5.6 Lab Information System Business Case-APP1€¦ · The existing Laboratory Information Management System (LIMS) within these three sites comprises of: LRS Medipath (Blood Sciences

REPLACEMENT OF LABORATORYINFORMATION MANAGEMENT SYSTEM

WITHIN NHS HIGHLAND

Business Case

Version: 1.1

21st DECEMBER 2012

Replacement LIMS Business Case v1.1 2

Contents

1. EXECUTIVE SUMMARY 4

2. INTRODUCTION 5

2.1 Purpose 5

2.2 Background 5

3. STRATEGIC CONTEXT 7

4. THE OPTIONS 9

5. INDICATIVE COSTS 10

6. PROJECT MANAGEMENT 11

7. EQUALITY AND DIVERSITY IMPACT 11

8. BENEFITS ASSESSMENT 11

9. CONCLUSION 13

APPENDICES

Appendix A – Options Appraisal

Appendix B – Benefits Analysis

Appendix C – Risk Analysis

Appendix D – Implementation Plan

Appendix E – Primary Care Reponses


Version and Configuration Management

Configuration History Sheet

VersionNo.

Date Details of Changes included in Update

1.1 21.12.12 Section 5 updated to include revenue savings

The issue of this document requires the approval of the signatories below onbehalf of the Project Board.

Name Title Signature Date

DistributionVersion No. Date


1. Executive Summary

Introduction

The Laboratory Services within NHS Highland consist of a number of specialised laboratoriesencompassing the disciplines of Blood Sciences, Blood Transfusion, Microbiology andPathology and operate from three locations; Raigmore, Belford and Caithness GeneralHospitals. The existing Laboratory Information Management System (LIMS) within thesethree sites comprises of:

LRS Medipath (Blood Sciences Laboratory and Microbiology) GE Ultra Centricity Laboratory (Pathology)

Background

The Medipath system was procured nearly twenty years ago, is supported by an Australianbased company (LRS) and the Western Isles Health Board is its only other NorthernHemisphere customer. There is no formal development programme for the version installedwithin NHSH, meaning that requirements of users have to be met by individual customisedalterations to the software. This limits the extension of functionality to that required of amodern LIMS, and management information tools are limited in range and function – dataextraction is cumbersome, time-consuming and not sufficient to support the requirements ofaudit, workload analysis, quality management and demand management/control. Critically,Medipath does not support electronic ordering, which is a key requirement of requestors andlaboratories, as well as being central to the benefits associated with the upcoming PatientManagement System. Electronic resulting from Medipath is of a form that does not fullymeet users’ needs.

The GE Ultra Centricity system was implemented in February 2009, but in July 2010, GEannounced that it would be undertaking no further development work on the Ultra product,and that its customers must withdraw the system from operational use by July 23 2013.However, because NHSH signed a 7 year support contract then support for NHSH onlywould be extended to February 2016 with the rest of the World no longer being supportedfrom July 2013. Without a supported LIMS in place the Pathology service of NHS Highlandwould no longer be able to function and service would cease.

Recommendation

This business case provides the rationale and benefits for replacing the current LIMS withthe preferred option of a unified system for all NHS Highland laboratory disciplines, beingone of the pillars of the eHealth strategy alongside replacement of the Patient Managementand Radiology Information Systems in delivering an end to end IT solution for laboratorydiagnostics. Cost savings related to reduction in WTE associated with booking in samplesand delivering paper reports, equating to £257K over the three year implementationtimescale. The extensive product sourcing and procurement lead-in times coupled with theobsolescence of GE Ultra from 2016 necessitates the approval of this business case withinFY 12/13.

Action Required

NHS Highland is requested to accept the above recommendation which will enable progresstowards commencing the replacement of the LIMS before the expiry of the GE UltraCentricity system and associated loss of service provision for Pathology.


2. Introduction

2.1 PURPOSE

The purpose of this Business Case is to set out the need, implications, risks, benefits andindicative costs of implementing the Laboratory Information Management Systems (LIMS)replacement programme in NHS Highland.

The Business Case also seeks to achieve the following:

Endorse the provision of a replacement LIMS which complements and supportsongoing eHealth developments in Order Comms and Patient Management Systems

Enabling of management information arising from LIMS to drive performanceimprovements with ensuing financial benefit

Endorse the provision of a replacement LIMS which reduces non value adding stepsin sample flow (such as manual data entry and authorisation)

2.2 BACKGROUND

Laboratory diagnostics is the science at the heart of modern medicine and is vital to thediagnosis and clinical management of disease, determining the cause of diseases andrevealing the targets for their treatment. Laboratory tests reveal the success or failure ofboth the progress and the final outcome of that treatment and the laboratory service istherefore integral to the patient pathway.

Royal College of Pathologists figures show that laboratory investigations are critical indetermining over 75% of patients’ treatment pathways and are therefore LIMS are crucial toenabling the results of these investigations to be communicated accurately and swiftly to aidrapid clinical decision-making as an output of a 24/7 diagnostic service. The LIMS must beresilient, in terms of hardware, software and support, to avoid downtime which would impacton the ability of the laboratories to deliver the required level of service to its stakeholders –principally GPs and hospital clinicians who act as the proxy for the patients.

The Laboratory Services within NHS Highland consist of a number of specialised laboratoriesencompassing the disciplines of Blood Sciences (Biochemistry and Haematology), BloodTransfusion, Microbiology (culture, molecular, serology [including the Scottish ToxoplasmaReference Laboratory and Specialist Service for Lyme borreliosis]) and Pathology(Histology, Mortuary, Cytology and Cytogenetics). NHS Highland has, owing to itsgeography, a larger number of laboratories than would be normal in a more denselypopulated area. Accordingly, there are four physical locations, all of which are vitalcomponents of the organisation in which these laboratories are sited – Raigmore, Belford,Caithness General and Lorn and Islands Hospitals in Inverness, Fort William, Wick and Obanrespectively. Blood transfusion is the responsibility of the respective laboratories on each ofthese sites with the exception of Raigmore Hospital and is therefore within the specificationof the current and future LIMS.

This business case considers the LIMS requirements of the first three sites, though isdesigned to accommodate the needs of the Lorn and Islands Hospital within Argyll and Bute,should that become a requirement.


The LIMS operated within the Raigmore, Belford and Caithness General Hospitals receiveand handle nearly 1 million requests and process over 11 million results per annum, and thisfigure rises incrementally due to workload increases and case complexity. The systemsprovide:

Accurate registration and management of samples and requests Interfacing with, and control of, a wide range of analysers, automated platforms and

printers used in the performing and tracking of tests and subsequent delivery ofresults

The processing and quality control associated with the sample and reagent utilisation Production and authorisation of results, with flagging of abnormal results Production of a printed report as required, along with the electronic transfer of results

into SCI Store with onward transmission into other clinical systems (such as EDT forGPs)

Storage of all data associated with the above in line with regulatory requirements andfuture utilisation

The existing LIMS within the three sites are:

LRS Medipath (Blood Sciences Laboratory and Microbiology) GE Ultra Centricity Laboratory (Pathology)

The Medipath system was procured nearly twenty years ago. The support provider, LastResort Support (LRS), is based in Australia, where the majority of its users are also based –Western Isles Health Board is its only other Northern Hemisphere customer. There is noformal development programme for the version installed within NHSH, meaning that therequirements of users have to be met by individual customised alterations to the software.Medipath does not support electronic ordering (order comms) by primary or secondary care,and transmits results to requestors as an image rather than discrete values, requiringresource to be used in transcribing results into systems such as National Sexual HealthSystem (NaSH) and Scottish Cervical Cytology Recall System (SCRS). The above issueslimit the extension of functionality to that required of a modern LIMS, and managementinformation tools are limited in range and function – data extraction is cumbersome, time-consuming and not sufficient to support the requirements of audit, workload analysis, qualitymanagement and demand management/control.

