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Board of Directors Meeting

Date: 28 May 2008

Agenda item: 7.1, Part 1

Title: Pathology IT System Business Case

Prepared by: Liz Boylan, IT Systems Project Manager

Presented by: Mike Stevens, Director of Finance & Business Development

Action required: Board to consider the business case and give approval to proceed to procurement

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Pathology IT System Business Case

Board Report 28 May 2008 of 2

1. PURPOSE

1.1 This paper sets out the proposals to replace the existing Pathology IT system (EDS Systems) with a new system (Clinisys)

2. BACKGROUND

2.1 The Trust has for many years operated a range of systems supported by EDS Systems. These systems originated from the former South West Regional Computer Centre which was subsequently sold to EDS Systems.

2.2 As a result of the contract award for the National Programme for IT, many of these systems are no longer being developed to meet current and future user requirements and are on a ‘care and maintenance’ basis only. EDS has given formal notice they will no longer support the Pathology system beyond December 2008 and although this date may be extended to a limited extent, the cost of support will escalate as the cost falls on an ever smaller user base.

3. KEY ISSUES

3.1

3.2

The identification of a replacement system has been undertaken by the Acute Trusts within the Peninsular (with the exception of Plymouth) acting together under the auspices of the Peninsular Pathology Network and have selected a single system for use across the Peninsular.

After much consideration the system selected is marketed by Clinisys. This system is already sold as a ‘non core’ application through the National programme for IT by BT and has therefore already been subjected to a competitive tendering process. The added advantage of this system is that it will be readily interfaced to the Cerner Millennium clinical system being installed as part of the national programme.

4. PROPOSALS

4.1 It is proposed that the Trust proceed to procure and install the Clinisys Pathology IT System.

5. FINANCIAL/OTHER IMPLICATIONS

5.1 The costs of the system over the next 7 years will be £2.1m comprising £1.3m initial capital cost and £0.8m in revenue costs. Offset against this will be revenue savings of some £1.5m such that over that period the net revenue benefit will be £0.7m equivalent to £100k per annum.

A capital provision for the procurement has already been included within the capital programme approved by the Board.

6. RECOMMENDATIONS

6.1 The Board is requested to consider the business case and give approval to proceed to procurement and implementation.

Pathology IT Systems Business CaseBoard Report 28 May 2008 of 2

Laboratory Information Management System (LIMS)

Business Case

Draft v. 0.9

Amendment History:

Version Date Amendment History

Readership for this document is intended as:

Key stakeholders involved in the management and delivery of the project;

Individuals involved in the scrutiny of the business case; and

Individuals involved in the approval for this investment

Reviewers:

This document must be reviewed by the following.

Name Signature Title Date of Issue Version

LIMS Project Board 7th December 2007 0.6

Approvals:

This document requires the following approvals.

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On receipt of a new version, please destroy all previous versions (unless a specified earlier version is in use throughout the project).

Related Documents

These documents will provide additional information.

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Glossary of Terms

List any new terms created in this document. Mail the librarian to have these included in the master glossary above [1].

Term Acronym Definition

Contents1. Executive Summary................................................................................................................... 1

1.1 Introduction and Purpose.......................................................................................................11.2 Strategic Case Overview........................................................................................................11.3 Economic Case Overview......................................................................................................1

1.3.1 Option Appraisal – Solution Choice.................................................................................11.3.2 Clinical Evaluation of Options..........................................................................................11.3.3 Risk Evaluation of Options..............................................................................................11.3.4 Identifying the preferred option........................................................................................11.3.5 Selection of LIMS Supplier..............................................................................................11.3.6 Pre –Contract Cost Estimates.........................................................................................1

1.4 Commercial Case Overview...................................................................................................11.5 Financial Case Overview........................................................................................................11.6 Management Case Overview.................................................................................................11.6.9 Conclusion..........................................................................................................................1

2 Strategic Case............................................................................................................................... 12.1 National Context..................................................................................................................... 12.2 Local Strategic Context..........................................................................................................12.3 The Case for Change.............................................................................................................12.4 Local Investment Objectives...................................................................................................12.5 Existing Workload................................................................................................................... 12.6 Future Business Needs and Service Gap...............................................................................12.7 Potential Scope...................................................................................................................... 12.8 Benefits.................................................................................................................................. 12.9 Main Risks.............................................................................................................................. 12.10 Constraints & Dependencies...............................................................................................1

3 Economic Case............................................................................................................................ 13.1 Introduction............................................................................................................................. 13.2 Options................................................................................................................................... 13.3 Economic Appraisal Assumptions..........................................................................................1

3.3.1 Costs............................................................................................................................... 13.3.2 Risks............................................................................................................................... 13.3.3 Benefits........................................................................................................................... 1

4 Commercial Case..........................................................................................................................14.1 Introduction............................................................................................................................. 14.2 Specification of Requirements................................................................................................14.3 Acquisition Timetable.............................................................................................................14.4 LIMS Supplier & Solution........................................................................................................14.5 Payment Mechanism..............................................................................................................14.6 Commercial Risk.................................................................................................................... 14.7 Performance Options..............................................................................................................14.8 Dispute Resolution................................................................................................................. 14.9 Proposed Contract Lengths....................................................................................................14.10 Key Contractual Clauses....................................................................................................14.11 TUPE.................................................................................................................................. 14.12 Implementation Time-scales...............................................................................................14.13 FRS5 Accountancy Treatment............................................................................................1

5 Financial Case............................................................................................................................... 15.1 Introduction............................................................................................................................. 15.2 Assumptions........................................................................................................................... 15.3 Current Trust Funding............................................................................................................15.4 Impact on Trust Income & Expenditure Account.....................................................................15.5 Impact on the Trust Balance Sheet........................................................................................15.6 Overall Affordability................................................................................................................1

6 Management Case........................................................................................................................16.1 Introduction............................................................................................................................. 16.2 Project Management Structure, Methodology and Governance.............................................1

6.2.1 Governance.....................................................................................................................16.2.2 Project Management Methodology..................................................................................16.2.3 NHS Gateways................................................................................................................1

6.3 Project Plan............................................................................................................................ 16.4 Milestones.............................................................................................................................. 1

6.5 Implementation Plan...........................................................................................................16.6 Project Reviews...................................................................................................................... 1

6.6.1 Post Implementation Reviews.........................................................................................16.6.2 Project Evaluation Reviews (PERs)................................................................................1

6.7 Risk Management Strategy and Framework..........................................................................16.8 Benefits Management.............................................................................................................1

6.8.1 Arrangements for Benefits Realisation Plan....................................................................16.9 Modernisation Agenda............................................................................................................16.10 Training............................................................................................................................... 16.11 Contract Management Strategy..........................................................................................16.12 Communications Management Strategy.............................................................................16.13 Security and Confidentiality................................................................................................16.14 Advisors.............................................................................................................................. 1

Appendix 1 Estimated Costs for Business Case.............................................................................1Appendix 2 Benefits by Business Process......................................................................................1Appendix 3 Benefits Realisation Plan.............................................................................................1Appendix 4 Project Risk Register...................................................................................................1Appendix 5 Existing Laboratory Interfaces.....................................................................................1Appendix 6 Detailed Project Plan..................................................................................................1

1. Executive Summary

1.1 Introduction and Purpose

This document is the Business Case to support the local investment in a Laboratory Information Management System (LIMS) and seeks to gain approval and commitment from the Royal Devon & Exeter NHS Foundation Trust Board and support from the Exeter Health Informatics Board.

Pathology services are an integral part of a modern healthcare organisation and play a key role in primary and secondary care involved in the cycle of diagnosis and management of illness across the whole spectrum from coronary artery disease prevention to cancer and infectious disease. `

Speedier diagnosis leads to quicker treatment and therefore achievement of access targets such as 18-week referral to treatment and 4-hour wait in ED and MIUs.

Although the national procurement, for an LIMS solution, has agreed the system suppliers costs with the Local Service Providers (LSP), local resources and funding in the form of cash savings and other funding sources will be required to implement it and to achieve the efficiency gains, across the health community, that LIMS can bring for the benefit of patients.

Approval is therefore required for a capital investment of £1,267k over the contract period until October 2015. Costs include VAT where applicable and exclude the future impact of inflation. Service charges have been applied from January 2009. Initial effects of costs and benefits are shown in the following table.

Table 1A Net Revenue Cost of Scheme (with RDE Implementation Staff capitalised) Net Revenue Cost of LIMS Implementation 2008/9 2009/10 2010/11 2011/12 2012/13 2013/14 2014/15

Apr/Oct 2015/16 Total

£000 £000 £000 £000 £000 £000 £000 £000

Capital Charges 0.0 12.4 10.5 8.6 6.7 4.8 2.9 1.0 46.9

Service Charges 30.5 122.0 122.0 122.0 122.0 122.0 122.0 71.2 833.7

Cash Benefits -0.0 -230.7 -230.7 -230.7 -230.7 -230.7 -230.7 -134.8 -1519.0

Total Net Revenue Cost 30.5 -96.3 -98.2 -100.1 -102.0 -103.9 -105.8 -62.6 -638.4

Note: 1. (- figure) denotes income expected to be realised from cash-releasing benefit

2. Capital charges calculated on 30% of Contract Price as advised by KPMG for NPfIT services (para 4.13

3. Cash benefits reflect the true cost of existing EDS maintenance contract (07/08 budget currently £45k overspent)

1.2 Strategic Case OverviewThe RDEFT Pathology Department serves a large geographical area in the middle of Devon. As well as providing local secondary acute services, the Royal Devon & Exeter NHS Foundation Trust (RDEFT) accepts tertiary referrals from a number of other trusts for orthopaedics, radiotherapy, thoracic surgery, plastic surgery, rheumatology, ophthalmology, cardiology and renal medicine

The RDEH (Wonford) site is currently supported by a 1Gb fibreoptic backbone with 100 Mb to the desktop. An upgrade to the network on the Heavitree site is planned for 2008/9. There is also a rolling replacement programme for desktop hardware over three years old. The trust currently has data transfer links for pathology to North Devon and currently working on links to Torbay for the transfer of first trimester Downs syndrome screening programme via the Viewpoint system.

