the clinical informatics...

THE CLINICALINFORMATICS REVOLUTION

April 2015

wwwasgbiorguk

1

Association of Surgeons of Great Britain and Ireland

ISSUES INPROFESSIONAL PRACTICE


AUTHORMr David A Rew

Director of Communications

PUBLICATION DATEApril 2015

PUBLISHED BYAssociation of Surgeons of Great Britain and Ireland

35-43 Lincolnrsquos Inn Fields London WC2A 3PE

IN PARTNERSHIP WITH

No part of this publication may be reproduced stored or transmitted in any form or by any means withoutthe prior written permission of the publisher or in the case of reprographic reproduction in accordancewith the terms of licenses issued by the Copyright Licensing Agency in the UK [wwwclacouk] Enquiriesconcerning reproduction outside the terms stated here should be sent to the publisher at the above addressThe use of registered names trademarks etc in this publication does not imply even in the absence of a specificstatement that such names are exempt from the relevant laws and regulations and therefore for general use

Imperial CollegeLondon

2

SERIES FOREWORDIssues in Professional Practice (IIPP) is an occasional series ofbooklets published by the Association of Surgeons of Great Britainand Ireland to offer guidance on a wide range of areas which impacton the daily professional lives of surgeons Some topics focus onclinical issues some cover management and service delivery whilstothers feature broader aspects of surgical working life such aseducation leadership and the lawThis latest IIPP booklet on The Clinical Informatics Revolutionrepresents a foray into subject matter which will profoundly influencethe shape of professional practice throughout the NHS in years tocome and with which many members and readers may presently berelatively unfamiliar This issue follows naturally from our recentsurvey of workplace attitudes among surgeons to the call by theSecretary of State to move to a Paperless NHS by 2018 publishedrecently as an IIPP We are grateful to the author for teasing out someof the principles and complexities in this national policy objectiveand in pointing us to some possible solutions as we engage with arapidly changing digital health economyThe Association of Surgeons of Great Britain and Ireland in commonwith many of the other surgical specialty associations and societies isproud to represent members across the four devolved UK homenations England Scotland Wales and Northern Ireland as well as theRepublic of Ireland However it would have been impractical to cross-reference the complexities of the clinical informatics revolution in alljurisdictions This Issue in Professional Practice booklet necessarilydraws heavily upon material published by the London-basedGovernment Digital Service and by NHS England Nevertheless wevery much hope that the guiding principles will be of value to surgeonsand others working across the Four Nations of the United Kingdom toour colleagues in Ireland and to those working further afieldThe Association intends that this publication and others in the series(all of which are accessible at wwwasgbiorgukpublications) willprovide concise advice and guidance on major current issues andprove to be a helpful and accessible resource to support yourprofessional practice We welcome feedback on this and otherbooklets in the Issues in Professional Practice series and proposalsand contributions for future issues in the series

Mr John MooreheadPresidentpresidentasgbiorguk

3

CONTENTSForeword to lsquoThe Clinical Informatics Revolutionrsquo 6

Introduction 7

ASGBI and Clinical Informatics 7

PART 1THE GOVERNMENT DIGITAL SERVICEAS AN EXEMPLAR 9

A Brief history of the UK Government Digital Service (GDS) 9

A summary of GDS Design Principles 11

The Digital Strategy of Central Government since 2010 11

The mechanics of building aldquoDigital by Defaultrdquo Public Service 13

The Phases of design testing andrelease of ldquoDigital by Defaultrdquo systems 15

PART IIldquoDIGITAL BY DEFAULTrdquoHEALTH SECTOR TRANSFORMATION 18

Translation of GOVUK digital principlesinto the ldquoHealthcare Spacerdquo 19

A UK-wide strategy for ldquoDigital by DefaultrdquoPublic Health Care Delivery 19

The History of Clinical Informatics within the NHS 21

The NHS Data Spine 22

The Summary Care Record 23

The Personal Demographics Service 23

The NHS Secondary Uses Service (SUS) 24

The NHS Hospital Episodes Statistics system (HES) 24

The Health and Social Care Information Centre 25

The move from ldquotop downrdquo to ldquobottom uprdquoNHS software systems development 26

The informatics needs of NHS clinicians 26

Health Information Security and presentation 26

The Electronic Patient Record (EPR) 28

The design of the ldquoidealrdquo EPR for an individual patient 29

The Collective Benefits of the ldquoidealrdquo EPR 30

4

PART IIITHE DIGITAL NHS HOSPITAL 32

The Clinical Digital Maturity Index (CDMI) 33

Hospital Digital Architecture and Digital Standards 33

Paperless and paper-light ClinicalInformation Systems in hospitals 35

Definitions of Paper-light and Paperless 36

The theoretical advantages of paperless medical records 36

PART IVPAPERLESS AND PAPER-LIGHT CHANGESIN THE SURGICAL WORKPLACE 38

Challenges to the implementation ofpaperless and paperlight systems 38

New ways of looking at old processes The outpatient letter 40

Digital transformation and clinical teachingtraining and education 41

The implications of digital transformationfor professional practice 41

PART V THE BIGGER PICTURE 42

PART VI SUMMARY 44

EXEMPLAR 1DEVELOPMENT OF A TIMELINESTRUCTURED DYNAMIC EPR IN THEUNIVERSITY HOSPITAL SOUTHAMPTONCLINICAL DATA ENVIRONMENT 45

The Maryland Lifelines timeline EPRconcept model (1996-97) 45

The University Hospital SouthamptonExemplar of an integrated EPR 46

EXEMPLAR 2TIMELINE STRUCTUREDDISEASE-SPECIFIC RESEARCH DATA BASESAN EXEMPLAR OF A DATA SYSTEMFOR BREAST CANCER 49

APPENDIX ACUTTING THROUGH THE JARGONSTANDARDS AND SEMANTICHARMONISATION 53

APPENDIX BNHS INFORMATICSORGANISATIONS AND RESOURCES 57

APPENDIX CSTANDARDS FOR DIGITALCOMMUNICATIONS IN HEALTHCARE 59

5

FOREWORD TO lsquoTHE CLINICALINFORMATICS REVOLUTIONrsquoHealthcare is on the brink - overwhelmed in the developed world bythe burden of chronic disease unsustainable cost and the demand forless intrusive healthcare and in the less developed world bylimitations in access to and availability of frugal models of caredelivery Healthcare systems are also on the brink of a technologyinflux that will revolutionise the unsustainable legacy delivery modelsthat have served us well in a bygone era The healthcare communityjoins as a laggard the list of well-evolved aspects of life that have beenso dramatically transformed by mobile technologies Clinicalinformatics is not really about the technologies themselves howeverbut rather their role as tools for both empowering self-care and forgenerating incredibly valuable data on population health and wellnessthat will transform evidence-based medical practice

There is substantial competition across Europe and throughout the worldto capture a leading position in the rapidly expanding digital health spaceThe UK is ideally placed to lead in this revolution in healthcare deliverymodels The NHS and its equivalents across the UK are viewed aseffective coordinated single-payer healthcare systems ideal forimplementation of innovative healthcare solutions at scale TheGovernment continues to establish attractive programmes in support ofinnovation investment and implementation Public and private businessescontinue to invest in new infrastructure RampD and centres of innovationthat bring skilled and higher paying jobs to the UK Cementing the UKrsquosleadership role in the implementation of these transformational practicesrequires determination and coordination both to empower existing digitalhealth activity and to attract expertise and investment

In this timely addition to the Associationrsquos Issues in ProfessionalPractice series David Rew highlights the specific areas of overlap andimpact of technological advances in surgical practice Given thecritically important role the surgical community has in the delivery ofhealthcare surgeons are well placed to drive and accelerate progress inthe safe application and development of new technologies Everyaspect of care delivery will be affected by the fundamental disruptionthat is taking place in the healthcare ecosystem and by improving ourindividual and collective understanding of the role technology playswe can help to ensure that we evolve quickly enough to maximise thebenefits for both our patients and our health economy

Nicholas S PetersProfessor of CardiologyImperial College London

6


7

INTRODUCTION

The UK Government has set an ambitious target for transition to aldquodigital by defaultrdquo public sector economy in this decade Insimple terms this envisages the transformation of public servicesthrough the application of the ldquobest of classrdquo strategies that havechanged the commercial world through digital technology It alsoempowers such change from the highest level of Government

ldquoDigital by Defaultrdquo transformation of Government is more thanabout providing slick websites or a social media presence It isabout the re-engineering of the State and its component servicesusing modern technology and informatics systems to transform theuser and customer experience rather than to meet the convenienceof the service provider In the process it is already securing hugeand measurable efficiencies in service design and delivery

The UK Government strategy has proved to be so persuasive andeffective to date that many other Governments are now adopting thesame approach to public service design and delivery including theUS and Australian Governments

ASGBI AND CLINICAL INFORMATICSASGBI is the SAC-defined Surgical Specialty Association forGeneral Surgery in Great Britain and Ireland and exertsconsiderable influence in a wide range of issues relating to theprofessional lives and to the clinical effectiveness of GeneralSurgeons in the workplace Thus the Association is well placed totake a leading role in informing professional debate and inpromoting innovation in the progressive adoption of ldquodigital bydefaultrdquo healthcare systems

ASGBI has its own ldquodigital by defaultrdquo informatics strategy 2014saw the launch of the Associationrsquos first paperless Congress and ofdigital publication for all ASGBI journals publications anddocuments There is also a flourishing website and an interactivelsquoapprsquo for mobile devices The speed of acceptance of thesetechnologies has confirmed the technical maturity and ldquoinformaticsadaptabilityrdquo of the general surgical workforce

In October 2014 the Association published a survey of workplaceviews and experiences of the Digital NHS in an Issue InProfessional Practice booklet entitled Operating within a digitalNHS which was widely viewed and well received Surgeons havean important role in leadership and innovation within theprofessional workplace It is therefore essential that surgeons arefully conversant with language and concepts of the ldquoDigital byDefaultrdquo health economy and that we are individually andcollectively able to articulate arguments and discussions on thestrategy and detail of implementation

8

This IIPP booklet seeks to build upon the Associationrsquos owneducational strategy on the subject of Clinical Informatics for theAdaptable NHS Surgical Workforce It also considers a wide rangeof issues which are relevant to the transition to the paper-light andpaperless workplace and the opportunities and constraintsassociated with that process

For the purposes of this Issues in Professional Practice bookletwe will focus discussion to the clinical informatics revolution as itaffects hospital practice and surgical practice in particular as theseare the areas where we have most experience

PART 1THE GOVERNMENT DIGITAL SERVICEAS AN EXEMPLARA BRIEF HISTORY OF THE GOVERNMENT DIGITALSERVICE (GDS)In 2010 the UK Central Government set up a Digital PublicServices Unit under the direction of the Cabinet Office Itsmandate was to transform the Governmentrsquos use in informatics andweb-based services in its interactions with the General Public TheGovernment recognised that the evolving information strategy wasnot fit for purpose in delivering services direct to the generalpublic and that it was not taking full advantages of the economiesand efficiencies inherent in digital services

Each of some 25 Departments of State and each major and minorbranch of government had developed its own web systems with aprovider focus rather than a user focus This had led to wastecomplexity duplication and inefficiency throughout GovernmentBy comparison user (customer) focussed private sector informaticshad surged ahead as evidenced by the success of many householdcommercial names in delivering attractive web-based services as inonline bookings within the travel industry