The GE Ultra Centricity system was procured in 2008 and fully implemented in 2009, as areplacement for the foremost Apex Pinnacle system which had reached the end of itsprojected lifespan. Only 17 months into its operational life GE announced that it would notbe selling the Ultra product anymore, and that all customers must withdraw the system fromoperational use by 23 July 2013. An extension of timescale to February 2016 for NHSHcustomers was granted, but the system must be removed from use by that time, as must on-site service provision unless a replacement is procured.


3. Strategic Context

Key to any organisation is the ability to communicate between systems both internal (EPR,PMS, Renal) and external (GP systems). This is identified as one of the five strategic aimsfrom the NHSS eHealth Strategy 2011-2017, as endorsed by the Scottish Government:

‘Improve the availability of appropriate information for healthcare workers and the tools touse and communicate that information effectively to improve quality.’

The current process of test requesting and reporting in NHS Highland sees specimens arriveat the laboratories with generally no advance notice or tracking facility, accompanied bymanually-filled out paper request forms, leading to the possibility of lost or delayedspecimens, or association of the specimen with the incorrect patient due to transcription erroror incomplete demographics and/or test requirements. Each specimen is manually bookedin by the laboratories staff, a laborious task which introduces delay, and transferred to therequisite laboratory for testing. Once testing is completed and verified, the current LIMS areable to relay results electronically to Primary Care from SCI store via the Electronic DataTransfer (EDT) but, due to discrete data values not being transmitted, these discrete valueshave then to be manually transcribed to the patients individual records, a rather timeconsuming exercise that, as with manual booking in, has the inherent potential for data inputerror. Results to Secondary Care are provided via SCI Store.

For Secondary Care, along with external NHS Highland customers such as NHS WesternIsles, paper results are required to be printed and despatched since accessing the results viaSCI Store does not provide adequate assurance that the results have been acknowledged bythe treating clinician. This requires 0.5 WTE staff resource in addition to stationery costsincurred.

It is therefore imperative that Laboratories have an IT system that is able to track thespecimen from source, associate sample with request and relay results electronically directto Primary and Secondary Care without the need for manual transcription. Use of such afacility would also allow audit of the time taken between specimen collection to receipt in thelaboratory which would facilitate identifying issues with specimen transportation to thelaboratory. The capability to send discrete values to associated interfaced system isessential. Any and all of the LIMS systems being considered must meet relevant nationalstandards and protocols as well as being flexible enough to respond to any future initiativesand requirements. The current LIMS are unable to fully support the functions needed toadminister and monitor the remote requesting as would be required to support any initiativespursued by the Board to provide Laboratory services to outside institutions. A modern LIMSsystem will fit with a number of other national and organisational strategies:

Enable electronic requesting from, and resulting to, Primary and Secondary Care Allow for the Laboratories to function in a paper-free environment Allow for integration of laboratory diagnostics with recognised technologies such as

digital voice recognition, synoptic reporting and image capture Allow connectivity and compliance with the national systems such as SCI Store and

GP systems such as Vision, such that diagnostic results are delivered in the requiredformat to the requestor

Support Point of Care (near patient) testing and disseminated laboratory servicesallowing Laboratories to monitor and audit results produced from these devices

Support comprehensive demand management Support the bringing together of systems and information to support Cancer Networks

and the development of other networks


Support national targets such as 62 day and 31 day wait-to-treatment for Cancer andCardiology, 18 week referral to treatment (RTT), 4 hour A&E by allowing flagging andprioritisation of cases

Support utilisation of the National Pathology Catalogue, comprised of a list ofstandardised tests and associated reference ranges which are identified by theirassociated Systematized Nomenclature of Medicine (SNOMED) concepts

Support the Primary Care Pathology Requesting and Reporting Project which willimplement a full requesting and reporting service between primary care andlaboratories using these national standards, leading to end-to-end IT infrastructure forall the laboratory disciplines

Allow the option of remote hosting of system Facilitate Laboratories’ ability to easily, cost effectively and efficiently provide

diagnostic services to other Boards and external organisations, supportive ofpartnership and income generation approaches

Will be fully compliant with and be developed by suppliers to implement any currentand future regulatory standards, (such as required by Clinical Pathology Accreditation(CPA), Medicines and Healthcare Regulatory Authority (MHRA) and associatedbodies), statutory developments being part of the yearly support costs

Support data export to external systems for surveillance of communicable diseases(ECOSS), infection prevention and control (ICNet) and other systems as required

Support measurement and monitoring of key performance indicators (KPIs),contributing to management dashboard and departmental scorecards

Enable ad hoc and scheduled reporting of KPIs using customisable queries at apatient-based level

Allow for extraction of information associated with each and every data object (e.g.patient flags, all standard demographics, test component(s), SNOMED codes,requesting and reporting clinician etc)

Support activity based costing budgetary approach by allowing a cost per test to beattributed to individual tests and components of tests

Support the extraction of data for statistical returns for Keele benchmarking andScottish Pathology Network (SPAN)

Allow for recurrent revenue savings by reducing the manual elements of datatranscription and report delivery


4. The Options

The following options were in scope for consideration:

1. Do nothing (maintain status quo)2. Replace GE Ultra Centricity Laboratory3. Replace both GE Ultra Centricity Laboratory and LRS Medipath with product(s) from

a single provider (PREFERRED OPTION)4. Replace both GE Ultra Centricity Laboratory and LRS Medipath with products from

separate providers5. Purchase Pathology module of LRS Medipath6. Outsource the LIMS function and support to another Health Board

Given the fundamental requirement to have correctly functioning and externally-supportedLIMS option 1 is deemed too great a risk to consider as it would leave the Board with noPathology service. Option 2 leaves Microbiology and Blood Sciences with an aged systemthat is unable to accommodate electronic ordering or true electronic resulting, with limitedvendor support delivered from the southern hemisphere. Option 3 would enable BloodSciences and Microbiology to upgrade to a system which meets the requirements outlined insection 2, and provides Pathology with a system supported beyond 2016 – this is thepreferred option in terms of procurement, implementation and support as it brings significantoperational benefits both to the laboratories and also to the eHealth team who will supportand develop its integration into the existing and future organisation-wide systems.

Option 4 has many of the benefits of option 3 but procurement, implementation andassociated support costs would be more complex. Option 5 would only be feasible ifMedipath were upgraded to the latest version, one that is supportive of order comms andmultiple interfaces with modern platforms and systems, along with the level of supportprovided being increased too. Option 6 would require as much training of staff as options 3and 4, without the control of future direction of service.

The options appraisal identified that replacing the current dual LIMS with a unifiedLIMS from a single provider was the preferred and best practice option. This will allowfor the maintenance of service delivery across all laboratory disciplines, facilitate theswitch to electronic ordering that would allow requestors to reduce reliance onmanual transcription and thereby enhance quality, effectiveness and efficiency ofservice throughout the spectrum from request to diagnosis to treatment.


5. Indicative Costs

Indicative costs are shown below, based NHS Lanarkshire’s proposal. Although broadlyequivalent in terms of laboratory services and multi-site delivery to a mix of primary andsecondary care, it is not representative of the geography or specific operational requirementsof NHS Highland and the costs are therefore provided for illustrative purposes only. Enteringa joint procurement exercise with NHS Western Isles would reduce the capital and revenuecommitment required from NHSH by approximately 10%, in line with the PartnershipAgreement between the two organisations.

Revenue savings associated with the implementation are shown below. These arepredominantly comprised of reduction in headcount of Medical Laboratory Assistants (MLAs)and A&C staff, both in the laboratory and wider hospital setting (the latter involved indelivering paper reports to requesting clinicians), the exact amounts being dependent onwhich laboratories ‘go live’ first; Blood Sciences has a current establishment of 8.5WTEMLAs, Microbiology 10.29WTE, Pathology 2.6WTE therefore greater revenue savings willaccrue if Medipath were to be replaced before Ultra. Non-pay savings associated withreduced printing costs are also included.