The current Integrated Pathology System (IPS), supported by EDS, was installed in 1994/5 with the addition of Histopathology in 1999 and Microbiology in 2005. The weaknesses of IPS can be summarised as follows:

No longer being developed by the supplier, thus:o a gradual decline from currently accepted requirements, such as integration with

NPfIT systems;o unable to provide comprehensive service management information, demand

management functionality or costing data;o unable to transfer cancer datasets electronically to the Cancer Intelligence Unit;o has no image handling, & is unable to adequately support long textual reports, such

as required by histopathologyo support for the system is only on a rolling year by year basis.

Because each laboratory system across the SW Peninsula has been setup & maintained separately, no transfer of patient data between laboratories is possible.

The RDEFT had been notified that EDS support for IPS would cease in December 2007. This has now been extended to December 2008 and proposed support costs for extended use of the EDS IPS in 2009 have been received by the trust. In view of the uncertainty this Business Case has been developed for the procurement of a modern Laboratory Information Management System (LIMS) that will meet present and foreseeable future requirements. This business case provides a comparative analysis of the potential pathology solutions available to the RDEFT and is designed to advise the Trust Board on the best option to pursue. Local resources and funding in the form of cash savings and other funding sources will be required to implement it and to achieve efficiency gains across the health community.

The RDEFT has identified a number of IMT investment objectives related to the development of pathology services which are summarised in the table below:

Table 1B

Overall Investment Objective

Improve health care provision within the Trust with improved turnaround time for tests in order to reduce delays in referral, improve pre-referral work up and enable more effective management of chronic disease (e.g. diabetes)

Enable the use of electronic test requesting (Order Communications) and results reporting for all acute hospital and GPs users.

Support service improvement and Pathology modernisation

Enable improved management reporting and business intelligence

Enable optimisation of processes and resources

Provide efficiency savings and release funds for clinical service delivery by reducing the average cost per test

Provide a single approach to service improvement covering people, process and technology with a common set of benchmarks and measures which are presented as part of a single IT and communications strategy

Deliver significant improvements in quality and value for money

More Specific ‘SMART’ Objectives

Reduce the potential for human error through the automation of pre analytical recording processes and reduced inappropriate testing with the associated risk/ distress to patients

Reduce clerical input and scientist recording time associated with sample and result handling

Improve and simplify the management of Pathology Services, through the production of integrated management information

Increase the Pathology Service’s ability to respond to developments emanating from the local Acute Services Reviews

Enhance Pathology support for the development of screening programmes for particular disease prevention/treatment programmes within the context of the National Service Frameworks (NSFs) and local Health Improvement Programmes.

Enhance Pathology’s strategic fit with wider clinical networking in such areas as cancer services

Ensure strategic alignment with the Connecting for Health (CfH) Programme and Pathology Modernisation

1.3 Economic Case OverviewThe economic case is intended to confirm the preferred option, to establish the preferred scope of the local option and to demonstrate Value for Money in terms of costs, risks and benefits.

1.3.1 Option Appraisal – Solution Choice

Based on the local requirement and the national strategy for IT, a number of options have been considered and these are outlined below. In addition to consideration of the system options and solutions there is some degree of option appraisal required for the purchasing solution of a preferred option and this will be outlined in the finance section below.

Table 1C

Option Pro's Con's Compliance with National Strategy

1. Do Nothing No capital outlay in the short term No disruption in the short term

EDS will not support the currentsystem beyond 2008

Lack of integration.Lack of support for current systems.Current system prone to crashing with risk or inputting errors

QA and CPA non-compliance System not future proof

System vulnerable to hardware and software failures

Does not comply with national solution for integrated systems and provision of information

2. Attempt to buyout the IPS license from EDS and purchase system support from a third party supplier (REALITY)

Reduced capital outlay in the short term.

Could be quickly implemented No significant training requirement

Would be reliant on old technology System Manager would have to be

appointed – are skilled persons out there?

Current system prone to crashing with risk of inputting errors

Does not comply with national solution for integrated systems and provision of information

3. Wait for R2 Cerner Millenium Pathology

Upgrade on existing system Integration with spine theoretically

assured by Cluster ally Fujitsu

Not clear when Cerner can deliver new product (Probably post 2009).

No proof of concept with the

Fits with acceptance of LSP solution from Fujitsu which should

Option Pro's Con's Compliance with National Strategy

Siemens Integration with new Cerner PAS

Cerner product Poor functionality would require

additional order communication software for primary care interface

ensure future proof compliance with developments for the national strategy

4. Migration to other LSP Path system

Integration with spine assured. Interface with new PAS should be

available.High resilience service.NPfIT compliant.High functionality. Single transition therefore less

disruption. Possible savings on

licence and maintenance costs.

Integration with existing PAS systems must be agreed

Capital outlay for new systemmay not be delivered from LSP data centre?

Supplier might be stretched with a number of simultaneous implementations

Delivery of a compatible system from another Cluster

5. Issue OBS via competitive tender route selecting best system on value for money and fit for purpose basis

Trust produces OBS and specifies exact requirements. Trust can select supplier that meets OBS and offers best value. Trust can determine exact implementation timetable Trust can ensure system chosen can exchange data with other UHCW & GEH Trusts.

Outside NPfIT and the National programme.

Integration with current trust strategies may not be proven.

Procurement process may take longer via G-CAT or OJEC as well as potentially being more expensive

Is not guaranteed to be NPfIT compliant, or if currently compliant, may not be able to keep pace with national developments within the strategy

1.3.2 Clinical Evaluation of Options

Option 1: Do Nothing is rejected on the basis that it does not meet any of the requirements outlined in the previous section.

Option 2: Procure licence for IPS from EDS in its entirety, purchasing additional support from a third party supplier (Reality) was rejected as this could not be a long-term strategic solution. It is uncertain whether EDS would sell the license, & there would be no enhancements to the functionality of the software.

Option 3: Implement Cerner PathNet. Fujitsu’s current track record and their partners Cerner does not inspire confidence to deliver either Millennium initially or the PathNet Pathology Solution in the long term.

Option 4: Procure LIMS from another LSP. An alternative supplier of pathology systems was identified in Clinisys who are providing the pathology solution for BT, the London Cluster LSP. Clinisys already have a robust system solution which has demonstrated the ability to interface with existing clinical systems. BT are also implementing Cerner Millennium giving assurance of compatibility with any future Millennium implementation the RDEFT may choose to undertake. Selection of a system offered by another LSP means that an extended procurement is not necessary. Purchase via an LSP also brings the financial benefit of VAT exemption.

Option 5: Procure LIMS via OJEU. This would delay the replacement of the current IPS system potentially years beyond the agreed support timescale of EDS. Market testing has indicated that direct purchase from IPS suppliers would be a more expensive option as Clinisys has already been discounted to CfH.

1.3.3 Risk Evaluation of OptionsIn relation to recurring revenue costs of the project, the economic analysis predicts (based on the achievement of planned benefits) that the recurring revenue consequences of the system implementation [£122k] will be offset by a potential cost avoidance of £230.7 per annum. This assumption is based on a 100% achievement in the planned benefit stream. The risk of not

achieving the stated benefits is offset by the potential for realising other cash-releasing but, at this stage, non-quantifiable improvements. Should the proposed benefits not be achieved the trust recognises that any short-fall will need to be funded from its operational revenue budgets.

The assessment of the risks for each of the options is based upon the factors that could prevent the successful implementation of that option. Risks were identified and impact assessed on the basis of the scoring shown in the table below:

Table 1D

Score Impact Score Probability1 This risk will have minimal impact 1 Rare2 This risk will have a significant impact on the Trust, but

should largely be contained via increased management effort

2 Unlikely

3 This risk will have a substantial impact on the Trust - its ability to deliver patient care effectively, financial viability, etc.

3 Possible

4 Likely5 Almost Certain

The exposure to each risk is the likelihood score multiplied by the impact score. The overall level of exposure to risk for each option is calculated by summing these scores for each risk factor. Exposure to risk is considered severe when the exposure score exceeds 12, i.e. risk has a substantial impact (3), and has a more than average likelihood of occurring (4 or more).

Option 4 is ranked as the least risk option. There is a distinct gap between the scores for option 4 (rank 1) and options 1 and 3 (rank 4). Assessing risk sensitivity, risks for option 4 would need to increase by 50% to be comparable with Option 2, 66% with Option 5 and 83% with Options 1 and 3.

1.3.4 Identifying the preferred optionSet out in the table below is a summary of the option analysis in terms of costs benefits and risks. From the analysis the preferred option is identified as Option 4.

Table 1E

Evaluation CriteriaOption 1

Do Nothing Do Minimum

Option 2Procure

Licence for IPS from EDS

Option 3Implement

Cerner PathNet

Option 4Procure

LIMS from another

LSP

Option 5Procure LIMS via

OJEU

Cost 12 9 12 6 12Non-financial benefits 9 6 9 6 6Risks not valued in monetary terms 12 12 12 6 12

Rank 4 2 4 1 3

A preferred solution for LIMS has been agreed between trusts within the Southwest. The decision to procure LIMS under the Standalone Service framework agreement (CCN1) through one of the LSPs within NPfIT will bring the following benefits:

Avoidance of the costs associated with tender/OJEU procurement processes

A “best of breed” LIMS product which has been appraised and selected to meet the immediate and future needs of Pathology

Proven deployments and service management provision A Best Practice Group approved “gold” standard configuration of the system after significant

consultation and review by clinicians Efficient and established contractual process providing improved SLAs terms and protection

for the Trust Clinical safety assessment report on the product.

1.3.5 Selection of LIMS SupplierThere exists, within the NPfIT agreement with Local Service Providers (LSPs), the opportunity for trusts to purchase ‘Additional Solutions’, such as Pathology, from LSPs outside their host Cluster. The two pathology solutions being offered by LSPs have been assessed against the requirements defined in the Output Based Specification (OBS) by the RDEFT, together with other Peninsula Pathology Network members.

1.3.6 Pre –Contract Cost Estimates

The charges provided are based on initial site survey carried out during March 2007 to supply under the Standalone Service framework agreement (CCN1) in accordance with BT’s contract as a Local Service Provider within the NPfIT have been refined through discussions between BT and RDEFT to agree full scope, requirements and implementation approach.

Charges shown are subject to annual indexation from 1st April 2008 and exclude VAT.

