Agenda Item No: 9
CTRT Business Case PURPOSE: Full Business Case for approval for chemotherapy clinical Trials Unit at Mount Vernon Hospital
IMPLICATIONS: Risks
Financial
Human resources
National Policy Links to Corporate objectives
Legal issues
A full risk management register has been compiled and forms part of the FBC Capital funding comes entirely from charitable funding and legacy funding. No funding from the Trust. Capital costs includes rental to Hillingdon for temporary accommodation. The facility will provide a better working environment and support the development and implementation of new models of care and treatment techniques To achieve recruitment targets of patients entering clinical trials as set out by National Cancer Research Network Compliance with requirement for quality and safe patient care: Ø Maintain and improve access to experimental and standard chemotherapy Ø Improve quality of care for patients involved in research Agreement between CTRT and the Trust is drafted and attached to FBC
RECOMMENDATION: Full Business Case to be approved subject to capital costs being confirmed at £1.4m and continuing assurances to the Project Board that no funding is to be provided by the Trust.
DIRECTOR:
Director of Strategic Development
PRESENTED BY:
Director of Strategic Development
AUTHOR:
Mike Cullum (Project Manager)
DATE:
March 2009
EAST AND NORTH HERTFORDSHIRE NHS TRUST
FULL BUSINESS CASE FOR REDEVELOPMENT OF THE CANCER CENTRE CHEMOTHERAPY SUITE TO INCORPORATE A CLINICAL TRIALS UNIT
Version: Final February 2009
Page 2 of 32
CONTENTS
Executive summary Section 1
National priorities and local objectives
p.8
Section 2
Guidance documents
p.8
Section 3
Strategic context
p.9
Section 4
Activity analysis
p.11
Section 5
Option appraisal
p.13
Section 6
Risk Management
p.17
Section 7
Costs
p.17
Section 8
Consultation
p.19
Section 9
Key Stakeholders and Project Management Team
p.19
Appendices Appendix I
Financial summary
Appendix II
Agreement between the CTRT appeal committee and East and North Herts Trust
Appendix III
Risk Management Plan
Appendix IV
FBC Report C&B (to follow)
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EXECUTIVE SUMMARY Introduction This Full Business Case (FBC) outlines the requirements to extend, and refurbish the Chemotherapy Suite at the Mount Vernon Cancer Centre, incorporating within the new design facilities for the treatment of patients involved in clinical trials of chemotherapy. A dedicated clinical trials facility is required to meet the needs of increasing patient numbers and respond to regulatory requirements for conducting research. The existing facilities for delivering chemotherapy are substandard and in need of investment. The planned construction of an extension to the building for clinical trials has provided an opportunity to review the function of the entire unit. Fundraisers, stakeholders, patients and carers have been involved in the review, and fully support the proposal to construct an integrated unit, which will benefit patients receiving standard and experimental chemotherapy. This case has been developed in response to a partnership developed between the Cancer Treatment and Research Trust and the East and North Hertfordshire NHS Trust, through its registered charity, to jointly fundraise with an appeal for
£1.5 million to
develop a clinical trials unit capable of delivering chemotherapy treatment to patients enrolled in clinical trials. Approval of the Full Business Case by the East and North Hertfordshire NHS Trust will trigger the appointment of a contractor subject to fundraised income targets being met. This document will identify the options that have been considered and identify the chosen option. Primary Care Trust (PCT) Support PCTs will be kept informed of the proposals set out in this document via the quadrant meeting system. Consumer involvement A survey to obtain the views of patients using the existing facilities has been conducted and has informed the design of the new development.
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Proposed Clinical Trials Facility Within the proposed unit there will be discrete areas for the treatment of patients involved in clinical trials and for those receiving standard chemotherapy treatment. However, the proposed design allows for shared resources such as consultation rooms and utility rooms, and for crosscover between the nonresearch and research clinical cases. Primary Objectives The purposes of this Full Business Case (FBC) are to: ·
describe the present position
·
justify the project proposals for the redevelopment of the Chemotherapy Suite
·
structure the proposals to meet the primary objectives for a business case as set out by the East and North Hertfordshire Trust.
The main objectives of this case are to: 1.
Maintain and improve capacity and access to cancer clinical trials involving chemotherapy.
2.
Provide a centralized treatment centre thereby enhancing efficiency of treatment delivery, increasing patients’ well being and staff productivity.
3.
Enhance the surroundings for patients receiving chemotherapy treatment in accordance with NHS standards (control of infection, privacy and dignity, etc).
4.
Deliver a service appropriate for a 21st century cancer centre thus sustaining the centre’s worldrenowned reputation.
5.
Achieve recruitment targets of patients entering clinical trials as set out by The National Cancer Research Network
6.
Ensure data confidentiality. At present lack of appropriate space means that case report forms containing research data by necessity must be left in nonsecure locations during treatment.
7.