Costs Procure newLIMS Systemfor allLaboratories

2013/14commitment

2014/15commitment

2015/16commitment

2016/17commitment

Capital (excluding VAT)

Purchase and interfacing ofmulti-lab system

£500K £250K £250K

Interfacing to eHealthsystems

£50K £50K

Hardware costs £150K £100K £25K £25K

Capital charges £42K £21K £20K £1KTotal Capital £742K £371K £345K £26K

Revenue

Software, hardware supportand licence

£170K £60K £60K £50K

Legal costs £10K £10K

Implementation costs £60K £30K £30K

Data transfer from currentsystems

£40K £20K £20K

Total Revenue Costs £280K £70K £110K £100K

TOTAL £1022K £441K £455K £126K

Revenue Savings(recurrent)

Cumulative (4years)

Laboratory staff (MLAs) £161K £23K £46K £92K

A&C staff (lab) £27K £5K £11K £11K

A&C staff (Raigmore) £44K £11K £22K £22K

Printing costs £25K £5K £10K £10KTotal Revenue Savings £257K £44K £89K £135K

Additional to the revenue savings identified above, estimations presented in Appendix Dshows that nearly 4000 working days per year are spent within NHSH Primary Care simplytransferring data from laboratory results into separate systems. This equates to 17.8 WTEinvolved in supporting the current inadequacies in the LIMS-Docman data transfer.


Any savings in primary care associated with implementation of the LIMS project would notoffset the associated capital and revenue commitments but would reduce the overall cost perreportable laboratory test.

6. Project Management

The NHS Highland eHealth Implementation Services Team has established a projectgovernance infrastructure in accordance with NHS Highland guidelines and using PRINCE2methodology and structure as source doctrine. The eHealth Implementation Services Teamare responsible, on behalf of the Laboratories Management team, for the ProjectManagement of this Business Case.

The Project is sponsored and led by the Laboratories Management Team with a strong focuson enabling benefits to patients and improvements in the service offered to Primary andSecondary care customers as well as any external agencies.

7. Equality and Diversity Impact

There are no equality and diversity issues anticipated with this proposal.

8. Benefits Assessment

The generic benefits expected of a Laboratory Information Management System for NHSHighland are detailed below.

1. To meet or exceed the current needs of the customer

The customer, whether GP Practice or secondary care department, is familiar with andrequires a certain level of service from the NHS Highland laboratories which mustcontinue to be met or exceeded to ensure their particular health care provision is notadversely affected.

2. To meet or exceed the needs of the user

The laboratory user, from consultant to data entry staff, provides a competent service toboth Primary and Secondary care using a LIMS functionality which must remain atpresent levels or be improved in order for the level of service provided to be maintainedor enhanced.

3. To represent value for money

Any LIMS should provide the expected or better functionality and service for the leastamount of expenditure.

4. To provide a continuity of service beyond 2016

As the pathology element of LIMS, provided by GE Ultra is due to expire in July 2016, areplacement system that meets or exceeds the needs of the customer and user must beprovided if the service is to continue beyond that date.


5. To improve specimen identification and tracking

A reported failing with the current systems, is the lack of uniformity and audit capabilityfor specimen identification and tracking.

6. To provide improved results reporting for GPs, including discrete values.

GP Practices report that extensive time is spent manually transferring laboratory resultsinto discrete values for entry into secondary systems. If a replacement LIMS option ischosen, then this would be a factored in feature.

7. To reduce the manual transcription component.

As reported by Highland GP Practices, and detailed at Appendix C, a great deal of timeis expended manually transcribing results data. If a replacement option is chosen, thenthis would be a factored in feature. Support for electronic order comms would negatethe need for laborious manual data entry at time of specimen booking.

The principal benefits for the preferred option of a unified replacement LaboratoryInformation Management System for NHS Highland are detailed at Appendix A.


9. Conclusion

The requirements for a suitably functioning LIMS are:

Accurate registration and management of samples and requests using electronicrequesting (including those elements provided by order comms)

Interfacing with, and control of, a wide range of analysers, automated platforms,printers and other external systems used in the performing and tracking of tests andsubsequent delivery of results

Scalability, allowing for inclusion of future diagnostic platforms, technologies such asimage capture and/or partner laboratories

The processing and quality control associated with the sample and reagent utilisation Production and authorisation of results, with flagging of abnormal results Production of a printed report as required, along with the electronic transfer of results

into SCI Store with onward transmission of discrete data values into other clinicalsystems (such as EDT for GPs)

Storage of all data associated with the above in line with regulatory requirements andfuture utilisation

The end of life notification for the Pathology LIMS system (provided by GE Ultra) means thata replacement must be sourced and implemented before February 2016, otherwise allPathology caseload (including that provided to partner organisations) will have to beoutsourced.

There is an opportunity to redress the shortfall in functionality of the Medipath system used inMicrobiology at Raigmore Hospital and Blood Sciences in Raigmore, Caithness General andBelford Hospitals at the same time as replacing the Pathology system and therecommendation is that a single supplier be commissioned to provide a multi-laboratory,multi-site solution. This would meet both the clinical requirements outlined earlier, along withenhancing the management tools available (such as demand management andmeasurement of KPIs) and facilitating the implementation of associated critical systems,particularly order comms and electronic resulting to both internal and external users.Recurrent revenue savings associated with electronic requesting and electronic resultstransmission to users would arise from reduction in staff resource needed for booking insamples and printing out and despatching reports

Should support be given to this business case the Laboratories, in conjunction with eHealth,will produce a specification describing their requirements in support of the tendering andprocurement process. Potential suppliers will be measured against their ability to deliver tothe organisational and laboratory level requirements to allow the benefits outlined earlier tobe delivered in full.


APPENDIX A TOREPLACEMENT LIMSBUSINESS CASE

LABORATORY INFORMATION MANAGEMENT SYSTEM (LIMS) OPTIONS APPRAISAL

The purpose of this document is to generate discussion on the future strategy of the ITprovision to support the laboratory service in NHS Highland. It is supplementary to Item 15on the NHS Highland eHealth Strategy Group meeting of 22 June 2011.

The plan is to take this appraisal to the eHealth Strategy Group, ask them to agree with therecommendations of the Laboratory IT Sub Group and to progress with the development ofthe associated Business Case.

This is section 5 of the outline Business Case for a replacement Laboratory InformationManagement System (LIMS) for NHS Highland.

The list of options is not exhaustive.

LONG LIST OPTIONS

The following options are in scope:

1. Do nothing (proceed with the existing systems).2. Replace GE Ultra.3. Replace both LIMS, GE Ultra and LRS MediPATH.4. Purchase Pathology module of MediPATH.5. Outsource the LIMS function to another Board (i.e. use the labs system run by

another Board and purchase support from them, similar model to NHS Orkney)

These are described in greater detail below.

1 DO NOTHING (PROCEED WITH THE EXISTING SYSTEMS)

BENEFITS

This option would not require any impact on the capital budget. No impact of implementation on the laboratory operation. Users familiar with using LIMS.

RISKS

GE are currently running down the support and services levels for Ultra since end oflife for North American and Asian customers by July 2013. This is beginning toimpact on NHS Highland. The Central Legal Office have been asked about thepossibility of litigation.

GE have listed the end of life for their product in the UK as 23 February 2016. Afterthis date Pathology will have no LIMS and the service will be unable to function.

MediPATH is currently supported by Last Resort Support (LRS) from Australia. Thesoftware has failed to meet the expectations of the users and laboratorymanagement. Significant investment would be required to reach an appropriate levelof functionality.

Medipath does not support Lab Links (electronic transfer of discrete values from SCIStore to GP Practices). As an interim measure, the EDT (Electronic Document


Transfer) project relays an image of the printed report into the GP Docman systems.No discrete values can be transmitted via this route and this is a GP requirement.

2 REPLACE GE ULTRA

BENEFITS

Impact of implementation would only affect the Pathology Department. (Histology,Non-Cervical Cytology and Mortuary).

Pathology Department would be able to maintain a service. Having recently undertaken the implementation of the current LIMS, there is expert

knowledge available and a wealth of lessons learned information.