Table 1F

DeliverablesPrice (£)

CliniSys Software, Licenses & Standard Interfaces (25)Implementation ServicesWard Enquiry ModuleHL7 & InfoCom InterfacesData Migration – BT/Histo/CytologyPath Manager Reporting Module (Medium)Total Purchase Price For Core System 882,005

Future Optional Elements Lab2Lab Electronic Referrals (bidirectional interface per department) 11,765

HL7 Electronic Requesting Interface (Order Comms) 21,765Total 33,530

Annual Support (BT and CliniSys) 121,992Total for 6.75 years support 833,612

1.3.7 Endorsement

The final Business Case document and Capital Funding request will be submitted to the RDEFT for approval.

1.4 Commercial Case OverviewThe LIMS service will be sourced through BT, the LSP for the London Cluster. The contractual arrangements are as specified between the LSP and the DH as the contracting Authority on behalf of the NHS. The contract will run until 31st October 2015, with an option for a one year extension, in line with the existing LSP contracts.

1.4.1 PROCUREMENT PRINCIPLES

The principles the Trust has developed to guide the procurement and manage risk are; The LIMS system will be procured via a nationally appointed LSP. An output based specification [OBS] of the requirements of the LIMS has been used as the

basis for assessing supplier submissions. The LIMS system should support all the mandatory requirements described in the OBS. If suppliers systems require enhancement to meet mandatory requirements the suppliers

should clearly identify development costs and timescales. All system development risks should be transferred to the supplier and contract penalties

defined for non delivery. All capital and revenue consequences of the alternative suppliers systems should be

identified and documented.

The Trust’s procurement principles are reflected in its criteria for evaluating system suppliers. The high-level evaluation criteria used for this assessment are summarised in the Table 1G below.

Table 1G - Procurement evaluation criteria

Criterion Sub CriteriaCapability Technical, financial and commercial record in the supply of LIMS systems to

hospitals.Proven experience, expertise, including project management, design, system integration, benefits realisation, quality control, and financial control.Scope of proposed development path for system.

Capacity Organisational, managerial and technical capability and availability to carry out the Project within the agreed timescale.Economic and financial capacity of the Interested Party, its shareholders and Relevant Companies.Extent to which use of sub-contractors is proposed. Avoidance of arrangements that might be considered to constitute a conflict of interest.

Compliance with OBS

Compliance with OBS requirements for:Chemical PathologyHaematologyImmunologyHistopathologyCytologyMicrobiologyVirologyBlood Transfusion Tissue typing

Usability Quality of user interface;Scope and flexibility of Information retrieval and reporting functionality;System maintenance and security facilities;Scope of technical Support services;

Compliance ICT Strategy

Compliance with NHS ICT standards.Compliance NHS ICT strategy.Compliance RDEFT ICT strategy.

Table 1H -- Timetable for acquisition of LIMS by the Exeter District Healthcare Community.

Activity Date

Determine Local Requirements Specification January 2007

Initiate baseline measurements of anticipated benefits October 2007

Establish Final Local Requirements Specification and agree in detailed discussions with LSP

October/December 2007

Agree central capital and other required funding December 2007

Complete and submit Business Case for approval December 2007

Trust Board approval of LIMS Business Case May 2008

Complete Purchase Requisition June 2008

Commence LIMS Implementation June 2008

Completion of Acceptance Testing December 2008

Implementation by Discipline January / February 2009

Issue of Milestone Achievement Certificate February 2009

Review Benefits Ongoing

1.5 Financial Case OverviewIn the Financial Case the affordability of the preferred option has been explored, taking into account both the expenditure and anticipated funding. The results are summarised in the table below.

The total expenditure (comprising hardware, software and support costs over 7 years will be £2,100.8k comprising a capital investment of £1,267.2k and revenue consequences of £833.6k. Cash releasing benefits/cost avoidance over the same period would realise £1,519.5k.

The financial risk assessment estimates that provision should be made for a contingency of £50k against additional local expenditure and staffing costs. The key elements of risk are around:

Costso Costs underestimated, e.g. funding for key staff (eg implementation manager),

training, etc. o Unforeseen cost of restructuring workforceo Change of funding priorities during project

Affordabilityo Ongoing running costs (revenue and capital) of LIMS unaffordable, e.g. hidden costs o Implementation costs (capital and revenue) unaffordable, eg tailoring, interfaces,

training, backfill staff; Benefits

o Benefit realisation delayed;o Cash releasing benefits not achieved;

The contract between NPfIT (DH) and the LSP divides the costs to be paid locally between the deployment charge and annual service charges.

Provisional deployment charges for the core system covers Clinisys software, licences, standard interfaces and implementation services. Future optional elements have been estimated but require confirmation. Funding will be sought via the Trust’s capital bid process.

Savings in the annual system support for the present system provide the majority of the cash releasing benefits that may be realised.

1.6 Management Case Overview

1.6.1 Organisational Change – Training & Staffing

The Trust recognises that the implementation a new LIMS system will result in changes to current operational practices. A detailed staff training requirements plan will be developed for each of the Pathology Business Functions/Disciplines as part of the implementation planning process. Where the implementation results in significant changes in the working practices or job roles of individual staff or staff groups, the Trust will ensure an effective staff consultation process is in place.

It is assumed that there are no issues relating to the transfer of existing staff to a new employer. There are no known HR issues associated with the LIMS implementation at this time, however all staff whose posts will be affected by the implementation of LIMS will be dealt with in accordance with the agreed Trusts’ policies and in full consultation with the HR department.

1.6.2 Risk management

The Trust recognises that the management of implementation is a critical management task to ensure the project is delivered on time with minimum service disruption and within budget. The Trust has therefore identified potential risks shown in Appendix 4. A Risk Log will be produced that will provide details of the identified project risks and allocate, for each risk, the management approach to be adopted and an initial assessment of the potential project impact. The overall responsibility for the management of project risks will fall to the Project Board. However, day to day risk monitoring will be the remit of the project manager who will provided risk status reports on a regular basis to the Project Board.

1.6.3 Benefits planning

A series of benefits workshops will be held with each the pathology disciplines to identify a range of potential benefits resulting from the implementation of the new LIMS system. The benefits identified will be categorised into the following types:

Cash-releasing; Non-cash quantitative; Qualitative.

The benefits workshops will also produce an Outline Benefits Realisation Plan for each of the business functions which constitute the RDEFT pathology service. These plans will identify the actions that are required to realise given benefits and also allocate management responsibility. Initial benefits aligned to business processes have been set out in Appendix 2. A full benefits realisation plan will be developed during the Project Initiation Stage.

1.6.4 Management and resources

The LIMS implementation project will be managed using the PRINCE2 project management methodology. PRINCE 2 comprises 5 standard components – Organisation, Plans, Controls, Products and Activities – which are linked together by Quality Management. Throughout the project controls ensure the proper management of the project. The management structure will ensure involvement of the following stockholders:

A Trust Executive; Pathology service managers; Pathology system user; Hospital and community based Clinicians; Hospital and PCT based ICT representatives.

The Trust has identified that a project manager and appropriate support staff will be required to manage day to day project activities. Business managers within the Pathology directorate have also agreed to allocate operational staff to the project on an “as required” basis. The overall structure is set out below, and management arrangements for the schemes are in place and operating. Members of the LIMS Project Board and Steering Group are identified in Tables 1J and 1K

LIMS Project Management Structure

Table 1J - Exeter District LIMS Project Board

NAME POSITION & RESPONSIBILITYMike Stevens Chair of LIMS Project Board and Director of Finance & Information.

Paul Newman Project Director & Deputy Chair – Consultant Histopathologist & Clinical Lead for Diagnostics

Elaine Hobson Head of Modernisation

Tony Cox Clinical Directorate - Diagnostics

(TBC ) PCT Representative

Wendy Ware Deputy Director of IMT

Change Team

LIMS Project Board

Project Steering Group

Project Team

Quality Assurance Group

Supplier Liaison Group

Training Team

Implementation Team

Benefits Realisation Team

Procurement Team

Liz Boylan Programme Manager

Table 1K - Exeter District LIMS Steering Group

NAME POSITION & RESPONSIBILITYPaul Newman Project Director & Chair of LIMS Steering Group – Consultant

Histopathologist & Clinical Lead for Diagnostics

John O’Connor Consultant Biochemist – Clinical representative

Mike Burden Pathology Manager – Clinical representative

Steve Walton Clinical representative – Blood Transfusion & Haematology

Julie King Clinical representative – Microbiology & Virology

Colin Heapy Clinical representative – Histopathology & Cytology

Adrian Cudmore Clinical representative – Biochemistry

Elaine Hobson Head of Modernisation

Tony Cox Clinical Directorate - Diagnostics

(TBC ) PCT Representative

Wendy Ware Deputy Director of IMT

Liz Boylan Programme Manager

Trevor Dymond Technical Manager

Kirsty Simpson Management Accountant

1.6.5 Project Plan & Key Milestones

An outline project plan for the implementation is shown in Appendix 6. Table 1L details the overall outline plan and key milestones to be achieved.

Table 1L -Overall Outline Plan & Key Milestones

Milestone DateInitial Engagement 26th Jun 2007LIMS Order placed by Trust 4th June 2008LIMS Implementation Commences 16th June 2008LIMS Master Training Dec 2008/Jan 2009 LIMS Acceptance Testing Dec 2008LIMS Go Live-Blood Transfusion 12th Jan 2009LIMS Go Live-Microbiology & Virology 26th Jan 2009LIMS Go Live- Biochemistry,Haematology& Immunology 9th Jan 2009LIMS Go Live-Histology 23rd Feb 2009LIMS Go Live -Cytology 23rd Feb 2009Final LIMS Milestone Achievement Certificate 27th Feb 2009

1.6.6 Post Project Evaluation

A full Post Project Evaluation Plan is being developed as part of the implementation planning work.

1.6.7 Security

The need to maintain system security and confidentiality of data have been essential components of the OBS used in the procurement. The Project Board are aware of the issues associated with this and are satisfied that risks have been identified and plans adjusted accordingly.

