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NHSSCOTLAND SHARED SERVICES
LABORATORIES PROGRAMME
BUSINESS CASE
V1.0
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Programme Title Shared Services Laboratories Programme
Programme Manager Kim Walker (KW)
Subject Matter Expert Bill Bartlett (BB)
Health Portfolio Director Brian Montgomery (BM)
Project Managers Heather Bryceland (HB) Suzanne Tate (ST)
Programme Support Officer Jennifer Downie (JD) Niove Jordanides (NJ)
Management Accountant Damien Snedden (DS)
Version Number
Date of First Issue
Original Authors
v0.1 07.02.2018 BB, HB, JD, DS, ST, KW
Version Number
Revision Date Contributors Comments
V0.2 21.03.2018 BB, HB,JD, ST,KW Appendix & text amendments made
V0.3 21.03.2018 BB, HB, JD, ST, KW Executive summary added to document
V0.4 29.09.2018 BB, HB, JD, ST, KW Changes made following Governance group meetings
V0.5
V0.6
V0.7
V0.8
V0.9
V0.10
V1.0 29.03.2018 BB, HB, JD, DS, ST, KW
Business Case complete for submission to Chief Executives
LABORATORIES PROGRAMME TEAM
VERSION CONTROL
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TABLE OF CONTENTS
Table of Contents ...................................................................................................................... 3 Glossary ..................................................................................................................................... 5 1. Executive Summary........................................................................................................... 7
1.1 An Incremental Approach to the Design and Development of a Distributed Service Model for Laboratory Services ................................................................................................ 7 1.2 Current Challenges Facing Laboratory Services ............................................................. 7 1.3 How the recommended solutions will address these challenges ..................................... 8
1.3.1 IT Connectivity Solution .................................................................................. 8 1.3.2 National Laboratories Data Mart Solution ...................................................... 9 1.3.3 Opportunities for Savings from Both Solutions .............................................. 9 1.3.4 Whole System Benefits from Progressing to the Final State – Distributed
Service Model for Laboratories ...................................................................... 9 1.4 If we do nothing ............................................................................................................... 10 1.5 What do we want from the chief executives ................................................................... 10
2. Strategic Case .................................................................................................................. 11 2.1 Introduction to Laboratories ....................................................................................... 11 2.2 The Status Quo .......................................................................................................... 12
2.2.1 Current Challenges Facing Laboratories ..................................................... 12 2.2.2 Changing Landscape – Regionalisation of Laboratory Services ................. 13 2.2.3 IT Connectivity Challenges Facing Laboratories ......................................... 14 2.2.4 Data Challenges Facing Laboratories .......................................................... 15 2.2.5 Governance of Laboratory Services............................................................. 16
2.3 Cost of Laboratories Services in Scotland ................................................................. 18 2.4 Summary of the Status Quo and Challenges Facing Laboratories ........................... 18
3. Economic Case ................................................................................................................ 19 3.1 Introduction ................................................................................................................. 19 3.2 Developing the Preferred Option - IT Connectivity .................................................... 20
3.2.1 National High Level Specification for LIMS .................................................. 20 3.2.2 Laboratory to Laboratory Electronic Communication .................................. 21 3.2.3 Non Monetary Benefits – IT Connectivity Solution ...................................... 22 3.2.4 Monetary Benefits – IT Connectivity Solution .............................................. 23
3.3 Developing the Options - National Laboratories Data Mart Solution ........................ 23 3.3.1 Non Monetary Benefits – National Laboratories Data Mart ......................... 26 3.3.2 Monetary Benefits – National Laboratories Data Mart ................................. 26
3.4 Summary .................................................................................................................... 27 4. Finance Case .................................................................................................................... 28
4.1 Introduction ................................................................................................................. 28 4.2 Investment .................................................................................................................. 28
4.2.1 Capital Funding – Transformation Fund ...................................................... 28 4.2.2 Revenue Funding – Transformation Fund ................................................... 29 4.2.3 Recurring Revenue Funding – NHSScotland Board Funded ...................... 29
4.3 Total Investment Required ......................................................................................... 31 4.3.1 Assumptions ................................................................................................. 31 4.3.2 Efficiency Gains ............................................................................................ 31 4.3.3 Lifecycle Costs.............................................................................................. 32
4.4 Summary .................................................................................................................... 32 5. Commercial Case ............................................................................................................. 33
5.1 Introduction ................................................................................................................. 33 5.2 IT Connectivity Solution ............................................................................................. 33
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5.2.1 Procurement Route Assessment ................................................................. 33 5.2.2 Procurement Approach and Plan ................................................................. 34 5.2.3 Benefits of Implementing NPEx within NSS ................................................ 35
5.3 National Laboratories Data Mart (NLDM) .................................................................. 35 5.3.1 Procurement Route Assessment ................................................................. 35 5.3.2 Procurement Approach and Plan ................................................................. 35 5.3.3 Benefits of Developing NLDM within NSS ................................................... 35
5.4 Summary .................................................................................................................... 37 6. Management Case ........................................................................................................... 38
6.1 Introduction ................................................................................................................. 38 6.2 Programme Implementation Strategy ........................................................................ 40
6.2.1 The IT Connectivity Project .......................................................................... 41 6.2.2 The National Laboratories Data Mart Project .............................................. 41 6.2.3 Design and Development of the Distributed Service Model ........................ 41
6.3 Implementation Plan .................................................................................................. 41 6.3.1 The IT Connectivity Project .......................................................................... 41 6.3.2 National Laboratories Data Mart Project ...................................................... 42
6.4 Programme Governance ............................................................................................ 42 6.5 Benefits Realisation ................................................................................................... 42 6.6 Programme Evaluation ............................................................................................... 43
7. Appendices ........................................................................................................................ 45 Appendix 1 – National Laboratories Blueprint (NLB) ................................................. 45 Appendix 2 – National Laboratories Programme Guiding Principles ........................ 49 Appendix 3 – Variation in LIMS Systems Across Scotland ....................................... 50 Appendix 4 – Five Year Trend in Laboratory Service Costs and Activity Data ......... 51 Appendix 5 – High Level LIMS Specification ............................................................. 53 Appendix 6 – NPEx Improvement Process ................................................................ 61 Appendix 7 – Variation in Keele Subscription Across NHSScotland ......................... 63 Appendix 8 – Data Project Group Outputs ................................................................. 64 Appendix 9 - Synergies with the National Laboratories Data Mart ............................ 65 Appendix 10 – Preferred Option for a National Laboratories Data Mart ................... 67 Appendix 11 – Current NPEx Status for all Boards ................................................... 68 Appendix 12 – Total Investment Requirements for IT Connectivity and the National
Laboratories Data Mart ................................................................................. 69 Appendix 13 – Breakdown of Investement Requirements by Solution ..................... 70 Appendix 14 – Clinical and Financial Benefits of the Application of the DSM in NHS
Tayside ......................................................................................................... 73 Appendix 15 – PIN Notice .......................................................................................... 74 Appendix 16 – Assessment of PIN Responses ......................................................... 76 Appendix 17 – IT Connectivity Project Team Roles .................................................. 79 Appendix 18 – Stages of Designing and Developing the National Laboratories Data
Mart 80 Appendix 19 – Implementation Team ........................................................................ 82
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GLOSSARY
The following terms appear throughout this document and its related attachments:
ADRC Administrative Data Research Centre
A&E Accident & Emergency
BAU Business as Usual
BI Business Intelligence
CDW Corporate Data Warehouse
CE Chief Executive
DSM Distributed Service Model
eDRIS Electronic Data Research and Innovation Service
GGC Greater Glasgow & Clyde
HSLWG Haematology Short Life Working Group
IMS Information Management System
ISD Information Services Division
IT Information Technology
KPI Key Performance Indicator
KUBS Keele University Benchmarking Service
LIMS Laboratory Information Management System
NIT National Implementation Team
NLB National Laboratories Blueprint
NLDM National Laboratories Data Mart
LSOB Laboratory Services Oversight Board
NLPIT National Laboratories Programme Implementation Team
NRAC National Resource Allocation Committee
NSD National Service Division
NSS National Services Scotland
PESTLE Political Economic Social Technological Logical Environmental
PHI Public Health & Intelligence
PIN Prior Information Notice
SCBMDN Scottish Clinical Biochemistry Managed Diagnostic Network
SMVN Scottish Microbiology and Virology Network
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SPAN Scottish Pathology Network
SWOT Strength Weakness Opportunities Threat
VEAT Notice Voluntary Ex-Ante Transparency Notice
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1. EXECUTIVE SUMMARY
1.1 AN INCREMENTAL APPROACH TO THE DESIGN AND DEVELOPMENT
OF A DISTRIBUTED SERVICE MODEL FOR LABORATORY SERVICES
The Chief Executives Group approved the Strategy Paper for laboratory services in August 2017 and the proposal to adopt an incremental approach to the design, development and delivery of a Distributed Service Model (DSM). Since approval of this paper considerable stakeholder engagement has taken place to work through achievable short to medium term solutions which will enable the progress to a DSM. In practice the incremental approach has lead to the development of the preferred options for two of the enabling projects which were described in the Strategy Paper; IT Connectivity and National Data Mart solutions. Stakeholders agree that these are critical to the design and development of a DSM and this Business Case will present the case for investment for both solutions along with the anticipated benefits. It is important to note from the outset that whilst an incremental approach is being taken with the view of achieving short to medium term benefits, and adding value to laboratory services, the focus is on the longer term transformational change which will be enabled through the delivery of the DSM. Additionally that longer term benefits are anticipated, financial and non financial benefits, which will be achieved through the consolidation of services, facilities and equipment and whole system laboratory service redesign. The national programme team, working with stakeholders, including the three regional laboratories leads, have developed a National Laboratories Blueprint (NLB) which provides a framework to deliver the national strategy for laboratories and progress towards a DSM. The regional laboratories plans are aligned to this.
1.2 CURRENT CHALLENGES FACING LABORATORY SERVICES
The current model of laboratory services delivery across Scotland is not equitable nor is it nationally sustainable in light of the challenges they face.
The existing model fails to deliver a critical mass and infrastructure to enable a whole system focus on service planning, delivery, workforce, IT systems and procurement to address the many challenges Boards face individually and collectively. Services operate within a complex environment that may necessitate some degree of variation in approach in different localities; however, there is still an unacceptable level of variation within and between laboratories that leads to unnecessary duplication of services nationally. These issues, along with those identified below have an impact on service cost effectiveness, resilience and sustainability.
Current challenges facing laboratory services in NHSScotland:
• Inequitable access to testing across boards
• No NHSScotland standard approach to data gathering, analysis or storage
• Standalone IT systems which are expensive to maintain and which do not connect with other clinical systems or other laboratories within and between Health Boards
• Service duplication
• Unutilised or underutilised capacity within laboratory facilities – buildings and equipment which are not compatible with the delivery of new service models
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• High risk of single points of failure, both within specialist analytical areas and within discipline specific IT staff
• Unsustainable workforce model that is not linked to national requirements with difficulties in succession planning, recruitment and retention
This is equivalent to the situation in radiology where delivery of the transformational change required to secure a sustainable model was dependent on investment in basic connected infrastructure and consistent practice in relation to data and data management.
Laboratory services have in the main evolved as part of the development of local acute services. Most laboratories are located within or close to acute hospitals with many also serving the local community and primary care services. This model is generally clinically effective but is not always cost effective and increasingly is becoming unsustainable. In terms of activity and staffing many laboratories do not achieve critical mass and associated economies of scale. In many instances costly analysers are not being used effectively with significant unutilised capacity.
1.3 HOW THE RECOMMENDED SOLUTIONS WILL ADDRESS THESE
CHALLENGES
It is estimated that laboratory tests play a part in 70 – 80% of patient contacts. This can be either in establishing a diagnosis or, increasingly, in providing ongoing monitoring in support of the management of long term conditions. Providing effective and efficient care is frequently dependent on the right clinician having timely access to the right tests and results. Many of the care pathways reliant on diagnostic testing have associated waiting time targets, for example A&E and cancer. Implementation of a DSM with the appropriate infrastructure and practices will have a positive impact on service quality and performance.
The focus of this Business Case is on the upfront investment required to deliver IT Connectivity and a National Laboratory Data Mart (NLDM); both are fundamental to the transformational change required to deliver the DSM. Support for this business case and investment in the IT Connectivity solution and a NLDM will facilitate the removal of the constraints associated with the current model.
1.3.1 IT CONNECTIVITY SOLUTION
The preferred option for the IT Connectivity solution for laboratories is the roll out the NPEx service across all Boards within NHSScotland. This service will deliver:
• pan Scotland laboratory to laboratory communications
• access to a UK wide network of laboratories providing specialist testing Additionally the Cancer Access Teams are using Q-FIT in symptomatic patients and the NPEx solution will enable rapid access to testing and reporting from distributed facilities. Funding for a pilot of Q-FIT, using NPEx, has been provided to NHS Fife and NHS Dumfries & Galloway. The QFIT initiative mentioned earlier resulted in a 14% fall in referrals to gastroenterology in one board demonstrates the impact of targeted use of diagnostics on patient flow and capacity. This IT connectivity solution will resolve the current issue of the absence of laboratory to laboratory electronic order communication, and flow of workload, between Boards in NHSScotland. The roll out of this service across Boards will introduce a consistent approach to connectivity across NHSScotland, which does not currently exist, which will enable a
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safer, more efficient and effective flow of work between NHSScotland Boards which will reduce manual input and errors, releasing staff time.
1.3.2 NATIONAL LABORATORIES DATA MART SOLUTION
The delivery of a NLDM will resolve the current issue of the absence of a standard approach to the gathering, reporting and storing of laboratories data and lack of comparable data within and between NHSScotland Boards. The NLDM solution described in this Business Case will provide the following benefits:
• promote the standardisation of data definitions and data sets
• enable access to a robust almost real time national laboratories data set for multiple business and clinical intelligence applications
• enable delivery of the data necessary for redesign of services and transformation towards an optimal DSM for laboratory services
• potential to link laboratories data with other clinical data marts
1.3.3 OPPORTUNITIES FOR SAVINGS FROM BOTH SOLUTIONS
The implementation of the IT Connectivity and NLDM solutions and could enable savings in the region of £5.5m over a 5 year period based on existing service costs (£225m in
2016/17) during this intermediate state.
1.3.4 WHOLE SYSTEM BENEFITS FROM PROGRESSING TO THE FINAL STATE –
DISTRIBUTED SERVICE MODEL FOR LABORATORIES
System wide financial and non financial benefits are anticipated from the delivery of the future state Distributed Service Model which will be achievable from the consolidation of services, facilities and equipment.
There is an opportunity to look not just at laboratory activity but to take a whole system view of clinical pathways where there are opportunities to invest in laboratory testing in a way that reduces demand elsewhere in the system with either a net saving or capacity gain. This fits well with the concept of demand optimisation which is whole system and not restricted to laboratories. An example would be the beneficial impact on the demand for cardiac imaging and outpatient consultations through the coordinated protocol-driven introduction of BNP testing. A further area of gain would be through optimising the use of automation which still varies significantly between laboratory disciplines and between Boards. Automation would further address some of the workforce challenges whether it relates to the use of electronic order-comms systems or fully exploiting the potential of analysers to work across disciplines. Implementation of this business case and the associated move to consistency of practice would create opportunities in relation to accreditation of laboratories. The ongoing process of the accreditation cycle presents a significant challenge particularly to smaller Boards but the potential has been identified to change the focus or unit of accreditation from individual laboratories to the DSM or sub components of the DSM. This would streamline the accreditation process and help mitigate some of the risk to sustainability of clinical services associated with an individual laboratory losing accreditation. Within appropriate governance structures this will enable co-ordination of improvement activities and facilitate a once for Scotland approach and optimised use of capacity and other resources. This approach will enable significant benefits to be accrued through wider system working and consolidating services to optimise resources. The benefits of this approach has been demonstrated within Boards for example within Blood Sciences in NHS
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Tayside (evidence provided in the Economic Case) highlighting the potential for similar benefits when applied to a larger DSM.
1.4 IF WE DO NOTHING
If the business case is rejected laboratory services will still face the challenges outlined above but will lack the opportunities highlighted in section 1.3. If no changes are made to the current delivery model for laboratory services, the existing pressures will increase and the resulting service will be one where:
• laboratories are using information and technical systems which are outdated and not fit for purpose
• lack of connectivity between laboratories continues without a standardised data set
• duplication of services still exists
• annual running costs continue to increase
• workforce challenges become worse Regional approaches to laboratory services are already underway and at different stages in each of the three regions. The South East region has had a proposal for a new governance structure, incorporating a new regional operational group, approved by the Chief Executives in the South East. It is likely that each region will prioritise addressing the issues of connectivity and data consistency but if these issues are addressed separately by each of the three regions there is a significant risk of moving from 14 Board level models to three regional systems which are unable to integrate and collaborate. Even if much of the focus is on regional planning and delivery there are advantages of a national approach to ensure there is consistency in delivery and equity for patients.
