Name of Meeting Board Date of Meeting 28 March 2019 Agenda item: 9.2.280319

Development of a Mid and South West Wales Regional Centre of Excellence Cellular Pathology Laboratory, Regional Diagnostic Immunology Laboratory & Regional Medical Microbiology Facility at Morriston Hospital, Swansea Executive lead: Dr Quentin Sandifer, Executive Director of Public Health Services and Medical Director Author: Ms Heather Edwards, Business Planning Manager, Abertawe Bro Morgannwg University Health Board, with amendment where necessary by Dr Quentin Sandifer, Executive Director of Public Health Services and Medical Director

Approval/Scrutiny Business Executive Team, 18 March 2019 route:

Purpose To seek Board approval on the Strategic Outline Case (SOC) prior to submission to Welsh Government.

Nationally NHS Pathology services face a number of challenges. Within the Mid and South West Wales’ region, Hywel Dda University Health Board (HDUHB), Abertawe Bro Morgannwg University Health Board (ABMUHB) and Public Health Wales NHS Trust (PHW) are struggling to manage workforce and sustainability pressures, to maintain quality and safety issues and to meet clinically driven targets. Without investment in sustainable services we cannot deliver essential improvements and fit for purpose laboratories. Investment would allow us to co-locate and develop regionalised services and to support more innovative and sustainable service models which could be future-proofed, and be flexible enough, to respond to changing demand, new technologies and innovations. In 2017 a South West Wales Regional Pathology Reconfiguration Project Board was established to draft a Strategic Outline Business Case (SOC) to address these regional challenges in line with the national direction of travel for regional pathology services.

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The purpose of this SOC is to: a) Confirm the strategic context of the proposal b) Present a case for change c) Outline, with indicative costs only at this stage, a short-list of options indicating a preferred way forward. At OBC stage these will be subject to a detailed economic analysis to include costs, benefits and risks.

Recommendation: APPROVE CONSIDER RECOMMEND ADOPT ASSURANCE

The Board is asked to: • Note the development of business continuity plans. • Note the short-listed options with estimated capital and revenue costs and identification of the preferred way forward (Option 3). • Approve this SOC and agree it can be submitted to Welsh Government to support this project progressing to Outline Business Case stage. Appendices: SOC attached for information with embedded appendices.

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Link to Public Health Wales Strategic Plan

Public Health Wales has an agreed strategic plan, which has identified seven strategic priorities and well-being objectives.

This report contributes to the following: Strategic 5 - Protecting the public from infection and Priority/Well-being environmental threats to health Objective Strategic 6 - Supporting the development of a Priority/Well-being sustainable health and care system focused Objective on prevention and early intervention Strategic Choose an item. Priority/Well-being Objective

Summary impact analysis

Equality and Health An Equality and Health Impact Assessment is Impact Assessment included as Appendices A and B to the SOC. These will be reassessed during the OBC. The investment will provide new technology which will improve diagnostic services e.g. molecular testing, improve quality systems and reporting structures in pathology (including microbiology) services, and provide all patients in community, primary and secondary care requiring microbiological/infectious disease diagnosis with more reliable/ timely and equitable services.

Facilities will be designed that are cognisant of the needs of the privacy and dignity of staff and the needs of disabled staff and visitors. Risk and Assurance The establishment of regional specialist microbiology services linked to other pathology services and in the setting of a teaching hospital with close links to higher education will make the service more attractive for recruitment and retention of staff. Health and Care This report supports and/or takes into Standards account the Health and Care Standards for NHS Wales Quality Themes Theme 3 - Effective Care

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Theme 5 - Timely Care Choose an item. Financial implications Yes, as set out in the report. It should be noted that the costs presented refer to the whole project and for all three organisations presenting this report. The estimates will be validated in the OBC stage. People implications A detailed workforce plan is being developed for the OBC stage

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1. Purpose / situation

This paper presents a proposal for the development of a regional centre of excellence for pathology services, including microbiology and infectious disease diagnostics, to the population of South West Wales. It has been developed by Public Health Wales NHS Trust (PHW), Abertawe Bro Morgannwg University Health Board (ABMUHB) and Hywel Dda University Health Board (HDUHB), working together as a South West Wales Regional Pathology Re-configuration Project Board.

The approval of the Boards of all three organisations on a Strategic Outline Case (SOC) is sought prior to submission to Welsh Government; all three Boards are meeting on the same day. The SOC recommends four options for further more detailed evaluation at the Outline Business Case (OBC) stage.

Nationally NHS Pathology services face a number of challenges including: • Workforce and sustainability pressures - ensuring the service has ‘the right staff with the right skills’; • Quality and safety issues (including estate and facility constraints); • Technological innovations (including automation, digital technology and innovative technologies/equipment/diagnostic methods) - this is a significant driver for change and is the catalyst for policy and strategy responses; • Major growth in demand, both demographically (ageing population with more complex investigations; antibiotic resistance and control of infection issues) and in cancer services e.g. Single Cancer Pathway, and; • Changing models of care – moving from traditional models of care towards personalised treatment.

Within the Mid and South West Wales’ region, Hywel Dda University Health Board (HDUHB), Abertawe Bro Morgannwg University Health Board (ABMUHB) and Public Health Wales NHS Trust (PHW) are struggling to manage workforce and sustainability pressures, to maintain quality and safety issues and to meet clinically driven targets. Without investment in sustainable services we cannot deliver essential improvements and fit for purpose laboratories. Investment would allow us to co-locate and develop regionalised services and to support more innovative and sustainable service models, which could be future-proofed, and be flexible enough, to respond to changing demand, new technologies and innovations.

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2. Background and Option assessment

In 2017 a South West Wales Regional Pathology Reconfiguration Project Board was established to draft a Strategic Outline Business Case (SOC) to address these regional challenges in line with the national direction of travel for regional pathology services. The Project Board agreed the case for change could be supported by developing a Mid and South West Wales Regional Centre of Excellence Cellular Pathology Laboratory, a Regional Diagnostic Immunology Laboratory and a co-located Regional Medical Microbiology Facility at Morriston Hospital, Swansea.

The Project Board has identified the key investment objectives of this project as follows: • To develop more sustainable South Wales Regional Cellular Pathology, Regional Diagnostic Immunology Laboratory and Regional Medical Microbiology services • To improve the quality and safety of South Wales Regional Cellular Pathology, Regional Diagnostic Immunology Laboratory and Regional Medical Microbiology services • To improve the efficiency and productivity of South Wales Regional Cellular Pathology, Regional Diagnostic Immunology Laboratory and Regional Medical Microbiology services • To improve the effectiveness of South Wales Regional Cellular Pathology, Regional Diagnostic Immunology Laboratory and Regional Medical Microbiology services • To improve economies within South Wales Regional Cellular Pathology, Regional Diagnostic Immunology Laboratory and Regional Medical Microbiology services

To meet these key challenges, satisfy the project’s investment objectives and to support development of a ‘one-site’ Cellular Pathology solution a potential range of options were identified by Project Board (Option 1, the ‘Business As Usual’ option was rejected for further detailed analysis but will be included as a baseline comparator for detailed economic appraisal at OBC stage). These potential options were as follows with Option 3 identified as the Preferred Way Forward at this stage: • Option 2 - ‘Do Minimum’: Development of ‘core’ regionalised services, i.e. development of a Regional Cellular Pathology (Cytology and Histopathology) & Regional Diagnostic (Laboratory) Immunology service; Co-location of Singleton‘s Body Store at Morriston Hospital service (future proofed capacity) & a 500 m² ATTC, i.e. Cell and Gene Therapy indicative shell and core area; • Option 3 Intermediate: Development of 'core’ regionalised services plus relocation of ABMUHB’s Regional PHW Medical Microbiology service to Morriston Hospital;

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• Option 4 Intermediate: Development of 'core’ regionalised services plus relocation of ABMUHB’s Regional PHW Medical Microbiology service to Morriston Hospital and development of a temporary modular Body Store solution at Singleton Hospital, and; • Option 5 ‘Do Maximum’: Development of 'core’ regionalised services plus relocation of ABMUHB’s Regional PHW Medical Microbiology service to Morriston Hospital, development of a temporary modular Body Store solution at Singleton Hospital and re-provision of ABMUHB’s Essential Laboratory Service.

Option 2 Option 3 Option 4 Option 5 Do PREFERRED Intermediate Do Max Functional Content by Health Minimum WAY FORWARD – far more ambitious Board Intermediate – ambitious more ambitious

Develop Regional HDUHB Cellular Pathology X X X X ABMUHB (Cytology and Histopathology) Regional Diagnostic HDUHB (Laboratory) X X X X ABMUHB Immunology service; Co-locate Singleton‘s Body Store at ABMUHB Morriston Hospital X X X X service (future proofed capacity) A 500 m² ATTC, i.e. Cell and Gene X X X X Therapy indicative shell and core area Provide dedicated car parking to support ALL X X X X regionalised services (300 spaces) Relocate ABMUHB’s PHW Medical PHW X X X Microbiology service to Morriston Hospital Reconfigure and refurbish local non- regionalised Blood Sciences services' accommodation to provide fit for purpose facilities - HDUHB X X X Refurbishment of Cell Pathology - Withybush Hospital, Prince Philip Hospital, Llanelli & West Wales General Glangwili (approx. 486 m2)

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Option 2 Option 3 Option 4 Option 5 Do PREFERRED Intermediate Do Max Functional Content by Health Minimum WAY FORWARD – far more ambitious Board Intermediate – ambitious more ambitious

Develop a temporary modular Body Store ABMUHB X X solution at Singleton Hospital Re-provide ABMUHB’s ABMUHB Essential Laboratory X Service

Depending on the scale of the investment, in the short term, the aim is to improve recruitment and retention within the Mid and South West Wales Cellular Pathology and wider Pathology service, improve quality and safety, foster training opportunities, and support modernisation of the workforce and service innovations. In the longer term, this investment supports more sustainable Pathology services in the region, supports technological innovations, promotes benefits in terms of improved specialist healthcare services, facilitates access to modern techniques and innovations, and enhances the patient experience and improve quality outcomes. Overall, this investment delivers urgent improvements in quality, safety and sustainability within Mid and South West Wales’ pathology services.

The assumption at SOC stage is that the work currently undertaken in the Swansea laboratories for Princess of Wales activity will continue following the boundary change. Further work on this will undertaken at OBC stage.

Work is progressing with the development of a business continuity plan, in relation to the immediate workforce challenges, including an action plan on how the three organisations could work together in the short, medium and long-term – with a focus on digital technology, joint posts, links to academia, joint training opportunities etc.

It is anticipated that this project will be delivered via the Designed for Life – Building for Wales 3 procurement route. The indicative programme is as follows:

Activity Due Date Welsh Government endorse SOC May 2019 Appoint Supply Chain Partner, Health Board Cost Advisor & July 2019 Health Board Project Manager from Designed for Life Regional Framework Welsh Government approval of OBC September 2020 Welsh Government approval of FBC January 2022 Mobilise and commence new build/extension main works February 2022 New build completed (subject to contractor’s programme) January 2024

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Activity Due Date New build commissioning (subject to accreditation February 2024 arrangements & technical commissioning) New build operational March 2024 Commence refurbishment April 2024 Refurbishment completed (subject to contractor’s October 2024 programme) Refurbishment commissioning (subject to accreditation November 2024 arrangements & technical commissioning) Refurbishment operational December 2024

3. Financial implications The indicative capital implications of the proposed investment for each shortlisted option were identified as follows:

(£000 incl non-recoverable VAT) Option 2 Option 3 Option 4 Option 5 Do Intermediate1 Intermediate Do Maximum Minimum Departmental 17,249 25,729 27,121 31,168 Costs On Costs 13,041 20,332 20,475 25,499 Provisional -908 -1,382 -1,427 -1,700 location adjustment Works Costs 29,382 44,679 46,169 54,967 Total Fees 4,701 7,149 7,387 8,795 Non Works Costs 1,741 2,694 2,641 2,745 Equipment Costs 3,611 5,059 5,231 5,718 Planning 3,943 5,958 6,142 7,222 Contingency VAT (adjusted for 7,576 11,678 12,036 14,130 reclaim) Base Project 50,954 77,217 79,606 93,577 Cost

The revenue impact on each of the shortlisted options are as follows:

Costs Option 2 Option 3 Option 4 Option 5 (£000) Do Minimum Intermediate 1 Intermediate 2 Do Maximum Service Pay 0 0 0 0 Service Non-Pay 0 0 0 0 Support Services 197 236 263 503 Total 197 236 263 503

A number of costs pressures associated with the staffing models exist, whether the service moves to a new facility or remains in-situ. These relate to increasing demand for pathology services. For that reason it is reasonable to recognise the current service and projected future demand,

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but to exclude them from the revenue financial model at this stage in the development of the business case.

In moving to a single facility, Hywel Dda would need to manage the workload of their Consultant staff using the Royal College points based system. This would mean an increased revenue cost pressure. However, over the last few months, work undertaken between both organisations, suggest this cost increase will be less than previously anticipated. In addition it now seems likely that as a result of the closer working relationship of the two organisations, Hywel Dda will be moving to the points based system in advance of any new building. This will allow them to reap the benefits of also moving to partly implement the Advanced Practitioner role that is being successfully adopted in ABM. The adoption of the Advanced Practitioner role will in effect lessen the cost base if it had not been adopted. At the SOC stage it has been assumed no additional cost pressure.

Further work will be required at Outline Business Case stage (OBC) to assess the impact of travel. There are likely to be additional lab specimens travelling to Morriston. However it is too early to estimate the extent of any additional costs, as it is likely that existing transportation journeys can be utilised. Further work will also be required during the OBC to assess the impact on IT.

There are likely to be additional costs associated with running a modern facility built to conform with the latest building and engineering standards. This will be due to the new facility requiring increased space to meet these requirements, approx. a 30% increase of an additional 2,000 sq metres and the cost of servicing a modern building environment are normally greater than older non-complaint buildings. At this stage no detailed building design work has been undertaken but a high level estimate indicates that it would not be unreasonable to expect additional annual running costs of around £236k for the preferred way forward. The share of the estimated additional revenue costs for each organisation on the preferred way forward will be dealt with during the OBC stage.

4. Risk assessment

The main risks are as follows:

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Risk Description Probability Impact Score Mitigating Actions Internal approvals delayed 3 4 12 (1) Continued liaison with key - There is a risk that board stakeholders' SROs approvals are delayed. Planning approval & 5 4 20 (1) Early engagement with planning conditions - Local Planners; (2) Appoint a Failure to achieve planning Planning Advisor and further permission conditions are investigate future planning excessive, that S106 development risks at demands building control Morriston Hospital & Submit a approvals are more pre-planning application; (3) involved than anticipated Monitor progress on Project and its interrelationship(s) with ARCH & other Morriston Hospital projects currently at planning stage; (4) Coordinate with ARCH Master Planners. Funding approval delayed 4 4 16 (1) Maintain regular dialogue or timing of funding does re the procurement not match our current arrangements with WG and programme due to WGov other key stakeholders. cashflow constraints Revenue affordability - 5 4 20 (1) Develop and sign off Affordability of revenue revenue model with DoFs; model is over/under (2) Project Board to review at estimated each formal meeting. Availability of capital - 5 3 15 Continued liaison with WGov. There is a risk that the scope of the project is reduced in order to fit within financial limit Staffing levels - Additional 3 4 12 (1) Develop Staff Modelling staffing levels / activity to inform, e.g. future car cannot be supported at parking requirements on site; Morriston Hospital, e.g. car (2) Liaise with Morriston parking provision and Hospital/ARCH projects essential infrastructure are currently at planning stage. insufficient to support planned operations Staffing model is 3 4 12 Establish a Project over/under estimated Management Team and secure project management support Recruitment of key staff - 3 4 12 Project Board monitors Sufficient numbers of recruitment progress/issues essential staff with key and report regularly to skills cannot be recruited Project Board/Executive level

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3.1 Fit to Public Health Wales strategic plans

Protecting the population from infection and environmental threats to health is Strategic Priority 5 in our Long Term Strategy to 2030. Critical to the achievement of this is the development of a National Health Protection Service (NHPS). The steps towards achieving this are set out in our medium term strategic plan to 2022. The aims is to develop a more responsive and resilient service. Within our plans for a NHPS, the long- term plan for Microbiology is to develop this service into an Infectious Disease Service for Wales. This recognises the need for a service redesigned to offer local ‘hot’ diagnostics within a national structure organised around a limited number of regional ‘cold’ testing facilities. One of the challenges to the achievement of this model is the need for a modern, fit-for-purpose laboratory estate. This proposal addresses that need in south-west Wales.

3.2 Well-being of Future Generations (Wales) Act 2015

Pathology is a key component in the delivery of prudent health services to the population of Wales and is a key enabler to Welsh Government health delivery plans including cancer and stroke. Investment in regionalised Pathology services will support the principles of Prudent Healthcare, enable the service to work more closely with clinical teams, to develop new techniques and innovate to realise benefits of more personalised health monitoring/ preventative medicine, e.g. providing more rapid treatment for patients / improved outcomes / timely responses, and providing more proactive management of patients.

Development of regionalised Diagnostic Immunology services will support more effective treatment and deliver better results and improved outcomes patients following Prudent Healthcare principles; to meet the All Wales Diagnostic Specification and ensure the highest quality of evidence based care and improve accessibility for patients.

This is a strategic commitment to long-term investment in regional services and to the ambition set out in strategic priority 5 in Public Health Wales’ long-term strategy.

This supports Public Health Wales’ strategic intentions set out in strategic priority 5 in Public Health Wales’ long-term strategy.

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The co-location of pathology services will support knowledge transfer, and skills and service development.

The three organisations have worked closely together to develop this proposal.

The proposals are informed by the strategic plans developed by all three organisations with stakeholder involvement.

5. Recommendation

Nationally NHS Pathology services face a number of challenges. Within the Mid and South West Wales’ region, Hywel Dda University Health Board (HDUHB), Abertawe Bro Morgannwg University Health Board (ABMUHB) and Public Health Wales NHS Trust (PHW) have developed a proposal for investment that would allow us to co-locate and develop regionalised services and support more innovative and sustainable service models. These could be future-proofed, and flexible enough, to respond to changing demand, new technologies and innovations.

The Board is asked to: • Note the development of business continuity plans. • Note the short-listed options with estimated capital and revenue costs and identification of the preferred way forward (Option 3). • Approve this SOC and agree it can be submitted to Welsh Government to support this project progressing to Outline Business Case stage.

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Health Impact Assessment Appraisal Tool Project title and brief description of the proposal: Development of a Mid and South West Wales Regional Centre of Excellence Cellular Pathology Laboratory, Regional Diagnostic Immunology Laboratory Facility and Regional Medical Microbiology facility at Morriston Hospital, Swansea

Key aims and objectives: Those on Older people / Adults / Children and young Minority General Target Groups low people* Noting this investment serves all these Ethnic population income groups Groups Factors that determine health: Individuals Lifestyle / capacities affecting health: Smoking, N/A Pathology services are integral to Health care N/A N/A nutrition and health eating, physical activity, alcohol / drug provision Access to effective and efficient pathology misuse, sexual health, Propensity to use heath and care services is essential to the delivery of a significant services Skills and knowledge, training and education proportion of national priorities and targets for the NHS, pathology results directly affect 80% of patient pathway in primary, secondary and tertiary care. Social and Community Influences affecting health: Family: N/A Structure and function, Parenting Community: Social support mechanisms, social networks, neighbourliness. Peer pressure. Community divisions, degree of isolation. Historical identity, Cultural and spiritual ethos.

Living conditions: Built environment, civic design and Provides a fully compliant built environment and a planning, housing, noise, smell, air and water quality, sustainable service. physical view and outlook, public safety, waste disposal, road hazards, injury hazards, Safe play spaces. Working conditions: Employment, workplace conditions, Achieves compliance with the following mandatory occupation, income. accreditation requirements:  The Human Tissue Authority ensures that there is compliance regarding the obtaining of tissue for further investigation, storage of such tissue etc.;  Medical Laboratories accreditation ISO15189 (replacing current Clinical Pathology Accreditation (CPA) requirements, which ensures laboratories operate a quality management system to integrate the organisation, procedures, processes and resources. The standards which have to be complied with include those around the building infrastructure of the laboratories, continuing professional development of staff, quality assessment of performance and individual performance review), and;  National External Quality Assessment (EQA) schemes, both medically and scientifically. Performance against EQA standards is used as a development tool at personal review and as a tool to improve Histopathology service provision and delivery. Services: (access to and quality of) Medical services, An integrated Cellular Pathology, Diagnostic caring services, careers advice and counselling, shops and Immunology facility will include sub-specialities, commercial services, public amenities, transport, education specialist national and international reference units and other services. Access to information technology. with scientific expertise, providing patients’ with more equitable access to expert knowledge optimising patient treatment.

Socio-economic, cultural and environmental and This investment will provide a more sustainable sustainability factors: Biological diversity, efficient use of Regional and all Wales pathology service which will: resources, pollution, diversity / local distinctiveness, climate.  Maintain business continuity; Support innovation Macro-economic factors: Political climate, GDP, economic and new investment in the Region; development, policy climate.  Improve recruitment to Pathology services across South West Wales;

 Improve the relationship between Pathology services and clinical research;

 Working more closely with the University to widen academic access to the range of undergraduate and postgraduate courses which are required for Pathology services, and;

 Improve regional Gross Value Added (GVA) measurements (through improved quality and reliability of regionalised specialist healthcare services).

Others** What positive effect(s) is the proposal Detailed information is not available at SOC stage. likely to have for people’s health and well being, and for which groups within the population? What negative effect(s) is the proposal likely to have for people’s health and well being, and for which groups within the population? If negative impacts were identified for one or more group within the population, are there ways in which these can be removed or mitigated? Is further investigation, information and evidence collection needed to find potential solutions? Are there opportunities to build in more actions to improve people’s health as a part of the proposal. Are there sources of information or experience elsewhere that may help explore this question more fully?

ABMU EqIA Form 1

Equality Impact Assessments (EqIA) Screening Tool to decide if an EqIA is needed 1. What is your Service Area and Directorate? Service area: Regional Pathology Laboratory, Regional Diagnostic Immunology Laboratory Facility and Regional Medical Microbiology facility at Directorate: A Regional Collaboration for Health (ARCH) Morriston Hospital, Swansea Name of Initiative: Development of a Mid and South West Wales Regional Centre of Excellence Cellular Pathology

2. What initiative are you screening for relevance to equality? New Service Project Service Review Care pathway Service change Financial decision/ Strategy Efficiency saving Policy Other Please write in:

3. Please give a brief description of the initiative including the aims, objectives, who will be affected and what you are trying to achieve Please write in This investment supports development of a dedicated and fit for purpose facilities on the Morriston Hospital site to support the healthcare needs of nearly 1 million people living in the Mid and West Region of Wales.

4. What does the initiative mainly relate to? Direct frontline service delivery e.g. face to face contact with service users Please explain why This investment supports improved turn-a-round time especially for urgent suspected cancers and for All Wales Lymphoma panel patients and improve the patient experience. Furthermore, this investment will support standardised protocols that reduce variability, reduce clinical risk, and strengthen clinical governance within the region. Indirect front line service delivery e.g. support service provided at a distance

Please forward a copy of this assessment to: 1 [email protected] [email protected] [email protected] ABMU EqIA Form 1

Please explain why This investment will support the development of a fit for purpose Regional Pathology Laboratory service at Morriston Hospital allowing co-locate of essential Pathology services in support of Future delivery of Pathology Services’ Welsh Assembly Government (2008) strategic direction. this project is supported at Ministerial level in Wales and by the NHS Wales Collaborative. Indirect back room service delivery e.g. support service with no patient contact Please explain why This investment will provide new technology which will improve diagnostic services for, e.g. molecular testing, improve quality systems and reporting structures in pathology services, and provide all patients in the secondary care, and those attending acute and regional hospital based services, with more reliable/ timely and equitable cellular pathology, histopathology specialists and services.

5. Would this initiative be delivered in partnership with other public sector partner organisations or contractors? Yes No

6. What is the potential impact on the following groups of people including patients or the wider community? Group High Negative Medium Low Neutral Positive Unknown Negative negative Different racial groups Please describe what existing evidence you have for your assessment n/a Different age groups Please describe what existing evidence you have for your assessment n/a Men, women Please describe what existing evidence you have for your assessment Appropiate changing facilities will be provided that are congnisant of the needs of the privacy & dignity of staff. People with disabilities Please describe what existing evidence you have for your assessment Appropriate facilities and services will be provided that are congnisant of the needs of disabled staff and visitors.

Please forward a copy of this assessment to: 2 [email protected] [email protected] [email protected] ABMU EqIA Form 1

Group High Negative Medium Low Neutral Positive Unknown Negative negative Different religions or beliefs Please describe what existing evidence you have for your assessment n/a Different sexual orientations Please describe what existing evidence you have for your assessment n/a Gender reassignment Please describe what existing evidence you have for your assessment Unisex changing and toilet facilities will be provided in accordance with Health Board Policy. Welsh language speakers Please describe what existing evidence you have for your assessment All signage in the new development will adhere to ABMU HB's Welsh Language Policy & to the Welsh Language Act's requirements. Pregnant women/women who have recently given birth to children Please describe what existing evidence you have for your assessment n/a Marital or civil partnership status Please describe what existing evidence you have for your assessment n/a Carers Please describe what existing evidence you have for your assessment n/a Different socio-economic groups Please describe what existing evidence you have for your assessment n/a

7. What is the potential impact on staff? Staff Group High Negative Medium Low Neutral Positive Unknown Negative negative

Please describe what existing evidence you have for your assessment

Please forward a copy of this assessment to: 3 [email protected] [email protected] [email protected] ABMU EqIA Form 1

Staff Group High Negative Medium Low Neutral Positive Unknown Negative negative Provision of fit for purpose, modern laboratory and research facilities with recruitment to Pathology services support facilities for staff in line with best practice. The new development will enhance recruitment and retention, and promote research and innovation. Working more closely with the University to widen academic access to the range of undergraduate and postgraduate courses which are required for Pathology services

8. What is the potential impact on the Human Rights of individuals and in particular to the principles of: Principle High Negative Medium Low Neutral Positive Unknown Negative negative Dignity Please describe what existing evidence you have for your assessment As above in No. 6. Respect Please describe what existing evidence you have for your assessment As above in No. 6 Fairness Please describe what existing evidence you have for your assessment As above in No. 6 Independence Please describe what existing evidence you have for your assessment As above in No. 6.

9. How visible is this initiative to the general public? High visibility to general public Medium visibility to general public Low visibility to general public

10. Does this proposal identify potential negative impacts? Yes No Unable to decide If yes

Please forward a copy of this assessment to: 4 [email protected] [email protected] [email protected] ABMU EqIA Form 1

Please explain why. Have you fully mitigated these in your plans? If there are residual issues, you will need to proceed to a full EqIA

If no Please explain why and attach an action plan, if necessary, indicating how you will ensure that you will have enough information to review this decision in the future. This investment proposal is still at a hi-level and will be developed as the design solution progresses. However, even at this early stage, it is not anticipated that any dis-benefits or negative impacts will be realised. If unable to decide Please explain why and indicate what steps you are going to take to be able to reach a conclusion either way.

11. Decision Full EqIA required Full EqIA not required

12. Sign off Assessment team Lead for the initiative: a. b. Karen Miles & Christine Morrell, Co-Project Signature: Directors Date: c. d.

Please forward a copy of this assessment to: 5 [email protected] [email protected] [email protected] Outline for Post Project Evaluation Introduction It is proposed that the project will be subject to formal Post Project Evaluation (PPE) in accordance with Department of Health Good Practice Guide “Learning lessons from Post Project Evaluation” dated January 2002 and Designed for Life: Building for Wales Guidance Note Procedure for Design and Construction Post-Project Evaluation (April 2014) and Welsh Government NHS Wales Infrastructure Investment Guidance (March 2015), or such subsequent guidance as becomes available and is appropriate to the value of the procurement route/capital scheme. Major capital investment projects will be reviewed 3 months following physical and financial completion to assess performance against anticipated construction related benefits and again 12 months following completion of all new build and refurbishment schemes to assess performance against time and cost targets contained in the Benefits Realisation Plan. The evaluation process will be driven primarily by the project’s Investment Objectives, Benefit Criteria, and Benefit Realisation Plan (these are detailed in the business case) and will seek to verify the extent to which each has been achieved. Methodology PPE sets out the framework for which the benefits realisation can be tested to identify which benefits have been achieved and which have not. NHS guidance on PPE identifies the following four stages that are applicable to this project: 1. Evaluation of the project procurement stage. The objective of this evaluation is to assess how well and effectively the project is managed from the from the constructor appointment stage and from the time of business case approval. Specifically, the effectiveness of project management of the scheme; the quality of the documentation prepared by the Health Boards; communications and involvement during procurement; the effectiveness of advisors utilised in the scheme; the efficiency of NHS guidance in delivering the scheme, and; perceptions of advice and guidance and support from Welsh Government & NWSSP – FS and NWSSP-PS, as appropriate. To occur post business case approval or completion of full tendering, whichever is most applicable. 2. Evaluation of the project once it is implemented. The objective of this evaluation is to assess how well and how effectively the project is managed from the time of the business case approval through to the commencement of operational commissioning. The evaluation at this stage will examine the effectiveness of Health Board project management of this scheme; the effectiveness of communications during construction; the effectiveness of working arrangements with other (partnering) stakeholders; support during this stage from NWSSP – FS and NWSSP-PS, etc., as appropriate. To occur before commissioning commences. 3. Evaluation of the project once the project is in use. The objective of this evaluation is to evaluate the lessons learned with the project team members and key stakeholders in order to assess how ell and how effectively the project was managed. The evaluation will examine the effectiveness of the Health Board project management of the scheme; the effectiveness of communications during technical commissioning the effectiveness of joint working arrangements with NWSSP – FS and NWSSP-PS, etc.; overall success in terms of quality, cost and time, and; meeting the brief (from the viewpoint of the clients), as appropriate. To occur 3 months after the project is commissioned. 4. Evaluation once the project is well established. The objective of this evaluation is to assess how well and how effectively the project was managed during the operational stage. The evaluation will examine the effectiveness of working arrangements with other (partnering) stakeholders; support during this stage from NWSSP – FS and NWSSP-PS, etc., as appropriate, and; the extent to which the design met users needs and delivered the key benefits identified in the benefits realisation plan. To occur 24 months after the entire project is completed.

1 Lessons learned from this process will be of benefit to the Health Boards (for future projects), other key stakeholders (to inform their approach to future projects), and the NHS more widely (to test whether the policies and procedures have been effective) The detailed plans for each of these stages will be agreed following consultation with key stakeholders and will detailed in the Project Execution Plan. As appropriate, the Health Boards may invite an externally appointed audit team to review the operation and performance of the project throughout the process, during implementation, on commissioning of the re-located services and when the service has been in operation for a suitable period. Management The above approach will be managed by the project team and will be endorsed by the project board.

2

Welsh Government

EXTERNAL ASSURANCE REVIEW PROCESS

RISK POTENTIAL ASSESSMENT STAGE 1

(RPA1 – FORM)

INTRODUCTION It is mandatory for all Senior Responsible Owners (SRO) to complete an (RPA1) at the beginning of a programme/project and at key decision points in their lifecycles (if you need additional guidance on completion of the RPA1 please contact the Integrated Assurance Hub via the Programmes and Projects mailbox [email protected]

The WG Risk Potential Assessment form part 1, (RPA1) is designed to provide a standard set of high-level criteria for assessing the initial risk potential of a programme/project in a strategic context.

The RPA1 has two purposes: (a) for identifying potential risk of all programmes/projects across WG for use by the Integrated Assurance Hub, and (b) for determining the most applicable assurance method for a programme/project.

The RPA enables a conversation to be had about the risks and responsibilities that the SRO has for delivery. The RPA can also help the programme/project to identify areas where specific skills sets may be required.

HOW TO COMPLETE THIS FORM

The RPA1 is the first step in the external assurance process, and requires the Senior Responsible Owner (SRO) supported by the programme/project manager, to consider the programme/project through a strategic assessment of the potential consequential impact, should the programme/project fail to deliver its objectives or outcomes.

These assessments are made using the knowledge and judgement of the SRO and programme/project team and should be considered in the light of a programme/project’s strategic context. The majority of answers require the appropriate box to be checked, however, a short explanatory note of the reasoning for each mark is also required to provide further detail for the Integrated Assurance Hub and an audit trail of the considerations.

The completed RPA1 will be assessed by the Integrated Assurance Hub and where programmes/projects have been primarily assessed as medium risk or higher then completion of a further Complexity Assessment (RPA2) is required. Where programmes/projects have been primarily assessed as low risk, the Integrated Assurance Hub will advise the SRO of the outcome and offer further support if required.