In 2010 a committee comprising many experts from digitalcommerce and which was chaired by (subsequently Baroness) MarthaLane Fox founder of last-minutecom recommended sweepingchanges to the UKrsquos public sector approach to digital communicationsand transactions across the breadth of public services The changeswere not (yet) directed at the NHS although they were influenced byexperience with failing programmes such as Connecting for HealthBaroness Lane Fox recommended that the Government

1 Make lsquoGOVUKrsquo (originally branded as DirectGov) thegovernment front end for all departmentsrsquo transactional onlineservices to citizens and businesses to set standards and to forcedepartments to improve citizensrsquo experience of key transactions

2 Make GOVUK a wholesaler as well as the retail shop front forgovernment services and content by mandating the developmentand opening up of Application Programme Interfaces (APls) tothird parties

3 Change the model of government online publishing by putting anew central team in Cabinet Office in absolute control of theoverall user experience across all digital channels

4 Appoint a new CEO for Digital in the Cabinet Office with absoluteauthority over the user experience across all government onlineservices websites and Application Programming Interfaces(APls) and the power to direct all government online spending

9

10

See wwwgovukgovernmentpublicationsdirectgov-2010-and-beyond-revolution-not-evolution-a-report-by-martha-lane-fox

These recommendations were accepted rapidly and in full Theyled to the formation of the Government Digital Service (GDS)This was underpinned by a new team of internet savvy thinkers anddevelopers based in Londonrsquos East End around ldquoSiliconRoundaboutrdquo and charged with implementing these changesMore insights can be gleamed from

httpsgdsbloggovuk

httpenwikipediaorgwikiGovernment_Digital_Service

httpswwwgovukgovernmentorganisationsgovernment-digital-service

The review process led to the consolidation of reforms under theCabinet Office leadership of Francis Maude and under the logo ofGOVUK The scale and breadth of the work involved is illustratedby the diversity of the seven departments which handle mostgovernment online transactions being

bull HM Revenue and Customs (HMRC)

bull Department for Transport (DFT)

bull Department for Work and Pensions (DWP)

bull Ministry of Justice (MOJ)

bull Department for Business Innovation and Skills (BIS)

bull Department for Environment Food and Rural Affairs (Defra)

bull The Home Office

The GDS identified a series of 25 high volume exemplar projectswhich would benefit from the ldquosimpler clearer and faster to userdquostrategy These included Voter registration (46M annualconfirmations) 6M annual Driving Licence views 32M CarerrsquosAllowance applications 10M Universal Credit transactionstracking 41M PAYE employees and so on An early example ofthe success of this approach with which many surgeons will befamiliar was the simplification of car tax renewal online

The idea has been that success with these exemplars would establishmomentum experience and knowledge for transformation across thebreadth of Government In the course of such changes huge savingsare being achieved in transactional costs by moving previously complexuser-driven processes online In this process employment patterns andskills would also change within the Civil Service and beyond

Some forms of work would be improved or superseded bytechnology particularly in the field of document and informationprocessing New categories of employment and skills requirementswould emerge to implement and manage the new digital publicsector see wwwgovukgovernmentpublicationsgovernment-digital-strategygovernment-digital-strategy

11

A SUMMARY OF GOVERNMENT DIGITAL SERVICEDESIGN PRINCIPLESThe GDS digital design principles for the re-engineering ofGovernment departmental services translate to the re-engineeringof national health systems These general principles are as follows

1 Start with an assessment of the usersrsquo needs

2 Aim to ldquoDo Lessrdquo

3 Base the design upon data and research rather than upon opinionand speculation

4 Do the hard work to make it simple In other words design forsimplicity

5 Iterate (repeat the process) then iterate again as the developmentprocess proceeds

6 Build for inclusion In other words aim to make the serviceaccessible to the least technically literate potential user

7 Understand context

8 Build digital services not websites Digital usage is increasinglyabout access through mobile phones and other information tools

9 Be consistent in the design principles including details such asfonts icons and presentational layouts

THE DIGITAL STRATEGY OF CENTRAL GOVERNMENTSINCE 2010The Government Service Design Manual (wwwgovukservice-manual) sets out how these key principles of digital reform aretranslated into practical product They emphasise

bull That the user needs and experience must be informed by markettesting rather than what the service provider thinks best

bull The importance of the evidence base including internettransactional data (such as provided by Google Analytics)website optimisation techniques and user evaluations

bull The importance of uniformity clarity and simplicity of searchfunctions and data presentation

bull The importance of ldquobottom-uprdquo development of new onlinesystems and services This is based upon design-test-adjustprinciples and continual reinforcement of ldquogood-enoughrdquofunctionality rather than ldquotop-downrdquo specification of ldquoperfectrdquosystems that may or may not work in practice and which may ormay not be what the user requires

We may draw a parallel with the history of the motor car since itsfirst inceptions No one was able to specify a modern highperformance vehicle in 1900 However by continuous evolution

12

of all components over a century the crude concept of the earlyand autonomous horseless carriage seamlessly evolved into thecars and road infrastructure which we enjoy today

bull The Digital by Default Service Standard (wwwgovukservice-manualdigital-by-default) This seeks to make the online serviceof choice so practical and attractive that users will usually preferto use the system to its slower transactional alternatives (egpaper based communications) while recognising that some userswill always require additional help

The Digital by Default Service Standard sets out a series of 26clear attainable and auditable criteria by which the standard can beachieved Individual services are evaluated as they aretransformed to ensure that they meet the standard and that they canfunction within the GOVUK system

bull The use of Open Software Standards providing flexibility andindependence from individual systems and commercial suppliers

bull The Speed of Change The Cabinet Office set a 400 daychallenge in 2013 under the ldquoSprintrdquo designation to establish themomentum and to secure the principal changes The lexicon ofchange includes buzz words and phrases such as ldquoAgileDevelopmentrdquo and ldquoSprint Pathwaysrdquo

bull The Utility of Data the new government approach does notclaim or seek ownership of data where alternative informationsets and sources exist

bull Simplicity of communication the language used will always beldquoPlain Englishrdquo and web design will be relentlessly focussedupon ease of use ease of navigation and ease of visualisation

The consequence of the strategy is intended to be that individualgovernmental departmental services are transformed in weeks andmonths rather than years and decades In the process new usesare found for the presentation and dissemination of existing dataFor example the combination of government data on flood plainsto public data from Google Maps helps developers insurers andhome buyers better to understand the risks of flooding in any onelocation

THE MECHANICS OF BUILDING A ldquoDIGITAL BYDEFAULTrdquo PUBLIC SERVICESelf-evidently organisations which seek to change and modernisetheir service delivery around digital informatics systems need tocreate a process by which change can be effected Within thepublic sector old hierarchies and ldquoWays of Doing Thingsrdquo require athorough overhaul The necessary skills in digital technology andprogramming may be unfamiliar but there are many wellestablished precedents in the public and independent sectors for thesuccessful management of complex projectsThe GDS has described the implementation of change around AgileMethodologies in a range of publications and blogs For examplesee httpswwwgovukservice-manualagile

Organisations which seek to go down the digital transformationroute need to build teams with the specialist skills in digitaltransformation management user research and programming Theyalso need to identify space for these teams to work with therequisite information technology infrastructure and a workspacewhich promotes teamworking and interaction A key element is thecreation of plenty of wall space on which to plot workstreams andprogress as illustrated in Figure 1

Figure 1 The Transition Programme Wall at Aviation HouseHolborn home of the GDS

See httpstransitionbloggovuk20131112transition-programme-stages-a-make-over

It may come as a surprise that such a digitally advancedorganisation resorts to white boards and colour coded stationerynotes to map complex processes However the effectiveness of

13

14

organisational tools is long established and somewhat analogous tothe RAF fighter control rooms of WWII

In this particular visual example the stages of the transformationprogramme are plotted out in a series of columns from a lsquoTo Dorsquolist through discovery user needs analysis content analysis digitalservice design and construction and so on Information flowsfrom left to right across the wall as projects progress

Once the team has mapped out the workload the team leader willprioritise the projects which are then progressed as a series ofSprints Each of these lasts one to two weeks and each of which isbased around ldquoScrumrdquo software development methodology Scrumis a process of close physical co-location of team members whichallows for flexibility and parallel working in addressing thequestions

bull What will we do

and

bull How will we do it

This recognises that project requirements change continuouslyas the project progresses and that these cannot be anticipatedfully understood or planned sequentially in advance Thedevelopment team is self-organising under the direction of theScrum Master and holds a short stand up meeting on a dailybasis around the project wall to coordinate its activities Aretrospective meeting to review lessons learned is a key elementof each Sprint phase

Continuous testing and individual responsibility for every elementof the process are also key elements of Agile methodology Thisminimises the risk of expensive and troublesome delays later in theacceptance process

Testing also takes a number of forms including

bull Technical performance at various user loads

bull Security and penetration testing to prevent malicious disruptionor data theft

bull Accessibility testing for different intended users for examplethose with visual auditory or motor skills impairment and forthose using a range of different access tools including keyboardstrack pads screen readers and voice recognition systems

bull Crowd sourcing testing where systems in development areregularly put out to large numbers of friends and colleagues fortesting and feedback

THE PHASES OF DESIGN TESTING AND RELEASE OFldquoDIGITAL BY DEFAULTrdquo SYSTEMSThere a series of stages in the implementation of each and everyldquoDigital by Defaultrdquo system that includes five phases and aretirement plan The key phases arebull The Discovery Phasebull The Alpha (Test) Phasebull The Beta (Test) Phase subdivided into Private and Public Test Phasesbull The Live Phasebull The Retirement Plan

The Discovery PhaseThis is the process by which user needs are researched User needsanalysis is based around creating a series of User Stories focussedupon user research User stories are an essential part of the agiledesign process They comprise three elementsbull The person using the service - the actor - (eg as a surgeon)bull What the user needs of the service - the narrative - (I need to be

able to access and analyse my operative workload data)bull Why the user needs the service - the goal - (so as to inform my

annual appraisal and job planning processes)

User stories help organise digital system development work intomanageable chunks which create tangible value and which can bediscussed and prioritised independently see httpswwwgovukservice-manualuser-centred-designuser-researchindexhtml

Figure 2 Example of a User Needs research board and workflowduring the development of a digital system for the Carerrsquos Allowancehttpsuserresearchbloggovuk20150121user-research-for-government-services-8-strategies-that-worked-for-us

15

16

Again the stationery note wall is a valuable tool for mapping out needsand processes Kate Towsey of the Carerrsquos Allowance DevelopmentTeam describes the importance of this process in a GDS blog

ldquoA quick walk around our offices and yoursquoll see that verticalsurfaces whether wall or not are both covered and covetedProject paraphernalia are our wallpaper Sticky notes imagesscreenshots survey results analytics and team photos namejust a small selection of lsquostuff that should be stuck up therersquoOur walls have purpose Theyrsquore vertical lsquocampfiresrsquo placeswhere teams connect stakeholders gather quick insight andpassersby take inspiration and add to themAs user-researchers our walls are an important and constantbroadcast signal A well-tended wall keeps research insights anduser needs constant in the collective lsquomindrsquo of the project teamrdquo

Ben Holliday from the same team states of the process that

ldquoWe try and post things up as they relate to each other and tounderstand relationships between insights user needs anddifferent parts of the transaction Most importantlyeverything is constantly discussed pulled apart and updatedby the project team not just the user researchersrdquo

httpsgdsbloggovuk20140903vertical-campfires-our-user-research-walls

Key Performance Indicators (KPIs) need to be identified for theproposed new service so that once the software is developed andreleased for public testing the digital service provider will have aclear understanding of its impact KPIs include the cost pertransaction user satisfaction the completion rate of transactionsand digital take-up of the service