1.5 WHAT DO WE WANT FROM THE CHIEF EXECUTIVES
The solutions have been endorsed by the regional laboratories leads and key laboratories stakeholders who are members of the project groups. Implementing these will enable the rapid delivery of laboratory to laboratory electronic communications and data repositories to drive the standardisation required to support the longer term goal of the delivery of shared,
interoperable IT systems and are fundamental to the design and development of a DSM.
To enable the achievement of these benefits the Chief Executives are asked to approve this business case to deliver;
1. An IT Connectivity solution which will enable laboratory to laboratory electronic communication and the management of work flow across NHSScotland Boards
2. A National Laboratories Data Mart which will provide an (almost) real time data set for multiple purposes e.g. clinical and business intelligence
3. A new governance framework to facilitate the design and development of the Distributed Service Model and the delivery of the National Laboratories Blueprint
4. A high level technical specification for the future procurement of Laboratory Information Management Systems
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2. STRATEGIC CASE
2.1 INTRODUCTION TO LABORATORIES
In July 2017 a Strategy Paper1 was approved by the Chief Executives Group to further develop the concept of a distributed service model (DSM) for laboratory services in NHSScotland. A compelling case for change was put forward in response to service challenges which were identified through a series of engagement workshops. Stakeholders
were in agreement on the case for change and challenges to be addressed.
It was proposed to the Chief Executives Group that, due to the significant scale and complexity of laboratory services, an iterative and incremental approach would be taken to service redesign to facilitate transformational change. The rationale being to ensure the required service provision to patients and clinical service users is maintained as the DSM is being designed, developed and delivered. An incremental approach is being followed and this Business Case is focused on two enabling projects; developing solutions for IT Connectivity and a National Laboratories Data Mart (NLDM) which are critical to the design,
development and delivery of the future state DSM.
Evolving discussions on the design and development of a DSM for laboratories has emphasised the significance of the enabler projects which were identified in the Strategy Paper.
Stakeholders have agreed that the delivery of a DSM is dependent upon the achievement of key enablers; an IT Connectivity solution and a National Laboratories Data Mart (NLDM); both are fundamental to enable the transformational change required to deliver the DSM and to meet the future needs of NHSScotland. The solutions will provide an accessible, consistent, national data set for laboratories and with standard data definitions and the capability, through laboratory to laboratory electronic order communications, to manage the flow of work across NHSScotland
Boards.
The IT connectivity solution (NPEx) described in this Business Case will resolve the current issue of the absence of laboratory to laboratory electronic order communication, and flow of workload, between Boards in NHSScotland. The solution will provide the ability to do this and enable a safer, more efficient and effective flow of work between NHSScotland Boards which will reduce manual input and errors, releasing staff time.
The delivery of a NLDM will resolve the current issue of the absence of a standard approach to the gathering, reporting and storing of laboratories data and lack of comparable data within and between NHSScotland Boards. The NLDM solution described in this Business Case will provide the following benefits:
• promote the standardisation of data definitions and data sets
• enable access to a robust almost real time national laboratories data set for multiple business and clinical intelligence applications
• enable delivery of the data necessary for redesign of services and transformation towards an optimal DSM for laboratory services.
1 http://www.sharedservices.scot.nhs.uk/health-portfolio/programmes/laboratories/
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The implementation of the IT Connectivity and NLDM solutions and could provide savings in the region of £5.5m over a 5 year period based on existing service costs (£225m in 2016/17) during this intermediate state. Further benefits from delivering the future state
DSM will be achievable from the consolidation of services, facilities and equipment.
2.2 THE STATUS QUO
There have been some changes to the status quo since the Strategy Paper was presented. Of significance is the further development of the regionalisation agenda. The National Laboratories Blueprint (NLB), (appendix 1), has been developed and approved by a Shared Services DSM Design Group, which included three regional laboratories leads. The NLB presents the current, intermediate and future states for laboratory services and can be used to enable incremental change towards the optimal DSM and delivery of consistency in service provision across Scotland. The NLB will support the delivery of clinical strategies such as Realistic Medicines and the National Clinical Strategy. Transformational change is required to deliver the vision for a new service model for laboratories in Scotland which will address current challenges
All three NHSScotland regions (North, South East and West) have identified laboratories as a priority service area where there are opportunities for service improvement through the consolidation of services, equipment, facilities and processes. There has been an increase in collaboration between Boards as they begin to explore the opportunities for a regional approach to service delivery. The NLB and DSM guiding principles (appendix 2) are compatible with the emerging regional approach to service delivery which is focused on efficiency, effectiveness, equitability, sustainability and affordability. This is shaping the design and development of a DSM that meets local and regional needs.
The delivery of the IT and Data project solutions will provide additional capability to enable national consistency of service delivery.
2.2.1 CURRENT CHALLENGES FACING LABORATORIES
As previously documented in the laboratories Strategy Paper (2017) the current model of laboratory services delivery across Scotland is not equitable nor is it nationally sustainable in light of the challenges they face.
Services operate within a complex environment that may necessitate some degree of variation in approach in different localities; however, there is still an unacceptable level of variation within and between laboratories that leads to unnecessary duplication of services nationally. There are service deficits within some Boards as a consequence of lack of resource. These issues have an impact on service cost effectiveness and resilience. The existing model also fails to deliver a critical mass and infrastructure to enable a whole system focus on service planning, delivery, workforce, IT systems and procurement to address the many challenges Boards face individually and collectively. The following represent some of the challenges currently facing laboratory services (not exhaustive):
• Inequitable access to testing across boards
• No NHSScotland standard approach to data gathering, analysis or storage
• Standalone IT systems which are expensive to maintain and which do not connect with other clinical systems or other laboratories within and between Health Boards
• Service duplication
• Unutilised or underutilised capacity within laboratory facilities – buildings and equipment which are not compatible with the delivery of new service models
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• High risk of single points of failure, both within specialist analytical areas and within discipline specific IT staff
• Unsustainable workforce model that is not linked to national requirements with difficulties in succession planning, recruitment and retention
• Difficulties in providing opportunities for training and career progression
• Local Board approach to capital planning does not maximise opportunities for efficiency, resilience and value
• Increasing costs and complexity in meeting standards for accreditation and regulation, multiple times
2.2.2 CHANGING LANDSCAPE – REGIONALISATION OF LABORATORY SERVICES
Whilst the above challenges are still relevant and require action, the operating environment has changed since approval of the Strategy Paper, largely influenced by the publication of
the NHSScotland Health and Social Care Delivery Plan in December 20162.
The national consistency of laboratory services is essential to enable the National Clinical Strategy. The improvement and delivery of clinical services requires the supporting diagnostics to be consistently available within all laboratories across Scotland. Currently the three regions are proceeding at varying pace and, if not aligned, may result in a siloed and inconsistent approach to the delivery of laboratory services across Scotland which exacerbates some of the challenges highlighted above and hinder the roll out of national improvements to patient pathways.
Stakeholders from the three regions recognise the need to change and have endorsed the IT Connectivity and NLDM solutions as well as agreeing to align regional service developments to the NLB in pursuit of the DSM. The Management Case describes a governance framework which will enable this which has been approved by the regional leads for laboratories and reflects the move towards regional delivery of NHSScotland services. The South East region have presented this to their Chief Executives and have been given approval to proceed to the implementation of an East Laboratory Medicine Operational Group which forms part of this governance framework.
Investment in an IT Connectivity and National Laboratories Data Mart solution is critical to the delivery of a more resilient and sustainable future DSM for laboratories.
2 http://www.gov.scot/Resource/0051/00511950.pdf
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2.2.3 IT CONNECTIVITY CHALLENGES FACING LABORATORIES
Effective laboratory information management systems are critical for the delivery of high-quality, safe laboratory services that are triple aim focused (better care, better experience of care and cost of care)
In the context of this Business Case, the definition of IT Connectivity is laboratory to laboratory communication which is interoperable and enables workflow across NHSScotland Boards. The requirement is the implementation of a single communications service that can be used by all laboratories to receive examination requests from anywhere in NHSScotland into their local system and to export results back to the requesting Board. The need for an IT Connectivity solution is detailed in the NLB, (appendix 1, ref T4 and T7) to support a future DSM and the delivery of a safe, efficient and effective laboratory service for NHSScotland.
Electronic connectivity to referral laboratories will enable reduced complexity of the request to report cycle for referred work (work sent on to another lab), reduce error and failure rates found in the existing manual approach to data transfer and open opportunities for delivery of the DSM and new services. Transfer of workloads without electronic connectivity impacts on the ability to sustainably move workloads while maintaining or improving turnaround times. Recent transfer of one service to another Board was complicated with15, 000 requests per annum to be managed by paper based systems. This delivers a rate limiting step in process that also impacts on capacity of the recipient laboratory and turnaround time of results. National access to new and emerging technologies delivered by specialist development sites can be better achieved through an interconnected system delivering rapid translation of benefits to a wider population and downstream services.
As the quantity of digital information increases, the ability to store, retrieve and analyse data has become increasingly important. Laboratory services will be unable to respond to either of these demands as a consequence ageing IT, inadequacies in existing infrastructure and continued working/development in silos.
It has been documented that there is variation in LIMS systems (appendix 3) used across Scotland. Differences in local service configurations and processes also lead to variation and complexity in LIMS configurations. Together these deliver barriers to cross border working of laboratory professionals (e.g. cross border reporting and results validations) and aggregation of data. Further, there are high volumes of work that currently flow between laboratories that necessitate manual processes to transfer information between LIMS systems. Current disparity between both laboratory software and data means that meaningful cross border analysis is not currently possible and does not enable optimal use of resources on a national basis.
The requirement for common IT systems has been identified as an essential prerequisite to the delivery of a DSM. The delivery of a common LIMS system for Scotland or a region requires convergence of laboratory and other processes, the use of shared protocols, common coding systems and taxonomies. The procurement of enterprise wide LIMS is potentially a longer term goal for the DSM.
In the short to medium term there is widespread agreement on the need for better supported IT that delivers interoperability and thus workflow across NHSScotland Boards. The need for laboratory to laboratory communications as an incremental change to progress towards inter-operability/integration of IT systems has been identified as one of the desired outputs of
the NLB.
IT Connectivity will enable the joining up of IT systems to provide the connectivity required to underpin a more resilient, sustainable future business model for laboratory services within Scotland.
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2.2.4 DATA CHALLENGES FACING LABORATORIES
There is no nationally agreed data set or definitions for laboratories in Scotland and therefore an inability to meaningfully collate data for strategic planning or service improvement. Information systems are not integrated and there is an inability to share patient information between NHS Boards with disparate and disjointed approaches to data collection, analysis and storage. A National Laboratories Data Mart will address the current and future data challenges and is fundamental to facilitating the design and delivery of a
DSM for laboratories in Scotland.
A standardised national data set that is accessible and can be used to compare laboratory service delivery across NHSScotland is therefore critical to achieving the anticipated benefits from implementing a new service model. The data and information requirements for delivery of efficient and effective laboratory services are substantial. The range of applications and requirements for data, identified as data requiring domains, are shown at a high level in Figure 1 below. This requirement has been endorsed by stakeholders as being representative of the current state and identifies the future requirement. A national data mart will also support the delivery of an Atlas of Variation and optimisation of laboratory test use. The delivery of a data mart for laboratories will provide the capability to address the current and future data challenges.
In November 2016, the laboratories programme team initiated a project to support national benchmarking and to use the results of the 2016/17 Keele University Benchmarking Service returns to support the development of a DSM for laboratories in Scotland. The data returns were not granular enough to support the DSM design process. Consequently the focus shifted to identifying a more sustainable data solution which goes beyond benchmarking towards an almost real time data solution that would capture national data requirements. As outlined in the Economic Case the Data Project Group supported the proposal for the development of a NLDM.
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Figure 1: High level schematic of future data requirements for NHSScotland laboratory services.
2.2.5 GOVERNANCE OF LABORATORY SERVICES
Currently, there is variation in the governance structures in place to manage the delivery of laboratory service across NHSScotland Boards. These have evolved in response to local clinical service demands and are no longer fit for purpose given the move towards regional working and the need to collaborate to provide the most efficient and effective services within regions. Stakeholders agree that the status quo does not enable speedy continuous improvement and a new governance structure is required to enable system wide transformational change that can be delivered through implementing the NLB and DSM. The proposed governance structure is depicted in the figure below along with the benefits which can be realised from implementing a DSM.
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Figure 2: DSM Regional Delivery Model.
Key Attributes of a Distributed Service Model
• Laboratories at different geographical locations will have differing configurations not necessarily include all disciplines.
• A critical mass of resource to enable tailored delivery of local services providing opportunities for local and national service development.
• Delivery of services against the backdrop of the national clinical strategy utilising residual local capacity to deliver a value added service with a national focus.
• Specialist services delivery not necessarily restricted to larger centres.
• Reduced intrinsic and extrinsic variation (demand optimisation).
• Reduced waste and improved patient safety.
• Right test, right place, right time.
• Efficiency, effectiveness, equitability, resilience and affordability.
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2.3 COST OF LABORATORIES SERVICES IN SCOTLAND
The total net costs for diagnostic laboratories are circa. £292m per annum 3. Appendix 4 demonstrates a five year trend in laboratory service costs and activity data, this information was taken from the Cost Book.
This shows continuous growth in the total net cost for laboratory services; from £278m in 2012/13 to £306m in 2016/17: A 10.1% increase over a five year period.
The structure of NHS Boards has evolved historically and the accountability for both financial, performance and quality targets remain within individual NHS Boards. As a result of this there has been limited cross boundary or regional working to address the laboratories challenges. It is anticipated that these costs will continue to escalate due to siloed working
and implementation of local solutions.
2.4 SUMMARY OF THE STATUS QUO AND CHALLENGES FACING
LABORATORIES
Due to the significant scale and complexity of laboratories, an iterative and incremental approach should be taken to service redesign and transformational change.
The IT Connectivity solution and a NLDM are fundamental to the development of the final DSM and both will deliver functionality that will increase service resilience and sustainability in the shorter term. Both enabling projects are part of the future state described in the NLB which can be delivered through a new governance framework as presented in Figure 2.
The approach delivers three regional governance Boards responsible for service delivery with a National Laboratories Oversight Board which will be accountable for facilitating a consistent approach to the delivery of the NLB. This approach has been endorsed by key stakeholders, including regional laboratories leads, and the case for investment will be
described in the remainder of this Business Case.
3 http://www.isdscotland.org/Health-topics/Finance/Costs/Detailed-Tables/Laboratory.asp
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3. ECONOMIC CASE
3.1 INTRODUCTION
The focus of the economic case is to compare the viable options with the “status quo” option. The Strategic Case has set the context to this work and identified some of the key challenges currently affecting laboratories. The national laboratories programme team have been working with 3 key stakeholder groups to develop options to address the following issues:
• Lack of comparable laboratories data within and between NHSScotland Boards with no standard approach to the gathering, reporting and storing of laboratories data
• Standalone IT systems which do not connect other laboratories within and between Health Boards
Addressing these issues through IT Connectivity and the NLDM solution is fundamental to enable the design and development of a new DSM. The process for agreeing the preferred options is described in the following section, along with the opportunities and anticipated benefits each solution will offer. The options for an IT Connectivity and NLDM solution emerged as outputs from detailed discussions and working sessions with 3 Project Groups, which were established for IT, Data and the DSM Design Group. In addition evidence was gathered from path finding services that have developed best practice and local solutions which set the direction of travel. The project groups agreed that two clear solutions emerged from this approach which negated the need to conduct a formal options appraisal. Therefore this section of the business case compares the preferred options to the status quo to demonstrate the benefits which can be realised through investing in the IT Connectivity and NLDM solutions. The preferred option for IT Connectivity is the procurement of the NPEx service which will enable laboratory to laboratory electronic communications and the effective management of work flow across Boards. Three large Boards have already successfully implemented this solution within Scotland which has enabled connectivity between laboratories and Boards. Additionally stakeholders agreed that a high level specification for a LIMS system would be a step towards addressing the challenges of variation in laboratories IT systems. The intention is that the specification can be used by Boards for future procurement. Table 1 below illustrates the current levels of variation in laboratories IT systems. Table 1: Current variation in laboratories IT Systems
Variation in laboratories IT Systems (15 Boards – not including SNBTS)
Laboratory Information Management
System (LIMS) Electronic Ordering (Order Comms)
• 11 different LIMS
• Supplied by 9 different system providers
• 3 Health Boards using multiple systems
• Where Health Boards are using the same systems they are using different software versions
• 8 different systems
• Only 5 offer between Health Board communication
• Most Health Boards use different systems for primary and secondary care
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The preferred option for the development of an accessible standardised data set is a NLDM which will support the provision of a nationally consistent approach to gathering, reporting and storing laboratories data. A National Data Mart is a tried and tested solution to manage and store national data which can be used for multiple purposes to support service planning/redesign, benchmarking and continuous improvement. The National Radiology Programme is currently implementing this solution and NSS Public Health and Intelligence have developed a number of Data Mart solutions for NHSScotland services. The preferred options for IT Connectivity and a NLDM will enable the rapid delivery of laboratory to laboratory electronic communications and data repositories to drive the standardisation required to support the longer term goal of the delivery of shared and interoperable IT systems. The solutions have been endorsed by the regional laboratories leads and key laboratories stakeholders who are members of the project groups. Implementing these will enable the rapid delivery of laboratory to laboratory electronic communications and data repositories to drive the standardisation support the longer term goal of the delivery of shared/interoperable IT systems.