PART 1: For completion by the SRO

SECTION A: PROGRAMME / PROJECT DETAILS Project Name Development of a Mid and South West Wales Regional Centre of Excellence Cellular Pathology Laboratory, Regional Diagnostic Immunology Laboratory Facility and Regional Medical Microbiology facility at Morriston Hospital, Swansea SRO Names Mrs Tracey Myhill, Chief Executive, ABMU Health Board Mr Steve Moore, Chief Executive, Hywel Dda Health Board Dr Tracey Cooper, Chief Executive, Public Health Wales SRO’s Contact Details [email protected] [email protected] [email protected] Department/Division Planning Directorates Programme/Project Type Policy Legislation ICT enabled (have you completed a ICT Project Approval Form (IPAF) x Business change Infrastructure x Construction x Capital Other (Please specify below:)

Please provide a brief overview of the programme/project: This SOC supports an investment in the range of £51 - £93m (including non-recoverable VAT) to support development of a development of a Mid and South West Wales Regional Centre of Excellence Cellular Pathology Laboratory, Regional Diagnostic Immunology Laboratory Facility and Regional Medical Microbiology facility at Morriston Hospital, Swansea

This investment will provide an integrated, regional and sustainable Cellular Pathology, Diagnostic Immunology and Local Medical Microbiology services providing regional support, which will include sub- specialities, specialist national and international reference units with scientific expertise, providing patients’ with more equitable access to expert knowledge optimising patient treatment. It is anticipated that this state-of-the-art modern facility will attract further investment from the private sector and University partners. Facilitating opportunities for R&D across the region, which will encourage local workforce stability and sustainability by the use of innovative technologies and the healthcare sciences. This investment will build on other planned regional infrastructure developments, e.g. internet expansion, websites, IM&T, and transport infrastructure, etc.

SECTION B: ORGANISATIONAL COMMITMENTS Does the programme/project satisfy a YES ministerial commitment? If YES, please state who is the responsible Mr Vaughan Gething AM, Cabinet Secretary for Health and minister(s) Social Services Does the programme/project cut across YES ministerial portfolios? If YES, please state which portfolios This investment is supported at Ministerial level in Wales and by the NHS Wales Collaborative. Does the programme/project satisfy a major NO policy commitment?

If YES, which policy? Eg Programme for Government Does the programme/project satisfy a YES legislative requirement? If YES, please clarify: Explanatory Note: Human Tissue Act’s (HTAs) mandatory license

requirements.

SECTION C: PROGRAMME / PROJECT BUDGET How much is the projected budget for the programme/project?

N.B. when completing this part of the form, please take into account the whole-life costs of the programme/project (as defined by HM Treasury Green Book) Up to £50k £50k - £250K £250K - £1m £1m - £5m £5m and above x

How long is the programme/project expected to run? Up to 1 yr Up to 2yrs Up to 3yrs Up to 4yrs Up to 10yrs Unknown x

Is funding secured and in place for the entire NO lifecycle of the programme/project? If NO, what is the deficit? Approx. £51 - £93m (including non-recoverable VAT) outturn (inclusive of reclaimable VAT)

Time: Approx. 4 years

Explanatory Note:

Does the programme/project receive external NO funding? Eg Wales Infrastructure Investment Plan Funding

SECTION D: STAFF IMPACT Is the programme/project concerned with YES business, operational or ICT-enabled change? If YES please provide additional information: Explanatory Note: - This investment will provide a state-of-the-art modern facility that will attract further investment from the private sector and University partners. Facilitating opportunities for R&D across the region, which will encourage local workforce stability and sustainability by the use of innovative technologies and the healthcare sciences. - This project is the first tranche of the A Regional Collaboration for Health’s (ARCH’s) programme of modernisation and will ‘show-case’ Mid and West Wales’ economic appetite for innovation, partnership working and modernisation of the local economy and workforce. - This integrated Cellular Pathology & Diagnostic Immunology facility will include sub-specialties, specialist national and international reference units with scientific expertise, providing patients’ with more equitable access to expert knowledge optimising patient treatment. - This investment will build on other planned regional infrastructure developments, e.g. internet expansion,

websites, IM&T, and transport infrastructure, etc. How many staff within the organisation will be affected by the programme/project? 1-100 100-250 250-500 500-1,000 1,000 + All staff x Does the programme/project involve the YES physical movement of staff?

If yes, how many approximately Transfer of Pathology / Diagnostic Immunology services staff from Singleton Hospital and the Hywel Dda area to a co- located Regional Unit at Morriston Hospital. Please refer to the SOC for details. Will there be any training requirements YES involved in the final delivery of the programme/project output(s)? If YES please provide more detail: Explanatory Note:

Familiarisation training.

SECTION E: PROGRAMME/PROJECT DEPENDENCIES Is the programme/project dependant upon NO the delivery of another programme/project to meet its objectives? If YES please clarify: Explanatory Note:

Is there another programme/project within the No organisation that is dependant on this programme/project delivering to time and cost? If YES please clarify: Explanatory Note:

Has a scoping exercise been undertaken to YES ensure that there is no duplication of work in any other part of the organisation? Does the programme/project have external NO stakeholders? Have all key stakeholders been identified and All key stakeholders identified and engaged engaged?

SECTION F: SECURITY Has Privacy Impact Assessment (PIA) screening YES been undertaken? If NO please complete the PIA screening tool:

Does screening indicate that a formal PIA NO assessment is required? If YES, has the PIA been undertaken? YES NO

Please supply the following documentary evidence: • Copy of completed PIA screening tool • Copy of PIA report (where formal PIA undertaken) Section G: SRO ENDORSEMENT I am satisfied that the initial Risk Potential Assessment provides an accurate reflection of the programme/project at this stage of development. Signed Date February 2019 Mrs Tracey Myhill, Chief Executive, ABMU Health Board Mr Steve Moore, Chief Executive, Hywel Dda Health Board Dr Tracey Cooper, Chief Executive, Public Health Wales I will re-asses the programme/project if there is a significant change to the programme/project scope or budget or if significant changes emerge that may threaten successful delivery. Signed Date February 2019 Mrs Tracey Myhill, Chief Executive, ABMU Health Board Mr Steve Moore, Chief Executive, Hywel Dda Health Board Dr Tracey Cooper, Chief Executive, Public Health Wales (Senior Responsible Owners) SECTION H: ASSESSMENT BY INTEGRATED ASSURANCE HUB I am satisfied that the SRO’s assessment of the programme/project, as recorded above, is an accurate reflection of the programme/project’s risk potential at this stage of development. Signed Date (Integrated Assurance Hub) Based on the information provided, the risk Very High Risk potential of this programme/project is High Risk assessed as: Medium Risk Low Risk Does the programme/project require external YES - RPA2 required for validation assurance? NO

SECTION I : FILING / RECORDING ARRANGEMENTS BY THE PROGRAMME/PROJECT Retain a copy of this completed and signed form with the official record for the programme or project.

If this assessment relates to a grant-funded project, a copy of this form must be sent to the Grants team. sent date: If this assessment relates to a Wales Infrastructure Investment Plan funded project, a copy of this form must be sent to the WIIP team. sent date: If this assessment relates to a Programme and Project Management-funded project, a copy of this form must be sent to the Programme and Project Management Division. sent date:

Option & Risk Appraisal Group Membership

Karen Miles Director of Planning, Performance & Commissioning HDUHB (Co-Project Director & Chair)

Christine Morrell Director of Therapies and Health Science ABMUHB (Co-Project Director)

Andrea Steins Head of Service Pathology (Pathology Project Team Co Chair) HDUHB

Andrew Jones Deputy Director of Public Health Services

Chris Bowden Nominated ARCH Project Manager ABMUHB

David Heyburn Programme Manager (Microbiology - Public Health Wales)

Ian Macdonald Head of Capital Finance ABMUHB

John Murphy Consultant Histopathologist (Clinical rep Pathology Services HDUHB)

Mike Simmons Consultant in Public Health Microbiology (Clinical Rep Microbiology – Public Health Wales)

Paul Williams Assistant Director of Planning HDUHB

Peter Mannion Portfolio Manager ARCH

Sally Buckland Jones Service Group Manager Clinical Support Services ABMUHB (Pathology Project Team Co Chair)

Simon Davies Assistant Director of Strategy (Capital) ABMUHB

Suzie Howarth Consultant Histopathologist (Clinical Rep Pathology Services ABMUHB)

Stephen Forster Interim Director of Finance HDUHB

Dylan Jones Blood Sciences Manager Hywel Dda Health Board, Pathology

Brendan Healy Consultant in Microbiology and Infectious Diseases, Microbiology

Julian Rogers Regional Manager Mid and West Wales, Microbiology

Investment Objectives and Benefits

Investment Objective Stakeholder Group Benefits Investment Objective Patients  Supports timely diagnosis or exclusion of malignancy 1: To develop more  Reduces complaints and incidents sustainable Regional  Appropriate prescribing of antimicrobials to treat infections in a timely and effective manner Cellular Pathology  Provides equitable access to routine and specialist testing and diagnosis of infectious disease Reduces Laboratory, Regional workload sent to external providers for reporting. Diagnostic  Improved attendance at MDT for individual case review. Immunology  A sustainable service means that variation in response to a testing request will be minimised. Laboratory and  Provides a reliable and consistent service delivery, application of knowledge to lift outcomes for Regional Medical individuals and populations and a more equitable opportunity to access specialist advice that may be a Microbiology service ‘hinge factor’ in the patients outcome. This will mean the service is less reliant on individuals and instead will have robust systems and processes in place to contribute to patient care and the resultant outcomes.  Model supports a workforce that is enhanced through adjacency and its environment with greater engagement and involvement in patient care.

Factors that contribute to this benefit will include (e.g.) :  Improves recruitment and retention of specialist workforce  Increases production of peer information through publications, trials and research  Improves attendance at MDT for individual case review  All / majority of service is delivered locally because there is sufficient capacity and capability and outcomes / outputs are not sub-optimal when compared to peers / alternatives Investment Objective Stakeholder Group Benefits Health Board: Clinical &  Develops a fit for purpose Regional Cellular Pathology & Diagnostic Immunology Unit - evidenced by the Management provision of appropriate accommodation and state-of-the-art technology and equipment in compliance with:

o Good laboratory practice; 1 2 o WHBN & HBN and WHTM & HTM guidance & safety standards , and; o Achieves accreditation and regulatory compliance e.g. , HTA, and Medical Laboratories accreditation ISO15189  Supports ABMUHB’s and HDUHB’s service strategies.  Develops a more sustainable regional and all Wales pathology service by maintaining business continuity, demonstrated by:  Provides services within budget and with appropriate resources, including staff.  Increases resilience of service (evidenced by, e.g. meeting service demand for routine and specialist clinical services throughout the Mid and West Wales Region).  Improves consultant retention and recruitment and, e.g. opportunities for collegiate working, specialism, increased support to MDTs, etc.  Improves BMS recruitment and retention, demonstrated by (evidenced by, e.g. improved skill mix with opportunities for multi-disciplinary working, extended roles, advanced practice etc.).  Supports a new service model for West & Mid Wales Region that integrates specialist pathology services providors (i.e. ABMUHB’s & HDUHB’s Cellular Pathology services services).  Supports innovation and new investment in the region.  Supports business innovation across the region.  Reduces reliance on agency locum staff Wider Health  Supports international. national, regional and local pathology services’ strategic objectives (including the Community/Region new Cancer Strategy for South Wales)

1 NHS Estates. Facilities for pathology services, HBN 15, 28 April 2005. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/149167/HBN_15.pdf 2 The Health, Safety and Wellbeing in Healthcare Partnership Group (HSWPG), Workplace health and safety standards, July 2013. http://www.nhsemployers.org/~/media/Employers/Publications/workplace-health-safetystandards.pdf

Investment Objective Stakeholder Group Benefits  Supports the National Pathology Programme Vision for alignment of pathology services across Wales with NHS Wales’ strategic direction.  Delivers of a world-class centre-of-excellence clinical facility that supports international, national, regional and local strategic objectives.  Supports and encourages the regional and wider UK economy by fostering research and development opportunities with University partners and other stakeholders.  Supports business innovation across the region by promoting and encouraging the development of UK and international projects and supporting collaboration through University links.  Develops a 21st century fit for purpose and appropriate environment for the delivery of health sciences and R&D.  Promotes and supporting business growth in the Life Sciences in Wales.  Encourages the development of local skills and health technology expertise through partnerships with local colleges and Universities.  Supports secondary care benefits and sustainable partnerships with commercial organisations, the third sector and training organisations that benefit residents in the region.  Unlocks job opportunities for local people, develops local talent and up-skills people in the region with desirable and transferrable science, technical and professional skills.  Boosts the incomes of local people by creating job opportunities for people within the Region.  Encourages sustainable employment opportunities, both directly and indirectly by supporting the development of a well-trained and resilient local workforce and a more resilient labour market.  Provides a service solution that is acceptable to staff.  Supports business innovation across the UK.  Unlocks high-tech job opportunities for local people, developing local talent and up-skilling people in the Region with desirable and transferrable scientific technological and professional skills.  Future proofs the service.  Attracts and retains people with scarce specialist skills to the region.  Supports undergraduate and postgraduate medical students in training.

Investment Objective Patients  Improves quality of care for patients (e.g. patients’ results issued within target requirements). 2: To improve the  Improves the patient experience. quality and safety of  Reduction in complaints and incidents Investment Objective Stakeholder Group Benefits South Wales Regional Health Board: Clinical &  Eliminates variations in practice within the region e.g. supporting standardised laboratory processes Cellular Pathology, Management  Improves patient flow and coordinates pathology services more effectively. Regional Diagnostic  Improves the quality of Cellular Pathology services (as evidenced by compliance with Medical Immunology Laboratories accreditation ISO15189, and HTA accreditation, and agreed quality standards, e.g. National Laboratory and Local Cancer Standards). Medical Microbiology  Supports improved outcomes for patients in Mid and West Wales area. services  Delivers best practice in terms of clinical standards and promotes improvements in those standards.  Provides equality of access to high quality healthcare for the population of Mid and West Wales.  Repatriates some tests back to the Mid & West Wales Region & Wales that are currently outsourced, supporting improved outcomes for patients.  Improves visibility pathology services representation in multi-disciplinary teams in Morriston Hospital (this site is designated as ‘a regional hub’ hospital) and compliance with best quality standards. Wider Health  Supports standardised protocols that reduce variability. Community/Region  Mitigates clinical risk and clinical governance risks by a providing safer and more reliable pathology service. Provides equality of access to high quality healthcare.  Delivers best practice in terms of clinical standards and promoting improvements in those standards. Opportunities for sharing lessons learned and promoting best practice across the UK.  Reduces clinical risk and clinical governance issues by providing safer and more reliable pathology service.  Repatriates tests back to the Mid & West Wales Region & Wales increases capacity in other provider organisations.  Provides more effective clinical communications.  Reduces clinical risk and clinical governance risks by providing a safer and more reliable pathology service.  Delivers best practice in terms of pathology clinical standards and promoting improvements in those standards.  Develops R&D partnerships with UK and international companies.  Supports the economy by fostering R&D opportunities.  Encourages private sector investment in the Region.  Provides all patients in the secondary care, and those attending acute and regional hospital based services, with access to improved, more reliable and timely Cellular Pathology services. Investment Objective Stakeholder Group Benefits Investment Objective Patients  Supports improved outcomes. 3: To improve the  Provides access to modern and responsive pathology techniques. efficiency and  Delivers secondary care and person-centred healthcare benefits to nearly 1 million people within the productivity of South region. Wales Regional  Supports patients in the region by providing equality of access to high quality diagnostics Cellular Pathology,  Provides people in the region with access to world-class pathology tests and services, including cancer Regional Diagnostic services diagnosis, national breast screening etc. Immunology All - evidenced and measured by KPIs. Laboratory and Local Medical Microbiology Health Board: Clinical &  Improves efficiency (as evidenced by, e.g. maximising opportunities to engage with staff in promoting services Management change and involving staff in service redesign & developing a one-site single management structure & by supporting inter-disciplinary working, etc.).  Improves quality systems and reporting structures by relocating the service to Morriston (an acute ‘Hub’), which eliminates significant transport & logistical issues (NB some non-benefits may be experienced in parts of HDUHB).  Promotes a more responsive service to the requirements of patients in the region.  Reduces reliance on agency locums All - evidenced and measured by KPIs.

Wider Health  Supports Carter Review’s objectives, i.e. tackles “unwarranted variation” in quality and finances by Community/Region adopting ‘model hospital’ standards and working more closely with neighbouring hospitals to promote improvements in staff productivity, performance and patient care within the NHS.

Investment Objective Patients  Access to more reliable, sustainable and equitable health services. 4: To improve the  Reduction in complaints and incidents effectiveness of South Health Board: Clinical &  Improves effectiveness (evidenced by providing all patients in the secondary care and those attending Wales Regional Management acute and regional hospital based services with more reliable, sustainable and equitable cellular Cellular Pathology, pathology services). Investment Objective Stakeholder Group Benefits Regional Diagnostic Wider Health  Provides more effective clinical communications between ABMUHB’s & HDUHB’s staff. (enabled by Immunology Community/Region shared management structures and by shared IT infrastructure/dedicated digital platforms, etc.). Laboratory and Local  Improves the effectiveness of local health services’ (evidenced by e.g. at local GP level and in healthcare Medical Microbiology screening services and in the secondary care services, etc.). services  Realises indirect benefits from accessing improved regional infrastructure (evidenced by e.g. new transport links, better IT support, and other and planned innovative technologies, to further improve pathology and wider NHS services). Investment Objective Patients  Makes more effective use of funding. 5: To improve  economies within Health Board: Clinical & Promotes service and operational economies, economies of scale, eliminates waste, reduces South Wales Regional Management procurement costs, etc. and by sharing and reinvesting cash and non-cash savings in regional healthcare 3 Cellular Pathology, services .  Regional Diagnostic Reduces duplication of resources across Pathology services within the Region (evidenced by e.g. shared Immunology IT/accreditation fees, etc.).  Laboratory and Local Improves economy as evidenced by improved regional Gross Value Added (GVA) in Mid and West Wales Medical Microbiology (evidenced by improved quality and reliability of regionalised specialist healthcare services).  services Promotes operational economies and economies of scale (evidenced by achieving ‘central mass’ in terms of optimum service configuration). Wider Health  Promotes better value from the NHS budget (evidenced by providing more cost effective regional Community/Region pathology laboratory services and by sharing and reinvesting operational savings).  Achieves direct cash and non-cash benefits through pathology service and operational economies, economies of scale, elimination of waste, reduced procurement costs, etc. and sharing and re-investing those savings in the Region.

3 Future Delivery of Pathology Services in Wales NHS Wales (August 2008)

ARCH Pathology Project Structure and Terms of Reference (February 2017 updated March 2018)

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Pathology Project Board - Terms of Reference

Purpose

The Project Board will be responsible for the overall direction and management of Chair: Karen Miles Director of Planning Hywel Dda HB (Chair) the project from development of the SOC and approval of the OBC / FBC through to Vice Chair: Christine Morrel Director of Therapies and HealtH Science construction and commissioning. ABMU Frequency: Monthly Roles and Responsibility Reports to: ARCH Service Transformation Programme Membership . Agree the overall Project Plans and authorise key stages within it. Name Designation . Ensure they support the delivery of regional service model and that they are Karen Miles Director of Planning Hywel Dda HB (Chair) appropriate, innovative and consistent with Prudent Healthcare principles. Christine Morrell Director of Therapies and Health Science ABMU . Ensure that the IMTP (transitional) workforce plans are properly aligned with Paul Williams Assistant Director of Planning Hywel Dda HB specialty/service workforce plans in terms of content and delivery timeframes Dr Suzie Howarth Clinical Rep Pathology Services ABMU HB and to identify any issues arising from specialty/service workforce plans and Mr John Murphy Clinical rep Pathology Services Hywel Dda HB draw them to the attention of relevant Health Boards and Public Health Wales. Mr Brendan Healey Nominated Rep Public Health Wales - Consultant in . Review progress against Project Plans. Microbiology and Infectious Diseases, Microbiology . Ensure capital and revenue costs of the schemes are developed and managed TBC Clinical Rep Microbiology – PHW by the Project Team. Sally Buckland Jones Pathology Project Team Co Chair . Receive highlight and exception reports from Project Team and agree necessary Andrea Stein Pathology Project Team Co Chair actions. Ian Macdonald Pathology Project Team Co Chair . Agree deviations from Project Plan if required. TBC Finance Hywel Dda . Review the Project Risk Register and Issue Log. Simon Davies Assistant Director of Strategy (Capital) ABMU . Receive updates on management actions in respect of key project risks/issues, Chris Bowden Nominated ARCH Project Manager i.e. those identified as high priority/red status. . Ensure that effective communication takes place at each stage with staff, patients, public and other stakeholders at local and national level. . Report progress to the Executive Teams and Boards of relevant organisations. . Ensure that key work streams notably, Pathology Strategy, Workforce and IT contribute effectively to the development of the project. . To manage service change, commissioning and communication activities. . Receive Project Director Reports and recommendations for consideration and approval, including ratification of decisions when required.

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Project Benefit Reference 1 Benefit category & class Qualitative Cash and Non-Cash Benefits

Description To develop a more sustainable South Wales Regional Cellular Pathology, Regional Diagnostic Immunology, and regional medical Microbiology service Baseline Describe Current situation Target/Measurement Metrics/Evidence (make SMART) - Improve staff mandatory training - Target is 85% - KPIs/Metrics. Demonstrated 12 compliance (Cell Path). Baseline months post operational, subject to currently 69% (January 2019) achieving appropriate staffing. - Improve staff appraisals - Health Board Tier 2 Target is 85%. - KPIs/Metrics. Demonstrated 12 compliance (Cell Path). Baseline months post operational, subject to currently 72% (January 2019) achieving appropriate staffing. - Workforce Plan (Cell Path) - To have in place appropriate staff to - Integrated Workforce Plan. 2018/19. meet demand in Cell Path services. - Capacity/Demand demonstrated - HDUHB currently has 6.0 vacant This will comprise a modernised through RC path points 12 substantive Consultant Cellular workforce utilising biomedical months post operational. Pathologist posts. scientists, advanced practitioners, - Substantive workforce as per - ABMUHB similarly has 3 vacant consultant bio medical scientists and Workforce plan post. Cellular pathology consultant pathologists. o - HDUHB’s Immunology services o Immunology based around small workforce - Evidence 90% support to MDT’s. teams creating fragile - For cancer MDTs the designated unsustainable services. There is lead cancer Pathologist should also no consultant lead. attend at least 66% of the - Neither Health Board is able to meetings. recruit into these vacancies. - Neither Health has the resilience to fully support Cancer MDT’s to RC standards. - Provision of medical microbiology, - Delivery of sustainable services in - Regular and consistent infection control and infectious compliance with best practice and in attendance at agreed MDTs, diseases services are limited due accordance with WHBN guidance. Ward Rounds and Clinics to shortfall in consultant numbers, - Attract staff to a new state-of-the-art including things like Burns and and siting of the Swansea Bay facility. Plastics, Nephrology, Critical consultant resource at Singleton Care and Orthopaedics as well as Hospital This means that some clinics to support OPAT (Out- MDT, ward rounds and clinics are patient Parenteral Antibiotic not delivered or not frequently delivered. Therapy) services.

- ABMU & PHW Microbiology are - Deliver a fully accredited Laboratory - Fully comply with National ISO compliant but HDU is not as at that achieves full compliance with External Quality Assessment 2018/19. ISO15189 (Welsh Government ISO (EQA) medical and scientific - Cellular Pathology HDUHB has compliance is now required) & Human accreditation requirements. Fully not registered with UKAS for Tissue Act’s (HTA’s) mandatory comply with ISO 15189. inspection against ISO 15189 licenses regulations - Fully comply with the MHRA standards – application to be accreditation requirements. submitted by end 2019 - Fully comply with Human Tissues - Immunology tests in HDUHB were Authority requirements regarding unable to achieve compliance with the obtaining of tissue for further ISO 15189 due to lack of dedicated investigation, storage of such consultant Immunologist sessions tissue, etc. accreditation - HDUHB is compliant with Human requirements. Tissue Authority Standards - Environmental & Accommodation - Provide fit for purpose - Achieve an acceptable AEDET lack of fitness for purpose accommodation in accordance with rating (externally facilitated by examples, e.g. obsolete AHUs, list WHBN/WHTN requirements NWSSP- SES). H&S issues across both Health - Medical Microbiology - Waste - Achieve a new build ‘excellent’ Board’s & in Immunology. management is effective and fully BREEAM rating. - ABMUHB’s service is centralised compliant with CL3 requirements - Deliver a fully accredited and on the Singleton Hospital site. It is compliant Unit and as per the Brief including autoclave sterilisation. not fit for purpose, space is - Evidence improvement using User constrained and does not comply Satisfaction Surveys and Annual with HBN guidance. The service Management Reviews. location is distant from the main - Comply with the agreed brief. source of cancer treatment, which - Technical Post Project Evaluation is all now located on the Morriston (externally facilitated by NWSSP- Hospital site. Due to lack of space SES) 3 months post at Morriston, Pathologists are split commissioning date. across multiple sites., which is not - Medical Microbiology - Minimal conducive to team working or overlapping of sample flow; recruitment. Minimal downtime of autoclaves; - Immunology in ABMUHB is Waste management consistent currently not in fit for purpose with national policy. premises and does not meet HBN guidance. - Cellular Pathology service HDUHB centralised to the GGH locality due to co-adjacency with new mortuary facilities. But laboratory facilities are not fit for purpose, space is constrained and does not comply with HBN guidance, backlog of estates maintenance, lack of adequate temperature control and segregation of tissue processing equipment is required. Consultant staff is not accommodated as a single team. - Medical Microbiology - Inefficient movement of samples with multiple exchanges rather than simple, linear flow due to spatial layout. - Inefficient and unreliable sterilisation of waste including containment level 3 waste. - Variation in approach to - Comply with Royal College of - Attract & retain more specialised distribution of Consultant workload Pathologist’s guidance to improve our staff. workforce and to recruit and retain - Medical Microbiology - Utilise staff new and existing scientific staff to undertake extended clinical roles to support the clinical service; High rates of non-medical authorisation of results and scientific clinical liaison. - Current variation in workforce skill - Support the future development of - Improved acceptability against mix and test repertoire supported pathology services in Wales, as baseline. across the two Health Boards. detailed in the Health Board’s - Improved patient experience response to the Carter Report, i.e. above baseline. The Future Delivery of Pathology Services in Wales 2017 Onwards: Proposals for Change. - Support All Wales Pathology Collaborative Project’s strategic plans and the National Immunology Project - Current services fragile and - Maintain business continuity, i.e. by - Substantive workforce as per unsustainable in terms of supporting a new co-located service workforce plan. workforce and potential impacts of model for Mid & South West Wales - Workforce succession planning future workforce retirements and Region that integrates specialist and workforce modernisation. loss of experienced staff pathology services providors (i.e. ABMUHB’s & HDUHB’s Cellular Pathology services) - Limited ability to support training - Support innovation and new - Number of research projects and education across the investment in the Region as supported workforce, e.g. HDUHB currently demonstrated by, e.g. improved - Additional trainee pathologists are unable to support trainee recruitment and retention of specialist able to be supported pathologists from the Cardiff staff and by provision of improved - Number of staff enrolled on Deanery. ABMUHB currently training opportunities. Work more educational programmes support two trainees but could closely with the University to widen support more, if suitable academic access to the range of accommodation was available. - Lack of capacity to support internal undergraduate and postgraduate and /or external research courses, which include Pathology services - Limited opportunities currently in - Improve the relationship between - Increased number of clinical trials both Health Board for research pathology services and clinical against baseline, i.e. expand the with University partners and private research, e.g. by increasing the limited research currently sector, etc. number of clinical trial undertaken with Swansea University - Variation in repertoire of test - Repatriate tests currently - Increased number of tests supported in-house and commissioned out of region due to undertaken within the Region outsourced lack of capacity, as appropriate against the baseline - Improvement in turn-a-round time for repatriated tests Potential costs Please see Discussion SOC for details. Activities required - Appoint a suitably qualified/experienced/resourced main contractor and design team to deliver this scheme as per the brief. - Equip and commission the new Unit on a timely basis to ensure seamless delivery of regional Pathology services during the transition process. Responsible officer Lead director responsible for delivering benefits Mrs Karen Miles, Director of Planning Hywel Dda HB (Chair) & Mrs Christine Morrell (Director of Therapies and Health Science, Therapies And Health Sciences) Lead manager responsible for monitoring benefits Mr Chris Bowden, Project Manager Full-year value N/a Timescale To be fully realised 24 months after full scheme delivery, i.e. by mid 2026/27.

Project Benefit Reference 2 Benefit category & class Quantitative Non-Cash Benefits and Cash Benefits

Description To improve the quality and safety of Cellular Pathology and Diagnostic Immunology Laboratory services Baseline Describe Current situation Target/Measurement Metrics/Evidence (make SMART) - ABMU is ISO compliant but HDU is - Deliver a fully accredited Laboratory - Fully comply with National not as at 2018/19. that achieves full compliance with External Quality Assessment ISO15189 (Welsh Government ISO (EQA) medical and scientific - Cellular Pathology HDUHB has compliance is now required) & Human accreditation requirements. Fully not registered with UKAS for Tissue Act’s (HTA’s) mandatory comply with ISO 15189. inspection against ISO 15189 licenses regulations - Fully comply with the MHRA standards – application to be accreditation requirements. - Support the delivery of the Pathology submitted by end 2019 - Fully comply with Human Tissues Networks’ Statement of Intent - Immunology tests in HDUHB were Authority requirements regarding unable to achieve compliance with - Support delivery of Welsh the obtaining of tissue for further ISO 15189 due to lack of dedicated Government/NHS Executive plans for investigation, storage of such consultant Immunologist sessions delivery of a National Infection tissue, etc. accreditation - HDUHB is compliant with Human Service. requirements. Tissue Authority Standards - Develop one Standardised Protocol for one service. - Increased automation delivering standardised process which evidence / support UKAS compliance - Neither Health has the resilience to - Improve visibility in multi-disciplinary - Evidence 90% support to MDT’s. fully support Cancer MDT’s to RC team meetings, e.g. by the - For cancer MDTs, the designated standards. introduction of regional lead cancer Pathologist should - MDT’s to cover the full range of sub attend at least 66% of the specialities. (a regional ‘Hub’ meetings. hospital),e.g. by complying with best - Regular and consistent attendance at agreed MDTs, quality standards; by developing a Ward Rounds and Clinics training team, and by attending all including things like Burns and MDTs Plastics, Nephrology, Critical Care and Orthopaedics as well as clinics to support OPAT (Out- patient Parenteral Antibiotic Therapy) services. - Limited access to capital funding - Provide new technology which - Greater opportunities for regional due to over commitment across improves diagnostic services for, e.g. capital bids. both Health Board limits access to Diagnostic Immunology and some - Greater opportunities for new and replacement technology cellular pathology testing. alternative financing for on a timely basis - Medical Microbiology - provide new replacement / new equipment to technology to roll out near / point of be explored. - Increased investment in new care testing in hot labs supported by technology compared to baseline the specialist staff from the regional and greater economies of scale microbiology laboratory. - Current variation in practice - Support for standardised protocols - Develop one Standardised between Health Boards that reduce variability, reduce clinical Protocol for one service. - Duplication of effort to achieve risk, and improve clinical governance - Medical Microbiology- Evidence compliance against ISO 15189 of compliance with SOPS - Reduction in Datix related to processing mistakes - High risks reflecting the inadequate - Improve the patient experience, e.g. - Reduce or eliminate current accommodation in both Health by reducing clinical risk and service related risks compared to Boards re corporate risk register strengthening clinical governance. baseline

Potential costs Please see Discussion SOC for details. Activities required - Design, deliver and commission new Unit as per the brief and as per design guidance. Responsible officer Lead director responsible for delivering benefits Mrs Karen Miles, Director of Planning Hywel Dda HB (Chair) & Mrs Christine Morrell (Director of Therapies and Health Science, Therapies And Health Sciences) Lead manager responsible for monitoring benefits Mr Chris Bowden, Project Manager Full-year value N/a Timescale To be fully realised 24 months after full scheme delivery, i.e. by mid 2026/27. Project Benefit Reference 3 Benefit category & class Qualitative Non-Cash Benefits Description To improve efficiency and productivity of Cellular Pathology and Diagnostic Immunology services Baseline Describe Current situation Target/Measurement Metrics/Evidence (make SMART) - Cellular pathology services in - Support achievement of the new - Demonstrate more effective use of ABMUHB/ HDUHB are only Cancer Strategy for South Wales scarce Pathology staff resources available on a 5/7 basis above baseline. - Deliver a more effective estates solution for Pathology services and enhanced support, laboratory and Mortuary stores accommodations. - Move towards 6 days working, and our aspiration, is to move onto 7 day working. - Cellular pathology services in - Improve turn-a-round time for tests, - Reduce turn-a-round time ABMUHB/ HDUHB are only including Urgent Suspected Cancers especially for Urgent Suspected available on a 5/7 basis and All Wales Lymphoma panel Cancers and All Wales Lymphoma patients against current levels as per panel patients Royal College guidance - Improve turn-a-round times for - Target is 100% within 8 days of - KPIs/Metrics. Demonstrated 12 urgent suspected cancers. receipt in laboratory months post operational, subject to Baseline currently 82.9% (January achieving appropriate staffing. 2019) - Improve turn-a-round times for - Target is 100% within 8 days of - KPIs/Metrics. Demonstrated 12 three urgent sample types, i.e. receipt in laboratory months post operational, subject to prostate cores, breast cores & achieving appropriate staffing. cervical biopsies. Baseline currently 91% (January 2019) - Improve turn-a-round times for non - Target is 100% within 8 days of - KPIs/Metrics. Demonstrated 12 gynae cytology samples. Baseline receipt in laboratory months post operational, subject to currently 91.8% (January 2019) achieving appropriate staffing. - Improve turn-a-round times for - Target is 75% within 20 days of - KPIs/Metrics. Demonstrated 12 routine samples (i.e. non urgent receipt in laboratory months post operational, subject to cancer samples). Baseline achieving appropriate staffing. currently 53.4% (January 2019) - Limited access to capital funding - Provide new technology which - Greater opportunities for regional due to over commitment across improves diagnostic services for, e.g. capital bids. both Health Board limits access to Diagnostic Immunology and some - Greater opportunities for new and replacement technology cellular pathology testing alternative financing for on a timely basis replacement / new equipment to be explored. - Increased investment in new technology compared to baseline and greater efficiencies - Current services are managed by - Introduce a one-site single - Agreed Regional service separate management structures management structure and by more performance metrics efficient inter-disciplinary working arrangements - Separate procurement processes - Reduce variation in operating - Greater benefits from economies expenditure between NHS providors of scale - Currently Cellular Pathology - Co-locate Cellular Pathology - Use scare resources more services in both Health Board are services on to main acute site efficiently. Demonstrates non-cash fragmented due to space savings from improved clinical limitations e.g. non Gynae adjacencies. preparation is centralised in PPH - Medical Microbiology - processing increasing turn-a-round times of non-time critical samples undertaken by regional centre allowing ‘hot’ rapid testing to be delivered effectively.