1.6.8 Project Advisers

Project advisors (NHS and potential suppliers) have supported the internal project team in formulating this investment bid. Project management will be undertaken by Trust resources. The following stakeholders have been consulted in the development of this business case:

Table 1M

Exeter District Healthcare Community External Organisations RDEFT LIMS Steering Group South West Health Authority Pathology Peninsula LIMS Steering Group Finance NPfIT Pathology Adviser IM&T Local Service Provider Estates

1.6.9 ConclusionThe procurement of a modern LIMS solution will provide considerable benefits in terms of improved workflow right across the healthcare community leading to efficiencies in many areas and contributing to central targets such as eighteen week targets from referral to treatment, four hour waiting in A&E departments, diagnostic services and reduced working hours for junior doctors.

Implementation of the proposed solution will put in place the basis to proceed with the implementation of order communications within the RDEFT and the local healthcare community and facilitate clinical networking across the South West Peninsula and beyond.

Lastly, but not least, the procurement and implementation of a replacement Pathology IT System will relieve the uncertainty surrounding future support and the anticipated lack of future development for the existing EDS IPS system.

2 Strategic Case

The purpose of the Strategic Case is to demonstrate that the project is necessary to deliver the Business and IM&T strategies of the national and local NHS, and is supported by clear and measurable objectives.

2.1 National ContextThe implementation of a Laboratory Information Management System (LIMS) supports the following National Drivers:

NHS Plan Development of Services Quality Improvement and reduction in errors Improvement in Efficiency Development of Staff Open Access to Information Delivering the NHS Plan NHS Information Strategy Information for Health Building the Information Core, Delivering the NHS Plan Delivering 21st IT Support for the NHS The New NHS; Modern and Dependable National Service Frameworks Clinical Service Networks Clinical Governance

At an operational level the main drivers flow from changing service requirements for: Enhanced support for preventative/treatment screening Cardiovascular Services Elective Orthopaedic Centres Outpatient and GP Diagnostic Centres Other Primary Care Developments

These service improvements reflect local plans for quality, access and efficiency improvements.

The National Programme for IT (NPfIT) was established to deliver: A robust infrastructure to support modernised health and social care. Electronic Booking of appointments. Electronic transfer of prescriptions. An Integrated Care Record Service (now NHS Care Record Service)

Pathology services are an integral part of a modern healthcare organisation and play a key role in primary and secondary care involved in the cycle of diagnosis and management of illness across the whole spectrum from coronary artery disease prevention to cancer and infectious disease. Speedier diagnosis leads to quicker treatment and therefore achievement of access targets such as 18-week referral to treatment and 4-hour wait in ED and MIUs.

The case for service improvement, through LIMS, to deliver waiting time and National Service Frameworks (NSF) targets is fully accepted. NPfIT has acknowledged pathology as a key service in its plans to support front line modernisation and, as such, is included as an Additional Service available from LSPs but requires local funding.

2.2 Local Strategic Context

The RDEFT Pathology Department serves a large geographic area in the middle of Devon The Royal Devon & Exeter NHS Foundation Trust (RDEFT) accepts tertiary referrals from a number of other trusts for orthopaedics, radiotherapy, chest surgery, plastic surgery, rheumatology, ophthalmology, cardiology and renal medicine.

The pathology departments are located in two main areas on the RDEFT (Wonford) site. Microbiology, Histology, Cytology and Molecular Genetics are based in the old pathology building with a reception area and the main pathology store. A recently upgraded and enlarged Mortuary Complex is adjacent. Clinical Chemistry, Immunology, Haematology, Blood Transfusion and the Directorate Offices are located with Reception in the main hospital.

The Pathology Sub-Directorate provides a quality pathology service for the RDEFT, local community hospitals and East Devon, Mid Devon and Exeter GP practices. Services are also provided for other healthcare sites via network arrangements and some specialist tests, e.g. for Molecular Genetics on a national basis.

The total numbers of specimens processed through the RDEFT Pathology Directorate is approximately 1.4 million patient’s requests per year, resulting in 5 million individual tests. Currently the service is provided by 188.41 WTE spread across the pathology disciplines shown in Fig. 2A

There has also been a proliferation of Point of Care Testing (POCT) where pathology testing is provided in the patient environment, e.g. Emergency Department, ITU, GP surgeries and community hospitals. The testing is carried out by non-pathology staff (usually nurses), the whole POCT being monitored and supervised by the Pathology Service.

Fig 2A Pathology Staffing by Discipline

Pathology staffing by disciplineBlood Transfusion

Clinical Chemistry

Cytopathology

Haematology

Histopathology

Immunology/Stem CellProcessing

Microbiology

Molecular Genetics

Mortuary

General Pathology

The healthcare community has a number of significant local drivers for the implementation of LIMS which include:

Delivering ‘order comms’ requesting to decrease requesting errors and inappropriate requesting

Establishing point-to-point connectivity across the Peninsula Pathology Network Maintaining services developed through modernisation and ensuring the local community is

able to meet future challengesThis Business Case covers the provision of a LIMS that will support the future implementation of ‘order comms’ and peninsular networking. Separate projects with associated funding will be developed to meet these strategic objectives.

There is a need to maintain services developed through modernisation and ensure the Department is able to meet future challenges. The Trust requires a modern, flexible, fully functional NPfIT, HL7 compliant IT solution, capable of being interfaced to the respective trust PAS systems, as part of the National Programme. The system should be capable of interfacing seamlessly with a wide variety of analysers and equipment. Modules must be fully functional in supporting the work of all clinical laboratories, be intuitive and easy to use, flexibly configurable and capable of results reporting on a variety of stationary forms as well as electronically. Inbuilt quality checking systems are essential. The system must be robust, with full service and 24hr support available, and an assured development pathway for the future.

This project is in keeping with the philosophy of both the National and Local IT agenda. It will have significant benefits to the Pathology Service and all the Clinicians within the local healthcare community who use this Directorate. These benefits will be manifested by an improvement in the quality of patient care.

2.3 The Case for Change

The current Integrated Pathology System (IPS), supported by EDS, was installed in 1994/5 with the addition of Histopathology in 1999 and Microbiology in 2005. Despite some deficiencies, it has excellent functionality and configurability as a laboratory system. The upgrade to a Cache platform in 2004 has made it very fast and reliable. IPS has no image handling, sophisticated word processing capabilities or significant demand management functionality. Middleware could be used to address these shortfalls, for example additional software that will address electronic requesting.

The advantages of implementing LIMS include: Reduced potential for human error through the automation of pre analytical recording

processes Reduced inappropriate testing with the associated risk/distress to patients Reduced clerical input and scientist recording time associated with sample and result

handling Improved and simplified Pathology Services management through the production of

integrated management information Increased ability for Pathology Services to respond to developments emanating from the

local Acute Services Reviews Enhanced Pathology support for the development of screening programmes for particular

disease prevention/treatment programmes within the context of the National Service Frameworks and local Health Improvement Programmes

Enhanced ability to fit with wider clinical networking in such areas as cancer services Strategic alignment with the Connecting for Health Programme (CfH) and Pathology

Modernisation.

There are potential future cost savings that will arise from request/result handling and consolidated maintenance of an integrated system. Time would no longer wasted completing manual request forms and chasing results.

Change management has been embraced by the pathology departments to meet the challenges posed by service development/ modernisation. Many departmental changes have been implemented over recent years to meet these challenges, such as:

24/7 Continuous Pathology Processing shift systems in clinical Chemistry, Blood Transfusion and Haematology

Extension of the Pneumatic Tube Transport System throughout the Trust to facilitate the rapid transport of pathology samples and other items

Procurement of an ‘intelligent’ request form scanner to enable rapid requesting and reading of patient data

Proliferation of Molecular Genetics testing and formation of the SCOBEC Cluster to offer a greater range of diagnostic testing

Establishment of a Stem Cell Processing Facility, licenced by the MHRA Microbiology transfer from PHLS to the RDEFT Advanced Practitioner working and role-redesign in Histology and Cytology Diagnostic Forum creation to enable closer liaison between senior pathology staff and GP

representation.

2.4 Local Investment ObjectivesLocal investment objectives are set out below:

Investment Objective 1To improve the operational efficiency of pathological diagnosis by 10 % by 2011 Reduce time spent by staff manually reproducing request information from printed forms

Reduce the administrative staff required in pathology department.

Investment Objective 2To achieve 90% electronic transfer of test requests and results by 2010. Reduce clerical input and scientist recording time associated with sample and result

handling

Investment Objective 3

To provide more effective clinical diagnostic services through utilisation of digital technology. Reduce the number of hard copy requests to 10% by March 2009 in line with implementation

roll-out.

Report 95% of investigations on-line

Demonstrate improved Clinician satisfaction with the Pathology Department after completion of the implementation.

Support the quality agenda by improving the quality of Clinical Services and governance.

Release Trust revenue for other purposes

Investment Objective 4To reduce potential for human error in diagnostic requesting by 95% by 2010. Automation of pre analytical recording processes

Implementation of ‘order communications’ directly from source of request

Investment Objective 5To integrate pathology services as a component part of IT-enabled National Care Record System Across a community of local users

As a component part of the NHS Care Record System

2.5 Existing Workload

The RDEFT pathology services currently process approximately 1.4 million requests annually, originating within the Trust and from local community hospitals, directly from GPs and from other NHS sites outside the Exeter District healthcare community. These requests result in over five million individual tests being undertaken per annum.

Table 2A Total Number of Requests 2005/6

Dis

cipl

ine

Loca

tion

Req

uest

s

Test

s

RD

EFT

GP

R

eque

sts

Oth

er H

osp

Non

-NH

SMicrobiology Old Path 347,829

Immunology Old Path 27,693 57.0%

41.0%

2.0%Haematology & Blood

TransfusionMain Hospital

414,193 766,159 49.0

%48.0

%3.0%

Clinical Biochemistry Main Hospital

434,859

3,036,718

45.6%

53.9%

0.5%

Histopathology & Cytology Old Path 29,337 203,350 73% 26% 0.5% 0.5

Local services are currently restricted by the following situations:

The provision of effective and speedy reporting services requires immediate access to previous test results. Lack of information can lead to inappropriate clinical decisions.

The management of hard copy is becoming increasingly expensive in terms of space and staff time.

The need for results to be viewed by clinicians involved in the care of a patient at the point of care.

2.6 Future Business Needs and Service GapAt a local level the existing arrangements are characterised by

Lack of integration between departmental systems.