3.2 DEVELOPING THE PREFERRED OPTION - IT CONNECTIVITY
Stakeholder engagement has been facilitated through workshops and an IT Project Group. Initial discussions focused on the requirement for a single national LIMS system, or systems with equivalent functionality, to enable the shared provision of laboratory services. Evidence gathered on similar approaches demonstrated that the scale, complexity, time and funding requirements to implement a national LIMS are considerable. This approach has been adopted within NHS Wales and Southern Ireland over a 10 year period. Stakeholders agreed that while a national LIMS would help mitigate current service challenges by enabling IT connectivity between Boards and supporting the delivery of a DSM, this is a long term solution. The immediate requirement is to provide interim measures which could be delivered in the shorter term and therefore also enable work to progress on the design and delivery of a DSM. The proposed solution will enable the rapid delivery of laboratory to laboratory electronic communications and data repositories to drive standardisation and support the longer term goal of delivery of shared/interoperable IT systems. The IT Project Group agreed that interim measures would include national delivery of:
• An IT Connectivity solution that would provide laboratory to laboratory communications to enable flow of laboratories workload between Boards
• A high level specification for a LIMS system which could be used as part of a national framework for the procurement of future systems.
3.2.1 NATIONAL HIGH LEVEL SPECIFICATION FOR LIMS
Boards are also in varying stages of their procurement life cycles for LIMS and the IT Project Group therefore agreed that producing a high level national technical specification for the future procurement of LIMS systems would be beneficial. This would mean that any LIMS procured by Boards in the interim will conform to the longer term requirements necessary to support a DSM. Essential criteria will be included in future procurement exercises to enable the alignment of systems, facilitate inter-operability and provide consistency across all Boards. This will enable a phased migration to a final state to develop standard approaches to LIMS configurations as is articulated / described in the national Blueprint. There is an opportunity and appetite to achieve this through a regional delivery approach which is aligned to the national Blueprint and guiding principles.
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A subgroup was established to produce the national technical specification for LIMS system. This can be found in appendix 5. It is recommended that this is mandated to all NHSScotland Boards for use in future procurement of LIMS systems. Adopting the national specification will, over time, deliver the following benefit:
• procurement of suitable future LIMS systems which include shared high level criteria
3.2.2 LABORATORY TO LABORATORY ELECTRONIC COMMUNICATION
The IT Project Group agreed that there are opportunities for delivering a connectivity solution the adoption of a third party laboratory to laboratory electronic communications system to manage cross border flow of specialist referred workloads or workload redistribution within a DSM. The NPEx solution is deemed to be a shorter term laboratory to laboratory communications solution with a longer term answer still to be identified and agreed (this could be a national LIMS). However in the event that a national LIMS is implemented in the longer term, NPEx will continue to provide the longer term capability of connecting to other laboratories in the UK. Following previous discussions, at the IT Project Group meeting on 11th December 2017, it was agreed that the IT connectivity solution could be achieved through NHSScotland wide implementation of NPEx, or a similar service. This was based on existing evidence from 5 Boards who have or are in the process of implementing NPEx. The preferred option for the IT Connectivity solution for laboratories is the roll out the NPEx service across all Boards within NHSScotland. This service will deliver:
• pan Scotland laboratory to laboratory communications
• access to a UK wide network of laboratories providing specialist testing
Additionally the Cancer Access Teams are using Q-FIT in symptomatic patients and the NPEx solution will enable rapid access to testing and reporting from distributed facilities. Funding for a pilot of Q-FIT, using NPEx, has been provided to NHS Fife and NHS Dumfries & Galloway. The IT Project Group published a PIN notice to test the market for suppliers and confirm whether any other supplier could provide a like-for-like service to NPEx. The result of this exercise is documented in the Commercial Case; in summary NPEx emerged as the most suitable supplier to meet the IT Connectivity requirements and was agreed as the preferred option by the IT Project Group. This agreement, alongside the responses from the PIN, negated any requirement to carry out a formal option appraisal. There is great impetus and drive within the laboratories community to progress to the preferred option. Table 2 below presents the key features of the preferred option for IT Connectivity solution compared to the ‘status quo’ option.
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Table 2: Description, key features of the ‘status quo’ and preferred option
Status Quo Preferred Option – Implement NPEx Nationally
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• Ageing IT and other existing infrastructure will affect ability to respond
• Continue working in silos
• Disparity between both laboratory software and data means that meaningful cross border analysis is not currently possible
• NPEx is a national service for NHS laboratory services to connect all labs together through a single exchange hub so that test requests and laboratory results are sent digitally from any laboratory to any laboratory
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• No additional costs above existing LIMS annual maintenance
• Manual processing of tests
• Paper based system
• A national solution for connecting LIMS systems together
• Elimination of manual request input
• Ability to track the progress and physical location of tests and results
• Decrease turnaround times
• No additional hardware required
• Supports service redesign
• Enables access to distributed services
• Rapid access to developing services (e.g. Q-Fit,)
3.2.3 NON MONETARY BENEFITS – IT CONNECTIVITY SOLUTION
Appendix 6 illustrates the improved laboratory to laboratory communications enabled by the implementation of NPEx. This will provide the following benefits to Boards, hospitals and patients within NHSScotland:
• improved patient safety by reducing transcription errors with reports from provider labs being delivered electronically with commentary
• improved turnaround times on referred patient results
• improvement in patient pathway through speedier availability of test results enabling speedier patient treatment and discharge
• improved sample tracking and audit information - reduce number of samples lost in transit and reduction in retest
• enables movement of significant workloads across locations using different LIMS systems
• increased flexibility - laboratories can gain access to wide range of service providers across a UK wide network
• improved cost information to support cross charging
• business intelligence enabling better management decisions
• improved performance monitoring of all laboratories providing external work
• facilitates end to end electronic requesting with access to testing across the country
• supports national clinical trials by enabling work flow to central laboratories
• supports incremental change and move to national LIMS system - new and old LIMS systems can be connected via NPEx
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3.2.4 MONETARY BENEFITS – IT CONNECTIVITY SOLUTION
The implementation of NPEx will provide the following non cash releasing monetary benefits:
• improved patient pathway – potential to reduce length of bed stays, faster availability of test results, quicker patient treatment and discharge
• economies of scale delivered through consolidation of staff workloads, equipment, facilities to centre’s within the DSM
• increased productivity - reduced error rates in lab to lab requesting - reduced numbers of repeat patient attendances at clinics as a consequence of missing results
• cost avoidance through reduction in laboratories staff time on retesting
• efficiencies through paperless working
• cost avoidance through access to testing at central locations that impact on outcomes, monitoring impact of interventions, patient flow and capacity (e.g. Q-Fit testing (reduced waiting times avoidance of cost of waiting time initiatives), NT-proBNP (triage to echoes, monitoring response to new CHF drugs)
• reduced error rates in lab to lab requesting therefore reduced numbers of repeat attendances at clinics as a consequence of missing results
• enhanced value for money by being able to see which other laboratories offer which tests for what price, can review turnaround and performance
• efficiencies by outsourcing those tests which can be done at a lower cost in other centres, while retaining flexibility and capacity to respond to local demand.
Finally there is potential for income generation as a consequence of NHSScotland available test repertoires being made visible UK wide.
3.3 DEVELOPING THE OPTIONS - NATIONAL LABORATORIES DATA
MART SOLUTION
Stakeholder engagement on developing an option to improve laboratories data has been facilitated through the Data Project Group. Initially the group focused on facilitating the improvement of benchmarking data to support the development of a DSM however it was evident that the University of Keele benchmarking data did not provide the granularity required and did not address the challenge of moving to standardised definitions or data sets. Currently intelligence at a national level around laboratory medicine services is primarily dependent upon a hybrid of data set made available via the Scottish Health Services, Cost(s) report, the Keele University Benchmarking Service (KUBS) and some individual network initiatives such as the Scottish Pathology Network (SPAN). The national annual total cost for laboratories subscribing to KUBS for 2016/17 was £32,740, however not all boards and disciplines subscribe to the service (see Appendix 7 for national variation). The ‘do nothing’ option is untenable and the static annual benchmarking exercise is both labor intensive, time consuming and only provides a snapshot of data at a specific point in time. The current view, shared by stakeholders, is that data available for most laboratory disciplines are in the main inadequate and not fit for the purposes of benchmarking, the laboratories service or the requirements of the national laboratories programme to support a DSM. The Data Project Group agreed that an annual benchmarking exercise provided limited benefits and that a more comprehensive approach was required which addresses the need for standardised definitions and data sets. This was further evidenced by existing work which NSS Information Management Services (IMS) and NHS Lothian are developing on almost
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real time data gathering and visualisation. The outputs of this work were presented to the Data Project Group and a wider stakeholder group at a number of events (see appendix 8) providing a compelling argument for the need to move towards a NLDM. The NLDM solution offers the same benefits and more of the best practice initiated by IMS and NHS Lothian with further progression to standardised definitions and data sets, providing accessible almost real time data with reporting and visualisation capabilities e.g. dashboards. The Data Project Group planned a formal options appraisal from October 2017 – January 2018; however stakeholders agreed in November 2017 that a NLDM was the only viable option to address the data issues currently facing laboratories in NHSScotland. The design, development and delivery of data marts is part of the core business of NHS PHI and BI and they are preferred supplier of this service for NHSScotland. There was therefore no requirement to publish a PIN notice to test the market for suitable suppliers.
The Preferred Option for a NLDM is a repository stored within the NSS Corporate Data
Warehouse which will provide:
• Nationally consistent, robust, comparable information on laboratory services held in a data mart (BI platform) within the NHSScotland CDW4 to:
o underpin the DSM, including service and strategic planning at a national, regional and local level; and
o support safe, efficient and resilient laboratory service delivery across Scotland.
The NLDM provides a solution to current challenges and is the preferred option as agreed by the Data Project Group, the Managed Diagnostic Networks and the regional laboratories leads. It will have a critical role in realising the vision of a DSM for laboratories in enabling a consistent and national approach to gathering, reporting and storing laboratories data. This can be achieved through an incremental approach (see Figure 1). Table 3 below outlines the key features associated with the preferred option of the NLDM in comparison to the ‘status quo’.
4 http://www.isdscotland.org/Products-and-Services/Datamarts/
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Table 3: Description, key features and risks of the options.
Do nothing Preferred Option - National Laboratories Data Mart
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National laboratories data is of variable quality and is gathered from unlinked, laboratory data sources for single function - annual benchmarking reporting of quality, workload, staffing, productivity and finance data.
Development and implementation of a NLDM with almost real time data analysis capabilities which will provide critical intelligence which can be used for multiple purposes including; strategic and operational planning of services, identification and reduction of variation, service benchmarking, continuous monitoring of key performance indicators, service improvement and demand and capacity planning
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• Current service delivery informed from existing data sources
• No additional costs other than annual subscription fee to KUBS (National annual cost 16/17 £32,740)
• Manual input
• Almost real time data system with dashboard and reporting capabilities which is stored centrally and is accessible to all laboratories/modalities
• Standardised data sets and reporting to enable effective and meaningful benchmarking
• Accessible almost real time data for multiple purposes to support laboratory services with service planning, operational delivery, continuous improvement
• Data that supports demand optimisation (atlas of variation) and improved clinical effectiveness
• Granular data to enable more effective planning and decision making through enhanced understanding of extrinsic improving clinical effectiveness
• Significant reduction of manual input • Data sets to link with other clinical Data Marts and
Public Health Scotland • Provide data to support clinical research (linkage
studies) There is great willingness within the laboratories community to support the development of a NLDM. Appendix 9 illustrates how this work compliments other national initiatives being delivered through the Managed Diagnostic Networks and the Demand Optimisation in Diagnostics 5programme. Appendix 10 displays the vision for the NLDM.
Further capability which will be provided by the delivery of the NLDM includes:
• A product which has been co-created in collaboration with key stakeholders to ensure it meets their needs
o Information presented in reports/dashboards e.g. Tableau Dashboard. The national reports and/or national dashboards required will be determined in collaboration with NHS Boards and diagnostic networks and will be developed via iterative development.
o The ability to ‘drill-down’ from national to patient/clinician level (with appropriate permissions) and to different geographical configurations (local, regional and national);
o A suite of analytics including visual analytics such as maps;
o KPIs, quality measures and process measures;
5 http://www.gov.scot/Resource/0051/00514237.pdf
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o Reports tailored to local needs with the ability for analysts and clinicians to develop additional visualisations and dashboards to meet local needs which can be shared via the national platform;
o Reports linking into data sets held locally (subject to demand and outcomes of engagement); and
Options for predictive modelling will also be explored.
One of the key benefits of delivering the NLDM via NSS is that this will provide a national BI platform that NHS Boards will be able use to create bespoke data analytics and visualizations, including:
• Content tailored to NHSScotland requirements (not ‘out of the box’).
• A ‘wrap around’ consultancy and analytical service:
• Ongoing engagement with the user community to ensure the solution remains fit for purpose and to govern future developments.
• A BI platform which enables NHS Boards to carry out ad hoc analyses and supplement any national dashboard(s) provided with local dashboards as required to meet local needs. These dashboards would include KPIs which are yet undefined but could
include:
o staff retention rates
o equipment utilisation
o service operating costs
o retesting rates
o test type, volumes and demographics e.g. per head in localities, regions, nationally
3.3.1 NON MONETARY BENEFITS – NATIONAL LABORATORIES DATA MART
The implementation of the NLDM will provide the following benefits:
• improved quality of laboratory data
• reduction in variation through standardised dataset
• improved business intelligence of laboratory services to enable service planning and redesign
• increased response time to emergent operational questions with access to almost real time data
• improved data security and information governance
• linkages to other national Data Marts
• high quality benchmarking data
• almost real time monitoring of key performance indicators
• synergies with other programmes – preventing duplication of effort e.g. Demand Optimisation Group and Atlas of Variation work
3.3.2 MONETARY BENEFITS – NATIONAL LABORATORIES DATA MART
• supports increased productivity by providing more accurate and accessible data, resulting in reducing errors and rework
• increased ability to redesign future service model and establish DSM
• enhances value for money by being able to see which other laboratories offer which tests for what price, ability to review turnaround and performance
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The development of a national standardised data set for laboratories will be held and managed within NHS National Services Scotland and has the advantage that the data is held within a Safe Haven and supported by robust Information Governance permissions. The linkage to other national data marts within the Corporate Data Warehouse will enable the operational management and strategic planning and modeling of the DSM and laboratory services based on historical data and linked to patient outcomes.
3.4 SUMMARY
The focus of this Business Case is on the upfront investment required to deliver IT Connectivity and a National Data Mart; both are fundamental to the transformational change required to deliver the DSM. The solutions have been endorsed by the regional laboratories leads and key laboratories stakeholders who are members of the project groups. Implementing these will enable the rapid delivery of laboratory to laboratory electronic communications and data repositories to drive the standardisation required to support the longer term goal of the delivery of shared interoperable IT systems and are fundamental to the design and development of a DSM.