Potential costs Please see Discussion SOC for details. Activities required New co-located Unit designed and delivered as per the agreed brief. Responsible officer Lead director responsible for delivering benefits Mrs Karen Miles, Director of Planning Hywel Dda HB (Chair) & Mrs Christine Morrell (Director of Therapies and Health Science, Therapies And Health Sciences) Lead manager responsible for monitoring benefits Mr Chris Bowden, Project Manager Full-year value N/a Timescale To be fully realised 12 months after full scheme delivery, i.e. by mid 2025/26. Project Benefit Reference 4 Benefit category & class Qualitative Non-Cash Benefits Description To improve effectiveness of Cellular Pathology services and Medical Microbiology services Baseline Describe Current situation Target/Measurement Metrics/Evidence (make SMART) - Reduce number of non- - Target is up to 20 per month - KPIs/Metrics 12 month following conformities – in 6 month period operational status, subject to ending February 2019 we reported achieving appropriate staffing. an average of 12 non conformities per month - Close non-conformities reported - Target is 95% - KPIs/Metrics. Demonstrated 12 within 30 days - baseline currently months post operational, subject to 79% (January 2019) achieving appropriate staffing. - Close incidents reported in DATIX - Target is 100% - KPIs/Metrics. Demonstrated 12 (Health Board formal reporting months post operational, subject to process) within 30 days - baseline achieving appropriate staffing. currently 87.5% (January 2019) - Cellular pathology services in - Provide all patients in secondary - Supports key stakeholder’s Annual ABMUHB/ HDUHB are only care, and those attending acute and Plans and strategic objectives. available on a 5/7 basis regional hospital based services, - Provides a more effective, timely with more sustainable and equitable and equitable pathology service to cellular pathology/microbiology the region. services; - Delivers higher quality services to local and regional population above current baseline - Move towards 6 days working, and our aspiration, is to move onto 7 day working. - Increase in personalised treatments against current baseline - Patients are not able to able to - Improve access to new technology - Improve and expand patient access personalised diagnosis in e.g. providing more personalised access to personalised diagnosis HDUHB. Limited access available diagnosis and more sensitive and access opportunities in both in ABMUHB. specific tests for patients within the Health Boards. Region. - Further roll out of genomic and molecular testing (both rapid and non-urgent) Potential costs Please see Discussion SOC for details. Activities required - Works cause minimal disruption to Pathology and to regional clinical services that are reliant upon an affective pathology services.

- Works are completed to target date and fully delivers the Brief - Staff are trained by the operational deadline. Responsible officer Lead director responsible for delivering benefits Mrs Karen Miles, Director of Planning Hywel Dda HB (Chair) & Mrs Christine Morrell (Director of Therapies and Health Science, Therapies And Health Sciences) Lead manager responsible for monitoring benefits Mr Chris Bowden, Project Manager Full-year value N/a Timescale To be fully realised 24 months after full scheme delivery, i.e. by mid 2026/27. Project Benefit Reference 5 Benefit category Quantitative Non-Cash Benefits and Cash Benefits & class Description To improve economy of Cellular Pathology services Baseline Describe Current situation Target/Measurement Metrics/Evidence (make SMART) - Current services undertake procurement - Improve operational economies and - Use scare resources more tenders as separate entities economies of scale from e.g. efficiently, e.g. eliminating waste optimised service configuration, cost against baseline, and by reducing avoidance and elimination of waste; procurement costs against standardised procedures and shared baseline. procurement - Increased benefits from economies of scale - To be advised at OBC stage - Improve regional GVAs (through - Improve regional GVAs. improved quality and reliability of regionalised specialist healthcare services) Potential costs Please see Discussion SOC for details. Activities - Design, deliver and commission of the new Unit as per the brief and as per design guidance. required - Operational by target date, subject to funding and planning approvals. Demonstrate ABMUHB making more effective use of scarce clinical staff resources above baseline. Responsible Lead director responsible for delivering benefits Mrs Karen Miles, Director of Planning Hywel Dda HB (Chair) & Mrs Christine officer Morrell (Director of Therapies and Health Science, Therapies And Health Sciences) Lead manager responsible for monitoring benefits Mr Chris Bowden, Project Manager Full-year value N/a Timescale To be fully realised 24 months after full scheme delivery, i.e. by mid 2026/27.

Appendix x – Benefit Realisation Plan This section sets out the overarching goal of the project and highlights how this will be enabled, the project that will be undertaken, and the outcomes to be achieved and outlines the benefits expected to ensue. Benefits Realisation Framework The ultimate responsibility for the delivery of this scheme rests with the Senior Responsible Owners for the Project. These are: - Chief Executive of the Abertawe Bro Morgannwg University Health Board, Mrs Tracey Myhill - Chief Executive of the Hywell Dda University Health Board, Mr Steve Moore - Chief Executive of Public Health Wales, Dr Tracey Cooper The SROs have ensured that the management arrangements are in place for the realisation of benefits in the implementation and operational phases of the project. Mrs Karen Miles, Director of Planning, Performance & Commissioning, Hywel Dda Health Board & Mrs Christine Morrell (Deputy Director of Therapies and Health Science, ABMUHB) are Co-Project Directors and have responsibility for delivery and implementation of this capital scheme. The Project Directors are supported by a nominated Project Manager, Mr Chris Bowden (Cellular Pathology Operations Manager, ABMU HB) who will deliver the project and has responsibility for ensuring that the operational benefits associated with the project are realised. The benefits will be classed using the following framework:

Class Relative Value Relative timescale Benefit Criteria Strategic High Medium term Qualitative Indirect/Direct Non cash releasing Operational Medium Medium term Qualitative Indirect/Direct Non cash releasing Design & Delivery Low Medium term Qualitative Indirect/Direct Non cash releasing Procurement Low Short term Qualitative Indirect/Direct Non cash releasing Commissioning Low Short term Qualitative Indirect/Direct Non cash releasing The managers responsible for the realisation of each benefit are identified in the Benefits Register. The targets sought to be achieved the deadlines for delivery and evidencing and the measures to be used to determine the extent of realisation of each benefit, the baseline, target and the timescale for implementation are set out in the Benefits Register.

Ref Comments Author Date [enter [Enter a description here of the [Enter the [Enter the date the changes made to this version] initial of the when the next person changes were numbe making the made] r in the changes sequen ce] v1 Draft - issued to editing group for HE 23/06/2017 comment v2 Revised HE 01/06/2017 v3 Revised HE Jul-17 v4 Revised HE 01/07/2017 v5 Revised HE 01/08/2017 v6 Draft - issued to PS group for HE 27/11/2017 comment v7 Draft updated following revie won the HE 14/12/2017 12/12/17 by PS/SBJ/HE - RE-ISSUED FOR REVIEWERS FINAL COMMENT & TABLE AT NEXT PROJECT BOARD IF NO CHANGES (NB Make final adjustment to £/% sum for final DSOC submission) v8 v9 v10 v11 v12 v13 v14 v15 v16 v17 Project: Regional Pathology Project

Project Risk Register - Discussion SOC Regional Pathology v8 (August 2018) - Strategic, Planning & Construction Risks Identification Assessment Quantification Management Risk Quantification Calculation

Nr Risk Description Risk Consequence: Scheme Probability Impact Score Category Quantified Estimated cost Management Actions Action Review Comments Cost if it Likelihood Factor Expected 1. Time Unquantified impact £ Owner Date happens £ Value Basis for assessment

2. Cost 3. Quality 4 O ti l STRATEGIC RISKS 1 Service requirements/scope significantly changes Time, Cost, Quality, Regional 2 4 8 Strategic Quantified 1,300,000 1) Continued liaison with All Wales advisory bodies, WG, Health OBC/FBC Review following WG Scoping session/post 1,300,000 0.32 416,000 Based on estimated at a strategic level, impacting on service scope, Operational Pathology partners' executive level & the ARCH Programme Board; (2) Boards stage exec level review. 4% of works capital costs/ revenue affordability /design footprint Continued liaison between partners' executive level and ARCH & national bodies. 2 Design brief is not clear with large scale schedule Time, Cost, Quality, Regional 3 5 15 Strategic Quantified 1,300,000 (1) Project Board signed off the design brief; (2) Sign off Health Project 1,300,000 0.60 780,000 Based on estimated of accommodation changes being made by the Operational Pathology refurbishment briefs, carry out hi-level site surveys to, e.g. identify Boards Board mtgs 4% of works client asbestos risk. 3 NHS reorganisation and planned changes to NHS Time, Operational Regional 4 2 8 Strategic Quantified 100,000 1) Progress scheme as planned, SROs liaising with WGov at Health Project Review following WG Scoping session/post 100,000 0.32 32,000 Based on delay of 4 boundaries in Wales delays decision making. Pathology strategic planning level. Boards Board mtgs reorganisation formal consultation period weeks (cumulative) concludes. 4 Capacity & Demand Planning - Significant changes Time, Operational Regional 2 4 8 Strategic Quantified 350,000 (1) Activity/capacity planning methodology developed with the Health OBC/FBC 350,000 0.32 112,000 Based on estimated in capacity/demand within the region Pathology Project Board; (2) Process in place for agreeing/signing-off the Boards stage 1% of works supply & demand/Schedule of Requirements with lead user. 5 Gateway '0' ('strategic assessment') review Time Regional 2 5 10 Strategic Quantified 150,000 (1) Clear governance structures and reporting procedures are in Health OBC/FBC 150,000 0.40 60,000 Based on delay of 4 performance fails to achieve an acceptable rating, Pathology place. Boards stage weeks (cumulative) of delaying ability to proceed with business £50k per week justification and delivery strategy business case stages 6 Senior management support/ Public / Political Operational Regional 2 4 8 Strategic Quantified 30,000 (1) Communication with local/All Wales public representatives/ Health Ongoing 30,000 0.32 9,600 support - Failure to maintain political /staff / Pathology Partners/ Staff Representatives; (2) Develop Communications Boards executive level / press support for agreed service Strategy. model/modernisation proposals

7 Leadership - Changes in key personnel/leadership Time, Cost, Quality, Regional 2 3 6 Programme Quantified 80,000 (1) Project structure is well established and has built in resilience; Health OBC/FBC SRO/executive level & ARCH programme 80,000 0.24 19,200 at project and senior operational level Operational Pathology (2) Comprehensive knowledge management and sharing. Boards stage level

8 Management resources - The project takes up Time, Operational Regional 4 3 12 Strategic Quantified 50,000 (1) Project Director to liaise with operational Project managers & Health OBC/FBC Put in place dedicated internal project 50,000 0.48 24,000 significant portion of senior managements time in Pathology partnering organisations' operational leads; (2) Agree resource Boards stage management support to free-up senior staff all partnering organisations and detracts from plan to mitigate impact. from their regular duties. operational management

9 Ineffective project management arrangements Time, Operational Regional 2 4 8 Programme Quantified 80,000 (1) Establish a Project Management Team; (2) Develop Staff Health OBC/FBC 80,000 0.32 25,600 during project planning and delivery stages Pathology Formal Consultation Plan; (3) Develop Communications Strategy Boards stage and Communications Action Plan. 10 Delivery arrangements - Changes to the delivery Time, Operational Regional 2 4 8 Strategic Quantified 80,000 (1) Continued liaison with key stakeholders' Planning Directors Health OBC/FBC 80,000 0.32 25,600 arrangements locally and/or regionally Pathology Boards stage

11 Essential licences - Mandatory licences may not be Time, Cost Regional 2 3 6 Strategic Quantified 150,000 Continued liaison with licensing authorities Health OBC/FBC 150,000 0.24 36,000 Based on delay of 4 achieved Pathology Boards stage weeks (cumulative) of £50k per week PROGRAMME RISKS 12 Internal approvals delayed - There is a risk that Time Regional 3 4 12 Programme Quantified 0 (1) Continued liaison with key stakeholders' SROs Health Ongoing 0 0.48 0 board approvals are delayed. Pathology Boards

13 Planning approval & planning conditions - Failure to Time, Cost Regional 5 4 20 Programme Quantified 70,950 (1) Early engagement with Local Planners; (2) Appoint a Planning Health OBC/FBC Planning approval linked to ARCH PDP, 70,950 0.80 56,754 Based on delay of 8 achieve planning permission conditions are Pathology Advisor and further investigate future planning development risks Boards stage SCC's LDP stipulates new highway access weeks (minor excessive, that S106 demands building control at Morriston Hospital & Submit a pre-planning application; (3) & road junction improvements at Morriston redesign & approvals are more involved than anticipated Monitor progress on Project and its interrelationship(s) with Hospital (& an updated Transport Impact resubmission of ARCH & other Morriston Hospital projects currently at planning Assessment (TIA). planning applications) stage; (4) Coordinate with ARCH Master Planners. 14 Funding approval delayed or timing of funding does Time Regional 4 4 16 Programme Quantified 0 (1) Maintain regular dialogue re the procurement arrangements Health OBC/FBC 0 0.64 0 not match our current programme due to WGov Pathology with WG and other key stakeholders. Boards stage cashflow constraints 15 Unrealistic programme set for new build and Quality, Operational Regional 2 4 8 Programme Quantified 0 (1) Review with appointed Designed for Life:Building for Wales3 Health OBC/FBC Impacts on D4L3 and operational plans. 0 0.32 0 refurbishment solutions Pathology Supply Chain Partner (SCP)/constructor. Boards stage 16 Phasing plans fail to deliver new build facilities, Time, Operational Regional 2 4 8 Programme Quantified 350,000 Review programme with main contractor Health OBC/FBC Impacts on D4L3 and operational plans. 350,000 0.32 112,000 Based on estimated compromising refurbishment plans Pathology Boards stage 1% of works 17 Refurbishment phasing plans do not happen Time, Operational Regional 3 3 9 Programme Quantified 250,000 Review programme with main contractor Health OBC/FBC Impacts on D4L3 and operational plans. 250,000 0.36 90,000 Based on estimated concurrently extending programme and delaying Pathology Boards stage 1% of works realisation of full benefits 18 Commissioning - Handover/technical and clinical Time, Cost, Operational Regional 2 3 6 Programme Quantified 0 Continued liaison with NWSSP-SES during design development Health OBC/FBC 0 0.24 0 commissioning may take longer than anticipated Pathology Boards stage

19 Engagement - Formal staff engagement plans / Strategic Regional 3 3 9 Programme Quantified 0 Formal Staff Consultation process to be agreed following Health OBC/FBC No TUPE implications. 0 0.36 0 processes are delayed / poorly coordinated Pathology executive level sign off of Discussion SOC. Boards stage

20 Equipment - The equipment strategy and Time, Cost, Quality, Regional 3 3 9 Programme Quantified 499,697 Continued liaison with Procurement advisors during design Health OBC/FBC Consider emerging equipment needs and 499,697 0.36 179,891 Based on estimated implementation fails Operational Pathology development & delivery stage; Equipment Strategy & Boards stage new technologies. Demand and capacity 10% of equipment Commissioning Plan in place with detailed standard & non- modelling will also inform equipment costs standard equipment lists (to inform robust OBC estimated costs) strategy. and identify opportunities for transfer equipment. 21 IM&T - The IM&T strategy and implementation fails Time, Cost, Quality, Regional 3 4 12 Programme Quantified 75,000 Continued liaison with IM&T advisors (via Project Board sub Health OBC/FBC 75,000 0.48 36,000 Based on estimated Operational Pathology group forum) during design development & delivery stage; Boards stage 10% of IM&T costs Commissioning Plan in place FINANCIAL RISKS 22 Capital costs - Capital Cost over-run Time, Cost, Quality Regional 3 4 12 Financial Quantified 1,300,000 (1) Finance Working Group established; (2) Appoint Health Board Health OBC/FBC 1,300,000 0.48 624,000 Based on estimated Pathology Cost Advisor (HBCA); (3) Finance lead(s) regularly report to Boards stage 3.75% of works Project Board.

Y:\Meetings\Board Meetings\01 Formal\2018-19\07 - 28 Mar 19\Final papers\Pathology\Appendix K – Risk Register.xlsx Nr Risk Description Risk Consequence: Scheme Probability Impact Score Category Quantified Estimated cost Management Actions Action Review Comments Cost if it Likelihood Factor Expected 1. Time Unquantified impact £ Owner Date happens £ Value Basis for assessment

2. Cost 3. Quality 23 Revenue affordability - Affordability of revenue Quality,4 O Operational ti l Regional 5 4 20 Financial Quantified 0 (1) Develop and sign off revenue model with DoFs; (2) Project Health OBC/FBC SOC stage is hi-level 0 0.80 0 model is over/under estimated Pathology Board to review at each formal meeting. Boards stage 24 Inflation - There is a risk that long-term inflation Cost Regional 5 3 15 Financial Quantified 150,000 Review at OBC & FBC stage Health OBC/FBC 150,000 0.60 90,000 varies from BISHUB indices Pathology Boards stage 25 VAT - anticipated reclaim not resolved to optimum Cost Regional 3 2 6 Financial Quantified 400,000 Review at OBC & FBC stage with independent VAT advisor Health OBC/FBC No VAT reclaim position assumed for 400,000 0.24 96,000 Based on estimated expectations Pathology Boards stage refurbishments at present 10% of external fees

26 Availability of capital - There is a risk that the scope Cost Regional 5 3 15 Financial Quantified 0 Continued liaison with WGov. Health OBC/FBC 0 0.60 0 of the project is reduced in order to fit within Pathology Boards stage financial limit 27 Regional economy - Patient/Health Board & Cost Regional 3 4 12 Financial Quantified 0 (1) Develop and sign off hi-level Project Benefits Realisation Health OBC/FBC 0 0.48 0 PHW/wider NHS/wider regional economy benefits Pathology (BRP) Strategy & Plan ; (2) Project Board regularly reviews BRP Boards stage are under/over estimated Plan. DESIGN RISKS 28 Staffing levels - Additional staffing levels / activity Operational Regional 3 4 12 Planning Quantified 100,000 (1) Develop Staff Modelling to inform, e.g. future car parking Health OBC/FBC Extended delivery programme. 100,000 0.48 48,000 Estimated additional cannot be supported at Morriston Hospital, e.g. car Pathology requirements on site; (2) Liaise with Morriston Hospital/ARCH Boards stage cost of alternative car parking provision and essential infrastructure are projects currently at planning stage. parking arrangements unsufficient to support planned operations

29 AEDET Review performance process identifies Time, Cost, Quality, Regional 4 3 12 Design Quantified 400,000 Continued liaison with NWSSP-SES during design development Health OBC/FBC Review post pre-construction and post 400,000 0.48 192,000 Based on estimated design conflicts requiring adjustment of designs Operational Pathology Boards stage construction AEDET stages. 2% of works 30 Fire regulations compliance may not be achieved Time, Cost Regional 2 2 4 Design Quantified 380,170 Continued liaison with NWSSP-SES Fire Officer during design Health OBC/FBC 380,170 0.16 60,827 Based on estimated Pathology development Boards stage 1% of works 31 Equality Act compliance may not be achieved Time, Cost Regional 2 2 4 Design Quantified 380,170 Continued liaison with NWSSP-SES during design development Health OBC/FBC 380,170 0.16 60,827 Based on estimated Pathology Boards stage 1% of works 32 Planning guidance - Changes to Legislation/ British Time, Cost, Quality Regional 3 3 9 Design Quantified 450,000 (1) Project Board monitors wider NHS design changes; (2) Health OBC/FBC Extended delivery programme. 450,000 0.36 162,000 Based on estimated Standard/ HTM/ HBNM/ ISO's/ CPA Accreditation/ Pathology Continued liaison between partners' executive level and ARCH & Boards stage 2.5% of works HTA's/ Royal Colleges' guidance/ best practice national bodies & Royal Colleges. CONSTRUCTION RISKS 33 Unforeseen ground conditions are encountered Time, Cost Regional 3 5 15 Construction Quantified 180,000 Undertake site surveys Health OBC/FBC 180,000 0.60 108,000 Based on estimated during project delivery Pathology Boards stage 0.5% of works 34 Archaeological interests are encountered on site(s) Time, Cost Regional 2 4 8 Construction Quantified 150,000 Undertake L&P searches Health OBC/FBC 150,000 0.32 48,000 Based on delay of 3 delaying works Pathology Boards stage weeks (cumulative) of 35 Drainage works may be more than expected Time, Cost Regional 2 3 6 Construction Quantified 380,170 Undertake site surveys Health OBC/FBC 380,170 0.24 91,241 Based on estimated Pathology Boards stage 1% of works 36 Damage to adjacent buildings/roads due to Time, Cost Regional 2 3 6 Construction Quantified 250,000 Review site logistics at design / programme stage with main Health OBC/FBC 250,000 0.24 60,000 Based on estimated construction works Pathology contractor Boards stage 1% of works 37 Unforeseen ground contamination is encountered Time, Cost Regional 3 5 15 Construction Quantified 300,000 Undertake site surveys Health OBC/FBC 300,000 0.60 180,000 Based on estimated during project delivery Pathology Boards stage 1.25% of works 38 Asbestos - Risk that more asbestos than Time, Cost Regional 3 3 9 Construction Quantified 300,000 Undertake site surveys; Consult asbestos register Health OBC/FBC 300,000 0.36 108,000 Based on estimated anticipated is encountered during refurbishments, Pathology Boards stage 2% of works reconfigurations and building extensions projects than allowances, causing delays to the project 58

289 Total £: 6,366,158 Contingency 3,943,540 Total £:

Y:\Meetings\Board Meetings\01 Formal\2018-19\07 - 28 Mar 19\Final papers\Pathology\Appendix K – Risk Register.xlsx Project: Regional Pathology Project

Project Risk Register - Discussion SOC Regional Pathology v6 (14th December 2017) - Operational Risks Identification Assessment Quantification Management Risk Quantification Calculation

Nr Risk Description Risk Consequence: Scheme Probability Impact Score Category Quantified Estimated Management Actions Action Review Comments Cost if it Likelihood Expected 1. Time Unquantified cost impact £ Owner Date happens £ Factor Value 2. Cost Basis for 3. Quality assessment 4. Operational 1 Policies & Standards - Issues with joint operational Operational Regional 3 3 9 Operational Unquantified 0 (1) Agree governance structures and integrate controls assurance Health OBC/FBC 0 0.36 0 policies / standards leads to increased legal / Pathology Boards stage professional exposure & professional boundary issues

2 Management - Lab management leadership / Operational Regional 2 3 6 Operational Unquantified 0 (10 Agree new Unit's operational policy and OOHs management Health OBC/FBC 0 0.24 0 delivery arranegments in new build accommodation Pathology arrangements; (2) Agree governance structures. Boards stage are unclear 3 Service model may not match overall clinical Operational Regional 2 4 8 Operational Unquantified 0 Establish a Project Management Team and secure project Health OBC/FBC 0 0.32 0 strategy for Health Boards due to changing health Pathology management support Boards stage service requirements 4 Staffing model is over/under estimated Operational Regional 3 4 12 Operational Unquantified 0 (1) Project Board develops and signs off new Staff Model. Health Ongoing 0 0.48 0 Pathology Boards 5 Operational Model needs to be sufficiently flexible Operational Regional 2 2 4 Operational Unquantified 0 Continued engagement with Pathology Collaborative & Royal Health 0 0.16 0 to reflect needs of digitisation Pathology Colleges Boards 6 Operational management arrangements are more Operational Regional 2 4 8 Operational Unquantified 0 Establish a Project Management Team and secure project Health OBC/FBC 0 0.32 0 challenging than anticipated during transitional Pathology management support Boards stage phases 7 Gateway 3 ('readiness to proceed') review Operational Regional 2 4 8 Operational Unquantified 0 (1) Establish a Change Management Working Group; (2) Develop Health OBC/FBC 0 0.32 0 highlights, e.g. uncoordinated transition to new Pathology an Overarching Transition Strategy to ensure that care pathways Boards stage service delivery model issues and new service models are delivered on time/seamlessly; (3) Project Plan Implementation; (4) Care pathway and new service models are designed and delivered.

8 Information management systems (LIMs) may be Operational, Quality Regional 3 4 12 Operational Unquantified 0 (1) IM&T Sub Group established; (2) IM&T Strategy developed; Health OBC/FBC 0 0.48 0 subject to failures compromising effective delivery Pathology (3) Existing Business Continuity Plan revised to reflect new Boards stage and monitoring of services working arrangements. 9 Recruitment of key staff - Sufficient numbers of Operational Regional 3 4 12 Operational Unquantified 0 Project Board monitors recruitment progress/issues and report Health OBC/FBC Service may need to rely on locum staff 0 0.48 0 essential staff with key skills cannot be recruited Pathology regularly to Project Board/Executive level Boards stage until resolved.

10 Retention of key staff - Staff leaver rates increase Operational Regional 3 2 6 Operational Unquantified 0 (1) Strong engagement process; (2) Manage process according to Health OBC/FBC 0 0.24 0 through dissatisfaction with transition process / new Pathology established policies and procedures for change; (3) Working with Boards stage arrangements staff side representatives throughout the change process.

11 Demand management - Service experiences lower Operational, Quality Regional 3 3 9 Operational Unquantified 0 (1) demand and capacity analysis to underpin service model and Health OBC/FBC 0 0.36 0 / higher than anticipated volumes Pathology build in growth assumptions; (2) Operational Plan will Boards stage accommodate demand surges. 12 Transition - As we move from existing model to Operational Regional 3 2 6 Operational Unquantified 0 Robust operational management arrangements. Health OBC/FBC 0 0.24 0 new model we may experience risks not previously Pathology Boards stage considered 13 Single Sourcing - Transfer of risk to a single source Operational Regional 3 3 9 Operational Unquantified 0 (1) Robust operational management arrangements; (2) Set Health OBC/FBC 0 0.36 0 supplier laboratory from current multiple suppliers Pathology performance levels; (3) Strong performance management Boards stage compromises delivery of quality service to local arrangements agreed before new model is implemented. population 14 Digitisation of pathology services leads to smaller Operational Regional 2 4 8 Operational Unquantified 0 Continued engagement with Pathology Collaborative Health Ongoing 0 0.32 0 number of pathology labs in Wales Pathology Boards

15 Risk of error - Risk of samples getting lost in transit Operational Regional 3 3 9 Operational Unquantified 0 (1) Quality management; (2) Traceability and traceability are Health OBC/FBC 0 0.36 0 increases; samples are delivered to the wrong Pathology already 'built-into' ISO standards; (3) Policies and standard Boards stage destinations; mis-labelling in error / forms Operating Procedures agreed. incompletely completed by source clients leads to increased need for repeat tests; transport tracking systems failures experienced 16 Revenue Costs - Increased revenue costs are Operational Regional 3 2 6 Operational Unquantified 0 Revenue modelling ongoing Health Ongoing 0 0.24 0 incurred in some areas / localities, e.g. transport Pathology Boards costs increase 0 Operational 0 Health 0 0.00 0 Boards

0 Operational 0 Health 0 0.00 0 Boards

0 Operational 0 Health 0 0.00 0 Boards

0 Operational 0 Health 0 0.00 0 Boards

58

38 Total £: 0 Contingency 0 Total £:

Probability To close a risk, enter 0into Probability enter andImpact arisk, close To

Almost Unlikely Possible Likely Rare 5% certain 25% 50% 75% 100% 1 2 3 4 5 Insiginificant 16 15 12 10 25 20 5 1 2 3 4 9 8 6 5 4 3 2 1 1 Minor Amber Green Red 10 2 4 6 8 2 Liklihood Factor % Factor Liklihood Moderate 0.80 0.64 0.60 0.48 0.40 0.36 0.32 0.24 0.20 0.08 0.04 1.00 0.16 0.12 Impact 15 12 3 6 9 3 Major 20 12 16 4 8 4 Catastrophic 25 10 15 20 5 5 NHS Wales Health Collaborative/South Wales Cellular Pathology Project’s New Service Model for Cellular Pathology Services for South Wales Option Appraisal Process

Timeline Process Appraisal Results

The All Wales Cellular Pathology (AWCP) Project Group identified a long list of options from previous options identified by both the South East Wales Collaborative and the South West Wales Collaborative.

In July a detailed non-financial appraisal This stage determined the short listed option’s rankings in order was undertaken by a multidisciplinary group as follows: of stakeholders and the long list was Option Rank st reduced to a short list. . Two duplicate sites 1 . One single cellular 2nd pathology site . Hub & Spoke 3rd . Do Nothing 4th . th Outsourcing 5

In October the short listed options were Using the same benefits criteria and weighting as previously the

uly to October 2014 October to uly ‘refreshed’ to exclude the outsourcing Group this stage determined the short listed option’s rankings in J solution. order as follows: Option Rank . Do Minimum (a single managed service across 1st Wales within Pathology which could be managed in a similar model to microbiology by one NHS organisation/Health Board . Two sites 2nd . Hub & Spoke – 1 Hub 3rd . One single cell path site 4th . Hub & Spoke – 2 Hubs 5th . th Do Nothing 6

A workshop, facilitated by AWPC This stage determined the short listed option’s rankings in order attendees, undertook further non-financial as follows: option appraisal to evaluate how well (or Option Rank not) each short listed option delivered . One single cell path site (expected to be located 1st against each of the agreed benefits criteria. either in either the Cardiff or Swansea area) These scores were then averaged for each . Two sites (expected to be located in both the Cardiff 2nd of the main key benefits. Post workshop, and Swansea area) . rd the workshop’s outcomes were averaged Hub & Spoke – 1 Hub (with the hub expected to be 3 located in either the Cardiff or Swansea area) and consolidated for further analyses and . Hub & Spoke – 2 Hubs (with the hubs expected to 4th weighted and non-weighted outcomes were be located in both the Cardiff and Swansea areas) determined. . Do Nothing / Do Minimum (baseline comparator) - 5th within Wales and the full implementation of LIMs, both of which are planned developments over the next year or so, irrespective of the outcome of this

service review and appraisal

Following the completion of this stage the This stage tested the outcomes by reversing the weightings, outcomes were tested further through a equalizing the weightings and reviewing the order options. The range of sensitivity analyses, designed to sensitivity tested ranking of the short listed options in order of assess how sensitive the outcome was to ranking are as follows:

changes in some of the input criteria and Option Rank data. . One single cell path site (expected to be located 1st either in either the Cardiff or Swansea area) . Two sites (expected to be located in both the Cardiff 2nd and Swansea area) . Do Nothing/Do Minimum (baseline comparator) - 5th January 2015 January within Wales and the full implementation of LIMs, both of which are planned developments over the next year or so, irrespective of the outcome of this

service review and appraisal

Following this non-financial option process Finding: The stage identified the proposed locations as follows: Directors of Planning from each of the . One single site (expected to be located either in either the health boards/trusts and colleagues from Cardiff or Swansea area): both Cardiff and Swansea Universities were - ABMUHB – Adjacent to current Morriston Site contacted to identify available space to - C&VUHB – UHW Site accommodate both the one site and two - CTUHB - Off site near to Royal Glam. Hosp. site options. - Cardiff University - Swansea University . Two sites (expected to be located in both the Cardiff and Swansea area): - ABMUHB - Adjacent to current Morriston Site - C&VUHB – UHW Site - CTUHB - Off site near to Royal Glam. Hosp. or on site at Royal Glam. Hosp. - Cardiff University - Swansea University

A further workshop, facilitated by This stage determined the weighted and unweighted outcomes, NHSWHC, undertook further non-financial & identified a short list of options to be financially appraised. sub-option appraisal using detailed benefit

criteria with a large stakeholder group. The financial and non-financial option appraisal at this stage was informed by the SWP and others who are developing South Wales, All Wales and pathology business cases.

