pdf SNBTS Strategy - Scottish National Blood Transfusion Service
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Meeting the <strong>Transfusion</strong> Needs of Patients in Scotland<br />
<strong>SNBTS</strong> <strong>Strategy</strong> 2009 - 2014<br />
STRATEGIC DEVELOPMENT PLAN<br />
Authors<br />
<strong>SNBTS</strong> <strong>Strategy</strong> Project Team<br />
Date 06 March 2009<br />
Version<br />
Version 2.0 Approved<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 1 of 62
CONTENTS<br />
Page<br />
EXECUTIVE SUMMARY 4<br />
1. INTRODUCTION 10<br />
2. BACKGROUND 12<br />
2.1 Context 12<br />
2.2 Operating Environment 14<br />
2.3 Key Drivers for Change 15<br />
3. <strong>SNBTS</strong> STRATEGIC THEMES 19<br />
3.1 ENOUGH BLOOD FOR PATIENTS 19<br />
3.1.1 Introduction 19<br />
3.1.2 Keeping <strong>Blood</strong> Safe 20<br />
3.1.3 Reversing the Decline in Donors 23<br />
3.1.4 Impact on Staff and Resources 25<br />
3.2 FACILITIES FOR THE FUTURE 27<br />
3.2.1 Introduction 27<br />
3.2.2 Keeping <strong>Blood</strong> Safe 28<br />
3.2.3 Modernising <strong>Blood</strong> Production Facilities<br />
to Maintain Safety 31<br />
3.3 SUSTAINABLE TISSUE SERVICES 37<br />
3.3.1 Introduction 37<br />
3.3.2 Keeping Tissues and Cells Safe 37<br />
3.3.3 Donor Recruitment 37<br />
3.3.4 Tissue Retrieval 38<br />
3.3.5 Processing and Storage of Tissues and Cells 39<br />
3.3.6 Cellular Products 39<br />
3.4 SERVICES FOR PATIENTS 41<br />
3.4.1 Introduction 41<br />
3.4.2 Supporting Better Health Better Care 41<br />
3.4.3 Specialist <strong>Service</strong>s 42<br />
3.4.4 Local Delivery Supported by <strong>National</strong> Specialisation 46<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 2 of 62
3.5 AN ORGANISATION FIT FOR THE FUTURE 47<br />
3.5.1 Introduction 47<br />
3.5.2 Supporting Effective and Efficient <strong>Transfusion</strong> Practice 47<br />
3.5.3 Ensuring Resilience and Compliance with cGMP and<br />
Clinical Standards 47<br />
3.5.4 Investing in High Impact Science that Benefits Patients 48<br />
3.5.5 E-Health and Improving <strong>Service</strong> Performance 50<br />
Page<br />
4. MANAGING CHANGE IN THE WORKFORCE 52<br />
4.1 Introduction 52<br />
4.2 Workforce Planning 52<br />
4.3 Workforce Projection 55<br />
5. FINANCIAL SUMMARY 56<br />
5.1 Funding the <strong>Blood</strong> Supply 56<br />
5.2 Summary Forecast 57<br />
5.3 Baseline Analysis – Review of Funding Requirement 58<br />
5.4 Breakdown of Additional Allocations 58<br />
5.5 Capital Investment 59<br />
5.6 Key Financial Assumptions and Risks 59<br />
6. EQUALITY & DIVERSITY 61<br />
7. RISKS 61<br />
8. COMMUNICATIONS STRATEGY 62<br />
Appendix I <strong>Strategy</strong> Communication Plan 2009 – 2014<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 3 of 62
1 EXECUTIVE SUMMARY<br />
1.1 BACKGROUND<br />
<strong>SNBTS</strong> is charged with the responsibility of providing safe and sufficient supplies of blood<br />
and tissues for NHS Scotland and also delivers a range of specialist Clinical <strong>Service</strong>s. The<br />
work is extremely challenging, highly regulated and experience has shown that the scope<br />
and stringency of the safety agenda and regulatory process will continue to increase.<br />
As a key part of NHS Scotland and division of NSS, <strong>SNBTS</strong> operates within the policy<br />
framework and strategic direction set by these wider organisations and this is reflected in<br />
the approach set out in the <strong>SNBTS</strong> Strategic Development Plan 2009-14.<br />
The plan is described within five Strategic Themes ie:<br />
• Enough <strong>Blood</strong> for Patients;<br />
• Facilities Fit for the Future;<br />
• Sustainable Tissue <strong>Service</strong>s;<br />
• <strong>Service</strong>s for Patients;<br />
• An Organisation Fit for the Future.<br />
The key strategic outputs from the plan include service modernisation; renewing and future<br />
proofing the <strong>SNBTS</strong> estate to maintain licences; continuous improvements in quality and<br />
efficiency; ensuring ongoing regulatory compliance; delivering improvements in blood and<br />
tissue safety; building a more resilient service; developing new and improved treatments for<br />
patients and developing our workforce.<br />
1.2 KEEPING BLOOD AND TISSUES SAFE<br />
The <strong>Scottish</strong> Government, NSS and <strong>SNBTS</strong> have a responsibility to ensure blood and<br />
tissue supplies are as safe as possible. Experts from NHSS and <strong>SNBTS</strong> actively<br />
contribute to UK Advisory Committees who evaluate possible new safety interventions and<br />
determine whether their implementation should be recommended to ministers. In the last<br />
10 years this agenda has been dominated by the introduction of measures designed to<br />
reduce the risk of transmitting vCJD with blood and tissues.<br />
A number of further measures are under active consideration and are being scoped for<br />
implementation within the timescale of this plan. Safety measures come in the form of<br />
additional criteria for donor deferral, additional processing steps or additional testing<br />
measures and may require the recruitment of more donors or the procurement of more<br />
advanced equipment, more staff and, consequently, more space within highly specified<br />
facilities.<br />
To provide clarity on the expected source of funding for the initiatives set out in this plan,<br />
initiatives likely to be funded via NSS are highlighted in green, whereas those where the<br />
source of funding is expected to be SGHD are highlighted in blue. This codified approach<br />
is used throughout the plan.<br />
Whilst NSS would normally fund the modernisation of existing systems, many safety<br />
measures mandated by government are expensive and cannot reasonably be funded by<br />
NSS and in these circumstances are funded by SGHD over and above the normal NSS<br />
funding allocation.<br />
1.3 ENOUGH BLOOD FOR PATIENTS<br />
Enough <strong>Blood</strong><br />
In keeping with many countries, <strong>SNBTS</strong> has been experiencing declining public support for<br />
blood donation. This has arisen as a result of mandated changes in donor selection criteria<br />
(ie deferral of donors who themselves have received a blood transfusion (vCJD risk, Apr<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 4 of 62
2004)), implementation of the <strong>Blood</strong> Safety and Quality Regulations (BSQR) Nov 2005 and<br />
general changes in public attitudes and lifestyle. By 2007, the active donor base in<br />
Scotland was at the lowest level since national records began.<br />
At that time it was known that tests to screen the donor population for vCJD were under<br />
development but might have limited accuracy resulting in further loss of public support.<br />
Consequently, in Dec 2007, NSS provided £2.32m for an <strong>SNBTS</strong> proposal to deploy an<br />
integrated Publicity and Marketing plan to halt the decline and rebuild the donor base in the<br />
short term. To date this has been highly successful. The longer term plan was to use<br />
service redesign to transform the donation experience to make it more accessible and<br />
rewarding.<br />
It was acknowledged this redesign would need to be developed in partnership and carefully<br />
evaluated/ piloted to ensure the various changes would be effective, efficient and<br />
sustainable. The key areas of work are Reaching out to New Donors; Improving<br />
Communication with Donors; Transforming Donor Venues and Transforming the Donation<br />
Experience. A number of initiatives have been or are being piloted whilst funding bids have<br />
been submitted to support other pilots or implement redesign solutions. Further funding<br />
bids will follow in support of this essential redesign process.<br />
This is a major and exciting opportunity to modernise our <strong>Blood</strong> Collection Programme and<br />
develop our staff. It is expected that some modernisation initiatives will require additional<br />
resource whilst others will release resource and <strong>SNBTS</strong> will, as far as possible, seek to<br />
minimise any increase in resource requirements.<br />
<strong>Blood</strong> Safety<br />
The measures shown below are currently being considered by the government Advisory<br />
Committee on the Safety of <strong>Blood</strong> Tissues and Organs (SaBTO), dates and impacts are<br />
best estimates:<br />
Measure Implement Comments Staff 2013/14<br />
£2013/14<br />
100%<br />
From<br />
~80% staging point ~ 29wte £2.3m<br />
apheresis<br />
2009/10<br />
achievable in current<br />
rev<br />
platelets<br />
premises. Significant<br />
£734k<br />
challenge to reach 100%<br />
cap<br />
Manage the<br />
adverse<br />
impact of a<br />
vCJD test on<br />
donor support<br />
From<br />
2010/11<br />
Counselling “worried well”,<br />
impact depends on specificity<br />
of test. Worst case scenario<br />
shown.<br />
~ 22wte,<br />
reducing over<br />
time<br />
£550k<br />
rev<br />
1.4 FACILITIES FOR THE FUTURE<br />
The NSS Property <strong>Strategy</strong> 2008 confirmed there are significant issues with much of the<br />
<strong>SNBTS</strong> estate. In general the estate does not meet the ESTATECODE standards and<br />
does not provide adequate accommodation or facilities for staff. Over time it will cease to<br />
meet regulatory requirements. In particular there are difficulties with the space, layout and<br />
plant in the blood Processing and Testing Centres in Edinburgh and Glasgow and the<br />
Tissue <strong>Service</strong>s premises in Edinburgh. Although these premises are currently licensed, it<br />
is firmly believed that this position will be severely challenged beyond the next two rounds<br />
of inspections by the Medicines and Healthcare Products Regulatory Agency (MHRA) and<br />
Human Tissues Authority (HTA) unless there are firm plans to provide suitable alternative<br />
accommodation.<br />
A comprehensive analysis by Pharmaceutical consulting engineers, followed by an option<br />
appraisal exercise was carried out in Partnership in March 2008. This identified the co-<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 5 of 62
location of processing and testing, IT support, engineering, head office, logistics, selected<br />
R&D and donor administration, Medical care of Donors and the Tissue <strong>Service</strong>s and<br />
Quality Directorates on a new national <strong>SNBTS</strong> site at a cost of some £35m, as the<br />
preferred strategic option. In Nov 2008, NSS Board supported this approach as part of the<br />
NSS Property <strong>Strategy</strong>.<br />
Doing nothing or minimum is not realistic and undertaking major refurbishment of existing<br />
properties whilst maintaining services is not feasible. Within the period of the plan we<br />
expect to be mandated to introduce additional blood and tissue safety measures which will<br />
compound our current accommodation issues and would almost certainly require<br />
agreement with MHRA and HTA that we had firm plans to relocate our operations to new<br />
premises within an agreed timescale. Consequently, the workable options are extremely<br />
limited and moving outside the chosen option or the timescale for its implementation carries<br />
considerable operational and regulatory risks and would almost certainly lead to a<br />
requirement to explore contracting out a proportion of our Processing and Testing to NHS<br />
<strong>Blood</strong> and Transplant in England and serious adverse comments from MHRA/HTA.<br />
Other Property Issues<br />
• Transforming Donation Venues - <strong>SNBTS</strong> will assess the feasibility of offering donor<br />
sessions across a wider range of venues including a move from current hospital based<br />
locations to convenient city centre locations.<br />
• Release of Space for use by Health Boards - <strong>SNBTS</strong>/ NSS Facilities are in discussion<br />
with Health Boards to determine how property that could be vacated by <strong>SNBTS</strong> might<br />
be used in future to the benefit of the wider NHS Scotland.<br />
• Space for Clinical <strong>Service</strong>s - <strong>SNBTS</strong> will assess the space required to support the<br />
delivery of effective Clinical <strong>Service</strong>s as described in this plan.<br />
<strong>Blood</strong> And Tissue Safety<br />
The measures shown below are currently being considered by the government Advisory<br />
Committee on the Safety of <strong>Blood</strong> Tissues and Organs (SaBTO), dates and impacts are<br />