Provide staff access to electronic research data at the point of treatment delivery
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Trust Estate The Mount Vernon Cancer Centre is situated on a site that is owned and managed by Hillingdon Hospitals NHS Trust. A lease is paid to that organisation based upon area of occupied space. The Trust provides estates management to the cancer centre. The areas currently used for research purposes are inadequate. Limited research space and lack of data confidentiality are just two examples. Many onstudy research patients are presently treated in nondesignated areas when nonresearch cases require the use of the facility. The proposed accommodation will partly utilise existing shared facilities, meaning that only a relatively small additional revenue charge associated with lease and maintenance service charges will be incurred. It is the intention that fundraised income will cover these revenue costs. The proposed development has the full support of the Hillingdon Hospitals Trust. The Head of Estates and Facilities has provided written confirmation that the Trust Board has agreed that the development may proceed. Strategic context Under the Investing in Your Health strategy for Bedfordshire and Hertfordshire, a proposal was developed in 2003 to build a new hospital in Hatfield that would host the Cancer Centre. However, a review of the revenue costs associated with the new hospital revealed that the proposal was not affordable. In September 2006, the new Hertfordshire PCTs were asked by the East of England Strategic Health Authority to review the original assumptions underpinning Investing in Your Health as part of a wider review of acute hospital services within the East of England.
Currently the findings of the review are subject to a wide consultation with a view to developing proposals. The time frame for this reprovision of services is likely to be 2013 at the earliest so services on the present site must develop to maintain the quality of service presently delivered to our patient population. To this end a developmental review of the Cancer Centre is being undertaken.
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Since the Mount Vernon Cancer Network joined the National Cancer Research Network in April 2002, 36 research staff (26.5 whole time equivalent) have been appointed within the Cancer Centre. Recruitment of patients to national studies has risen from a baseline of 85 patients in 2001/02 to 591 patients in 2007/08 (204 patients to treatment trials, 387 patients to genetic studies). In addition, there is a large portfolio of commercial and early phase trials operational within the Cancer Centre. 113 patients were recruited to these studies during 2007/08.
Option Appraisal Five main options have been considered. Option I
Do Nothing.
Option II
Redesign and refurbish the existing chemotherapy suite at the
Mount Vernon Cancer Centre, incorporating within the new design facilities for the treatment of patients involved in clinical trials of chemotherapy. This option will involve adjustment to the existing building and arrangements have been made to relocate the chemotherapy service during the construction phase. The first floor of the building will be redeveloped within the project to improve office accommodation for research staff. Option III Relocation of the existing chemotherapy suite to the Upper West Wing at Mount Vernon Hospital and development of the clinical trials unit within the same area. This option would permit the use of existing facilities and may involve less structural work than option II. Option IV Relocation of the existing chemotherapy suite to the Ged Adams building within the Gray Cancer Institute Mount Vernon Hospital and development of the clinical trials unit within the same area. This option would permit the use of existing facilities and may involve less structural work than option II.
Costs and Affordability It is critical that all options are cost neutral both in capital and revenue terms for the Trust in order to secure the support of the Trust Board and PCTs.
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Procurement Procurement of this facility will follow standard NHS policies and procedures to ensure value for money. It should be noted that some of the required equipment is already in place and in use within the centre. Timetable This scheme has several timetabling requirements. A practical and realistic timetable has been defined and will be adhered to. A proposed timetable for approval of the project is as follows: Feb 2009
Submit full business case with pretender estimate to E&N Herts Treasury and Investment Committee
Feb – March 09
Tendering process and appointment of contractor
Feb 09
Relocation of chemotherapy unit to outpatient department
April 09
Construction commences
November 09
Return of chemotherapy service to new unit
Conclusion This Full Business Case (FBC) describes the need for a dedicated clinical trials area within the chemotherapy suite at the Cancer Centre at Mount Vernon Hospital. The proposal has the support of the Sponsors and the Mount Vernon Cancer Board. The local PCTs will be consulted at every stage of development. A full options appraisal has been conducted and justification for the preferred option is provided. It is envisaged that once the refurbishment is complete the Cancer Centre will be able to attract additional funds to support research and development in chemotherapy. Approval of this FBC is sought in order to confirm the following: ·
Approval that the scheme meets Trust priorities
·
Approval to commence the building phase, on the basis that sufficient funding has been raised or underwritten to cover the cost
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Section 1
NATIONAL PRIORITIES AND LOCAL OBJECTIVES
The key objectives of the Mount Vernon Cancer Centre Cancer Board are: ·
Maintain and improve access to standard and experimental chemotherapy within the Mount Vernon Cancer Centre
·
Improve the quality of care provided for patients involved in research.
·
Enhance the surroundings for patients receiving chemotherapy
·
Deliver a service appropriate for a 21st century cancer centre thus sustaining the centre’s worldrenowned reputation in research.
·
Achieve and maintain clinical trials recruitment targets set out in the National Cancer Plan
At present, the national priorities for research and local objectives described above cannot be achieved due to the lack of dedicated facilities for clinical research on the Mount Vernon Site. This Full Business Case describes the disadvantages and risks associated with the existing facilities. These are set out in the Options Appraisal and the chosen option is indicated.
The FBC is intended to be a planning document that
contains relevant information about the project. The document reenforces the importance of a clear and transparent framework for making capital investment decisions via local strategic planning, asset management strategies, business case and option appraisal.
Section 2
ALIGNMENT WITH THE UK’s STRATEGIC GOALS FOR CANCER SERVICES AND RESEARCH, THE NHS PLAN (2000)
The NHS Plan sets out a strategic and operational framework for the modernisation of the facilities and services within the NHS, in line with the needs of the 21st century. The aim of the NHS plan is to deliver a more patient focussed service with greater integration both within the NHS and other agencies, thus promoting a seamless service. The plan places significant emphasis on the delivery of care within local high quality facilities.