Post this workshop, information from This stage presented the non-weighted & weighted scores and attendees’ scoring sheets was combined reversed scoring & averaged weighted sensitivity analyses were and consolidated for further analyses. ranked as follows: Non-Financial Scoring Ranking Non Weighted Sensitivity Analyses Weighted Reversed Averaged Adding 5% to Adding 5% to Weighting Weighting each score of each score of the 2nd ranked the 2nd ranked Options option (Non option Weighted) (Weighted) Single site (ABMHUB/Swansea 3rd 3rd 3rd 3rd 3rd 3rd University) Single site (CVUHB/Cardiff University) 2nd 2nd 2nd 2nd 2nd 2nd th th th th th th

Single site (CTUHB) 5 4 5 4 5 4 Two site (ABMUHB/Swansea 1st 1st 1st 1st 1st 1st University) Two site (CVUHB/Cardiff University) 1st 1st 1st 1st 1st 1st th th th th th th

Two site (CTUHB) 4 5 4 5 4 5

Finding: The non-financial option appraisal’s two top ranked

November 2015 November options were the Two site (ABMUHB/Swansea University) & Two site (CVUHB/Cardiff University) solutions. Detailed sensitivity analyses was undertaken and this stage of analyses confirmed these rankings as the preferred option.

The financial appraisal stage was The next stage of financial analyses considered the of the concluded and the results were taken to the estimated capital costs, revenue costs and capital charges in AWPC meeting in November and the respect of each of the following short listed options: outcome shared with all participants of the . Do Nothing (retained as a benchmark workshop, and with members of the Cellular comparator) Pathology Project Group. . Two site (ABMUHB/Swansea University) . Two site (CVUHB/Cardiff University)

Conclusion: This stage concluded that, from a financial perspective, the option of a single site is the lowest cost option of those short listed. However, when a cost per weighted benefit score from the non-financial option appraisal was applied to the estimated revenue costs of each option, the two site option had the lowest. The preferred financial model was confirmed as the Two site solution, from both a financial (cost per weighted benefit score) and non-financial option appraisal perspective.

Hywel Dda University Health Board - Regional Laboratory Facilities Design Guidance Compliance Audit Communications Sheet Version 0.8 23nd March 2018 Health Planner: SM Reviewer: CD

Summary of approach and version control

For the facility we have taken the agreed most relevant guidance as detailed in the table below and undertaken a comparison of inclusion and sizing. Missing functional content for the exiting departments is highlighted in yellow fill cells in column A on each tab titled "Description/Department". Any additional accommodation that the existing units have which is not included within the guidance is annotated in red text in column E titled "comment". The guidance used for the audit is the most update date version of the design guidance for healthcare in the United Kingdom to avoid risks associated with applying compliance against documents that are currently significantly out pf date for NHS Wales in comparison to NHS Scotland or NHS England's design guidance. This ensures that the audit is as robust as it can possibly be.

DATE VERSION COMMENTS Single Site: For the purpose of the review of this unit, WHBN 15 "Facilities for pathology services" 2nd edition June 2005 has been used for the audit. The net departmental areas have been used for the comparison, because the indicative schedule of accommodation does not include any allowances for planning, engineering of circulation. However, the gross departmental area has been calculated and applied for the option using the design guidance allowances of 5% planning, 3% engineering and 25% circulation for facilities for pathology services. The gross departmental area can be seen on tab titled "Single site". For the detail of the audit on a room by room basis see the tab titled "single site". East Site: For the purpose of the review of this unit, WHBN 15 "Facilities for pathology services" 2nd edition June 2005 has been used for the audit. The net departmental areas have been used for the comparison, because the indicative schedule of accommodation does not include any allowances for planning, engineering of circulation. However, the gross departmental area have been calculated and applied for the option using the design guidance allowances of 5% planning, 3% engineering and 25% circulation for facilities for pathology services. The gross departmental area can be seen on tab titled "East site." For the detail of the audit on a room by room basis see the tab titled "East site" 05/02/2018 V 0.1 West Site: For the purpose of the review of this unit, WHBN 15 "Facilities for pathology services" 2nd edition June 2005 has been used for the audit. The net departmental areas have been used for the comparison, because the indicative schedule of accommodation does not include any allowances for planning, engineering of circulation. However, the gross departmental area have been calculated and applied for the option using the design guidance allowances of 5% planning, 3% engineering and 25% circulation for facilities for pathology services. The gross departmental area can be seen on tab titled "West site." For the detail of the audit on a room by room basis see the tab titled "West site". Morriston "New build": For the purpose of the review of this unit, WHBN 15 "Facilities for pathology services" 2nd edition June 2005 has been used for the audit. The net departmental areas have been used for the comparison, because the indicative schedule of accommodation does not include any allowances for planning, engineering of circulation. However, the gross departmental area have been calculated and applied for the option using the design guidance allowances of 5% planning, 3% engineering and 25% circulation for facilities for pathology services. The gross departmental area can be seen on tab titled "Morriston New build." For the detail of the audit on a room by room basis see the tab titled "Morriston New Build". 12/02/2012 V0.2 Review and QA prior to client issue. 27/02/2018 V0.3 SoA update following scope meeting dated 26th February 2018 28/02/2018 V0.4 Review and QA prior to client issue. Update and re-structured following discussions with Heather Edwards (01/03/2018). Single Site and East site 01/03/2018 V0.5 options removed, and master schedule areas for Microbiology added to the Morriston "New Build" West Site re- labelled as Swansea Site SoA update following user comments from Cellular Pathology and Medical Microbiology 09/03/19. Also 14/03/2018 v0.6 operationally essential accommodation has been added to support the unit inline with the design guidance Final update of SoA and restructure following telecom with Heather Edwards on 20th March 2018. West site 22/03/2018 v0.7 option tab removed. The summary sheet totall includes a plant allowance of 15% and communcation allowance of 5% to provide an indictative GIFA in addition to a gross departmental area 23/03/2018 v0.8 Review and QA prior to client issue. Hywel Dda University Health Board - Regional Laboratory Facilities Design Guidance Compliance Audit Summary Version 0.8 23nd March 2018 Health Planner: SM Reviewer: CD

Facility Option Departmental Comments Net Area (proposed)

Regional Laboratory Services (Morriston A. Shared entrance and reception facilities. 116.00 New Build) Total Shared Entrance and Reception Facilities 116.00 B. Laboratory facilities: Cellular Pathology. 888.14 C. Laboratory facilities: Cellular Pathology - Wales Cancer 52.00 Bank Sub Total D. Staff support facilities: Cellular Pathology Education and 658.00 Offices. Total Cellular Pathology 1,598.14 E. Laboratory facilities: Medical Microbiology 771.00 F. Staff support facilities: Medical Microbiology Education 280.00 and Offices Total Medical Microbiology 1,051.00 G. Cryptosporidium Reference Unit (CRU) 212.00 Total Cryptosporidium Reference Unit (CRU) 212.00 H. Toxoplasma Reference Unit (TRU) 199.00 Total Toxoplasma Reference Unit (TRU) 199.00 I. Health Protection Unit (HPU) 115.00 Total Health Protection Unit (HPU) 115.00 J. Shared Staff support facilities: Cellular Pathology and 254.50 Medical Microbiology Total Shared Staff support facilities: Cellular Pathology and Medical Microbiology 254.50 Net Departmental Grand Total 3,545.64 Planning Allowance 5% 177.28 Sub Total 3,722.92 Circulation Allowance 25% 930.73 Engineering Allowance 3% 111.69 Total (Gross department) 4,765.34 Plant Allowance 15% 714.80 Assuming no connection to other departments - entrance 238.27 Communication Allowance 5% areas only. Total (GIFA) 5,718.41

2 Hywel Dda University Health Board - Regional Laboratory Facilities Design Guidance Compliance Audit Version 0.8 23nd March 2018 Health Planner: SM Reviewer: CD

Option Indicative area Comment (Morriston "New Build" option) sqm Morriston "New Build" site Based on using Swansea Site (West) as the baseline for Cellular Pathology plus Medical Microbiology SoA Jul 16, and User review/update March 2018

A. Shared Entrance and reception (including specimen) facilities Entrance foyer/draught lobby 11.00 Reception 10.50 Departmental and specimen reception Specimen reception cytopathology 42.00 Sorting and request processing area: specimen 21.00 Cellular pathology, receipt of bloods & Medical microbiology sample reception. Processing area: specimen (to support data entry) 31.50 LIMS entry (8-person office sort up for Cell Path & MM). Includes a specimen hold.

A Shared Entrance and Reception Facilities Total 116.00 Total Shared Entrance and Reception Facilities Total 116.00 B. Laboratory facilities: Cellular Pathology Entrance lobby 6.00 required at entrance to each laboratory cluster. Lab: cellular pathology, specimen cut up area 90.00 Area includes 9 x cut up bays Store: cellular pathology, wet specimens 10.50 Lab: cellular pathology, high risk specimen cut up 10.50 Lab: cellular pathology, processing 8.30 processing area Lab: cellular pathology, general embedding area 18.55 16 x stations. Lab: cellular pathology, general sorting area 10.00 Lab: cellular pathology, general microtomy 33.84 26 x bench stations. Includes 35m2 work area.

Lab: cellular pathology staining area 16.95

Store: cellular pathology specimen buckets 30.00

Quality control area 1 10.00 Virtual slide scanning Quality control area 2 10.00 Store: cellular pathology, general slide and block 16.00

Store and chemical preparation area: cellular pathology 8.00 Lab: immunohistochemistry, specimen cut up area 130.00 This service is a discrete function that is co-locating with other cell path activities. It includes: research area and , 2 x -80° freezers Store: bulk flammable goods 20.00 Query external area? (stores formalin, alcohol, xylene, etc.)

Store: archive block and slide 100.00 Storage of medium term histology, non gynae, mortuary blocks & slides function - 5 yrs

Store: lab working stock 1 12.00 DSR 1 7.00 Disposal hold 1 10.00 Switch room 1 4.00 Store: gas cylinders 0.00 external area B. Laboratory facilities: Cellular Pathology Total 888.14 C. Laboratory facilities: Cellular Pathology - Wales Cancer Requirement TBC Bank Specialised Lab: Molecular Extraction 10.00 DNA/RNA Extraction - Wales Cancer Bank Processing

Specialised Lab: Cellular Pathology Molecular Extraction 18.00 Wales Cancer Bank Extraction Lab Specialised Lab: Molecular Extraction - amplification 24.00 C. Laboratory facilities: Cellular Pathology - Wales Cancer 52.00 Bank Total D. Staff support facilities: Cellular Pathology Education and Office: single 1 12.00 Type B with microscope bench Office: single 2 12.00 Type B with microscope bench Office: single 3 12.00 Type B with microscope bench Office: single 4 12.00 Type B with microscope bench Office: single 5 12.00 Type B with microscope bench Office: single 6 12.00 Type B with microscope bench Office: single 7 12.00 Type B with microscope bench Office: single 8 12.00 Type B with microscope bench Office: single 9 12.00 Type B with microscope bench Office: single 10 12.00 Type B with microscope bench Office: single 11 12.00 Type B with microscope bench Office: single 12 12.00 Type B with microscope bench Office: single 13 12.00 Type B with microscope bench Office: single 14 12.00 Type B with microscope bench Office: single 15 12.00 Type B with microscope bench Office: single 16 12.00 Type B with microscope bench Office: single 17 12.00 Type B with microscope bench Office: single 18 12.00 Type B with microscope bench Office: single 19 12.00 Type B with microscope bench Office: single 20 12.00 Type B with microscope bench Office: single 21 12.00 Type B with microscope bench Office: single 22 12.00 Type B with microscope bench Office: single 23 12.00 Type B with microscope bench Office: single 24 12.00 Type B with microscope bench Office: single 25 12.00 Type B with microscope bench Office: single 26 12.00 Type B with microscope bench Office: single 27 12.00 Type B with microscope bench Office: single 28 12.00 Type B with microscope bench Office: single 29 12.00 Type B with microscope bench Office: single 30 12.00 Type B with microscope bench Office: single 1 10.50 Type A - Sprs Office: single 2 10.50 Type A - Sprs Office: single 3 10.50 Type A - Sprs Office: single 4 10.50 Type A - Sprs Office: 15 person 75.00 Secretaries x 15. Based on 5m2 per desk space with integral storage Office: single with meeting space 1 16.00 Senior Clinical Manager Office: single with meeting space 2 16.00 Senior Clinical Manager Office: single with meeting space 3 16.00 Senior Clinical Manager Office: single 1 10.50 Senior Clinical Manager Office: single 2 10.50 Senior Clinical Manager Office: 10 person 40.00 Staff x 10. Based on 4m2 per desk space "Hot Desk" Seminar/training Room 1 36.00 Seminar/training Room 2 36.00 D. Staff support facilities: Cellular Pathology Education and 658.00 Offices Total Total Cellular Pathology 1,598.14 E. Laboratory facilities: Medical Microbiology

Bacteriology and Virology Laboratory Entrance lobby 6.00 Automated Laboratory 42.00 Serology analysis Lab: Microbiology -wounds/MRSA 72.00 Lab: Microbiology - faeces/mycology (shared) 70.00 Lab: Microbiology - genital 70.00 Lab: Microbiology - urines 51.00 Lab: Microbiology - fluids/blood cultures 70.00 Lab: Microbiology - genomics 37.00

Lab: Virology (main) 26.00 Lab: Virology - sample preparation 40.00 Lab: Virology - molecular analyser 8.00

Lobby: Lab, high risk/containment level 3 5.00 Specialised Lab: containment level 3 21.00 Lab: category 2 & 3 facility 30.00 Lab: PCR preparation room - enteric 27.00 Lab: PCR Chlamydia NAATS 18.00 Lab: PCR clean and dirty rooms 28.00

Central wash up 20.00 Sterilizer loading/unloading area 21.00 2 x autoclaves/sterilizers. Plant room 17.00 2 x autoclaves/sterilizers.

Cold room 1 12.00 antibiotic/reagents and kits Cold room 2 12.00 bacteriology media Refrigerator/freezer room 1 9.00 -20 degree freezer Store: lab working stock 2 19.00 Store: lab working stock 3 19.00 DSR 2 7.00 Disposal hold 2 10.00 Switch room 2 4.00 E. Laboratory facilities: Medical Microbiology Total 771.00 F. Staff support facilities: Medical Microbiology - Education and Offices Office: CMN 1 12.00 Office: CMN 2 12.00 Office: CMN 3 12.00 Office: CMN 4 12.00 Office: CMN 5 12.00 Office: CMN 6 12.00 Office 12.00 Infectious diseases (Consultants) Office 18.00 Infectious diseases (Sprs) Office 12.00 University academic Office 24.00 Operational management: Bacteriology/Virology/Quality (AT/AR).

Office 16.00 RSM Office 36.00 Senior Staff Office 12.00 Lab Administrator Office 24.00 Admin: 3 x staff Office 18.00 Infection Control Team x 4 staff Seminar/training Room 3 36.00 F. Staff support facilities: Medical Microbiology Education 280.00 and Offices Total Total Medical Microbiology 1,051.00 G. Cryptosporidium Reference Unit (CRU) Only unit in the united kingdom CRU Lab 60.00 Microscopy suite 21.00 in CRU SoA but no area allocated. PCR Reagent - clean room 20.00 DNA room 15.00 Post amplification room 40.00 Refrigerator/freezer room 2 9.00 Refrigerator/freezer room 3 9.00 Store: lab working stock 4 19.00 Office: 4 person 19.00 CRU Office G.CRU Total 212.00 Total Cryptosporidium Reference Unit (CRU) 212.00 H. Toxoplasma Reference Unit (TRU) One of only 2 units in the united Kingdom, the other is in Edinburgh Specialist reference unit 68.00 Void area 10.00 Clean area 24.00 Laboratory and Office area 97.00 H.TRU Total 199.00 Total Toxoplasma Reference Unit (TRU) 199.00 I. Health Protection Unit (HPU) Re-located from the Central Clinic, Central Swansea

Office: team base 85.00 based on 4.0m2 per person this would accommodate approx. 20 people Meeting room 30.00 based on 1.8m2 per person this would accommodate approx. 15 people I.HPU Total 115.00 Total Health Protection Unit (HPU) 115.00 J. Shared Staff support facilities: Cellular Pathology and Medical Microbiology Rest and dining room 45.00 50 staff .Required for approx. (200 staff) Could be 2 separate rest rooms as opposed to one

Beverage bay 12.00 Integral to the Rest and dining room Bay: vending machine 3.00 Integral to the Rest and dining room Staff changing room 39.00 50 places. Male staff. 100 staff required Shower: ambulant (non patient) 1 2.50 Male staff. Integral to the Male change Shower: ambulant (non patient) 2 2.50 Male staff. Integral to the Male change WC: ambulant 1 2.00 Male staff. Integral to the Male change WC: ambulant 2 2.00 Male staff. Integral to the Male change WC: ambulant 3 2.00 Male staff. Integral to the Male change Staff changing room 1 50.00 40 places. Female staff. 50 staff required Staff changing room 2 31.50 40 places. Female staff. 50 staff required Shower: ambulant (non patient) 1 2.50 Female staff. Integral to the Female change and split between the 2 female changing rooms Shower: ambulant (non patient) 2 2.50 Female staff. Integral to the Female change and split between the 2 female changing rooms Shower: ambulant (non patient) 3 2.50 Female staff. Integral to the Female change and split between the 2 female changing rooms Shower: ambulant (non patient) 4 2.50 Female staff. Integral to the Female change and split between the 2 female changing rooms WC: ambulant 1 2.50 Female staff. Integral to the Female change and split between the 2 female changing rooms WC: ambulant 2 2.00 Female staff. Integral to the Female change and split between the 2 female changing rooms WC: ambulant 3 2.00 Female staff. Integral to the Female change and split between the 2 female changing rooms WC: ambulant 4 2.00 Female staff. Integral to the Female change and split between the 2 female changing rooms WC: accessible/assisted 4.50 Mixed gender Store: Protective clothing 4.00 Office MDT 36.00 Required for 15 people, this would accommodate 20 at 1.8m2 per person. VC facilities needed.

J. Shared Staff support facilities: Cellular Pathology and 254.50 Medical Microbiology Total Total Shared Staff support facilities: Cellular Pathology and 254.50 Medical Microbiology Net Departmental Grand Total 3,545.64 Planning Allowance 5% 177.28 Sub Total 3,722.92 Circulation Allowance 25% 930.73 Engineering Allowance 3% 111.69 Total (Gross Departmental) 4,765.34 Option 1 Option 2 Option 3 Option 4 Option 5 BAU Do Minimum Intermediate1 Intermediate2 Do Maximum Departmental Net Departmental Net Departmental Net Departmental Net Area (proposed) Area (proposed) Area (proposed) Area (proposed) Regional Laboratory Services A. Shared entrance and reception - 116.0 116.0 116.0 1,868.0 (Morriston New Build) facilities. Total Shared Entrance and Reception Facilities - 116.0 116.0 116.0 1,868.0 B. Laboratory facilities: Cellular Pathology. - 888.1 888.1 888.1 888.1

C. Laboratory facilities: Cellular Pathology - - 52.0 52.0 52.0 52.0 Wales Cancer Bank Sub Total

D. Staff support facilities: Cellular - 658.0 658.0 658.0 658.0 Pathology Education and Offices. Total Cellular Pathology - 1,598.1 1,598.1 1,598.1 1,598.1 E. Laboratory facilities: Medical - - 771.0 771.0 771.0 Microbiology F. Staff support facilities: Medical - - 280.0 280.0 280.0 deduct 12 m2 university space at next stage Microbiology Education and Offices G. Cryptosporidium Reference Unit (CRU) - - 212.0 212.0 212.0

H. Toxoplasma Reference Unit (TRU) - - 199.0 199.0 199.0 I. Health Protection Unit (HPU) - - 115.0 115.0 115.0 deduct at next stage Total Medical Microbiology - - 1,577.0 1,577.0 1,577.0 Total Staff support facilities - 254.5 254.5 254.5 254.5 Total (Net Departmental) - 1,968.6 3,545.6 3,545.6 5,297.6 Planning Allowance 5% - 177.3 177.3 177.3 264.9 Sub Total - 2,145.9 3,722.9 3,722.9 5,562.5 Crculation Allowance 25% - 536.5 930.7 930.7 1,390.6 Engineering Allowance 3% - 64.4 111.7 111.7 166.9 Total (Gross Department) - 2,746.8 4,765.3 4,765.3 7,120.0 Plant Allowance 15% - 549.4 714.8 714.8 1,068.0 Communication Allowance 5% - 137.3 238.3 238.3 356.0 Sub Total New Build (GIFA) - 3,433.5 5,718.4 5,718.4 8,544.0

Cell and Gene Therapy 500.0 500.0 500.0 500.0 Mortuary - Extensions to existing 565.0 565.0 565.0 565.0 Pathology - Refurbishment of existing 1,884.0 1,884.0 1,884.0 - Essential Laboratory - Singleton - - 367.0 367.0 367.0 Refurbishment of Cell Pathology - Withybush Hospital - - 103.0 103.0 103.0 Refurbishment of Cell Pathology - Prince Philip Hospital, Llanelli - - 77.0 77.0 77.0 Refurbishment of Cell Pathology - West Wales General Glangwili - - 306.0 306.0 306.0 Modular Mortuary Facilities - Singleton - - - 380.0 380.0 Sub Total Other Services New Build / Refubishments (GIFAs) - 2,949.0 3,802.0 4,182.0 2,298.0

Grand Total (GIFA) 5,710.0 6,382.5 9,520.4 9,900.4 10,842.0

Long Listed Options Appraisal 1. The sections below summarise the assessment of each agreed scoping option as they were assessed against the Investment Objective and CSF criteria to determine their short list suitability.

Scoping Options 2. The summary assessment of the potential Scoping options is as follows:

Figure – Summary Assessment of Scoping Options SC01 SC02 SC03 SC04

SC01 SC02 SC03 SS04 Business As Usual 'Core’ services, i.e. As SC02 plus As SC03 plus Re- Develop Regional Relocate provide ABMUHB’s Cellular Pathology ABMUHB’s PHW Essential (Cytology and Medical Laboratory Service Histopathology) & Microbiology Regional service to Morriston Diagnostic Hospital &/or (Laboratory) Develop a Potential Scoping Options Immunology temporary modular service; Co-locate Body Store solution Singleton‘s Body at Singleton Store at Morriston Hospital Hospital service (future proofed capacity) & a 500 m² ATTC, i.e. Cell and Gene Therapy indicative shell and core area Investment Objectives:

IO 1: Sustainable X    IO 2: Quality & Safety ~    IO 3: Efficiency & Productivity ~    IO 4: Effectiveness ~    IO 5: Economy ~    CSFs: CSF 1: Business Needs X    CSF 2: Strategic Fit X    CSF 3: Benefits optimisation X    CSF 4: Potential achievability     CSF 5: Supply side capacity & ~    capability CSF 6: Potential affordability ~  ~ ~ Summary: Discount Carried forward Carried forward Carried forward (retained as baseline comparator)

Key: X Not Achieved ~ Partially achieved  Fully achieved 3. The advantages and disadvantages of each of the Scoping Options are as follows: SC01 – Business As Usual Advantages: Maintains a continuum of local service delivery. Disadvantages: Maintains current unsustainable & non co-located service model. Fails to achieve most of the IOs and CSFs and delivers no benefits within the region by maintain current non co-located service models in ABMUHB & HDUHB Health Boards. Current services are unsustainable. Continuing with business as usual fails to support innovations or to modernise pathology services. Physically, most services operate with poorly configured facilities that is no longer fit for purpose. Existing equipment does not support innovative production techniques. Conclusion: This option is unsustainable and fails to address productivity, acceptability, workforce sustainability, recruitment and retention, safety, and compliance issues within Mid & South West Wales’ pathology services. Solution was discounted for further detailed analysis but was retained as a baseline comparator. SC02 – Do Minimum - 'Core’ services, i.e. Develop Regional Cellular Pathology (Cytology and Histopathology) & Regional Diagnostic (Laboratory) Immunology service; Co-locate Singleton‘s Body Store at Morriston Hospital service (future proofed capacity) & a 500 m² ATTC, i.e. Cell and Gene Therapy indicative shell and core area Advantages: Delivers all of the IOs and maximises achievement of all CSFs.by supporting regionalisation of Cellular Pathology and Diagnostic Immunology services. Disadvantages: Requires a significant capital investment. Conclusion: This solution was carried forward. SC03 – Intermediate - As SC02 plus Relocate ABMUHB’s PHW Medical Microbiology service to Morriston Hospital &/or Develop a temporary modular Body Store solution at Singleton Hospital Advantages: Delivers all the IOs and CSFs and supports modernisation of ABMUHB’s PHW Medical Microbiology by re-providing at Morriston Hospital. Disadvantages: Requires a significant capital investment. Transportation of PHW’s samples constrained by distance and inadequate existing transport arrangements, which could impede timely receipt and processing of samples required for urgent specimen investigation. Conclusion: This option was carried forward. SC04 – Do Maximum - As SC03 plus Re-provide ABMUHB’s Essential Laboratory Service Advantages: Delivers all the IOs and CSFs by maximising opportunities for delivering long-term sustainability within regional services; Supports wider modernisation/innovation within the service. Disadvantages: Requires a very significant capital investment. Conclusion: This solution was carried forward.

4. SWOT analysis conclusion (NB all new build options included a 500 m² ATTC, i.e. Cell and Gene Therapy indicative shell and core area):

Service Scope Options Outcome SC01 - Business As Usual is unsustainable and fails to address Discount (retained as productivity, acceptability, workforce sustainability, recruitment and baseline comparator) retention, safety, and compliance issues within regional pathology services. SC02 – Do Minimum - 'Core’ services, i.e. Develop Regional Cellular Carried forward. Pathology (Cytology and Histopathology) & Regional Diagnostic (Laboratory) Immunology service; Co-locate Singleton‘s Body Store at Morriston Hospital service (future proofed capacity) & a 500 m² ATTC, i.e. Cell and Gene Therapy indicative shell and core area. SC03 – Intermediate - As SC02 plus Relocate ABMUHB’s PHW Carried forward Medical Microbiology service to Morriston Hospital &/or Develop a temporary modular Body Store solution at Singleton Hospital. SC04 – Do Maximum - As SC03 plus Re-provide ABMUHB’s Essential Carried forward Laboratory Service. Service Solution Options 5. The potential Service Solution options in relation to the preferred scope were assessed as follows: Figure – Description of Potential Service Solution Options SS01 SS02

New Build/Reconfigure co-located New Build all co-located regionalised services’ regionalised services’ accommodation on one site &; accommodation on one site; Provide dedicated car parking to Provide dedicated car parking to Potential Service Solution support regionalised services support regionalised services &; Options Reconfigure and refurbish local non-regionalised services accommodation to provide fit for purpose facilities Investment Objectives: IO 1: Sustainable   IO 2: Quality & Safety   IO 3: Efficiency & Productivity   IO 4: Effectiveness   IO 5: Economy  ~ CSFs: CSF 1: Business Needs   CSF 2: Strategic Fit   CSF 3: Benefits optimisation   CSF 4: Potential achievability  ~ CSF 5: Supply side capacity &   capability CSF 6: Potential affordability  ~ Summary: Preferred Way Forward Carried forward - do more ambitious

Key: X Not Achieved ~ Partially achieved  Fully achieved 6. The advantages and disadvantages of each of the service Solution options are as follows:

SS01 New Build/Reconfigure co-located regionalised services’ accommodation on one site &; Provide dedicated car parking to support regionalised services. Advantages: Provides a co-located regional cellular and diagnostic immunology service solution. Meets WHBN & WHTM & accreditation standards. Solution supports personalised treatment opportunities, makes regional pathology services’ more attractive as an employer & supports wider funding opportunities. Solution supports economies of scale and business needs. More efficient estates solution. Disadvantages: Significant capital implications. Some ‘in scope’ services’ transport arrangements in the HDUHB area may incur additional transport costs as a result of regionalisation of those services. Planning approvals risk, subject to planning constraints. Conclusion: Solution is located at Morriston Hospital and maximises benefits from co-location of regionalised services. SS02 - New Build all co-located regionalised services’ accommodation on one site; Provide dedicated car parking to support regionalised services &; Reconfigure and refurbish local non-regionalised services accommodation to provide fit for purpose facilities Advantages: Provides a fully compliant and co-located regional service solution in a purpose built facility. Provides fully compliant local services. Disadvantages: As SS04’s disadvantages but involves very significant capital implications and extended delivery programme. Is potentially less achievable, less economical and less affordable. Conclusion: Solution proposed is potentially the most efficient estates solution.

7. SWOT analysis conclusion: Service Solution Options Outcome SS01 – New Build/Reconfigure co-located regionalised services’ Solution delivered all the accommodation on one site &; Provide dedicated car parking to support relevant IOs and CSFs and regionalised services. was identified as the preferred way forward. SS02 – New Build all co-located regionalised & Regional Medical Carried forward - do more Microbiology services’ accommodation on one site; Provide dedicated ambitious car parking to support regionalised services; plus Reconfigure and refurbish local non-regionalised services accommodation to provide fit for purpose facilities Service Delivery Options 8. Given this service is an essential NHS service the only practicable and acceptable service delivery option available is a wholly in-house NHS staffed solution, as it delivers all of the IOs and CSFs. An NHS in-house solution was carried forward as the preferred way forward.

Implementation Options 9. The potential implementation options were assessed against the Investment Objective and CSF criteria to determine their short list suitability as follows:

Figure – Description of Potential Implementation Options IMP01 IMP02

Potential Implementation Options Phased (e.g. build some Single Phase with staged elements as a shell and occupy occupancy of new build and later and phase local concurrent local refurbishments refurbishments) Investment Objectives: IO 1: Sustainable   IO 2: Quality & Safety ~  IO 3: Efficiency & Productivity X  IO 4: Effectiveness ~  IO 5: Economy ~  CSFs: CSF 1: Business Needs   CSF 2: Strategic Fit X  CSF 3: Benefits optimisation ~  CSF 4: Potential achievability X  CSF 5: Supply side capacity & capability X  CSF 6: Potential affordability X  Summary: Carried forward - do less Preferred Way Forward ambitious

Key: X Not Achieved ~ Partially achieved  Fully achieved 10. SWOT analysis conclusion:

Implementation Solution Options Outcome IMP01 (i.e. Phased (e.g. build some elements as a shell and occupy Carried forward - do less later and phase local refurbishments)), was considered less attractive ambitious. as it involved a longer and more complex delivery programming and change management process. It delays realisation of local and regional scheme benefits e.g. cash savings, economies of scale, staffing recruitment, training opportunities, etc. – these benefits will not be full realisable until the entire scheme was delivered. IMP02 (i.e. Single Phase with staged occupancy of new build and Solution delivered all the concurrent local refurbishments), was considered the most effective relevant IOs and CSFs and means of delivering regional service change for a complex and inter- was identified as the preferred related number of pathology services. It was likely to minimise risk of way forward. disruption to local and regional clinical services. It achieved realisation of local and regional scheme benefits on a timely basis, and delivered all of the IOs and CSFs.

Funding Options 11. The potential Funding options were assessed as follows:

Figure – Description of Potential Funding Options FUN01 FUN02 FUN03 Potential Funding Options Private funding Public funding Mix of Public and Private funding Investment Objectives: IO 1: Sustainable X  X IO 2: Quality & Safety n/a n/a n/a IO 3: Efficiency & Productivity n/a n/a n/a IO 4: Effectiveness n/a n/a n/a IO 5: Economy X  X CSFs: CSF 1: Business Needs X  X CSF 2: Strategic Fit X  X CSF 3: Benefits optimisation n/a n/a n/a

CSF 4: Potential achievability X  X CSF 5: Supply side capacity & n/a n/a n/a capability CSF 6: Potential affordability X  X Summary: Discount Preferred Way Discount Forward

Key: X Not Achieved ~ Partially achieved  Fully achieved 12. SWOT analysis conclusion:

Funding Solution Options Outcome FUN01 (Private funding) was impracticable and unaffordable, no Solution failed to deliver any potential sole funder(s) having been identified for this strategically of the relevant IOs and CSF important service. and was discounted. FUN02 (Public funding) This option was considered the most Solution delivered all the practicable and appropriate for this strategically important NHS relevant IOs and CSFs and service. was identified as the preferred way forward. FUN03 (Mix of Public and Private funding) It failed to deliver any of the Solution failed to deliver any relevant IOs and CSFs. of the relevant IOs and CSF and was discounted.