best estimates:<br />
Measure Implement Comments Staff 2013/14 £ 2013/14<br />
Introduce Prion Filtration 2009/10 Impacts shown are for 100% red cells, but<br />
of red cells<br />
may be phased in by patient group 25wte £10.1m<br />
Implement Pathogen<br />
reduced platelets<br />
Late 2009/10<br />
Will significantly reduce risks of bacterially<br />
contaminated platelets, support shelf<br />
life and wastage<br />
4wte<br />
£1.8m<br />
100% apheresis<br />
platelets<br />
From 2009/10<br />
~80% staging point achievable in current<br />
premises. Significant challenge to reach<br />
100%<br />
~ 2.5wte £357k rev<br />
Introduce vCJD test From 2010/11 estimated costs guestimated at £7 per<br />
donation – may be much higher ~ 8wte, £3.5m rev<br />
Further mandatory safety measures such as pathogen reduction of red cells and screening<br />
for an as yet undiscovered infectious agent are likely and have been factored into planning<br />
assumptions.<br />
1.5 SUSTAINABLE TISSUE SERVICES<br />
Products prepared from bone, tissues and cells are relatively new therapeutic agents and<br />
are regulated by the HTA. Close collaboration already exists between <strong>SNBTS</strong> Tissue<br />
<strong>Service</strong>s and its counterpart in NHS <strong>Blood</strong> and Transplant (NHSBT) and this approach will<br />
be promoted to maximise efficiency of service delivery and make optimal use of the<br />
significant resources and economies of scale in NHSBT.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 6 of 62
Cellular Therapies<br />
Haemopoietic Stem Cell and Cord <strong>Blood</strong> - <strong>SNBTS</strong> has considerable experience in<br />
processing these specialist cellular products and, once the location of the <strong>National</strong> Centre<br />
is known, will consult with interested parties to establish the extent to which central<br />
processing and storage of these cells would be the most effective and secure working<br />
option for NHS Scotland.<br />
Pancreatic Islet Cells – NSS <strong>National</strong> <strong>Service</strong>s Division has recently funded the<br />
establishment of a <strong>Scottish</strong> Islet Cell transplantation programme in <strong>SNBTS</strong> Tissue<br />
<strong>Service</strong>s.<br />
New Cellular Therapy and Regenerative Medicine - <strong>SNBTS</strong> has been at the forefront in<br />
supporting the research and development of new cellular therapies including an<br />
international T cell immunotherapy bank for post-transplant lymphoproliferative disease,<br />
adult stem cell therapies for heart, musculoskeletal and liver disease and the generation of<br />
pluripotential embryonic stem cells at cGMP grade.<br />
The new <strong>SNBTS</strong> <strong>National</strong> Centre will partner with the new University of Edinburgh Medical<br />
Research Council Centre for Regenerative Medicine in helping to position Scotland in the<br />
vanguard of this highly competitive international field to benefit the health of the people of<br />
Scotland.<br />
1.6 SERVICES FOR PATIENTS<br />
The <strong>SNBTS</strong> Clinical Directorate provides front line medical care for patients in Scotland<br />
over a range of specialties including Immunohaematology, Histocompatibility and<br />
Immunogenetics (H&I), and Clinical Apheresis and Stem Cell services. Over the course of<br />
the strategy the Directorate will move from predominantly regional working to a nationally<br />
managed clinical network, thereby providing secure and effective specialist services,<br />
supporting more efficient working arrangements and simplifying compliance arrangements.<br />
The modernisation which will require funding of additional posts will also secure on call and<br />
out of hours rotas.<br />
The changing position in terms of increasing workload, regulatory compliance, European<br />
Working time Directive and new standards of practice means that investment is needed to<br />
ensure the Clinical Directorate functions to the required standards. The strategy addresses<br />
these shortcomings, proposing an additional 26 staff over the period of the plan. The<br />
Organ Transplant Taskforce is recommending a 50% increase in solid organ transplants<br />
over the next five years and the impact of this major expansion has been factored into the<br />
plan.<br />
1.7 AN ORGANISATION FIT FOR THE FUTURE<br />
<strong>SNBTS</strong> front line services are enhanced by range of absolutely essential support functions.<br />
Supporting Effective, Efficient and Safe <strong>Transfusion</strong> Practice<br />
The Better <strong>Blood</strong> <strong>Transfusion</strong> Programme (BBTP) will continue to improve the quality and<br />
safety of clinical transfusion processes across Scotland as an integral part of the work of<br />
the Clinical Directorate.<br />
Ensuring Resilience and Compliance with cGMP and Clinical Standards<br />
The key regulatory objective is to ensure that all <strong>SNBTS</strong> operations remain compliant with<br />
all relevant legislation and accreditation requirements. The Quality Team will be<br />
reorganised to take account of the new opportunities that will arise when the <strong>National</strong><br />
Centre is opened and will continue to support the rest of NHSScotland and monitor the<br />
extent of its compliance with the BSQR on behalf of the SGHD.<br />
Investing in High Impact Science that Benefits Patients<br />
<strong>SNBTS</strong> Research and Development Directorate work in support of clinical delivery will<br />
continue to focus on regenerative medicine and cellular therapy, making use of <strong>SNBTS</strong><br />
skills in GMP and cell/tissue therapy to assess and deliver novel therapies such as islet cell<br />
transplantation for the treatment of diabetes or cell therapy for the treatment of post-<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 7 of 62
transplantation virus infections. <strong>SNBTS</strong> has recently received funding from the Welcome<br />
Trust to attempt to develop blood cells in culture, which if successful, would revolutionise<br />
transfusion practice.<br />
E-Health and Improving <strong>Service</strong> Performance<br />
The <strong>SNBTS</strong> <strong>Strategy</strong> is fully aligned with the NSS Corporate IM&T <strong>Strategy</strong> and will<br />
facilitate the delivery of a range of e-health initiatives including the provision of safe and<br />
secure systems in support of efficient blood and tissue management, efficient and effective<br />
IT tools for the improved management of donors and enhanced Interaction with NSS<br />
Corporate business systems to support and inform service decisions and benefit patients<br />
and the wider NHS in Scotland.<br />
1.8 MANAGING CHANGE IN THE WORKFORCE<br />
<strong>SNBTS</strong> has set out an extremely ambitious and challenging agenda and will take every<br />
opportunity to facilitate its delivery by working in partnership with staff side and with staff,<br />
using the full range of NSS and NHS Scotland policies, resources and guidance. <strong>SNBTS</strong><br />
will ensure there are effective partnership structures in place with sufficient time and<br />
resources to ensure all concerned can deliver successful outcomes through the<br />
development and deployment of a comprehensive Workforce Plan.<br />
1.9 FINANCIAL SUMMARY<br />
In line with planning guidance, the table below outlines a breakeven position based on the<br />
assumption that 2% savings per annum will be deliverable and that SGHD will normally<br />
fund those new safety measures which may be mandated over the period of the <strong>Strategy</strong>,<br />
but could not reasonably be funded within the NSS funding envelope. It is assumed that<br />
as far as possible, NSS resources will support modernisation and development of the<br />
<strong>Service</strong>.<br />
REVENUE PLAN 2009/10 2010/11 2011/12 2012/13 2013/14<br />
£000 £000 £000 £000 £000<br />
EXPENDITURE<br />
Modernisation/Business as Usual<br />
Pay 38,578 39,352 40,392 41,968 43,229<br />
Non-Pay 20,814 19,873 20,668 21,666 22,661<br />
Capital Charges 4,408 4,408 4,408 4,408 4,408<br />
Savings Plan (943) (1,984) (3,056) (4,167) (5,318)<br />
Total NSS Funded 62,857 61,649 62,412 63,876 64,980<br />
Anticipated Mandatory Safety Measures<br />
Pay 1,112 3,178 4,287 4,287 4,287<br />
Non-Pay 3,448 11,956 13,953 13,650 13,650<br />
Total SGHD Funded 4,560 15,134 18,240 17,937 17,937<br />
Total Expenditure 67,417 76,783 80,652 81,812 82,917<br />
INCOME/FUNDING SOURCES<br />
Baseline incl inflation uplift 54,169 53,618 55,528 57,563 59,664<br />
Savings Plan (943) (1,984) (3,056) (4,167) (5,318)<br />
Capital Charges 4,408 4,408 4,408 4,408 4,408<br />
Additional Allocation - NSS 1,642 2,026 1,951 2,490 2,645<br />
NHS SLA Income 2,618 2,618 2,618 2,618 2,618<br />
Third Party Income 964 964 964 964 964<br />
Total NSS Income 62,857 61,649 62,412 63,876 64,980<br />
Total SGHD Income 4,560 15,134 18,240 17,937 17,937<br />
Total Income 67,417 76,783 80,652 81,812 82,917<br />
Surplus/(Deficit) 0 0 0 0 0<br />
Some £35m capital investment is required towards the end of the plan to deliver the<br />
proposed new <strong>National</strong> Centre for <strong>SNBTS</strong>. Costs for the New <strong>National</strong> Centre will be<br />
phased over the life of the construction works and treated as an asset under construction<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 8 of 62
until the building is completed and the asset capitalised which is expected towards the end<br />
of 2012/13.<br />
Whilst there are interim revenue costs for planned maintenance of the current estate, the<br />
option appraisal for the new <strong>National</strong> Centre demonstrates the potential to achieve<br />
recurring savings in property related revenue costs, estimated at around £0.5m, once the<br />
site is fully operational. However, as described in the approved NSS Property <strong>Strategy</strong><br />
some of these savings are dependant upon releasing accommodation for use by NHS<br />
Scotland.<br />
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1. INTRODUCTION<br />
Operating within the support provided by NHS <strong>National</strong> <strong>Service</strong>s Scotland (NSS), the<br />
<strong>Scottish</strong> <strong>National</strong> <strong>Blood</strong> <strong>Transfusion</strong> <strong>Service</strong> (SNTBS) plays a fundamental role in the<br />
delivery of healthcare in Scotland. <strong>SNBTS</strong> works 24/7/365 to ensure that the donor’s gift<br />
of blood or tissues is transformed into safe and effective medicinal products, which allow<br />
NHSScotland to save and improve the lives of tens of thousands of people in Scotland<br />
every year. <strong>SNBTS</strong> is a key division of NSS, employing almost 1200 staff and is<br />
responsible for:<br />
• recruiting blood and tissue donors and encouraging them to continue to support<br />
NHSScotland;<br />
• collecting donations of blood, tissue and cells;<br />
• manufacturing donations of blood, tissue and cells, within tightly prescribed regulatory<br />
standards, into medicinal products that are judged safe for use;<br />
• providing ‘approved’ blood, tissue and cellular products to hospitals where they will be<br />
prepared for patients;<br />
• providing direct patient care in a range of clinical specialties (including the selection and<br />
provision of blood components for specific patients); and<br />
• supporting the delivery of all of the above key services.<br />
The <strong>SNBTS</strong> workforce is extremely professional, conscientious and committed to delivering<br />
the high level of service NHSScotland and the <strong>Scottish</strong> public expect. Achieving<br />
continuous quality improvement and full compliance with regulatory and other standards<br />
are embedded within its culture.<br />
In common with other blood services, over the last decade <strong>SNBTS</strong> has experienced a<br />
number of major, high impact changes with short, often competing, deadlines. These have<br />
come in the main from statutory and regulatory imperatives requiring additional tests;<br />
processes and safety measures and increasing levels of compliance, which generally<br />
require more advanced equipment, more staff and consequently, more highly specified<br />
facilities. Many of these constraints apply equally to the provision by <strong>SNBTS</strong> of bone,<br />
tissues and cellular products such as stem cells, which are a growing feature of modern<br />
clinical care.<br />