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The NHS Plan describes a new NHS National Cancer Research Network (NCRN). The initial aim of NCRN is to double the total proportion of adult cancer patients entering clinical trials. Report of the Science and Technology Committee on Cancer Research (2000) The National Cancer Research Network (NCRN) was created in response to the need to improve the infrastructure within the NHS for clinical research in cancer and to ensure that research is better integrated with cancer care. Section 3 3.1
STRATEGIC CONTEXT
Overview of the Trust and Cancer Centre
Mount Vernon Cancer Centre was, until March 31st 2005, under the management of West Hertfordshire Hospitals NHS Trust. On 1st April 2005 the management was transferred to East and North Hertfordshire Hospitals NHS Trust.
This transfer was a
strategic decision relating to the delivery of the “Investing in Your Health” programme. The design of this new facility falls under the remit of East and North Hertfordshire Hospitals NHS Trust and the cancer centre team can now assist in the development process from within that organisation. The present population served by the cancer centre is over 1.9 million. This is due to rise to 2.2 million by 2013. The centre has to provide services to meet the needs of this increased population. The Clinical Trials Unit will be an essential facility to meet this increased demand effectively. Mount Vernon Cancer Centre is within the Mount Vernon Cancer Network but also provides radiotherapy and complex chemotherapy services to parts of North and West London as well as the Thames Valley cancer network. The population areas currently served by the cancer centre include Hillingdon, Harrow, East Berkshire, South Buckinghamshire, Barnet, Luton, Watford, Hemel Hempstead, St Albans, Hatfield, Hitchin, Baldock and Stevenage. The East and North Hertfordshire Hospitals NHS Trust comprises three hospital sites including the Mount Vernon Cancer Centre. The Trust offices are on the Lister Hospital site in Stevenage. All administrative work associated with cancer clinical research is carried out on the Mount Vernon site.
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The Mount Vernon Cancer Centre is situated on a site that is owned and managed by Hillingdon Hospital NHS Trust, which provides estate management services. A lease is paid to that organisation based on the area of the occupied space. There are 64 cancer beds within the centre over three wards, of which one covers fiveday stay patients only.
Services within the cancer centre include a large radiotherapy
department delivering over 4000 new courses of external beam radiotherapy per year, and chemotherapy suite delivering approximately 2000 courses per year. 3.2
The ‘Vision’
The Centre’s vision is to continue to deliver the best cancer treatment service possible and to develop new and updated techniques and systems of work that are patient focussed underpinned by evidencebased medicine. The Trust’s vision is to provide safe and effective services to our catchments population whilst supporting clinical research and development. The proposed development of the will facilitate the achievement of that vision. 3.3
The NHS Plan
The NHS Plan sets out a strategic and operational framework for the modernisation of the facilities and services, in order to provide a service in line with the needs of the 21st century. The aim of the NHS plan is to deliver a more patient focussed service with greater integration both within the NHS and other agencies, thus promoting a seamless service. The plan places significant emphasis on the delivery of care within local high quality facilities. 3.4
Strategic Fit
The development of the clinical trials unit and upgrading of existing facilities is totally aligned to the strategic aspirations of both the National Priorities for Cancer Research and the Mount Vernon Cancer Centre Board. For example: New Ways of Working – Revised and updated patient pathways and models of care will be developed to fully utilise the upgraded facilities. Higher Quality of Care – Whilst retaining its own identity, the trials unit will be fully integrated with the existing Chemotherapy Suite to enable a supportive and dynamic environment. The unit will provide a dedicated area for the administration of innovative treatments and techniques associated with ongoing clinical research.
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Better Conditions for NHS Staff – The new facility will be a purposedesigned area providing a better working environment and will support the development and implementation of new models of care and treatment techniques. Maintain Reduced Waiting Times – The reprovision of the service will allow a more efficient use of existing equipment and administrative processes, keeping waiting times to a minimum. Patient Centred Care – The design of the unit incorporates enhanced patient and carer waiting facilities and improved privacy during both treatment and consultations. Better Facilities – This unit will be a 21st century facility, fit for purpose and ready for future developments in this form of treatment delivery.
Section 4
ACTIVITY ANALYSIS
The proposed facility will have no effect on the level of treatment activity for patients receiving standard chemotherapy within the chemotherapy suite.
It will however
accommodate the projected increase in research activity shown in table 1.
The
financial benefits for the Trust are twofold. Firstly, a significant number (see table 2) of research patients that are currently treated on the cancer wards will to be treated in the new unit as outpatients.
This will increase capacity on the wards, providing
opportunities for generating income.
Capacity in outpatient clinics will also be
increased as the proposed unit will provide facilities for other researchrelated activity currently performed in the clinics such as obtaining consent and data collection. The second financial benefit is that the new unit will enable more patients to be treated within clinical trials. The new funding arrangements for R&D are firmly linked to research activity and it is therefore essential to increase accrual to trials in order to sustain the level of funding allocated to the Trust in previous years. The new unit will also facilitate growth in the portfolio of commercial trials within the Cancer Centre, giving patients access to new agents and providing industry funding.
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Table 1 Projected increase in research activity assuming proposed unit goes ahead. Pts recruited to non commercial treatment trials
Pts recruited to commercial treatment trials
Total patients recruited to treatment trials
2005/06
131
41
172
2006/07
152
111
263 (up 52% on previous year)
2007/08
204
113
317 (up 20%)
2008/09 (projected)
228
120
348 (up 10%)
2009/10 (projected)
252
130
382 (up 10%)
2010/11 (projected)
280
140
420 (up 10%)
2011/12 (projected)
312
150
462 (up 10%)
2012/13 (projected)
348
160
508 (up 10%)
NB Rate of increase in research activity 05/06 to 06/07 reflects rapid expansion in workforce. The expansion in staff numbers was less marked between 06/07 and 07/08 and is likely to be slow but sustained in future years.