Framework Options Summary 13. The framework options long list options findings are summarised below as per business case guidance:

Figure - Long List Options Framework Business As Usual Do Minimum Intermediate Do Maximum Options Potential SC01 SC02 SC03 SS04 Service Scope Business As Usual 'Core’ services, i.e. As SC02 plus Relocate As SC03 plus Re- Options Develop Regional Cellular ABMUHB’s PHW Medical provide ABMUHB’s Pathology (Cytology and Microbiology service to Essential Laboratory Histopathology) & Regional Morriston Hospital &/or Service Diagnostic (Laboratory) Develop a temporary Immunology service; Co- modular Body Store locate Singleton‘s Body solution at Singleton Store at Morriston Hospital Hospital service (future proofed capacity) & a 500 m² ATTC, i.e. Cell and Gene Therapy indicative shell and core area Discount (retained as Carried Forward Carried Forward – do more Carried Forward – do baseline comparator) ambitious most ambitious Potential SS01 SS02 Service New New Build all co-located Solution Build/Reconfigure co- regionalised services’ Options located regionalised accommodation on one services’ site; Provide dedicated car accommodation on parking to support one site &; Provide regionalised services &; dedicated car parking Reconfigure and refurbish to support local non-regionalised regionalised services services accommodation to provide fit for purpose facilities Preferred Carried forward – do more ambitious Potential NHS in-house solution Service Delivery Preferred Way Forward Options Potential IMP01 IMP02 Implementation Phased (e.g. build Single Phase with staged Options some elements as a occupancy of new build shell and occupy later and concurrent local and phase local refurbishments refurbishments) Carried forward – do Preferred Way Forward less ambitious Potential FUN01 FUN02 FUN03 Funding Private funding Public funding Mix of Public and Private Options funding Discount Preferred Way Forward Discount

Summary of Short List Options Framework 14. The preferred and possible solutions identified in the table above have been carried forward into the short list for further appraisal and evaluation. All the options that were ‘discounted’ as impracticable have been excluded at this stage. Given a one-site Cellular Pathology regional solution was supported by the South West Wales Regional Pathology Re-configuration Option 1 (Business As Usual) was excluded from further detailed analysis but was retained as a baseline comparator. Based on this hi-level non-financial analysis, the recommended short list for further appraisal as per business case guidance are as follows: Figure – Short List of Options Framework Option 2 Option 3 Option 4 Option 5 Options Do Minimum Intermediate – more Intermediate – far more Do Max ambitious ambitious ambitious Potential SC02 SC03 SC03 SS04 Service 'Core’ services, i.e. As SC02 plus Relocate As SC02 plus Relocate As SC02 plus Relocate Scope Develop Regional Cellular ABMUHB’s PHW Medical ABMUHB’s PHW Medical ABMUHB’s PHW Options Pathology (Cytology and Microbiology service to Microbiology service to Medical Microbiology Histopathology) & Regional Morriston Hospital Morriston Hospital & service to Morriston Diagnostic (Laboratory) Develop a temporary Hospital & Develop a Immunology service; Co- modular Body Store temporary modular locate Singleton‘s Body solution at Singleton Body Store solution at Store at Morriston Hospital Hospital Singleton Hospital plus service (future proofed Re-provide ABMUHB’s capacity) & a 500 m² Essential Laboratory ATTC, i.e. Cell and Gene Service Therapy indicative shell and core area Carried Forward Carried Forward – do more Carried Forward – do more Carried Forward – do ambitious ambitious most ambitious Potential SS01 SS02 SS02 SS02 Service New Build/Reconfigure co- New Build all co-located New Build all co-located New Build all co- Solution located regionalised regionalised services’ regionalised services’ located regionalised Options services’ accommodation accom. on one site; accom. on one site; services’ accom. on on one site &; Provide Provide dedicated car Provide dedicated car one site; Provide dedicated car parking to parking to support parking to support dedicated car parking support regionalised regionalised services; regionalised services; to support regionalised services plus Reconfigure and plus Reconfigure and services; plus refurbish local non- refurbish local non- Reconfigure and regionalised services regionalised services refurbish local non- accommodation to accommodation to regionalised services provide fit for purpose provide fit for purpose accommodation to facilities facilities provide fit for purpose facilities Preferred Way Forward Carried forward - do more Carried forward - do more Carried forward - do ambitious ambitious more ambitious Potential NHS in-house solution Service Preferred Way Forward Delivery Options Potential IMP02 IMP01 IMP02 IMP02 Implementati Single Phase with staged Phased (e.g. build some Single Phase with Single Phase with staged on Options occupancy of new build elements as a shell and staged occupancy of occupancy of new build and concurrent local occupy later and phase new build and and concurrent local refurbishments local refurbishments) concurrent local refurbishments refurbishments Preferred Way Forward Carried forward - do less Preferred Way Forward Preferred Way Forward ambitious Potential FUN02 Funding Public funding Options Preferred Way Forward

1. Under the proposed arrangement all Histology and non-Gynae cytology samples taken anywhere within ABMUHB will be transported to the central Morriston site for dissection, processing and reporting. Singleton will follow the NeathPortTalbot and PoW Hospital’s model of having sample reception areas staffed by Laboratory Medicine.

2. An MDT presence shall continue across all ABMUHB sites with specialist Histopathologist input sustained through the use of digital microscopy cameras and improved access to videoconference facilities (including poly com videoconferencing) for all pathologists. The frozen section service for PoW Hospital shall be sustained and the Singleton Hospital’s frozen section service (average 4 per year) will be provided from Morriston Hospital. Surgeons will communicate with the Consultant pathologist and if required Theatre staff will then arrange for the transport of samples by a Welsh Ambulance Services NHS Trust (WAST) ‘blue light service’ to Morriston Hospital. These specimens will be reported within 60 minutes of receipt at the Pathology reception in Singleton.

3. All samples Cervical Screening will be transported to the Morriston site for data entry and will then be transported to Magden Park for processing and screening. Positive smears will be returned to Morriston Hospital for consultant pathologist opinion.

4. The existing Mortuary pre-term and intra-partum storage and viewing facilities will be re- located in Singleton Hospital. All other body storage and viewing will in Morriston. This will require a new transport agreement. The new facility at Morriston will accommodate re-located body-store facilities from Singleton Hospital with medium-term future proofing for bariatric patients. Co- location with existing body stores at Morriston Hospital will support more efficient use of scare pathology staff resources.

5. The development of future transport requirements and standards will be managed by a Transport Sub-Group with representation from key stakeholders and Transport providors. Discussions with transport providors are already underway to develop an acceptable and efficient transport model to support transport requirements of the new service going forward.

6. The new transport model will be linked to the evolving LIMs2 National Programme which will replace the current LIMs1. It is anticipated the new model will support tracking and monitoring of individual samples supporting improved governance and reduction of risk.

Date Key Milestone At the Combined Pathology Group Meeting (precursor to the National Pathology Network), it was confirmed, following CEO approval, that the provision of the Cellular Pathology Service in South West Wales had been formally transferred to the ARCH project.

Further dialogue on the provision of the Service in South East Wales was to take May place, with initial discussions taking place between the Chair of the SWCPP and Directors of Planning (SE), which would be extended to discussions with clinical representatives at a later date.

The Combined Pathology Group members agreed with this approach, and that the SWCPP for the West was formally closed.

Chief Executives approved the recommendations for Cellular Pathology to be 27th focused in two centres in South Wales. ABUHB and HDUHB would form one

February centre and work to implement this was being undertaken as part of the ARCH Project.

The Combined Pathology group were given the following options to progress the 2018 SWCPP:

• Continuing with the status quo for Cellular Pathology services • Continuing with the original plan to finalise the Business Case and submit it to CEOs • Progress with the proposal on a regional basis, which was probably the best chance of making any progress for the service 18th February Members agreed to the approach that the South West Wales service would be developed within the ARCH project as part of the regional footprint for ABMUHB and HDUHB, which was supported by their Directors of Planning; The South East Wales service would be developed by the SWCPP Board members who represented ABUHB, CTUHB and CVUHB engaging with the respective Directors of Planning. The opportunity for establishing a single-managed service for Cellular Pathology (supported by DCP) would be explored further.

Proposal from the chair to the SWCPP group to not submit the business case to CEOs for approval as it would just add costs into the system without maximising the opportunities to integrate with other laboratory services, embrace digitisation and truly modernise.

23rd The chair suggested that the following recommendations be made to CEOs that the January option appraisal undertaken, recommending 2 sites for South Wales - one in

2017 Swansea, one in Cardiff, should now be progressed by the 2 regional planning teams – to develop cellular pathology as part of the broader laboratory redesign, enabling ARCH to progress its plans and SE Wales to look at the evolving integrated diagnostic agenda including genomic requirements.

The SWCPP agreed the recommendations.

09th Draft OBC completed and discussed at SWCPP meeting. January

Update to the Combined Pathology Group reported that work to develop the Business Justification Case (BJC) was continuing.

The group were advised that a high level assessment had been made of the impact of Digital Cellular Pathology on the SWCPP, and that the implications of this would September need to be discussed further.

Paper assessing the impact of the National Digital Cellular Pathology Programme on the SWCPP submitted for discussion and action.

January Work commences on Financial Option Appraisal of the OBC for SWCPP.

November Non-financial aspect of the OBC for SWCPP completed.

June CVUHB submission of high level costs for the preferred service model options,

to progress the OBC.

January ABMUHB submission of high level costs for the preferred service model options, to progress the OBC. 2016

Request sent to ABMUHB and CVUHB to provide high level costs for preferred December options in support of the production of an OBC.

Further Non-Financial Appraisals & Financial Appraisal:

A 2nd workshop, led by NHSWHC, undertook further non-financial appraisal with a large stakeholder group. The financial and non-financial option appraisal at this stage was informed by the SWP and others who are developing South Wales, All Wales and pathology business cases. This stage determined the weighted and unweighted outcomes, & identified a short list of options to be financially November appraised.

Post workshop, information from attendees’ scoring sheets was used to further analyse the options’ various scenario rankings to date. This stage confirmed that the top two ranked options were the Two site (ABMUHB/Swansea University) . Detailed sensitivity analyses 2015 & Two site (CVUHB/Cardiff University) solutions was undertaken and this stage of analyses confirmed these rankings as the preferred option.

The next stage involved financial analyses, which considered each short listed locations option's estimated capital costs, revenue costs and capital charges. Although this stage concluded that from a financial perspective, the option of a Single site was the lowest cost option, a cost per weighted benefit score from the non-financial option appraisal applied to the estimated revenue costs of each option concluded that the Two site option was the preferred option, from both a financial (cost per weighted benefit score) and non-financial option appraisal perspective.

Further Non-Financial Appraisals:

A workshop led by AWPC evaluated how well (or not) each short listed option delivered against each of the agreed benefits criteria. This stage ranked the One single site (expected to be located either in either the Cardiff or Swansea area) option 1st, and the Two sites (expected to be located in both the Cardiff and Swansea area) option 2nd out of 5 potential options.

These outcomes were tested further through a range of sensitivity analyses, designed to assess how sensitive the outcome was to January changes in some of the input criteria and data. This stage ranked the One single cell path site (expected to be located either in either the

2015 Cardiff or Swansea area) option 1st, the sites (expected to be located in both the Cardiff and Swansea area) 2nd, and the Do Nothing/Do Minimum option 5th out of 5 potential options.

Next, the Directors of Planning from each of health board/trust and reps from Cardiff and Swansea Universities identified available space to accommodate both the one site and two site options, i.e. a One single site (expected to be located either in either the Cardiff or Swansea area) & Two sites (expected to be located in both the Cardiff and Swansea area solution - each with various locations therein. Non-Financial Appraisals:

The All Wales Cellular Pathology (AWCP) Project Group identified a long list of 14 options from previous options identified by both the South East Wales Collaborative and the South West Wales Collaborative.

A detailed non-financial appraisal by a multidisciplinary group of stakeholders reduced the long list to a short list of 5 options, which July to were then ranked in order of preference. This stage ranked the October development of a South Wales Cellular 2014 Two duplicate sites Pathology solution option 1st out of 5 potential options.

The short listed options were ‘refreshed’ to exclude the outsourcing solution. Using the same benefits criteria and weighting as previously this stage determined ranked the Do Minimum (i.e. a single managed service across Wales) 1st & a Two site option 2nd out of 5 potential options.

Strategic Outline Case (SOC)

Strategic Outline Case (SOC)

Development of a Mid and South West Wales

Regional Centre of Excellence Cellular Pathology

Laboratory, Regional Diagnostic Immunology Laboratory Facility and Regional Medical

Microbiology facility at Morriston Hospital, Swansea

v. Final Document control sheet Client Hywel Dda University Health Board (HDUHB), Abertawe Bro Morgannwg University Health Board (ABMUHB) and Public Health Wales NHS Trust (PHW) Document Title Development of a Mid and South West Wales Regional Centre of Excellence Cellular Pathology Laboratory, Regional Diagnostic Immunology Laboratory Facility and Regional Medical Microbiology facility at Morriston Hospital, Swansea Version Final (4) Status Final Reference Author Heather Edwards, ABMUHB Date 14th March 2019 Further copies email: [email protected] quoting reference and author from

Contact details

Main point of Telephone Email address Postal address contact number Heather Edwards 01792 286119 [email protected]

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Strategic Outline Case (SOC)

Contents Executive Summary ...... v 1 Purpose ...... 1 1.1 Introduction ...... 1 1.2 Structure and Content of this Document ...... 1

2 Strategic Case Part A: The Strategic Context ...... 2 2.1 Introduction ...... 2 2.2 Background ...... 2 2.3 Organisational Overview ...... 9 2.4 Regional Geography and Catchment Population ...... 9 2.5 Stakeholder Engagement ...... 9 2.6 Regional Population ...... 10 2.7 Health Status ...... 10 2.8 Health Board Boundary Changes ...... 11 2.9 Benchmarking ...... 11 2.10 Business Strategies ...... 11 2.11 Accreditation Requirements ...... 13

3 Strategic Case Part B: The Case for Change ...... 15 3.1 Investment Objectives ...... 15 3.2 Existing Arrangements ...... 16 3.3 Estates Profile ...... 18 3.4 Current Workforce ...... 18 3.5 Pathology Activity ...... 19 3.6 Business Needs ...... 21 3.7 Potential Scope ...... 23 3.8 Main Outcomes and Benefits ...... 24 3.9 Main Risks ...... 24 3.10 Constraints ...... 25 3.11 Dependencies ...... 26

4 The Economic Case...... 27 4.1 Introduction ...... 27 4.2 Critical Success Factors ...... 27 4.3 Methodology ...... 27 4.4 Benefit Measurement ...... 28 4.5 Framework Options Summary ...... 28 4.6 Summary of Shortlisted Options Framework Findings ...... 29 4.7 Transport Arrangements ...... 31

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Strategic Outline Case (SOC)

4.8 Information Management & Telecoms (IM&T) Arrangements ...... 31

5 The Commercial Case ...... 32 5.1 Introduction ...... 32 5.2 Required Services ...... 32 5.3 Potential for Risk Transfer and Management ...... 32 5.4 Personnel Implications (Including TUPE) ...... 32 5.5 Indicative Timescales ...... 32 5.6 FRS5 – Accountancy Treatment ...... 33

6 Funding and Affordability ...... 34 6.1 Introduction ...... 34 6.2 Capital ...... 34 6.3 Revenue ...... 35 6.4 Income and Expenditure Analysis ...... 35

7 The Management Case ...... 36 7.1 Introduction ...... 36 7.2 Project Management Arrangements ...... 36 7.3 Project Roles and Responsibilities ...... 37 7.4 Use of Special Advisors ...... 37 7.5 Workforce Planning & Operational Arrangements ...... 37 7.6 Health Impact Assessment (HIA) ...... 37 7.7 Equality Impact Assessment (EIA) ...... 37 7.8 Building Research Establishment Environmental Assessment Method (BREEAM) 37 7.9 Achieving Excellence Design Evaluation Toolkit (AEDET) ...... 37 7.10 Arrangements for Benefits Realisation ...... 38 7.11 Arrangements for Risk Management ...... 38 7.12 Post Evaluation Arrangements ...... 38 7.13 NHS Wales Gateway Review (Stage 0 – Business Justification) ...... 38 7.14 Contingency Plans ...... 38

Figures Figure – Service Scope ...... viii Figure – Short List of Options ...... viii Figure – Capital Requirements (£000 incl non-recoverable VAT) ...... x Figure – Revenue Impact £000’s ...... x Figure – Project Structure ...... xi Figure – Key indicative milestones ...... xi Figure 1 – Population Base (as at March 2019) ...... 10 Figure 2 – Morbidity ...... 10

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Strategic Outline Case (SOC)

Figure 3 – Investment Objectives ...... 15 Figure 4 – Location of Current Pathology Services within HDUHB ...... 17 Figure 5 – Location of Current Pathology Services within ABMUHB...... 17 Figure 6 – Cellular Pathology/Histopathology/Diagnostic Immunology/ Medical Microbiology Workforce Profile (2018) ...... 18 Figure 7 – HDUHB: Histology Activity (2010 to 2018) ...... 19 Figure 8 – ABMUHB: Histology Activity (2010 to 2018) ...... 19 Figure 9 – HDUHB & ABMUHB: Non-Gynae Cytology Activity (2015/16 to 2017/18)...... 20 Figure 10 – PHW Activity by Health Board (2015/16 to 2017/18)...... 20 Figure 11 – Main Risks and Mitigations ...... 24 Figure 12 – Critical Success Factors (CSFs) ...... 27 Figure 13 - Long List Options ...... 28 Figure 14 – Service Scope ...... 29 Figure 15 – Short List of Options ...... 30 Figure 16 – Key indicative milestones ...... 32 Figure 17 – Capital Requirements (£000 incl non-recoverable VAT) ...... 34 Figure 18 – Revenue cost impact of the Shortlisted Options (£000’s) ...... 35 Figure 19 – Reporting Structure ...... 36 Figure 20 – Special Advisors ...... 37

Appendices

Appendix A – HIA ...... 39 Appendix B – EIA ...... 40 Appendix C – Post Evaluation Arrangements ...... 41 Appendix D – Gateway Review - (RPA1) ...... 42 Appendix E – Option & Risk Appraisal Group Membership ...... 43 Appendix F – Investment Objectives and Benefits ...... 44 Appendix G – Terms of Reference ...... 45 Appendix H – Benefits Realisation Register ...... 46 Appendix I – Benefits Realisation Plan ...... 47 Appendix J – Management Control Plan ...... 48 Appendix K – Risk Register ...... 49 Appendix L – AWCP Group’s non-financial and financial appraisals ...... 50 Appendix M – SoA ...... 51 Appendix N – Framework Options Apppraisal ...... 52 Appendix O – Transport Arrangements ...... 53 Appendix P – Summary of South Wales Cellular Pathology Project’s (SWCPP’s) Key Milestones 54 Abbreviations ...... 55 Glossary ...... 56

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Executive Summary

Introduction

1. This Strategic Outline Business Case (SOC) was prepared through a process of engagement with key stakeholders. Principally, it seeks support from Welsh Government in the form of investment in Mid and South West Wales’ Pathology services in the range of £50.954 - £93.577m (including non- recoverable VAT) to support the development of a Mid and South West Wales Regional Centre of Excellence Cellular Pathology Laboratory, Regional Diagnostic Immunology Laboratory and Regional Medical Microbiology facility at Morriston Hospital, Swansea.

2. We envision a Mid and South West Wales’ Pathology services Regional Centre of Excellence supporting the following:

 Wales being at the forefront of digital pathology – delivering fully digitised pathology across Wales which allow us to assess images from a range of disease areas and work with partners to develop and validate emerging Artificial Intelligence (AI) tools; Promoting opportunities for AI/Machine Learning (ML) to improve microscopic assessment of diseases.

 Using advanced techniques and combining different modalities to give more accurate diagnostic information & to provide more timely and improved diagnostic pathways for patients; Improving quality and reducing screening times in, e.g. Cervical screening; Building on partnerships with Universities and industry.

 Supporting Genomics and Genetics to enhance diagnosis and treatment; ‘Tailoring’ therapies to individual patients; Promoting gene and cell therapy research and development.

 Improving standardisation, service delivery, patient safety and communications, including patients’ access to information.

 Developing new technologies that allow to embrace research opportunities and innovations, and allow the NHS to a deliver better service in a faster and more efficient way.

Background 3. The main challenges facing NHS Wales’ Pathology services are:

 Workforce and sustainability pressures - recognising that a significant number of current vacancies, an ageing workforce, and loss of staff due to retirement creates pressures for the service we must ensure, that the service has ‘the right staff with the right skills’;  Quality and safety issues (including estate and facility constraints;  Technological innovations (including automation, digital technology and innovative technologies/equipment) - this is a significant driver for change and is the catalyst for policy and strategy responses;  Major growth in demand, both demographically (aging population with more complex investigations; antibiotic resistance and control of infection issues) and in cancer services e.g. Single Cancer Pathway, and;  Changing models of care – moving from traditional models of care towards personalised treatment.

4. Pathology services must address these challenges by providing a sustainable workforce, safer and higher quality services whilst improving outcomes but these will not be achieved simply by investing in new local facilities; we need to co-locate within the region and adopt new and more acceptable delivery models that can improve service resilience and business continuity , demonstrate quality

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Strategic Outline Case (SOC)

through independent accreditation assessments, reduce potential error-rates, better support diagnosis, be more acceptable and accessible to users, and reduce risk.

5. Furthermore, new service models must be future-proofed, and flexible enough, to respond to changing demand, new technologies and innovations, and complement the UK’s playing a lead role in developing a network of emerging Advanced Therapy Treatment Centres (ATTCs) - the promotion of gene and cell therapy’s Advanced Therapy Medicinal Products (ATMPs) research and development. ATMP’s having the potential to benefit patients with challenging conditions that cannot be cured with current treatments by promoting access to breakthrough medicines.1 6. This investment aligns with the recently approved Swansea Bay City Region’s ‘Internet Coast’ £1.3bn City Deal for South West Wales, which supports public and private investment in Carmarthenshire, Neath Port Talbot, Pembrokeshire and by developing sustainable and energy efficient laboratory facilities, by promoting regional state-of-the-art digital innovations and, by delivering a sustainable and resilient workforce with the required scientific and technological skills necessary for modern health services. 7. This investment supports Informed Health and Care – A Digital and Social Care Strategy for Wales (WGov 2015)2 by improving Pathology in Wales’ clinicians’ access to information and by supporting opportunities for delivering care with new digital technologies in support of prudent and value based healthcare. Overall, benefits to the service could include improvements in standardisation, service delivery, patient safety and communications, including patients’ access to information, as well as reduced potential error rates, lower costs, and better and more efficient use of data.

The Strategic Case

A. Strategic Context

8. The key national and regional strategic drivers for this investment are summarised as follows:

 Review of NHS Pathology services in England (DoH, 2006)  Report of the Second Phase of the Review of NHS Pathology Services in England (DoH, 2008)  The Future Delivery of Pathology Services in Wales (WG, 2008)  The National Pathology Framework (NPF) for Wales (NHW Wales, 2008)  Review of the Histopathology Services in NHS Wales (2010)  Digital First: Clinical Transformation through Pathology Innovation (National Pathology Programme, NHS England, February 2014)

 Prudent Healthcare – Securing Health and Well-Being for Future Generations (Wales) Act 2015  The Carter Review - Review of Operational Productivity and Performance in English NHS Acute Hospitals: Unwarranted Variation (UK Government, 2016)

 Pathology Statement of Intent (Draft: 19th April 2018 – endorsed by All Wales Chief Executives, following endorsement by the Pathology Service, and currently is with Welsh Government awaiting publication)

9. This investment supports partners organisation clinical strategies: HDUHB’s A Healthier Mid and West Wales: Our Future Generations Living Well strategy; ABMUHB’s Clinical Services Plan (2019 –

1 Innovate UK Competition: Establishing UK Treatment Centres for Advanced Therapies - 01 Nov 2017 2 Pathology Statement of Intent (Draft: 19th April 2018)

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Strategic Outline Case (SOC)

2024), and; and Public Health Wales’ Long Term Strategy: Working to Achieve a Healthier Future for Wales (2018 – 2030)

10. This investment supports HDUHB’s, ABMUHB’s and Public Health Wales’3 long term Service Strategies (please refer to Section 3) support these strategic drivers and we are working with the A Regional Collaboration for Health (ARCH) programme to develop a sustainable regional strategy for pathology services in Mid and South West Wales. It is consistent with the recommendations from the All Wales Pathology Collaborative Project and the Pathology Statement of Intent (Draft: 19th April 2018), which addresses the challenges facing Pathology services and identifies strategic approaches to facilitate the development of high quality, effective and resilient pathology services for NHS Wales consistent, with Welsh Government ambitions outlined in Taking Wales Forward: Healthy and Active, the key recommendations of The Parliamentary review of Health and Social Care in Wales, and ‘A Healthier Wales’ strategy released by WGov in 2018 in response to the Parliamentary Review. This SOC will be shared with the Pathology Network to ensure full alignment with the national approach.

B. The Case for Change 11. Pathology services within Mid and South West Wales must provide the right level of services in the right place, be sustainable, resilient and improve quality and safety. Future Vision 12. Depending on the scale of the investment, in the short term, this investment aims to improve recruitment and retention within the Mid and South West Wales Cellular Pathology and wider Pathology service, improve quality and safety, foster training opportunities therein, and supports modernisation of the workforce and service innovations. In the longer term, this investment supports more sustainable Pathology services in the region, supports technological innovations, promotes benefits in terms of improved specialist healthcare services, facilitates access to modern techniques and innovations, and enhances the patient experience and improve quality outcomes. Overall, this investment delivers urgent improvements in quality, safety and sustainability within Mid and South West Wales’ pathology services. 13. The ‘status quo’ cannot be maintained and this document proposes investment to support development of regional pathology services where they promote tangible regional benefits, support delivery of more sustainable regional services and satisfy international, national, regional and local strategic direction.

The Economic Case

Investment Objectives and Benefits 14. The main benefits to staff, patients and visitors are classified in terms of cash releasing benefits (CRBs), non-cash releasing benefits (NCRBs), quantifiable benefits (QBs), and non-quantifiable benefits (Non QBs) are outlined in Appendix F – Investment Objectives and Benefits. Service Scope 15. The South West Wales Regional Pathology Re-configuration Project Board agreed the following range of service scope options:

3 Public Health Wales Long term strategy 2018-2030. http://www.wales.nhs.uk/sitesplus/documents/888/Long%20Term%20Strategy_English_single%20pages%20%28pri nt%20version%20191118%29.pdf

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Strategic Outline Case (SOC)

Figure – Service Scope . Functional Content by Health Board Option 2 Option 3 Option 4 Option 5 Do PREFERRED Intermediate Do Max Minimum WAY – far more ambitious FORWARD ambitious Intermediate – more ambitious HDUHB/ABMUHB Develop Regional Cellular     Pathology (Cytology and Histopathology) HDUHB/ABMUHB Regional Diagnostic     (Laboratory) Immunology service; ABMUHB Co-locate Singleton‘s     Body Store at Morriston Hospital service (future proofed capacity) A 500 m² ATTC, i.e. Cell     and Gene Therapy indicative shell and core area ALL Provide dedicated car     parking to support regionalised services (300 spaces) PHW Relocate ABMUHB’s PHW    Medical Microbiology service to Morriston Hospital HDUHB Reconfigure and refurbish    local non-regionalised Blood Sciences services' accommodation to provide fit for purpose facilities - Refurbishment of Cell Pathology - Withybush Hospital, Prince Philip Hospital, Llanelli & West Wales General Glangwili (approx. 486 m2) ABMUHB Develop a temporary   modular Body Store solution at Singleton Hospital ABMUHB Re-provide ABMUHB’s  Essential Laboratory Service The Shortlist 17. The Project Board recommends the following shortlisted options for more detailed evaluation at the OBC stage:

Figure – Short List of Options Option 2 – Do Minimum Service Scope SC02 - 'Core’ services, i.e. Develop Regional Cellular Pathology (Cytology and Histopathology) & Regional Diagnostic (Laboratory) Immunology service; Co-locate Singleton‘s Body Store at Morriston Hospital service (future proofed capacity) & a 500 m² ATTC, i.e. Cell and Gene Therapy indicative shell and core area Service Solution SS01 – New Build/Reconfigure co-located regionalised services’ accommodation on one site &; Provide dedicated car parking to support regionalised services

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Service Delivery DEL1 - NHS in-house solution Implementation IMP02 - Single Phase with staged occupancy of new build and concurrent local refurbishments Funding FUN02 - Public funding Option 3 – Intermediate 1 Service Scope SC03 - 'Core’ plus Relocate ABMUHB’s PHW Medical Microbiology service to Morriston Hospital Service Solution SS02 – New Build all co-located regionalised services’ accommodation on one site; Provide dedicated car parking to support regionalised services; plus Reconfigure and refurbish local non-regionalised services accommodation to provide fit for purpose facilities Service Delivery DEL1 - NHS in-house solution Implementation IMP01 - Phased (e.g. build some elements as a shell and occupy later and phase local refurbishments) Funding FUN02 - Public funding Option 4 – Intermediate 2 Service Scope SC03 - 'Core’ plus Relocate ABMUHB’s PHW Medical Microbiology service to Morriston Hospital & Develop a temporary modular Body Store solution at Singleton Hospital Service Solution SS02 – New Build all co-located regionalised services’ accommodation on one site; Provide dedicated car parking to support regionalised services; plus Reconfigure and refurbish local non-regionalised services accommodation to provide fit for purpose facilities Service Delivery DEL1 - NHS in-house solution Implementation IMP02 - Single Phase with staged occupancy of new build and concurrent local refurbishments Funding FUN02 - Public funding Option 5 – Do Maximum Service Scope SC04 - 'Core’ plus Relocate ABMUHB’s PHW Medical Microbiology service to Morriston Hospital & Develop a temporary modular Body Store solution at Singleton Hospital & Re-provide ABMUHB’s Essential Laboratory Service Service Solution SS02 – New Build all co-located regionalised services’ accommodation on one site; Provide dedicated car parking to support regionalised services; plus Reconfigure and refurbish local non-regionalised services accommodation to provide fit for purpose facilities Service Delivery DEL1 - NHS in-house solution Implementation IMP02 - Single Phase with staged occupancy of new build and concurrent local refurbishments Funding FUN02 - Public funding 18. The preferred way forward is Option 3 – Intermediate 1 (Develop Regional Cellular Pathology (Cytology and Histopathology) & Regional Diagnostic (Laboratory) Immunology service; Co-locate Singleton‘s Body Store at Morriston Hospital service (future proofed capacity), a 500 m² ATTC, i.e. Cell and Gene Therapy indicative shell and core area, & relocate ABMUHB’s PHW Medical Microbiology service to Morriston Hospital to new build/reconfigured and co-located regionalised services’ accommodation, supported by dedicated car parking.

The Commercial Case Procurement Strategy 19. It is anticipated this scheme’s procurement strategy will follow the Designed for Life – Building for Wales3 procurement route and be publicly funded.

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The Financial Case 20. The indicative financial implications of the proposed investment for each shortlisted option are as follows: Figure – Capital Requirements (£000 incl non-recoverable VAT) Option 2 Option 3 Option 4 Option 5 Do Minimum Intermediate – Intermediate – Do Max ambitious more ambitious far more ambitious Departmental Costs 17,249 25,729 27,121 31,168 On Costs 13,041 20,332 20,475 25,499 Provisional location -908 -1,382 -1,427 -1,700 adjustment Works Costs Total 29,382 44,679 46,169 54,967 Fees 4,701 7,149 7,387 8,795 Non Works Costs 1,741 2,694 2,641 2,745 Equipment Costs 3,611 5,059 5,231 5,718 Planning Contingency 3,943 5,958 6,142 7,222 VAT (adjusted for 7,576 11,678 12,036 14,130 reclaim) Base Project Cost 50,954 77,217 79,606 93,577 Based on BCIS PUBSEC Firm Price Index 248 reporting level Overall Affordability and Balance Sheet Treatment 21. The additional revenue impact on each of the shortlisted options are as follows: Figure – Revenue Impact £000’s Costs Option 2 Option 3 Option 4 Option 5 Do Minimum Intermediate – Intermediate – far Do Max ambitious more ambitious more ambitious Service Pay 0 0 0 0 Service Non-Pay 0 0 0 0 Support Services 197 236 263 503 Total 197 236 263 503 22. The revenue cost impact of the short-listed option includes the estimated costs of running a modern facility built to conform with the latest building and engineering standards. There will be other costs that will need to be reviewed during the OBC stage, including travel and IT support. There are two areas of cost additionality that have not been included in this case, as both exist whether the service moves to a new facility or remains in-situ; current staffing pressures due to increasing demand and the need for Hywel Dda to manage the workload of their Consultant staff using the Royal College points based system.