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4. FINANCE CASE
4.1 INTRODUCTION
The purpose of the financial case is to demonstrate the affordability of the preferred option and provide details of investment requirements. This section will set out the investment requirements (both capital and revenue) of the preferred options for the IT Connectivity solution and a NLDM. Given that the implementation of this Business Case will not create a new legal entity and a number of territorial Boards will be impacted, there has been no attempt to artificially produce a balance sheet or statement of consolidated net expenditure for Laboratories in Scotland. Instead, the financial consequences are documented below. Upfront capital investment of circa £1.1m and £5.5m of revenue investment over 5 years is required from the Scottish Government Transformation Fund to ensure full implementation of the IT Connectivity solution and a NLDM. There is an assumption that NHS Scotland Boards will cover recurring revenue costs of circa £1.5m over a 5 year period for on-going license costs, maintenance and support. This could be based on a fair measure such as number of users or NRAC.
4.2 INVESTMENT
Table 4 below presents the total capital, revenue and non recurring revenue investment required to implement the IT Connectivity solution and the NLDM.
4.2.1 CAPITAL FUNDING – TRANSFORMATION FUND
The capital investment required from the Transformation Fund for full implementation of the IT Connectivity solution over a 2 year period to roll out the NPEx service and enable laboratory to laboratory communications across NHS Scotland is £0.3m. Currently 7 Boards in NHSScotland have procured the NPEx service, 3 of the Boards are live and have implemented the solution and 4 have not implemented the solution. The remaining 7 Boards have not procured the NPEx service and so investment is required to provide these Boards with equal access to this IT Connectivity solution. Appendix 11 summarises the current NPEx status for all Boards. To enable equal access to the NPEx service and provide laboratory to laboratory communication for all Boards across NHSScotland investment is required to provide:
1. 7 Boards with the NPEx service, the interface between the LIMS systems and NPEx and implementation of the IT Connectivity solution for one laboratory discipline per Board initially with a phased roll out to remaining disciplines, handing over to BAU
2. 4 Boards with the implementation of the NPEx service and IT Connectivity solution
for 1 laboratory discipline per Board initially with a phased roll out to remaining disciplines, handing over to BAU
The capital investment required from the Transformation Fund for full implementation of the NLDM is £0.8m over a 5 year period.
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4.2.2 REVENUE FUNDING – TRANSFORMATION FUND
The revenue funding required from the Transformation Fund for the IT Connectivity solution is £0.16m which includes an annual maintenance cost for the NPEx service and LIMS interface for the 11 Boards, phased over 2 years. Details of the phased approach are found in appendix 12. The NLDM revenue funding requirement from the Transformation Fund is £1.3m over a 5 year period which includes services provided by NHS National Services Scotland Public Health and Intelligence and IT that will develop and host the NLDM. A National Laboratories Programme Team is required to deliver the IT Connectivity solution and NLDM and funding of £4.1m over a 5 year period is required for this from the Transformation Fund. Further details are provided on the implementation team in the Management Case.
4.2.3 RECURRING REVENUE FUNDING – NHSSCOTLAND BOARD FUNDED
Table 4 presents the recurring investment required by Boards over a 5 year period to support the continued IT Connectivity service and the NLDM is in the region of £1.5m. Circa £0.74m of this is required for annual NPEx subscriptions and interface costs to maintain IT Connectivity and a further £0.74m required for Tableau licenses, maintenance and hosting costs for the NLDM. Further detail around the assumptions and a breakdown of individual project investment requirements can be found in appendix 13. The 7 Boards who have procured NPEx are currently paying the annual license and maintenance costs for this service along with interface costs. For the remaining 7 Boards who require the NPEx service, the recurring revenue will be from year 2 or 3, depending on which phase the Board will become live, and are not included in existing budgets. The NLDM will be a new service to all Boards therefore associated revenue costs will not be included in existing budgets and the assumption is that Boards will cover the ongoing costs required to maintain the service. A summary of the NPEx service recurring costs are found in table 4 below, a detailed breakdown by Board is included in appendix 13. The recurring costs for the NLDM cannot be broken down to a Board level at present.
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Table 4: Summary of Transformation Fund and Board Funded Investment Requirement – IT Connectivity and NLDM.
Funding Year 1
£m
Year 2
£m
Year 3
£m
Year 4
£m
Year 5
£m
Total
£m
Transformation Fund
Capital cost
IT Connectivity 141,360 182,400
0 0 0 323,760
NLDM 235,000
295,000
156,000
114,000
0
800,000
Total capital cost 1,123,760
Revenue cost
IT Connectivity 88,800
76,800
0 0 0
165,600
NLDM 198,902
322,423
355,471
356,136
67,068
1,300,000
Implementation 1,255,965
1,213,348
588,363
600,129
448,685
4,106,490
Total revenue cost 5,572,090
Total Transformation
Fund
6,695,850
Board Funded
Recurring revenue
cost
NPEx licenses, maintenance and interface support
0 127,600
204,400
204,400
204,400
740,800
Tableau licenses, development and hosting
76,000
101,000
101,000
203,667
255,000
736,667
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Total Board Funded 1,477,467
Total Programme
Funding
8,173,317
4.3 TOTAL INVESTMENT REQUIRED
To summarise this Business Case is looking for upfront investment of circa £6.7m from the Transformation Fund over 5 years and £1.5m Board funding to cover recurring revenue costs.
• IT Connectivity costs were taken from supplier information gathered from the PIN notice (explained in the Commercial Case), from contacting LIMS suppliers and from evidence provided by those Boards who have gone live with the solution
• NLDM costs were supplied by NSS PHI/IT and include Tableau license, maintenance and host costs
4.3.1 ASSUMPTIONS
The following assumptions have been made:
• The upfront investment for the implementation of the IT Connectivity solution is for 1 laboratory discipline per Board initially with a phased roll out to remaining disciplines, handing over to BAU
• Each Board will absorb the recurring revenue for the NPEx service and associated maintenance costs
• Each Board will absorb the recurring revenue for Tableau licenses, maintenance and hosting of the NLDM
• Implementation costs will be provided by the Transformation Fund
4.3.2 EFFICIENCY GAINS
There is anecdotal evidence from the laboratories service that improving laboratory to laboratory communication and developing a national, quality data set could improve productivity by reducing manual intervention, reducing variation and speeding up existing processes. Opening up and sharing capacity will enable a conservative 1% efficiency gain on NHS Scotland laboratories service costs (2016/17 Cost Book data, £225m annual) following the implementation of the IT Connectivity solution, the NLDM and could provide savings in the region of £5.5m over a 5 year period. A practical example of this is the current transfer of immunology workloads from NHS Fife to NHS Tayside. This amounts to transfer of circa 15,000 test requests per annum that are paper based and which require manual transcription of patient demographics, clinical information and order details into the NHS Tayside LIMS. The tests are performed and printed reports containing the results are returned to the Fife laboratory. The Fife laboratory then manually scan those reports into local systems which means that granular data is not
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available to enable local electronic reporting. This delivers process overheads in managing the requests, potential data quality issues associated with data transcription, inefficiencies and risk associated with the reporting process for the receiving laboratory and for end users in terms of ease of access to reports. NPEx negates these issues and further improves the capacity of the service by removal of a rate limiting step in the request to reporting cycle. Efficiencies afforded by laboratory to laboratory electronic requesting provides capacity within the immunology service to meet the needs of other boards in a way that is consistent with the DSM. Further examples are included in appendix 14.
4.3.3 LIFECYCLE COSTS
Based on advice from procurement specialists, a capital refresh every five years was factored into this Business Case. From an affordability perspective, in order to maintain the IT Connectivity solution, investment on a 5 year cycle may be required. Assuming this would be required and based on the original estimate, the required investment would be in the region of £0.22m of capital every 5 years. The assumption is that this would be top sliced from NHS Boards on an equitable basis.
4.4 SUMMARY
Investing in IT Connectivity and the NLDM facilitates the achievement of the future DSM. The implementation of the DSM will enhance value for money and will present significant opportunities to consolidation of services, improved productivity and time releasing savings which can be reinvested in the service. The investment required to deliver laboratory to laboratory communications and a common national data set, which is fundamental to the development of a DSM, through IT Connectivity and a NLDM is in the region of £8.1m over a 5 year period. Based on 2016/17 Cost Book data this equates to 0.36% of the annual laboratories budget for NHS Scotland. By opening up and sharing capacity and improving turnaround times then taking a conservative estimate of a 1% efficiency gain over a 5 year period there is potential to provide non cash releasing savings of £5.5m.
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5. COMMERCIAL CASE
5.1 INTRODUCTION
The Commercial Case outlines the proposed commercial arrangements and implications for
the IT Connectivity solution and a NLDM. It describes the process used by the laboratories
programme team, working with stakeholders, to agree the solutions and commercial
implications.
The Economic Case has provided details on the process applied to achieve the preferred
options for these solutions and the Finance Case has set out the investment required.
5.2 IT CONNECTIVITY SOLUTION
5.2.1 PROCUREMENT ROUTE ASSESSMENT
In July 2016, the laboratories programme team started engagement with key stakeholders to identify the current challenges and opportunities for improvement within laboratories IT systems. The output was agreement that an IT Connectivity solution was required to enable laboratory to laboratory communication which will support the development of a DSM.
Subsequent discussions and the work of the IT Project Group revealed that an existing IT Connectivity solution is operational in three large NHS Scotland Boards (NHS Lothian, Greater Glasgow and Clyde and Grampian). The solution is the NPEx service which these Boards have implemented in the last 12 months with success. Additionally, 4 further NHS Boards have procured the NPEx service and are at varying stages of implementation.
The IT Project Group agreed that there was an opportunity to explore the suitability of this solution for all Boards and sought guidance on this from the national procurement team within NHS National Services Scotland (NSS).
A Prior Information Notice (PIN) (appendix 15) was issued by NSS to test the market of suitable external suppliers who could provide a laboratory to laboratory communications service. The PIN for Electronic Requesting and Reporting of Examinations was published on the 15th December 2017 to enable external suppliers to note their interest, gather market intelligence and identify available solutions for consideration. The closing date for responses was the 8th January initially, with an extension provided to the 19th January to allow for further responses. The PIN published the following:
“NSS wishes to procure a service/system that will enable electronic requesting and reporting of examinations between clinical laboratories within Scotland and the rest of the UK. The requirement is to replace current paper based processes used to enable referral and reporting of examinations between laboratories. The system to enable this should deliver a common user interface that enables end to end connections to many different laboratory information systems within a UK wide network of referral laboratories. There should also be access to a directory of available test repertoires of connected sites. In addition to functionality that addresses the requirements of the Blood Sciences modalities, the identified solution should have available, or have in an advanced stage of development, functionality to manage the additional requirements to process information and data exchange for medical microbiology and histopathology and their constituent modalities.”
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Three responses to the PIN were received from the following suppliers:
The supplier submissions were subject to assessment (appendix 16) and analysis to determine their ability to meet the service requirements. Dr Bill Bartlett led the discussion on the assessment with the IT Project Group at the meeting on the 8th February 2018. The Group agreed that, based on the information received; only one company, namely X-Labs (NPEx service) currently had a system that could deliver all the service requirements and had a readily available product. The other two responses did not meet all the service requirements, did not have a readily available product and therefore had included in the price costs for developing a solution.
5.2.2 PROCUREMENT APPROACH AND PLAN
The recommendation, as a result of the information gathered from suppliers and the assessment which was agreed by the IT Project Group, is that it would be in the best interests of NHSScotland to pursue the sole source supplier procurement route,
selecting the X-Labs supplier to deliver the NPEx service.
Failure to go down this sole source supplier procurement route would cause significant inconvenience to existing “live” Boards and a huge duplication of time, cost and effort.
The X labs proposal addresses the brief identified in the PIN and can provide access to a proven and nationally established exchange service that meets NHSScotland requirements. To procure another service would necessitate the entire process of implementation to start from the beginning for the existing live Boards without the reassurance of technical success.
The recommended procurement approach is to follow EU Procurement regulation 14 of the
Public Contracts (Scotland) Regulations 2015:
14. (i) a contracting authority may use the negotiated procedure without the prior publication of a contract notice in accordance with regulation 17(3) in the following circumstances
(iii) when, for technical or artistic reasons, or for reasons connected with the protection of exclusive rights, the public contract may be awarded only to a particular economic operator;
On approval of this Business Case the plan is to follow the sole source supplier route and a Voluntary Ex-Ante Transparency (VEAT) Notice will be placed to notify the market of our intention to enter into a contract with X-Labs for the NPEx service solution.
Details of the capital and revenue funding requirements to deliver this solution are included in the Finance Case. The proposed National Programme Board will be accountable for overseeing the delivery of the IT Connectivity solution through an implementation team. Further information is provided in the Management Case.
• X-Lab Ltd. National Pathology Exchange or (NPEx)
• https://www.x-labsystems.co.uk/
• ForeCare - www.forcare.com
• Tiani Spirit - https://www.tiani-spirit.com/
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5.2.3 BENEFITS OF IMPLEMENTING NPEX WITHIN NSS
The key benefits associated with the implementation of NPEx are that:
• It is a tried and tested solution which has been implemented, successfully, in NHS Greater Glasgow and Clyde, Grampian and Lothian
• It has been purchased by a further 4 Boards as a laboratory to laboratory solution (the latter Boards are at varying stages of implementation).
• The wider implementation of this system nationally would provide laboratory to laboratory communication across all laboratories in NHSScotland
• An added capability of implementation nationally would be to open up communication to NHS England laboratories and vice versa.
5.3 NATIONAL LABORATORIES DATA MART (NLDM)
5.3.1 PROCUREMENT ROUTE ASSESSMENT
The Strategic Case identifies the current data challenges facing laboratories and the Economic Case outlines the process undertaken to achieve a preferred option for the NLDM solution.
The Data Project Group planned a formal options appraisal from October 2017 – January 2018; however stakeholders agreed in November 2017 that a NLDM was the only viable option to address the data issues currently facing laboratories in NHS Scotland.
Designing, developing and delivering National Data Marts is part of core business of NSS Public Health Intelligence (PHI) and therefore it was agreed that NSS is ideally placed to provide the required information and intelligence products. This was based on a similar approach developed by the national Radiology programme and in line with NHS National Services Scotland’s remit and NSS PHI’s proven track record in:
• Developing data marts to store and analyse NHS Scotland data (in conjunction with NSS Business Intelligence), including providing facilitation and definitional expertise to define and refine data requirements in association with stakeholders;
• Developing, capturing, analysing and publishing a wide range of information on health and social care in support of NHS Scotland; and
• Providing information and intelligence consultancy services to NHS Scotland
5.3.2 PROCUREMENT APPROACH AND PLAN
The skills and expertise available within NSS will be utilised to work with the relevant stakeholders to co-design and implement the NLDM, thus providing the information required
to plan and deliver a DSM for laboratory services.
The development of the NLDM sits within the remit of NSS PHI and BI and therefore there is no requirement to tender externally. However, for completeness the laboratories programme team has included the ‘status quo’ option along with the NLDM as a comparator within the Economic Case.
5.3.3 BENEFITS OF DEVELOPING NLDM WITHIN NSS
The key benefits associated with developing the NLDM within NSS are that:
• It will provide a national solution which is critical to the design and delivery of a DSM for laboratories in Scotland
• It will provide the national, regional and local reporting and analytics required to design and deliver a DSM
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• It will address the need for robust, comparable information to plan and deliver quality and resilient laboratory services in Scotland which are aligned with the National Laboratories Blueprint and delivered locally, regionally and nationally
• It will provide critical health intelligence to NHS Boards, i.e. it will be more than just a data solution
• It will be backed up by national infrastructure and will use nationally agreed data set definitions and standards to ensure data comparability
• It will address data quality issues, coding differences etc. to ensure that the data required at local, regional and national level are consistent
• It will provide a national data resource which can be used for multiple purposes e.g. strategic service planning, monitoring, patient pathway work, benchmarking etc
• It provides the possibility of linkage to other data sets that may be required now or in the future to facilitate diagnostic analytics and support complex predictive and prescriptive modeling, such as:
o Linkage to other data marts within the Corporate Data Warehouse (CDW) (i.e. acute, A&E, waiting time, deaths, workforce [including sickness absence and payroll] and finance)
o Linkage to common dimensions (reference data) within the CDW to enrich the data by providing details such as patient and population demographics, deprivation categories, rural/urban flags etc
• It provides the ability to tap into the wider expertise within the wider NSS:
o Expertise in running and supporting existing national networks (NSD)
o National Information and Intelligence teams (PHI)
o Data collection, data management and data quality expertise (NSS:PHI’s Data Management Service and NSD IMS)
o Information Governance - data protection and data security expertise
o Expertise and infrastructure / capacity to support data linkage e.g. linkage of patient-level laboratory (results) data to other patient-level data to illuminate pathways of care, identify quality of care and monitor outcomes and value; and
o Strong links with the electronic Data Research and Innovation Service (eDRIS)6, the Farr Institute in Scotland7 and the Administrative Data Research Centre for
Scotland (ADRC)8 which will help to facilitate research and knowledge creation.