Table 2 Projected increase in availability of inpatient beds Number of research patients relocated from inpatient to outpatient facilities based on 20% of patients relocated
Number of ‘bed days’ released (assuming 6 treatments per patient)
2008/09 (projected)
70
420
2009/10 (projected)
76
456
2010/11 (projected)
84
504
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2011/12 (projected)
92
552
2012/13 (projected)
101
606
Section 5
OPTION APPRAISAL
Five options have been considered for the improvement of the accommodation to a modern standard at the hospital, the benefits and drawbacks associated with each option have been outlined.
5.1
The Options The four options are as follows:
Option I
Do Nothing
This has been considered to assess whether there is any merit in maintaining the status quo. This business case has assumed activity growth in research of at least 10% per annum. The existing facilities for treating patients receiving standard chemotherapy are inadequate and not fit for purpose. ·
The reception area is dark, drafty and unwelcoming.
·
The consultation rooms are gloomy and oppressive mainly because they do not receive any natural light.
·
The treatment area is badly designed resulting in very poor use of space and restriction to the number of patients that can be treated.
·
The views from the windows are bleak and patients do not have access to outside areas.
·
There is no sluice for disposal of patients’ body fluids.
·
Security is poor.
·
There is no nurse call system within the unit (apart from the toilet areas)
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The space for research within the current chemotherapy unit is barely adequate for meeting the needs of patients in clinical trials. At present only 4 research patients can be treated per day. The research team has limited access to a bed in the chemo suite. Overflow research patients at present are treated in the cancer ward. This procedure is clearly inadequate because: a.
It blocks intake of new patients into the cancer centre
b.
It scatters resources and personnel
c.
It increases level of anxiety of patients because of unfamiliar surroundings
d.
Lack of privacy for holding private consultation between staff and patients compromises confidentiality
Furthermore, there is no additional space, either as an internal or external sitting area, for patients requiring rest and respite during treatment. The waiting area in the current chemotherapy unit is not big enough to accommodate both research and nonresearch patients and their relatives or carers. There is no space for storing expensive monitoring equipment, which at present must be left in wards or corridors. The current chemotherapy suite does not have Dirty Utility area where one can process and store blood products and dispose of patients’ body fluids.
Option II Development of an integrated area for the treatment of patients receiving standard and experimental chemotherapy. This option takes into account the generous offer of volunteers who aim to fundraise for the sum of £1,500,000 towards this project. This option also involves some redevelopment of the first floor of the existing building. This option has the major advantage of sharing facilities with an existing service, namely the Chemotherapy Suite. This new structure would contain:
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1.1.1
An area for treating a maximum of 15 patients receiving standard chemotherapy and 6 patients receiving experimental chemotherapy at any one time. The area will contain 19 treatment chairs and 2 beds.
1.1.2
3 consulting rooms: for examination of patients, clinical procedures, followup appointments and private discussions with patients or relatives.
1.1.3
1 counselling room for consultations that may involve breaking distressing news.
1.1.4
Dedicated area for safe storage of clinical data
1.1.5
2 storage areas for monitoring equipment, chemotherapy administration equipment and disposables
1.1.6
Dirty Utility Room: this will be a shared facility with the Chemotherapy Suite and would allow the safe disposal of body fluids. A sluice would be essential for disposing of waste in purpose built containers. The area will also contain a dedicated area for sample preparation (for example separating blood products by spinning in centrifuge) and storage of samples in specialised freezers at required temperature.
1.1.7
2 prep areas for laying up trolleys for phlebotomy and chemotherapy administration, and for checking drugs.
1.1.8
Enlargement of waiting room area: to accommodate increase numbers of research and nonresearch patients together with their relatives and or carers.
1.1.9
2 landscaped gardens viewed from the clinical areas: for those patients requiring access to fresh air and respite during treatment.
1.1.10 Refurbishment of staff room. Work will also be undertaken in the first floor. The two main aims are to improve access to the lecture room and to improve the fire escape as the building does not comply with fire regulations. Finally 2 opened planned offices, used by research staff, need to be refurbished, their privacy improved to improve data protection and staff wellbeing.
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Option III Relocation of the existing chemotherapy suite to the Upper West Wing at Mount Vernon Hospital and development of the clinical trials unit within the same area.
This option utilises existing facilities and would involve less structural work than the development of a new unit, however adjustments would be required to the fire escape and lift. The main drawback to this option is that the area is situated on the first floor and access would need to be considered.
Option IV Relocation of the existing chemotherapy suite to the Ged Adams Building within the Gray Institute and development of the clinical trials unit within the same area.
This option utilises existing facilities and would involve less structural work than the development of a new unit, however significant internal adjustments would be required. The main drawback to this option is that the area is situated at some distance from the facilities used by patients within the Cancer Centre such as the Lynda Jackson support centre.
5.2
Rejected options
Option 1 should be discounted for the following reasons: 1. The existing arrangement means that clinical research is not conducted in one place, leading to an inefficient use of resources and personnel. 2. At present the space allocated to research patients in the Chemotherapy Suite is inadequate. 3. Inpatient facilities are used for research patients that could be treated as outpatients leading to unnecessary expenditure. 4. There are no facilities in the current unit for the disposal of body fluids. 5. The waiting area is too small resulting in overcrowding at busy times. 6.