Several of these additional safety measures have excluded previously eligible donors,<br />
making it ever more challenging to collect enough blood and tissues from a shrinking donor<br />
base. Future tests such as that for the infective agent of vCJD are thought to have the<br />
potential to deter donors from giving blood for fear that they may test positive.<br />
In response to these changes and anticipating more in the future, <strong>SNBTS</strong> has formulated a<br />
strategy. This is designed to consolidate recent developments, modernise our service and<br />
future proof the organisation, whilst still allowing flexibility to enable it to contribute to the<br />
challenges that the NHS will face over the next ten to twenty years. The <strong>SNBTS</strong> <strong>Strategy</strong><br />
has been developed from the paper – ‘The Strategic Direction of <strong>SNBTS</strong> 2007-2011’ -<br />
which was endorsed by the NSS Board in July 2007. It has also been the subject of wide<br />
consultation and the responses to that consultation exercise have been incorporated into<br />
this document and rolled out to staff in a series of road shows across Scotland and a<br />
response document has been issued to all stakeholders.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 10 of 62
In this Strategic Development Plan, we outline the steps that <strong>SNBTS</strong> will undertake to<br />
modernise and strategically position the <strong>Service</strong> to accommodate anticipated and likely<br />
blood safety measures in the near and medium term, for example:<br />
• Ensuring that there is enough blood for patients by rebuilding the donor base,<br />
improving accessibility, choice and efficiency for donors;<br />
• Providing a structured approach to the expected implementation of anticipated and<br />
future blood safety measures;<br />
• Consolidating our operations into a new <strong>National</strong> Centre to allow the introduction of<br />
lean pharmaceutical-like blood and tissue processing and testing (P&T) that will<br />
ensure that we can meet the regulatory standards for the future;<br />
• Delivering new cellular therapies as well as our existing tissue services by improving<br />
the resilience of the referral, retrieval and processing systems for bone, tissues and<br />
cells to enable the introduction of emerging regenerative medicine, one of the most<br />
important medical developments of the 21 st century;<br />
• Ensuring that our clinical services can deliver both locally and nationally by<br />
providing services in line with ‘Better Health Better Care’ (BHBC), making certain<br />
that patients benefit from the best possible delivery of transfusion medicine; and<br />
• Ensuring that every aspect of support is focussed in delivering the modernisation<br />
and safety agenda by continuing to invest in our Quality Management System and<br />
Better <strong>Blood</strong> <strong>Transfusion</strong> Programme.<br />
All of this will take place within the context of enabling our workforce to develop and deliver<br />
this ambitious agenda.<br />
This Strategic Development Plan translates the strategic aims into operational terms. A<br />
project-based approach is being taken to manage the implementation of the <strong>SNBTS</strong><br />
<strong>Strategy</strong>, the scope of which covers the entire <strong>Service</strong>. In this way, each of the<br />
developments is brought together in a single high-level plan.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 11 of 62
2. BACKGROUND<br />
2.1 CONTEXT<br />
Government<br />
The <strong>Scottish</strong> Government has set out its single overarching purpose – to focus Government<br />
and public services on creating a more successful country, with opportunities for all of<br />
Scotland’s population to flourish through increasing sustainable and economic growth.<br />
The five strategic objectives that support this purpose aim to create a Scotland that is:<br />
• Wealthier and fairer – enabling businesses and people to increase their wealth and<br />
more people to share fairly in that wealth;<br />
• Smarter – expanding opportunities for the people of Scotland to succeed from nurture<br />
through to lifelong learning, ensuring higher and more widely shared achievements;<br />
• Healthier – helping people to sustain and improve their health, especially in<br />
disadvantaged communities, ensuring better, local and faster access to health care;<br />
• Safer and stronger – helping local communities to flourish, becoming stronger, safer<br />
places to live, offering improved opportunities and a better quality of life; and<br />
• Greener – improving Scotland’s natural and built environment and the sustainable use<br />
and enjoyment of it.<br />
NHSScotland, as a major employer as well as a provider of services, will have a major part<br />
to play in achieving each of these five objectives.<br />
A range of performance management systems, including the NHSScotland Health<br />
improvement, Efficiency, Access and Treatment (HEAT) targets, ensure that services and<br />
activities are aligned with the objectives.<br />
Better Health Better Care (BHBC)<br />
The <strong>Scottish</strong> Government Health Directorate (SGHD) ‘Better Health, Better Care Action<br />
Plan’ reflects a nationwide discussion around the actions that need to be taken to move<br />
towards creating a “Healthier Scotland”. There are three main components to the Action<br />
Plan:<br />
• health improvement;<br />
• tackling health inequality; and<br />
• improving the quality of health care.<br />
A key focus of the approach set out in the Action Plan is moving towards a mutual<br />
NHSScotland in which the people of Scotland and the staff of the health service are<br />
partners, or co-owners, and have real involvement in determining how NHSScotland will<br />
improve health and health care.<br />
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Delivery of BHBC depends to a large extent on the NHSScotland workforce. Uniquely,<br />
Scotland has in place staff governance legislation that allows priority to be given to the<br />
workforce role alongside the two complementary streams of clinical and financial<br />
governance. NHSScotland is also renowned for its strong partnership working with<br />
Government, employers and trade unions. Together, these two factors provide a robust<br />
foundation upon which to build the workforce and deliver better outcomes for the people of<br />
Scotland.<br />
Building on ’Delivering for Health’, the ‘BHBC Discussion Document (2007)’ further<br />
underscores the strategic trends in health care: towards care of long term conditions;<br />
greater emphasis on prevention; the patient as partner with increased responsibilities for<br />
self care; carers as partners; and high technology. The follow on ‘BHBC Action Plan’ is<br />
configured around three major themes:<br />
• Public ownership and mutuality – representing a further move from market based<br />
approach; greater emphasis on rights and responsibilities of ‘patients’ and on the role of<br />
staff as partners;<br />
• Improving health and tackling health inequalities – focus on children and families,<br />
substance misuse, obesity, sexual health; and<br />
• Ensuring better, local and faster access to health care - improving quality, patientcentred<br />
service, patient safety, effectiveness (especially in relation to long term<br />
conditions), efficiency (including environmentally sustainable), equity and timeliness.<br />
HEAT targets are being realigned, both to reflect the changed emphasis and to add rigour<br />
to the performance management arrangements (by integrating the various strands of<br />
planning, while attempting to reduce duplication and reporting requirements).<br />
BHBC ‘A Force for Change (January 2009)’, highlights the importance of workforce<br />
planning being integrated into service planning and redesign.<br />
Strategic Implications for NSS <strong>Service</strong>s<br />
For all NSS services, the need to focus on stakeholders and their changing requirements is<br />
paramount, as is the gathering momentum for re-designed, patient-centred services, which<br />
have been benchmarked to ensure they are efficient and offer value for money. Aligned<br />
with this is the requirement to deliver the highest clinical and staff governance standards.<br />
For the NSS Health Support portfolio, adjustments will be made to meet the range of<br />
specific ‘BHBC Action Plan’ clinical priorities – rigorous clinical governance to protect<br />
patients’ safety and meeting the 18-week referral to treatment for example, and changed<br />
focus for information services. Increased emphasis on prevention suggests enhanced roles<br />
for disease prevention and Hospital Acquired Infection (HAI) reduction/protection services.<br />
For the Business Support portfolio, the automation of many routine operations is likely to<br />
lead to ‘leaner’ services: payments to practitioners, patient registration, and the routine<br />
acquisition and distribution of health care information, for example.<br />
Equally the efficiency and joined up working imperatives offer opportunities for NSS,<br />
notably in providing NHSScotland with the increasingly complex national systems and data<br />
warehouses it needs, and in the continued drive for cost effective procurement of goods<br />
and services. This <strong>Strategy</strong> for <strong>SNBTS</strong> is fully aligned with these principles.<br />
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The NSS 5-Year <strong>Strategy</strong> – 2008-2012<br />
Reflecting the research about our operating environment, the 5-year NSS Corporate<br />
<strong>Strategy</strong>, running from April 2008 to March 2013, includes contributions from staff across all<br />
divisions and has been developed in Partnership.<br />
The <strong>Strategy</strong> sets out:<br />
• what we are planning to deliver over the coming years;<br />
• how we are proposing to address the challenges of the ‘BHBC Action Plan’; and<br />
• how we are developing ourselves to become a high performing and valued partner in<br />
NHSScotland.<br />
2.2. OPERATING ENVIRONMENT<br />
<strong>SNBTS</strong> is charged by Government to be the supplier of blood and tissue for NHSScotland.<br />
This means it must ensure that supplies are sufficient to meet demand in compliance with<br />
relevant regulatory and statutory requirements.<br />
Regulation and compliance in healthcare continues to develop both in terms of stringency<br />
and increased frequency of change. The introduction of the EU <strong>Blood</strong> Directive (transposed<br />
into UK Law as the <strong>Blood</strong> Safety and Quality Regulations, 2005 (BSQR)) resulted in a<br />
phased shift in the extent and stringency of achieving regulatory compliance and our<br />
Tissue <strong>Service</strong>s activity has experienced a similar situation arising from the Human Tissues<br />
Act (HTA).<br />
These developments have meant that the standard of premises in which blood and tissue<br />
manufacturing take place, and the quality systems and resources required to support this<br />
activity and maintain licences, have significantly increased. Furthermore, the emergence of<br />
new infectious agents that can be transmitted by blood or tissues and of new technologies<br />
that improve blood and tissue safety, leads to the need to introduce new tests and<br />
technology to keep the blood and tissue supply safe by current standards. Not surprisingly,<br />
this continually drives up the costs of blood, tissues and related services whilst driving<br />
down operational flexibility. The <strong>SNBTS</strong> <strong>Strategy</strong> takes account of these ongoing<br />
developments and will deliver a renewed, modernised and future proofed <strong>Service</strong>.<br />
Prior to these major regulatory changes, accommodation used by <strong>SNBTS</strong> for the<br />
manufacture of blood and tissue products evolved around procedures developed in our<br />
laboratories over many years. These arrangements will become unacceptable and it has<br />
become abundantly clear that blood and tissue products need to be manufactured in<br />
premises that meet the standards expected in the pharmaceutical industry. This will<br />
include a move from general laboratory manufacturing towards manufacturing carried out in<br />
‘clean rooms’.<br />
A consequence of many of these changes is the adverse impact on the donor base (for<br />
blood and tissues). The requirements to enable donors to donate have become more<br />