2.7 Potential ScopeThe RDEFT wishes to ensure that it can achieve the maximum benefits of LIMS and has requested that additional software/modules are offered within the Pathology Standalone Service Functional Description. These include:

Path Manager HL7 Message Processor

HL7 Results Reporting Interface to third party Scanning Software

Future Additional Modules that will facilitate the implementation ‘Order Communications’ (Order Comms) within the local community and wider clinical networking across the Peninsula include:

Lab2Lab Electronic Referrals HL7 Electronic Requesting Interface (to an Order Comms solution)

2.8 Benefits

The implementation of a new Pathology System must provide both qualitative and financial releasing benefits to the Trust.

Qualitative benefits deriving from the new system will be:

providing minimum dataset returns for Cancer Registry standardising reports within each discipline enhancing provision for near patient testing enabling evaluation and re design of processes across pathology supporting Payment by Results providing a full audit trail and access to history to facilitate governance both internally and

externally as appropriate facilitating Trust strategy for achievement of Information for Health IT targets by providing

future interfaces to electronic requesting and reporting, electronic alerts, and image archiving

facilitating future integration of the RDEFT Pathology system with PCT, GP’s and other Pathology units within the Region and the national framework .

There are financial benefits to be gained in all disciplines within Pathology with the introduction of new ways of working, standardised reporting, utilising decision support software and having appropriate history and audit information accessible. Many of these will be dependent upon the implementation of a full order communications system across the RDEFT and the local healthcare community. This will be the remit of a separate project. Specific benefits include:

Reduction in duplicate tests – To be quantified Streamlined specimen handling– To be quantified Speed of response increase freeing up beds earlier – To be quantified Reduced number of wasted Outpatient appointments – To be quantified Reduced secretarial costs with standardised reporting – To be quantified Introduction of Demand Management reducing unnecessary tests – To be quantified Introduction of Cascade testing by setting system boundaries and controls to inform

clinicians without need for reference to specialists – To be quantified Reduced cost of information management with links between systems and PCT,

GP’s etc – To be quantified

Further financial and qualitative benefits will be identified during the life of the project

The main outcomes and benefits anticipated are set out below against the relevant investment objectives.:

Table 2B Benefits related to Investment Objectives

Investment Objectives Ref Related Benefits Criteria

Cas

h R

elea

sing

Non

-

Cas

h R

elea

sing

Qua

litat

ive

1. To improve the operational efficiency of pathological diagnosis by 10 % by 2011

B01 Reduce necessity for repeat tests Y

B02 Faster turnaround on test results Y

B03 More effective use of Biomedical Scientists

Y

B04 More time for diagnostic processing Y

B05 Greater service throughput e.g. Eighteen week targets from referral to treatment

Y

B06 Improved Performance Y

B07 Improvement in waiting times performance e.g. A&E 4 hr waiting times targets

Y

B08 Reduce administrative function within pathology department

Y

2. To achieve 90% electronic transfer of test requests and results by 2010

B09 Improved patient journey as requests and reports available on-line

Y

B10 More effective use of clinic time as tests can be requested whilst patient is with clinician

Y

3. To provide more effective clinical diagnostic services through utilisation of digital technology

B11 Improved support for pathology staff and Junior Doctors “out of hours” as requests can be sent and results received electronically

Y

B12 Reduce number of hard copy requests to 10% by 2009 in line with implementation rollout

B13 Report 95% of investigations on line Y

B14 Demonstrate improved clinician satisfaction with the Pathology Service

Y

after completion of implementation

B15 Support the quality agenda by improving the quality of clinical services and governance

Y

B16 Facilitation of existing professional & academic links

Y

4. To reduce potential for human error in diagnostic requesting by 95% by 2010

B17 Automation of pre analytical processes

B18 Implementation of ‘order communications’ directly from source of request

5. To integrate pathology services as a component part of IT-enabled National Care record System

B19 Across a community of local users

B20 As a component part of the NHS Care Record System

2.9 Main Risks

There are a number of risks associated with this business case. It is important that the risks are understood and the Project Team ensures that a robust process is put in place to manage them.

There is still uncertainty around the national agenda for IT solutions which has led to a significant level of uncertainty about the true status of possible options that are open to the Trust. This business case has been written on the basis that the Trust understands that Pathology is not a core system and therefore it is possible to consider options other than Cerner within the LSP solution, as it would be appropriate to remain within the national framework. There is a risk associated with a lack of clarity on this situation.

In relation to the above point, the Trust has identified its preferred solution as Option 4 which is to nominate Clinisys for the procurement of a Pathology System. The Trust has identified that the current LSP solution (Cerner Millenium) is not ready for deployment. The degree of uncertainty about the development status of the final solution means that the Trusts would be exposing themselves to both clinical and financial risks.

There is a degree of urgency in agreeing to purchase a new Pathology Information system for the Trust. There is a significant risk to the Trust that there may be no system support for the existing EDS system beyond Dec 2008.

Risks have been divided into categories (based on key relevant risks contained within the DH IM&T Business Case Guidance standard risk register). The Risk Modelling Tool component of the Costing Model enables risks to be quantified and evaluated and the key risks are considered to be:

Table 2C Risks Identification and Management

1.0 Design Risks Countermeasure

1.1 Change in requirements of the NHS Trust Requirements set out in OBS

1.2 Change in Requirements of Service New analysers will be integrated and added to contract

1.3 Change in Design required by Users Selected system will possess all major elements of functionality therefore design risks are minimised

2.0 Development/Implementation Risks

2.1 Trust change to specification Specification has been formally set out and agreed by the LIMS Project Board. Any changes would be subject to a formal change control process managed at Board level

2.2 Supplier fails to implement system on time LIMS Project Manager will work closely with supplier to draw up achievable plan for implementation

2.3 System unable to interface to external organisations e.g. Other trusts

LIMS Project Manager will work closely with supplier to understand and agree best action plans to manage risk in this area.

2.4 Trust's implementation costs exceed budget LIMS Project will aim to minimise costs and monitor expenditure throughout project. Do not expect overspend to fall outside normal limits.

3.0 Change Management Risks

3.1 Organisation & staff not geared up culturally or practically e.g. inadequate prep, start planning, train & develop, change management

The LIMS Project Steering Group will engage clinically based Key Stakeholders to involve in the project and disseminate information to all user departments.

3.2 Organisation not sufficiently prepared or trained to implement.

Training/ Implementation Plans will be developed to ensure all users across the community adequately prepared

3.3 Services disrupted because of implementation/lack of familiarity with systems

The LIMS Steering Group will be proactive in engaging staff in the project..

3.4 Loss of key staff e.g. project manager, project champions, IT specialists, Chief Executive

The RDEFT has a committed local team, who have been in the local health organisation employ for many years

4.0 Training/User Risks

4.1 Training Costs Increase The RDEFT has significant IT training facilities and will work with the supplier to agree Train the Trainer and end-user training requirements

4.2 Loss of user interest and motivation due to project delays, poor communication etc

The LIMS Project Steering Group will engage staff across the community in planning and implementation processes. A proactive communication plan will be actioned

5.0 Operational Risks

5.1 Higher than expected operating costs for prime contractor seven-year Contract for capital spend at deployment, hardware/ software refresh and associated service charges from supplier agreed at Cluster level

5.2 System unavailable This is not likely to fall outside agreed limits due to the use of highly configurable and fault tolerant hardware/ software

5.3 System/services unable to respond to increased activity/throughput

The seven-year contract is based on predicted growth for that period.

5.4 Data loss All data is backed up in real time, minimising this risk

5.5 Non Cash releasing benefits not realised or delayed A Benefits Realisation Team will be established, involving clinical and non-clinical staff. A benefits realisation reports will be produced

5.7 Cash releasing benefits not realised or delayed As above

5.9 Cost of additional activity/throughput The seven-year contract is based on predicted growth for that period.

6.0 Termination Risks

6.1 Termination because Software/services not able to meet changed requirements resulting from Trust changes e.g. merger, new services

7.0 Technology & Obsolescence Risks

7.1 Failure of the LIMS and Pathology Services to deliver outputs & meet existing and future business needs

2.10 Constraints & DependenciesThe potential constraints can be grouped into 4 main areas. The project has sought to address each of these to ensure that they do not impact on the LIMS implementation:

Financial AffordabilityThe national procurement approach has obtained competitive costs for LIMS, if purchased via one of the Local Service Providers (LSP). The negotiated capital costs and service charge together with associated costs required locally for implementation indicate

considerable local investment and there will be an affordability gap before any cash releasing benefits can be realised.

Commitment to future revenue support from PCTs and DPTs who will be ‘using’ the LIMS, in particular the ‘order comms’ element, need to be firmly established.

CommunicationsThe RDEFT has invested considerably in the main hospital LAN infrastructure over the past few years. All RDEFT sites and community hospitals have access to the existing IPS system to view results. Most GP practices receive results directly into their chosen clinical system. These links should prove adequate for the implementation of ‘order comms’ in the same locations.

TimescalesNotification that the current IPS would not be supported by the supplier (EDS) post December 2007 meant the RDEFT needed to seek solutions to maintain business continuity, with interim and long term solutions. Although this support has now been extended to December 2008, the uncertainty requires RDEFT to plan for a permanent solution. These plans and this Business Case provide for implementation of a new LIMS by February 2009.

Strategic and OrganisationalOther initiatives, including the relocation of services (renal dialysis, pain clinic) to the Heavitree site, Emergency Hub, etc., may compete for investment and local skills.

Dependencies that will impact upon a successful LIMS implementation include: Infrastructure

The project is dependent on the availability of a suitable communications network across the community. N3 will provide networking capability over a WAN link to GPs, community hospitals and other NHS organisations. Local community hospitals also have WAN connections to the RDEFT. The need for any LAN upgrades and desktop hardware will need to be assessed.

The support of the stakeholders A successful implementation of LIMS and the required business change to realise the benefits anticipated will depend on Pathologists, Biomedical Scientist and other Clinicians in the Acute and Primary Care Sectors including GPs and managers across the wider healthcare community. .