The rooms designated for private discussions are unwelcoming and in need of refurbishment.
Option III should be discounted because the space required for the existing chemotherapy services and the proposed clinical trials unit is estimated at 340m2. The space in the Upper West wing is 210m2 .
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Option IV should be discounted because the space required for the existing chemotherapy services and the proposed clinical trials unit is estimated at 340m2. The space in the Ged Adams Building is 162m2.
5.3
Preferred Option
Option II is the preferred option because it would provide a centralized treatment area, with good and more costeffective use of resources and personnel. It also minimizes risks to patients and provides comfortable, familiar surroundings to them, personnel and ancillary staff. Planning permission for this option has been granted and is effective for 5 years from September 2005. 5.4
Staffing
Existing staff will provide manpower for the proposed development. As an additional member of staff, a Clinical Trials Assistant with administrative responsibilities of stocktaking and maintenance, supervisor and receptionist is being considered, providing sufficient funding becomes available from nonNHS Trust sources. The unit could be developed and satisfactorily run without this change to staffing.
Section 6
RISK MANAGEMENT PLAN
The risks associated with this project have been identified and risk management plans identified (see appendix III – p24).
Section 7
COSTS
The income and costs associated with this project are summarised in appendix I (p20). 7.1
Capital Costs
The cost estimate for Option II is £1.47 million. This estimate is fully inclusive of all costs associated with the project apart from revenue costs, which will be covered by the
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anticipated increase in research income as a result of the improved facilities for research. 7.2
Equipment costs
The cost of additional medical equipment is £41,732 including VAT 7.4
Revenue costs
There are no additional staff costs associated with this project as the proposed unit will be covered by existing staff. As research activity increases, additional staff will be funded from existing funding streams. 7.5
Cost of relocating chemotherapy service for the duration of building works
The costs associated with decanting services to the Hillingdon outpatients department building during the building works of the project are included within the attached financial summary. 7.6
Funding
The entire cost of the project will be funded by voluntary donations. The Cancer Treatment and Research Trust will make a significant contribution including £150,000 raised via previous fundraising activities. It will also provide a volunteer fundraising committee. A Memorandum of Understanding has been agreed between the CTRT and the East and North Hertfordshire NHS Trust in order to clarify the funding relationship between the parties (Appendix II)
Section 8 CONSULTATION A consultation plan and communication protocol will be implemented with appropriate consultation mechanisms which will facilitate and ensure transparent decision making at all levels where all the key stakeholders will be encouraged to give their views and provide feedback on the project proposals and the service provision.
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Section 9
8.1
KEY STAKEHOLDERS AND PROJECT MANAGEMENT TEAMS
Key Stakeholders Louise Hobday
Manager Chemotherapy Suite
Heather Phillips
Research Network Manager
Kay Bell
Head of Nursing Cancer and Palliative Care
Jane Boxall
Research Nurse
Michael Powell
Network Lead Pharmacist
Teresa Young
Research Data Manager
Professor Gordon Rustin
Consultant Oncologist
Project Management Team Cathy Williams
Cancer Centre General Manager
Heather Phillips
Research Network Manager
Kay Bell
Head of Nursing for Cancer and Palliative Care
Professor Gordon Rustin
Consultant Oncologist
Dean Goodrum
Senior Capital Projects Manager
Malcolm Lynch
Capital Projects Manager
Michael Powell
Network Lead Pharmacist
Louise Hobday
Senior Sister Chemotherapy Day Unit
Mark Wheeler
Deputy Financial Controller
Project Board Stephen Posey
Director of Strategic Development
Heather Phillips
Research Network Manager
Professor Gordon Rustin
Consultant Oncologist
Daniel Fletcher
Head of Fundraising Development
Brian Abbott
Head of Fundraising
Malcolm Lynch
Capital Projects Manager
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Appendix 1 Financial summary
CTRT Project Cost Summary
£000
Capital Build including refurbishment and professional fees Decanting Costs Rent of Gray Labs Porter IT Infrastructure Removal Costs
£000
1,203
140 11 4 11 166
Equipment Additional Chairs Other
4 38 42
Project Management Cost
60
Total Project Cost
1,471
Charitable Funding Summary Charitable Fund (V8515) (This amount includes £300k transferred from V2265) as at 31/1/09 R&D funding Legacy funding
963 50 100
Wolfson Pledge
405
Total Charitable Funds
1,518
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Appendix II– Agreement between CTRT and the Trust This Agreement is made the
day of
2006 between:
1. East and North Hertfordshire NHS Trust, of Lister Hospital, Coreys Mill Lane, Stevenage, SG1 4AB (‘the Trust’) and 2. East and North Hertfordshire NHS Trust Charitable Fund, registered charity 1053338, trading as ‘enhance herts’ of Lister Hospital, Coreys Mill Lane, Stevenage, SG1 4AB (‘enhance herts’) 3. Professor Gordon Rustin and Dr Paul Nathan being two of the trustees of the Cancer Treatment and Research Trust, registered charity 292909, of Clocktower, Mount Vernon Cancer Centre, Rickmansworth Road, Northwood, HA6 2RN (‘CTRT’) Background: The parties are working together to raise funds for a clinical trials unit and ongoing cancer research as described in the attached document which sets out the project goals, responsibilities, governance and financial controls (‘the Project’). The parties recognise that the Trust needs a clinical trials unit to be built at Mount Vernon Cancer Centre to support clinical trials and ongoing research into cancer and its treatments. The cost of the Project is expected to be no less than £1,000,000 including approximately £750,000 towards the capital project to construct a clinical trials unit, and £250,000 to cover revenue requirements to run the unit and for ongoing research activity. The Trust and enhance herts recognise that CTRT has experience in fundraising towards cancer treatment and research at Mount Vernon Cancer Centre. Heads of Agreement: 1.
