensionalmatrix 82 5.4.2 Using the time and events matrix to manage the production, distributionandinventoryofclinicaltrialmaterials 83 5.4.3 Usingthe time and eventsmatrix to monitor receipt andvalidity checkingofincomingspecimencollectionkits 84 5.5 Managing protocol-driven time and events using matrix-dependent controlstructures 86 5.5.1 Controlstructuresusedintheaceessioningprocess 88 5.5.2 Managing the data clarification and data revision processes throughcontrolstructures 89 5.5.3 Usingcontrol structurestosupport multilevel range-checking functionalities 90 5.5.4 Usingcontrolstructuresto manage anddocument phonealert andreflexmessagingfunctionalities 92 5.6 Managing protocol-driven time andevents using matrix-dependentoutput structures 93 5.6.1 Constructingprotocol-specificlaboratory reports and requisitions usingmatrix-dependentouputstructures 93 5.6.2 Using protocol-synchronousoutputstructurestosupportthe dataclarificationprocess 94 5.6.3 Supportingelectronicdataservices usingprotocol-synchronous outputstructures % 5.7 Summary % 6 MedicalLaboratoryInformationSystems(LIS) 97 K.E. BLICK 6.1 Historyofclinicallaboratorycomputerization 97 6.2 Computerizationandautomationofthe'testingprocess' 98 xii CONTENTS 6.3 Howcomputersfunctionintheclinicallaboratory 99 6.3.1 Admission,dischargeandtransfer(ADT) 99 6.3.2 Orderentryandordercommunication 99 6.3.3 Phlebotomyservice 100 6.3.4 Receiptofspecimensandprioritizationoftesting 100 6.3.5 Analysisofspecimenswithschedulinganddatacollection 100 6.3.6 Qualitycontrol(QC)andresultsverification 103 6.3.7 Interpretativefunctions 104 6.3.8 Resultsreporting 104 6.3.9 Statisticsandqualityassurancefunctions 104 6.3.10 Billing 104 6.4 AcquisitionofaLIS 105 6.4.1 Areasofthelaboratorycomputerized 105 6.4.2 Singlevendorversusmultivendor 105 6.4.3 Computerhardwarefeatures 106 6.4.4 Minicomputerversusmicrocomputersolutions 107 6.4.5 Softwareanddatabasedesign 107 6.4.6 MostimportantissueswhenselectingaLIS 108 6.5 Futureoflaboratoryinformationsystems 109 References 110 7 EPA's Relational Laboratory Infonnation Management System:Developmentandimplementation 111 W.M. SHACKELFORD, D.M CLINE and D.L. CLAY 7.1 Introduction 111 7.2 Development 112 7.2.1 Generalprinciples 112 7.2.2 Developmentalphilosophy/approach 113 7.2.3 Facetofacewiththeuser 114 7.2.4 Completionandtesting 115 7.3 Implementation 116 7.3.1 Thefinishedproduct 116 7.3.2 Laboratoryinstallationandimplementation 119 7.4 Conclusions 122 References 122 8 LIMStoroboticsinterface: Apracticalapproach 123 R. YUILLE 8.1 Introduction 123 8.2 Thecaseforautomation 124 8.3 RoleofaLaboratoryInformationManagementSystem 126 8.4 Sampleplanningandscheduling 126 8.4.1 Samplecontainertypes 127 8.4.2 Sampleshelf-life 128 8.4.3 Transportationofsamplestoequipment 128 8.4.4 Sampleandcontainerrecognitionsystems 129 8.4.5 Controlofservicesandconsumableitems 130 8.5 Auditability 130 8.5.1 Errorloggingandreporting 130 8.6 Informationtransferredviatheinterfaces 131 8.7 LaboratoryInformationManagementSystemnetwork 131 8.8 Analyticalprocessautomation 133 8.9 Impactonthelaboratoryworkingenvironment 136 Appendix 137 References 140
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