23. A full assessment of capital and revenue affordability will be made at OBC stage.

The Management Case

Project Management Arrangements 24. The project management arrangements are shown below:

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Strategic Outline Case (SOC)

Figure – Project Structure

Indicative Project Milestones

25. The indicative milestones are set out below: Figure – Key indicative milestones

Activity Due Date HDUHB & ABMUHB Executive Teams endorse ‘Discussion’ SOC November/December 2018 HDUHB Executive Team approves SOC February 2019 ABMUHB’s Investments and Benefits Group (IBG) endorses SOC 12th March 2019 ABMUHB Executive Team approves SOC 13th March 2019 ABMUHB Board approves SOC 28th March 2019 Submit SOC to Welsh Government for endorsement April 2019 Welsh Government endorse SOC May 2019 Appoint Supply Chain Partner, Health Board Cost Advisor & July 2019 Health Board Project Manager from Designed for Life Regional Framework ABMUHB’s IBG and HDUHB & ABMUHB Executive Teams June 2020 approve OBC Submit OBC to Welsh Government for approval June 2020 Welsh Government approval of OBC September 2020 ABMUHB’s IBG and HDUHB & ABMUHB Executive Teams October 2021 approve FBC Submit FBC to Welsh Government for approval October 2021 Welsh Government approval of FBC January 2022 Mobilise and commence new build/extension main works February 2022 New build completed (subject to contractor’s programme) January 2024 New build commissioning (subject to accreditation arrangements February 2024 & technical commissioning) New build operational March 2024

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Strategic Outline Case (SOC)

Activity Due Date Commence refurbishment April 2024 Refurbishment completed (subject to contractor’s programme) October 2024 Refurbishment commissioning (subject to accreditation November 2024 arrangements & technical commissioning) Refurbishment operational December 2024 Technical PPE (approx. 3 months post new build handover) March 2025 Recommendation 26. This SOC presents a compelling case for change and supports the development of a regional Mid and South West Wales Regional Centre of Excellence Cellular Pathology Laboratory, Regional Diagnostic Immunology Laboratory and Regional Medical Microbiology facility at Morriston Hospital, Swansea.

27. We recommend on this basis that Welsh Government endorse this SOC and that this project progress to Outline Business Case (OBC) stage.

Signed & dated:

Mrs Tracey Myhill, Mr Steve Moore Dr Tracey Cooper Chief Executive Chief Executive Chief Executive Senior Responsible Senior Responsible Owner Senior Responsible Owner Owner Hywel Dda University Health Public Health Wales Abertawe Bro Board Morgannwg University Health Board

……………………………… ……………………………… ………………………………

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1 Purpose

1.1 Introduction 1.1.1 This document outlines the strategic direction supporting investment in Mid and South West Wales Regional Centre of Excellence Cellular Pathology Laboratory, Regional Diagnostic Immunology Laboratory and Regional Medical Microbiology facility at Morriston Hospital, Swansea. 1.2 Structure and Content of this Document 1.2.1 The SOC is in two volumes:  Volume 1 – The SOC comprises the following components:  The Strategic Case section.

 The Economic Case section.

 The Commercial Case section.

 The Funding and Affordability Case section.

 The Management Case section.

 Volume 2 - SOC Appendices 1.2.2 This document has been prepared using 5-case Model guidance:

 HM Treasury - The Green Book: Central Government Guidance on Appraisal and Evaluation (2018).  Welsh Government – WHC 2018 043 NHS Wales Infrastructure Investment Guidance (2018).

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Strategic Outline Case (SOC)

2 Strategic Case Part A: The Strategic Context 2.1 Introduction 2.1.1 This Strategic Outline Business Case (SOC) was prepared through a process of engagement with key stakeholders. Principally, it seeks support from Welsh Government in the form of investment in Mid and South West Wales’ Pathology services in the range of £50.954 - £93.577m (including non-recoverable VAT) to support the development of a Mid and South West Wales Regional Centre of Excellence Cellular Pathology Laboratory, Regional Diagnostic Immunology Laboratory and Regional Medical Microbiology facility at Morriston Hospital, Swansea. 2.2 Background 2.2.1 Pathology is the study of disease. It bridges science and medicine and underpins every aspect of patient care, from diagnostic testing and treatment advice to the use of cutting-edge technologies and the prevention of disease.4 Pathologists work with other doctors, healthcare scientists, nurses and healthcare professionals in hospitals and GPs' surgeries to diagnose, treat and prevent illness5. 2.2.2 Pathology services are integral to health care provision. Access to effective and efficient pathology services is essential to the delivery of a significant proportion of national priorities and targets for the NHS. Pathology is involved in 70% of all diagnosis made in the NHS6. Pathology also play a significant role in screening and monitoring and in relation to chronic conditions, and underpins all clinical services. Over 95% of clinical pathways rely on patients having access to efficient, timely and cost-effective pathology services7. 2.2.3 There are 19 specialties within Pathology of these the four main specialties are Blood Sciences (this includes Haematology & Chemical Pathology services and is also called Laboratory Medicine, Blood Transfusion, Cellular Pathology (the study of disease in human tissue) and Medical Microbiology (the study of infection). 2.2.4 Pathology is a key component in the delivery of prudent health services to the population of Wales and is a key enabler to Welsh Government health delivery plans including cancer and stroke. 2.2.5 Current Pathology services are under increasing pressure with changing clinical models shifting the balance of care, which has resulted in a major growth in demand as a result of more effective clinical pathways; increasing numbers of older people; increasing cancer incidence, and; improved technology, new techniques and workforce pressures. 2.2.6 Pathology is a key enabler within healthcare in NHS Wales and undertakes around 50 million tests per annum. Analysis of the costing information available highlights we currently spend in excess of £117.6 million8 per year (2015/16) on Pathology services in Wales, representing 1.9% of the total budget for health (£6.1bn 2015/16). 2.2.7 Diagnostic Immunology services are under pressure to deliver evidence based services which support effective treatment and deliver better results and improved outcomes patients following Prudent Healthcare principles; to meet the All Wales Immunology Specification and ensure the highest quality of evidence based care, to provide sustainable Diagnostic Immunology services, and; to improve accessibility for patients.9

4 The Future Delivery of Pathology Services in Wales 2017 onwards: Proposals for Change v0.7 Draft 060917 5 Royal College of Pathologists, www.rcpath.org (2017) 6 Report of the Second Phase of the Review of NHS Pathology Services in England, Lord Carter of Coles (2008) 7 Service Improvement in Blood Sciences, NHS Improvement - Diagnostics (Jan 2013) 8 Pathology Costs NHS Wales 2015/16, NHS Wales Health Boards (R.Tovey) May 2017 9 Recommendations Paper to develop services throughout Wales which meet the All Wales Immunology Service Specification (NHS Wales Health Collaborative) May 2012 (v0.1)

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Strategic Outline Case (SOC)

2.2.8 Cellular Pathology, Molecular Pathology and Diagnostic Immunology services are vital for patients. Almost all cancer patients, plus many patients with non-malignant diseases, require a histological or cytological test for initial diagnosis. Increasing stratified treatment options and prolonged survival with disease, including cancer relapses, are creating new requirements for further cellular pathology input. There is a rapidly escalating need for innovative testing to assess prognosis and to support stratified medicine approaches.10 These services are explained in more detail as follows: Cellular Pathology Services 2.2.9 Cellular Pathology services provide essential diagnostic information to enable the care of patients in and out of hospital. Histopathology services play a crucial role in the diagnosis, prognosis and management of both benign and malignant diseases, and make a major contribution to treatment selection and monitoring. Implementation of the Single Cancer Pathway will place further demands on this service with a requirement for faster turnaround times and more specialist testing and reporting. Pathology research generally is critical for many diseases, especially cancer – almost every cancer patient requires a histological or cytological test from pathology for initial diagnosis. Furthermore, personalised medicine and the rapidly increasing need for innovative testing to assess prognosis and to support stratified medicine approaches will also impact on this service. Laboratory Medicine/Blood Sciences & Laboratory/Diagnostic Immunology 2.2.10 Laboratory Medicine & Blood Sciences are terms to describe the integrated laboratory disciplines of clinical biochemistry, laboratory haematology, Diagnostic Immunology, genetics and blood transfusion. Analysis of clinical samples will establish information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease. Diagnostic Immunology / Laboratory Immunology Services 2.2.11 Diagnostic Immunology studies the immune system and is an important branch of the medical and biological sciences. The immune system protects us from infection through various lines of defense. If the immune system is not functioning as it should, it can result in disease, such as autoimmunity, allergy and cancer. It is also now becoming clear that immune responses contribute to the development of many common disorders not traditionally viewed as immunologic, including metabolic, cardiovascular, and neurodegenerative conditions such as Alzheimer’s. Workforce for Essential Laboratory Services 2.2.12 Essential Laboratory Services comprises Consultant Haematologists, Consultant Biochemists, Clinical Scientists, Biomedical scientists and supporting laboratory staff. Medical Microbiology Services 2.2.13 Medical Microbiologists study the causes and management of infectious diseases and play a key role in the prevention, management and control of infection in both hospitals and the community. The service is clinically led and is supported both by local and specialist laboratories which deliver diagnostic support. 2.2.14 In Wales, this service is in a period of transition due to the planned introduction of molecular and genomic services which aims to provide a more detailed and responsive service. The re-design of the Medical Microbiology service is subject to a national programme and needs to take account of possible consolidation of some testing and/or expanding the number of locations for near/point of care testing. Rapid access to results is essential to influence acute management of infection in patients and the prevention of infection in others. The long-term plan for Medical Microbiology is for PHW to develop itself into an Infectious Disease Service for Wales as this recognises the need for more local clinical engagement within a national structure.

10 “A National Co-ordinating Cellular and Molecular Pathology Programme (CM-Path) to reinvigorate UK academic cellular pathology” by Dr Bridget & S. Wilkins CM-Path Summary April-May 2015.

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Strategic Outline Case (SOC)

2.2.15 In recognition that health security has become a greater public health priority, and following their having signed up to the UK Antimicrobial Resistance (AMR) Action Plan the Welsh Government is seeking to strengthen the National Health Protection Service so our health security can at all times provide an effective response. One of the challenges the Welsh Government faces is ensuring we have fit for purpose laboratory estates which are able to implement rapid testing technologies. PHW, in collaboration with policy colleagues in Welsh Government, has been working on a model to strengthen our National Health Protection Service by providing comprehensive diagnostic testing. Key to this is development of two centres for ‘cold’ tests in Wales, one in north Wales and one in mid & south Wales, and the development of more ‘hot’ tests’ laboratories in other parts of Wales, including Carmarthen. 2.2.16 This will involve reconfiguration of microbiology laboratory establishment across Wales to provide fit for purpose, value for money and high quality diagnostic services that support local care. Delivery of this model will involve expansion of ‘hot’ diagnostics (in all 16 acute hospitals) to provide rapid (<4 hour) molecular facilities to provide testing for CSF, blood cultures, respiratory samples, norovirus, C. difficile, MRSA and CPO. Welsh Government are taking forward proposals to strengthening the National Health Protection Service and is holding a workshop with NHS Wales’ Medical Directors & Nurse Directors, and Directors of Public Health to ensure we are resilient at both a local and national level so plans can be taken forward at pace during 2019-20. Cell and Gene Innovations – Opportunities for Collaboration 2.2.17 This project complements the UK’s, Wales and the regional ambitions under the Industrial strategy and also playing a lead role in developing a network of emerging Advanced Therapy Treatment Centres (ATTCs) and the promotion of gene or cell therapy’s Advanced Therapy Medicinal Products (ATMPs) research and development. ATMP’s having the potential to benefit patients with challenging conditions that cannot be cured with current treatments by promoting access to breakthrough medicines.11 2.2.18 Working together to develop complementary infrastructure and partnership arrangements, a co- located Regional Pathology Unit and ATTC development, will have the potential to deliver breakthrough therapies and treatments to patients throughout the region and across the UK. The benefits of both projects being at feasibility stage is that this project has been able to incorporate a 500 m2 indicative shell and core area into its schedule of accommodation to host a future ATTC development. A co-located and integrated Regional Pathology and ATTC will benefit the region and optimise opportunities for carrying out clinical trials to develop “novel medicines” and stimulate domestic and international investment. Challenges facing Pathology Services in NHS Wales 2.2.19 Since The Future Delivery of Pathology Services in Wales was published in 2008 the pathology service or community within Wales has been promoting a modernisation agenda, that is in part, responsive to increasing sustainability, workforce and major growth demand pressures on the service or community, and; is responsive to rapidly changing technology, new techniques and demographic change. This document and the views expressed herein are reflective of these challenges. 2.2.20 The key challenges and the future vision for pathology services in Wales are summarised in the below:

 Current strategic role is focused on “cost” of Pathology services need to focus on ‘quality’, reduce duplication and variation and the number of errors, do less unnecessary testing, to standardised testing protocols, provide and have access to more robust management information and data, implement best practice, and add more ‘value’, e.g. through innovative service design projects  Major growth in demand Pathology services need to develop more effective clinical

11 Innovate UK Competition: Establishing UK Treatment Centres for Advanced Therapies - 01 Nov 2017

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Strategic Outline Case (SOC)

pathways, ‘optimise’ pathways, introduce new techniques to support cancer diagnosis (recognising the incidence of cancer is increasing) and demographic pressures (recognising there are increasing numbers of older people, many of whom have multiple health conditions as they age), and re-design the workforce skills to meet future needs.  Changing models of care Pathology services need to support the principles of Prudent Healthcare, Work more closely with clinical teams, develop new techniques and innovate to realise benefits of more personalised health monitoring/ preventative medicine, provide more rapid treatment for patients / improved outcomes / timely responses, and provide more proactive management of patients.  Workforce pressures Pathology services need to support more sustainable and resilient pathology services, improve recruitment, retention and make more effective use of scare resources, support more modern workforce models that are flexible and appropriately skilled and equipped to deliver future requirements, and support innovative & sustainable solutions. There are national crises related to shortage of healthcare professionals in these services, and most particularly Consultant Histopathologists.  Technology and Informatics Pathology services need to promote digital technologies to improve patient safety and which support multidisciplinary team communications, develop IT platforms that support transformation of Pathology delivery model, improve Information Governance/Performance Indicators, support Genomics and Genetics enhance diagnosis and treatment, ‘tailor’ therapies to individual patients and ‘empower’ patients to manage their own health. Service Change 2.2.21 NHS Pathology services throughout the UK have been undergoing a transformational process over the last ten years since publication of the Carter Review (2006). Traditionally, Pathology services are delivered from main District General Hospitals (DGHs) in Wales. Moves to rationalise appropriate elements of this service, based on our experience of the pressures expressed in Figure 2, support the development of a single site solution for regionally co-locating Cellular Pathology Laboratory Services at Morriston Hospital. This equally applies to other elements of the service, e.g. Diagnostic Immunology, and the final scope of this business case shall be determined following a review of further regional opportunities this development might present. 2.2.22 Co-location and integration of these services supports a number of national and regional strategic drivers allowing delivery of a modern, efficient, effective, responsive and more economical evidence-based healthcare, leading to better health outcomes and improved patient pathways, including screening for disease, diagnosis and treatment, as well as optimising treatment for patients and stakeholders. 2.2.23 It supports working with research partners and oncology to develop personalised medicine, benefitting patients’ with access to more effective and targeted treatments and benefitting the NHS in terms of time and cost savings. 2.2.24 Development of this service also supports Emergency Preparedness Resilience and Response initiatives in accordance with the civil protection duties and under the auspices of the Civil Contingencies Act (CCA), 2004 by strengthening the resilience of Morriston Hospital’s Delivery Unit response to a major incidents, by providing access to dedicated CT Scanner diagnostic services and by providing infrastructure to support access to temporary emergency mortuary facilities in our capacity as a Category 1 Responder.

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Strategic Outline Case (SOC)

The NHS Wales Health Collaborative, The National Pathology Board & The All Wales Pathology Collaborative 2.2.25 Ensuring the sustainability of future services by concentrating expertise and enhancing efficiency, the group, building on the significant work already undertaken by the NHS Wales Health Collaborative, which was established in February 2015 and brought together, into a single structure, three teams undertaking work on a regional or national basis on behalf of Health Boards and NHS Trusts. The NHS Wales’ Collaborative’s work programme, including Diagnostic services modernisation programme (pathology and imaging), is directed by Chief Executives. The National Pathology Network is also supported by the All Wales Pathology Collaborative which is leading work on individual pathology disciplines. All Wales Pathology Collaborative’s Cellular Pathology Project Group’s Preferred Model 2.2.26 In January 2014, under the auspices of the All Wales Pathology Collaborative, the Cellular Pathology Project Group was formed. Chaired by an Executive Director of Therapies and Health Science, membership of the Cellular Pathology Group included Cellular Pathology representation from each of the health boards (both medical and biomedical scientists), academic representation from Cardiff University and Swansea University, workforce representation and members of the NHS Wales Health Collaborative. Recognising the existing Cellular Pathology Services in South Wales are fragile and unsustainable, with many of the services experiencing difficulties in recruiting consultant Cellular Pathologists and in gaining accreditation of the service, the Group was tasked with identifying options for the future provision of the Cellular Pathology service in South Wales (including the West) whilst aligning with advances made in North Wales. 2.2.27 The Cellular Pathology Project Group, building on the significant work already undertaken by both the South East and South West of Wales, developed proposals for the reconfiguration of Cellular Pathology services within South Wales. A clear steer was provided by All Wales Chief Executives and the proposed model options underwent a robust non-financial and financial option appraisal process between 2014 and 2015. 2.2.28 The Cellular Pathology Project Group’s non-financial and financial appraisals outcomes (see Figure 1) support the creation a Two Site solution for the location of Cellular Pathology services’ in South Wales (i.e. one in Cardiff and one in Swansea). Their findings were presented to the All Wales Chief Executives for approval before proceeding to the next stage, the development of a detailed Implementation Plan for the preferred option. 2.2.29 Please refer to Appendix L - AWCP Group’s non-financial and financial appraisals for a detailed summary of the AWCP process and timeline. Please see Appendix P – Summary of the AWCP non-financial and financial appraisal timeline and process to date for information: 2.2.30 The solution proposed in this SOC (i.e. the development of a Mid and South West Wales Regional Centre of Excellence Cellular Pathology Laboratory and Regional Diagnostic Immunology Laboratory Facility at Morriston Hospital, Swansea) ‘fits’ strategically with the Cellular Pathology Project Group’s preferred Two Site Cellular Pathology services model outcome; ‘Fits strategically with Morriston Hospital’s site Development Control Plan (SDCP) and with the City & County of Swansea’s Local Development Plan for the north and east of Morriston (published in June 2016) as regards proposals for development of an ARCH/Morriston Health Campus and further development as a regional ‘Hub’ hospital site for specialist treatments for South West Wales, and; Supports excellent communication links due to this site’s adjacency to the M4 corridor. As a centre of excellence, we aim for the new co-located service to be recognised as a centre of excellence in clinical diagnostics and investigations service. 2.2.31 Furthermore, the solution is consistent with the recommendations from the All Wales Pathology Collaborative Project and the Pathology Statement of Intent (Draft: 19th April 2018), which addresses the challenges facing Pathology services and identifies strategic approaches to facilitate the development of high quality, effective and resilient pathology services for NHS Wales consistent, with WGov ambitions outlined in Taking Wales Forward: Healthy and Active and the key recommendations of The Parliamentary Review of Health and Social Care in Wales.

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Strategic Outline Case (SOC)

All Wales Pathology Collaborative’s National Immunology Project Group’s Preferred Model 2.2.32 The National Immunology Project was formed under the auspices of the All Wales Pathology Collaborative (AWPC). Its objective was to develop, explore and appraise options for the establishment of safe, sustainable, affordable and high quality immunology services throughout Wales, which meet the All Wales Immunology Service Specification (as developed by the National Immunology Project Group and was adopted by the Combined Pathology Group). 2.2.33 On the 3rd November 2016 the National Immunology Project Group identified six options, including a Business As Usual option. This list was analysed and a short list presented to the then All Wales Pathology Collaborative. 2.2.34 A non-financial Sub Option Appraisal for Immunology Services was undertaken by representatives from Immunology, Biochemistry and Haematology Specialist Standing Advisory Committees (SSAGs). The outcome of the Immunology Project Groups non-financial and high- level financial option appraisal was to consolidate testing to four laboratory sites in South Wales and to one site in North Wales, along with the re-distribution of some assays, in particular specific IgE tests to rare allergens, in South East West (considered to be achievable without equipment, capital or infrastructure being required). 2.2.35 The NHS Wales Collaborative Executive Group National Immunology Project’s Recommendation’s Paper (January 2018) noted “it will be difficult to consolidate, reorganise or centralise anything in Immunology without considering the wider Blood Sciences, Biochemistry and Haematology laboratories within which Immunology sits” and that key benefits, e.g. improved efficiencies, improvements in quality and the ability to achieve accreditation, etc. will be achieved by consolidating testing to four laboratory sites in South Wales and one in North Wales.12 2.2.36 Concerns exist as to the sustainability of the current models, the lack of accreditation of services and as a result, the ability to deliver high quality, cost effective Immunology services in the future. Consideration should also be given to what is thought to be an aging workforce, the predicted loss of expertise over the coming years and the resulting skills gap. The implementation of shift work within laboratories has also had an impact on the Immunology service leaving the service short staffed due to the need to cover shifts on a 24/7 basis. Staff are required to cover other disciplines within Blood Sciences and form part of the core group required to cover 24/7 working. 2.2.37 The solution proposed in this SOC (i.e. the development of a Mid and South West Wales Regional Diagnostic Immunology service) ‘fits’ strategically with Morriston Hospital’s site Development Control Plan (SDCP) and under the ARCH programme. Medical Microbiology Services 2.2.38 We recognise that Medical Microbiology services within the region (currently provided by PHW and by Health Boards) need to be aligned. As set out in paragraphs 2.2.14-16, Medical Microbiology’s strategic intentions are to review the clinical and service model across Wales to create a fit for purpose arrangement that allows for appropriate and clinically informed turn-a- round of diagnostics and the use of these to inform clinical decision-making. The way Microbiology services operate differs from other Pathology specialities, for example, in sample preparation and the requirement for incubation. Taken together with our proposed new service model this introduces some distinct differences in our modus operandi, for example, extended times between taking samples and definitive guidance given back to the requesting clinician. For these reasons regional centralisation for specific Microbiology services will form one element, albeit significant, in the future arrangements PHW establishes.

12 NHS Wales Collaborative Executive Group National Immunology Project Recommendations Paper 30th January 2018 v.1.3

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Strategic Outline Case (SOC)

2.2.39 The transfer of ABMUHB’s current Medical Microbiology services from Singleton Hospital to the new site in Morriston Hospital would bring the microbiology service closer to its main clinical customers and this adjacency would have a number of advantages. Space within Singleton Hospital is not optimal and restricts access to technologies. Furthermore, the Singleton site does not support good flow of samples from principal sources, Key to this investment is significantly decreased transport times leading to a more rapid service with shortened turnaround time and concatenation for real-time patient results and shorten patient pathway. Dedicated Mid and South West Regional Cellular Pathology Laboratory 2.2.40 A dedicated Regional Cellular Pathology Laboratory development on the Morriston Hospital site provides a fit for purpose facility to support the healthcare needs of nearly 1 million people living in the Mid and South West Region of Wales. This new facility will:  Support delivery of a new service delivery model, replacing the existing fragmented and inefficiently configured Cellular Pathology services in ABMUHB & HDUHB Health Boards and align with the Welsh Ministerial Directive for Pathology services in Wales by providing Mid and South West Wales Region with an integrated and more effective Cellular Pathology service;  Support the strategic objectives and vision of the National Pathology Programme Board (now National Pathology Network), which was established in April 2009 to ensure that the integrated approach to service planning and delivery established through the Pathology Modernisation Project was maintained at both national and local levels;  Support the CEO’s of ABMUHB and HDUHB Health Boards as guided by the South West Wales Regional Pathology Re-configuration Board;  Support the review recommendations of the South West Wales Regional Cellular Pathology & Histopathology Re-configuration Boards that Pathology services in Wales be provided from two sites within South Wales;  Support the aims and objectives of the ARCH Prospectus - This project is part of the first tranche of projects under ARCH, and fits strategically within the emerging ARCH Portfolio Delivery Plan (PDP);  Support technological innovations and increase potential for investment in the regional economy from national and international health care providers;  Promote regional benefits in terms of improved specialist healthcare services;  Promote stronger ties with training organisations, promote a more sustainable and resilient regional workforce, and facilitate access to modern technology and techniques, and;  Enhance the patient experience and outcomes, and improve access to high quality Cellular Pathology services. 2.2.41 This project is sponsored by The Swansea City Region Board, a UK Government and HM Treasury (HMt) sponsored ‘Health and Wellbeing’ regional development, and aligns with ARCH vision by promoting development of medical technologies, economic development and regeneration, and evidence based health and wellbeing benefits within the Mid and South West Wales Region. The Internet of Health and Wellbeing Programme interconnects with its complementary Internet of Energy and Internet of Economic Acceleration Programmes in the City Deal to create a coherent City Region-led vision. 2.2.42 The submission of a high-level Strategic Outline Business Case (SOC) application for investment support from City Deal funds in October 2016 to support the development of a Regional Pathology Laboratory service for Cellular Pathology in Mid and South West Wales was well received and was formally approved by Mrs Theresa May (Prime Minister), on the 20th March 2017. 2.2.43 This project ‘fits’ strategically within HDUHB’s Clinical Strategy (agreed November 2018) and ABMUHB’s Clinical Services’ Plan 2019 - 2024 (agreed January 2019).

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Strategic Outline Case (SOC)

2.3 Organisational Overview Abertawe Bro Morgannwg University Health Board (ABMUHB) 2.3.1 As of the 1st April 2019 ABMUHB will cover a population of approx. 400,000 within West Glamorgan and its bordering counties. Currently it has a budget of over £1 billion and employs around 16,000 staff, 70% of whom are involved in direct patient care. In 2017/18 it treated in excess of 16,000 planned inpatients and 54,000 emergency inpatients per year as well as undertaking 53,000 day case procedures. Over 442,000 outpatient and 78,000 accident and emergency attendances are also seen per annum. The total number of beds in the Health Board was 2,288 as at 2016/17. Hywel Dda Health Board (HDUHB) 2.3.2 HDUHB provides health services for 384,000 people in Mid and West Wales covering Carmarthenshire, Ceredigion, Pembrokeshire and bordering counties, and has a budget of over £947 million. Employing approx. 9,891 staff, 70% of whom are involved in direct patient care. The Health Board covers the second most sparsely populated health board area in Wales, 47.9% of the population in the region live in Carmarthenshire, 20.7% in Ceredigion and 31.4% in Pembrokeshire. Public Health Wales (PHW) 2.3.3 PHW NHS Trust is the national public health agency in Wales. We have an annual budget of £108 million and employ around 1,500 employees 43% of whom are clinical, professional, scientific and technical staff. Our estate is located across Wales and currently comprises of 53 properties, including Screening Centres, Laboratories and Support Accommodation. 2.4 Regional Geography and Catchment Population 2.4.1 Pathology tests are provided for patients within the South and West Wales area including, Swansea, Bridgend, NeathPortTalbot, Pembrokeshire, Ceredigion, Carmarthenshire, and parts of Powys and South Gwynedd. 2.5 Stakeholder Engagement 2.5.1 Stakeholder engagement shall be managed in accordance with the Organisational Change Policy for the NHS in Wales (commonly known as OCP). 2.5.2 Key partners under the auspices of the South West Wales Regional Pathology Re-configuration Project Board and ARCH Project Board shall directly manage the formal staff consultation process. 2.5.3 A Consultation document shall be drafted and circulated to all staff directly affected by the changes together with their Trade Union representatives. This will be supported by a series of ongoing staff communications, including staff meetings (collective and\or individual, as requested) to ensure staff are supported during this period of change. 2.5.4 Based on the range of preferred options the staff directly affected includes the following (list is not exhaustive):

 Consultant Cellular Pathologists and Consultant Microbiologists  Cellular Pathology Management staff  Biomedical Scientists, Associate Practitioners/Health Care Scientists  Biomedical Support Workers, Anatomical Pathology Technicians & Anatomical Pathology Support Workers  Medical Secretaries & Clerical Staff

2.5.5 This project engages with the wide range of stakeholders and organisations including the following:

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Strategic Outline Case (SOC)

 Cellular Pathology, directly and indirectly affected by the project, including Scientific Technical staff and Support staff & Service Users, including Cervical and Bowel Screening Wales  Professional Groups & The Royal College of Pathologists  Cellular Pathology, Cytology/Gynae, staff groups, laboratory managers, staff managers, staff and HR/staff side representatives  Diagnostic Immunology staff  GPs in Mid & South West Wales area  CEO’s of ABMUHB & HD Health Boards  Welsh Government  Community Health Councils

2.5.6 The following partners and key stakeholders shall be consulted with via the following collaborative and consultative forums (list is not exhaustive):

 NHS Wales Health Collaborative Project  The National Pathology Network  The South Wales Regional Pathology Re-configuration Board

2.6 Regional Population 2.6.1 The following figure provides the latest population statistics for Wales, HDUHBs and ABMUs Health Board’s population: Figure 1 – Population Base (as at March 2019)

Key Statistics Wales HDUHB ABMUHB Total population 3,099,100 383,200 525,500 Population aged 75 and over 9.1% 10.4% 8.8% Source: Public Health Wales Observatory (ONS) 2.6.2 Comparing the latest population estimates for mid-2015 with the mid-2014 estimates shows the population of Wales increased by 7,100 (up 0.23%) to 3,099,100 since mid-2014 and accounts for 5% of the UK’s population. Population growth in the year to mid-2015 was greatest in southern and eastern England. In Wales, the population growth was only 0.23%, one of the lowest in the UK. This rate is reflective Wales having the lowest net international migration and birth rates, i.e. a similar number of births and deaths resulted in no natural change to the population of Wales. 2.7 Health Status 2.7.1 The following figure provides the latest morbidity statistics for Wales and details HDUHB’s and ABMUHB’s populations: Figure 2 – Morbidity

Key Statistics Wales HDUHB ABMUHB Life expectancy at birth – males 78.3 years 79.2 years 77.4 years (years) Life expectancy at birth – females 82.3 years 82.9 years 81.7 years (years) Adults who are overweight or obese 58.6% 59.8% 58.0% Adults who smoke 20.0% 18% 18.7% Adults who drink above guidelines 40.1% 38.1% 41.3% MMR take up 95.3% 93.6% 95.1% Live births per 1,000 women aged 59.1 56.8 56.9 15-44 years Emergency hospital admissions 112.4 105.3 112.8 Source: Public Health Wales Observatory (ONS)

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Strategic Outline Case (SOC)

2.7.2 The number of males aged 85 and over in the UK has increased by 54% since mid-2005, compared to a 21% increase for females, largely driven by changes in tobacco smoking and advances in health treatments for circulatory illnesses. However, the incidence of cancer is increasing. In particular, the rising incidence of cancer and an ageing population (many of whom experience multiple health conditions as they age) is a major issue for pathology services. 2.8 Health Board Boundary Changes 2.8.1 Following a period of public consultation Vaughan Gething AM, Cabinet Secretary for Health and Social Services, announced on the 14th June 2018 that from 1st April 2019, the responsibility for providing healthcare services for people in the Bridgend County Borough Council area will move from ABMUHB to Cwm Taf University Health Board (CTUHB). It is anticipated that transition changes discussions regarding Pathology services will take account of recent Carter principles’ reviews, promoting cost efficiency, effectiveness, standardisation and consolidation, and efficiencies from maximising economies of scale. Executive support exists for continuation, with for example, Histology activity levels continuing as predicted, with delivery of the services to the population of Bridgend by ABMU Pathology via a Service Level Agreement (SLA) with CTUHB. Responsibility for PoWH’s existing microbiology activity will remain with PHW. 2.9 Benchmarking 2.9.1 Benchmarking visits to similar Pathology facilities have been undertaken, including North Bristol NHS Trust, which has .similar current pathology workloads. Their Department of Cellular Pathology provides a wide-ranging and comprehensive diagnostic Histopathology, diagnostic Cytopathology and Cervical cytology screening service. 2.9.2 The Department of Cellular Pathology is well-equipped and provides routine histological and cytological techniques, together with a wide range of immunofluorescence and immunohistochemical techniques. There is shared provision of an electron microscopy service, particularly for the examination of renal biopsies, in their Neuropathology department. The department works closely with the Bristol Genetics Laboratory for the provision of a portfolio of molecular genetics testing. Clinical consolidation of services had brought together the work of some teams whilst in others Cellular Pathology has instigated this. 2.10 Business Strategies 2.10.1 Pathology services have been the subject of a wide series of reviews and the All Wales Pathology Collaborative Project was established to respond to the significant points raised in the following strategic documents and reviews:

 Review of NHS Pathology services in England (DoH, 2006)  Report of the Second Phase of the Review of NHS Pathology Services in England (DoH, 2008)  The Future Delivery of Pathology Services in Wales (WG, 2008)  The National Pathology Framework (NPF) for Wales (NHW Wales, 2008)  Review of the Histopathology Services in NHS Wales (2010)  Digital First: Clinical Transformation through Pathology Innovation (National Pathology Programme, NHS England, February 2014)  Prudent Healthcare – Securing Health and Well-Being for Future Generations (Wales) Act 2015  The Carter Review - Review of Operational Productivity and Performance in English NHS Acute Hospitals: Unwarranted Variation (UK Government, 2016)  Emergency Preparedness Resilience and Response initiatives in accordance with the civil protection duties and under the auspices of the Civil Contingencies Act (CCA) 2004

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Strategic Outline Case (SOC)

2.10.2 In particular, Lord Carter of Coles’ Report of the Second Phase of the Review of NHS Pathology Services in England (DoH, 2008), which advised significant savings could be made throughout the NHS by consolidating pathology services influenced this project’s direction of travel by focusing on the key themes of modernisation, improving quality and patient safety and improving efficiency. Background 2.10.3 Over the last ten years ABMUHB’s and HDUHB’s pathology services have introduced many modernisations and have contributed towards the development of regional and national best practice within the service. Savings and efficiencies realised from those modernisations have been re-invested in services in response to local pressures. For example, ABMUHB consolidated and re-designed its cytology, histology, laboratory medicine, immunology and post mortem pathology services by 2015, and; HDUHB Blood Sciences laboratories at Prince Philip, Withybush and Bronglais Hospitals were designed with LEAN strategies in terms of workflow. Cellular Pathology processing was centralised to Glangwili Hospital, but due to infrastructure constraints Non-gynae cytology is processed in Prince Philip Hospital. Post mortems were centralised to the new Mortuary facility at Glangwili Hospital (the benefits of this and other process engineering strategies include maximization of workforce efficiencies and empowerment, and improved quality particularly for processes, which remain largely manual13). 2.10.4 Both Health Boards actively participate in the ARCH programme to support Pathology service change within the region and are supportive of work of All Wales Pathology Collaborative Project in Diagnostic Immunology and Cellular Pathology, and previously the SWW Regional Cellular Pathology Project. 2.10.5 ABMUHB has supported national benchmarking using Keele University Benchmarking Services’ (KUBSs’) and is fully engaged in feedback processes. HDUHB’s Cellular Pathology service is actively involved in the Cancer Pathway through weekly feedback via Patient Tracking List (PTL) to cancer services and HDUHB’s Microbiology service provides tailored feedback on reports to educate and nudge good practice. 2.10.6 In HDUHB, additional pre-analytical automation is being implemented as part of the Roche managed service contract in Chemistry and Diagnostic Immunology services have been centralised to a single site based at Prince Philip Hospital. Whilst in ABMUHB, Six sigma was used as the methodology for re-design of four-sample receptions across the Health Board and to establish fully automated laboratory facilities for Biochemistry and Haematology as part of the procurement programme. 2.10.7 In ABMUHB, skill mix reviews have been conducted as part of pathology clinical strategy across Laboratory Medicine and Cellular Pathology, with a reduction in senior staff and increase in Support Workers. Associate Practitioner roles have been developed. Cross discipline training within Laboratory Medicine has commenced with staff to develop dual expertise in support of service sustainability. Enhanced Biomedical Scientist roles in specimen dissection and slide reporting have been developed in Histology in line with The Royal College Pathology framework in support of Consultant Histopathologists’ workloads. 2.10.8 In HDUHB, continual skill mix assessments are evaluated as opportunities arise and investment in support worker grades have been undertaken wherever possible in Blood Sciences, Cellular Pathology and Microbiology and staff are encouraged to achieve the associated level of qualifications. 2.10.9 Both Health Boards have been working together under the ARCH programme to develop a regional strategy for pathology services, which is consistent with the preliminary recommendations from the All Wales Pathology Collaborative Project.