The Alpha PhaseThis covers the construction of a working prototype of the systemThis is used to test the design approach to build a developmentteam and to understand the technology and the possible softwareand coding solutions GDS sets a target to complete the Alphaphase within two months using a small core team of designersdevelopers and stakeholders The outputs for the alpha phase (seewwwgovukservice-manualphasesideal-alphas) arebull High level story cardsbull Plan for beta testing and running the live servicebull A working system with limited functionality for user testingbull Planning for replacement or integration with legacy data systemsbull A decision to progress (or not) to the beta phasebull Final analysis on the research on user needsbull Options for the support of users who are not digitally proficient

or capable

17

The Beta PhaseThis is the process of development to the production of a workingprototype and introduction of the system to the user firstly to aselected group of users (the Private Beta) and then to a widerpublic audience (the Public Beta) The phase would be expected totake a few months

The development team will now include Web operations engineers(also known as the systems administrators operations engineers orsite reliability engineers) They have expertise in infrastructureconfiguration management monitoring deployment and operatingsystems (see wwwgovukservice-manualthe-teamweb-operationshtml) They will understand the new language ofrunning the production systems and oversee the development ofsoftware which is easy to operate scale and secure This is also thepoint at which the particular service receives accreditation sign-offso as to ldquoGo Liverdquo

The Live PhaseA GOVUK web service will now be fully accredited forperformance and security standards with appropriate analyticaltools in place to monitor the KPIs The new service will becontinuously monitored and subject to regular upgrades withoperational support security testing and subsidiary developmentsoptimised hosting technical and customer support disasterrecovery planning and so on

The Retirement PhaseThe process also recognises that services come to an end becausethey are superseded or taken over by other bodies The designprocess of any service also needs to take into account the manyfunctions required to wind up or transfer a service at the end of itsfunctional operational life

18

PART IIldquoDIGITAL BY DEFAULTrdquo HEALTHSECTOR TRANSFORMATION

Why are the previous sections significant to health professionals Inthe past software sourcing and provision has been devolved to largeproviders who have worked to prior specifications - remote from theend user - to produce systems that then fail to deliver the goods

Any health professional who has worked in the development ofuser-focussed clinical software will understand just howcomplex iterative and unpredictable this process is and howimportant the practical experience of the GDS design andimplementation teams has become to those seeking to improveclinical informatics

Unlike the authorship of a book or film script any but the mostbasic software programmes require continuous engagement anditeration between the developers and the users Excellence insoftware development is clearly critically important to the designand implementation of clinical systems which advance rather thanimpede the workplace efficiency of health professionals

As purchasing decisions are devolved from central bodies toindividual Trusts and as any one healthcare provider will have acomplex mix of legacy systems requiring different programmingso health professionals will need to understand and influence theprocesses of development and improvement of software systemswhich will rapidly and increasingly come to dominate theirworking lives

Some readers of this document will work in hospitals andhealthcare units which have made their own investment in softwaresystems development and which are fortunate to have access to theskill sets to shape their informatics space

However most hospitals will not have access to such humanresources Many are dependent upon proprietary software systemswhich are imposed by commercial firms with little commitmentto agile and continuous improvement or responsiveness to end-user feedback beyond the purchasing managers We hope that thisdocument will help shape and inform discussion and negotiationwith previously intransigent suppliers for whom continuous agileproduct development in the clinician end user workplace is as yetunfamiliar

19

TRANSLATION OF GOVUK DIGITAL PRINCIPLES INTOTHE ldquoHEALTHCARE SPACErdquoThe informatics design revolution as espoused by the GDS hasnot yet explicitly and publicly extended to the NHS workplaceNevertheless self-evidently ldquoDigital by Defaultrdquo principles haveconsiderable implications for IT implementation in the UK HealthSystem and they have profound implications for the developmentof integrated healthcare over the coming decade

They will inexorably lead to a transition from provider definedservices (by hospitals GPs and health service managers) toconsumer user and patient demand-led services where healthinformation is far more transparent than at present and where thecomfortable certainties of current service provision will beradically challenged

It is also clear that once the public realises how efficient publicsector data management can be in the provision of commonlyused services the demand for change and the rate of change arelikely to be dramatic It is thus essential that clinicians areprepared to influence and to manage this change We need tounderstand what is already out there in the ldquohealth informaticsspacerdquo and to understand where development energies need to bedirected

A UK-WIDE STRATEGY FOR ldquoDIGITAL BY DEFAULTrdquoPUBLIC HEALTH CARE DELIVERYThe ldquoDigital by Defaultrdquo principles espoused by UK CentralGovernment can also be applied to the huge challenges ofmodernisation and integration of the public health and social careservices around user needs While much of the material presentedin this booklet is gleaned from NHS England resources theprinciples apply equally to health services in all of the devolvednation health services and indeed to public health service in othercountries as the principles are universal

In November 2014 HM Government published a strategydocument to capture the principles of GDS Transformation forHealth Care under the leadership of Tim Kelsey Chair of theNational (Health) Information Board and Dr Will Cavendish theAccountable Informatics Officer at the Department of HealthThe paper Personalised Health and Care 2020 - A Frameworkfor Action envisages the use of data to transform outcomes forall citizens

Kelsey and Cavendish introduce the new National InformationBoard at the Department of Health and describe its roots in theDoH Power of Information paper of 2012 the DoH DigitalStrategy Leading the Culture Change in Health and Care paper

20

of 2012 the Government Digital Strategy paper of 2013 and theambitions of the Care Act of 2014 They set out a series ofproposals to

bull Enable citizens to make the right health and care choices withfull access to personal care records and the information necessaryto make those choices in modern and accessible forms

bull Provide information to professionals and carers in real time to aiddecision making on citizen-specific care

bull Make the quality of care transparent

bull Build and sustain public trust

bull Advance effective new treatments innovation and growth

bull Support care professionals to make the best use of data andtechnology

bull Assure best value for the taxpayer in all settings

Clearly clinical informatics is now a high priority on the nationalhealth agenda It therefore merits detailed appraisal and anunderstanding of its principles by healthcare professionals Thepractical benefits of a ldquodigital by defaultrdquo health strategy may befar reaching It should secure substantial efficiency gains in termsof the flow of information between social care agencies primaryand secondary healthcare providers suppliers of materialsequipment medicines and consumables and risk managementbodies such as the Medicines and Healthcare Regulatory Agency(MHRA) and the NHS Litigation Authority (NHS LA)

It may also cause a major upheaval in the way that health and socialcare is delivered and in the working practices of many healthprofessionals How for example will General Practice changewhen individual citizens are substantially more empowered withhealth information and health records under personal control suchthat individual health information flows around rather than beingcontrolled through Primary Care Centres

There are substantial practical and technical hurdles to be overcomeif the high level ambitions for a fully digital health economy are tobe realised and there is considerable potential for servicedisruption clinical and political risk if and when things go wrongThese hurdles include

bull The lack of the technical infrastructure to support a fullyintegrated digital service

bull The lack of an agreed design for a ldquocradle to graverdquo electronicpatient record and the software systems to support it

bull The lack of digital transformative skills within the healthcareworkforce to secure the necessary changes

21

THE HISTORY OF CLINICAL INFORMATICS WITHINTHE NHSThe NHS has made major strides towards a digital health economyin the past two decades Progress to computerisation from aninformatics infrastructure based upon paper has been patchy anddisjointed but the workforce is now entirely technology-literateand computers are the norm throughout the workplace

Nevertheless centrally directed national IT infrastructure projects havebeen plagued with similar problems to those which drove CentralGovernment to establish the GDS The large IT suppliers have beenfound wanting in their ability to address the complexity of problemsand challenges within the health environment through grandiose andoverambitious projects upon which NHS Connecting for HealthProject and the NHS National Programme for InformationTechnology (NPfIT) also foundered between 2005 and 2013

We now recognise that the complexity of the healthcare informaticsenvironment defies top down command and control design of ITsystems Hard and expensive lessons have been learned about thecomplexity and impracticality of specifying a single project totransform healthcare informatics systems

The citizenry of any country provides a highly complex social andbiological ecosystem with a huge diversity of individual healthneeds each of which places different demands upon primarysecondary and tertiary healthcare services and the related socialservices and support systems

In turn healthcare delivery is compartmentalised in a large numberof delivery organisations each of whom are ldquostakeholdersrdquo in thedesign process for an integrated healthcare informatics systemThese include

bull Citizens patients and their friends and families

bull Hospital Managers

bull General Practice Managers

bull Clinicians Nurses and Allied Health Professionals

bull Local regional and national health bodies

bull Public supervisory boards and private purchasing consortia andfunding bodies

bull Ambulance and Patient Transport Services

bull Health educational bodies

bull Healthcare Charities

bull Health Information Technologists and so on

Despite the critical press that failings in the national healthinformatics programmes have attracted over several decades therehas nevertheless been considerable progress towards more effective

22

digital data systems in Health Services The worldwide revolutionin informatics provides a near universal digital infrastructure inhardware and software from which healthcare can take advantage

This infrastructure includes the internet the personal computer andthe mobile phone and the tools to reach the entire citizenry in avery cost-effective way through cheap and efficientcommunications underwritten by national fibre-optic and mobilecommunications networks

The UK healthcare workforce has consequently become much moretechnically literate in the past two decades the understanding anduse of computers and mobile communications is virtually universaland the national informatics and hardware infrastructure iscontinually improving as the communication network providersroll out high capacity broadband systems down to the level ofindividual domestic properties

While the overall ambitions of earlier NHS IT programmes havenot been realised there has been significant progress in a numberof areas including

bull The establishment of a national fibre-optic healthcommunications infrastructure

bull The NHS Data Spine

bull The introduction of an NHS-wide email system

bull The NHS Care Record Service and the Summary Care Record(SCR)

bull The Personal Demographics Service (PDS) based upon theuniversal NHS Number

bull The Secondary (data) Uses Service (SUS)

bull The Picture Archiving and Communications System (PACS)

THE NHS DATA SPINEMany clinicians will be unaware as to just how much activity datais already collected centrally for the Department of Health TheNHS Data Spine is

ldquoa collection of national applications services anddirectories that support the NHS in the exchange ofinformation across national and local NHS systems TheSpine connects clinicians patients and local service providersthroughout England to essential national services forexample the Electronic Prescription Service Summary CareRecord Choose and Book and Demographics servicesrdquo

See httpsystemshscicgovukspine

23

The Spine services are delivered on a large scale As of August 2014 it

bull Connected more than 21000 organisations and linked over27000 ICT systems within these organisations

bull Provided a single consistent source of demographic data for 80million patients Information is requested and amended morethan 26 billion times a year

bull Enabled over 42 million Summary Care Records to be createdand stored

bull Was processing around 50 million records per month through theDBS (Demographic Batch Tracing Service)

bull Had transmitted over 13 billion EPS prescription messages and50 million EPS dispense notifications

bull Was registering some 2500 new smartcard users per week

bull Was delivering some 77000 GP to GP record transfers a month

THE SUMMARY CARE RECORDThe SCR master planning document stated in 2011 that the SCR is

ldquodesigned to provide a summary of clinical information whichwould be deemed useful in the event of urgent or emergencycare for a patient particularly when other sources ofinformation may not be readily available The aim is that theSCR will contain only significant aspects of a personrsquos carethose deemed to deliver benefit to a patient when receivingurgent and emergency carerdquo