• It provides the potential for utilisation of future developments in NSS NHS infrastructure arising from technical modernisation programmes.
Timescales for implementing the NLDM are provided in the Management Case.
6 http://www.isdscotland.org/Products-and-Services/EDRIS/FAQ-eDRIS/ 7 http://www.farrinstitute.org/ 8 https://www.adrn.ac.uk/about/network/scotland/
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5.4 SUMMARY
In summary, the laboratory programme team, responding to approval from the Chief Executives Group in July 2017 to develop a DSM has developed solutions for IT Connectivity and a NLDM. These two enabling projects are fundamental to facilitating the design and delivery of a DSM for laboratories in NHS Scotland and the anticipated benefits from implementing a new service model.
There is a sound case for investing in both the IT Connectivity and the NLDM solutions. This evidence is detailed in the Finance Case.
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6. MANAGEMENT CASE
6.1 INTRODUCTION
This section of the business case sets out the proposed arrangements that would be put in place to facilitate the implementation of the IT Connectivity solution and the NLDM both of which underpin the design, development and delivery of the DSM. This includes the proposed programme implementation structure and associated governance.
The Chief Executives Group approved the laboratories Strategy Paper in July 2017 and the proposed incremental approach to developing solutions for the enabling projects which are fundamental to the delivery of DSM.
It has been agreed that the IT Connectivity and NLDM solutions, described within this Economic and Commercial Cases will be implemented by teams within NHS NSS with support from local Boards and external suppliers including X-Lab, for the NPEx service, and Laboratory Information Management Systems (LIMS) interface providers.
It is proposed that the implementation will be managed by a National Laboratories Programme Implementation Team (NLPIT), which will adopt best practice programme and
project methodologies.
The primary focus of the NLPIT for the first five years will be implementation, of the proposed solutions for IT Connectivity and the National Data Mart. In addition to this the NLPIT will also have a key role in working with the regions to facilitate the design and
development of the DSM.
A new governance structure is required to deliver the transformational change in laboratories. This has been developed with the DSM Design Group and approved by the 3 regional laboratory leads. The proposed structure, to enable the delivery of the National Laboratories Blueprint (NLB), is a Laboratory Services Oversight Board (LSOB) with 3 Regional Laboratories Operational Boards.
The South East region has recently had approval from the Chief Executives within this region to proceed with establishing a Laboratory Medicine Operational Group further supporting the proposal for a new governance structure. This is presented in figure 3 below.
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Figure 3: Proposed Governance Framework
Laboratory Services Oversight Board
National Laboratories Programme
Implementation Team
South East Region
Operational Board
West Region Operational
Board
North Region Operational
Board
6.2 PROGRAMME IMPLEMENTATION STRATEGY
A national programme approach is essential not only to oversee the implementation of the solutions for IT Connectivity and the NLDM projects but also to facilitate consistency in the roll out of the NLB, to align national and regional plans for laboratories and maintain the principle of the delivering the right test, to the right patient at the right time, in the most efficient and effective way. The high level programme plan is displayed in figure 4 below.
Figure 4: National Laboratories Programme Implementation – Milestones
6.2.1 THE IT CONNECTIVITY PROJECT
The IT Connectivity Project will be managed by the NLPIT in conjunction and collaboration with NHS Boards, X-Lab (NPEx service) and LIMS interface providers. There will be a phased roll out of the service which will require the support of a central technical team, with experience of rolling out NPEx both within and between NHS Boards, working alongside local Board IT teams. The required skills and expertise of the team are described in appendix 17 Delivery of the project will be managed by a project manager with oversight from the NLPIT.
6.2.2 THE NATIONAL LABORATORIES DATA MART PROJECT
The NLDM Project will be managed by the NLPIT with NHS NSS Business Intelligence (BI) and Public Health Intelligence (PHI) teams being responsible for the delivery of the solution, working with the Managed Diagnostic Networks, local Boards and key stakeholders. The key roles are described in appendix 17.
6.2.3 DESIGN AND DEVELOPMENT OF THE DISTRIBUTED SERVICE MODEL
The design of a DSM will be supported by the NLPIT working with the Regional Laboratories Operational Boards and the National Managed Diagnostic Networks. It is anticipated that members of the NLPT will be represented on the Laboratory Services Oversight Board however the Terms of Reference for this Board will be determined following approval of this business case.
The South East Region have developed a draft Terms of Reference for the Operational Board, the purpose of which is to manage the delivery of an integrated Laboratory Medicine service for the region which delivers high quality, equitable, affordable, sustainable and accessible services for patients that cut across geographical boundaries. This is aligned to the proposed governance structure, see figure 4 above for NLPIT to facilitate the consistency in the roll out the National Laboratories Blueprint and develop a future DSM.
6.3 IMPLEMENTATION PLAN
Implementation plans for the IT Connectivity and NLDM solutions have been developed by the individual projects. These reflect the timescales, people and financial resources required. A summary of these requirements are captured in figure 4above. Appendix 18 provides further detail of the likely stages of designing and developing the NLDM. Whilst delivery of the projects will be at a regional and local level they will adhere to the guiding principles and
align with the National Laboratories Blueprint.
6.3.1 THE IT CONNECTIVITY PROJECT
A phased approach to implementation will be applied which is based on the lessons learned and evidence gathered from the successful delivery of the NPEx service in NHS Greater Glasgow and Clyde and NHS Lothian. Each Board will be supported by the project team to implement the NPEx service, based on bi-directional links and flows of information, for 1 way traffic, for a minimum of 1 laboratory discipline. It is anticipated that this will initially include approximately 35 of the most frequently conducted tests. It is predicted that Boards will accelerate the wider implementation of the IT Connectivity solution as soon as the baseline service is established. Figure 4 above provides details of the phased approach and timelines for roll out of laboratory to laboratory communications across NHS Scotland with the expected duration of 24 months from starting phase 1 through to completion and handover to business as usual.
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6.3.2 NATIONAL LABORATORIES DATA MART PROJECT
The implementation of the NLDM will follow a phased approach. The project will be managed by the NLPIT with NHS NSS PHI and BI teams leading on the design, development and delivery of the NLDM. This will be achieved in phases, with phase 1 involving the Managed Diagnostic Networks leading on the development of standardised data definitions and codes, working in parallel with PHI starting the data profiling. It is the intention to develop the NLDM with the discipline with the most advanced data set, to pave the way for other disciplines to follow. This laboratory discipline is still to be agreed. The
overall timeline and resources required to deliver the NLDM is included in Figure 4 above.
6.4 PROGRAMME GOVERNANCE
There is a requirement to establish a NLPIT which will be responsible for the implementation of the IT Connectivity, National Laboratories Data Mart solutions and will facilitate the design and development of the DSM. The NLPIT will report to the Laboratory Services Oversight Board. As with the Scottish Radiology Transformation Programme, the escalation route for the Laboratory Services Oversight Board will be the Chief Executives Group. This governance structure is depicted in figure 4 above.
6.5 BENEFITS REALISATION
Delivering a future DSM and the benefits it will provide is dependent on the implementation
of the IT Connectivity and NLDM solutions to support the delivery of the National
Laboratories Blueprint. The benefits of implementing these 2 solutions are outlined in the
table below.
Table 5: Benefits realisation timescales
Benefit
Outcome Anticipated Timescale
Increased service resilience Electronic communication between laboratories will enable between laboratory work flow and standardisation
2018/19 onwards
Rapid access to new effective testing
Impact of access to testing modalities on referral rates (e.g. impact rapid deployment of QFIT in symptomatic patients on GI clinic referrals; Cancer access initiative)
2019/2020
Increased productivity due to improved IT connectivity
Reduction in manual processing of tests, time releasing capacity 1% productivity gain per annum
2019/20 onwards
Increased service sustainability
Enables transfer of workloads to existing services with available capacity and secure infrastructures.
Repatriation of referred workloads from NHS England to make use of capacity in Scotland
2020/21 onwards
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Improved strategic planning Demand and capacity planning via the National Laboratories Data Mart
2019/20 onwards
Optimisation of workforce Increased reporting capacity, quicker response time to emergent operational questions, increased time on value adding activity
2020/21
onwards
Optimised use of services Change in requesting behaviours as a consequence of outputs from understanding of extrinsic variation
(linkage with Atlas of Variation)
2020/21 onwards
Service improvement Performance management capability - KPI dashboard – National Laboratories Data Mart
2021/22
onwards
It is anticipated that the delivery of the IT Connectivity and NLDM solutions will realise the
above medium term benefits within a 5 year period. The delivery of a DSM and increasing
the efficiency, resilience and sustainability of the service will demonstrate the successful
realisation of the longer term benefits which result from the consolidation of services,
equipment, facilities etc. This could take up to 10 years to deliver. An underlying principle of
the DSM is that a functional distribution of workload should be enabled that meets local
needs and makes optimal use of resource invested. Value comes from increasing efficiency
and reducing waste to invest in effectiveness. Examples of waste include over/under use of
capacity and failing to capitalise on available knowledge and skills.
KPIs will need to be developed that not only reflect efficiency and productivity measures
(e.g. cost per test, cost per WTE), but also enable assessment of impact on outcomes (e.g.
bed stays, clinic attendances, drug bills). Laboratory to laboratory connectivity and a
national, consistent, standardised data set required to enable delivery of these goals and
measures.
6.6 PROGRAMME EVALUATION
Benefits realisation will be monitored through analysis of available data, which will be
developed and improved as part of the progression towards a NLDM. The programme
duration is estimated as 2 years for the delivery of the IT Connectivity solution and 5 years
for the NLDM. It is anticipated that benefits will be realised on the achievements of the key
milestones displayed in the implementation plan in figure 4. Table 5 above indicates the
anticipated timescales for when benefits will start to be realised.
At the end of the 5 year change programme, the IT Connectivity solution and the NLDM will
be delivered and it is anticipated that the design and development of the DSM and
implementation of the NLB will have progressed significantly. It is therefore expected that
ongoing evaluation beyond the 5 year timeline be required and will continue to evaluate the
implementation of the NLB and a new service model, the DSM. This will be monitored by the
by the Laboratory Services Oversight Board, who will oversee the regional delivery of the
NLB and facilitate the implementation of the DSM.
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As the DSM and NLB progress there will be additional demands for the NLDM and increased capability enabled through the IT Connectivity solution. This will be a business as usual function which can be undertaken at national, regional and local levels supported by an accessible, consistent national data set which will be included in the NLDM.
7. APPENDICES
.
APPENDIX 1 – NATIONAL LABORATORIES BLUEPRINT (NLB)
Current model not optimised to deliver sustainable
services to underpin current and future NHSScotland
requirements
Intrinsic Variation- variation in service provision/
configuration within disciplines across territorial
Boards.
Extrinsic Variation – variation in clinical practice
Considerable overhead associated with delivery of
quality systems and compliance with regulatory
requirements proving challenging to individual Boards
Sub optimal use of service capacity
Inconsistency in testing repertoires, report content and
delivery format/mode within disciplines across boards.
Multiple electronic ordering systems delivering an
inconsistent interface with labs and varying capacity to
support demand optimisation
Baseline and activity map of service use and projected
requirements.
Design and incrementally deliver a distributed service
to meet current and emerging demands
Convergence of approaches to enable reduction of
intrinsic variation
Engagement with users to align service delivery/use
with best practice
Convergence of quality management systems,
discussions with accreditation bodies to enable
flexibility of approach across a distributed service:
develop do once and share approach
Identification of resource envelope surrounding
current model and development of suitable funding
model
Document,map and plan capacity of existing /future
systems/processes and identify opportunities for
optimal utilisation while enabling equitable access
Work with MDNs and users to enable convergence of
reporting mechanisms. Convergence of testing
strategies/reference intervals etc where possible.
Specification and development of electronic
requesting interfaces to enable optimal service usage
by health care professionals
Identification of logistics requirements to support a
distributed service model. Identify existing transport
systems that may be utilised to enable transformation
Common quality management system/service across
Scotland. NHSScotland distributed service model
compliant with ISO standards and all relevant
regulatory instruments.
National funding framework
National distributed service model (DSM) with unified
vision configured to enable consistent delivery of
national, regional and local plans/ priorities enabling
equity of access to servics..
Optimal distributed service configuration subject to
optimal demand.
Efficient, effective, equitable & affordable
Efficient and effective use of planned capacity
Timely, safe accurate and effective application of
laboratory outputs across NHSScotland with
standardised reporting processes addressing
governance issues
Information, data and knowledge management team/
infrastructure with appropriate national and local focus
to enable best care
Electronic interface with lab services that hides
organisational complexity of the provider, but enables
optimal use of service.
Logistics operation designed to deliver safe and
resilient transport of materials to and between
laboratories
Start EndInterim
Blueprint Laboratories: Process
Complex logistics for transport of materials and samples
from locations to labs and between labs
Funding models vary from board to board and are board
focussed
P1
P9
P8
P7
P6
P5
P4
P3
P2
Indentify information, data & knowledge needs and
devise an infrastructure to deliver requirements
making best use of current resource while planning
future infrastructure
High dependence of all lab service providers and users
on information data and knowledge to enable business
processes and to address clinical impact/effectiveness
Compliance of Boards/Regions with guiding
principles, development of shared priorities, sharing of
outputs from processes such as procurement
exercises
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Absence of optimised workforce to deliver sustainable
services to underpin current and future NHSScotland
requirements
Identify future model and use six steps methodology to
delivery of an optimised workforce plan
Workforce plan matched to the DSM delivering
sustainable national work force for labs
Intrinsic service variation across Boards, extending also to
management and governance structures, delivers
complexity of workforce issues and prevents cross
boarder/discipline working.
Identify future model and remove constraints to
delivery of new ways of workingStaff working across traditional board boundaries
Variation in application of knowledge and skill: staff not
being used to full potential or capitalising upon existence
of generic skills
Release knowledge & skills to enable focus on value
added tasks and utilise full potential of staff. Deliver
job enrichment and role development to provide
opportunities for future service improvement and staff
development
Optimal use of knowledge & skills within a DSM model
developing a productive and motivated workforce
Variation in interpretation of roles and job descriptionsReview of roles applications of JD’s
(Workforce Reference Group)
Reduction of variation in roles and remuneration
delivering a level playing field to support staff mobility
Service requirement outstripping capacity of various staff
groups
Identify opportunities for role extension through
service redesign. Identify mechanism to expand critical
workforce groupings
Sustainable and resilient workforce with staff groups
working co-operatively and synergistically
Variation in AFC bandings across boards and pay
protection agreements (e.g. AFC out of hours)
Develop a framework to enable convergence of
bandings and remove impediments to mobility arising
from protection
Equality of remuneration for staff and increased
mobility across geography and between grades
Conservatism and resistance to changes in working
practices and roles
Fully engage professions and support staff in design
and change processes
Delivery of a DSM with an engaged staff open to
development and change
New skills sets required to enable delivery of services
dependent upon new technologies
Identify needs, enable central developments and
appropriate dissemination of education training and
skills
Process in place to deal with skills gap arising from
new and emerging technologies
Resources for education and training not necessarily
linked to need across the whole system
Work with NES to develop an approach that links to a
national workforce plan and supports CPD
Develop and invest in education and CPD consistent
with the delivery of the workforce plan and
requirements of DSM
There is a deficit of staff appropriately skilled in
Information and Knowledge Management Services (IKMS)
Identify the skills and knowledge requirement to
support IKMS needs and develop infrastructure.
Implement training and development plan which
increases staff skills and extends our IKMS capability in
health intelligence and business intelligence
Developing demand for delivery of diagnostics in the
community with requests for laboratory support
outstripping available resource or delivering requirements
for new staff resource
Identify current and future scope with staffing
requirements to support community diagnostics/POCT
Laboratory service able to deliver appropriate support
to community diagnostic services in ways that address
accreditation and governance issues
NHS/University interfaces lead to complexity of
management of services
Identify the interdependencies of the NHS/Universities
on delivery of respective and shared roles. Engage with
Universities to involve them in the service redesign
exploring responsibilities and accountability
A DSM that is engaged with the Academic partners that
is focussed on good care with buy into shared values
and goals
Start EndInterim
Blueprint Laboratories: Organisation
O1
O9
O8
O7
O6
O5
O4
O3
O2
O12
O11
O10
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Variation in levels of automation across disciplines across
boards and failure to take full advantage of functionality
Identify potential in existing systems and exploit them.