stringent leading to a reduction in donors and a resulting drop in donations. All of this is<br />
occurring at a time when it is proving challenging to maintain a suitably robust donor base<br />
for the continued supply of blood for patients that require transfusion. Additionally, the<br />
demand profile for blood and blood components is changing and future demand<br />
requirements are difficult to predict accurately.<br />
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The changing demographics within Scotland will have an impact on the services that<br />
<strong>SNBTS</strong> will provide. Scotland’s ageing population is key to the need for a change in the<br />
way healthcare is delivered. Longer term, initial indications show that the demand for blood<br />
usage will increase, though increased efficiencies will stem this in the short-term to medium<br />
term. These changes will be key in managing the future blood collection programme to<br />
process and test blood and blood components to meet future demand.<br />
Health provision has changed a great deal and will continue to change within the timescale<br />
of this <strong>Strategy</strong>.<br />
<strong>SNBTS</strong> recognises its duty to ensure that it values equality and diversity to ensure equal<br />
opportunities for both donors and staff. <strong>SNBTS</strong> continues to review access arrangements<br />
for donors and will continue to monitor services to ensure that they do not directly or<br />
indirectly discriminate against staff or donors. All of these developments have an impact on<br />
<strong>SNBTS</strong>’s provision of services and products informing the ways in which the <strong>Service</strong> must<br />
continue to develop and embrace change to meet the transfusion needs of patients in<br />
Scotland.<br />
2.3. KEY DRIVERS FOR CHANGE<br />
There are a number of key drivers which impact on the whole <strong>Strategy</strong> and these are set<br />
out below.<br />
2.3.1 Keeping <strong>Blood</strong> and Tissues Safe<br />
Whilst blood transfusion and tissue transplantation are safe compared with most other<br />
medical interventions, they are not, and cannot be, zero risk. Nevertheless, the <strong>Scottish</strong><br />
Government, NSS and <strong>SNBTS</strong> have a responsibility to ensure the blood and tissue supply<br />
is as safe as possible and to this end, SGHD and <strong>SNBTS</strong> actively contribute to a number of<br />
UK surveillance and policy setting committees which evaluate new safety interventions and<br />
determine whether their introduction should be recommended to Ministers. The processes<br />
also extend to regular review of existing safety measures to determine whether there is<br />
scope for improvement/modernisation.<br />
The amount of testing and processing that blood has undergone has increased dramatically<br />
over the years either as a result of emerging clinical and scientific knowledge about<br />
transfusion medicine, or as a result of coping with emerging transfusion transmissible<br />
threats to the blood and tissue supply.<br />
From the 1940s, blood was screened for syphilis and various blood group factors. From<br />
1971 a screening test for Hepatitis B was introduced and this was followed by testing for<br />
HIV in 1985.<br />
Later, as Hepatitis C was discovered, tests were introduced from September 1991 and a<br />
test for the Human T Lymphotrophic Virus (HTLV) was introduced in 2002. These tests,<br />
along with others, have become more sensitive and accurate ensuring that by all clinical<br />
standards blood is very safe, but is not, and cannot be, zero risk.<br />
The emergence of variant vCJD in the UK population as a result of eating contaminated<br />
beef has been a huge challenge, as this deadly and unusual disease has proven difficult to<br />
detect and apply countermeasures that we can be absolutely confident about. Nevertheless,<br />
we have introduced a whole range of measures including, leucodepletion of all blood<br />
components (except granulocytes), banning the use of UK plasma for fractionation,<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 15 of 62
importing some blood components for vulnerable groups of patients and deferring<br />
previously transfused donors.<br />
So far, the number of transmissions of vCJD with blood and tissues has been very low<br />
despite the Spongiform Encephalopathy Advisory Committee still estimating that 1:4000 of<br />
the population could be “carriers”. However, based on the precautionary principle, we<br />
expect to be instructed to deploy further vCJD countermeasures over the next few years as<br />
they become demonstrably effective and available for routine use.<br />
2.3.1.1 Mandatory Safety Measures<br />
Over the past decade, reducing the threat of transmitting vCJD with blood and tissues has<br />
dominated UK <strong>Blood</strong> and Tissues Policy and this is expected to continue into the future.<br />
The UK Advisory Committee on the Safety of <strong>Blood</strong>, Tissues and Organs (SaBTO) provides<br />
expert advice on these matters to Government - several experts from Scotland have been<br />
appointed to this committee. In Scotland, the Cabinet Secretary for Health and Wellbeing<br />
considers the advice from SaBTO and if it is determined that action should be taken, would<br />
instruct <strong>SNBTS</strong> to proceed to implementation within a defined timeframe. Such instructions<br />
are considered mandatory and those safety measures that could not reasonably be funded<br />
within the NSS funding envelope would normally be funded directly by the <strong>Scottish</strong><br />
Government.<br />
Ultimately, having given due consideration to a potential safety measure, SaBTO might<br />
determine that it offers no significant benefit in health economics or public health terms, in<br />
which case it would not progress to implementation. Similarly, Government may decide that<br />
on balance, a measure recommended by SaBTO should not be implemented or should be<br />
implemented at a later date or in a more restricted way than anticipated by <strong>SNBTS</strong>. Clearly,<br />
in these circumstances, <strong>SNBTS</strong> would not proceed further with the initiative, which would be<br />
deferred from our planning processes or would adjust the implementation date/plan as<br />
required.<br />
Since such mandated measures generally represent major change, it is essential that<br />
planning for potential implementation begins as soon as possible to inform decision-making<br />
and prepare for timely implementation. This means that in its normal planning processes,<br />
<strong>SNBTS</strong> will identify those potential mandatory safety measures, which are currently under<br />
active consideration and which need to be flagged up to allow appropriate budgetary and<br />
operational planning. It is timely planning and a strong science base that has allowed<br />
<strong>SNBTS</strong> to deploy safety measures in the past and it is <strong>SNBTS</strong> strategy to continue with this<br />
preparedness..<br />
These new measures include those which have been fully developed and are undergoing<br />
final trials, those which are in advanced stages of development of testing and those which<br />
are very early in development, but which show great promise. In formulating this <strong>Strategy</strong>,<br />
<strong>SNBTS</strong> has used its judgement to anticipate when these measures might be implemented<br />
and what their impact will be in terms of new resources. For blood and tissue safety<br />
measures which are currently under active consideration, implementation plans, costs and<br />
dates shown are best estimates, which will be further refined as implementation is<br />
instructed. Other safety measures may arise during the course of this <strong>Strategy</strong> and these<br />
will be dealt with on a case-by-case basis.<br />
<strong>SNBTS</strong> does not rely solely on its own expertise but draws heavily on the advice of the UK<br />
Joint Professional Advisory Committee (JPAC), which is funded and managed by all four<br />
UK <strong>Blood</strong> <strong>Service</strong>s acting in concert though the UK <strong>Blood</strong> <strong>Transfusion</strong> <strong>Service</strong>s Forum, a<br />
body which co-ordinates UK wide inter service activity. <strong>SNBTS</strong> and the other UK blood<br />
services also participate in the European <strong>Blood</strong> Alliance, which has been an effective<br />
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means of representing the common interests of all the member European <strong>Blood</strong> <strong>Service</strong>s to<br />
the EU regulators.<br />
The anticipated impact of these mandatory measures on our strategic themes has been<br />
incorporated in Section 3, in tabular form and pale blue shading has been used throughout<br />
to indicate that if the cannot reasonably be funded from within the NSS allocation, they are<br />
likely to require funding by SGHD and distinguishes them from service improvement and<br />
modernisation initiatives (see 2. 3.1.2 below) which are shaded green.<br />
2.3.1.2 <strong>Service</strong> Improvement and Modernisation<br />
<strong>SNBTS</strong> regularly reviews the performance of its operations including, blood safety<br />
measures, to identify whether systems need to be updated to improve performance,<br />
efficiency or quality. Such modernisation initiatives are generally funded through the normal<br />
resource allocation process operated by NSS, informed by <strong>SNBTS</strong>, and a number of these<br />
are included within the strategic themes described in Section 3 – as mentioned above,<br />
tabulated detail is shown with green shading to clarify that the anticipated funding source<br />
would generally be NSS/ <strong>SNBTS</strong>. Those safety initiatives, which cannot be funded through<br />
the normal allocation process, are generally funded by SGHD increasing the allocation of<br />
resources to NSS for use by <strong>SNBTS</strong>. All of the recent vCJD precautionary measures have<br />
been funded in this way.<br />
Whilst <strong>SNBTS</strong> will continue to focus on the delivery of quality and safety initiatives<br />
throughout the implementation of the <strong>Strategy</strong>, modernising our operations is a key driver<br />
as this will not only set <strong>SNBTS</strong> up to deliver future challenges, it will enable us to do so in a<br />
much more efficient way, for example:<br />
• Making best use of donors' time through the redesign and use of more efficient<br />
processes is critical to rebuilding and sustaining Scotland’s donor base and blood<br />
supply in the longer term.<br />
• We will make use of technology to deliver the concept of ‘intelligent blood component<br />
inventory’ and improved blood stock management both within <strong>SNBTS</strong> and <strong>Scottish</strong><br />
hospitals, making the most efficient use of the donors’ gift.<br />
• By consolidating and re-designing manufacturing and related activities in a single<br />
national site, we will ensure that our facilities meet regulatory standards required by<br />
the MHRA and HTA for processing and testing blood and tissues now and into the<br />
future. We will also deliver significant efficiencies in the use of our resources – staff,<br />
facilities and equipment and will be able to make use of opportunities for the exploitation of<br />
synergies and development of staff.<br />
• Significant future expenditure will be avoided by more efficient implementation of<br />
safety initiatives on a single site as opposed to the two sites we currently operate from.<br />
• Consolidating specialist clinical services (see section 3.4 <strong>Service</strong>s for Patients) is key<br />
to maintaining service delivery and will lead to more resilient service provision and<br />
more efficient ways of working. It will also deliver more appropriate working<br />
arrangements for staff.<br />
• We will also explore opportunities for exploiting operational, quality and other support<br />
system synergies between blood component processing and the Tissue <strong>Service</strong>s and<br />
Quality Directorates.<br />
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2.3.1.3 Increasing Quality and Regulatory Standards<br />
<strong>SNBTS</strong> products and services must be compliant with regulatory and accreditation<br />
standards that are continually increasing in scope and stringency e.g. the <strong>Blood</strong> Safety and<br />