By September 2013 approximately 5800 General Practices hadparticipated in the creation of some 43 million such records with avoluntary public opt out rate of only 14 Nevertheless the futureuse and the branding of the SCR as a component of the overall GPrecord is uncertain in the context of continuing evolution of theelectronic patient record in general practice Seehttpsystemshscicgovukscr

THE PERSONAL DEMOGRAPHICS SERVICEThe Personal Demographics Service (PDS) is a key component ofthe NHS Data Spine It is the national electronic database of NHSpatient demographic details including name address date of birthand the 10 digit NHS Number which is issued at birth forimmediate identification purposes Data in the PDS allows apatient to be identified quickly and accurately Seehttpsystemshscicgovukdemographics

24

THE NHS SECONDARY USES SERVICEThe SUS has been the central repository of health data inEngland since 2006 under the control of the Health and SocialCare Information Centre (HSCIC) The data is used for arange of health planning purposes service provision andcommissioning including ldquoPayment by Resultsrdquo It is alsoavailable to applicants for research purposes in anonymised andpseudo-anonymised forms SUS also supplies the NHSHospital Episodes Statistics (HES) system The history ofHES is of interest as recorded by HSCIC HES emerged in1987 from a report on collection and use of hospital activityinformation published under the leadership of Dame EdithKoumlrner (1921-2000)

Prior to 1987 10 sample of patient admission records werecollected nationally HES now aims to collect a detailed record foreach lsquoepisodersquo of admitted patient care delivered in England Thismay be either by NHS hospitals or in the independent sector whencommissioned by the NHS Data was initially collected annuallythen quarterly and it is now collected monthly

Such data is available for every financial year from 1989-90onwards HES data was collated by regional health authorities until1996 when the NHS-Wide Clearing Service (NWCS) was set upIn 2006 this work was taken over by the SUS within the HSCICof the NHS Programme for IT (NPfIT)

HES data also underpins the work of Dr Foster Intelligence acompany which was founded in 2000 by two journalists and inwhich the NHS bought a share in 2006 In turn the company linkswith and supports the health statistical research work of ProfessorSir Brian Jarman at Imperial College Seehttpwwwhscicgovuksus

THE NHS HOSPITAL EPISODES STATISTICS SYSTEMHES stores a detailed record for each patient activity across everyNHS hospital and contracted independent facility in England Thisamounts to some 15 billion records to which some 125 millionnew records are added every month

HES sub-serves a number of functions including the reconciliationof payments to NHS hospitals and affiliated units for servicesprovided It also generates substantial analytical data of use forplanning benchmarking and academic research HES alsoillustrates the benefits of the new strategy of outsourcing theldquoDigital by Defaultrdquo programme to innovative Small and MediumEnterprises (SMEs) see httpwwwhscicgovukhes

25

The infrastructure of HES was fully modernised in 2014 by a Leedsbased IT consultancy firm BJSS Ltd whose team reported that

ldquoAs HES grew it became increasingly resource-intensive Itlacked adequate testing and staging facilities and requiredsignificant manual processing It had become unwieldy andexpensive to maintain An external third party retained all ofits process knowledge

In line with Government IT policy the NHS decided to bringHES in-house Within six months a small team of developershad completely re-written the HES system for one instead ofsix computers and had produced a rationalised maintainablecode base

The original 35 million lines of SQL code and 500 stepmanual process which ran on six machines has been reducedto just 100000 lines of SQL code and a two-step automatedprocess running on a single machine BJSS completed acomprehensive knowledge transfer by supplying fullydocumented code and operational procedures and a detailedsoftware architecture and design documentrdquo

In September 2013 BJSS was also engaged to design and build anNHS-wide e-referral service to supersede Choose and Book seehttpwwwbjsscom

THE HEALTH AND SOCIAL CARE INFORMATION CENTRE

The Health and Social Care Information Centre (HSCIC) is thenational provider of information data and IT systems forcommissioners analysts and clinicians in health and social care Itis an executive non-departmental public body set up in April 2013and sponsored by the Department of Health Its employs 2500staff including IT specialists programme and project managersstatisticians analysts and information security experts It isresponsible for

bull Collecting analysing and presenting national health and socialcare data

bull Publishing a register of this information

bull Setting up and managing national IT systems

bull Setting standards and guidelines in the fields of data collectionand reporting

bull Publishing rules on the management of personal confidentialinformation

bull Creating indicators of the quality of health and care services

bull Helping health and care organisations to improve the quality ofdata collection

26

httpswwwgovukgovernmentorganisationshealth-and-social-care-information-centreabout

httpwwwhscicgovukabout-us

More information on HSCIC functions is listed in Appendices A to C

THE MOVE FROM ldquoTOP DOWNrdquo TO ldquoBOTTOM UPrdquo NHSSOFTWARE SYSTEMS DEVELOPMENTIn 2013 the Department of Health also pulled the plug on theincreasingly expensive and unproductive strategy of support forlarge ldquotop downrdquo commercial IT projects in favour of a bottom-upevolutionary approach using local initiatives and innovative SMEsto solve local problems and to drive national solutions

Top down ldquoCommand Informaticsrdquo has thus been replaced by abetter understanding of the value of development of effective ITsystems from the end user upwards and by the recognition of thebenefits of locally purchased systems and solutions within aframework of common data and communications standards Suchsystems can be progressively networked and integrated into thewider health data economy as they are improved and refined

THE INFORMATICS NEEDS OF NHS CLINICIANSWithin any one clinical unit different users have different dataneeds in different places and at different times All hospitals havecomplex data requirements for diverse users who include

bull Managers and administrators who must optimise the allocationand safe use of resources including beds outpatient clinics staffmaterial logistics and estate maintenance

bull Clinicians and allied health professionals engaged in inpatientand outpatient service provision

At present data about patients is severely disjointed andincomplete at any point of need Primary care hospitals and socialservices keep different data in different formats For exampleindividual NHS hospitals independent hospitals NHS funded andindependently managed Treatment Centres and private hospitalsmaintain their own data in locked ldquosilosrdquo Any future system thatseeks to integrate all clinically useful data on any one patient willthus have to overcome a series of very significant institutional andorganisational barriers

HEALTH INFORMATION SECURITY ANDPRESENTATIONThere are two particular elements which need to be addressed ifhealthcare information is to flow freely around the healthcareinformatics space to the benefit of all citizens at any and all pointsof need

27

The first is a secure identity system to underwrite confidentialityso that each and every citizen and healthcare worker can be clearlyand confidently identified at every point of contact with digitalclinical date

The second is a simple understandable and elegantly structuredelectronic patient record

Secure Personal Identity OnlineMany transactions between individual citizens and Governmentagencies require reliable and trusted identification of the individualto prevent fraud and identity theft Until similar reliability is builtinto online transactions involving health data it will prove difficultto realise the full potential of health informatics

The Government is undertaking a range of experiments in thedevelopment of a nationally acceptable system of clinical identityverification

Government Gateway is a system of registration to obtain a secureonline identity for individuals organisations and agents (ie thosewho act on behalf of individuals and organisations) It is arelatively cumbersome process which requires the individual toregister for identity check and to wait for the receipt ofconfirmation several days later

GOVUK Verify is the new system to establish and prove personalidentity online in a much more efficient and responsive mannerInstead of a single government database individual commercial andcredit identification companies such as Verizon Experian and themajor banks are licensed to provide the information Individuals canselect their nominated and designated ldquoidentity providerrdquo and checkthe information held This also reduces the government holding ofdata regarding individuals that it does not otherwise need

The designated company then provides identity checks in real timein support of any particular transaction Using ldquoTwo-FactorrdquoAuthentication which is now widely used in online transactions aldquoone timerdquo code is then sent to the individual by mobile phoneemail or by landline telephone GOVUK states that the benefit ofthis system which is presently under development is that

ldquoWorking with certified companies means your informationand transactions with government are safer simpler andfaster than any other method This is because

bull there is no central storage of information so your personaldata is more secure

bull itrsquos completely online

bull the company you choose canrsquot use or share your datawithout your permissionrdquo

28

Once the system is set up subsequent use by registrants is rapidand is believed to be safe and reliable Time and experience willtell if this proves to be the case

GOVUK is also committed to working with the Open IdentityExchange (OIX see httpoixukorg OIXUK is a not-for-profitorganisation which works with industry and government to developreliable on line identity systems

THE ELECTRONIC PATIENT RECORDA consistent framework and ldquoHighway Coderdquo for The ElectronicPatient Record (EPR) is key to the development of an efficientdigital health economy Unfortunately the concept of the EPRpresently means different things to different people and no onedefinition or operational standard has yet been achieved

In general terms we can define an EPR as a continuing electroniccollection of health-related information on any one patient TheEPR may contain a wide variety of notes documents lettersreports and test results based around a framework central to whichis the patientrsquos demographic data and unique identifiers

In its most basic format the component data are held in a varietyof different computer systems which are accessed independently bythe user Such an EPR is a list of documents results and reportsabout a patient held in a list form by the computer of an agent orinstitution which might be a General Practitioner a health centreor a hospital Anyone who has worked with such records willrecognise that any but the shortest of such records becomes tiringtiresome and time consuming to search and read

In more sophisticated systems all relevant data are ldquopulled inrdquo(linked directly) to the master EPR so that the user movesseamlessly from one document to another through a single EPRinterface An example of such an interface is set out in Exemplar 1at the end of this booklet

Development of the EPR should be seen as evolutionary ratherthan a single ldquotop-downrdquo specification With time an optimalfunctional design should emerge much as the domestic motorvehicle has evolved around what is now a standard core design

Moreover personal records are invariably fragmented betweenprimary care centres across any number of hospitals and acrossa variety of care agencies each of which uses a range ofdifferent bespoke and proprietary software systems oftenworking in isolation

29

THE DESIGN OF THE ldquoIDEALrdquo EPR FOR AN INDIVIDUALPATIENTA set of criteria that would describe an ideal EPR would

bull Integrate clinical and administrative information in practicalways

bull Bring together all of the diverse information that impacts upon anindividualrsquos health into an integrated single information system

deg in a secure manner both in terms of the reliability of the dataentered and stored in the record and in terms of control ofaccess and addition or amendment to that data

deg have lifelong resilience and reliability

deg which optimised the individualrsquos healthcare and outcomesthrough clarity accuracy of data content and through context-sensitive linkage to relevant evidence based information

deg optimise the use of human and material resources to securesuch outcomes

deg collate display and distribute information in the individualEPR in the most efficient form of access and contentvisualisation for users

However rather than setting out ldquotop downrdquo to define the softwarecoding for a single overarching EPR we would do much better byfinding out

deg who needs to use the EPR

deg where and when this need arises and critically

deg what are the specific needs of the users in a range of differentcircumstances

We can then cut loose the programmers do the development workin a competitive market of small medium and large independentsector firms and public sector agencies

Again the evolution of the motor industry may be instructive inthis regard It has developed from a cottage industry of small-scaleproducers a century ago to a sophisticated modern industry addingnew features to the fundamentally stable design In the processmany different vehicle designs and a host of incrementalimprovements to individual components were trialled in acompetitive international marketplace

From the products of this process we can select the ldquobest in classrdquodesigns and software tools to serve the EPR function from a rollingconveyor belt of innovation These products can then be subjectedto rigorous usability testing in a variety of settings and by a rangeof users