The parties agree that CTRT will work with the Trust through its registered charity, East and North Hertfordshire NHS Trust Charitable Fund, known as enhance herts, in order to raise at least £1,000,000 (net of certain expenses) for the Project.
2.
The parties agree that all funds raised towards the Project shall be paid into the enhance herts bank account. CTRT shall forthwith transfer all monies held by CTRT designated for the Project net of ongoing expenses and commitments to the enhance herts bank account.
3.
The CTRT designated representatives will only undertake such fundraising activities for the Project as have previously been agreed in writing in advance with the enhance herts Head of Fundraising Development.
4.
The Trust and enhance herts undertake to spend the money raised only in connection with the Project or any part or parts of the Project (or if that is not possible, as otherwise agreed in writing with CTRT). The manner of the expenditure of the monies raised shall be in the discretion of the Trust in the context of the Project.
5.1
In respect of the building construction element of the Project, the parties agree that construction of the clinical trials unit will not commence until a Full Business Case has been completed and approved by the Trust, and the Trust is satisfied that all necessary money has been raised to meet all financial commitments described within the Full Business Case. CTRT’s consent to the Full Business Case is not required.
5.2
In respect of the research element of the Project, expenditure on the research activities envisaged by the Project will occur in the Trust’s discretion in accordance with the Trust’s policy for research initiatives (involving consultation with relevant specialist consultant practitioners employed by the Trust) and the Trust may use the monies raised in connection with the Project for those research activities as and when it sees fit.
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6.
The parties may at any time end their fund raising relationship envisaged by this agreement on giving written notice to the other parties. Notwithstanding termination of the relationship between the parties, clauses 4 and 5 shall continue to have effect and monies donated or raised by CTRT shall not become repayable to CTRT provided they are used within a period of [5] years from the date hereof as envisaged by this agreement or as otherwise specifically agreed in writing between the parties.
7.
This agreement shall be governed by English Law
The parties confirm their agreement by signing on the day before written.
………………………………………………………………………………………… Dr Paul Nathan Dr David Miles Professor Jane Maher Trustees of the Cancer Treatment and Research Trust
Robin Ellison
………………………………………………………………………………………… Chief Executive Director of Finance Treasury Investment Committee Chairman on behalf of The East and North Hertfordshire NHS Trust
………………………………………………………………………………………… Chief Executive Director of Finance Treasury Investment Committee Chairman on behalf of The East and North Hertfordshire NHS Trust acting as Trustee of enhance herts ‘the Project’ Project goals The object of the relationship is to fund the development of a new clinical trials unit for cancer research alongside funding of ongoing and new noncommercial research activity in the unit. Construction is aimed to commence January 2007. Approximately £215,000 has been committed so far from CTRT, with a potential additional £200,000 also available from funds earmarked for cancer research within enhance herts. A SOC for constructing the clinical trials unit with an estimated cost of £750,000 is nearing completion. The aim is to raise a further £250,000 to fund the ongoing research activity for 20067. The project has the potential to form an ongoing fundraising campaign to fund an increasing proportion of cancer research for the Trust, and current fundraising frameworks are being considered in light of this. Project responsibilities The Project involves close liaison between East and North Hertfordshire NHS Trust, enhance herts and the Cancer Treatment and Research Trust (CTRT). Enhance herts was established in 1996 and is known formally as East and North Hertfordshire NHS Trust Charitable Fund. It has stated objects of any charitable purpose or purposes relating to the National Health Service wholly or mainly for the service provided by East and North Hertfordshire NHS Trust. Its income has varied from £400,000 to more than £3m over the past five years. The CTRT was established in 1985 with the stated objects of the promotion of medical and scientific research into the causes and treatment of cancer and related diseases and the dissemination of the useful results of such research and for the treatment and care of people suffering from cancer and related diseases. Its annual income has varied from £250,000 to £860,000 over the last five years. CTRT includes four (Rustin, Maher, Nathan, Miles) Mount Vernon clinicians on its eightstrong trustee board, led by Professor Gordon Rustin. The CTRT has recruited a volunteer fundraising committee chaired by Ray Payne. Committee members will be approaching companies, including pharmaceuticals, schools, community organizations and individuals who are interested in fundraising events and sponsored activities. Other fundraising activity will be undertaken either directly by or under the supervision of enhance herts, including contacting current and former patients of initially Prof Rustin, to ask them if they are prepared to get involved in the appeal, and if so, to ask them for ongoing support and applying to grantmaking trusts. All the other oncologists have agreed to their patients also being approached. Enhance herts will also provide training and oversight of approaches made to high net worth individuals known to committee members.