Quality Regulations (BSQR), which are the subject of criminal law. Our <strong>Strategy</strong> is<br />
designed to ensure that our premises and systems of work, which are regularly inspected<br />
by the MHRA and HTA, are carefully reviewed and modernised to facilitate compliance into<br />
the future. Achieving these outcomes is extremely challenging and will require further<br />
investment in resources such as staff, processes, equipment and premises. This is<br />
particularly relevant to our facilities for the processing and testing of blood and tissues but it<br />
is also relevant to the modernisation of our blood collection programme, clinical services,<br />
indeed our entire organisation.<br />
2.3.2 ‘Better Health Better Care’<br />
<strong>SNBTS</strong> delivers direct clinical care for patients, promoting safe transfusion practice via the<br />
Better <strong>Blood</strong> <strong>Transfusion</strong> Programme (BBTP) and provides specialist testing in related<br />
fields such as transplantation, and collaborates in the development of new tissue and cell<br />
therapies.<br />
The changing demographics in Scotland are driving increasing demand for healthcare. The<br />
population is getting older, certain parts of the country have persistent health inequalities<br />
and the paradigm of disease is shifting towards chronic and more complex conditions.<br />
These changes are driving both the long-term increase in workload in the blood sector and<br />
our work in the development of new therapeutics for degenerative disease. <strong>SNBTS</strong> is much<br />
more than a provider of blood and tissue products and has a strong clinical interface in<br />
hospital blood banking, screening, testing and directly treating patients.<br />
The ever-developing areas of clinical application and increasing complexity of healthcare in<br />
this field means that in the future, the regional structure of our services for patients will not<br />
be sustainable. We need nationally managed specialisation delivered locally. All of this is<br />
aligned with delivery of BHBC and is the direction we have set out in our Strategic Plan.<br />
Specifically and in support of the ‘BHBC <strong>National</strong> Improvement Programmes for Patient<br />
Safety, treatment experience and service delivery’, <strong>SNBTS</strong> will ensure that all aspects of<br />
the <strong>Strategy</strong> will be based on delivering the six dimensions of quality as defined by the<br />
Institute of Medicine – safe, timely, patient centred, equitable, effective and efficient.<br />
2.3.3 Sustainability<br />
Analysis of the <strong>SNBTS</strong> workforce shows there are a large number of staff with very long<br />
service that will be reaching the end of their career around the time the <strong>National</strong> Centre will<br />
be available for occupancy. Many of these staff are in management positions. This<br />
represents a major risk to the organisation. However the consolidation onto a national site<br />
presents an opportunity to rationalise and improve management and staffing arrangements<br />
to ensure ongoing viability.<br />
It is essential that we make best use of this considerable experience and expertise to assist<br />
with the transition to our <strong>National</strong> Centre whilst developing staff to guarantee there is<br />
adequate succession planning to support service delivery in the future.<br />
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3. <strong>SNBTS</strong> STRATEGIC THEMES<br />
Throughout the consultation, response and planning processes we have been using a set<br />
of themes to describe the <strong>SNBTS</strong> <strong>Strategy</strong>. These are:<br />
• Enough <strong>Blood</strong> for Patients.<br />
• Facilities for the Future.<br />
• <strong>Service</strong>s for Patients.<br />
• Sustainable Tissue <strong>Service</strong>s.<br />
• Organisation Fit for the Future.<br />
The structure and process for creating, managing and implementing the plans which<br />
emerge from the <strong>SNBTS</strong> <strong>Strategy</strong> has trade union representation at all levels, which will<br />
strengthen our Partnership working. In preparing for and implementing the workforce<br />
changes, we will ensure that within our <strong>Strategy</strong> objectives there will be ample opportunity<br />
to enhance leadership capability and develop our staff.<br />
The remainder of this Strategic Development Plan deals with each of the strategic themes,<br />
giving the proposed changes, their benefits, key assumptions and conditions which require<br />
to be met to ensure success. Timescales, the impact on staffing levels, and potential costs<br />
or savings are also set out at a high level to be refined later through the NSS business<br />
case process. Clearly, it will not be possible to define all such impacts and where further<br />
work is required this will be scheduled into the plan.<br />
3.1 ENOUGH BLOOD FOR PATIENTS<br />
3.1.1 Introduction<br />
3.1.1.1 Operating environment<br />
The considerable challenges that <strong>SNBTS</strong> faces in terms of maintaining a safe and sufficient<br />
blood supply now and into the future have already been described.<br />
To achieve this we need a strategy that anticipates future challenges, designs effective<br />
solutions to address them and ensures successful and timely implementation. Our ability to<br />
achieve this objective will be greatly influenced by clinical demand trends, regulatory<br />
changes and mandated risk reduction measures.<br />
Achieving a successful outcome for these difficult challenges will require co-operation<br />
across the whole blood supply chain in Scotland in a manner that provides added value to<br />
the NHS. This theme will be led by the <strong>SNBTS</strong> Supply Chain Directorate, but will require<br />
the formation of effective partnerships with the <strong>SNBTS</strong> Clinical Directorate, Better <strong>Blood</strong><br />
<strong>Transfusion</strong> Team and the wider NHSScotland.<br />
Sections 4 and 5 show high-level workforce and financial plans in support of this <strong>Strategy</strong>.<br />
However, where there are elements of the <strong>Strategy</strong> which have reached pilot or planning<br />
stage and are judged to have a significant impact, more details have been provided in<br />
tabular form to ensure there is clarity of intent.<br />
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3.1.1.2 Future Challenges<br />
<strong>SNBTS</strong> developed a new staffing model in 2003 following a review of donor services.<br />
These changes, together with more effective targeting of particular blood groups (Group O<br />
or A), resulted in considerable gains in efficiency and productivity. This was clearly<br />
demonstrated by the results of the UK benchmarking exercises which indicated that <strong>SNBTS</strong><br />
blood collection had the highest level of productivity at that time when compared to the<br />
other four UK and Irish services, despite more difficult logistics. The gold standard<br />
benchmark is the number of useable donations per funded Whole Time Equivalent (WTE),<br />
which measures the effect of donor deferral rates and loss rates on productivity. The<br />
figures for 2007 for both the UK and European <strong>Blood</strong> Alliance benchmarking demonstrate<br />
that other services are now achieving greater productivity than <strong>SNBTS</strong>. Multiple factors<br />
contribute to this, which include higher deferral rates for donors and an overall reduction in<br />
the number of people coming forward to donate. This trend underlines the need to<br />
streamline and modernise blood collection processes to improve efficiency, ensure cost<br />
effectiveness and improve donor satisfaction.<br />
3.1.2 Keeping <strong>Blood</strong> Safe<br />
3.1.2.1 Safety Measures Under Evaluation by SaBTO<br />
Currently, there are a number of blood safety measures that are under evaluation by<br />
SaBTO. For planning purposes we have assumed that these will be mandated and<br />
implemented within the timescales described in the document - it should be understood that<br />
these may, or may not, move forward to implementation. Many of these issues relate to<br />
vCJD precautionary measures. Others may arise during the course of the <strong>Strategy</strong> and<br />
these will be dealt with on a case-by-case basis.<br />
(a) 100% Apheresis Platelets<br />
A Department of Health risk assessment indicates that provision of platelets by apheresis<br />
represents a significant measure to reduce the risk of transmission of vCJD by transfusion,<br />
by reducing the number of donors that recipients of platelet transfusion are exposed to. It<br />
is anticipated that the UK <strong>Blood</strong> <strong>Service</strong>s may be instructed to increase the provision of<br />
apheresis platelets, initially to 80%, progressing to 100%.<br />
For planning purposes, it is anticipated that this instruction will be received during 2009 and<br />
this represents a significant challenge, which will require significant additional resource and<br />
may take two to three years to complete.<br />
With our current technology, apheresis platelets can only be reliably collected in our static<br />
sites, although trials with community based apheresis are underway. <strong>SNBTS</strong> believe that if<br />
sufficient additional resource is made available, the target of 80% can be achieved within<br />
18 months within existing premises. Achieving the 100% target will need collaboration<br />
between <strong>SNBTS</strong> and hospitals to improve the usage of platelets (thereby reducing demand<br />
and the size of the 100% target) and/or the deployment of some additional blood collection<br />
strategy outwith our existing premises and may take two to three years.<br />
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Proposed source of Funding: SGHD<br />
TABLE SHOWS IN YEAR MOVEMENT<br />
Implement mandatory safety measures as<br />
required by Government (currently under<br />
consideration)<br />
2009/10 2010/11 2011/12 2012/13 2013/14<br />
Implementing 100% Apheresis<br />
Platelets<br />
• Increase the % of apheresis<br />
platelets issued to 100% via a<br />
staging post of 80%.<br />
Estimate prepared Jan 2009.<br />
Additional Staff and Goods and<br />
services.<br />
Assumes new or expanded<br />
collection footprint in 2011/12.<br />
100%<br />
apheresis<br />
platelets<br />
Staff<br />
Impact<br />
Roll out<br />
100%<br />
apheresis<br />
platelet plan /<br />
keep under<br />
review<br />
+ 12.75 WTE<br />
apheresis<br />
+1.5 WTE<br />
management<br />
£ Impact £813k Rev<br />
£423k Cap<br />
Roll out<br />
100%<br />
apheresis<br />
platelet plan/<br />
keep under<br />
review ~80%<br />
+ 4.25 WTE<br />
apheresis<br />
+ 0.25 WTE<br />
management<br />
£418k Rev<br />
£0 Cap<br />
Roll out 100%<br />
apheresis<br />
platelet plan /<br />
keep under<br />
review ~100%<br />
+ 9.4 WTE<br />
apheresis<br />
£1017k Rev<br />
£311k Cap<br />
Maintain<br />
donor<br />
recruitment,<br />
monitor and<br />
review<br />
requirements<br />
Monitor and<br />
review<br />
requirements<br />
£0 Rev<br />
£0 Cap<br />
Maintain<br />
donor<br />
recruitment,<br />
monitor and<br />
review<br />
requirements<br />
Monitor and<br />
review<br />
requirements<br />
£100k Rev<br />
£0 Cap<br />
(b) vCJD Screening Test<br />
<strong>SNBTS</strong> is currently deploying an integrated marketing and publicity campaign to halt the<br />
decline in the donor base and rebuild it to a level that will allow us to cope with the<br />
expected loss due to the introduction of a screening test for vCJD. In preparing for such an<br />
eventuality, preliminary plans have been developed for the worst-case scenario to provide<br />
additional staff to counsel and support concerned donors at blood collection sessions. This<br />
has been factored into our plans for 2010/11.<br />
However, information is emerging that a test may be available during 2010, which may<br />
have less impact on the donating public than our current planning scenario. Whilst this<br />
would be good news and may significantly reduce the number of additional staff required,<br />
the situation will be kept under continual review and plans will be revised as firmer<br />
information becomes available.<br />
Proposed source of Funding: SGHD<br />
TABLE SHOWS IN YEAR MOVEMENT<br />
Implement mandatory safety measures as required<br />
by Government (currently under consideration)<br />
2009/10 2010/11 2011/12 2012/13 2013/14<br />