RISKS

eHealth will still need to support two different LIMS. MediPATH is currently supported by Last Resort Support (LRS) from Australia. The

software has failed to meet the expectations of the users and laboratorymanagement. Significant investment would be required to reach an appropriate levelof functionality.

The last procurement took 5 years, as a result of a major supplier walking away at thecontract stage. There is a possibility that a new procurement would take as longresulting in Ultra being decommissioned prior to it’s successor being implemented.

The introduction of order comms would be more problematic. Medipath does not support Lab Links (electronic transfer of discrete values from SCI

Store to GP Practices). As an interim measure, the EDT (Electronic DocumentTransfer) project relays an image of the printed report into the GP Docman systems.No discrete values can be transmitted via this route and this is a GP requirement.

3 REPLACE BOTH LIMS (GE ULTRA AND LRS MEDIPATH)

BENEFITS

This would offer the greatest flexibility to allow the laboratory’s operation to run mosteffectively.

The benefits would include instigation of order comms and integration with otherlaboratory services.

In Microbiology many requests are pre-screened prior to testing which has had theeffect of reducing unnecessary requests and duplicate testing and has resulted insignificant savings. In contrast the workload in Blood Sciences is too high to pre-screen requests. A rule based order comms system would be beneficial in controllingworkload which in turn will result in savings.

LRS is based in Australia and has a small customer base with fourteen laboratories inAustralia and only one other user (Western Isles Health Board) in the northernhemisphere. Therefore current support is limited. Replacing MediPATH with a LIMSthat has more prevalence in the UK would be beneficial.

Currently any development in MediPATH requires NHS Highland requesting the work.LRS are not pro-active in keeping up with current NHS Scotland requirements.

In house support will only have to maintain one LIMS. Knowledge could therefore be more in depth. New data (addition of referring clinicians etc.) would only need to be entered

once. A LIMS that supports Lab Links could be purchased and would meet GP

requirements.


RISKS

This option would maximise our capital spend and create the greatest impact on alloperational areas.

The savings caused by efficiency gains would only be fully realised in an environmentwhere headcount reduction was possible.

No saving on revenue as an currently support costs are very cost effective. The last procurement took 5 years, as a result of a major supplier walking away at the

contract stage. There is a possibility that a new procurement would take as longresulting in Ultra being decommissioned prior to its successor being implemented.

Unless all data could be migrated from MediPATH there would be maintenance coststo be paid for the upkeep of a legacy system to access historical Blood TransfusionService records.

Unless a single pan-laboratory system was purchased, eHealth would have tosupport two or more LIMS. There would also be the likely increase in maintenancecosts from multiple suppliers over a single supplier.

4 PURCHASE PATHOLOGY MODULE OF MEDIPATH

BENEFITS

No anticipated disruption of the existing services in laboratories other than Pathology. This option would be cheaper in capital terms than replacing everything or replacing

Ultra directly.

RISKS

LRS is based in Australia and has a small customer base with fourteen laboratories inAustralia and only one other user (Western Isles Health Board) in the northernhemisphere.

Currently any development in MediPATH requires NHS Highland requesting the work.LRS are not pro-active in keeping up with current NHS Scotland requirements.

MediPATH has failed to meet the expectations of the users and laboratorymanagement. Significant investment would be required to reach this level.

Staff resourcing – specific skill sets within and out with the labs would be difficult torecruit/ get consultancy for or replace.

The introduction of order comms would only be possible if all disciplines upgraded tothe latest version of MediPATH, which would have an associated cost.

There would be limited benefits to Laboratories and the organisation unlessMediPATH was also upgraded for Microbiology and Blood Sciences as well asPathology.

MediPATH does not support Lab Links (electronic transfer of discrete values from SCIStore to GP Practices). As an interim measure, the EDT (Electronic DocumentTransfer) project relays an image of the printed report into the GP Docman systems.No discrete values are transmitted and this is a GP requirement.

The Pathology module of MediPATH has previously been reviewed and found to bedeficient in a number of key areas of functionality. Purchase of this system would bea retrograde step and negate the efficiencies created by the implementation of Ultra 2years ago. There would be an undoubted reduction in quality and an increase inclinical risk (patient identification errors etc). Staffing reductions since implementationwould need to be reversed to maintain Turn-Around-Times.


5 OUTSOURCE THE LIMS FUNCTION TO ANOTHER BOARD (I.E. USE THE LABSSYSTEM RUN BY ANOTHER BOARD AND PURCHASE SUPPORT FROM THEM).

BENEFITS

We would no longer be exposed to a shortage of technical expertise or if this werethe case it would not be exacerbated by the size of this organisation (NHS Highland).

We currently have infrastructure in place for this. This is currently modelled to allowNHS Tayside in Ninewells, Dundee access Ultra for the writing and authorisation ofCytogenetics reports.

We would have a greater leverage with our software supplier.

RISKS

We are unaware if another Board actually wants or has capacity to offer this service. The obvious candidates would be NHS Grampian, NHS Tayside, NHS Greater

Glasgow & Clyde – (other Boards are available) and NSS for Transfusion functions. Other Health Boards may not have the capacity to be able to undertake this. The local wishes of the Board would be of secondary consideration with the provision

of this service – we would have to accept a junior role in the decision making process. NHS Highland’s laboratory service provision will be negatively affected as a result of

having to use a LIMS that has been set up to suit the working practices of anotherHealth Board. None of the other systems offer the high level of functionality currentlyused in NHS Highland. This will result in a degradation in quality and reporting Turn-Around-Times.

As a consequence NHS Highland’s purchasing policies regarding analysers andreagents would need to flex to meet the needs of the host organisation.

If MediPATH is replaced in this process, there may be an associated cost in comingout of the Managed Service Contract with Siemens.

MediPATH does not support Lab Links (electronic transfer of discrete values from SCIStore to GP Practices). As an interim measure, the EDT (Electronic DocumentTransfer) project relays an image of the printed report into the GP Docman systems.No discrete values are transmitted and this is a GP requirement. If MediPATH is notreplaced then GP requirements are not met.

MARKET APPRAISAL

There are several LIMS currently for sale on the open market that offer pan-laboratorysystems. The companies with current UK sites include Integrated Software Solutions;Sunquest, Intersystems, Cerner, Sysmex, iSOFT and CliniSyS.

Supplier UK NHS CustomersOmnilab (IntegratedSoftware Solutions)

Addenbrooke’s HospitalBirmingham Children’s HospitalGreat Ormond Street HospitalNorth Tees – Hartlepool HospitalsDoncaster and Bassetlaw HospitalsStates of Jersey Hospital

Sunquest Royal Liverpool and Broadgreen University Hospitals NHS TrustUniversity College London Hospital NHS TrustNorfolk and Norwich University Hospitals NHS TrustCentral Manchester Healthcare TrustPreston Acute Hospitals NHS TrustBarnsley District General Hospital NHS TrustWest London Pathology Consortium (Hammersmith, CharingCross, Chelsea & Westminster, St Mary's Hospitals)United Leeds Teaching Hospitals NHS Trust


Bradford Hospitals NHS TrustUnited Birmingham Hospitals NHS Trust

Intersystems Pan – Wales. 18 laboratories across 7 Boards for a population of3 million.