3 Economic Case

3.1 IntroductionThe preferred solution for LIMS has been agreed across the Southwest Peninsula. The decision to procure LIMS under the Standalone Service framework agreement (CCN1) through one of the LSPs within NPfIT will bring the following benefits:

Avoidance of the costs associated with tender/OJEU procurement processes A “best of breed” LIMS product which has been appraised and selected to meet the

immediate and future needs of Pathology Proven deployments and service management provision A Best Practice Group approved “gold” standard configuration of the system after significant

consultation and review by clinicians Efficient and established contractual process providing improved SLAs terms and protection

for the Trust Clinical safety assessment report on the product.

The economic case is intended to confirm the preferred option, to establish the preferred scope of the local option and to demonstrate Value for Money in terms of costs, risks and benefits.

3.2 OptionsSeveral options have been considered that will ensure business continuity is not compromised by the cessation of IPS support by EDS. The options have been clinically evaluated and assessed from a business perspective as follows:

Option 1: Do Nothing is rejected on the basis that it does not meet any of the requirements outlined in the previous section.

Option 2: Procure licence for IPS from EDS in its entirety, purchasing additional support from a third party supplier (Reality) was rejected as this could not be a long-term strategic solution. It is uncertain whether EDS would sell the license, & there would be no enhancements to the functionality of the software.

Option 3: Implement Cerner PathNet. Fujitsu’s current track record and their partners Cerner does not inspire confidence to deliver either Millennium initially or the PathNet Pathology Solution in the long term.

Option 4: Procure LIMS from another LSP. An alternative supplier of pathology systems was identified in Clinisys who are providing the pathology solution for BT, the London Cluster LSP. Clinisys already have a robust system solution which has demonstrated the ability to interface with existing clinical systems. BT are also implementing Cerner Millennium giving assurance of compatibility with any future Millennium implementation the RDEFT may choose to undertake. Selection of a system offered by another LSP means that an extended procurement is not necessary. Purchase via an LSP also brings the financial benefit of VAT exemption.

Option 5: Procure LIMS via OJEU. This would delay the replacement of the current IPS system potentially years beyond the agreed support timescale of EDS. Market testing has indicated that direct purchase from IPS suppliers would be a more expensive option as Clinisys has already been discounted to CfH.

3.3 Economic Appraisal Assumptions

3.3.1 CostsThe following assumptions have been made when developing the costs:

The contract period for the investment appraisal will be for seven years. Revenue payments are made in line with the commencement of delivery of services Costs are discounted at 3.5% as advised by the Green Book 2003 Implementation is unconstrained by other programmes and will continue in line with the

project plan (as described in the Management Case). Technology refresh treatment is embedded in service charges for those items included in the

deployment package and any additional hardware/software purchased via the LSP provider. Local implementation costs are included along with the cost of change management and

additional costs to support ongoing operation of the service e.g. Training etc

3.3.2 RisksThe following assumptions have been made when developing the risks:

The risk retained by the Trust under the LSP bids is determined by the clauses of the contract.

All potential risk impacts are annual All likelihoods are annual Risks exclude inflation. Discounted risks exclude inflation Risks are discounted at 3.5% as advised by the HMT Green Book 2003 Risks have been identified in Appendix 4 and will be quantified and appraised with input from

key stakeholders during the Initiation Stage.

3.3.3 BenefitsThe following assumptions have been made when developing the benefits:

Benefits are assumed to be common across all options in terms of the list of individual benefits. The values/scores of individual benefits can, however, be different between these.

Benefits exclude inflation. Discounted Benefits exclude inflation Benefits are discounted at 3.5% as advised by the HMT Green Book 2003 Benefits have been identified in Appendix 2 and will be quantified and appraised with input

from key stakeholders during the Initiation Stage.

4 Commercial Case

4.1 IntroductionThe purpose of the Commercial Case is to outline the arrangements with the LSP for the delivery of LIMS.

The LSP is contracted to the Secretary of State for the Department of Health, as the Contracting Authority. The contract is managed centrally by NPfIT who are the Authority’s representative and is supported at cluster level by the Regional Implementation Director (RID).

The LSP LIMS has been negotiated to provide a high level of performance specification and service availability at local level and to ensure the solution provided is in line with the overall NHS Care Record Service vision.

4.2 Specification of RequirementsThe LIMS Steering Group and LIMS Project Board have reviewed the Southwest Peninsula output based specification (OBS) for LIMS in respect of existing and required functionality to ensure it meets the requirements of the Exeter District healthcare community. The LSP will provide services, through the LIMS supplier, to the specification set out in the contract and the Local Requirements Specification developed with the RDEFT Pathology Department.

The Business Case will be submitted for approval, which will be subject to the business case demonstrating a strategic case for funding and agreement of the implementation timetable with the LSP. A firm purchase order will then be placed with the LSP for the LIMS service. The LIMS Project Board will engage with the LSP to survey the site, share the Local Requirement Specification and firm up the local requirements and definitive costs.

4.3 Acquisition TimetableThe timetable for the LIMS acquisition is as follows.

Activity Date

Initial engagement 26th June 2007



Complete and submit Business Case for approval 14th December 2007

Trust Board approval of LIMS Business Case 28th May 2008

LIMS Order placed by RDEFT 4th June 2008

LIMS Implementation Commences 16th June 2008

Completion of Acceptance Testing 19th December 2008

Issue of Milestone Achievement Certificate 27th February 2009

Review Benefits March 2009 ongoing

4.4 LIMS Supplier & Solution

The solution for the provision of a Laboratory Information Management System (LIMS) will be delivered under the Standalone Service framework agreement (CCN1) in accordance with BT’s contract as a ‘Local Service Provider (LSP)’ within the NPfIT. The proposed solution is provided by CliniSys Solutions Limited and will be classed in its current version as a “Standalone, Trust hosted non-managed service”.

Following the Trust’s acceptance of this proposal, a full set of contract schedules, and a Standalone Service Specific Change Control Note (SSSCCN) will be issued by BT to Connecting for Health (CfH) for acceptance, and final signature.

The LSP will provide a fully operational, formally accepted LIMS which meet the requirements set out in the Southwest Peninsula Outline Based Specification (OBS) and supports relevant Trust policy. The LIMS will be fully compliant with the current and emerging requirements of the National Programme and comply with all the RDEFT requirements.

The supplier’s solution does not cover IT network (LAN) upgrades or external networks (WAN, N3 etc), analyser upgrades, change management, backfill, ongoing training, data migration, local IT support and LIMS administration support. These are shown as additional capital / revenue costs as applicable.

4.4.1 Project Scope

The main items covered in the project include : Pathology Application Server Hardware

Based on industry standard hardware, specified to provide a high degree of resilience and reliability.

Laboratory Information Management System SoftwareSoftware licence to an application that will enable pathology staff to streamline their work and to achieve accreditation including` facilities to process requests, link results from analysers to patient records, identify and flag abnormal results, authorise the release of results and provide management and clinical information.

Interface to AnalysersAutomatically connect to analysers, link samples to requests and receive results to be filed in the patient database. It will also be able to inform staff of test progress.

DevelopmentsLinks to the existing Trust systems, developments of specialist pathology needs and facilities that would allow linking to future systems, such as NHS CRS.

GP LinksLinks for the local GPs have already been implemented and the new LIMS system must be fully implemented to PMIP standards. The Pathology Department has also piloted and implemented 2D barcode generation in conjunction with label trace and utilise their scanning software to automate the requesting process.

InfrastructureThe annual technology refresh programme will ensure that no desktop hardware has been in use for more than four years. A review of LAN infrastructure at the RDEFT is underway.

TrainingAppropriate training for pathology staff and users to use the new facilities and to move to new methods of working.

Support ServicesSupporting service that will ensure a trouble-free implementation and a reliable and reactive service to keep the application running at an optimum level.

4.5 Payment MechanismThe organisation will make payments to the LSP in respect of the proposed above LIMS Services as follows:

Item Proposed Supporting Payment

Deployment Charge

Deployment to include Capital- Installation, Training (Train the Trainer

Initial one off payment £882,005 (excl. recoverable VAT ) for Deployment

Service Charges Annual Contract Service Charge paid in quarterly amounts commencing from June 2008: £121,992 p.a.(excl. recoverable Vat)

The LSP contract is a fixed price contract. Certain costs i.e. labour costs contributing to LIMS service charges are subject to indexation on 6 April each year.

4.6 Commercial RiskThis section provides a high level assessment of how the associated risks areas might be apportioned between NHS organisations and the selected LSP, in accordance with the general principle that risks should be passed to “the party best able to manage them”, subject to Value for Money.

Risk Category Potential allocation

Trust LSP Shared

1. Design Risk √

2. Development & Implementation Risk

3. Change Management Risk

4. Training/User Risk

5. Operational Risk

6.Termination Risk

7. Technology & Obsolescence Risks

4.7 Performance OptionsThis information is contained within the schedule of the Service Agreement which sets out the standards to which the Contractor must deliver the Services, the mechanism by which Service

Failures will be managed, and the method by which the Contractor's performance under this Agreement will be monitored. This Schedule comprises three key areas:

Service Level Specification – which details the services to be provided and the levels of performance to be attained

Service Failures – setting out the definitions, levels of failure and consequences

Performance Monitoring System – describing the procedures to be followed in gathering and reporting the performance achieved in the delivery of the contract.

The principles of the mechanism employed are to give a well defined boundary of what must be delivered together with a fair mechanism to allow the deduction of points where this has failed to occur and a clear and well structured process that allows all parties to determine both what has happened and the reasons and responsibilities where it has not been in line with the expectations of the contract.

Failure of the contractor to perform in line with the contractual requirement will incur compensatory payments in the form of service deductions.

4.8 Dispute ResolutionIn the first instance disputes will be raised with the Regional Implementation Director (RID)

4.9 Proposed Contract LengthsThe agreement with the LIMS supplier will be for the remaining length of the LSP contract, i.e. until 31st October 2015.

4.10 Key Contractual ClausesThese are contained within the Schedules of the main LSP agreement between the Authority and the LSP as amended by the Change Control Note for LIMS and its associated schedules. Of particular note are the Authority Responsibilities, Annex 2, covering the key responsibilities that each Trust as the Authority’s Service Recipient (ASR) will undertake on behalf of the Authority.

Annex 2 covers: Infrastructure Readiness Infrastructure Maintenance and Support Local Deployment Scoping Obligations

4.11 TUPEIt is assumed that there are no issues relating to the transfer of existing staff to a new employer. All staff whose posts will be affected by the implementation of LIMS will be dealt with in accordance with the agreed Trust policies and in full consultation with the HR department.