Managing the Consequences of a<br />
vCJD Test<br />
• Maintain enough blood for<br />
patients against an instruction<br />
from Government to implement a<br />
vCJD donation screening test.<br />
vCJD test may be available earlier than<br />
predicted.<br />
Appropriate Publicity materials<br />
prepared.<br />
Costs for Donor <strong>Service</strong>s and Medical<br />
only shown here, mainly required to<br />
provide counselling support for<br />
concerned donors. Staff not<br />
permanent worst case scenario shown.<br />
In 2009/10 Publicity/ Appeal to ensure<br />
sufficiency of the blood supply in the<br />
face of vCJD test implementation.<br />
Initiative<br />
Staff Impact<br />
£ Impact<br />
Business as<br />
usual<br />
Business as<br />
usual<br />
Business as<br />
usual<br />
Ensure<br />
sufficiency<br />
of the blood<br />
supply<br />
+ 20 WTE<br />
Donor<br />
<strong>Service</strong>s<br />
+ 2 MOs<br />
Review<br />
performance<br />
and S&D<br />
Action as<br />
required<br />
Staffing<br />
needs<br />
should<br />
reduce<br />
£550k £550k<br />
Business as<br />
usual<br />
Lookback<br />
MOs<br />
Significantly<br />
less say<br />
£250k<br />
Business as<br />
usual<br />
Business as<br />
usual<br />
Business as<br />
usual<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 21 of 62
c) Other <strong>Blood</strong> Safety Measures<br />
With regard to further vCJD precautions, we know that SaBTO are considering whether it<br />
would be prudent to reduce donor exposures for patients who are dependant on repeated<br />
red cell transfusions by providing them with double dose red cells (two donations collected<br />
in series from a single donor) using apheresis technology.<br />
This would clearly require careful planning by donor services and would involve coordination<br />
across all steps in the blood transfusion chain from donor to recipient -<br />
implementation has not yet been factored into the plan.<br />
<strong>SNBTS</strong> is aware that there are other potential safety measures under consideration or that<br />
will come forward in the future, which will impact on ensuring there is “Enough <strong>Blood</strong> for<br />
Patients” and we will determine how these can be most effectively implemented on a case<br />
by case basis.<br />
3.1.2.2 <strong>Service</strong> Modernisation/ Improvements<br />
<strong>SNBTS</strong> will regularly review service performance and delivery to identify opportunities for<br />
modernisation and improvement. Wherever possible and practicable, such change will<br />
take place within existing <strong>SNBTS</strong> (or NSS) funds or will avoid the deployment of significant<br />
additional expenditure. The tables provide details of those activities for which pilots have<br />
already been planned/funding bids submitted. Clearly, this will extend to other initiatives<br />
over time.<br />
Improved Management of Donor Deferrals<br />
Currently <strong>SNBTS</strong> defer approximately 18% of all donors who attend to give blood. This<br />
figure has risen significantly since the implementation of the UK BSQR in Nov 2005. Within<br />
this timeframe, the number of donors permanently deferred has increased by 50%. It is<br />
well recognised that deferral adversely affects donor loyalty and retention and is directly<br />
linked to declining donor numbers. Additionally, increased deferral rates adversely affect<br />
collection productivity and efficiency. It is therefore clear that we need to ensure that we<br />
minimise both the number of donors deferred and the impact on those donors who are<br />
deferred. Some of the initiatives being considered include:<br />
• <strong>SNBTS</strong> is committed to the systematic review of donor selection criteria at<br />
UK/European level to ensure that deferral criteria are accurate and protect the<br />
safety of both donor and patient whilst minimising the deferral of donors e.g. recent<br />
changes to high blood pressure, diabetes and upper age limit criteria.<br />
• <strong>SNBTS</strong> will develop systems to improve the accuracy and objectivity of donor<br />
selection e.g. by using Haemocue for haemoglobin screening and browser<br />
technology for the selection guidelines.<br />
• <strong>SNBTS</strong> will design on-session strategies to improve the deferral process to promote<br />
return e.g. deferral information card.<br />
• Following the implementation of e-Progesa (<strong>SNBTS</strong> blood management computer<br />
system), <strong>SNBTS</strong> will develop a direct marketing approach for contacting donors at<br />
the end of the deferral period to promote return.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 22 of 62
3.1.3 Reversing the Decline in Donors<br />
In the last decade, <strong>SNBTS</strong> has experienced a dramatic decline of almost 30,000 in the<br />
number of active blood donors in Scotland. It is essential that we reverse this decline if we<br />
are to secure enough blood for patients.<br />
3.1.3.1 Rebuild the Active Donor Base and Build in Resilience<br />
In December 2007, with donor base levels at an all time low and projecting downwards, the<br />
NSS Board approved an <strong>SNBTS</strong> proposal to use a £2.32m integrated publicity and<br />
marketing campaign to halt the decline in the active donor base and rebuild it to a level that<br />
would provide sufficient resilience to cope with the potential loss of up to 10% of donors<br />
when a vCJD screening test was introduced (possibly in 2010/11).<br />
As of January 2009, excellent progress has been made. The decline has been halted and<br />
the rebuild is underway with the donor base reaching its highest level since 2005. This<br />
work will continue to deliver the required level of resilience in the active donor base by<br />
March 2010.<br />
Throughout, a key objective is to avoid activating the integrated plan for managing blood<br />
shortages, which might result in the cancellation of planned surgery because of insufficient<br />
blood.<br />
3.1.3.2 Reaching out to New Donors<br />
<strong>SNBTS</strong> will deploy a range of measures that are designed to reach out to new donors and<br />
retain them as active donors once recruited. These measures include:<br />
• Deployment of new strategies in our integrated publicity and marketing plan (including<br />
new media);<br />
• Strategies to improve donor retention; and<br />
• Sample only donation for those new donors deferred for non high-risk reasons to make<br />
them feel part of the donor community and significantly increase their retention.<br />
Proposed source of Funding: Funded 2008/08 by NSS<br />
TABLE SHOWS IN YEAR MOVEMENT<br />
Reaching out to New Donors presently being<br />
implemented<br />
2009/10 2010/11 2011/12 2012/13 2013/14<br />
Sample Only Donation<br />
• <strong>Blood</strong> samples will be taken and<br />
tested for new donors deferred for<br />
low risk reasons. This will increase<br />
the retention of these donors by an<br />
estimated 10,000 per annum.<br />
Recruit new<br />
donors<br />
Staff Impact<br />
+ 10 WTE<br />
in 2008/09<br />
baseline<br />
Review perf<br />
Business<br />
as usual<br />
Business<br />
as usual<br />
Business<br />
as usual<br />
£ Impact<br />
£220k<br />
Funded<br />
2008/09<br />
Review perf<br />
Business<br />
as usual<br />
Business<br />
as usual<br />
Business<br />
as usual<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 23 of 62
3.1.3.3 Communication with Donors<br />
<strong>SNBTS</strong> will deploy a range of measures that are designed to modernise and improve the<br />
effectiveness of communication with donors to ensure that once recruited we retain them<br />
as active donors. These measures include:<br />
• The procurement and use of customer relationship management software;<br />
• Further development of the <strong>SNBTS</strong> website and improving accessibility tools for deaf<br />
donors, allowing on line appointment booking, etc.;<br />
• Allowing donors to complete their donor session record (DSR) at home – which will<br />
provide increased confidentiality and reduce queuing at sessions;<br />
• Exploring the on line completion of the health check form; and<br />
• Using a range of new media tools to interact more effectively with younger and potential<br />
donors.<br />
Certain aspects of our communications plan will be heavily dependent upon the renewal of<br />
our IT infrastructure and the replacement of our core blood systems software which will<br />
allow the deployment of new customer relationship management software, hugely improving<br />
our ability to communicate with the 250,000 donors on our database.<br />
Proposed source of Funding: NSS<br />
TABLE SHOWS IN YEAR MOVEMENT<br />
Communication with Donors 2009/10 2010/11 2011/12 2012/13 2013/14<br />
Home DSR<br />
• During 2009/10, <strong>SNBTS</strong> will be<br />
piloting sending donors their DSR to<br />
complete at home, thereby improving<br />
confidentiality and reducing waiting<br />
times at sessions. If successful will<br />
be rolled out 2010/11.<br />
Home DSR<br />
Staff Impact<br />
1 year Pilot<br />
Nil<br />
Business<br />
Case<br />
Business<br />
Case<br />
+1 WTE<br />
Implement<br />
as<br />
approved<br />
Implement<br />
as<br />
approved<br />
Business<br />
as usual<br />
Business<br />
as usual<br />
Business<br />
as usual<br />
Business<br />
as usual<br />
£ Impact<br />
Bid<br />
Submitted<br />
2009/10<br />
£16k<br />
Business<br />
Case<br />
+£134k<br />
Implement<br />
as<br />
approved<br />
Business<br />
as usual<br />
Business<br />
as usual<br />
3.1.3.4 Transforming Donor Venues<br />
<strong>SNBTS</strong> recognises the need to critically review the current collection infrastructure to<br />
improve access and opportunity to donate by reviewing where and when we provide<br />
donation opportunities. We anticipate that increasing workplace and fixed site collections<br />
will change the shape of the collection programme and would expect this change to bring<br />
improvements for staff whilst reducing moving and handling and associated Health and<br />
Safety Issues. During 2009 we will analyse our current footprint, identify opportunities to<br />
change and model the impact of these. Simultaneously we will research donor and<br />
company requirements and the current levels of satisfaction in each sector. Specific<br />
consideration will be given to:<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 24 of 62
• Fixed sites - we will option appraise relocation from current hospital based sites and<br />
whether we should increase the number of fixed or semi permanent sites, we are<br />
currently in dialogue with several of our host Health Boards;<br />
• Community Collection, Workplace - during 2009, <strong>SNBTS</strong> plans to pilot the<br />
introduction of additional corporate sector collections in the North East with a view to<br />
assessing the feasibility of increasing corporate collections from 18% to 30%; and<br />
• Community Collection, Remote and Rural - during 2009 we will review the logistics,<br />
costs and potential benefits to the donor base and blood supply in accessing more<br />
remote communities and islands (Orkney pilot planned 2009).<br />
Proposed source of Funding: NSS<br />
TABLE SHOWS IN YEAR MOVEMENT<br />
Transforming our Donor Venues 2009/10 2010/11 2011/12 2012/13 2013/14<br />
Community Collection: Workplace<br />
• Plan to increase workplace<br />
sessions from 18 to 30% of the<br />
total.<br />
• 3.42 Wte (£123k) bid for funding in Dec<br />
2008 to allow pilot to proceed during<br />
2009/10.<br />
Increase<br />
Workplace<br />
sessions<br />
Staff Impact<br />
1 year Pilot<br />
planned<br />
+3.42 Wte<br />
bid<br />
submitted<br />
Business<br />
Case<br />
Business<br />
Case<br />
Prob+9.5<br />
WTE<br />
Implement<br />
as<br />
approved<br />
Implement<br />
as<br />
approved<br />
Business<br />
as usual<br />
Business<br />
as usual<br />
Business<br />
as usual<br />
Business<br />
as usual<br />
£ Impact £123k NR<br />
Bid 2009/10<br />
Business<br />
Case<br />
Implement<br />
as<br />
approved<br />
Business<br />
as usual<br />
Business<br />
as usual<br />
3.1.3.5 Transforming the Donation Experience<br />
During 2009/10 we will critically review every interaction we have with blood donors ‘on<br />
session’ to design a care strategy that meets their individual needs, developing systems<br />
that will transform the donation experience. Factors to be considered include:<br />
• Appointments - excellent feedback has been received when deployed in the corporate<br />