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Governance and financial controls Money raised to date comes from CTRT reserves, and specific donations of around £15,000 made to the Appeal. An additional £200,000 has been earmarked from enhance herts, from the Cancer Research fund, based at Mt Vernon. This essentially is being used to underwrite part of the project, in order to enable preconstruction surveys and work to commence before all the funds have actually been received. All new donations resulting from the CTRT appeal will be deposited into an enhance herts fund designated for the CTRT Appeal. Gordon Rustin will be the fund manager. As such, the standard accountability between enhance herts trustees and fund managers will be applicable, and fund transactions will be under the Trust’s Standing Financial Instructions and Standing Orders. All fundraising activity, including that undertaken by volunteers, comes under the auspices of enhance herts and will be managed by the Head of Fundraising Development. Daytoday oversight of the committee will be undertaken by the paidCTRT administrator Brian Abbott, who will work closely with the Head of Fundraising Development. The appeal will be called the CTRT Appeal, recognising the support of the CTRT and also because the majority of potential donors do not have a geographic affiliation to East and North Hertfordshire and would be happier with the concept of giving to a ’Cancer’ charity linked to Mount Vernon Cancer Centre. It will however be made clear to donors that enhance herts will hold funds raised for this project.
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Appendix III Risk Management Plan MOUNT VERNON HOSPITAL CLINICAL TRIALS & CHEMOTHERAPY SUITE CONSTRUCTION RISK REGISTER 20/11/08 1 TO 8 LOW, 9 TO 16 MED, 17 TO 25 HIGH No. Risk
Consequence
Control
Manager Owner
1.
Design changes
Clear brief at outset
2.
Potential delay and disruption Project delay
Refusal of planning variation Building Regulation Project delay refusal Fire Authority Project delay refusal
Client PM Architect
3. 4.
5.
Insufficient electrical capacity
Project delay/large additional cost
6.
Design difficult to construct
7.
Unsafe design
Inefficient construction & poor value for money Dangerous to all
Impact Rating Rating
M Lynch
Proba bility 2
8
16
Med
J Haigh
2
8
16
Med
Architect
J Haigh
1
8
8
Low
Architect Fire Safety Manager H of CP Client PM and M&E Designer Architect
J Haigh/ B Rennie
2
10
20
High
8
20
160
High Very High
J Haigh
1
8
8
Low
Architect M&E Designer P C
J Haigh & J Sims A Carey
1
8
8
Low
Design programme Information required schedule Project Execution Plan to detail approvals process map
Architect Architect Client PM
J Haigh J Haigh M Lynch
2
3
6
Low
2
3
6
Low
Milestones to be on design programme
Architect
J Haigh
Early informal meeting with the Planners Early informal meeting with BCO Negotiation on scope
Decision to proceed at risk Early site survey and monitoring with “hawks”
Construction input to design meetings Design risk assessments
Planning Coordinator to review 8.
Design Process Late information
Delay & cost
9.
Late approvals
Delay & cost
D Goodrum M Lynch & J Sims
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Low
10.
Insufficient resources
Programme loss
11.
Unrealistic programmes Operational Issues Unsafe environment
We all fail
12.
13 14.
15.
16.
17. 18.
19.
Nuisance/ Noise/Dust Interruption of services to Chart Lodge
Unplanned project overrun
Existing Data Inadequate / unreliable record information Damage to buried services Asbestos
Client Routines Fire Alarm Tests
All partners to ensure adequate resources are made available All team members to challenge if concerned
All
All
1
5
5
Low
Architect
J Haigh
1
5
5
Low
Adherence to Trust procedures
Site Manager
TBA
1
5
5
Low
Adherence to H&S Plan
TBA
Detailed planning Liaison meetings to discuss Detailed survey to establish locations of services
Site Manager Site Manager Client PM
TBA
2
5
10
Med
M Lynch
2
5
10
Med
Marking and protection of the service routes Regular programme review.
Site Manager Architect
TBA 1
5
5
Low
Honest, realistic reporting.
Site Manager
TBA
All records to be collated and handed to the site team
Planning Co ordinator Site Manager Client PM
A Carey
1
3
3
Low
TBA
2
5
10
Med
M Lynch
1
10
10
Med
Partial Hospital Consult Hillingdon Trust’s closure if asbestos is asbestos survey found in the electrical ducts
Planning Co ordinator
A Carey
10
25
250
Very high
None
Site Manager
TBA
1
2
2
Low
Potential injury. Client and/or construction operations halted
Production stopped Residential accommodation unavailable
Missed targets. Threat to Trust Foundation status. Reduced future funding. Injury / lost production / disruption / cost Disruption to Hospital operations Disruption & delay to site operations.
As Item 14 Conduct Type 2 Asbestos survey of Chemo’ Suite
Site induction training
J Haigh
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20.
Site Safety Issues Restricted access
21.
Restricted Site
22.
Confined working spaces
28.
Falls from heights
Congestion / increased risk of injury / lost production Congestion / increased risk of injury / lost production Congestion / increased risk of injury / lost production Disruption / partial hospital closure /missed targets / future funding threat / lost production Unnecessary loss of life and property / prosecution Disruption to both Client & Contractor Infection risk. Safety hazard. Personal injury. Dismissal. Prosecution. Personal injury
29.
Theft
Criminal prosecution
30.
Vandalism
Criminal prosecution
31.
Terrorism
Criminal prosecution Hospital closure / missed targets / lost production
23.
Site fire
24.
Obstructed Fire Brigade access
25.
Obstruction due to delivery vehicles Poor waste management Drugs & alcohol abuse
26. 27.
Detailed planning. Good site control
Site Manager
TBA
1
2
2
Low
Detailed planning. Good site control.