Consolidate workloads where appropriate to deliver the
step volumes that make automation viable and
affordable. Enable integration of automatable
workloads
Integrated automated facilities that deliver cross
disciplinary repertoires, exploiting functionality
afforded by robotics, integrated technologies and IT to
deliver efficiencies, effectiveness and value from
investment
Enable delivery of do once and share proof of concept
projects and affordable economy of scale
developments.
Delivery of transferable business cases for Boards or
identification of centralised funding frameworks to
enable faster delivery of benefits from new
technologies.
All patients within NHSScotland have equitable access
to the benefits of emerging and proven technologies.
Rapid adoption of new technologies to deliver Triple
Aim benefits.
There are new a technologies available that will enable
transformation of service provision and clinical pathways,
that may prove difficult to introduce/or access under
existing organisational arrangements
Identify transformational opportunities and remove the
constraints delivered by historical IT configurations.
Begin a process of convergence of systems around
sound laboratory processes. Enable consolidation of
databases removing historical barriers to
multidisciplinary reporting and cross system working
Application of differing technologies to deliver clinical
results with different values values between boards (e.g.
haematology cell counters and MCV, troponin)
Identify issues, assess risks and impacts and deliver
strategies to address the findings. Aim for convergence
of technologies where negate where necessary
Reduced variation test results across NHS Scotland
enabling delivery shared pathways with common
reference intervals and decision limits
Multiple configurations of multiple IT systems perpetuating
historical approaches to service delivery making
transformation and cross system working challenging.
Convergent interoperable or uniformly configured
national IT systems that work for and support the
service rather than define the service
Generational changes in analytical technology with
varying rates of adoption by boards leading to variation in
clinical pathways between boards
Identify issues and enable convergence to enable best
care.
Equitable access to patients to technologies that afford
best care
Identify systems of working to be delivered and remove
barriers underpinned by IT.
NHS Labs have limited capacity for development of new
tests and are reliant on diagnostic companies to deliver
R&D and opportunities for co-production
Identify opportunities for co-production with industry
and Academia. Consider delivery of an environment in
Scotland that provides opportunities for diagnostic
companies to develop concepts, validate and extend
the applications of their systems.
Delivery of science based service that has an
innovation focus at all levels of delivery and able to co-
produce with multiple stakeholders
IT limits capacity for wider system working within and
between boards
IT configurations and functionality that support cross
system working within and between boards
Quantify scale of the challenge and identify potential
solutions across the wider system. New builds?
Consolidation of workloads into alternate sites with
suitable real estate
Laboratory accommodation limiting realisation of benefits
of combined multi- disciplinary approaches to automation
(Total laboratory automation (TLA))
TLA solutions in place delivering benefits of
discretionary delivery of wide repertoires of testing
within very predictable time frames. Reduced time to
diagnosis.
Adoption of common codings, taxonomies and delivery
of standardised data archetypes across Scotland for
lab investigations. Explore development of
infrastructure in terms of staff and technical
architecture to enable big data benefits
IT and data heterogeneity limits big data approachesLaboratory data for a service serving 5.3 million
available to deliver benefits of big data studies.
Explore new approaches to service delivery with new
boundaries. Consider technology rather than speciality
based distribution of resource, using information
technology to deliver outputs to specialists (digital
images, web enabled access to knowledge, information
and data.
Technologies blurring the historical boundaries between
disciplines providing opportunities for improvement in
efficiency and effectiveness of the wider service
Technology clustered and shared across disciplines
with technical specialists delivering high quality data to
laboratory medicine specialists at remote locations.
Clusters and expertise may be around molecular
facilities, mass spectrometry, separation sciences.
Start EndInterim
Blueprint Laboratories: Technology
T2
T10
T9
T8
T7
T6
T5
T4
T3
T1
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Start EndInterim
Current resource envelope for delivery of Laboratory
Diagnostics to NHSScotland not well defined
Define required data sets, assess veracity of existing
information and data sources. Survey boards to
address deficiencies.
Documented understanding of existing resource
allocation. Improved business intelligence
Extent of variation (i.e. variation and usage of services)
poorly characterised
Identify systems and processes to enable
characterisation and reporting of variation in service
usage
Extrinsic variation characterised and monitored to
enable constructive challenge of users to enable
demand optimisation.
Heterogeneity across lab services in Scotland in codings,
taxonomies and terminologies delivers challenges to
combining data and delivery of big data approaches.
Develop requirements through data and
standardisation enablers groups with a plan to develop
frameworks to enable convergence across Scotland.
Usage of common, coding systems, taxonomies and
terminologies to deliver standardised, and well defined,
data sets available for clinical, business and research
use.
Lack of comparable data set for benchmarking process
Development of benchmarking standards and develop
systes/processes to enable real time access to
benchmarking data
Delivery of a national real time system for gathering
and reporting of Labs data for multiple purposes –
benchmarking/service and quality improvement
(National Data Mart)
Performance indicators focussed on efficiency and
variation rather than clinical impact. Wider system value of
investment therefore difficult to assess.
Develop and measure KPIs based on outcomes and
whole system impacts (e.g. impact on drug bills, length
of stay, patient flow and capacity. Develop an approach
to enable delivery of outcome based business cases
using those KPIs with a requirement for user input.
A service that can demonstrate whole system value
value, which is, user focussed and able to justify
existing and new investment.
Blueprint Laboratories: Information
I1
I5
I4
I3
I2
APPENDIX 2 – NATIONAL LABORATORIES PROGRAMME GUIDING PRINCIPLES A series of guiding principles for laboratory service improvement/transformation were developed and endorsed by stakeholders in December 2016. They have been subject to widespread circulation without objections received in response. The Access Directorate of NHS Tayside has already adopted these as a point of reference to be considered in any imminent laboratory developments. The guiding principles that underpin the development of the DSM are listed below.
1 Enables national planning of services while enabling a focus on local needs (right testing, right place, and right time).
2 Is aligned with the National Clinical Strategy, supporting health care improvement with a Triple Aim focus.
3 Employs a Once for Scotland approach through an appropriate governance structure.
4 Enables national workforce planning.
5 Allows the free flow of materials, information, data, knowledge and skills across organisations.
6 Enables optimised demand on services locally and nationally via appropriate interfaces with users and planners.
7 Supports local education and training of laboratory, other NHS personnel and students to ensure optimal delivery and usage of laboratory resource.
8 Ensures a sustainable Laboratory Service provision configured to deliver what is required locally to deliver equitable patient access and outcomes across NHSScotland (right testing, right place, right time frame; support delivery of optimal patient flow and capacity).
9 Delivers services designed upon Lean principles.
10 Enables appropriate standardisation of systems and processes, and sharing of resources and best practice (simplify, standardise and share).
11 Has an infrastructure that enables maximisation of return on investment in laboratory services (e.g. optimal use of distributed capacity).
12 Focused on delivery of efficient, effective, resilient, and affordable laboratory services that address waste, harm and variation in terms of both service provision and clinical application of their outputs (deliver efficiencies and invest in effectiveness).
13 Enables appropriate distribution of services to deliver economies of scale and to enable investment in new or complex technologies.
14 Is able to innovate and has developed mechanisms to enable rapid translation of best practice/guidance and the benefits of new technologies uniformly into national approaches.
15 Supports delivery of POCT in primary and secondary care.
16 Supports clinical research and other forms of research and development within NHSScotland.
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APPENDIX 3 – VARIATION IN LIMS SYSTEMS ACROSS SCOTLAND
North Region
Grampian
East Region
West Region
Tayside
OrkneyShetland
Western Isles
Clinisys/LabCentre
V1.1
DXC/iLab
V6.0P1B6
Clinisys/LabCentre
V1.12MedPath
Clinisys/iLab
V1.1
Borders
Fife
Lothian
DXC/iLab
V5.8.1002sp2b5
Clinisys/LabCentre
V1.13
Clinisys/LabCentre
V1.11
Ayrshire & Arran
Forth Valley
Greater Glasgow & Clyde
Golden Jubilee
Lanarkshire
DXC/iLabtp
Version 1.9
Clinisys/WinPath
Version 7.22.73
Dumfries & Galloway
Clinisys/labcentre
Version 1.11
DXC/iLab
Version 5.8
Intersystems
Version 2011
DXC/iLab
Version 5.8.10022.3b3
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APPENDIX 4 – FIVE YEAR TREND IN LABORATORY SERVICE COSTS AND ACTIVITY DATA
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APPENDIX 5 – HIGH LEVEL LIMS SPECIFICATION
1. Requirements This section highlights the high level features that any LIMS procured for use in any board within NHS Scotland must meet.
1.1 General
Priority: D – Desirable, I – Information, M – Mandatory
Ref. Requirement Priority Comments
1
The solution MUST be fully compliant with EU EU General Data Protection Regulation (GDPR).
M
2
The solution MUST already be in live use in sites comparable with NHS Scotland.
M
3
The solution MUST have a clear product roadmap and robust service management process.
M
4
The solution provided MUST be scalable, highly available (no single point of failure), capable of delivering 24 x 7 x 365 uptime except in periods of agreed downtime and fully supported including key system interfaces.
M Details of NHS Board key system interfaces will be provided as an addendum as required.
6
The solution MUST allow a degree of configuration and customisation to reflect NHS Scotland operating model.
M
7 The supplier MUST deliver site to site transfers as standard functionality.
M
8
The system MUST include functionality to integrate with the Board’s Business Intelligence systems.
M Details of NHS Board business intelligence systems will be provided as an addendum as
required.
9 The system MUST support electronic order requesting and electronic results reporting.
M
10
The solution MUST provide functionality to export cancer support data, inc Synoptic data as a necessity, with data fields to hold clinical detail allowing capture of clinical notes to be included in the LIMS framework.
M
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Ref. Requirement Priority Comments
11
The supplier MUST indicate their experience, current capability and expertise in interfacing with integration engines such as the InterSystems Ensemble integration product.
M
12
Explain the license model(s) available (e.g. number of active connections, number of sites, number of databases).
I
13
Provide a list of all existing supported interfaces, These MUST include SCI Store, ICE, TRAK.
I
14
Explain the costing structure for implementing interfaces, discounts available for multiple interfaces/sites and the average lead time for interface development.
I
15
Provide a full list of all Middleware vendors that are currently supported and indicate a typical timeline for new middleware vendor solutions to be supported by the supplier.
I
16
The supplier MUST address the legal requirements to retain and enable access to the NHS organisation’s legacy data and outline available options on how legacy data and access is managed.
M
1.2 Policies and Guidelines
Ref. Requirement Priority Category & Response
17
The supplier MUST adhere to all NHS Scotland eHealth standards, policies and guidelines in respect of data definitions, NHS Scotland information governance, technical operation and security. http://www.ehealth.nhs.scot/resources/standards-library/
M
18
The supplier MUST adhere to the NHS Scotland Server Vulnerability and Patch Management Policy.
M
19
The supplier MUST provide evidence of all security accreditations and ISO standards that they adhere to.
M
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1.3 Architecture / Infrastructure / Scalability
Ref. Requirement Priority Category & Response
20
The solution MUST provide Dedicated Training and UAT environments dedicated to a particular board/site allowing specific training/testing to take place.
M
21
The supplier MUST provide a detailed system architecture diagram and a description of how this architecture enables excellent performance, business continuity and resilience. Suppliers MUST show where each part of the architecture would be hosted, highlighting what components would be hosted within the NHS network and what components would be held externally (if required)
M
22
The supplier MUST provide the ability to manage upgrades in a way which minimises disruption across all laboratory disciplines and locations.
M
23
Data stored by the solution MUST be stored in a modern industry standard DBMS/RDBMS with direct database connections made possible to enable future data migration.
M
24
User access MUST be controlled via individual logins and security MUST meet Board security policies. Access MUST be based on RBAC.
M Details of NHS Board security policies will be provided as an addendum as required.
25
Client software SHOULD run on Windows 10 and above, support for 32bit/64bit editions where applicable.
D
26
The supplier SHOULD deliver a web based client with integration for wireless devices, iPads, tablets etc.
D
27
Web clients MUST be fully functional on Internet Explorer 11 and above (HTML 5) with minimal or no plug-ins.
M
28
Client and server applications MUST be compatible with NHS Scotland anti-virus and security products.
M Details of NHS Board anti-virus and security products will be provided as an addendum as required.
29 The proposed solution MUST allow scalability across multiple sites/Boards.
M
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Ref. Requirement Priority Category & Response
30
The bidder’s solution of architecture and infrastructure MUST provide service/system resilience including data redundancy and interoperability between Boards including contingencies to mitigate loss of service/IT disaster within a board. This must contain a diagrammatic presentation of the proposed solution.
M
31
The solution MUST offer sophisticated business resilience and disaster recovery functionality.
M
32
The supplier, or a subcontractor of their choice, MUST undertake or partner in an annual test to verify resilience, validate backups and ensure the successful recovery and usability of the system.
M
33
System MUST be capable of networking across multiple sites and will clearly distinguish which site made the request and which site performed the test.
M
34 The Supplier MUST be N3/SWAN compliant M
1.4 Data Transmission / Messaging
Ref. Requirement Priority Category & Response
35
The system MUST be capable of accepting and transmitting industry standard messaging protocols including, but not limited to ASTM, HL7 and XML and standard file transfer protocols. http://www.isdscotland.org/Products-and-Services/Data-Advice/Interoperability-Working-Group/
M
36 Interfacing with other information systems SHOULD meet HL7 FHIR standards.
D
37
The solution MUST provide links to computer based information systems both within and outside the participating boards via HL7 interface protocol standards.
M
38
The system MUST retain and support Rich Text Format and Synoptic Report Format transfer across boards and systems.
M
39
The system MUST be capable of sending electronic copies of final reports to other systems (for example SCI Store, Scottish Cancer Registry, Electronic Communication Surveillance in Scotland (ECOSS), EDT and ICNET for Microbiology)
M
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Ref. Requirement Priority Category & Response
40
The system SHOULD provide functionality and a facility to automate data transfers to national systems within ISD for turnaround time reporting etc.
D
41
The proposed solution SHOULD deliver internal messaging and links to external SMTP mail systems including SMS to mobile and ability to email reports (e.g. path reports) from within the system.
D
1.5 Interfacing with 3rd Party Systems including other LIMS
Ref. Requirement Priority Category & Response
42
The solution MUST be capable of interfacing with equipment and systems already implemented within NHS Scotland. These include but are not limited to:
• Middleware systems - such as those that control large numbers of Analysers in multiple physical locations
• Electronic Patient Record systems
• Patient Management Systems - with excellent support for Electronic Order Communications
• Integration Engines - such as Mirth or Ensemble
• Digital Pathology Systems - with full support for sophisticated bi-directional communications
• Point of Care management systems
• Lab to Lab communications systems such as NPEx.
M Details of NHS Board interface requirements will be provided as an addendum as required.
43
The system MUST interface with any other LIMS system(s) using current integration standards.
M
44
The solution MUST allow laboratory orders and results communications to other LIMS via NPEx.
M
45
The system MUST be capable of full integration with any current or future third party GP Practice Order Comms system or integration engine between GP systems and LIMS
M
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Ref. Requirement Priority Category & Response
46
The system MUST be capable of full integration with any current or future third party Acute Hospital Order Comms system.
M
1.5 Standardised Coding Structure
Ref. Requirement Priority Category & Response
47
The system MUST support the national coding standards for Scotland (including SNOMED-CT)
M
48
The system MUST be capable of supporting a standardised code set for test codes, units of measure, organisms.
M
49
The system MUST be capable of importing and utilising appropriate ISD reference files, for example sending and receiving location, hospital consultant, specialty, GP practice and individual GP. http://www.isdscotland.org/Products-and-Services/Data-Definitions-and-References/National-Reference-Files/
M
1.6 LIMS Functionality
Ref Requirement Priority Category & Response
50
The system MUST cover all disciplines including Haematology, Clinical Biochemistry, Immunology, Clinical Microbiology, Virology, Cellular Pathology and Mortuary.
M
51
Proposed LIMS MUST be evidenced as working within a multi-site and multi-discipline environment for a full repertoire of disciplines including Haematology, Clinical Biochemistry, Immunology, Clinical Microbiology, Virology, Cellular Pathology and Mortuary.
M
52
The solution SHOULD be capable of supporting Laboratory Genetics Laboratories either as a separate module or an interface to a 3rd party application.
D
53
The solution SHOULD be capable of supporting Blood Transfusion departments either as a separate module or an interface to a 3rd party application.
D
54
The supplier solution MUST allow entry, ordering of tests and input Patient demographics by direct input, or order comms (ICE, TRAK), and NPEx systems at a single point of entry.