sector and we now have an agreed system which has reduced waiting times and<br />
complaints from the busiest venues;<br />
• Streamlining the donation process – redesign the blood collection process; review<br />
staffing structure, skill mix and model; and consider the opportunity for advances in<br />
technology to support this; and<br />
• Multi Component Collection - implement ‘intelligent’ inventory control to maximise the<br />
potential of the donor base.<br />
3.1.4 Impact on Staff and Resources<br />
The ‘Enough <strong>Blood</strong> for Patients’ strategic theme has identified a wide range of activities that<br />
include mandated blood safety measures, continuing regulatory compliance issues,<br />
improving customer satisfaction and a major modernisation of the <strong>Service</strong>.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 25 of 62
For mandated safety measures (and those which we believe may be mandated in the<br />
foreseeable future) we have detailed resource plans and can clearly show their impact in<br />
terms of additional staff and other resources.<br />
The NSS Board has previously acknowledged that redesigning the blood collection<br />
programme requires careful development of options and extensive piloting to demonstrate<br />
their effectiveness, efficiency and sustainability. A number of these modernisation/<br />
improvement initiatives have been implemented within the existing funding allocation; some<br />
are being piloted whilst bids have been submitted for non-recurring funds to allow us to pilot<br />
others.<br />
This is a major piece of work which, in terms of transforming the donor experience, will help<br />
us determine which options have greatest impact, are most cost efficient and have greatest<br />
ease of implementation. However, until the results of pilots have been analysed we will not<br />
be in a position to clearly identify the impact on staff or funding.<br />
A number of the options for modernisation and redesign will release resources and<br />
depending on the options selected, could release up to 25 WTE from the current<br />
establishment of 311.<br />
However, the need to redesign the collection programme to increase opportunity and<br />
accessibility will require additional resources. It is therefore anticipated that, as far as<br />
possible, the options for service redesign and modernisation will minimise the effect of<br />
change on the size of the blood collection establishment. More detailed consideration is<br />
given in Managing Change in the Workforce, Section 4.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 26 of 62
3.2 FACILITIES FOR THE FUTURE<br />
3.2.1 Introduction<br />
The NSS Property <strong>Strategy</strong> 2008 confirmed that there are significant issues with much of<br />
the <strong>SNBTS</strong> estate. In particular, there are difficulties with the space and layout in the<br />
processing and testing centres in Edinburgh and Glasgow as well as the Tissue <strong>Service</strong>s<br />
Directorate premises in Edinburgh. A number of blood and tissue safety developments are<br />
anticipated which will compound these difficulties. Currently, these premises are licensed<br />
but it is likely that they will remain so for a limited period of four or five years, particularly as<br />
the accommodation becomes ever more compressed and the mechanical and engineering<br />
plant ages further.<br />
Also, it is believed that regulators will expect to see blood and tissue manufacturing taking<br />
place in premises that meet the standards achieved in the pharmaceutical industry. The<br />
new NHS <strong>Blood</strong> and Transplant (NHSBT) blood processing centre in Filton, Bristol,<br />
achieves these standards and this is expected to become the accepted standard in the UK.<br />
This standard is already adopted in certain other EU countries. Current premises simply<br />
cannot support such an objective.<br />
The 2008 ESTATECODE survey established that the majority of <strong>SNBTS</strong>’ current<br />
accommodation is in an unacceptable condition (as judged by the ESTATECODE<br />
standards). Whilst the estate is presently compliant with regulatory standards, it is not<br />
flexible enough to allow essential changes in work processes, and there is concern over<br />
the ability to continually meet stringent regulatory compliance requirements. Additionally,<br />
the current accommodation offers poor facilities for staff in respect of training, canteen and<br />
changing areas.<br />
Pharmaceutical consulting engineers employed by NSS carried out a review of the existing<br />
blood and tissue manufacturing and testing processes, future requirements to support the<br />
implementation of anticipated blood safety measures and the regulatory standards that<br />
facilities need to meet to ensure delivery of contemporary GMP requirements. These<br />
requirements were matched against the existing facilities especially in Gartnavel, Lauriston<br />
Place and Ellens Glen Road to inform a Site Master Plan study and support a<br />
comprehensive option appraisal exercise concerning reuse of existing facilities and/ or<br />
building new facilities. This option appraisal exercise was carried out in Partnership and<br />
identified the co-location of P&T, IT support, engineering, head office, logistics, selected<br />
R&D and donor administration, and the Tissue <strong>Service</strong>s and Quality Directorates on a new<br />
national <strong>SNBTS</strong> site as the preferred strategic option. The Site Master Plan Study that was<br />
used to inform the option appraisal exercise identified an estimated capital requirement of<br />
£35m in 2012/13 for a new <strong>National</strong> Centre (assuming a capital funded build).<br />
This approach was approved by the NSS Board in November 2008 and it is intended to<br />
prepare an outline business case (OBC) for consideration by the NSS Board and SGHD<br />
Capital Investment Group by December 2009. On the current plan, the new <strong>National</strong><br />
Centre for <strong>SNBTS</strong> should be ready for occupancy in 2013.<br />
Sections 4 and 5 show high-level workforce and finance plans in support of the <strong>Strategy</strong>.<br />
However, where there are elements of the <strong>Strategy</strong>, which have reached the planning<br />
stage and are judged to have a significant impact on staff or funding, more details have<br />
been provided in tabular form to ensure there is clarity of intent.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 27 of 62
3.2.2 Keeping <strong>Blood</strong> Safe<br />
3.2.2.1 Safety Measures Under Evaluation by SaBTO<br />
Currently, there are a number of blood safety measures that are under evaluation by<br />
SaBTO. For planning purposes, we have assumed that these will be mandated and<br />
implemented within the timescales described in the document - it should be understood that<br />
these may, or may not, move forward to implementation or be delayed for further evaluation<br />
by SaBTO. Many of these issues relate to vCJD precautionary measures. Others may<br />
arise during the course of this strategic plan and these will be dealt with on a case-by-case<br />
basis.<br />
In the short term, any new safety measure will need to be implemented within our existing<br />
premises prior to completion of the new <strong>National</strong> Centre. This will require new safety<br />
measures being implemented in areas that have been previously used for prior processing<br />
steps, leading to inefficiency and the imposition of additional controls to guarantee GMP.<br />
Other tests will need to be located in space not currently used for blood processing,<br />
potentially necessitating the relocation of staff to create space. Whilst this will be<br />
acceptable as a short-term measure, it will lead to inefficiency, increased risk and will not<br />
be sustainable in the longer term.<br />
(a) Prion Filtration of Red cells<br />
Abnormal prions are thought to be associated with vCJD infection. Filters have now been<br />
developed and approved for use, which have been shown to remove prions from red cell<br />
components. The introduction of these filters would be an additional precautionary measure<br />
against the possible transmission of vCJD by blood components. These filters are<br />
undergoing final safety and efficacy trials. Costs and impacts shown below represent prion<br />
removal for all red cell components on a UK basis. A more limited implementation would<br />
clearly reduce costs overall but might increase the unit cost of prion removal.<br />
Proposed source of Funding: SGHD<br />
TABLE SHOWS IN YEAR MOVEMENT<br />
Implement mandatory safety measures as required by<br />
Government (currently under consideration)<br />
2009/10 2010/11 2011/12 2012/13 2013/14<br />
Introduce Prion Filtration of red cells<br />
Introduce Prion removal of red cells.<br />
Start with neonates etc implement<br />
over 12-18 months. Costs based on<br />
current estimates.<br />
Prion<br />
Removal<br />
Staff<br />
Impact<br />
Implement<br />
Implement<br />
+ 5 WTE +20 WTE<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
£ Impact £2.5m Rev £7.6m Rev<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
(b) Pathogen Reduction of Platelets<br />
There are now approved pathogen reduction methods for the treatment of platelets to<br />
substantially reduce their infective risk whilst supporting an extension of shelf life to seven<br />
days. This would confer significant advantages and facilitate the process, prospects and<br />
costs of achieving 100% apheresis platelets (as a vCJD risk reduction measure).<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 28 of 62
Proposed source of Funding: SGHD<br />
TABLE SHOWS IN YEAR MOVEMENT<br />
Implement mandatory safety measures as required by<br />
Government (currently under consideration)<br />
2009/10 2010/11 2011/12 2012/13 2013/14<br />
Implementing Pathogen Reduction of<br />
Platelets<br />
Introduce Pathogen Reduction of<br />
Platelets.<br />
Reduces expiry, releases costs<br />
facilitates 100% apheresis Platelets.<br />
Pathogen<br />
Reduction<br />
of platelets<br />
Staff<br />
Impact<br />
Funding bid<br />
prepared<br />
Implement<br />
+ 1 WTE +3 WTE<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
£ Impact<br />
£343k Rev £1.4m<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
c) Universal Apheresis Platelets<br />
As mentioned under ‘Enough <strong>Blood</strong> for Patients’, a DoH risk assessment indicates that<br />
risks of transmitting vCJD to recipients of platelets could be significantly reduced by<br />
supplying platelets derived by apheresis technology, thereby reducing donor exposures.<br />
The SaBTO advisory committee has asked NHSBT to determine the feasibility of achieving<br />
this objective via a staging post of ~80% and will discuss their response in April 2009.<br />
Proposed source of Funding: SGHD.<br />
TABLE SHOWS IN YEAR MOVEMENT<br />
Implement mandatory safety measures as required by<br />
Government (currently under consideration)<br />
2009/10 2010/11 2011/12 2012/13 2013/14<br />
Implement Universal Apheresis<br />
Platelets<br />
Projected 2009-12 impacts include<br />
additional lab staff and test kits for<br />
increased mandatory marker and anti-<br />
HBc testing, increased BatALert<br />
testing.<br />
100%<br />
Apheresis<br />
Staff<br />
Impact<br />
Funding bid<br />
prepared<br />
+2.5 WTE<br />
Implement Implement Business<br />
as Usual<br />
Business<br />
as Usual<br />
£ Impact £368k Rev -£11k<br />
Business<br />
as Usual<br />
l<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
(d) vCJD Test<br />
Testing kits, which are capable of detecting abnormal prions are now under evaluation and<br />
<strong>SNBTS</strong> will be closely monitoring this developing situation. Whilst indicative test costs from<br />
suppliers are not yet available, from experience with, for example, nucleic acid tests, we<br />
have prepared an indicative assessment of the anticipated impacts on staff and costs and<br />
these are shown in the table below.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 29 of 62
Proposed source of Funding: SGHD.<br />
TABLE SHOWS IN YEAR MOVEMENT<br />
Implement mandatory safety measures as required by<br />
Government (currently under consideration)<br />
2009/10 2010/11 2011/12 2012/13 2013/14<br />
Introduce a Donor Screening Test for<br />
vCJD<br />
Initially projected availability 2010/11<br />
May become available late 2009/10<br />