30

THE COLLECTIVE BENEFITS OF THE ldquoIDEALrdquo EPRJust as the Highway Code allows drivers of a diverse range of motorvehicles to share a common highway so the collective framework ofrules for a standard or ideal EPR would allow healthcareinformation on individual patients to flow freely around theldquoCollective Health Spacerdquo of primary secondary and social care

The standard EPR would work in a wide variety of different healthcare settings and in a wide range of different circumstancessubject to appropriate controls on user access and confidential dataprotection

Standardisation would allow suitably anonymised data andmetadata from a wide variety of health providers to be put toeffective collective uses These would include the better use ofresources and a better understanding of the healthcare ofpopulations whether locally regionally nationally orinternationally

Standardised EPR data should also bring a wide range of clinicalbenefits from the simplified longitudinal study of the patterns andrelationships between diseases and health interventions inindividuals and in complex populations of patients

The evolving EPR will thus contain a mix of administrativeinformation about any one patient - the Who Where and When -and the clinically significant information ndash the What And theWhich (test results decisions and clinical actions)

EPR data will also advance clinical research by allowing theldquoHowrdquo and lsquoWhyrsquo questions to be asked in relation to treatmentinputs and clinical outcomes

Timelines and the design of the ideal EPRThe passage of time and its measurement is a central feature of anEPR The Timeline is the key to the graphical representation oftime-structured data Conventionally it runs from left to rightacross the printed page screen or graph It permits the layout andorientation of records reports and results in a logical linear formatThis allows the user to understand the content and the relationshipof events

The timeline of any one patient may be comprehensive in that itdescribes the whole of his or her life from birth to death or to thepresent time across a wide range of health parameters includingfor example immunisation and medicinal history primary andsecondary health care contacts and interventions (see Exemplar Aat the end of this booklet)

The Timeline structured EPR may also be Episode or Diagnosisbased following the course of a particular illness or sequence ofinterest (see Exemplar 2 at the end of this booklet)

31

In all circumstances the content of the EPR will be determined by theavailability of records in a useable electronic format Where theinformation exists only in paper or non-digital image form as inarchival medical records the content must either be re-entered inelectronic format or it must be captured as digital images (usually inPDF format) A number of companies now provide high capacityElectronic Document Management System (EDMS) to organisationswhich process large volumes of paper including NHS hospitals

Parallel TimelinesHuman lives can be described by a series of parallel timelineswhich may include professional social and domestic eventsPersonal health histories can also be represented by a parallel seriesof timelines that may represent a variety of activities includingvaccinations and travel history medications General Practitionervisits hospital visits and so on

Granularity describes the data density or the level of detail in thedata record A timeline with low granularity may give an overviewonly of occasional events over a lifetime A timeline with highgranularity may show data which changes over seconds minutesand hours such as arises with continuous monitoring by ananaesthetic machine or within an intensive care unit

In general terms a patientrsquos personal medical timeline will includeperiods where there is relatively little activity on the GP andhospital timeline Contact with a GP or with the local hospital maybe limited to the occasional outpatient referral or investigations

When a patient is admitted to hospital the clinical activity andhence the frequency and volume of data generation increasessubstantially Additional services come into play includingNursing Physiotherapy and Pharmacy systems and the clinicallogistic and administrative aspects of care (food consumables andso on) must also be carefully coordinated In some cases care maybe necessarily intensive and prolonged generating very largequantities of data in series over weeks and months

To account for such fluctuations in data density over time the EPRdesign needs to have an adaptable and adjustable timeline whereinthe scaling changes from weeks months and years to minuteshours and days according to the prevailing activity

32

PART IIITHE DIGITAL NHS HOSPITAL

In July 2013 the Government and NHS England published aguidance document entitled Safer Hospitals Safer Wards that setout the goal of achieving an integrated care record in all hospitalsas an enabling step towards integrated care records across thehealth and care system The paper foresaw progression throughpaper-light to paperless record keeping for which financial supportwas made available from a Safer Hospitals Safer WardsTechnology Fund

The Safer Hospitals Safer Wards strategy has major implicationsfor all hospital employees but particularly for surgeons both in thedelivery of care in Outpatients and within the hospital

The Safer Hospitals Safer Wards paper acknowledged the varyingmaturity of digital hospital systems across the NHS andemphasised the criticality of having clinicians at the heart ofdecision making and implementation

The Safer Hospitals Safer Wards paper also gives priority torecommendation 244 of The Mid Staffordshire NHS FoundationTrust Public Inquiry also known as the Francis Inquiry Reportof 2013 which stated that

bull There is a need for all to accept common information practicesand to feed performance information into shared databases formonitoring purposes The following principles should be appliedin considering the introduction of electronic patient informationsystems

deg Patients need to be granted user friendly real time andretrospective access to read their records and a facility to entercomments They should be enabled to have a copy of recordsin a form useable by them if they wish to have one Ifpossible the summary care record should be made accessiblein this way

deg Systems should be designed to include prompts and defaultswhere these will contribute to safe and effective care and toaccurate recording of information on first entry

deg Systems should include a facility to alert supervisors whereactions which might be expected have not occurred or wherelikely inaccuracies have been entered

deg Systems must be designed by healthcare professionals inpartnership with patient groups to secure maximum professionaland patient engagement in ensuring accuracy utility andrelevance both to the needs of the individual patients andcollective professional managerial and regulatory requirements

33

The paper sets out the ambition to develop an Integrated DigitalCare Record This implies the creation of a Record that extendsbeyond local and institutional EPRs which would allow thecoordination of all forms of information held in primary secondaryand social care organisations about any one patient and that wouldbe available to that patient inter alia The paper also recognised theneed for the interface to be intuitive adaptable and widelyaccessible

THE CLINICAL DIGITAL MATURITY INDEXThe paper also set out the intention to classify every hospital andmental health provider with a measure of organisational maturity indigital systems This Clinical Digital Maturity Index (CDMI)would be based upon a range of factors which include

bull Hardware and software infrastructure

bull The current level of clinical digital capability

bull The current level of clinical digital usage

bull The current use of key information standards

bull The level of interoperability within and external to an organisation

bull The capability for business change

bull Clinical and managerial leadership and buy-in

The self-evident ambition of this programme is to assist allorganisations to move progressively up the ladder of digitalcapability under a variety of headings

HOSPITAL DIGITAL ARCHITECTURE AND DIGITALSTANDARDSThe Safer Hospitals-Safer Wards strategy is not prescriptive ofsystems and technologies so long as they conform to the principlesthat have already been set out by the Government Digital Serviceand the new and overarching national public digital strategy being

Open Application Programming Interfaces must be used to secureand ensure the flow of information in and out of the systemThe use of the NHS Number (rather than local identifiers) as theprimary patient identifier and central coordination of the PatientIdentity through the Personal Demographics ServiceEngagement with Small and Medium Enterprise suppliers to secureldquobest of breedrdquo technologies and digital servicesEffective and efficient Digital Data Capture

Storage and IndexingIn response to the top level drive to digitisation many hospitals havemoved towards the acquisition of Electronic DocumentManagement Systems (EDMS) An effective EDMS tracks alldocuments and their metadata in any one patient record These

34

include letters discharge summaries operation records and so onThis metadata includes the date and time of production of eachdocument the author context (eg clinical discipline outpatient orinpatient) and other information that subsequently allows thedocument to be plugged into the EPR framework These documentsmay include PDF images for archiving of handwritten documents

The Safer Hospitals-Safer Wards paper states the following

Once information is captured it needs to be heldelectronically in a repository so that it can be accessed bythose who need it Information held electronically needs tobe properly structured so that it can be categorised indexedlinked and searched This will allow clinicians to access thespecific information they need to make decisions

An EDMS can provide a shared repository for clinicaldocumentation It can be linked with scanning solutions tosupport moving away from paper records It can also holdelectronically generated documents from the various systemsin the organisation

It is important to consider what historic information needs tobe captured electronically For example very old paperbased historic records required solely for medico-legalpurposes may be better stored on paper indefinitely It isoften cheaper than scanning provided storage space isavailable For files of ongoing patients Trusts need to decidewith clinical input the level of indexation required

When paper records are scanned consideration should begiven to the use of Natural Language Processing and theAutomatic SNOMED-Encoding of Free Text

Patient Access to RecordsThis is a challenge for information governance The SaferHospitals-Safer Wards paper states that

The process used to register the patient should be robust andproportionate to the information that will be made availablewhen the service is accessed The following key activities arerequired

bull Registration the act of establishing the identity of a subject

bull Service access the process by which a registered userrsquosentitlement to access a particular service is confirmed andauthorisation is then granted

bull Authentication The process by which the electronic identity of auser is validated using a credential issued following a successfulregistration

35

bull The need to maintain privacy in the handling of personal andorcommercially sensitive information

bull Capability for layered access (ie separation of access to therecord from transactions) and the capacity to provide aparentalcarer view to enable appointment booking andprescriptions requests without sight of other transactions

More details relating to these technical capabilities can be found at httpwwwtechnologystrategyenglandnhsukhttpsystemshscicgovukqipplibraryidentityfspdfhttpsystemshscicgovukinfogov

Standards of descriptive coding and Semantic HarmonisationClinical information must be recorded consistently to improvecommunication and to minimise risk of error The meaning ofwords terms and phrases must thus be standardised using agreeddefinitions and reference works The Safer Hospitals-Safer Wardspaper lists the sources of the key standards to which localorganisations should adhere see Appendix A

Plain EnglishWhatever digital systems are introduced there remains a criticalrequirement for Plain English in digital communication andexpression An absolute emphasis upon simplicity readability andcomprehension of content helps reduce risk It will also become acritical factor in reducing misunderstanding as medical records aremade more widely available to patients

There are many examples of ill-conceived badly implemented andsometimes incomprehensible language that are met in daily lifeand which arise from thoughtless adherence to rigidities ofcomputer coding For example in Read Code the otherwise cleardescription of ldquosimple mastectomy sentinel node biopsy andauxiliary clearancerdquo becomes translated in computer speak on onelocal system to the impenetrable and superfluous description of aldquo(primary operation) (secondary operation) (secondaryoperation) NEC (not otherwise specified)rdquo

PAPERLESS AND PAPER-LIGHT CLINICALINFORMATION SYSTEMS IN HOSPITALSThe direction of travel is now clear Nevertheless all surgeons willbe familiar with the paradoxical explosion in paperwork forms andform-filling that has accompanied and paralleled the introductionof computers into the workplace Many more senior readers willremember with wry cynicism the misplaced optimism of the gurusof office computerisation two decades ago in extolling the ill-considered myth that the end of paper was nigh Such optimismwas an excellent signal to buy shares in office printer papersuppliers

36

There is a need to work through the challenge of what amounts to afundamental re-engineering of information flow in the professionalworkplace to discover what works and what does not and tochange the all encompassing form mentality of the present era

DEFINITIONS OF PAPER-LIGHT AND PAPERLESSPaper-light In the context of medical records paper-light impliesthe minimisation of paper-based activity within a conventionalpaper-based records infrastructure

Paper-less This implies a system in which paper-based documentsare eliminated completely and all information is storedelectronically

THE THEORETICAL ADVANTAGES OF PAPERLESSMEDICAL RECORDSMany customer-facing businesses have made a very successfultransition to paper-light systems whereby all processes that can bedigitised are digitised and paper documents are immediatelycaptured and disseminated as electronic (primarily PDF) images