HNA MillenniumPathNet (Cerner)

Wirral University Teaching Hospital NHS Foundation Trust(currently on Ultra, but moving to PathNet)North West Hospitals NHS Trust (London)

MOLIS (Sysmex) The Walton Centre for Neurology and Neurosurgery (Liverpool)Warrington Hospital NHS Trust

APEX (iSOFT)(No longer marketed)

Multiple sites alsorunning Telepath

Aberdeen Royal Hospitals NHS TrustEast Cheshire NHS Trust (Macclesfield)Freeman Group of Hospitals NHS Trust (Newcastle upon Tyne)Leicester General Hospital NHS TrustGlenfield Hospital NHS Trust (Leicester)Leicester Royal Infirmary NHS TrustWestern General Hospitals NHS Trust (Edinburgh)Royal Infirmary of Edinburgh NHS TrustPinderfields (Wakefield) & Pontefract Hospitals NHS TrustJames Paget Hospital NHS Trust (Great Yarmouth)West Suffolk Hospitals NHS Trust (Bury St Edmunds)Chesterfield & North Derbyshire Royal Hospital NHS TrustNorth Middlesex Hospital NHS TrustSurrey & Sussex healthcare NHS Trust (Crawley & Redhill)PathLinks (Grimsby, Scunthorpe, Boston, Lincoln and Grantham)

WinPath (CliniSys) East London Consortium (Homerton, Newham, Barts and theLondon)Kingston Hospital NHS TrustRichmond Twickenham & Roehampton Healthcare NHS TrustNorth Hampshire Hospitals NHS Trust (Basingstoke)Royal Brompton Hospital (London)The Royal Marsden NHS TrustWinchester & Eastleigh Healthcare NHS TrustSwindon & Marlborough Hospital NHS TrustRoyal Free Hampstead NHS Trust (London)Nottingham Group of Trusts (University Hospital NHS Trust,Nottingham City Hospital NHS Trust, Sherwood Forest HospitalsNHS Trust)King’s College Hospital NHS Foundation Trust (London)

Most data correct as of November 2009. It is believed that they are still currently marketingtheir software.

There are other companies supplying pan-laboratory LIMS in Europe and they includeAutoscribe, Labware and Swisslab. Meditech supply a fully integrated LIMS, however, theyhave no UK LIMS customers only 14 customers of Meditech’s EPR system.

Sunquest bought Misys which were the original preferred supplier of the Pathology LIMS.They withdrew due to their unwillingness to meet NHS Scotland IT requirements at the time.This requirement has now been rescinded.

Intersystems supply the TrakCare Lab LIMS which is a module of the National PMS that isbeing rolled out. Go Live for the pan Wales system starts in February 2012.


COST

This section would review the capital cost of replacing the LIMS (single or both) and thesubsequent revenue costs.

The capital purchase cost for Ultra was £550K. The current maintenance cost for MediPATH is approx £25K a year excluding licence

costs (TBC). The maintenance of Ultra cost £37,428.88 for the year April 2010-11. Any anticipated savings as a result of the various options will be listed, although it is

difficult to confirm how much purchase and maintenance of a completely new LIMS(not MediPATH) would be.

There may be cost implications and other complications if transfusion functions aresupplied by NSS/SNBTS – also provides patient safety elements that would not beavailable if Highland uses an independent IT system for transfusion

RISK APPRAISAL

Whichever option is decided upon, there will be common risks involved. These include:

The upcoming loss of critical resources including staff. Some staff involved in the implementation of the GE Ultra LIMS have already left

NHS Highland. Others involved are currently awaiting retiral dates. Staff with knowledge of the LRS MediPATH LIMS are also in a similar position. None of this takes into account staff who may leave for other employment. Key personnel need to be identified.

Backfill required to facilitate planning, specification and implementation There are significant risks regardless of which option is approved especially with the

migration of data to a new system. Wirral UTH NHS Foundation Trust is moving from Ultra to PathNet because it is the

laboratory system owned by Cerner who supply them with an enterprise solutioncovering the whole hospital. They are unhappy with this move as it gives them adrastic reduction in functionality from Ultra.

APPENDIX B TOREPLACEMENT LIMSBUSINESS CASE


Benefits Analysis

QualityDimensions:Safe - Patient safety is increased

Efficient - Use of resources is maximised

Effective - Positive patient outcomes are increased

Timely - Waiting times for care are reduced

Patient-centred - Patients are involved in their care

Equitable - Accessibility to care is increased

Ben

efi

tID

Quality Dimensions

Benefit description

Who willreceive the

benefitLikelihood Impact

Priorityscore

Fin

an

cia

l

Safe

Eff

icie

nt

Eff

ecti

ve

Tim

ely

Pati

en

t-C

en

t.

Eq

uit

ab

le

H= NHSHS= Staff

P=Patients

(5= high,3=med.,1=low)


(likelihood ximpact)

1X X X

Provides a faster and more accurate service to thepatients including improved turnaround times. S & P

5 5 25

2

XProvides support to enable NHSH to be at theforefront linking with partners as part of thepartnership strategy

H

4 5 20

3

X XSupports and streamlines the processes involved inperforming tests and services for institutions eitherwithin or outwith NHSH

H & S

5 4 20

4X X

Contains systems to allow NHSH to promote itsservices to external organisations. H & S

4 4 16


5

X X

Ability for the vast majority of laboratory activity to berecorded and maintained on a single robust andreliable infrastructure

S

5 5 25

6

X X

Easier to use, more flexible and intuitive allowing forstreamlining of processes to accommodateincreasing workload without requiring a pro-rataincrease in staff, thereby increasing operatingefficiency as well as potentially aiding staff retentionby removing hindrances to their work

S

5 4 20

7

X X

To make it easier for staff to cross train and work inall laboratory areas across NHSH as the servicedevelops by establishing a common look and feel tothe system. This too could aid staff retention asredeployment or staff rotation would become morefeasible

S

3 5 15

8

X

Flexible enough to facilitate service re-configurationas appropriate, allowing the seamless transfer oforders and results between clinical locations andprocessing sites both within and external to NHSH

H & S

5 5 25

9X

Removes any IT-related barriers to cross-departmental methods of service development S

4 4 16

10

X X X

An Industry standard system which will be able easilyand economically to interface to external systems(order comms, PMS, GP and other primary caresystems etc) allowing bi-directional informationtransfer

S

5 5 25

11

X X

To allow costs (pay and non-pay) to be attributed toall aspects of the diagnostic testing process insupport of an activity based costing approach tobudgetary management

H & S

4 4 16

X

12X

Scalable in ongoing additions of analysers and otherhardware/software requiring interfacing S

4 4 16


13

X X X

Demonstrates functionality that at least and in manycases exceeds modern Laboratory Good Practiceguidelines

S

4 5 20

14

X

Develops and enhances current LIMS functionalities,building on previous developments (to be defined in astringent specification)

S

4 5 20

15

X X

Utilises highly developed rules based systems topromote good clinical practice and to ensureappropriate testing of the patient (including demandmanagement). Some of this functionality will residewithin NHSH systems but in some sections (inparticular the more specialised areas) clinicians relyon the laboratory to select the testing profile as theyhave a greater experience

S & P

5 5 25

16

X X

To allow for the production of more comprehensiveand complete management and clinical information ina timely manner. To be less resource intensive,enabling a wider range of queries to be run for whichthere is no staffing capacity currently

H, S & P

4 4 16

17

X X

To achieve as much as possible a “paperless”system within Laboratories as well as in theirinteractions throughout NHSH, including primary care

H & S

4 5 20

X

18

X

To conform to CPA standards (better auditinformation for example) and close the numerousgaps in the current systems audit capabilities

H

5 5 25

19

X

To facilitate Laboratory systems being compliant withany legal requirements such as European UnionBlood Tracking Directives as specified by the MHRA

H & S

5 5 25

20

X

To ensure more robust back up facilities (data losscaused by a major disaster) - using moderntechnology it will be possible to restore the system ina much more efficient and timely manner resulting inminimum downtime.