M
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Ref Requirement Priority Category & Response
55
The system MUST support CHI numbers (equivalent to Patient No) and MUST validate any CHI number that is used. Other alias numbers MUST also be supported (temporary residents, anonymous patients, VIPs etc.)
M
56
The system MUST support a common patient index using the CHI number as the key patient identifier supported by Admission, Discharge and Transfer (ADT) data from TRAK.
M
57
The solution SHOULD provide functionality to cope with single/multiple ADT feeds into a central LIMS.
D
58
The solution MUST ensure laboratory specimen numbers are unique throughout the lifetime of the system.
M
59
The solution MUST be capable of providing sample accession / run through labelling between order comms and the LIMS.
M
60
The solution SHOULD provide functionality for clinical system(s) with integration with voice recording and onscreen reporting.
D
61
The solution MUST provide Rich Text Formatting of reports for Microbiology and Synoptic Reports for Pathology.
M
62
The solution MUST be scalable to accommodate movement of workloads, preferably without requirement to purchase additional hardware.
M
63
The solution MUST provide functionality to uphold UKAS/Quality control and Monitoring.
M
64
The solution MUST be fully auditable for the life of the system, including full logging of user activity.
M
65
The solution SHOULD Include functionality to flag user accounts which have been suspended by the trust or board and provide a description field capable of recording the reason for suspension.
D
66 The solution SHOULD provide an audit of all electronic data extraction processes.
D
67
The solution MUST be capable of storing, retrieving and reporting images within the LIMS.
M
68 The solution MUST provide interoperability with Digital Pathology Systems.
M
69
The solution SHOULD provide an interface to scanned document storage with online/retrieval for compliancy purposes.
D
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1.7 Management Reporting
Ref Requirement Priority Category & Response
70
The solution SHOULD provide management Information, ad-hoc and scheduled reporting - clinical reporting around the end of the month, turnaround times, breaches etc. Functionality for sample locations, pick-up and drop-off.
D
71
The solution SHOULD provide as part of system reporting provide electronic dashboards with real-time indicators.
D
72
The solution SHOULD provide communication links to the Boards' data warehouse for information and reporting services, business objects integration.
D
73
The solution MUST have advanced business information functionality and be capable of providing detailed real-time electronic operational activity reports and system monitoring tools including integration with commonly used reporting solutions such as Microstrategy and Business Objects.
M
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APPENDIX 6 – NPEX IMPROVEMENT PROCESS
NPEx Process Improvement
The process in blue describes the general process of referring a specimen using NPEX. The process in green describes the process for returning results. This system highlights the improvement
APPENDIX 7 – VARIATION IN KEELE SUBSCRIPTION ACROSS NHSSCOTLAND
2015 / 2016 2016/2017
Biochem Haem Micro Path Imm Biochem Haem Micro Path Imm
Ayrshire & Arran
Borders
Dumfries & Galloway
Fife
Forth Valley
Golden Jubilee
Grampian
Greater Glasgow & Clyde
Highland
Lanarkshire
Lothian
Orkney
Shetland
Tayside
Western Isles
KEY
Subscribed
Not Subscribed
APPENDIX 8 – DATA PROJECT GROUP OUTPUTS
APPENDIX 9 - SYNERGIES WITH THE NATIONAL LABORATORIES DATA MART
Synergies with the NLDM
Demand Optimisation in Diagnostics
A joint vision of a national standardised data set and a national data mart solution are shared by the DOG for Diagnostics and the Laboratories Programme. Within the 2017 report9 it was recommended that The data workstream within the DOG should be taken forward within the existing work in the shared services programme.
SCBMDN The SCBMDN 5 year work plan10 identifies data synergies and initiatives that a NLDM would support.
All networks are committed to the development of the NLDM and will use the data on an ongoing basis to further develop audit, benchmarking and a range of quality improvement initiatives
SPAN SPAN have a well developed data collection process, however a NLDM would enable smoother extraction of data. The SPAN 5 year work plan11 identifies data synergies and initiatives that a NLDM would support.
SMVN The SMVN 5 year work plan12 identifies data synergies and initiatives that a NLDM would support.
HSLWG The HSLWG are a subgroup of the SCBMDN and are working towards becoming established as a network. They are currently using Keele data to identify key pieces if work that could be progressed. A NLDM would support this and future data needs of the group.
IMS Dashboards The Information Management Service (IMS)13 use data to support clinical and diagnostic networks and to drive service improvement. IMS are helping networks to assess performance across Scotland and present results in an engaging, accessible and systematic way. They have been supporting the Atlas of Variation and Demand Optimisation programmes using multiple data sources through Tableau to populate meaningful and comparative dashboards14 The NLDM would provide large, fast and varied data to support the dashboard outputs.
9http://www.gov.scot/Resource/0051/00514237.pdf
10 http://www.mcns.scot.nhs.uk/scbmdn/wp-content/uploads/sites/10/2016/04/SCBMDN-5-YEAR-
WORKPLAN.pdf
11 http://www.pathology.scot.nhs.uk/5-year-work-plan/
12 http://www.smvn.scot.nhs.uk/5-year-workplan
13 http://www.mcns.scot.nhs.uk/ncas/about-the-ims/
14 https://public.tableau.com/profile/james.thom6168#!/vizhome/2017-10-19GPWebsite/GP-Dash
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Lothian Data Cube The Lothian Data Cube has been developed by NHS Lothian Laboratory Services. It that analyses monthly extracts from LIMS to provide meaningful data. Through excel pivot the data can be broken down to what is required. The SE regional laboratory programme have a workstream that is extending the data cube to the other health boards within the region, however has put this on hold awaiting the decision of the NLDM. A NLDM would provide large, fast and varied data to support the data cube.
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APPENDIX 10 – PREFERRED OPTION FOR A NATIONAL LABORATORIES DATA MART
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APPENDIX 11 – CURRENT NPEX STATUS FOR ALL BOARDS
Health Board
LIMS Provider
Current NPEx Status
NHS Ayrshire & Arran
Clinisys Not Connected
NHS Borders
Clinisys Not Connected
NHS Forth Valley
DXC Not Connected
NHS Highland
Cirden Ultra Not Connected
NHS Orkney
Clinisys Not Connected
NHS Shetland
Clinisys Not Connected
NHS Western Isles
Medpath Not Connected
NHS Dumfries & Galloway
DXC Not Connected but Cancer Networks funding
NHS Fife
Clinisys Not Connected but Cancer Networks funding
NHS Lanarkshire
Technidata UK Subscribed – awaiting implementation
NHS Tayside
Clinisys Subscribed – awaiting implementation
NHS Grampian
DXC Live
NHS GG&C
DXC Live
NHS Lothian
DXC Live
Funding Requirement
Full Funding Implementation
Costs None
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APPENDIX 12 – TOTAL INVESTMENT REQUIREMENTS FOR IT CONNECTIVITY AND THE NATIONAL
LABORATORIES DATA MART
Cost
Year 1 inc. VAT £
Year 2 inc. VAT £
Total inc. VAT £
Initial Capital Costs
NPEx Purchase
36000 48000 84000
LIMS Interface Cost
76560 110400 186960
eHealth VPN
28800 24000 52800
Total capital costs
141360 182400 323760
Revenue Costs
NPEx annual maintenance
72000 60000 132000
LIMS interface annual maintenance
16800 16800 33600
Total revenue costs
88800 76800 165600
Total costs 230160 259200 489360
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APPENDIX 13 – BREAKDOWN OF INVESTEMENT REQUIREMENTS BY SOLUTION NATIONAL LABORATORIES DATA MART
*Board breakdown will depend on existing infrastructure. IT CONNCECTIVITY
Cost
Year 1 inc. VAT
£
Year 2 inc. VAT
£
Total inc. VAT
£
Initial Capital Costs
NPEx Purchase 36000 48000 84000
LIMS Interface Cost 76560 110400 186960
eHealth VPN 28800 24000 52800
Total capital costs 141360 182400 323760
Revenue Costs
NPEx annual
maintenance
72000 60000 132000
LIMS interface annual
maintenance
16800 16800 33600
Total revenue costs 88800 76800 165600
Total costs 230160 259200 489360
Cost Year 1 £
Year 2 £
Year 3 £
Year 4 £
Year 5 £
Total £
Initial Capital Costs
235000 295000 156000 114000 0 800000
Revenue Costs – PHI
198902 322423 355471 356136 67068 1300000
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RECURRING REVENUE COSTS BY BOARD – IT CONNECTIVITY
Recurring revenue cost by Board
2019/20 £
2020/21 £
2021/22 £
2022/23 £
2023/24 £
Total £
NHS Western Isles 0 14,400 14,400 14,400 14,400
NHS Forth Valley 0 13,800 13,800 13,800 13,800
NHS Fife 0 13,000 13,000 13,000 13,000
NHS Dumfries & Galloway 0 13,800 13,800 13,800 13,800
NHS Ayrshire & Arran 0 15,600 15,600 15,600 15,600 NHS Tayside 0 15,600 15,600 15,600 15,600
NHS Borders 0 0 15,600 15,600 15,600
NHS Shetland 0 0 15,600 15,600 15,600
NHS Highland 0 0 14,400 14,400 14,400
NHS Orkney 0 0 15,600 15,600 15,600
NHS Lanarkshire 0 0 15,600 15,600 15,600
NHS Lothian 0 13,800 13,800 13,800 13,800
NHS Grampian 0 13,800 13,800 13,800 13,800
NHS Greater Glasgow & Clyde
0 13,800 13,800 13,800 13,800
Total 0 127,600 204,400 204,400 204,400 740800
Recurring revenue costs*
76,000 101,000 101,000 203,667 255,000 736,667
Total costs 509902 718423 612471 673803 322068 2836667
Implementation Costs
Implementation Costs
Year 1 £
Year 2 £
Year 3 £
Year 4 £
Year 5 £
Total £
Band WTE
National Programme Board
Programme Director 8d 1 112427 114675 116969 119308 121694 585073
Clinical Director 8d 1 112427 114675 116969 119308 121694 585073
Programme Manager 8a 1 64440 65729 67044 68385 69752 335350
Project Manager 7 1 55344 56451 57580 58731 59906 288012
PSO 5 1 38268 39034 39814 40611 41423 199150
Operational costs 148356 140033 59071 60252 34216 441928
Total - DSM 531262 530597 457447 466595 448685 2434586 Data Mart
Project Manager - 7 1 55344 56451 57580 58731 0 228114
PSO 5 1 38268 39034 39814 40611 0 157727
Programme Manager 8a 0.5 32220 32865 33522 34192 0 132799
Total - Data Mart 125832 128350 130916 133534 0 518640 IT Connectivity
Clinical scientist 8a 1 64440 65729 0 0 0 130169
Technician 5 1 38268 39034 0 0 0 77302
Technician 5 1 38268 39034 0 0 0 77302
IT/eHealth Posts – Local Board 7 11 332063 282254 0 0 0 614317
Programme Manager - NSS 8a 0.5 32220 32865 0 0 0 65085
Project Manager - NSS 7 1 55344 56451 0 0 0 111795
PSO - NSS 5 1 38268 39034 0 0 0 77302
Total - ITConnectivity 598871 554401 0 0 0 1153272
Total - All 24 1255965 1213348 588363 600129 448685 4106490
APPENDIX 14 – CLINICAL AND FINANCIAL BENEFITS OF THE APPLICATION OF THE DSM IN
NHS TAYSIDE
Efficiency Saving at NHS Tayside Innovative Solutions deliver efficiencies and enable investment
What Optimisation of laboratory services.
How An integrated management model for laboratory services was introduced which featured state of the art automation, data management and order communications software. The transformation delivered:
• AN INTEGRATED MANAGEMENT MODEL FOR LABORATORY
SERVICES;
• MERGING OF THE BIOCHEMICAL MEDICINE, HAEMATOLOGY AND
IMMUNOLOGY DEPARTMENTS INTO THE 1ST FULLY UKAS
ACCREDITED INTEGRATED BLOOD SCIENCES DEPARTMENT IN
SCOTLAND;
• CONSOLIDATION OF 4 DISCIPLINES INTO A SINGLE AUTOMATED
TRACK;
• CONSOLIDATION OF GP WORKLOADS ON TO A SINGLE SITE; AND,
• TRANSFER OF MEDICAL MICROBIOLOGY FROM PERTH ROYAL
INFIRMARY (PRI) TO NINEWELLS HOSPITAL WITH INTRODUCTION OF
PAPERLESS WORKING.
Benefit • ENABLED NINEWELLS HOSPITAL TO TAKE ON 73% OF PRI
WORKLOAD AVOIDING A £5M LAB REBUILD COST IN PRI;
• 97% OF CORE BLOOD SCIENCES WORKLOAD IS NOW RELEASED IN
JUST OVER 2 HOURS, PREVIOUSLY 4 HOURS;
• CONSOLIDATION TO NINEWELLS HOSPITAL HAS INCREASED
EFFICIENCY IN BLOOD SCIENCES BY 62%;
• MOVE TO MSC TRANSFERRED RISK AND GENERATED 500K /ANNUM
REVENUE SAVING IN YEAR 1 WITH A PROJECTED FINANCIAL SAVING
OF £4.59M OVER THE COURSE OF THE CONTRACT AND £100K
RECURRENT REDUCTION IN MANAGEMENT COSTS. NOVEL
APPLICATION OF ADVANCED ROBOTICS COMBINED WITH HIGH
FUNCTIONALITY ORDER COMMUNICATIONS IS DELIVERING A
TURNAROUND TIME TO DIAGNOSIS OF LIVER DISEASE OF 2.5 HOURS
THROUGH THE INNOVATIVE ILFT PROGRAMME DEVELOPED WITH
SUPPORT FROM THE CSO; AND,
• REDEFINITION OF ROLES AND ROLE EXTENSION TO ENABLE MORE
EFFECTIVE USE OF STAFF.
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APPENDIX 15 – PIN NOTICE
Prior Information Notice
This notice is for prior information only
Directive 2014/24/EU - Public Sector Directive
Section I: Contracting Authority
I.1) Name and addresses
The Common Services Agency (more commonly known as NHS National Services Scotland) ("NSS")
Gyle Square (NSS Head Office), 1 South Gyle Crescent
Edinburgh
EH12 9EB
UK
Telephone: +44 1698794410
E-mail: [email protected]
NUTS: UKM
Internet address(es)
Main address: http://www.nhsscotlandprocurement.scot.nhs.uk/
Address of the buyer profile:
http://www.publiccontractsscotland.gov.uk/search/Search_AuthProfile.aspx?ID=AA11883
I.2) Joint procurement
The contract is awarded by a central purchasing body
I.3) Communication
Additional information can be obtained from the abovementioned address
I.4) Type of the contracting authority
Body governed by public law
I.5) Main activity
Health
Section II: Object
II.1) Scope of the procurement
II.1.1) Title
Electronic Requesting and Reporting of Examinations
II.1.2) Main CPV code
72000000
II.1.3) Type of contract
Services
II.1.4) Short description
NSS wishes to procure a service/system that will enable electronic requesting and reporting of
examinations between clinical laboratories
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within Scotland and the rest of the UK. The requirement is to replace current paper based processes
used to enable referral and reporting of
examinations between laboratories. The system to enable this should deliver a common user interface
that enables end to end connections
too many different laboratory information systems within a UK wide network of referral laboratories.
There should also be access to a
directory of available test repertoires of connected sites. In addition to functionality that addresses the
requirements of the Blood Sciences
modalities, the identified solution should have available, or have in an advanced stage of
development, functionality to manage the
additional requirements to process information and data exchange for medical microbiology and
histopathology and their constituent
modalities.
II.1.5) Estimated total value
Value excluding VAT: 1 000 000.00 GBP
II.1.6) Information about lots
This contract is divided into lots: No
II.2) Description
II.2.2) Additional CPV code(s)
48814400
II.2.3) Place of performance
NUTS code:
UKM
II.2.4) Description of the procurement
NSS wishes to procure a service/system that will enable electronic requesting and reporting of
examinations between clinical laboratories
within Scotland and the rest of the UK. The requirement is to replace current paper based processes
used to enable referral and reporting of
examinations between laboratories. The system to enable this should deliver a common user interface
that enables end to end connections
too many different laboratory information systems within a UK wide network of referral laboratories.
There should also be access to a
directory of available test repertoires of connected sites. In addition to functionality that addresses the
requirements of the Blood Sciences
modalities, the identified solution should have available, or have in an advanced stage of
development, functionality to manage the
additional requirements to process information and data exchange for medical microbiology and
histopathology and their constituent
76 | P a g e
modalities.