13 The Future Delivery of Pathology Services in Wales, August 20018 (p38)

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Strategic Outline Case (SOC)

2.11 Accreditation Requirements 2.11.1 Welsh Health Circular Diagnostic Services Strategy WHC (2004)061 recommends that all Pathology service providors should enrol in accreditation schemes where they exist and meet licensing and accreditation requirements. 2.11.2 Laboratory compliance against the international standard ISO 15189 is a mark of quality and provides objective evidence that a laboratory is not only competent, but safe, patient-focused, efficient and reliable. Through an externally assessed accreditation process, medical laboratories can demonstrate that they comply with defined standards and best practice and provides authoritative assurance of their technical competence to undertake specific analysis or measurements according to validated methods. The accreditation of laboratories against the ISO 15189 standard in Wales is not statutory but has been mandated by Welsh Government 2.11.3 All laboratories in Wales are working towards quality accreditation. Pathology laboratories are accredited by the United Kingdom Accreditation Services (UKAS). PHW has UKAS ISO:15189 and been re inspected once and is scheduled for re-insertion in May 2019. The relevant standards are:

 The Human Tissue Authority (HTA) ensures that there is compliance regarding the obtaining of tissue for further investigation, storage of such tissue etc.;

 Compliance with Medical Laboratories accreditation ISO15189:2012 (replacing current Clinical Pathology Accreditation (CPA) requirements, which ensures laboratories operate a quality management system to integrate the organisation, procedures, processes and resources. The standards which have to be complied with include those around the building infrastructure of the laboratories, continuing professional development of staff, quality assessment of performance and individual performance review);

 ISO standard 22870:2006 Point-of-care testing (Near-patient testing), and;

 National External Quality Assessment (EQA) schemes, both medically and scientifically. Performance against EQA standards.

Summary 2.11.4 Without investment the following ‘Status Quo’ or ‘Business as Usual’ scenarios are real possibilities:  Pathology services, which are already struggling to maintain quality, fail to deliver essential quality improvements and will fail to meet clinically driven targets.  Workforce arrangements, which are already unsustainable due to staff shortages and problems recruiting & retaining consultant and scientific staff, further destabilise; services fail to meet minimum safety standards, and; services incur more errors and delays in diagnosis and treatment, which in turn, attracts more legal claims and loss of reputation.  The resilience of Mid and South West Wales’ NHS pathology services further weakens, placing more even more pressure on existing staff and local services.  Service costs continue to increase as the service fails to eliminate duplication/adopt innovative digital technologies and techniques,  Local pathology services remain fragmented and increasingly operate within non-fit for purpose facilities and with aging equipment.  Production rates fall, staff morale suffers and we experience more skill mix issues, and restrictive and traditional working patterns persist.  Local pathology services’ increasingly fail to support their local populations, fail to meet rising demand, and will not deliver be capable of delivering personalised treatment.

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Strategic Outline Case (SOC)

 Pathology services, if left in their current form, become increasingly unsustainable, lack resilience, and risk becoming unsafe.  Clinical services in Mid and South West Wales will no longer have access to a medical and technical expert Cellular Pathology service for the diagnosis, prognosis and treatment planning for their populations 2.11.5 The case for change is supportive of these strategies and processes and proposals, which, given the challenges currently facing pathology services, clearly need to adopt a new strategic approach to the development of safer, high quality, effective and resilient pathology services for NHS Wales that addresses the needs of the population, is responsive to current and future policy direction and ensures long term sustainability. 2.11.6 Central to this ambition, are alternatively configured service models for pathology, which support workforce development and increased modernisation of skill mix, embrace new innovative technologies and automation e.g. digital, requiring informatics and information support which can lead to optimisation of the opportunities from further research and innovation. 2.11.7 This SOC supports this ambition by promoting the development of a sustainable Regional Cellular Pathology Laboratory service at Morriston Hospital. This solution will provide the best outcomes for Welsh patients, and will be supportive of Ministerial direction and of the All Wales Pathology Collaborative Project’s recommendations. It will provide a state-of-the-art modern facility and attract opportunities for R&D across the region, which in turn, will encourage local workforce stability and sustainability. 2.11.8 This investment builds on other planned regional infrastructure developments, e.g. internet expansion, websites, IM&T, and transport infrastructure, etc. and contributes towards improvement of regional GVAs.

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Strategic Outline Case (SOC)

3 Strategic Case Part B: The Case for Change

3.1 Investment Objectives 3.1.1 In accordance with HMT’s The Green Book: Central Government Guidance on Appraisal and Evaluation (2018), the key investment objectives have been identified as follows: Figure 3 – Investment Objectives

Investment Objective 1: To develop more sustainable South Wales Regional Cellular Pathology, Regional Diagnostic Immunology Laboratory and Regional Medical Microbiology services Develop a more sustainable Regional and All Wales pathology service as evidenced by compliance with Royal College of Pathologist’s guidance to improve our workforce and to recruit and retain staff, supporting All Wales Pathology Collaborative Project’s strategic plans and the National Immunology Project, maintaining business continuity, supporting innovation and new investment in the Region, improving the relationship between pathology services and clinical research, working more closely with the University to widen academic access to the range of undergraduate and postgraduate courses, which include Pathology services, and repatriation of some tests currently commissioned out of region due to lack of capacity, as appropriate. The presence of the regional microbiology laboratory at the regional centre will improve the attractiveness of the service, providing adjacency between laboratory and clinical settings. This will help recruitment and retention, particularly of specialist and medical microbiology staff, without which the service will not be sustainable. To be fully realised 24 months after full scheme delivery, i.e. by mid 2026/27. Investment Objective 2: To improve the quality and safety of South Wales Regional Cellular Pathology, Regional Diagnostic Immunology Laboratory and Regional Medical Microbiology services Improve the quality of Pathology services in support of the Carter Report’s recommendations as evidenced by supporting achievement of the new Cancer Strategy for South Wales including the Single Cancer Pathway, improved turn-a-round time for tests, including Urgent Suspected Cancers and All Wales Lymphoma panel patients against current levels as per Royal College guidance, implementing new technology and innovation, which improves diagnostic services, e.g. digital technology, support for standardised protocols and improving the patient experience. The appropriate consolidation of cold tests will improve the processing and standardisation of the tests which will facilitate our compliance with quality standards and reporting e.g. UKAS. This regionalised approach to sample flow will support the provision of hot labs at all acute hospitals in the region. These will provide rapid and timely diagnostics to guide treatment resulting in improved Turn Around Times in particular for situations such as sepsis, CNS infection urgent screening for Infection Control.To be fully realised 12 months after full scheme delivery, i.e. by mid 2025/26 (metrics to be detailed at OBC stage). Investment Objective 3: To improve the efficiency and productivity of South Wales Regional Cellular Pathology, Regional Diagnostic Immunology Laboratory and Regional Medical Microbiology services Improve efficiency in support of the Carter Reports recommendations as evidenced by providing access to state-of-the-art technology and equipment, one-site single management structure, improved quality systems; reduced duplication and variation and co-location on a main acute site. The current spatial layout of the main microbiology laboratory in Singleton is not conducive to optimal sample flow. A purpose built space will allow the optimisation of automated systems. This will allow workforce redesign with more practitioners delivering routine diagnostics freeing our biomedical workforce to provide greater clinical engagement and hands on infection management skills to the Health Board clinical services. To be fully realised 12 months after full scheme delivery, i.e. by mid 2025/26. Investment Objective 4: To improve the effectiveness of South Wales Regional Cellular Pathology, Regional Diagnostic Immunology Laboratory and Regional Medical Microbiology services

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Strategic Outline Case (SOC)

Improve effectiveness as evidenced by providing all patients in secondary care, and those attending acute and regional hospital based services, with more sustainable and equitable cellular pathology services and improved access to new technology / more personalised diagnosis and more sensitive and specific tests for patients within the Region. For microbiology, the provision of a cold laboratory at Morriston which can process routine non-time urgent samples will enable the hot laboratories to concentrate on implementing new molecular technology equitably across the region. This will provide effective guidance to clinicians to improve the care to scheduled and unscheduled patients across secondary care. The cold laboratory will be able to provide a genomic diagnostic service due to more space and its attractiveness to staff with the required skills. To be fully realised 24 months after full scheme delivery, i.e. by mid 2026/27. Investment Objective 5: To improve economies within South Wales Regional Cellular Pathology, Regional Diagnostic Immunology Laboratory and Regional Medical Microbiology services Improve economy and optimise use of scare resources in support of the Carter Reports recommendations on improving cost effectiveness as evidenced by operational economies and economies of scale and improved regional GVAs. Being able to deliver the regional service from a fit for purpose facility will provide economies of scale through better use of automation and the resultant workforce redesign. The use of hot laboratories will also reduce the logistical demands on moving urgent samples around the region by applying the right technology locally when appropriate. To be fully realised 24 months after full scheme delivery, i.e. by mid 2026/27. 3.1.2 Delivery and operational dates are dependent on timely planning, funding approvals and agreed construction programmes. 3.2 Existing Arrangements Cellular Pathology Services (including Histopathology and Cytology) 3.2.1 In ABMUHB, pathology services are delivered by laboratories based at Morriston and Singleton Hospitals, Swansea to the population of ABMUHB. ABMUHB’s Cytology service is located at Singleton Hospital, Swansea; In HDUHB, cellular Pathology services are mainly delivered by the laboratories at Glangwili Hospital, Carmarthen; due to a lack of facilities and space at Glangwili, non-gynae cytology has to be processed at Prince Philip Hospital, Llanelli. Medical Microbiology Services 3.2.2 Medical Microbiology services to the population of ABMUHB are provided by PHW via laboratories at Singleton Hospital, Swansea. HDUHB provides Medical Microbiology services to the population of Pembrokeshire via laboratories at Withybush Hospital, Haverfordwest. PHW provides Medical Microbiology services to the population of Ceredigion and Carmarthenshire via laboratories at Bronglais Hospital, Aberystwyth and at Glangwili Hospital, Carmarthen. Mortuary and Body Store Services 3.2.3 In ABMUHB Post Mortem services to the population of ABMUHB are located at Morriston Hospital and at Princess of Wales Hospital, Bridgend. ABMUHB’s Body Store services are provided at Morriston and Singleton Hospitals, Swansea, and at NeathPortTalbot Hospital and the Princess of Wales Hospital, Bridgend. 3.2.4 HDUHB’s Post Mortem services are centralised at Glangwili Hospital, Carmarthen. HDUHB’s Body Store services are provided at Bronglais Hospital, Aberystwyth, Prince Philip Hospital, Llanelli, Glangwili Hospital, Carmarthen, and Withybush Hospital, Haverfordwest. Contingency Post Mortem services are located at Withybush Hospital, Haverfordwest. Blood Sciences’ / Laboratory Medicine and Diagnostic Immunology Services 3.2.5 In ABMUHB Laboratory Medicine (Blood Sciences’) services are located at Morriston, Singleton Hospitals, Swansea and the Princess of Wales Hospital, Bridgend. A small sample reception and blood issue facilities are located at NeathPortTalbot Hospital with transfer of samples as relevant to Morriston or Singleton Hospitals. In ABMUHB Laboratory Immunology services are located at Morriston and Singleton Hospitals, Swansea.

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Strategic Outline Case (SOC)

3.2.6 HDUHB provides Blood Sciences’ services at Prince Philip Hospital, Llanelli, Glangwili Hospital, Carmarthen, Bronglais Hospital, Aberystwyth and Withybush Hospital, Haverfordwest. HDUHB provides centralised Diagnostic Immunology services at Prince Philip Hospital, Llanelli. Location of Pathology Services within South & West Wales 3.2.7 The following figure illustrates the distribution of HDUHB’s local pathology services by service provider (pre Health Board boundary changes end 2018/2019): Figure 4 – Location of Current Pathology Services within HDUHB

3.2.8 The following figure illustrates the distribution of ABMUHB’s local pathology services by service provider (post 1st April 2019, delivery of the services to the population of Bridgend by ABMU Pathology will be managed via a Service Level Agreement (SLA) with CTUHB): Figure 5 – Location of Current Pathology Services within ABMUHB

Service Modernisations 3.2.9 Both Health Boards have made innovations and modernisations in their pathology services in recent years, for example: Between 2010 and 2015, HDUHB completed a series of modernisation projects including developing a new Mortuary at Glangwili Hospital, centralising post mortems in the Health Board; Centralising Cellular Pathology laboratory processing at Glangwili and centralising Diagnostic Immunology workload at Prince Philip Hospital;; Providing Blood Sciences’ laboratories with integrated specimen reception areas at Bronglais Hospital Aberystwyth, Withybush Hospital, Haverfordwest and at Prince Philip Hospital, Llanelli as well as improved Phlebotomy facilities at Withybush Hospital, Haverfordwest and Prince Philip Hospital, Llanelli and new Microbiology laboratory and Containment level 3 facilities at Bronglais Hospital, Aberystwyth.

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Strategic Outline Case (SOC)

3.2.10 From 2011 ABMUHB has re-configured its laboratory medicine (blood science) services to create a main hub laboratory in Morriston for all ABMUHB OPD and Primary Care testing of bloods, and 2 smaller essential service labs in Singleton and POWH for acute urgent testing of bloods from ward and A&E services. NPT hospital testing is all undertaken in Morriston, and; As recently as 2015, Health Board-wide, ABMUHB rationalised its Cellular Pathology services by relocating activity in its entirety from the PoWH at Bridgend to Morriston and Singleton Hospitals in Swansea. This relocation supported service efficiencies with pathology services and the expansion of the existing PoWH radiology services to support local service demand. 3.3 Estates Profile 3.3.1 Welsh Government’s and Health Boards’ have been investing in their estate in recent years but currently both ABMUHB’s and HDUHB’s Cellular Pathology service’s accommodation experiences significant issues with aging and inadequately configured accommodation, poor environmental systems, and general non-compliance with Health Building Note (HBN) requirements, for example, Glangwili’s pathology floor space is functionally unsuitable for its personnel and equipment operating requirements (floor space therein is currently 1,028 m² - it should be 2,064 m²). Likewise, ABMUHB’s Singleton and Morriston Hospital Cellular Pathology service’s and Medical Microbiology accommodation are similarly constrained by accommodation and configurations that are no longer fit for purpose. Regional Cellular Pathology laboratory services should be fully compliant, fit for purpose, fully accredited and would preferably be co- located and equipped with appropriate support services and IM&T infrastructure. 3.4 Current Workforce 3.4.1 HDUHB/ABMUHB’s laboratory based staff currently operate similar shift patterns over a 5-day working week, with the majority ABMUHB’s laboratory staff working Monday to Friday on flexible shifts between the hours of 07:00 and 18.30; HDUHB’s histology staff work between the hours of 08:00 to 17:00. ABMUHB’s Mortuary staff work between the hours of 08:00 to 18:30 Monday to Sunday. HDUHB and ABMUHB currently employs the following cellular pathology/histology staff: Figure 6 – Cellular Pathology/Histopathology/Diagnostic Immunology/ Medical Microbiology Workforce Profile (2018) Staff Cellular Pathology/Histology Diagnostic Immunology Medical Grades/Bands: Microbiology HDUHB ABMUHB HDUHB ABMUHB ABMUHB Staff wte Staff wte Staff wte Staff wte Staff No. wte No. No. No. No. Laboratory 21 20.02 40 38.67 3 2.8* 4* 4.0 96 87.08 Technical Staff Consultants 5 9.0014 11 1415 1 0.2 10 10.10 Management & 8 7.40 28 26.2 10 9.43 Admin. Total 38 83 3 5 116 * Includes bands 2/3, 4, 5/6 & 7 day & night staff due to OOHs 3.4.2 All of HDUHB/ABMUHB’s cellular pathology/histology staff will re-locate from their current Glangwili and Singleton Hospital bases to a new facilities at Morriston Hospital together with ABMUHB’s Singleton Hospital’s mortuary staff. The regionalisation and co-location of these services supports the introduction of more flexible working patterns, with aspirations of expanding cellular pathology/histology services into 6-day and 7-day day working. We anticipate this and other workforce initiatives will alleviate traffic/car parking pressures on hospital sites and will support more flexible and attractive working arrangements for staff.

14 HDUHB have budgeted for 9.00 consultants. In post there are 3 wte substantive consultants; 1 wte NHS Locum,on a one year fixed contract, and ; 1 wte Agency Locum (appointed 12th March for 6 months). HDUHB has 4 vacancies. HDUHB is unable to provide support to Cancer speciality MDT meetings. 15 ABMUHB have budgeted for 14 wte consultants.

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Strategic Outline Case (SOC)

3.5 Pathology Activity 3.5.1 The following histology activity was recorded in HDUHB and ABMUHB during 2010 – 2018 inclusive: Figure 7 – HDUHB: Histology Activity (2010 to 2018)16

90000 80000 70000 60000 Requests 50000 Specimens 40000 Blocks 30000 Stained Slides 20000 IHC 10000 0 201020112012201320142015201620172018

Figure 8 – ABMUHB: Histology Activity (2010 to 2018)17

16 Prior to implementation of the All wales LIMs in the summer 2015, HDU were utilising Telepath to record activity. 17 Prior to implementation of the All Wales LIMs in the summer 2015, ABMU were utilising Master Lab to record activity.

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Strategic Outline Case (SOC)

3.5.2 Figures 7 & 8 (above) show Pathology Laboratory projected activity is increasing slightly each year but this does not reflect a true picture of the level of complexity, which has increased significantly due to reliance on immune-histochemistry and personalised medicine to deliver more specific diagnosis. For example, ABMU has expanded its Immunohistochemistry (IHC) repertoire in 2018 by 30% since 2015 (this includes expansion of the lymphoma panel and introduction of PDL-1, MMR and ALK-1 tumour markers. An increased repertoire of tests has impacted significantly on pathology services’ staff time and resources and on consultant and technical grades’ time. The benefits of this include the ability to provide cancer services’ clinicians’ in particular, with more targeted treatment options from the wider range of tests currently available compared to traditional delivery. 3.5.3 The following non-gynae cytology activity was recorded in HDUHB and ABMUHB during 2015/6- 2017/18: Figure 9 – HDUHB & ABMUHB: Non-Gynae Cytology Activity (2015/16 to 2017/18)

3.5.4 Figure 9 (above) shows non-gynae and histology tests, the sample activity appearing to remain static because specimens of non-clinical value have been removed. This level of activity in recent years does not demonstrate the increased complexity of laboratory analysis which is integral to the final reported result. 3.5.5 The following number of tests processed by Health Board was recorded by PHW 2015/6- 2017/18: Figure 10 – PHW Activity by Health Board (2015/16 to 2017/18)

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Summary 3.5.6 Whilst activity for Cellular Pathology work only increases slightly over time workload increases year-on-year significantly in terms of complexity to support complex clinical service needs and developing more personalised treatment. Immunohistochemistry increased in the 2016-2017 period by 13%, illustrating the increased complexity on each request. Correspondingly, in situ hybridisation (this process is used in the diagnosis of breast cancer) has increased by 18.2% in the period, reflective of the more complex testing regime now required to support more definitive diagnoses. 3.5.7 Within PHW, technology has enabled high productivity with batching of high volume work whilst the complexity particularly associated with Antimicrobial resistance continues to grow e.g. dealing with joint fluids and sepsis. 3.5.8 Service changes will continue to re-shape pathology services over the next three years. These will have a significant impact on sustainability and workforce. These changes includes: The adoption of LEAN principles; standardisation of working practices and re-defining of roles; Adoption of 24/7 working and shared rotas - supporting regional processing and autopsy services (this investment could provide flexible and resilient contingency support for West Wales autopsy services) ; Improvements in quality standards and Standard Operating Procedures (SOPs); New imaging technologies - improving quality and reduce screening times in, e.g. Cervical screening; All Wales LIMS; Building on partnerships with Universities and industry, and; Modernisation of scientific careers within pathology services and empowering staff to rise to new challenges. 3.6 Business Needs Problems with the ‘Status Quo’ 3.6.1 The problems, difficulties and service gaps associated with the existing arrangements are as follows: Quality, Sustainability & Workforce Issues 3.6.2 Both health boards are struggling to manage workforce and sustainability pressures, to maintain quality and safety issues and to meet clinically driven targets. Workforce re-modelling based on meeting future demand and moving to a points based consultant staff and support system was jointly established in September 2017 and is ongoing. It is important to note that these workforce pressures will exist whether the service moves to a new facility or remains in-situ and that HDUHB will be moving to the points based system in advance of any new regionalised solution. This will allow HDUHB to supplement the benefits of regionalisation to partly implementing the Advanced Practitioner role that has already been successfully implemented in ABMHB. 3.6.3 Services’ are fragmented and are struggling to appropriately support their local populations. The current workforce is over stretched trying to meet rising demand. 3.6.4 Reviews of regional and local staffing assumptions recognise the ‘gap’ between historical staffing models and future staffing models. For example, HDUHB currently has only three substantive consultant staff, relying on the ability to attract NHS locum and expensive agency locum staff, it actually needs nine consultants to satisfy current levels of service, and predicts the need for another two consultants to maintain quality of service and timely reporting through implementation of the points based system in the future. 3.6.5 Recruitment and retention, especially of Consultant grade staff are major issues within Mid and South West Wales’ Pathology services. Staff morale is suffering and a retirement ‘bulge’ will further compromise service sustainability. 3.6.6 Maintaining the ‘status quo’ is unsustainable and not in the interests of patients in the region. Providing a sustainable, resilient workforce with the appropriate skills and education and ensuring we have the right staff in the right place to meet national guidelines is an essential requirement.

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3.6.7 Pathology services are struggling to maintain quality and meet clinically driven targets. In their current configuration and with existing staffing levels they have limited success delivering essential quality improvements and meeting current demand. Pathology services need the right skill mix in place and access to innovative and state-of-the-art technology and equipment in order to meet demand, support best quality outcomes (specifically the new Cancer Strategy for South Wales) within the region. Accommodation & Configuration Issues 3.6.8 Lack of space and insufficient storage within cellular Pathology services in ABMUHB and HDUHB contribute to increased risk of health and safety related incidents. The PHW Medical Microbiology service based in Singleton Hospital is spread across two floors and has limited adjacency between the different parts of the laboratory. This is not conducive to cross-cover nor does it facilitate collaboration. Significant space is ‘wasted’ as corridors and the diagnostic areas are sub-optimally configured, and the existing physical layout makes for inefficient workflows. Infrastructure Issues 3.6.9 ABMUHB’s Cellular Pathology services do not fully comply with ISO15189, HSE guidance, the Human Tissue Act (HTA) requirements or with WHBN 15 Accommodation for Pathology Services as regards existing environmental standards. This threatens staff welfare, compromises quality and safety, and places wider health services at threat by compromising Pathology services’ ability to comply with mandatory requirements and licenses. In HDUHB, specifically Glangwili Hospital, inadequate pathology infrastructure and space across all disciplines, which is not fit for purpose or conducive to 21st century laboratory technology or work flow and is also non-compliant with WHBN 15, sits as a high level risk within the Health Board. 3.6.10 Morriston and Glangwili Hospitals’ Histology facilities experiences issues with inadequate temperature controls. This leads to, e.g. intermittent analyser failures in Histology during times of extremes of hot and cold weather, which significantly delays tissue-processing tissue and compromises appropriate storage of reagents. Poor temperature controls generally make for unacceptable working conditions for Laboratory staff. Glangwili Hospital’s Histology tissue processing and cut up room is not fit for purpose and additional co located space is required to segregate the tissue processing equipment and reduce the time staff are exposed to chemicals such as xylene and formalin through improved segregation and ventilation controls. Future Requirements 3.6.11 The Mid and South West Wales Cellular Pathology service urgently needs a co-located facility which can support technological innovations, promote benefits in terms of improved specialist healthcare services, facilitate access to modern technology and techniques, enhance the patient experience, and increase potential for investment in the local economy. Projected Activity 3.6.12 Pathology Laboratory projected patient activity is forecast to continue to increase over the next ten years to support a predicted 10% increase in cancer in that period. 3.6.13 Changes in clinical service delivery, including a move towards seven-day working in Endoscopy Services, implementation of the Single Cancer pathway, proposed changes to Bowel Screening age eligibility, and a predicted increase in the number of Cervical Screening Services’ ‘opportunistic’ cervical biopsies, activity will impact on Cellular Pathology service activity within the region and potentially across Wales. The service has seen increasing workloads dependent on services that ensure appointments of clinicians, e.g. Dermatology Locums are generating more biopsies in 2017 compared with 2016 activity. In general requests for molecular testing are increasing, although this increasing Pathologists’ block and slide work workloads.

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3.6.14 Precision Medicine will continue to evolve over the next decade and it is anticipated blood based biomarkers will be used routinely to assess a person’s risk for cancer and to aid personalizing cancer treatment. Genomic testing to personalize cancer screening will also become routine in clinical practices all over the world through rapid adoption of technology that allows for the assessment of cancer risk among the population. These advances will lead to a dramatic drop in deaths from preventable cancers. Further advances in genetic analysis and gene mutation will result in more patients being monitored for early detection of cancer. This, in time, could increase pathology activity from screening programmes. 3.6.15 The forecast increase in obesity levels in the UK – with 35% of the population projected to be obese in 2030, will impact on Pathology Laboratory services. Overweight and obesity is associated with increased risk of several cancers, including uterine, kidney, oesophageal, gallbladder, bowel, pancreas and breast cancers. Cancer incidence in the UK is expected to continue to rise further if current trends in overweight and obesity prevalence persist. Overall, overweight and obesity causes, a conservatively estimated, 5% of cancer cases in the UK each year18. Summary of Business Needs 3.6.16 The ‘status quo’ cannot be maintained and this document proposes investment in a realistic ‘Do Minimum’ solution plan for service re-design of ‘Core’ regional services. Specifically, it supports development of a Regional Cellular Pathology (Cytology and Histopathology) & Regional Diagnostic (Laboratory) Immunology service, and co-location of Singleton’s Body Store at Morriston Hospital with future proofed capacity. This solution, which largely excludes local service scope solutions (as detailed in the ‘Intermediate’ and ‘Do Maximum’ solutions) except where they promote tangible regional benefits, support delivery of more sustainable regional services and satisfy national, regional and local strategic direction. 3.6.17 In terms of volume, the majority of the work undertaken by the new facility will be direct pathology activity as part of the primary, secondary care and acute hospital activity in Mid and South West Wales Region. Merged cellular pathology services and access to state-of-the-art technology should facilitate improvements in the patient experience. Management arrangements will be streamlined and skill mix will be modernised and should support more efficient and effective ways of working. The involvement of the private sector should boost technological innovation and assist a direction of travel for the service, focusing on delivering more personalised treatment to the population of Mid and South West Wales.

3.7 Potential Scope 3.7.1 This section describes the potential scope for the project in relation to the above business needs in terms of modalities and service drivers. The potential scope has been assessed against a continuum of need ranging from:  A Business As Usual – essential for baseline comparison.  A Do Minimum – essential or core requirements/ outputs.  An Intermediate – with essential and desirable delivery requirements/ outputs to a greater and lesser extent.  A Do Maximum – with essential, desirable and optional requirements/outputs.

3.7.2 ABMUHB’s Cellular Haematology Laboratory services may form part of this project’s final service scope solution. Currently these services are provided at Singleton Hospital and a short-term solution is being considered in that site’s emerging Site Development Master Control Plan. In the longer-term (i.e. within 6-7 years) a more appropriate longer-term solution may be considered. All new build options included a 500 m² ATTC, i.e. Cell and Gene Therapy indicative shell and core area.

18 cf

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3.8 Main Outcomes and Benefits 3.8.1 The main outcomes and benefits to patients, the Health Board and the wider health community are classified in terms of cash releasing benefits (CRBs), non-cash releasing benefits (NCRBs), quantifiable benefits (QBs), and non-quantifiable benefits (Non QBs) as follows: 3.8.2 The main benefits of this project are outlined in Appendix I – Benefits Realisation Plan. 3.8.3 At OBC, stage benefits will be quantified in accordance with the principles of additionality. This is defined as “the extent to which something happens as a result of an intervention that will not have occurred in the absence of the intervention”19. An assessment of benefits on this basis will be applied at key stages of this project’s lifecycle, success will be measured against clear and measurable criterion, which will in turn be assessed at key stages of the project under the OGC ‘Gateway’ process, and benefits realisation Welsh Government led assessment processes. Additionality benefits will be categorised as follows:

 Economic multipliers analysis will capture additional economic activity stimulated locally and throughout the region by this project.  Leakage effects analysis will capture non-direct effects both in qualitative and quantitative cash and non-cash terms, demonstrating VfM, as per Welsh Government and Treasury guidance.  Displacement or Substitution analysis will take into account the re-location of staff between different Health Boards and other organisations because of service change across health Board boundaries and between current locations and Morriston Hospital.  Deadweight analysis - what will happen, or will not happen if this project did not proceed. 3.9 Main Risks 3.9.1 The main business and service risks and mitigations are as follows: Figure 11 – Main Risks and Mitigations

Risk Description Probability Impact Score Mitigating Actions Internal approvals delayed - 3 4 12 (1) Continued liaison There is a risk that board with key stakeholders' approvals are delayed. SROs Planning approval & planning 5 4 20 (1) Early engagement conditions - Failure to achieve with Local Planners; (2) planning permission conditions Appoint a Planning are excessive, that S106 Advisor and further demands building control investigate future approvals are more involved than planning development anticipated risks at Morriston Hospital & Submit a pre- planning application; (3) Monitor progress on Project and its interrelationship(s) with ARCH & other Morriston Hospital projects currently at planning stage; (4) Coordinate with ARCH Master Planners.