H & S

5 5 25


Taking up the option of a remotely hosted systemtransfers much of the risk associated with having thetraining and equipment to perform disaster recoveryto the party hosting the system

21X

To reduce maintenance/repair costs of propping upan ageing system with ad hoc expenditure H

5 5 25X

22

X X

In conjunction with a modern PMS, diagnostic reportswill be made available to treating clinicians muchmore quickly and comprehensively

P

5 5 25

23X

Plugs current data gaps by receiving improvedclinical information for other systems e.g. PMS S & P

5 5 25

24

X X

Chain of custody: allow for auditable ownership andresponsibility for samples and requests at pre-analytical, analytical and post-analytical phases ofthe processing

S & P

5 5 25

25

X X

Allows laboratory based clinicians to view, commenton and report together all patient’s results. S

5 4 20

26

X X

Allows clinical staff to view results securely (resultscan be graphed to show trends and images can beattached to reports)

S & P

4 5 20

27

X

Rules based system ensures the Laboratory aspectsof any protocols or care pathways are followed i.e.requesting protocols and the ability to makeappropriate comments on results

S

4 4 16

28

X

Compliance with national guidelines: British SocietyFor Clinical Cytology (BSCC) “Requirements for theCytopathology Component of a Laboratory ComputerSystem”, the Pritchard Report and the BSCC“Recommended Code of Practice for laboratoriesproviding a Cytopathology Service of 1997”. It alsofully complies with Data Protection legislation andCaldicott Guidance

H & S

4 5 20


29

X

Development of Cancer and Royal College Minimumdata sets: Reports can be developed that utilise theRoyal College of Pathologists and National Cancerminimum data sets. This will make the data collationprocess easier and enable better benchmarking datadue to consistent data assumptions applied throughthe UK

H & S

4 5 20

30

X

Support for SNOMED-CT clinical terminology: TheLIMS solution will support the use of SNOMED CTfor the unambiguous identification of clinical conceptssuch as diseases, findings, and procedures.Integration with other clinical services will then bepossible, providing a standard terminology for clinicalreporting and governance

H & S

4 5 20

31

X

Definition of Standard Operating Procedures:“Standard Operating Procedures” can be defined andmodified. These enable laboratories to meet theirobligations for CPA by providing a standard formatfor the documentation and publication of a definedstandard for working practice

S

4 4 16

32

X X X X

Blood Stock Management: Management of bloodproducts and their stock control with interfaces to theScottish National Blood Transfusion Service(SNBTS)

S

5 4 20

33

X X

Interfaced to the Health Protection (Scotland) systemfor the notification of infectious diseases as part of aHospital-based Infection Control system

H & S

4 5 20


APPENDIX C TOREPLACEMENT LIMSBUSINESS CASE

RISK ANALYSIS

RISKPotentialImpact ofRisk (a)Low 1 –

High 5

Likelihoodof Risk

Escalating(b)

Low 1 – 5High

Score

(axb) QUALIFICATION

Annual support costs for replacement LIMS potentially higher than withprevious system.

5 4 20 Support costs with MediPath are reflected in the limitedfunctionality and lack of development. A unified system thatreplaces both Medipath and GE Ultra is most likely to incur ahigher support cost.

Failure to upgrade MediPath 5 4 20 The financial benefits associated with replacement of MediPathimpinge on services out with laboratories, notably primary care.These cannot be realised without implementing a system thatsupports electronic requesting and transfer of discrete results,with associated reduced reliance on administration staff

Extended developmental timeframe 5 4 20 A large multi-laboratory IM system may well require adevelopmental timeframe that could impact on the deadline ofFebruary 2016.

Additional training burden with replacement system 4 4 16 The training burden will be unknown until the agreed system ischosen.

Potential maintenance costs associated with the provision of a legacysystem to allow access to historical blood transfusion records

5 3 15 There is a likelihood that historical blood transfusion recordsheld in Medipath may not be able to migrate into a replacementsystem. Accordingly, an additional system with associatedsupport costs may be required. This cannot be verified until thefunctionality of the agreed system and interface practicalities areknown. A paper copy of all records mitigates the risk

Potential requirement for separate storage of historical data 5 3 15 This cannot be verified until the functionality of the agreedsystem and interface practicalities are known.


APPENDIX D TOREPLACEMENT LIMSBUSINESS CASE

NHS HIGHLAND HIGH LEVEL REPLACEMENT LIMS IMPLEMENTATION PLAN

Activity/Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

Phase 1 - Research and procurement

Produce LIMS specification

Negotiate with potential suppliers

Establish final specification and cost

Evaluate systems and establish supplier

Negotiate contract

Procure preferred solution

Inform all stakeholders and customers

Phase 2 - Implementation

System installation

Process and documentation

Initial Training

Database set up

Develop interfaces and data migration

Prepare Order Communications

Test system

Train users

Phase 3 - Operation

Go live

Evaluate system operation


APPENDIX E TOREPLACEMENT LIMSBUSINESS CASE

Dear GP Practice Manager.

A business case is currently being drafted by the Laboratory manager to explore the possibilities and costs involved in the procurement of a new laboratory systemfor NHS Highland. Were this business case to get a positive reception from senior management one of the absolutes in the specification would be that any newsystem should be able to transfer the discreet values of laboratory results to GP practice systems. This would reduce greatly the amount of manual input workassociated with laboratory results.

In order quantify and support this as a benefit to GP practices it would be useful to quantify the amount of time that GP practice staff currently spend transcribinglab result values into your practice system. I would therefore be grateful if you would be so kind as to complete the attached form to allow the laboratoryManager to use this information in the Business case.

REPLACEMENT LIMS BUSINESS CASE - GP PRACTICE QUESTIONNAIRE RETURNS

GP PRACTICE ID Hrs/Day Hrs/Wk COMMENTS

1 Canisbay & Castletown Group Practice 55080 4 20 None

2 Tweeddale Medical Practice 55624 2 10 Include an electronic sample request facility for practices. Include riskmanagement reports e.g. sample requested and not received at lab or lab reports aresult but it is not received at the practice. Include risk management reports e.g.sample requested and not received at lab or lab reports a result but it is notreceived at the practice. Include option to record reason for sample or a commentand to have this displayed on incoming results. Results out with normal lab rangesto be highlighted in red in incoming mail & clinical system.

3 Ullapool Medical Practice 55451 5 25 This would greatly enhance patient safety as it would remove the possibility ofhuman error in entering test results.

4 Aird Medical Practice 55696 2 10 It would be very helpful to have results automatically populating the clinical systemin Highland as I believe this is what happens throughout the rest of Scotland.

5 Armadale Medical Practice 55183 1.5 7.5 None


6 Dunbeath 55075 2 2 Approximately 2 hours of staff time (list size 530) plus extra 15-20 minutes GP timeclicking button "add to records"

7 Lybster Medical Centre 55094 6 6 The process of inputting the information into the practice systems is quite difficultas you have to work between 2 different screens. This means it can easily lead toinputting the wrong values into the patient's record.

8 Kingussie Medical Practice 55930 1 5 None

9 Culloden Medical Practice 55766 7 We currently use DOCMAN EDT so the entire process is electronic and fairlyefficient as it stands.

10 Tain and District Medical Group 55427 1 6 I think it would be very helpful to circulate the suggestions around the practicesbecause it may trigger thoughts from other practices. One of the main things wewould like is access to measurements etc taken in hospital and OP clinics – e.g. allpatients attending for clinics are asked for their smoking status, given advice aboutstopping etc, additionally they are all weighed and BPs checked. I’m not sure whatblack hole of information this goes into but if all of these things could wend theirway back to us this would be great

11 Small Isles Medical Practice 55677 2 2 None

12 Kinlochleven Medical Practice 55639 1 We spend only 15 minutes approx putting lab results onto our GP system. Most ofthe results are posted to us electronically and this saves us time. So on average wespend less than an hour a week inputting data on the system.

13 Portree Medical Centre 55573 4 20 The Safety Improvement in Primary Care took this forward as a project in phase 2and NHS Borders undertook this work. I don’t know the outcome but if you contactNeil Houston he may be able to give you some additional information to supportthe business case from a safety perspective. [email protected] are huge concerns, with the current system: duplication of work,transcribing /transposing errors, values don’t always go in against the date that thetests were taken so it can look as it test results are missing or duplicate tests havebeen ordered, human error – wrong read codes used e.g. recent change fromHbA1C to new codes, Time delay in getting results into clinical system and Missingtests or results.Please tell me that you are looking at a complete order comms system and not justone that reports. A full order comm would be beneficial to the labs as it wouldallow them to know what work is coming in, and management.


14 Riverview Practice 55131 2 Unfortunately it is difficult for us to quantify this as we only enter pertinent resultsand values required for QOF and enhanced services. We do not enter all results.Therefore the amount of time spent on this depends on several factors: time ofyear, what recalls we are working on and obviously number of other bloods taken.A laboratory system that populated our clinical system in some way would be veryuseful though!