Large volumes of laboratory work flow between the Health Boards within Scotland and to sites
elsewhere within the UK. There is a
requirement that all this work flow for NHSScotland should be facilitated through electronic systems.
Seven boards have/ or will have
deployed the same solution to address requirements. This procurement will deliver a solution for at
least 7 of the remaining Boards with
connection to the 7 Boards with a solution deployed to enable national consistency in process.
This is a market testing exercise and we ask that you complete the questionnaire and return by 8th Jan
2018.
II.3) Estimated date of publication of contract notice:
18/07/2018
Section IV: Procedure
IV.1) Description
IV.1.8) Information about Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
Section VI: Complementary information
VI.3) Additional information
NOTE: To register your interest in this notice and obtain any additional information please visit the
Public Contracts Scotland Web Site at
http://www.publiccontractsscotland.gov.uk/Search/Search_Switch.aspx?ID=522948.
(SC Ref:522948)
VI.5) Date of dispatch of this notice
14/12/2017
APPENDIX 16 – ASSESSMENT OF PIN RESPONSES
Public Information Notice: Electronic Requesting and Reporting of Examinations between Clinical laboratories
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Introduction A public information notice (PIN) was published on 15/12/17: - NSS wishes to procure a service/system that will enable electronic requesting and reporting of examinations between clinical laboratories within Scotland and the rest of the UK. The requirement is to replace current paper based processes used to enable referral and reporting of examinations between laboratories. The system to enable this should deliver a common user interface that enables end to end connections to many different laboratory information systems within a UK wide network of referral laboratories. There should also be access to a directory of available test repertoires of connected sites. In addition to functionality that addresses the requirements of the Blood Sciences modalities, the identified solution should have available, or have in an advanced stage of development, functionality to manage the additional requirements to process information and data exchange for medical microbiology and histopathology and their constituent modalities. Large volumes of laboratory work flow between the Health Boards within Scotland and to sites elsewhere within the UK. There is a requirement that all this work flow for NHSScotland should be facilitated through electronic systems. Seven boards have/ or will have deployed the same solution to address requirements. This procurement will deliver a solution for at least 7 of the remaining Boards with connection to the 7 Boards with a solution deployed to enable national consistency in process. This is a market testing exercise and we ask that you complete the questionnaire and return by 8th Jan 2018. Position Three responses were received: -
1. X-LAB LTD. NATIONAL PATHOLOGY EXCHANGE OR (NPEX) (HTTPS://WWW.X-
LABSYSTEMS.CO.UK/ )
2. FORECARE (WWW.FORCARE.COM )
3. TIANI SPIRIT (HTTPS://WWW.TIANI-SPIRIT.COM/ )
Both X-Lab Ltd and Forecare submitted completed questionnaires with indicative costings for a proposed solution. Tiani delivered a descriptive overview of there systems in the context of the PIN without costs. X-Lab Ltd Overview The National Pathology Exchange or (NPEx) is proposed and comprehensively described. It is recognised as the solution already in place at various stages of implementation in 5 health boards and about to be funded in 2 others. Their proposal is for delivery of a system that will enable electronic requesting and reporting of examinations between clinical laboratories within Scotland and the rest of the UK that is consistent with the requirements of the PIN. The system enables messaging of examination requests and reports between diverse laboratory information systems (LIMS) through a secure exchange process. The proposal is not addressing extra-laboratory requesting of examinations by clinical staff or reporting of results to extra-laboratory systems (e.g. EPR) which is outside of scope. The X-Lab Ltd response to the PIN clearly articulates an understanding of the environment into which their system is to be deployed. NPEx delivers immediate access to a network of all UK laboratory services already connected to the exchange. Forecare overview The Forecare proposal takes the approach of delivery of a LIMS information exchange into the Scottish laboratories. The solution would involve connection of the various LIMS systems
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through an interoperability highway. This is a step further than the n-PEX solution. The proposal indicates potential to deliver an overarching system that allows existing LIMS systems in Scotland to remain in place, but linked to enable significant exchange of necessary information between them. The inference is that requesting and reporting between labs to support referral lab testing is possible, but it is not explicitly described within the proposal. There is also a potential confounder in the model, in that they state that in some cases, where a LIMS cannot be connected to the exchange for technical or commercial reasons then, a web based viewer would be used to enable the exchange of information. This suggests there would be no exchange of information between LIMS to enable process; this will deliver a requirement for intermediary processes and systems (e.g. NPEx) to enable delivery of a functional fully automated examination requesting and reporting between constituent labs on the highway. It leaves a question mark also around connectivity (process and cost) with the wider UK network as there would be a requirement to establish this, for data sharing agreements with all connected labs and deliver a need for the use of a 3rd party system such as NPEx. Tiani-Spirit overview The response here is in a different format to that of the others. It gives no financials. The response describes a system that is compliant with IHE laboratory testing workflow (https://wiki.ihe.net/index.php/Laboratory_Testing_Workflow). The solution is proposed in the context of a provision of Tiani’s health information exchange to enable examination reports to be delivered to a wider audience of care providers. The scope of the response is extending beyond lab to lab communication. There is no clear articulation of how the solution might fit the Scottish landscape with multiple organisations requiring linkage, or how this might enable connection to deliver lab to lab communication UK wide. The response focuses more on the reporting side to users rather than upon the practicalities of supporting lab to lab exchange of workloads. Assessment Three responses have been submitted. The X-labs solution delivers a UK wide applicable solution that has already been adopted by 5 of the 14 Scottish Territorial Health Boards (GG&C, Lothian, Tayside, Grampian and Lanarkshire) with two others potentially funded (Fife and Dumfries and Galloway). The proposal directly deals with the lab to lab process and describes a well established circumscribed system with a development road map identified to enable the process for all disciplines. Adoption of his approach by the remaining boards will deliver national consistency in lab to lab communication processes. It will also access to the larger UK network of linked laboratories and utilisation of existing extra-laboratory requesting and reporting mechanisms. It will therefore enable the delivery of service improvement and remain transparent to clinical users. The Forecare response describes a solution that enables an interoperability of many LIMS system and enables information exchange. It does not address the practicalities of UK wide applicability of the system to enable lab to lab communication around referred workloads. Potential difficulties were identified with either technical or commercial impediments to linkage of some LIMS to the interoperability highway. This raises the concern that some laboratories, in the event that they could only be provided with web based viewing of exchangeable information facilities, would require a 3rd party system such as NPEx to deliver the functionality described in the PIN. This level of integration is something that may need to be considered within any discussions re an affordable roadmap towards Regional or National LIMS, but those are different discussions to be had. The logical conclusion is that, although not explicitly stated in the response, the interoperability of systems delivers the ability for all lab modalities to share reports in formats that will enable initiate workflow in referral labs and translation of reports in requesting labs in such a way that reporting to third party systems in the requesting locality are enabled. As stated earlier the Forecare proposal does not address the UK wide requirement. The required functionality would necessitate all the Boards to have data sharing agreements with all referral labs, and for those labs to be attached to the interoperability highway. The NPEx
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solution simply requires data sharing agreements between the user organisation (e.g. Boards) and the organisation hosting the exchange to a large network of labs already attached with similar agreements. This delivers additional costs and organisational overhead. The Tiani-Spirit solution does not address all points in the PIN questionnaire and like the Forecare proposal does not specifically contextualise the proposal in terms of a Scottish and UK wide applicable solution to the challenges within the scenario identified in the PIN. The response focuses more on sharing of reports with users rather than the detail of lab to lab communication with access to a directory of available tests. Many of the Boards have to a greater or lesser extent already developed solutions to enable the elements of reporting to clinical users of lab services. This has been achieved either through development of clinical portals or SCI store via existing interfaces with LIMS systems and integration engines. The PIN response therefore is not appropriately focused on the challenge that compromise safe, efficient and effective management of lab to lab workflow. Conclusion The X-Lab Ltd response is clearly focused on the delivery of a robust and resilient solution for management of lab to lab ordering and reporting of examinations. It proposes a solution that is consistent and compatible with that identified and already deployed independently by the 5 largest NHSScotland Boards. NPEx delivers lab to lab communication between those boards and to other UK laboratory services through an established exchange process. Extension of the deployment to the remaining boards will deliver the same benefits from a well proven system. The deployment of NPEx will deliver required lab to lab communications and not impact on extra-laboratory e-health systems and thus deliver improved laboratory processes and significant improvement to service via changes hidden from lab users. Both the Forecare and Tiani-Spirit responses fail to address the UK wide element of the requesting/reporting process identified as a requirement within the PIN. Their responses cover a wider remit than that requested. In contrast X-lab’s response clearly identified and addressed scope and scale ability of the proposal in context. The X labs proposal addresses the brief identified in the PIN and can provide access to a proven and nationally established exchange service that meets NHSScotland’s requirements. Both Forecare and Tiani-Spirit fail in their response to clearly describe a solution that will meet the required scope.
APPENDIX 17 – IT CONNECTIVITY PROJECT TEAM ROLES
Job Title Project Role
Clinical Scientist, Expertise in using LIMS system and understanding operational
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Biochemistry (or equivalent)
needs/requirements and workflow
Technician x 2 Required to carry out the initial link between the LIMS system and
NPEx and further system testing thereafter.
Project Managers Required to work with the national implementation programme team and local Boards to implement the NPEx service and handover to Boards as business as usual. Internal Board PM or part of network of ‘super users’.
NPEx Project Manager
Responsible for liaising with the IT Connectivity Project Team at a local Board level and responding to technical support requirements and developments
Project Support Provide project support for central co-ordination of roll out across Boards
APPENDIX 18 – STAGES OF DESIGNING AND DEVELOPING THE NATIONAL LABORATORIES
DATA MART The high level steps involved in the development and implementation of a national data intelligence solution are shown in the table below. Some of the steps can be carried out simultaneously or overlap and others cannot be progressed until completion of the previous step e.g. functional specification, IT design and build. To date the requirements have been scoped for the business case and the NLDM dataset development is scheduled to be completed with the National Managed Diagnostic Networks and Demand Optimisation Group data groups.
Phase Purpose
Scoping the Requirements
Detailed engagement to identify the information/outputs and intelligence infrastructure that are needed in future. The current position is identified in order to establish the gap between the current and future state. This helps to inform discussions about approaches, scale, timescales and costs to enable the customer to decide whether to progress to detailed costing for a business case.
National Dataset Development and Data Profiling
The development of a national dataset is a key building block to the development of national information as it ensures information is captured in a consistent and standardised way to enable meaningful comparative outputs to be produced at regional and national level. PHI works with stakeholders to develop and maintain a huge number of national datasets, definitions and reference files in the Health and Social Care Data Dictionary15 PHI can work with the outputs from the laboratory workshops, and engage with the networks further to refine, consult on and finalise a national dataset for laboratories. The dataset would be developed in line with scoping of the requirements to ensure the data items captured can feed the outputs that the laboratories community require. Data profiling involves engaging with sites to obtain test data in order to carry out data quality and completeness checks. It identifies issues to be resolved e.g. data items recorded differently within or between
15 http://www.ndc.scot.nhs.uk/Dictionary-A-Z/index.asp
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NHS Boards. This informs future engagement and/or IT system changes required in order to enable data to be collected in line with the nationally agreed dataset.
Business Requirements
PHI complete business requirements documentation to outline what it is they need the information solution to be able to do – this is based on the findings of the scoping the requirements stage, but will consider in detail requirements for things like validation, linkage to other data marts, levels of access etc
Functional Specification
Detailed technical analysis of requirements including data file specification, submission schedule, data volumes, file processing, data validation, mapping, derived items, CHI seeding, security and historical data.
Information Governance approvals
Robust information governance needs to underpin national data developments. The national collection of personal identifiable data requires approval from the Public Benefit and Privacy Panel for Health and Social Care (PBPP). A PBPP application can take around 2-3 months to complete and gain approval. Approvals need to be in place before the IT design and build phase, and the application is usually written around the same time as the development of the functional specification as it requires the applicant to have detailed knowledge of the data to be collected and submitted, and outputs to be produced from it.
IT Design Technical design including data model, ETL (extract, transform and load) processes, security and Tableau TDEs (Tableau Data Extracts).
IT Build Development of solution including ETL procedures, job controls, security packages, historical data loads, Tableau environment, Tableau TDEs. Includes unit testing.
System Testing and UAT
Independent end to end system testing. Support of User Acceptance testing, plus any rework.
Development of Outputs
Production of outputs such as tableau dashboards which form the main output from the intelligence solution.
Training Development of user guides and training of end users as required
Implementation and Rollout
Ensuring end users have access to the appropriate information in line with information governance agreements. Rollout as planned e.g. phased.
Transition to Business as Usual
Following completion the work will transition into BaU teams in PHI and IT with the appropriate resources and skills in place e.g. support/helpdesk requirements, submission of data, data quality monitoring, production of analysis and any future developments.
APPENDIX 19 – IMPLEMENTATION TEAM National Laboratories Programme Implementation Team
Role Required
Responsibility
Senior Responsible
Officer (SRO)
Accountable for the programme, together with personal responsibility for ensuring that it meets its objectives and realises the expected benefits from implementing the preferred options
Programme Director
Provide executive leadership and responsible for managing the programme team and programme delivery. Responsible for defining programme benefits, assessing progress towards realisation, and achieving measured improvements
Medical Director
Provide clinical leadership work with senior clinical stakeholders within 3 regions and wider stakeholder community to facilitate
programme delivery and the design and development of DSM
Programme Manager
Lead and manage the set up of the programme and work with regional programme managers to develop the implementation plan to facilitate delivery of the IT Connectivity and National Laboratories Data Mart solutions
Project Manager
Manage individual projects to produce the preferred option within budget, time and to the desired quality to ensure benefits are achieved
Project Support Officer (PSO)
Responsible for supporting the programmes and projects in delivering the preferred option
National Laboratories Programme Implementation Team – Resource Requirements
Implementation Costs Year 1
£
Year 2
£
Year 3
£
Year 4
£
Year 5
£
Total
£
Band WTE
National Programme Board
Programme Director 8d 1 112427 114675 116969 119308 121694 585073
Clinical Director 8d 1 112427 114675 116969 119308 121694 585073
Programme Manager 8a 1 64440 65729 67044 68385 69752 335350
Project Manager 7 1 55344 56451 57580 58731 59906 288012
PSO 5 1 38268 39034 39814 40611 41423 199150
Operational costs 148356 140033 59071 60252 34216 441928
Total - National Programme Board 531262 530597 457447 466595 448685 2434586
IT Connectivity Project Team Roles
Role Required Responsibility
Clinical Scientist, Biochemistry (or equivalent)
Expertise in using LIMS system and understanding operational needs/requirements and workflow
Technician x 2 Required to carry out the initial link between the LIMS system and NPEx and further system testing thereafter.
IT/eHealth Posts (Project Managers)
Required to work with the national implementation programme team and local Boards to implement the NPEx service and handover to Boards as business as usual. Internal Board PM or part of network of ‘super users’.
NPEx Project Manager Responsible for liaising with the IT Connectivity Project Team at a local Board level and responding to technical support requirements and developments
Project Support Provide project support for central co-ordination of roll out across Boards
IT Connectivity Project Team – Resource Requirements
IT Connectivity Project Team
Year 1 £
Year 2 £
Total £
Post Band WTE
Clinical scientist 8A 1 64440 65729 130169
Technician 5 1 38268 39034 77302
Technician 5 1 38268 39034 77302
IT/eHealth Posts – Boards 7 11 332063 282254 614317
Programme Manager – NSS 8A 0.5 32220 32865 65085
Project Manager – NSS 7 1 55344 56451 111795
PSO – NSS 5 1 38268 39034 77302
Total 16.5 598871 554401 1153272
NLDM Project Team
Role Required Responsibility
NSS PHI – various roles – to be defined further
Expertise in data set development, profiling, mapping, validating data, file processing, data security and information governance
NSS BI team Expertise in design of IT model, system testing, data security, training
Project Support Provide project support for central co-ordination of roll out across Boards
National Laboratories Data Mart – Resource Requirements
NLDM Project Team
Year 1 £
Year 2 £
Year 3 £
Year 4 £
Year 5 £
Total £
Post Band
Project Manager - 7 55344 56451 57580 58731 0 228113
PSO 5 38268 39034 39814 40611 0 157732
Programme Manager 8a 32220 32865 33522 34192 0 132799
PHI/BI - Data Analysis, Information, IT, Business Intelligence Consultants Various
198902 322423 355471 356136 67068 1300000
Total 324734 450773 486387 489670 67068 1818644