19 Additionality Guidance, 3rd Edition, English Partnerships, October 2008

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Funding approval delayed or 4 4 16 (1) Maintain regular timing of funding does not match dialogue re the our current programme due to procurement WGov cashflow constraints arrangements with WG and other key stakeholders. Revenue affordability - 5 4 20 (1) Develop and sign off Affordability of revenue model is revenue model with over/under estimated DoFs; (2) Project Board to review at each formal meeting. Availability of capital - There is a 5 3 15 Continued liaison with risk that the scope of the project is WGov. reduced in order to fit within

financial limit Staffing levels - Additional staffing 3 4 12 (1) Develop Staff levels / activity cannot be Modelling to inform, e.g. supported at Morriston Hospital, future car parking e.g. car parking provision and requirements on site; (2) essential infrastructure are Liaise with Morriston insufficient to support planned Hospital/ARCH projects operations currently at planning stage. Staffing model is over/under 3 4 12 Establish a Project estimated Management Team and secure project management support Recruitment of key staff - 3 4 12 Project Board monitors Sufficient numbers of essential recruitment staff with key skills cannot be progress/issues and recruited report regularly to Project Board/Executive level 3.9.2 Please refer to Appendix K – Risk Register. 3.10 Constraints 3.10.1 The scheme is subject to the following constraints:

 The solution must provide a regional solution for Cellular Pathology Laboratories and Immunology Laboratories services’ capacity and quality requirements.  The solution must be fit for purpose (i.e. it must comply with ISO, WHBM/HBN & WHTM/HTM requirements and guidance) and make best use of the available development space.  The delivery of Pathology Laboratory services to patients must be maintained seamlessly during the works, commissioning periods and re-location of services.  Revenue resources are limited and the solution should offer value for money.  The solution must be affordable in capital and revenue terms.  The solution must be delivered within project budget/programme.  The solution must ‘fit’ within the available developable footprint.  The solution must provide adjacency and connectivity with the existing Pathology facility at Morriston Hospital.  The solution must allow the service to meet national targets for turn-a-round of pathology

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tests.

3.11 Dependencies 3.11.1 The success of this scheme is subject to the following dependencies:

 Obtaining planning permission approval. NB Planning permission approval is dependent upon Site Development Control Plans for Morriston Hospital; and on demonstrating a sustainable travel plan and improving road infrastructure at Morriston Hospital.  Continued support for the agreed service care and workforce model locally and regionally.  Availability of capital funding from the Welsh Government.  Ability of ABMUHB & HDUHB to support any revenue consequences from this investment.  The commitment of ABMUHB & HDUHB at the highest level, to drive the project.  Continued effective and transparent engagement with key stakeholders at all stages of the project and support the transformational process.  Senior pathology services’ management commitment to an integrated transformational and modernisation project.  Development of a single management structure to ensure smooth daily operation of the new Regional Pathology Unit.  Continued commitment of the project owner(s), senior Health Board management and pathology services’ senior staff to develop and own the new regional service model.  Ensuring that appropriate governance structures and change management procedures are embedded throughout the development, delivery and benefits realisation stages of this project.  Development of a Formal Staff Engagement Process, Change Management Process and Communications Plan.  Co-ordination of recruitment and training processes to support future staffing arrangements.  Access to appropriate / experienced construction resources.

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4 The Economic Case 4.1 Introduction 4.1.1 In accordance with the Capital Investment Manual and requirements of HM Treasury’s Green Book (A Guide to Investment Appraisal in the Public Sector), this section of the business case demonstrates the wide range of options that have been considered in response to the potential scope identified in this SOC. 4.2 Critical Success Factors 4.2.1 The Critical Success Factors (CSFs) have been identified to allow evaluation of the potential options. These are shown below: Figure 12 – Critical Success Factors (CSFs)

 CSF 1 Business needs How well the option satisfies the existing and future needs of the service and NHS Wales, i.e. by providing more sustainable Pathology Laboratory services across the region.  CSF 2 Strategic fit How well the option provides holistic ‘fit’ and synergy with other key elements of the national, regional and local strategies, i.e. supporting ABMUHB’s & HDUHB’s IMTPs and the All Wales Pathology Collaborative Project’s strategic objectives.  How well the option optimises the potential return on expenditure.  CSF 4 Potential achievability The organisations’ ability to innovate, adapt, introduce, support and manage the required level of change, including the management of associated risks, and; the need for supporting skills (capacity & capability) .  CSF 5 Supply side capacity and capability The ability of the marketplace and the potential suppliers to deliver the required services and deliverables.  CSF 6 Potential affordability The organisation’s ability to fund the required level of expenditure, viz, the capital and revenue consequences associated with the proposed investment.

4.3 Methodology 4.3.1 The Appraisal Group (please see Appendix E – Option & Risk Appraisal Group Membership). identified a range of options in accordance with Treasury Green Book and Capital Investment Manual the five categories of framework options have been considered as follows:

 Potential Service Scope Options – what is the potential coverage of the service to be delivered (the ‘what’);  Potential Service / Technical Solution Options – potential options for delivering the preferred service scope option (the ‘how’);  Potential Service Delivery Options – who will deliver the preferred scope & preferred service / technical solution options (the ‘who’);  Potential Implementation Options – potential timescales options for delivering the preferred scope, preferred service / technical solution and preferred delivery options (the ‘when’);  Potential Finance Options – potential funding and affordability options for delivering the preferred scope, preferred service / technical solution, preferred delivery preferred implementation options. 4.3.2 The Mid & South West Wales Regional Pathology Re-configuration Board previously considered and rejected the following options:  Business As Usual – retained as a baseline comparator.

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 Develop one single site for the future configuration of Cellular Pathology services in Mid and South West Wales (in either Cardiff or Swansea) with ‘hot’ laboratories based on a number of other hospital sites – rejected following non-financial appraisal.  Develop a ‘hub and spoke’ model (with variants on the same) on one or two spokes with the hub located in either Cardiff or Swansea – rejected following non-financial appraisal. 4.3.3 A one-site Cellular Pathology solution was supported by the South West Wales Regional Pathology Re-configuration Project. 4.3.4 The South West Wales Regional Pathology Re-configuration Project Board met in May 2018 and agreed the following:  The preferred location of the one-site Cellular Pathology solution was Morriston Hospital;  The ‘Do Nothing’ option should be discounted from further detailed evaluation;  All new technical solutions should include a dedicated 300 space car park and a 500 m² ATTC shell and core. 4.3.5 The long list and shortlist of options are summarised in Section 4.5. Please refer Appendix N – Framework Options Appraisal for a detailed SWOT analysis. 4.3.6 An independent Health Care Planner (KD Health) assessed the draft Schedule of Accommodation (SoA) against WHBN/HBN requirements (please see Appendix M – SoA). 4.4 Benefit Measurement 4.4.1 The economic gross value added benefits shall be measured at OBC stage in terms of additionality guidance (Additionality Guide, 3rd Edition, English Partnerships - October 2008), measuring, and the extent to which something happens within regional Pathology services as a result of an intervention as against, the absence of the intervention. The principal focus of this economic appraisal will be the direct employment related benefits the project is expected to deliver in the short, medium and long-term. The quantification of these benefits will concentrate on the wider-NHS and Welsh economy rather than the UK generally.

4.5 Framework Options Summary 4.5.1 The framework options long list options findings are summarised below:

Figure 13 - Long List Options Framework Options Potential Service SC01 - Business As Usual Discount (retained Scope as baseline comparator) SC02 - 'Core’ services, i.e. Develop Regional Cellular Pathology Take forward for (Cytology and Histopathology) & Regional Diagnostic (Laboratory) further evaluation Immunology service; Co-locate Singleton‘s Body Store at Morriston Hospital service (future proofed capacity) & a 500 m² ATTC, i.e. Cell and Gene Therapy indicative shell and core area SC03 - 'Core’ services plus Relocate ABMUHB’s PHW Medical Take forward for Microbiology service to Morriston Hospital &/or Develop a temporary further evaluation modular Body Store solution at Singleton Hospital SS04 - 'Core’ services plus Relocate ABMUHB’s PHW Medical Take forward for Microbiology service to Morriston Hospital; Develop a temporary further evaluation modular Body Store solution at Singleton Hospital plus Re-provide ABMUHB’s Essential Laboratory Service. Potential Service SS01 - New Build/Reconfigure co-located regionalised services’ Preferred Solution accommodation on one site &; Provide dedicated car parking to support regionalised services

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SS02 - New Build all co-located regionalised services’ Carried forward - do accommodation on one site; Provide dedicated car parking to support more ambitious regionalised services; plus Reconfigure and refurbish local non- regionalised services accommodation to provide fit for purpose facilities Potential Service DEL1 - NHS in-house solution Preferred Way Delivery Forward Potential IMP01 - Phased (e.g. build some elements as a shell and occupy later Carried forward - do Implementation and phase local refurbishments) less ambitious IMP02 - Single Phase with staged occupancy of new build and Preferred Way concurrent local refurbishments Forward Potential Funding FUN01 - Private funding Discount FUN02 - Public funding Preferred Way Forward FUN03 - Mix of Public and Private funding Discount

4.6 Summary of Shortlisted Options Framework Findings 4.6.1 The South West Wales Regional Pathology Re-configuration Project Board agreed the following range of service scope options: Figure 14 – Service Scope . Functional Content by Health Board Option 2 Option 3 Option 4 Option 5 Do Intermediate Intermediate Do Max Minimum – more – far more ambitious ambitious ambitious HDUHB/ABMUHB Develop Regional Cellular     Pathology (Cytology and Histopathology) HDUHB/ABMUHB Regional Diagnostic     (Laboratory) Immunology service; ABMUHB Co-locate Singleton‘s     Body Store at Morriston Hospital service (future proofed capacity) A 500 m² ATTC, i.e. Cell     and Gene Therapy indicative shell and core area ALL Provide dedicated car     parking to support regionalised services (300 spaces) PHW Relocate ABMUHB’s PHW    Medical Microbiology service to Morriston Hospital HDUHB Reconfigure and refurbish    local non-regionalised Blood Sciences services' accommodation to provide fit for purpose facilities - Refurbishment of Cell Pathology - Withybush Hospital, Prince Philip Hospital, Llanelli & West Wales General Glangwili (approx. 486 m2) ABMUHB Develop a temporary   modular Body Store solution at Singleton Hospital

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ABMUHB Re-provide ABMUHB’s  Essential Laboratory Service 4.6.2 The range of potential service solutions identified in the table above were carried forward into the short list for further appraisal and evaluation. All the options that were ‘discounted’ as impracticable were excluded at this stage. The recommended short list for further appraisal was confirmed as follows Figure 15 – Short List of Options Option 2 – Do Minimum Service Scope SC02 - 'Core’ services, i.e. Develop Regional Cellular Pathology (Cytology and Histopathology) & Regional Diagnostic (Laboratory) Immunology service; Co-locate Singleton‘s Body Store at Morriston Hospital service (future proofed capacity) & a 500 m² ATTC, i.e. Cell and Gene Therapy indicative shell and core area Service Solution SS01 - New Build/Reconfigure co-located regionalised services’ accommodation on one site & Provide dedicated car parking to support regionalised services Service Delivery DEL1 - NHS in-house solution Implementation IMP02 - Single Phase with staged occupancy of new build and concurrent local refurbishments Funding FUN02 - Public funding Option 3 – Intermediate 1 Service Scope SC03 - 'Core’ plus Relocate ABMUHB’s PHW Medical Microbiology service to Morriston Hospital Service Solution SS02 - New Build all co-located regionalised services’ accommodation on one site; Provide dedicated car parking to support regionalised services; plus Reconfigure and refurbish local non-regionalised services accommodation to provide fit for purpose facilities Service Delivery DEL1 - NHS in-house solution Implementation IMP01 - Phased (e.g. build some elements as a shell and occupy later and phase local refurbishments) Funding FUN02 - Public funding Option 4 – Intermediate 2 Service Scope SC03 - 'Core’ plus Relocate ABMUHB’s PHW Medical Microbiology service to Morriston Hospital & Develop a temporary modular Body Store solution at Singleton Hospital Service Solution SS02 - New Build all co-located regionalised services’ accommodation on one site; Provide dedicated car parking to support regionalised services; plus Reconfigure and refurbish local non-regionalised services accommodation to provide fit for purpose facilities Service Delivery DEL1 - NHS in-house solution Implementation IMP02 - Single Phase with staged occupancy of new build and concurrent local refurbishments Funding FUN02 - Public funding Option 5 – Do Maximum Service Scope SC04 - 'Core’ plus Relocate ABMUHB’s PHW Medical Microbiology service to Morriston Hospital & Develop a temporary modular Body Store solution at Singleton Hospital & Re- provide ABMUHB’s Essential Laboratory Service Service Solution SS02 - New Build all co-located regionalised services’ accommodation on one site; Provide dedicated car parking to support regionalised services; plus Reconfigure and refurbish local non-regionalised services accommodation to provide fit for purpose facilities Service Delivery DEL1 - NHS in-house solution Implementation IMP02 - Single Phase with staged occupancy of new build and concurrent local refurbishments Funding FUN02 - Public funding Funding FUN02 - Public funding

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4.6.3 Confirmation of the Preferred Way Forward Option (Option 3) 4.6.4 The preferred way forward is Option 3 – Intermediate 1, i.e. Develop Regional Cellular Pathology (Cytology and Histopathology) & Regional Diagnostic (Laboratory) Immunology service; Co-locate Singleton‘s Body Store at Morriston Hospital service (future proofed capacity), a 500 m² ATTC, i.e. Cell and Gene Therapy indicative shell and core area, & relocate ABMUHB’s PHW Medical Microbiology service to Morriston Hospital to new build/reconfigured and co-located regionalised services’ accommodation, supported by dedicated car parking. 4.7 Transport Arrangements 4.7.1 The development of a co-located Regional Laboratory service must be supported by appropriate, safe and reliable transport arrangements. Transport arrangements going forward will support the NHS Wales’ Health Collaborative’s Diagnostic Services Modernisation Programme’s National Pathology Transport Project Group’s key recommendations, which recognising the variety of providors ion Wales advised, requested All Wales Chief Executives comply with the National Pathology Transport Service Specification. This specification promotes higher quality, safer, temperature controlled services, which encompass robust performance measurements through the contained key performance indicators.20 Please see Appendix O – Transport Arrangements for further details. 4.8 Information Management & Telecoms (IM&T) Arrangements 4.8.1 Similarly, the development of a co-located Regional Laboratory must be supported by sustainable and reliable local and regional IM&T systems. The development of detailed IM&T requirements will be managed by an IM&T Sub-Group with representation from key stakeholders.

20 NHS Wales’ Health Collaborative’s Diagnostic Services Modernisation Programme’s National Pathology Transport Project Group’s recommendations, February 2018 v. final 1.0

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5 The Commercial Case

5.1 Introduction 5.1.1 This section of the SOC outlines the proposed ‘deal’ as outlined in the Economic Case and is seeking to secure public funding from the Welsh Government’s ‘All Wales Capital Programme’. 5.2 Required Services 5.2.1 The required services are as follows:

 Enabling works, including development of approx. 300 car parking spaces to support this development;  1st phase - Development of a fit for purpose, co-located, state-of-the-art facility for South West Wales’ Cellular Pathology and ABMUHB’s Medical Microbiology service. This new facility could be located at Morriston Hospital, Swansea (this includes a 500 m² ATTC, i.e. Cell and Gene Therapy indicative shell and core area), and;  2nd Phase - Refurbishment of existing Morriston Hospital accommodation to support a Regional Diagnostic Immunology service & Extension of the Mortuary facility at Morriston Hospital (future proofed capacity).

5.3 Potential for Risk Transfer and Management 5.3.1 Following agreement of the target cost the final allocation of risk between the Health Boards and the SCP/Main Contractor will be agreed. 5.3.2 A risk register has been compiled and costed relative to risks that apply over the whole of the project lifecycle at this stage (please see Appendix K – Risk Register). The risk register will be developed by the Health Board Project Liaison Manager in consultation with the Health Board’s Cost Advisor during the development and construction phases of the project, through to hand over and operational commissioning. It is planned to review the risk register, which will be regularly reviewed and updated accordingly, to maintain tight financial cost control relative to the risks noted in the register. 5.3.3 The Project Director will report to the South West Wales Regional Pathology Re-configuration Project Board. It is planned to review the risk register regularly and update accordingly to maintain tight financial cost control relative to the risks noted in the register. 5.3.4 Cellular Pathology and Diagnostic Immunology services’ management will manage service implications and will endeavour to mitigate any risk of disruption to hospital services and performance during the works and re-instatement phase. 5.4 Personnel Implications (Including TUPE) 5.4.1 TUPE (Transfer of Undertaking and Protection of Employee) will apply to this investment. 5.5 Indicative Timescales 5.5.1 The indicative milestones are set out below: Figure 16 – Key indicative milestones

Activity Due Date HDUHB & ABMUHB Executive Teams endorse ‘Discussion’ SOC November/December 2018 HDUHB Executive Team approves SOC February 2019 ABMUHB’s Investments and Benefits Group (IBG) endorses SOC 12th March 2019 ABMUHB Executive Team approves SOC 13th March 2019 ABMUHB Board approves SOC 28th March 2019

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Activity Due Date Submit SOC to Welsh Government for endorsement April 2019 Welsh Government endorse SOC May 2019 Appoint Supply Chain Partner, Health Board Cost Advisor & July 2019 Health Board Project Manager from Designed for Life Regional Framework ABMUHB’s IBG and HDUHB & ABMUHB Executive Teams June 2020 approve OBC Submit OBC to Welsh Government for approval June 2020 Welsh Government approval of OBC September 2020 ABMUHB’s IBG and HDUHB & ABMUHB Executive Teams October 2021 approve FBC Submit FBC to Welsh Government for approval October 2021 Welsh Government approval of FBC January 2022 Mobilise and commence new build/extension main works February 2022 New build completed (subject to contractor’s programme) January 2024 New build commissioning (subject to accreditation arrangements February 2024 & technical commissioning) New build operational March 2024 Commence refurbishment April 2024 Refurbishment completed (subject to contractor’s programme) October 2024 Refurbishment commissioning (subject to accreditation November 2024 arrangements & technical commissioning) Refurbishment operational December 2024 Technical PPE (approx. 3 months post new build handover) March 2025 5.5.2 Please see Appendix J – Management Control Plan. Note, are subject to confirmation of planning and funding approvals and agreed construction programmes. 5.6 FRS5 – Accountancy Treatment 5.6.1 It is assumed public funding will be allocated for this project and therefore capital will be included on the balance sheet.

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6 Funding and Affordability

6.1 Introduction 6.1.1 The purpose of this section is to set out the indicative financial implications as set out in the Economic Case. 6.2 Capital 6.2.1 A capital cost assessment of the shortlisted options has been undertaken by Gleeds, Cost Advisors based on NHS Departmental Cost Allowances (DCAGs) applied to the proposed schedules of accommodation. The costing was undertaken in accordance with guidance for the costing of capital schemes. 6.2.2 The hi-level capital costs of the shortlisted options (including revoverable VAT) are as follows: Figure 17 – Capital Requirements (£000 incl non-recoverable VAT) Option 2 Option 3 Option 4 Option 5 Do Minimum Intermediate – Intermediate – Do Max ambitious more ambitious far more ambitious Departmental Costs 17,249 25,729 27,121 31,168 On Costs 13,041 20,332 20,475 25,499 Provisional location -908 -1,382 -1,427 -1,700 adjustment Works Costs Total 29,382 44,679 46,169 54,967 Fees 4,701 7,149 7,387 8,795 Non Works Costs 1,741 2,694 2,641 2,745 Equipment Costs 3,611 5,059 5,231 5,718 Planning Contingency 3,943 5,958 6,142 7,222 VAT (adjusted for 7,576 11,678 12,036 14,130 reclaim) Base Project Cost 50,954 77,217 79,606 93,577 Capital Assumptions

6.2.3 The key planning assumptions are as follows:  Capital Costs include a breakdown of works and non-works elements.  Where in-house fees will usually have been outsourced these fees have not been charged against revenue. Their contribution towards delivery of this scheme has been based on an agreed resource allocation.  Construction costs were calculated applying the BCIS PUBSEC Firm Price Index 248 reporting level. The Location Factor is 0.97.  A VAT rate of 20% has been reflected in the capital costs. The level of revoverable VAT is 100% on professional fees. Other elements of VAT recovery will be limited to areas of refurbishment and an assessment of this oppourtunity will be assessed by specialist VAT advisors at OBC stage.  Planning contingencies of 10% has been allowed to the shortlisted options, as appropriate, and in line with the generally accepted norm at this stage of the project.  Optimism Bias has been excluded as per guidance.  The Business As Usual option (Option 1) was rejected for further detailed analysis. It provides a baseline comparator.

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6.3 Revenue 6.3.1 A number of costs pressures associated with the staffing models exist, whether the service moves to a new facility or remains in-situ. These relate to increasing demand for pathology services. For that reason it is reasonable to recognise the current service and projected future demand, but to exclude them from the revenue financial model at this stage in the development of the business case. 6.3.2 In moving to a single facility, Hywel Dda would need to manage the workload of their Consultant staff using the Royal College points based system. This would mean an increased revenue cost pressure. However, over the last few months, work undertaken between both organisations, suggest this cost increase will be less than previously anticipated. In addition it now seems likely that as a result of the closer working relationship of the two organisations, Hywel Dda will be moving to the points based system in advance of any new building. This will allow them to reap the benefits of also moving to partly implement the Advanced Practitioner role that is being successfully adopted in ABM. The adoption of the Advanced Practitioner role will in effect lessen the cost base if it had not been adopted. At the SOC stage it has been assumed no additional cost pressure 6.3.3 Further work will be required at OBC to assess the impact of travel. There are likely to be additional lab specimens travelling to Morriston. However it is too early to estimate the extent of any additional costs, as it is likely that existing transportation journeys can be utilised. Further work will also be required during the OBC to assess the impact on IT. 6.3.4 There are likely to be additional costs associated with running a modern facility built to conform with the latest building and engineering standards. This will be due to the new facility requiring increased space to meet these requirements and the cost of servicing a modern building environment are normally greater than older non-complaint buildings. At this stage no detailed building design work has been undertaken but a high level estimate indicates that it would not be unreasonable to expect additional annual running costs of at least £200k. 6.3.5 Further work on depreciation and impairment will be undertaken at OBC stage. 6.4 Income and Expenditure Analysis 6.4.1 The estimated additional recurring revenue costs for the shortlisted options are outlined in the figure below: Figure 18 – Revenue cost impact of the Shortlisted Options (£000’s) Option 2 Option 3 Option 4 Option 5 Do Minimum Intermediate – Intermediate – far Do Max more ambitious more ambitious ambitious Service Pay Service Non-Pay Support 197 236 263 503 Services Total 197 236 263 503

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7 The Management Case

7.1 Introduction 7.1.1 The section of the SOC addresses the achievability of the scheme. 7.2 Project Management Arrangements 7.2.1 To ensure successful project delivery a robust project management reporting structure has been established. The structure is based on the Prince2 principles, with key members of the project team trained in Prince2 methodology. Our experience of developing and delivering complex projects in a Prince2 environment ensures diligent management and thorough clinical involvement throughout all parts of the development. Reporting Structure 7.2.2 There are three Senior Responsible Owners (SROs). These are the Chief Executive Officers of ABMUHB and HDUHB Health Boards and Public Health Wales respectively. The co-Project Directors are, Mrs Karen Miles (Director of Planning HDUHB) and Mrs Christine Morrell (Deputy Director of Therapies and Health Science, ABMUHB). They have the authority and responsibility to manage delivery of the project on behalf of the key stakeholders. The Project Director reports via the South West Wales Regional Pathology Re-configuration Project Board to the SROs. A nominated Project Manager, Mr Chris Bowden (Cellular Pathology Operations Manager, ABMUHB), supports the Project Director. The reporting structure is below: Figure 19 – Reporting Structure

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7.3 Project Roles and Responsibilities 7.3.1 The Project Director takes lead responsibility for the overall success of the project, and the services which support the change; Agrees and directs the activity of the project; Takes the lead responsibility for risk relating to the project and for the realisation of associated benefits; Agrees and directs the activity of the project; Instructs and manages external consultants; Ensures the brief set by South West Wales Regional Pathology Re-configuration Project Board is adhered too, and; Provides the key contact in respect of high level decisions required in order to progress work. 7.3.2 The Project Manager, Mr Chris Bowden (Cellular Pathology Operations Manager, ABMUHB) provides effective liaison with the wider clinical team. The Project Manager provides highlight reports and exception reports to the Project Board on all aspects of project performance; Ensures the project team (which will include technical and capital planning, construction and service planning leads) is effectively directed and managed during SOC stage; Supports effective liaison with the wider team; Ensures effective monitoring of all project activities is undertaken regarding time, quality and cost, and; Develops the Post Project Evaluation plan. 7.3.3 A Health Board Project Manager and Health Board Cost Advisor will be appointed from the Designed for Life: Building for Wales Framework once this scheme is approved to enter OBC stage. 7.3.4 For the terms of reference and South West Wales Regional Pathology Re-configuration Project Board and Project Team’s membership, please see Appendix G – Terms of Reference. 7.4 Use of Special Advisors 7.4.1 The following special advisors have been appointed:

Figure 20 – Special Advisors Role Appointment VAT Advisor Ernst & Young Cost Advisor (SOC stage) Gleeds Health Care Planner KD Health 7.5 Workforce Planning & Operational Arrangements 7.5.1 The Project Director is lead for service change and operational arrangements in collaboration with agreed service stakeholder representatives. These arrangements will be detailed at OBC stage. 7.6 Health Impact Assessment (HIA) 7.6.1 A HIA is attached in Appendix A – HIA for information. 7.7 Equality Impact Assessment (EIA) 7.7.1 An EIA is attached in Appendix B – EIA for information. 7.8 Building Research Establishment Environmental Assessment Method (BREEAM) 7.8.1 A pre-construction BREEAM assessment will be provided at OBC stage, following confirmation of detailed design and consultation with the BREEAM Advisor and planning authorities once outline planning permissions are agreed. 7.9 Achieving Excellence Design Evaluation Toolkit (AEDET) 7.9.1 An AEDET assessment will be progressed with NWSSP-SES representatives at OBC stage once design proposals has been detailed.

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7.10 Arrangements for Benefits Realisation 7.10.1 A Benefits Register and Benefits Realisation Plan have been developed which will provide a working document throughout the life of this project. A draft register and benefits realisation plan are attached in Appendices H & I – Benefit Realisation Register & Plan. These arrangements will be detailed at OBC stage. 7.11 Arrangements for Risk Management 7.11.1 A risk framework has been established which outlines the process for managing risk associated with developing a Regional Pathology project, including a structure for identifying and mitigating operational and construction related risks. 7.11.2 The risk register will use qualitative and quantitative measures to calculate the overall level of risk according to likelihood of any risk occurrence multiplied by the potential impact and South West Wales Regional Pathology Re-configuration Project Board will formally review the risk register at key stages of the project. 7.12 Post Evaluation Arrangements 7.12.1 All projects are subject to post construction review evaluation in accordance with recognised best practice and NHS guidance. Post evaluation arrangements and timescales detailed at OBC stage will be agreed with the key stakeholders. A team constituting planning, construction and design will undertake PPE, and management leads at key stages, as appropriate. Please refer to Appendix C – Post Evaluation Arrangements for information. 7.13 NHS Wales Gateway Review (Stage 0 – Business Justification) 7.13.1 A Risk Potential Assessments 1 (RPA 1) has been carried out for this scheme. A copy is included in Appendix D - Gateway Review - RPA1. A Gateway ‘0’ review will be arranged Welsh Government post submission of this SOC and prior to the submission of an OBC in accordance with Welsh Government Investment Guidance. Further Gateways will be completed according to Office of Government Commerce (OGC) guidelines following further evaluation. 7.14 Contingency Plans 7.14.1 The Health Board can identify two major category of project failure: failure to achieve business case approval to deliver the scheme; failure of the main contractor(s) to deliver the new build and complex series of refurbishments to time. 7.14.2 The contingency plan for the project in the event of failure to achieve business case approval is for the Health Board to continue to revise its plans, working with Welsh Government to develop an acceptable pathology solution for the region. 7.14.3 In the event of Supply Chain failure, ABMUHB will seek recompense in line with the agreed contractual arrangements and other contractor(s) to complete the project.

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Appendix A – HIA

Appendix A - HIA v3.doc

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Appendix B – EIA

Appendix B - EIA v3.doc

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Appendix C – Post Evaluation Arrangements

Appendix C - PPE v2.doc

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Appendix D – Gateway Review - (RPA1)

Appendix D - RPA1 (2).doc

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Appendix E – Option & Risk Appraisal Group Membership

Appendix E - Membership.docx

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Appendix F – Investment Objectives and Benefits

Appendix F - Investment Objective

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Appendix G – Terms of Reference

Appendix G - Terms of Reference (2).docx

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Appendix H – Benefits Realisation Register

Appendix H - Benefits Realistion R

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Appendix I – Benefits Realisation Plan

Appendix I - Benefits Realisation

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Appendix J – Management Control Plan

Appendix J - Indicative Programm

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Appendix K – Risk Register

Appendix K - Risk Register v8.xlsx

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Appendix L – AWCP Group’s non-financial and financial appraisals

Timeline diagram.doc

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Appendix M – SoA

Appendix M - SoA.pdf

Appendix M2 - SOA.xlsx

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Appendix N – Framework Options Apppraisal

Appendix N - Framework Options

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Appendix O – Transport Arrangements

Appendix O - Transport Arrangeme

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Appendix P – Summary of South Wales Cellular Pathology Project’s (SWCPP’s) Key Milestones

Appendix P - South Wales Cellular Patho

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Abbreviations ABMUHB Abertawe Bro Morgannwg OCP Organisational Change Policy University Health Board AEDET Achieving Excellence Design OGC Office of Government Commerce Evaluation Toolkit AME Annually Managed Expenditure PACU Post Anaesthetic Care Unit ARCH A Regional Collaboration for PDP Portfolio Delivery Plan (ARCH) Health ATMPs Advanced Therapy Medicinal PEP Project Execution Plan Products ATTC Advanced Therapy Treatment PHW Public Health Wales NHS Trust Centre (i.e. Cell and Gene Therapy) BIS PUBSEC Firm Price Index PIA Privacy Impact Assessment BREEAM Building Research Establishment PLU Pathology Laboratory Unit Environmental Assessment BRP Benefits Realisation Plan POCT Point of Care Testing CPA Clinical Pathology Accreditation PPE Post Project Evaluation CSF Critical Success Factor PTL Patient Tracking List CTUHB Cwm Taf University Health Board RIBA Royal Institute of British Architects DECAG Departmental Cost Allowance RPA Risk Potential Assessment Guide DGH District General Hospital RTT Right to Treatment DGM Divisional General Manager SDCP Site Development Control Plan DoH Department of Health SLA Service Level Agreement DOSA Day of Surgery Admission SOC Strategic Outline Business Case ECAG Equipment Cost Allowance Guide SOP Standard Operating Procedure EIA Equality Impact Assessment SSAGs Specialist Standing Advisory Committees EPRR Emergency Preparedness TAT Turn Around Time Resilience and Response EQA External Quality Assessment TPN Total Parenteral Nutrition FBC Full Business Case WG Welsh Government GEM Generic Economic Model GIRFT Get it Right First Time WHBN Welsh Health Building Note GMP Guaranteed Maximum Price WHTM Welsh Health Technical Memorandum GVA Gross Value Added HAI Hospital Acquired Infection HBCA Health Board Cost Adviser HBPM Health Board Project Manager HDUHB Hywel Dda University Health Board HIA Health Impact Assessment HMt Her Majesty’s Treasury HTA Human Tissue Authority IMTP Integrated Medium Term Plan LIMS Laboratory Information Management System MDT Multi-Disciplinary Team NEC New Engineering Contract NPF National Pathology Framework NWSSP – SES NHS Wales Shared Services Partnership – Specialist Estates Services OBC Outline Business Case

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Glossary

Term Definition

‘Cold tests’ Generally, means non-inpatients e.g. outpatients and GP tests whose Turn Around Time (TAT) requirements can exceed 8 hours. ‘Diagnostic Immunology’ Also known as ‘Laboratory Immunology’. Gross Value Added (‘GVA’) The measure of the value of goods and services produced in an area, industry or sector of an economy. ‘Hot Lab’ This is a shared laboratory facility, staffed by a BMS for pre-booked frozen sections. The facility must have appropriate digital communication with a “Site”. This option only to be used when transport to the centralised site(s) will render an unacceptable clinical delay. ‘Hot tests’ Generally, means inpatients prioritising unscheduled care e.g. A&E whose TAT requirements are 8 hours or less. ‘LEAN’ principles LEAN is an improvement approach, developed by Toyota, to improve flow and eliminate waste. It is about getting the right things to the right place, at the right time, in the right quantities, while minimising waste and being flexible and open to change. Lean is increasingly being applied to healthcare in both the United Kingdom and overseas to: Improve the quality of patient care; Improve safety, and; Eliminate delays and reduce length of stay. ‘Pathology’ An ‘umbrella’ term used within this document to describe the four main specialties, i.e. Blood Sciences (Haematology & Chemical Pathology services, also called Laboratory Medicine, Blood Transfusion, Cellular Pathology and Medical Microbiology. Temporary Mortuary A pre-designated location which can be used as a mortuary if the scale of the incident renders existing facilities inappropriate. Such locations require detailed pre-planning and will be used as a centre for the examination and identification of the deceased

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