Site Manager
TBA
1
2
2
Low
Health & Safety Plan
Site Manager
TBA
1
2
2
Low
Site fire plan. Site induction training. Hot works permits.
Site Manager
TBA
1
5
5
Low
Traffic management plan. Site induction training
Site Manager
TBA
1
5
5
Low
Add instructions to all material and plant orders Environmental plan
Site Manager Site Manager Site Manager
TBA
1
5
5
Low
TBA
1
5
5
Low
TBA
1
5
5
Low
Site Manager Site Manager
TBA
2
5
10
Med
TBA
2
3
6
Low
Site Manager
TBA
2
3
6
Low
Site Manager
TBA
1
5
5
Low
CTA Training
Site policy. Health & Safety Induction Training Health & Safety Plan H&S procedure Increased awareness of suspicious incidents. Report to Site Manager. Increased awareness of suspicious incidents. Report to Site Manager Increased awareness of suspicious incidents. Report to Site Manager. Follow Trust’s Major Incident Procedures.
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32
Lack of protection
Damage to property Injury to personnel
33.
Construction accidents
Personal injury
34.
Unplanned restricted working hours Disruption caused by smoking, radios, mobile phones Inadequate car parking
37.
Prohibition by HSE
Project delay
38.
Insufficient funds available
Project curtailed
35.
36.
39.
Decant Operation OPD not available
40.
OPD only available for 6 months
41.
Insufficient data outlets in OPD Partnership Issues Poor communications Personality clashes
42. 43. 44.
Loss of key personnel
Detailed method statements Detailed Planning Liaison meets to discuss Health & Safety Plan procedure
Site Manager
TBA
1
5
5
Low
Site Manager
TBA
1
5
5
Low
Increased cost
Detailed planning Liaison meetings to discuss
Site Manager
TBA
2
2
4
Low
Production stopped
Detailed planning Liaison meetings to discuss Induction training Site parking plan. Incorporate plan into subcontract orders. Robust Safety Plan and site control Accurate accounting of the Charitable Funding. Accurate cost reporting. Value engineering.
Site Manager
TBA
1
5
5
Low
Site Manager
TBA
5
1
5
Low
Site Manager Finance
TBA
1
5
5
Low
M Wheeler
1
5
5
Low
Client PM
M Lynch
Don’t even contemplate. Huge delay. Would create an impossibly short construction period. Huge delay. Additional cost
Plan B – Negotiate rental of Gray Lab Building
General Manager
C Williams
5
15
75
High
Plan B – Negotiate rental of Gray Lab Building
General Manager
C Williams
10
15
150
Very high
Survey of existing
IT Project J Roberts Manager
5
2
10
Low
Dysfunctional team
Project Execution Plan
M Lynch
1
4
4
Low
Dysfunctional team
Project Execution Plan
M Lynch
1
3
3
Low
Loss of information continuity
Keep consistent staff as far as possible. No staff changes without prior discussion with Client PM.
Client PM Client PM All
All
2
3
6
Low
Disruption & inconvenience
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REGISTER OF RISKS NOT RELATED TO CONSTRUCTION 20/11/08
1 TO 8 LOW, 9 TO 16 MED, 17 TO 25 HIGH
No. Risk
Consequence
Control
Manager
Owner
Proba bility 2
Impact Rating Rating
1
Reluctance of staff to relocate temporarily to Outpatients Dept during construction phase
Discord within the staffing team
Robust communications with staff and involvement in planning service relocations.
Research Network Manager/ Head of Nursing
Kay Bell
3
6
Low
2
Temporary Disruption to service accommodation not fit for purpose
Full assessment of area prior to relocation and remedial works (eg improvements to IT infrastructure) completed.
Research Network Manager/ Capital Planning Manager
Malcolm Lynch
1
10
10
Med
3
Different patterns of Discord within the working due to staffing team integration of research and service provision
Robust communications with staff and involvement in planning integrated service.
Research Heather Network Phillips Manager/Che mo manager Louise Hobday
7
3
21
High
4
Loss of pneumatic chute during relocation period
Drugs and blood specimens will need to be transported manually
Employ porter dedicated to working in unit during construction phase
Head of Nursing
Kay Bell
4
4
16
Med
5
Temporary accommodation is distant from Cancer Centre
May cause difficulties for patients with low mobility
Employ porter dedicated to working in unit during construction phase
Head of Nursing
Kay Bell
4
5
20
High
6
Temporary accommodation is
Patients may have difficulty finding the
Ensure good signage
Research Network
Estates Department
1
5
5
Low
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distant from Cancer chemotherapy unit Centre
7
8
9
10
Manager
Damage to equipment during move to and from temporary location Disruption to chemotherapy service during move to Outpatients Dept Costs of capital project are higher than income from CTRT charity
Cost implications and disruption to service
Employ removal company known to Cancer Centre
Service Manager
Jillian David
1
10
10
Med
Delay in treatment
Relocate over weekend
Service Manager
Jillian David
2
6
12
Med
Insufficient funding to complete project
Deputy Financial Controller
Mark Wheeler
2
8
16
Med
Costs of services once unit is open are higher than FBC costings.
Unforeseen costs to Trust
Realistic costings at FBC stage. Robust financial management of project. Notification to Trust at early stage of shortfall in income. Realistic costings at FBC stage.
Deputy Financial Controller
Mark Wheeler
2
2
4
Low
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