15 Dunedin Medical Practice 56011 3.5 17.5 None

16 Golspie Medical Practice 55220 6 None

17 Thurso and Halkirk Medical Practice 55003 3.25 17 It was in the early 1990s that we first raised the subject of being able to receiveresult values direct into our GP clinical systems. We have always believed that thiswould be a huge step forward from a patient safety point of view and theconsequent saving in admin time. We are pleased that the option is now beingexplored.

18 Dornoch Medical Practice 55201 1 5 None

19 Prison 0 0 unknown still waiting for Docman to be set up in the prison

20 Culloden Surgery 55751 2 10 This project is long overdue and in comparison to other health boards in Scotland,NHS Highland is way behind. It is not just time saved in General Practice but anissue of patient safety - as the number of steps grows in any process so does therisk of human error. Having lab results going directly into our clinical systems willnot only save valuable time but also reduce the risk of error. For the above reasonsthis has to be a high priority area.

21 Fortrose Medical Practice 55381 5 25 LabLinks would obviously remove a huge burden of rather boring work from ourstaff and would eliminate the risk of human error. As the last health board to offerthis service to link directly with GP systems I think it is long overdue and wouldfinally bring us up in line with all other GP practices.

22 Kinmylies Medical Practice 55860 0.5 2.5 None


23 Glenelg Health Centre 55554 1 5 The administration staff will scan in or file EDT lab results for work flow daily. Thistime can vary anything from 10 mins to an hour depending on amount/number ofpatients and number of lab results received. The GP on average can then take10ish mins per patient just inputting the data from multiple lab results into visionalone before contacting patients with results and writing notes. On average wemight have 4 - 5 patients with lab results in a morning.

24 Brora and Helmsdale Medical Practice 55287 2 14 Staff inputting results to patient notes is open to mistakes being made enteringwrong values and entering to wrong patient.

25 Assynt Medical Practice 55253 1 4 None

26 Craig Nevis Surgery 55605 3 15 None

27 Riverside Medical Practice 55841 1.5 7.5 The numbers above are based on my average manual input speed of 70 labdocuments per hour, 500 documents per week. To make things easier and fasterfor myself I’ve developed an app (written in AutoIt) which has increased my speedby 13% in addition to other benefits. As you know, it is not enough for discrete testresults to end up in the clinical system. Results, even if they are normal, oftentrigger other actions (i.e. in our Practice low eGFR requires a CKD form to beprinted, filled and passed to the relevant doctor, abnormal Glucose is re-routed toour Diabetic Nurse, HbA1c required additional ReadCode for annual review to beadded, and so on). All these actions can be triggered and at least semi-automatedby the system, which my app does. From my point of view there is a huge potentialin making computers do more of our human work, or at least make it easier andfaster. I’m sure the new system you’re exploring now is worth developing, so if youthink our Practice can help with your project, please don’t hesitate to contact us.

28 Riverbank 55037 1.5 7.5 None


29 Aultbea and Gairloch Medical Practice 55357 2 10 Any Business Case should not be just based on this estimate, as it needs to bejustified against the additional administrative and clinical workload of anyreplacement system. This is at present an unknown.The Business Case should be instead justified on the following points:1. Clinical Governance - The existing Highland primary care results model reliesupon manual transcription of result values, comments and value limits by non-clinical staff. This is potentially unsafe and can lead to significant patient harm dueto human error.2. Inconsistency - Different practices code different values based on localpreference. This leads to a combination of manual and electronic results decisionmaking, which will be made worse once GP to GP transfer of Read codes isintroduced in Scotland.3. Archaic systems - It is clear the current lab system is well beyond its useful lifeand is often quoted as the reason in Highland why things cannot be done, changedor improved. The majority of other UK health boards have had an electronic resultsservice for many years. It is time for Highland to attempt to catch up.

30 Grantown Medical Practice 55925 0.5 3.75 At this practice we do not code every single result which comes in, although I amaware in other practices that they do and so they will have additional time savings(and we will have additional benefit). With EDT we have found our error rate(misfiling) has been virtually eliminated because of the automatic tagging of clinicalcorrespondence, and consistency of information has been better because thetemplates used are automatically selected. I would expect we would get a similarresult from an automated results system as the element of human choice in whereto record data is taken away. We made savings in admin hours when we went fullylive on EDT and I would expect a similar benefit from automated results coding.Finally, automated data entry removes an element of clinical risk which is always agood thing.


31 Glen Mor Medical Practice 55610 5 The current system also "loses" the clinical data input by the clinicians / lab staff.This used to be very useful in helping determine the route of the result - e.g.diabetic screening or CKD monitoring could be sent to a group of recipientssimultaneously. We still have to write this on the lab forms but it doesn't appearon the result, even though I understand the lab staff can still enter it into thesystem it gets suppressed and not printed on the result. Consequently a singleresult for diabetic screening could go to the registered GP instead of the Diabeticclinic nurse Diabetes GP. That means one GP who didn't want the result in the firstplace has to open it, read it and forward it to the correct recipients. Hugelyretrograde step and adds unnecessary delay to processing results at the practice.Manually keying results will always have an inherent risk and it is possible that anincorrect entry could lead to incorrect interpretation and treatment, therebyimpacting on patient safety.Moving from an image-based system to a data transfer would also open up thesystem to more flexibility for audit by 3rd parties and may provide a strongresearch tool.

32 Nairn Healthcare Group 55041 6 30 I’m told by our Docman lead that this is generally around 6-8 hours of work per day,depending on the volume of results & the skill of the individual entering – we arethe largest practice in the Highlands now, at 14.5k patients, so this will be at thetop end of the scale, I’d expect. It would be great to free up such resource at thepractice, especially given the additional pressures that we’re facing in various wayswith cuts to our income streams & the expectation that we take on more & moreun-resourced work. However, one thing that is difficult to measure is the value inincreased patient safety. We have had a significant event analysis in the last coupleof months that revolved around incorrect data being entered manually from a labresult, which could have ended up causing our patient significant harm. I do hopethat this is a big consideration when making the decision around whether toadvance with a new system in the labs.

33 55874 2 10 None

34 Dunvegan Medical Practice 55535 0.5 2.5 We are only a small practice of 1650 patients, hence the relatively small amount oftime we spend on this each day

35 Lochcarron 55395 1 5 None

36 Lairg Medical Practice 55249 0.5 4 None


TOTAL HOURS 73.25 303.25

EST AVERAGE TOTAL (67 GP Practices) 136.326 564.382

EST AVERAGE CUMULATIVE ANNUAL HOURS 29347.9

EQUATES TO WORKING DAYS/YEAR 3913.05

Number of Practices Contacted 67 Notes:If the Practice Manager has provided a range of estimated hours, the lower valueshave been inserted.

Number of returns received 36

Response 53%

Values in red are extrapolated minimums based on respondent's text.

1

LABORATORY INFORMATION MANAGEMENT SYSTEMS BUSINESS CASE

Background

The business case supporting the replacement of the NHS Highland Laboratory InformationManagement Systems (LIMS) was presented at the December 2012 Asset ManagementGroup meeting, following its ratification by the eHealth Strategy Group on October 30th 2012.The benefits and risk analysis are shown in the accompanying appendix.

Funding

Costs contained within the Business Case are indicative and are used for illustrativepurposes only. The funding stream for this proposal lies within the existing eHealth capitalallocation built into their five year plan. Implementation and therefore funding can be phased,commencing with the Pathology module of the chosen system, to allow flexibility and spreadof financial commitment over financial years 2013/14, 2014/15 and 2015/16.

Alex Javed

Service Manager – Laboratories and Radiology

APPENDIX A TOREPLACEMENT LIMSBUSINESS CASE

2

Benefits Analysis

QualityDimensions:Safe - Patient safety is increased

Efficient - Use of resources is maximised

Effective - Positive patient outcomes are increased

Timely - Waiting times for care are reduced

Patient-centred - Patients are involved in their care

Equitable - Accessibility to care is increased

Quality Dimensions

Ben

efi

tID

Benefit descriptionWho will

receive thebenefit

Likelihood ImpactPriorityscore

Fin

an

cia

l

Safe

Eff

icie

nt

Eff

ecti

ve

Tim

ely

Pati

en

t-C

en

t.