The potential efficiency gains from information transactions bypaperless and paper-light health systems are considerable Suchprocesses will need to be implemented throughout public andprivate health systems including

bull Within primary care services

bull At the interface of these services with secondary care includingpublic and private providers of hospital mental health and socialcare

bull Many different types of clinical transaction including referralsdischarges and the movement of patients across providerboundaries

bull Within hospitals and between hospitals

bull Within social community nursing rehabilitation prisonpalliative veterans charitable and voluntary services

bull Between primary secondary and tertiary health care providersand central information collaters (eg government insurersstatistical agencies risk management agencies)

bull Between health care providers and the supply chain

Within secondary care services a large hospital andor a busysurgical unit will generate many thousands of new documents andclinical records every year Hospital- wide there may be half amillion or more paper based record folder movements betweenclinics secretaries admissions offices and records stores

37

Within this data ecosystem there are many millions of informationtransactions recording temporal (time-stamped and sometimestime-critical) events Paper folders and document wallets often failto move as fast as patients so records are not always where theyneed to be at the point of use This generates additional costsduplicate records and unnecessary transactions which - in turn -waste time and resources Inefficiency also creates additionalclinical risk from the absence of useful or critical clinicalinformation at the point of need

It is therefore self-evident that well designed IT systems will havethe capability to transform healthcare delivery as usefulinformation flows in a timely and appropriate manner between allparties in primary secondary and social care However there ismany a slip twixt cup and lip

38

PART IVPAPERLESS AND PAPER-LIGHTCHANGES IN THE SURGICALWORKPLACE

Surgeons will be primarily concerned about the drive to paperlessand paper-light information transactions within their immediateclinical environment These include the computerisation of

bull Outpatient letters and referrals

bull Inpatient activity (ward based clinical notes and operationrecords

bull Consent forms procedure records and operation notes

bull Discharge summaries

bull Nursing and governance documentation of patient episodes

bull Physiological records such as TPR measurements fluid balanceand prescription charts

There are many other practical applications for the data generatedby such activity including data for appraisals revalidation job-planning and multidisciplinary meetings

The key element in this process of transformation is an intuitiveframework EPR to which digital transformation can be addedincrementally through ldquoDesign Test and Adjustrdquo principles

CHALLENGES IN THE IMPLEMENTATION OFPAPERLESS AND PAPERLIGHT SYSTEMSThere are a number of significant constraints to the efficient uptakeof paperless working practices in surgical units These include

1 The lack of agreement as to what constitutes a standardpatient recordThe information to be recorded and retained needs to be agreed

bull In the record maintained by clinicians

bull In the records maintained by allied health professionals

bull In the ldquochartsrdquo record

bull In the ldquoancillaryrdquo documents (for example the check listswhich are now a major component of every hospital record)

It is invariably argued that every scrap of information in theclinical record should be retained for ldquomedico-legalpurposesrdquo However those familiar with medico-legal reportwriting will recognise that the vast majority of information inany individual record is quite irrelevant to causation caseevolution and case resolution This produces substantial

39

costs in records storage There needs to be a rationalisationon the principles and practice of record keeping informed bythe experience of organisations such as the NHSLA indiscussion with the legal authorities

2 The lack of common standards for document storage andretrievalPDF documents are very data intensive Form based andstructured data entry systems (enter once - use often) offersignificant advantages for paper-light records but standardshave yet to be set and agreed as to optimised form design

3 The lack of access to electronic information throughout theworkplaceIt seems likely that current hard-wired desktop systems will belargely supplemented and superseded by wireless networkstablet computers and other mobile devices However theassumed superiority and durability of these systems overhistoric paper-based recording systems has yet to be proven

4 Data securityIt is reasonable to assume that all electronic data is vulnerable tounauthorised use hacking misuse and corruption if individualsor organisations are sufficiently determined skilled andresourced to access and manipulate it While paper records arealso open to theft or unauthorised access digital abuse ischaracterised by its scale and speed Health system securityprocedures are strong but they have the unfortunate andparadoxical side effect of slowing information transactions andcreating user and security fatigue through the incessant need tolog-in and log-out of disparate hospital systems with differentaccess codes and passwords

Data security also covers the long-term preservation of datasystem redundancy back-up and data warehousing This raisesquestions as to how much digital data to retain of what type inwhat format and for how long

One of the great advantages of paper is its integrity as aninformation storage medium over generations subject topreservation and conservation A major advantage of electronicdata is the ability to conduct powerful analyses and to extractclinical intelligence from the mass of raw data

As yet there is no assurance of the ultimate reliability andintegrity of long-term electronic data storage However theusefulness of electronic data increases with time assophisticated longitudinal studies on large populations and onlong-term outcomes are conducted over decades compared tothe impracticality of using paper based records

40

5 Disparate information requirementsThere is a challenge in meeting the conflicting informationrequirements of different information users in hospitals To datemost IT investments have been directed to administrativefunctions in hospitals The design requirements of systemswhich produce actionable clinical intelligence and clinicalinsight are somewhat different

6 Speed of access and operation of digital systemsCurrent hospital computer systems are often slow in booting upand in loading relevant software and documents It is essentialfor workforce efficiency that all systems are optimised for speedof use and that they are robustly tested with users to optimisescreen and content formats

NEW WAYS OF LOOKING AT OLD PROCESSES THEOUTPATIENT LETTERThere are many component processes in hospital practice which arehighly inefficient but which are presently taken for granted They aresuitable targets for stepwise modernisation as ldquoexemplarrdquo test modelsduring digital transformation The outpatient letter is a primeexample It is worth considering in detail the natural history of such adocument in typical conventional hospital practice from the point ofconsultation in the outpatient clinic where the clinician will typicallydictate a letter into an analogue or digital Dictaphone Voicerecognition systems remain largely error prone and un-adopted

Outpatient dictation of content is generally highly permissiveClinic letters and their content are rarely formally structured otherthan by the most general of linguistic conventions There can be avery substantial variation in the ldquoinformation deliveryrdquo from anyone letter and any one clinician to another even within a singleservice which is treating large numbers of patients with similarproblems in similar workflows

A standard structured and significantly automated letter couldreadily be optimised for information delivery rather than socialdiscourse although this would challenge much accepted outpatientpractice and perceived ldquoclinical freedomrdquo

Once dictated the collection of letters from that dayrsquos clinic istypically passed on to a secretaryPAtyping pool whowhich maybe local to the hospital or remote in a ldquocall centrerdquo possibly as faraway as another continent where the cultural and linguisticnuances of many letters and regional UK accents may bemisunderstood misconstrued or mistyped

On return from the typing pool the letter may need corrections or otherprocessing before the final document is cleared for sending on paperthrough the ldquosnail mailrdquo postal system to the intended GP recipient

On receipt of the letter at the GP surgery it is usually scanned andconverted into ldquoPDFrdquo format for electronic archiving The entire

41

process can at best take a few days and sometimes it can take upto six weeks by which time events will often have moved waybeyond the original clinical decision

It is clear that this is an archaic and inefficient method ofcommunication It would be significantly circumvented if mostletters were created and posted electronically during orimmediately after the clinic This could readily be achieved byintelligent design and modest changes to working practice

An improved electronic outpatient letter is but one element of amore seamless and automated communication system between theGP consultation and the computer screen of the hospital clinicianThis has been made possible by the national Choose and Booksystem but it has yet to be widely implemented in surgical units

DIGITAL TRANSFORMATION AND TEACHINGTRAINING AND EDUCATIONA move to a digital health economy requires a major adaptation ofcore skills by the entire work force which has been trained to usepaper systems for centuries and for which the human eye and brainare well adapted It also requires a rethinking of all aspects ofprofessional practice

There is therefore a need to educate and adapt the workforce todifferent ways of thinking about information flows and the use ofhealth informatics Most health professionals are now veryfamiliar with the workings and benefits of digital technologyNevertheless full realisation of the potential will require ldquocradle tograverdquo changes in workforce education and in particular within theUniversity medical and nursing schools

THE IMPLICATIONS OF DIGITAL TRANSFORMATIONFOR PROFESSIONAL PRACTICEImplementation of the Integrated Digital Care Record mayultimately have a profound impact on professional workingpractices for clinicians allied health professionals and for manyother professionals working in health and social care

For example the General Practitioner is presently the gatekeeper tomuch clinical information Once the IDCR is implemented andonce open access to personal health data becomes the normpatients will be able to access results and reports directly and torelate them to ldquobest practicerdquo healthcare delivered through healthinformation internet portals

The rapid growth of personal physiological micro-sensors such asfor cardiac rhythms and diabetic monitoring are now beingpioneered for and by the ldquoiPhone generationrdquo and will furtherchange the dependency upon GPs The implications of suchtechnological advances for the hospital workforce have yet fully tobe thought through

42

PART VTHE BIGGER PICTURE

ldquoThe variation in the quality of health and adult social careis too wide This unacceptable variation in quality needs tobe widely acknowledged and addressed That care can bedelivered in different ways does not justify poor quality forsome people settings or locations Everyone should receivegood quality care no matter how or where it is beingdelivered This means improving the care that is inadequateor requires improvement while leaving others to flourish todevelop their good and outstanding carerdquoThe state of healthcare and adult social care in England201314Care Quality Commission Report October 2014

In February 2014 Jeremy Hunt Secretary of State for Healthcommissioned Sir David Dalton Chief Executive Officer of SalfordRoyal NHS Foundation Trust to examine new options andopportunities for providers of NHS care along with an Expert Panelof very senior and experienced NHS Executive Officers The reportis published at httpwwwgovukgovernmentpublicationsdalton-review-options-for-providers-of-nhs-care

This review focussed on organisational structures and exemplarsInter alia Sir David and his Expert Panel considered that

ldquoThe gap between required and actual standards manifestsitself in variation of standards across the country reducing thisvariation and ensuring uniformly high standards of care acrossthe provider sector is vitally important

As demand and complexity continue to increase it has becomeincreasingly difficult for providers of all types to navigate thechallenges that the NHS faces

The NHS Five Year Forward View identifies that the NHS needsbetter ways of delivering care at greater scale It identifies that

a care should be personal whilst based on population health needs

b there should be a new focus on co-ordinated care systemsand networks

c a greater emphasis should be given to redesigning out-of-hospital care

d centralisation should be supported where it demonstrablydelivers improvements in quality and safety and

e to achieve greater productivity new approaches should adoptgreater standardisation of processes use of technology andshared information

43

The new approaches to developing care models proposed by theNHS Five Year Forward View help to address some of the keychallenges faced by providers

i There are more people living with long term conditions thenumber of people with three or more conditions is expectedto rise from 19 million in 2008 to 29 million by 2018

ii Patients with chronic disease have complex and variedneeds often accessing services across a spectrum of care

iii Between 201112 and 201213 the number of emergencyadmissions increased by 18 outpatient appointments by39 and day case episodes by 23 and this demandpattern further increased in 201314

Overall demand is predicted to rise to 7 per annum This iscoupled with an aging demographic where the number ofpatients over the age of 85 is expected to double by 2030 manyof whom will have one or more chronic conditions

Establishing models and systems of care which meet the needsof individuals and communities is essential and it is crucial forlocal leaders to determine what will work best for their localityIt is for provider organisations and their leadershipgovernance structures and workforce to deliver the requiredtransformational change New models of care require neworganisational responsesrdquo

It is clear that excellence in clinical informatics will make a majorcontribution to these worthy objectives