4.12 Implementation Time-scalesIt is anticipated that all service contracts and associated Service Level Agreements will commence in line with the go-live dates of each pathology discipline, between April and December 2008, as shown within the project plan in the Management Case.

4.13 FRS5 Accountancy TreatmentThe deal is “on balance sheet” under the application of accounting advice received by KPMG for NPfIT Core services since the deals are under the same [varied] Project Agreement. Approximately 30% of the total contract price amounting to the deployment charge including additional elements will appear on the Trust Balance Sheet and will attract capital charges in line with normal NHS accounting procedures (including depreciation over the remaining contract period and a 3.5% return on investment). At the end of the contract all assets will remain in the ownership of the service provider.

5 Financial Case

5.1 IntroductionThe purpose of the Financial Case is to demonstrate affordability for the preferred option (Standalone LIMS) established in the Economic Case and the affordability of the proposed deal over the life of the contract.

It also sets out the anticipated payment stream (£) for the investment over the life expectancy of the project and the Balance Sheet treatment of any assets underpinning the service provision.

5.2 AssumptionsThe following assumptions have been made when considering affordability:

National / Local funding – LIMS is considered an “Additional” module within the NPfIT NHS Care Record Service and, as such, does not attract any central NPfIT funding. The RDEFT will need to provide the capital resource and associated local costs including:. Trust Implementation Backfill Training Change Management Local IT support Local LIMS Administration

Recoverable VAT – As VAT goes to Her Majesty’s Treasury (HMT) it has no effect on the Public Sector as a whole and is therefore excluded from the economic analysis.

o For the initial deployment and on-going service charges VAT is fully recoverable. o Additional equipment purchased as goods either from the LSP but, outside of the

catalogue, or from another source: VAT is not recoverable.o Items of expenditure that are not part of the NPfIT contract with the LSP, but are

essential to and associated with LIMS implementation e.g. network upgrades: VAT will be treated in accordance with rulings for such contracts i.e. non-recoverable.

Capital Charges – All Public Sector bodies are expected to make a 3.5% return on assets.

5.3 Current Trust FundingThe RDEFT has allocated a provisional sum in its three year investment plans for the funding to support this programme. Realisation of cash releasing savings/improved efficiencies from the implementation of the LIMS solution will be needed to meet the revenue consequences outlined earlier in this case.

The RDEFT will also continue to fund IM&T infrastructure improvements to networks and ward based PCs. These investments are critical to a successful LIMS implementation.

5.4 Impact on Trust Income & Expenditure AccountThis shows that the expenditure (comprising hardware, software and support costs plus the cost of peripherals to support LIMS) over the contract period will cost £2,090.6k including VAT based on the charges and benefits summarised in Appendix 1.

5.5 Impact on the Trust Balance Sheet

The proposed capital expenditure of £1,267.2k in 2008/09 for LIMS will appear on the balance sheet of the Trust.

The contractual commitment, as described in the Commercial Case, to pay a Service Charge over the life of the contract for LIMS-related Services will be recorded in the Annual Accounts as a long term financial obligation.

5.6 Overall AffordabilityThe proposed cost of the project is £2,090.6k over the seven years remaining in the LSP contract).

6 Management Case

6.1 IntroductionThe purpose of the Management Case is to demonstrate that the project is well managed and can be seen to be successful.

6.2 Project Management Structure, Methodology and GovernanceWith an investment of the size and complexity of that proposed under this business case, sound project management is recognised as being of paramount importance.

A Project Steering Group, comprising staff from each pathology discipline and key stakeholders within the RDEFT and local healthcare community, has therefore been established to take forward the work required.

The project is seeking the support of trust, senior executives and clinicians, and the key decision-making and consultative bodies within the healthcare community. The LIMS project team has sought the views and opinions of users and aims to involve as many of them as possible in planning the implementation of the system.

Management commitment extends to rigorous planning and regular progress monitoring. A detailed project plan is provided in Appendix 6.

The LIMS Project Board will report regularly to the RDEFT Trust Board and the Exeter District Informatics Board. These Boards will stipulate any other reporting requirements

6.2.1 GovernanceThe project has adopted the NPFIT Programme Governance Framework, in order to ensure consistency of approach.

6.2.2 Project Management MethodologyAn established project management methodology will be utilised which, brings these requirements together into a structured process. The project management methodology used in the project is PRINCE2 (which meets the requirements outlined above and promotes arrangements to ensure both rigorous and structured planning and monitoring and the appropriate involvement of senior staff).

6.2.3 NHS GatewaysThe National Programme has rigorously followed the OGC Gateway process in order to provide assurance of ongoing commitment and application of best practice in the acquisitions. This project will be considered for gateway review.

6.3 Project PlanThe project technical and resource plans are set out in outline form and as a Gantt chart in Appendix 6. A detailed project plan will be produced in conjunction with the appointed supplier.

Once the acquisition phase of the project is completed the membership of the LIMS Steering Group will be reviewed to ensure that it is appropriate for the implementation phase. Discussions are already taking place on the implementation phase so that the project can move smoothly into implementation following signing of any formal agreement.

6.4 MilestonesThe diagram below presents the main milestones in the LIMS implementation plan.

Activity Date

Initial engagement 26th June 2007



Complete and submit Business Case for approval 14th December 2007

Trust Board approval of LIMS Business Case 28th May 2008

LIMS Order placed by RDEFT 4th June 2008

LIMS Implementation Commences 16th June 2008

LIMS Master Training Dec 2008 / Jan 2009

Completion of Acceptance Testing 19th December 2008

LIMS Go Live – Blood Transfusion 12th January 2009

LIMS Go Live – Microbiology & Virology 26th January 2009

LIMS Go Live – Biochemistry, Haematology & Immunology 9th February 2009

LIMS Go Live - Histology 23rd February 2009

LIMS Go Live – Cellular Pathology 23rd February 2009

Issue of Milestone Achievement Certificate 27th February 2009

Review Benefits March 2009 ongoing

6.5 Implementation PlanThe LIMS solution will be a stand-alone, trust-hosted, non-managed service and the management of process changes and continued drive for the project will rest with the RDEFT. With payments not commencing until the system is accepted, the supplier will be fully motivated to progress the project to completion.

The Project Board recognises that it has to be proactive to make the project a success. Towards this end the implementation has been broken down into manageable phases by discipline.

The Project Board retains the right to grant approval to move onto the next stage, and if any of the component parts of the previous stage are not fully completed the authority to continue will not be granted until such time as the board is satisfied that everything is resolved. The LIMS Project Board will continue to monitor the project.

The implementation project will start with a full site survey and final workflow analysis.

Commitment to Implementation PlanFull agreement to the implementation plan by all parties will be evidenced by the Business Case approval.

6.6 Project ReviewsIn accordance with good practice the project has the following outline arrangements in place for project reviews:

6.6.1 Post Implementation ReviewsThe lessons learned will be fed back to key stakeholders in order to improve the effectiveness of those projects that follow. The project plan (Appendix 6) contains a formal date for completion of the post-implementation review.

6.6.2 Project Evaluation Reviews (PERs)The Trust intends to use a formal post-project evaluation tool, using the benefits detailed in this business case as the success criteria. The project plan (Appendix 6) contains a formal date for completion of the project evaluation review. The objectives of the evaluation will be:

Identify how well the project aims and objectives have been achieved.

Determine if the project timescales were met, both overall and for each key milestone, and what corrective actions, if any, were taken.

Determine if the project costs were controlled and were within budget, both overall and for each of the parts of the project, and what corrective actions, if any, were taken.

Against the benefits realisation plan identify what benefits have been achieved (both cash releasing and non-cash releasing) and seek the realisation of any outstanding benefits, including the implementation of any procedural and process changes.

Assess the efficiency of the acquisition process and document the shortcomings for the benefit of future projects.

This will be carried out for the project, in consideration of and in conjunction with any NHS Gateway 5 criteria being used as the framework for these reviews.

6.7 Risk Management Strategy and FrameworkThe project will be managed in accordance with PRINCE 2.

The project’s Risk Management Strategy is twofold. Firstly, to manage, mitigate and control risks and, secondly, to ensure that risks allocated – or transferred to the Service Provider(s) – remain the responsibility of the Service Provider(s).

As part of its project management approach the project team is developing a comprehensive risk register to track and manage project, service and business risks. This register will be developed to support the management of the contract during live service operation and will be considered at quarterly service meetings. Risks will be managed at the appropriate level with escalation to the relevant programme board via the service management board when appropriate.

The risk register will be managed and monitored on a regular basis by the project team and periodically assessed by the LIMS Project Board

6.8 Benefits Management

6.8.1 Arrangements for Benefits Realisation PlanA detailed benefits realisation plan will be produced during the Initiation Stage.

The high level Benefits Realisation Strategy is to:

Identify the benefits and responsibility for their delivery

Establish baseline measurement where possible

Quantify benefits where possible

Periodically assess likely realisation and any actions required

Record further expected benefits identified during the project

Measure outcomes

6.9 Modernisation AgendaModernisation is a key driver for LIMS. The LIMS Steering Group has consulted with the local lead director for modernisation. Elaine Hobson, Director of Operations, will represent the local modernisation agenda within this project.

6.10 TrainingThe LSP will carry out initial training of clinical staff, using a “train the trainer” approach. On-going training will be picked up by the local community IM&T trainers working with the RDEFT LIMS project manager.

The LSP will produce a training plan which identifies the recommended configuration of training and associated training days.

The LSP will ensure that the training plan identifies the resources required for delivery of the training (including the number of trainers; number, location and capacity of rooms; and infrastructure and equipment requirements). The LSP will ensure that the training plan identifies the split of training responsibilities.

6.11 Contract Management StrategyThe LSP contracts are let at national level, by the DH, and will require central contract management being largely administered at Cluster level. Contracts with LIMS suppliers will be managed via the LSPs.

6.12 Communications Management StrategyThe Communications Management Strategy will be developed in terms of Cluster, SHA, and local trust communications – e.g., internal website within trust.

6.13 Security and ConfidentialityMaintaining the confidentiality and security of patient information has been paramount in the NHS CRS specification (see section 730 of the ICRS Output Based Specification), design and procurement of the NPfIT solutions.