Eq

uit

ab

le



(likelihood ximpact)

X X

1 Provides a faster and more accurate service tothe patients including improved turnaroundtimes.

GPs,2ndarycare,patients

5 5 25

X

2 Provides support to enable NHSH to be at theforefront linking with partners as part of thepartnership strategy

4 5 20

X

3 Supports and streamlines the processesinvolved in performing tests and services forinstitutions either within or outwith NHSH

X4 Contains systems to allow NHSH to promote its

services to external organisations.

3

X X

5 Ability for the vast majority of laboratory activityto be recorded and maintained on a singlerobust and reliable infrastructure

X

6 Easier to use, more flexible and intuitiveallowing for streamlining of processes toaccommodate increasing workload withoutrequiring a pro-rata increase in staff, therebyincreasing operating efficiency as well aspotentially aiding staff retention by removinghindrances to their work

X X

7 To make it easier for staff to cross train andwork in all laboratory areas across NHSH as theservice develops by establishing a commonlook and feel to the system. This too could aidstaff retention as redeployment or staff rotationwould become more feasible.

X

8 Flexible enough to facilitate service re-configuration as appropriate, allowing theseamless transfer of orders and resultsbetween clinical locations and processing sitesboth within and external to NHSH

X9 Removes any IT-related barriers to cross-

departmental methods of service development

X X X

10 An Industry standard system which will be ableeasily and economically to interface to externalsystems (order comms, PMS, GP and otherprimary care systems etc) allowing bi-directionalinformation transfer

11 To allow costs (pay and non-pay) to beattributed to all aspects of the diagnostic testingprocess in support of an activity based costingapproach to budgetary management

X

4

X12 Scalable in ongoing additions of analysers and

other hardware/software requiring interfacing

X X X

13 Demonstrates functionality that at least and inmany cases exceeds modern Laboratory GoodPractice guidelines

X

14 Develops and enhances current LIMSfunctionalities, building on previousdevelopments (to be defined in a stringentspecification)

X

15 Utilises highly developed rules based systemsto promote good clinical practice and to ensureappropriate testing of the patient (includingdemand management). Some of thisfunctionality will reside within NHSH systemsbut in some sections (in particular the morespecialised areas) clinicians rely on thelaboratory to select the testing profile as theyhave a greater experience

X X

16 To bring the support and development ofeHealth product specialists together on onesystem, giving less reliance on key individualsand providing economies of scale in areas suchas adding new sources and tests, codemaintenance, out of hours support

X

17 To allow for the production of morecomprehensive and complete management andclinical information in a timely manner. To beless resource intensive, enabling a wider rangeof queries to be run for which there is nostaffing capacity currently

X

18 To achieve as much as possible a “paperless”system within Laboratories as well as in theirinteractions throughout NHSH, includingprimary care

X

5

X

19 To conform to CPA standards (better auditinformation for example) and close thenumerous gaps in the current systems auditcapabilities

NHSH

X

20 To facilitate Laboratory systems beingcompliant with any legal requirements such asEuropean Union Blood Tracking Directives asspecified by the MHRA

X

21 To ensure more robust back up facilities (dataloss caused by a major disaster) - using moderntechnology it will be possible to restore thesystem in a much more efficient and timelymanner resulting in minimum downtime. Takingup the option of a remotely hosted systemtransfers much of the risk associated withhaving the training and equipment to performdisaster recovery to the party hosting thesystem

X22 To reduce maintenance/repair costs of propping

up an ageing system with ad hoc expenditureX

X

23 In conjunction with a modern PMS, diagnosticreports will be made available to treatingclinicians much more quickly andcomprehensively

X24 Plugs current data gaps by receiving improved

clinical information for other systems e.g. PMS

X

25 Chain of custody: allow for auditable ownershipand responsibility for samples and requests atpre-analytical, analytical and post-analyticalphases of the processing

X

26 Allows laboratory based clinicians to view,comment on and report together all patients’results.

Labs staff

6

X

27 Allows clinical staff to view results securely(results can be graphed to show trends andimages can be attached to reports)

X

28 Rules based system ensures the Laboratoryaspects of any protocols or care pathways arefollowed i.e. requesting protocols and the abilityto make appropriate comments on results

X

29 Compliance with national guidelines: BritishSociety For Clinical Cytology (BSCC)“Requirements for the CytopathologyComponent of a Laboratory Computer System”,the Pritchard Report and the BSCC“Recommended Code of Practice forlaboratories providing a Cytopathology Serviceof 1997”. It also fully complies with DataProtection legislation and Caldicott Guidance

X

30 Development of Cancer and Royal CollegeMinimum data sets: Reports can be developedthat utilise the Royal College of Pathologistsand National Cancer minimum data sets. Thiswill make the data collation process easier andenable better benchmarking data due toconsistent data assumptions applied throughthe UK

X

31 Support for SNOMED-CT clinical terminology:The LIMS solution will support the use ofSNOMED CT for the unambiguous identificationof clinical concepts such as diseases, findings,and procedures. Integration with other clinicalservices will then be possible, providing astandard terminology for clinical reporting andgovernance

7

X

32 Definition of Standard Operating Procedures:“Standard Operating Procedures” can bedefined and modified. These enablelaboratories to meet their obligations for CPA byproviding a standard format for thedocumentation and publication of a definedstandard for working practice

X X X

33 Blood Stock Management: Management ofblood products and their stock control withinterfaces to the Scottish National BloodTransfusion Service (SNBTS)

X

34 Interfaced to the Health Protection (Scotland)system for the notification of infectious diseasesas part of a Hospital-based Infection Controlsystem

8

APPENDIX B TOREPLACEMENT LIMSBUSINESS CASE

RISK ANALYSIS

RISKPotentialImpact ofRisk (a)Low 1 –

High 5

Likelihoodof Risk

Escalating(b)

Low 1 – 5High

Score

(axb) QUALIFICATION

Annual support costs for replacement LIMS potentially higher than withprevious system.

5 4 20 Support costs with Medipath are reflected in the limitedfunctionality and lack of development. A unified system thatreplaces both Medipath and GE Ultra is most likely to incur ahigher support cost.

Extended developmental timeframe 5 4 20 A large multi-laboratory IM system may well require adevelopmental timeframe that could impact on the deadline ofJuly 2016.

Additional training burden with replacement system 4 4 16 The training burden will be unknown until the agreed system ischosen.

Potential maintenance costs associated with the provision of a legacysystem to allow access to historical blood transfusion records

5 3 15 There is a likelihood that historical blood transfusion recordsheld in Medipath may not be able to migrate into a replacementsystem. Accordingly, an additional system with associatedsupport costs may be required. This cannot be verified until thefunctionality of the agreed system and interface practicalities areknown. A paper copy of all records mitigates the risk

Potential requirement for separate storage of historical data 5 3 15 This cannot be verified until the functionality of the agreedsystem and interface practicalities are known.

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APPENDIX C TOREPLACEMENT LIMSBUSINESS CASE

NHS HIGHLAND HIGH LEVEL REPLACEMENT LIMS IMPLEMENTATION PLAN

Activity/Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

Phase 1 - Research and procurement

Produce LIMS specification

Negotiate with potential suppliers

Establish final specification and cost

Evaluate systems and establish supplier

Negotiate contract

Procure preferred solution

Inform all stakeholders and customers

Phase 2 - Implementation

System installation

Process and documentation

Initial Training

Database set up

Develop interfaces and data migration

Prepare Order Communications

Test system

Train users

Phase 3 - Operation

Go live

Evaluate system operation

Documents

5.6 Lab Information System Business Case-APP1€¦ · The existing Laboratory Information Management System (LIMS) within these three sites comprises of: LRS Medipath (Blood Sciences