44

PART VISUMMARY

The purpose of this booklet in the ASGBI Issues in ProfessionalPractice series has been to stimulate awareness and interest inclinical informatics among surgeons at a time of rapid technicaland organisational change within the public services

Change driven by technological advance is inevitable and it will beas disruptive to the health service as it has been to many otherindustries and services in recent times

Overly optimistic or overly rapid introduction of digital technologyinto the healthcare sector nevertheless carries the potential forunwanted operational disruption at a time of severe overstretch ofthe public health service

It is therefore essential that surgeons as professional leaders havethe knowledge and skills both to advance change where it is clearthat the new technologies are appropriate and properly tested toprovide informed advice where the risks exceed the gains and toexperiment with new systems and technologies in all areas of theirclinical practice

Above all we hope that this booklet will promote debate ideasexchange and communication between surgeons and more widelyon all facets of the implementation of digital technology in theworkplace

45

EXEMPLAR 1DEVELOPMENT OF A TIMELINESTRUCTURED DYNAMIC EPR IN THEUNIVERSITY HOSPITALSOUTHAMPTON CLINICAL DATAENVIRONMENT

THE MARYLAND LIFELINES TIMELINE EPR CONCEPTMODEL (1996-97)Various attempts have been made to develop a practical structurefor an informative EPR The presentation of data using graphicaltechniques colour and icons allows patterns within complex datato be readily and rapidly visualised

An effective and useful visualisation tool should conform to themantra of ldquoOverview gt Zoom gt Filterrdquo which has been promotedby Professor Schneiderman of the Human ComputerInteraction Laboratory (HCIL) at the University of Maryland asa key concept in the design of visualisation tools for the study ofcomplex and heterogenous data The design of any such toolshould

bull Allow for an Overview of the Data

bull Allow the user to Zoom in on any feature of interest (suchas the content of an individual document)

bull Allow the user to Filter out unwanted information

In the 1990s a HCIL team under the direction of ProfessorSchneiderman created a model health record which they termedLifelines (see Figure 3) This contained a number of innovativedesign features which are particularly attractive as a basis for aclinically useful EPR in that

bull The model was Windows based

bull It was structured along a timeline along the X axis and bysubject matter Immunisations hospital visits medicationsprescribed test results and so on were allocated separatetimelines with origins on the Y axis

bull By selecting individual icons the user could drill down intocontent and call up individual letters reports and images

However the model was focussed upon primary care and it wasnot further developed or implemented in practice

46

Figure 3 Basic format of the clinical LifeLine prototypedeveloped by HCIL at the University of Maryland

THE UNIVERSITY HOSPITAL SOUTHAMPTONEXEMPLAR OF AN INTEGRATED EPRIt was recently decided to build a practical EPR using the designprinciples in Lifelines future EPR concept within the UniversityHospital Southampton Clinical Data Environment (UHS CDE)The Discovery and Alpha Phase design team comprised onesurgeon one systems design specialist with detailed knowledge ofthe local hardware and software architecture and the leader of theTrustrsquos Information Management Directorate

The Southampton CDE has been in progressive and incrementaldevelopment since the early 1990rsquos with a mix of legacy nationallyspecified and locally developed systems This is a challenge whichis common to all hospitals in the UK Specifically all documentsand clinical results are accessible on a common digital platform Itwas aimed to build a system and a patient-specific EPR which

bull Was highly intuitive and easy to use by clinical andadministrative staff to the point at which the model wouldultimately become the preferred route of entry into the UHSCDE for the majority of data transactions

bull Automatically loaded and was accessible in real time

bull Was timeline structured and continuously updated

bull Gave an Overview of all data (documents results reports) ona single screen

47

bull Allowed individual documents reports and result to beselected out and called up (expanded) individually thusaddressing the Filter and Zoom functions

The resulting prototype (ldquoAlphardquo) tool (see Figure 4) wasproduced in a few months at minimal cost through an iterativedesign-test-adjust process It provided an intuitive andcontinuously adaptable EPR interface that is now being rewrittenand updated in modern code

The screenshot in Figure 4 is taken from the records of a youngpatient with a complex clinical condition (spina bifida) involvingmultiple specialities Each icon indicates a document test resultor report Hovering over any icon reveals the metadata describingwhen and where it was generated and by whom Clicking on theicon brings up the full document record report The subjectcolour coding reflects an established coding of paper recordswhich has been in use in UHS for around 50 years and istherefore familiar to all staff

Figure 4 The prototype Southampton Electronic PatientRecord (2010)

This particular model is coded to work within the UHS CDEUnfortunately it cannot be ldquoshrink wrappedrdquo and importeddirectly into any other hospital computer system in its presentform without specialist programming skills because it is takingdata feeds from a variety of different software systems

The interface will thus need to be separately coded into each hospitalsystem given the substantial variation in hardware and softwarearchitecture from hospital to hospital Nevertheless it seems highlylikely that this will become an attractive and practical design fordevelopers of the next generation of clinical informatics systems

48

The direct and indirect benefits of such an EPR are readilyapparent They include

bull Simplification of access to diverse documents and datatypes

bull Simple and instant visualisation of relationships betweenactivity and documents in different clinical disciplines andtreatment streams

bull A comprehensive overview of all clinical records relating toany patient at any time rather than a narrow focus on onediscipline or treatment stream

bull A breadth and depth of focus on a patientrsquos entire clinicalhistory whether lifelong or within a single institution

bull An expandable and scalable record along both X and Y axes

bull Reduced costs of duplication of effort and tests

This model has been developed within a controlled hospital dataenvironment but it is easy to see how it could be readily appliedin primary care to generate a ldquowhole of liferdquo overview of anindividual patient history

49

EXEMPLAR 2TIMELINE STRUCTURED DISEASE-SPECIFIC RESEARCH DATA BASES ANEXEMPLAR OF A DATA SYSTEM FORBREAST CANCER

The extraction of knowledge and actionable clinical intelligencefrom electronic information and documents is a particularintellectual and software design challenge

Timeline based data visualisation opens a range of creativeopportunities for the display and analysis of clinical data Theconcepts of the Lifelines EPR have been extended to thedevelopment of an integrated data system within the SouthamptonClinical Data Environment using breast cancer as an exemplar

This model can be used as a generic tool with applications in thestudy of all chronic diseases of childhood and adulthood and as aframework for other forms of clinical research It also hasapplications as a clinical Decision Assistance Tool in specialistpractice and for multidisciplinary teams

The Southampton Breast Cancer Data System has evolved on aldquodesign test and adjustrdquo basis over three years of localdevelopment It currently holds some 12000+ records on allpatients diagnosed and treated locally and a further 4000+ casesreferred for chemotherapy and radiotherapy from other regionalhospitals since the records began in 1949 The framework recordsare continuous since 1979 and supported by complete pathologyrecords since 1990

This data system is structured using conventional MicrosoftWindows tools drop down menus check boxes and so on for easeof use and data population It incorporates a number of originalfeatures which include

bull Intrinsic timelines supporting documents generated withinselected sub-specialities including Surgery Cancer CareMedicine (for co-morbidities) and Histopathology

bull Direct linkage to all document and report files allowingdynamic and continual updating of all records and timelinesfor living patients

bull A LifeTrak timeline modelled on the railway marker onOrdnance Survey maps This highlights the month of onset ofkey episodes of beast cancer progression Diagnosis LocalRecurrence Metastasis and Death (in the case of breastcancer) are represented as stations on the LifeTrak with asimple colour code for laterality (red = port = left green =

50

starboard = right) The LifeTrak permits measurement ofintervals between episodes and the correlation of theseintervals with pathology and treatments

bull A ldquocause of deathrdquo menu for deceased patients which canoften be populated with accurate information from thosedocuments relating to end of life admissions which are heldwithin the UHS CDE

bull Semi-automation of data loading The hospital servers aretrawled at midnight every 24 hours and new skeletal recordsare created for all new patients with a breast cancer diagnosisFurther population of records is primarily manual at presentbecause of the range and complexity of legacy data resources(for example hand written card indices) However it lendsitself to future automation

bull A Data Mining tool which permits the selection and analysisof cohorts of patients by a wide range of demographicpathological and treatment criteria as well as by the year oftreatment This function allows the direct comparison ofoutcomes between cohorts treated in different years and eras

The following images illustrate the key components of the ldquowholetime course of the diseaserdquo structure and function of theSouthampton Breast Cancer Data System as an exemplar ofapplied clinical informatics

Figure 5 The Cancer Lifetrak records the month of PrimaryDiagnosis (circle) local recurrence (inverse triangle) andmetastasis (yellow triangle)

The terminal icon indicates the cause of death which in thisparticular patient was from late onset oesophageal cancer ratherthan progressive breast cancer as evidenced in the supportingdocuments indicated by the microscope icons

51

Figure 6 This prototype Data Entry screen for the primarydiagnostic and treatment episode illustrates the use of drop downmenus for ease of data entry

The screen contains a section for entering the disease pathology(for left right or bilateral cancers) and the primary and adjuvanttreatments The data entry screen for Local Recurrence is similar

Figure 7 This prototype screen allows recording of the fact andtiming of diagnosis and treatment of tumour metastasis

52

Figure 8 A test model data mining tool within the SouthamptonBreast Cancer Data System which allows cohorts of patients tobe selected by a range of criteria

The ability to display and read the LifeTraks of the patients in thecohort and to link them back directly to the source data opens thedoor to a range of further studies based upon the ldquosurvivalanalysisrdquo of intervals between episodes in relation to pathology andtreatments

53

APPENDIX ACUTTING THROUGH THE JARGONSTANDARDS AND SEMANTICHARMONISATIONMedicine provides a rich and complex language of unique termseponyms acronyms and abbreviations which vary from region toregion and hospital to hospital A standard national terminology isessential to underpin developments in clinical informatics and toensure that all diseases conditions and procedures and referencedin the simplest most accurate and most efficient manner Thefollowing notes may help the confused and bewildered to hack theirway through the terminological jungle

The NHS Classifications Service a division of the Health andSocial Care Information Centre is responsible for the developmentandor maintenance and implementation of the clinical classificationsand the associated standards in support of this objective Thefollowing resources are used and available to help standardisemedical terminology in the move towards an integrated care record

1 Read codesRead codes are the standard clinical terminology system forGeneral Practice in the UK It supports diagnostic coding alongwith of many other factors including occupation socialcircumstances ethnicity and religion clinical signs symptoms andobservations laboratory tests and results therapeutic and surgicalprocedures performed and a range of administrative factors

The first version was developed in the early 1980s by Dr JamesRead a Loughborough GP It had a four character code structureand was more commonly known as 4-Byte READ The finalofficial release of 4-Byte READ occurred in April 2009

In order to cross-map to ICD-9-CM and OPCS-4 a new READschema was devised with a code structure of five Bytes Thiswas known as READ2 or 5-Byte READ which was firstreleased in 1990 The October 2010 release contained 82967discrete 5-byte codes

A third version of the READ code was devised through the1990s to address technical limitations of the earlier designsThis was known as Clinical terms Version 3 or CTV3

The first release of CTV 3 occurred in the late 1990s TheOctober 2010 release contained 298102 discrete concept codesof which 55829 were marked as inactive and 58130 werepharmaceutical products or devices

The two active versions of the READ codes (READ-2 andCTV3) are now maintained by the UK Terminology Centre