All issues of security and confidentiality have been addressed in the Output Based Specification (OBS) and follow Caldicott principles. The issues of patient confidentiality have been taken into consideration when outlining requirements for the system. This includes the requirement for system security that ensures that all those who access and change patient information can be clearly identified through an audit trail. The OBS has also addressed the access to appropriate persons.

6.14 AdvisorsConsultancy Support may be required at various stages throughout the project and for various purposes. This may include advice on implementation matters, quality review, audit and legal. A record will be kept of any specialist advisors used to support the project. This will include any expertise available from within the local cluster.

The project has used the following specialist advisors in the Business Case preparation .

Specialist Area Adviser

LSP Contract Dean Eggleton, BT

Technical Donald Saum, Clinisys

The following people have been consulted in the development of this business case:

Exeter District Healthcare Community:

LIMS Steering Group comprising:Pathology – Paul Newman, Tony Cox. Mike Burden, John O’Connor, Colin Heapy, Julie King, Steve WaltonFinance – Mike Stevens, Kirsty SimpsonIM&T – Wendy Ware, Trevor Dymond, Rowenna Laws, Liz BoylanModernisation – Elaine Hobson

External :

SHA – SWP LIMS Steering GroupLSP – Dean Eggleton

LIMS Business Case NPFIT-PATH-ORG-IPL-0001 V0.912th May 2009 Draft

Appendix 1 Estimated Costs for Business Case This section includes the detailed costs and identified cash releasing benefits for the replacement LIMS.

2008/9 2009/10 2010/11 2011/12 2012/13 2013/14 2014/2015 2015/2016Capital Costs (Hardware & Software) Apr-Sept TotalClinisys Software, Licences , Interfaces & Implementation 882,0053rd Party Interfaces Costs 50,000Data Extraction for Migration 90,000LIMS Server 65,000Barcode Scanners 10,000Printers 20,000RDE Programme Manager (Band 8a 0.5wte to 03/09) 26,580RDE Implementation Manager (Band 7 for 9/12) 34,154Data Migration Support (Band 2 for 9/12) 12,953RDE Change Analyst(Band 6x 0.5 for 9/12) 8,588RDE Technical Support(Band 6 for 3/12) 8,588RDE Training(Band 5 for 6 /12) 13,797Pathology Implementation Leads(6xBand 7 for 2/12) 45,539

Totals 1,267,204 0 0 0 0 0 0 0 1,267,204Revenue CostsAnnual Support (BT & Clinisys) 30,498 121,992 121,992 121,992 121,992 121,992 121,992 71,162 833,612Cash Releasing/Cost Avoidance BenefitsEDS maintenance 0 230,717 230,717 230,717 230,717 230,717 230,717 134,849, 1,519,151


Appendix 2 Benefits by Business Process

Shown in the tables below are the benefits identified by the business process affected, benefit type and weighting [1-5]. The weighting allocated reflects RDEFT’s assessment of the benefits realisation potential. Some benefits are dependent upon the implementation of Order Comms (electronic requests and results reporting) which the proposed LIMS system will support.

Ref. Process Step

Benefit Description Type Weight1-5

B1 Specimen Reception

Reduced manual data entry in specimen reception - [electronic requesting and bar coding of requests].

CR 3


Reduced transcription errors on data input leading to lower levels of repeat requests and problems with results reporting destination and patient identification queries.

Q 3


Improved access to clinical details by BMS and consultants [through scanning of request forms].

Q 1


Removal of manual filing activity associated with paper based request forms. Q 1


Removal of filing space associated with storage of paper request forms. Q 1

B5 CS

Phlebotomyservice

Improve flexibility of phlebotomy service through provision of sample bar-coding at clinic and bedside and accurate patient bleeding lists, etc. [Core Services]

CR/Q? 5

B6 Request validation

Reduced level of inappropriate tests due to Rules based test request validation. Q 4

B6V Request validation

Reduced level of patients recalled to clinics [antenatal] through incorrectly identified samples. Q 5

B7 Processing Increased throughput due to reduced manual input of test request information on analysers by BMS.

Q 2

B8 Processing Capacity to trace problem testing kits and reagents - through recording of reagent batches, etc.

Q 2

B9 Processing Improved quality control - automatic audit trail of tests activity - who did what - and automatic tracking of sample/specimen through lab in real time.

Q 3

B10 Processing Improved throughput through reduced manual checking by collating results with details on request forms and adding additional tests - rules base.

Q 2

B10H Processing Reduce replication of unnecessary blood films through rules based delta checking. [Haematology]

Q 4

B13 Results reporting

Improved utilisation of consultants through remote authorisation off-site. NQ 1


Ref. Process Step

Benefit Description Type Weight1-5


Reduced manual results reporting activity - mail room activity - posting results to requester. CR 3


Reduced results reporting postage, stationery and courier costs - due to electronic reporting. CR 3

B15V Results reporting

Facilitate the transfer of statutory information electronically to other agencies, i.e. CDSC. [Virology]

NQ 2

B15M Results reporting

Facilitate the transfer of statutory information electronically to other agencies, i.e. COSERVE and other external databases. [Microbiology]

Q 5

B16 Mgt Increased capacity through more efficient use of BMS and consultants time and increased analyser throughput.

NQ 3

B17 Mgt Reduced level of repeat and clinically unnecessary tests - through improved request protocols and rules base.

Q 2

B18 Mgt An improved audit capability to support accreditation, clinical governance, quality assurance and potential clinical negligence enquires.

NQ 1

B19 Mgt Improved mechanism for BMS feedback to clinicians to improve diagnosis, training and level of inappropriate test requesting.

NQ 1

B20 Mgt Improved access to results by clinicians. NQ 1B21 Mgt Reduced LOS of patients through improved access to results. NQ 1B22 Mgt Improved access to management information to support -

Invoicing, SLA management, Research, Benchmarking, CPA.NQ 2

B23 Mgt Info Improved access to management information to support - service planning and performance/demand management including feed back to users on comparative use of tests.

NQ 1

B24 Mgt Info Reduced costs in producing management information. CR 2B24M Mgt Info Provide access to database of results to support infection control and epidemiological

research -clinical governance. [NQ 5

B26 General/ strategic

Meeting IfH requirements for EPR, EHR. NQ 1

B27 General/ strategic

Reduced level of telephone enquires for results. Q 2

B30 General Ensure all interfaces for current and future equipment is available Q 5

LIMS Business Case

Appendix 3 Benefits Realisation PlanTo be developed locally. For each benefit identified, the following information will be documented:

a description of the benefit

the investment objective(s) to which it is related

the nature of the benefit

o financially quantifiable, cash-releasing – state the value

o financially quantifiable, non-cash-releasing – state the value

o quantifiable – state the quantity and units

o qualitative

any assumptions on which the benefit is based

the tasks required to realise the benefit

the monitoring mechanism / performance indicator to be used to track delivery of the benefit

ownership of the benefit (i.e. responsibility for its realisation)

review date (to asses realisation of the benefit)

LIMS Business Case

Appendix 4 Project Risk RegisterFor each risk listed below and others identified during the life of the project the following information will be documented in the Risk Register:

risk number (a unique identifier] the date raised who raised the risk the risk owner (responsible for tracking the risk) a description of the risk an assessment of the probability of the risk materialising an assessment of the risk’s potential impact(e.g., high / medium / low) the importance of the risk (a combination of the probability and the impact) proposed countermeasures or mitigating actions

Ref Risk DescriptionOrganisational Risks

1 Failure to support clinical and business objectives of the RDEFT2 Inability to support RDEFTs ability to deliver their wider Information Systems Strategies3 Inadequate project management4 Inadequate skills and resources5 Resource requirements underestimated6 Lack of senior management/clinical support7 Lack of user involvement8 Inadequate organisational change processes9 Failure to manage expectations of partners and customers

Technical Risks11 Solution not flexible enough to meet changing requirements12 Inadequate interfaces/integration13 Unproved technology14 Capacity to manage technical obsolescence15 High levels of development required Contractual/ Financial Risks

16 Inability to control revenue implications17 Inability to manage demand18 Inability to manage and resource19 Inability to establish effective contract(s) for delivery of services.20 Inability to vary requirements21 Inability to opt out of arrangements

Inability to fund contract22 External Risks22 Inability to support Information for Health targets23 Inadequate flexibility for other customers (General Practice)

24Trust unable to meet external requirements for information, e.g.NSFs, Controls Assurance

25 Inability to support local health strategy & PCT requirements, etc.26 Inability to support changes in policy/legislation


Appendix 5 Existing Laboratory Interfaces

Blood Transfusion

Biochemistry Central Reception

Haematology Immunology Microbiology / Virology

Histology / Cytology / Mortuary

General

AnalysersAnalyser Interfaces

- IBG- Galileo

- Roche Modula via PSM via Modulab- post analytical robot RSD Roche 800A via PSM- Gem IL Gas analyser via Modulab- all interfaces to analysers via Modulab

- Sysmex XE2100 (x2) via Modulab- IL Futura- ESR

- ACL 9000 - Vidas (x3)- BacT Alert Blood Culture- UF100 urinalysis- BEP 2000- Abbott Axsym- Taqman

- Raymond lamb cassette labeller- Slide labellers- Immuno histochemistry- cytic thin prep liquid based cytology - mortuary system

Other Interfaces

- Blood Tracking (n)

- Infocom Scanning for request entry- DAWN AC- Proton Renal (via Reality)- Viewpoint DOWNS- Reality (renal feed, code files for Anglia ICE)- Anglia ICE (GP reports fro pathology, radiology & discharge summaries)- Order Comms (decision on supplier TBC)

- CoSurv (Control of Infection)- ICNET (Control of Infection)

- FHSA (Cytology)

Blood Transfusion

Biochemistry Central Reception

Haematology Immunology Microbiology / Virology

Histology / Cytology / Mortuary

General

Other Functions

- uses Electronic XM

- Key to Image- pre-printed bar code labels- skeleton requesting- specimen tracking post analytical

- pre-printed barcodes used- alpha prefixes for lab numbers

- separate request entry- touch screens in cut-up- Dragon voice recognition- cut-up worklists

-


Appendix 6 Detailed Project Plan

Detailed project plan to be completed with supplier

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