54

2 SNOMED CT

SNOMED CT is the internationally recognised SystematisedNomenclature of Medicine Clinical Terms and has beenadopted as the standard clinical terminology for the NHS inEngland See httpsystemshscicgovukdatauktc

SNOMED CT is a computer processable collection of medicalterms providing codes terms synonyms and definitions used inclinical documentation and reporting It is considered to be themost comprehensive multilingual clinical healthcareterminology worldwide

The primary purpose of SNOMED CT is to support the effectiverecording of clinical data It provides the core generalterminology for electronic health records Its coverage includesclinical findings symptoms diagnoses procedures bodystructures organisms and other aetiologies substancespharmaceuticals devices and specimens

SNOMED CT is maintained and distributed by theInternational Health Terminology Standards DevelopmentOrganisation (IHTSDO) an international non-profit standardsdevelopment organisation based in Copenhagen

SNOMED CT permits consistent information interchange andprovides a consistent way to index store retrieve and aggregateclinical data across specialties and sites of care It also providesthe user with a number of linkages to clinical care pathwaysshared care plans and other knowledge resources

SNOMED CT can cross-map to other international standardsand classifications Specific language editions are availablewhich contain translations and additional national terms

UK SNOMED CT releases both UK Clinical Extension and UKDrug Extension are now available in the UK SNOMED CTdownload area of the HSCIC web site

A complete UK Edition of SNOMED CT requires theInternational Release the UK Clinical Extension and the UKDrug Extension (information from Wikipedia)

The relationship between READ and SNOMED Coding

SNOMED CT was created in 2001 out of a technical editorialand content merger of CTV3 and SNOMED RT an Americansystem A significant part of the International Core content ofSNOMED CT derives directly from CTV3

CTV3 continues to be released biannually by the NHSindependently of SNOMED CT but maintenance of bothsystems occurs in parallel

The NHS in England is committed to move to SNOMED CTand systems using SNOMED are now being deployed within the

55

NHS primary and secondary care estates READ versions 2 and3 were still the core clinical terminology used in UK primarycare in 2010 with some 90 of the primary care estate stillusing READ version 2 (information from Wikipedia)

3 The OPCS Classification of Interventions and Procedures OPCS4The first NHS procedural classification was published in 1987by the Office of Population Censuses and Surveys (OPCS) asthe Classification of Surgical Operations In 1992 the 4th

revision was released as the OPCS Classification of SurgicalOperations and Procedures (4th revision) (OPCS-42)Responsibility for the OPCS classifications passed to the NHSInformation Authority in 1999 (information from Wikipedia)

By 2003 OPCS-42 no longer accurately reflected many of theprocedures being performed A project to replace OPCS-4 witha more robust method of procedure coding was proposed usinga sequence of alphanumeric code up to 15 characters long

A programme of annual revisions to OPCS-4 was implementedin 2005 Since the implementation of OPCS-43 in April 2006there have been various further revisions to OPCS-4 eachbecoming mandated on 1st April in the year of publication

4 The International Statistical Classification of Diseases andRelated Health Problems (ICD10)ICD-10 is the 10th revision of the International StatisticalClassification of Diseases and Related Health Problems (ICD)of the World Health Organisation (WHO) It contains morethan 14400 different codes for diseases signs and symptomsabnormal findings complaints social circumstances andexternal causes of injury

The International version of ICD can be confused with NationalClinical Modifications (CM) of ICD that frequently includemuch more detail including procedures The US ICD-10Clinical Modification (ICD-10-CM) has some 70000 codesWork on ICD-10 began in 1983 and was completed in 1992(information from Wikipedia)

httpsystemshscicgovukdataclinicalcodingcodingstandards

5 The Dictionary of Medicines and DevicesThe Dictionary of Medicines and Devices (dm+d) is the NHSdictionary which contains unique identifiers (codes) andassociated textual descriptions for representing medicines andmedical devices in information systems and electroniccommunications It is linked to SNOMED CT and supports thenational electronic prescriptions service seehttpsystemshscicgovukdatauktc

56

ldquodm+drdquo has been developed jointly by the Health and SocialCare Information Centre and the NHS Business ServicesAuthority It provides consistency in how medicines andmedical devices are described through a robust Editorial Policy

6 The Unified Code for Units of Measure (UCUM)The Unified Code for Units of Measure (UCUM) is a codesystem intended to include all units of measures currently usedin international science engineering and business seehttpunitsofmeasureorg

57

APPENDIX BNHS INFORMATICS ORGANISATIONSAND RESOURCES

The NHS Data DictionaryThe NHS Data Model and Dictionary provides a reference point forassured information standards to support healthcare activitieswithin the NHS in England httpwwwdatadictionarynhsuk

The Organisational Data Service (ODS)This provides codes for organisations sites wards and individualsacross UK health and social carehttpsystemshscicgovukdataods

The Information Standards Board (ISB)This provides support appraisal and approval services for thedevelopment of standards for the NHS and social carehttpwwwisbnhsuk

The Professional Records Standards Body (PRSB)This body has been set up to consider the development and use ofrecord keeping standardshttpwwwtheprsborguk

The Academy of Medical Royal Colleges Record KeepingStandards and Core Data ModelThis is a set of core information relating to clinical documentationhttpsystemshscicgovukclinrecords

The NHS Technology Reference data Update DistributionService (TRUD)TRUD is hosted by the Health and Social Care InformationCentre It provides a range of reference resources for informationtechnology developershttpsisdhscicgovuktrud3userguestgroup0home

The UK Terminology Centre (UKTC)The UKTC at the HSCIC is responsible for the UK management ofSNOMED CT Read codes and other healthcare terminologyproducts and Clinical Classifications The UKTC maintains theNHS Dictionary of Medicines and Devices (dm+d) in partnershipwith the NHS Business Service Authorityhttpsisdhscicgovuktrud3userguestgroup2home

The Clinical Classifications Service (CCS)This is the definitive source of clinical coding guidance and setsthe national standards used by the NHS in coding clinical datahttpsystemshscicgovukdataclinicalcoding

58

The NHS Interoperability FrameworkThis is a collection of software interoperability products intendedfor use by care system providers in England They are classifiedinto a number of categories including

bull Architectural specifications for transport and infrastructuralrequirements

bull Domain Message Specifications for the interoperabilitypayloads

bull Reference Data to assist in the creation of payloads

bull Tools and guidance to assist developers in implementing thespecifications and payloads

httpsisdhscicgovuktrud3userguestgroup41home

59

APPENDIX CSTANDARDS FOR DIGITALCOMMUNICATIONS IN HEALTHCARE

Clinical Document Architecture (CDA)The CDA Release 20 provides an exchange model for clinicaldocuments such as discharge summaries and progress notes

eXtensible Mark up Language (XML)XML is a World Wide Web Consortium (W3C) standardspecifying a syntactic format for conveying information

The NHS Message Implementation Manual (MIM)NHS organisations have many different computer systems used formany different purposes from pathology results to patient trackingHealth Level 7 (HL7) specifies a number of flexible standardsguidelines and methodologies by which various healthcare systemscan communicate with each other

Domain Message Specification (DMS)This is the replacement system for the Message ImplementationManual The first version was released in 2012

Standards for Secure Information TransmissionTransport Layer Security (TLS) is a protocol that ensures privacybetween communicating applications and their users on theInternet When a server and client communicate TLS ensures thatno third party may eavesdrop or tamper with any message TLS isthe successor to the Secure Sockets Layer (SSL) It is theapproved Cryptographic Standard for NHS communications

The Common User Interface toolkitThe Common User Interface toolkit (wwwcuinhsuk) provides aset of standards and specifications governing presentation orgraphical user interface components of electronic health recordsystems



Tel 020 7973 0300 Fax 020 7430 9235wwwasgbiorguk

A Company limited by guarantee registered in England 06783090

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INTRODUCTION







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2 SNOMED CT













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and















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or capable

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2 SNOMED CT













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wwwasgbiorguk

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and















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or capable

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PART VISUMMARY






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2 SNOMED CT













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wwwasgbiorguk

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and















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or capable

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PART VISUMMARY






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2 SNOMED CT













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wwwasgbiorguk






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and















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or capable

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PART VISUMMARY






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2 SNOMED CT













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wwwasgbiorguk

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and















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or capable

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PART VISUMMARY






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2 SNOMED CT













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or capable

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PART VISUMMARY






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2 SNOMED CT













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wwwasgbiorguk

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or capable

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PART VISUMMARY






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2 SNOMED CT













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wwwasgbiorguk

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PART VISUMMARY






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2 SNOMED CT













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wwwasgbiorguk

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PART VISUMMARY






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54

2 SNOMED CT













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wwwasgbiorguk

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PART VISUMMARY






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2 SNOMED CT













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wwwasgbiorguk

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PART VISUMMARY






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2 SNOMED CT













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59












wwwasgbiorguk

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PART VISUMMARY






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54

2 SNOMED CT













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wwwasgbiorguk

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PART VISUMMARY






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54

2 SNOMED CT













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wwwasgbiorguk

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PART VISUMMARY






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54

2 SNOMED CT













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wwwasgbiorguk

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PART VISUMMARY






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51




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54

2 SNOMED CT













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59












wwwasgbiorguk

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44

PART VISUMMARY






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51




52



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54

2 SNOMED CT













55










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59












wwwasgbiorguk

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PART VISUMMARY






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54

2 SNOMED CT













55










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59












wwwasgbiorguk

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PART VISUMMARY






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51




52



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54

2 SNOMED CT













55










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59












wwwasgbiorguk

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PART VISUMMARY






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54

2 SNOMED CT













55










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59












wwwasgbiorguk

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44

PART VISUMMARY






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51




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54

2 SNOMED CT













55










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57










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59












wwwasgbiorguk

30










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44

PART VISUMMARY






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54

2 SNOMED CT













55










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59












wwwasgbiorguk

31







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PART VISUMMARY






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47







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50








51




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54

2 SNOMED CT













55










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59












wwwasgbiorguk

32











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44

PART VISUMMARY






45












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54

2 SNOMED CT













55










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59












wwwasgbiorguk

33














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40









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44

PART VISUMMARY






45












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47







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50








51




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53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

34












35








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44

PART VISUMMARY






45












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47







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50








51




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53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

35








36














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44

PART VISUMMARY






45












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47







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49










50








51




52



53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

36














37



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40









41









42













43








44

PART VISUMMARY






45












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47







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49










50








51




52



53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

37



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40









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43








44

PART VISUMMARY






45












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47







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50








51




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53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

38


















39








40









41









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43








44

PART VISUMMARY






45












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47







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49










50








51




52



53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

39








40









41









42













43








44

PART VISUMMARY






45












46








47







48









49










50








51




52



53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

40









41









42













43








44

PART VISUMMARY






45












46








47







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49










50








51




52



53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

41









42













43








44

PART VISUMMARY






45












46








47







48









49










50








51




52



53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

42













43








44

PART VISUMMARY






45












46








47







48









49










50








51




52



53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

43








44

PART VISUMMARY






45












46








47







48









49










50








51




52



53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

44

PART VISUMMARY






45












46








47







48









49










50








51




52



53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

45












46








47







48









49










50








51




52



53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

46








47







48









49










50








51




52



53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

47







48









49










50








51




52



53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

48









49










50








51




52



53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

49










50








51




52



53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

50








51




52



53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

51




52



53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

52



53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

53









54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

54

2 SNOMED CT













55










56



57










58







59












wwwasgbiorguk

55










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57










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59












wwwasgbiorguk

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