Donor <strong>Service</strong>s Issues dealt with in<br />
Enough <strong>Blood</strong> for Patients.<br />
Prion<br />
Removal<br />
Staff<br />
Impact<br />
Funding bid<br />
prepared Implement Implement<br />
Funding bid<br />
prepared<br />
+4 WTE +4 WTE<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
£ Impact<br />
Funding bid<br />
prepared<br />
£1.2m Rev<br />
£1.2m Rev<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
(e) Pathogen Reduction of Red Cells<br />
Pathogen Reduction systems for the treatment of red cell components have been under<br />
development for some time and it is anticipated that by 2012/13 there will be systems that<br />
are sufficiently practicable, safe for patients and well proven to support their routine<br />
introduction. Therefore it is essential that we include this activity when planning our future<br />
facilities. The staffing impact of these systems is currently estimated to be of the scale of<br />
implementation of prion filtration i.e. around 25 additional WTE (mainly MLA staff).<br />
(f) Screening for a new Infectious Agent<br />
We know from experience that we can anticipate the emergence of a new transfusion<br />
transmitted pathogen within this planning timeframe. Therefore it is essential that we plan<br />
for the inclusion of such a development in our new facilities, possibly from 2012/13,<br />
involving some eight additional staff to deal with the introduction of the test and associated<br />
look back exercise.<br />
3.2.2.2 Developments of Existing Tests<br />
The following key blood safety measures represent the modernisation of services already<br />
provided and have been funded from within the NSS allocation. They will be implemented<br />
during 2009 and it is anticipated that further quality improvements will be required in the<br />
future.<br />
(a) Automated NAT<br />
The nucleic acid amplification test (NAT) is a highly sensitive method for detection of<br />
viruses present in donated blood. The manual NAT method currently used by <strong>SNBTS</strong> was<br />
developed in-house over 10 years ago. Although this method has been fully inspected by<br />
the MHRA, the current industry standard uses automated technology and test kits, which<br />
are approved in Europe through the ‘CE mark’ system. NSS has set aside funding to allow<br />
<strong>SNBTS</strong> to introduce this standard of test during 2009.<br />
(b) Syphilis Testing<br />
The incidence of sexually transmitted diseases in the general population is increasing. This<br />
includes syphilis and this increase is reflected in the increasing incidence of syphilis in the<br />
donor population. A more sensitive test is now available and NSS has agreed that this<br />
should be implemented during 2009. Funding includes +4 WTE staff.<br />
(c) Automated Red Cell Antibody Screening Test<br />
This is a test used in the preparation of specific red cell concentrates for use in infants,<br />
neonates and in utero. The test needs to be improved as a consequence of an increase in<br />
standards required. Funding to achieve this service improvement was approved by NSS<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 30 of 62
and a tender exercise is underway. This new technology will be implemented during 2009,<br />
with an associated increase in the P&T establishment of 1 WTE.<br />
3.2.3 Modernising <strong>Blood</strong> Production Facilities to Maintain Safety<br />
3.2.3.1 New <strong>National</strong> Centre<br />
As previously discussed under section 3.2.1. , the NSS Corporate <strong>Strategy</strong> highlighted a<br />
number of strategic deliverables for <strong>SNBTS</strong>, which cannot be supported by significant<br />
elements of the current <strong>SNBTS</strong> estate.<br />
a) Options and Outcome<br />
A comprehensive option appraisal exercise was carried out in Partnership in March 2008<br />
and a summary of the outputs is shown below.<br />
No.<br />
Option Description<br />
Weighted Benefits Score<br />
Con’s<br />
us<br />
Risk<br />
Lifecycle<br />
Costs<br />
Cost per<br />
benefit point<br />
Opt Pess Rank Score Rank £m Rank £000 Rank<br />
0<br />
Do minimum (backlog<br />
maint.)<br />
233 234 229 5 378 5 104 4 444 5<br />
1<br />
Lauriston & Gartnavel refurb<br />
(P&T) + new build (new site)<br />
473 473 473 4 368 4 105 5 223 4<br />
2 Single New build, (new site) 823 835 798 1 126 1 88 1 107 1<br />
3<br />
Gartnavel (P&T only) + new<br />
build (new site)<br />
644 647 644 3 306 3 101 3 157 3<br />
4<br />
Gartnavel (T only) + new<br />
build (new site)<br />
726 739 710 2 148 2 97 2 134 2<br />
As can be seen, Option 2 single new build (all functions) on a new site was the preferred<br />
option on all appraisal measures. It identified the co-location of P&T, IT support,<br />
engineering, head office, logistics, select R&D functions and donor administration, and the<br />
Tissue <strong>Service</strong>s and Quality Directorates on this new <strong>National</strong> <strong>SNBTS</strong> site and this was<br />
identified as the preferred strategic option. This approach was approved by the NSS Board<br />
in November 2008.<br />
The new <strong>National</strong> Centre will allow <strong>SNBTS</strong> to guarantee ongoing blood and tissue service<br />
support for patients in Scotland. It will allow future blood and tissue safety measures to be<br />
implemented in a timely and cost effective manner and will also provide sufficient flexibility<br />
to accommodate future changes to both operational and workforce practices within the<br />
‘Patient Focus Public Involvement’ (PFPI) framework for delivering a culture change in<br />
NHSScotland where patient-focus is at the heart of service design and delivery.<br />
This approach will also support the introduction of manufacturing processes in premises<br />
that will meet the pharmaceutical industry standards our regulators (MHRA and HTA)<br />
increasingly expect to see. We anticipate this approach will become the minimum standard<br />
in future and it is already in place in the newly opened flagship NHSBT Centre at Filton<br />
near Bristol.<br />
Clearly, this initiative will have a significant impact on our staff and these issues will be<br />
addressed in our workforce plan, which is summarised in Section 4. During 2009/10 in<br />
preparing the OBC, we will work in Partnership to establish what conceptually different<br />
ways of operating and achieving compliance will mean for processes and staff.<br />
b) Outcomes and Possible Solutions if Preferred Option is Delayed/Not Funded<br />
<strong>SNBTS</strong> is mindful of the extremely challenging economic climate and has given<br />
consideration to the outcomes and possible solutions if the new <strong>National</strong> Centre is delayed<br />
or not funded.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 31 of 62
Against the background of shortage of space, increasing regulatory standards and lack of<br />
ideal working conditions for staff, this plan has described a number of additional,<br />
mandatory blood and tissue safety measures which are likely to be introduced before a<br />
<strong>National</strong> Centre will be available for occupancy.<br />
These new safety measures will need to be accommodated within existing premises,<br />
adding significantly to the challenge of working in limited space that will not support optimal<br />
workflow and will not meet future regulatory requirements. MHRA/ HTA may tolerate such<br />
arrangements provided there is a clear plan to provide a more appropriate solution within<br />
an agreed timeframe. In the absence of such an approach we would be at risk of losing<br />
our <strong>Blood</strong> and Tissue Establishment licences.<br />
If the <strong>National</strong> Centre were to be delayed, it may be possible to continue to operate from<br />
existing premises for a limited period. This would probably be no more than two years ie<br />
until 2015 but may be significantly less. Any delay in commissioning the <strong>National</strong> Centre<br />
would clearly bring significantly increased regulatory and operational risks. Our Regulators<br />
(MHRA and HTA) have been advised we are developing options/ plans for new premises<br />
and will be very concerned at any significant delay. We would almost certainly need to<br />
enter into extensive discussions with them to outline how we planned to proceed and<br />
secure their approval.<br />
The mechanical and engineering plant in the Lauriston Building is approaching the end of<br />
its serviceable life and, as a result, the risk of its failure will increase significantly over time.<br />
There are very similar issues with the plant in PFC, which houses Tissue <strong>Service</strong>s and, as<br />
a result of space constraints within the Lauriston Building, we will need to locate vCJD<br />
screening and confirmatory tests within PFC. Plant failure in either of these buildings<br />
would become increasingly likely and could result in acute loss of service with serious<br />
consequences for NHS Scotland and the patients it serves.<br />
If the creation of a <strong>National</strong> Centre for <strong>SNBTS</strong> is not supported or is delayed beyond 2015,<br />
the level of organisational and regulatory risk would increase significantly. The increasing<br />
risk of mechanical and engineering plant failure at the Lauriston facility, allied to the<br />
increased regulatory risk and with no obvious means of refurbishing or otherwise bringing<br />
the Lauriston Building up to standard would mean that in order to avoid the risk of<br />
unplanned failure of the blood supply we would be required to plan to discontinue<br />
processing and testing of blood components on that site.<br />
With no suitable alternative accommodation available and authorised by MHRA, we would<br />
be required to seek to subcontract some or all of this work to NHS <strong>Blood</strong> and Transplant in<br />
England. The logistics of this would be challenging and would have the potential to<br />
adversely impact on blood component availability, especially platelets. Furthermore, there<br />
would be the potential for loss of control over blood safety policy for that proportion of the<br />
blood supply being sent to NHSBT for processing and testing. Whilst all UK <strong>Blood</strong><br />
<strong>Service</strong>s work to the same minimum standard, some differences prevail eg NHSBT<br />
currently do not test all platelet donations for bacterial contamination.<br />
Clearly, these are radical measures which reflect the gravity of the situation and the<br />
importance of delivering the preferred option.<br />
3.2.3.2 Transforming Donation Venues<br />
Within the <strong>Strategy</strong>, there is a commitment to transforming the donation experience to<br />
make it more accessible and rewarding for donors. As part of this, we will assess the<br />
feasibility of offering donor sessions across a wider range of venues in semi-permanent or<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 32 of 62
permanent locations, including a move from current hospital based locations to convenient<br />
city centre locations.<br />
Future property requirements for fixed site donor centres will be determined following<br />
completion of feasibility exercises. Meanwhile, we will continue to operate from our existing<br />
fixed site donor facilities. <strong>SNBTS</strong> and NSS Facilities Department are currently in<br />
discussions with Health Boards about how space currently occupied by <strong>SNBTS</strong> on their<br />
sites, could be better used. This will be further progressed during 2009/10. The possibility<br />
of relocating hospital based donor centres to city centre sites is a key element of those<br />
discussions.<br />
The NSS Property <strong>Strategy</strong> envisages transfer of surplus space from premises occupied by<br />
<strong>SNBTS</strong> to territorial Health Boards as a key strand in the creation of a national site for<br />
<strong>SNBTS</strong>.<br />
3.2.3.3 Sustainable <strong>Service</strong>s for Patients<br />
There are a number of issues relating to the quality, location and size of accommodation<br />
used by <strong>SNBTS</strong> in delivering its laboratory and clinical services as set out in the <strong>Service</strong>s<br />
for Patients strategic theme. In particular, there is a lack of space in Edinburgh and<br />
Dundee and excess space in Inverness and Aberdeen.<br />
In Edinburgh, the clinical laboratories and related services relocated to the new Royal<br />
Infirmary in 2003 where space to deliver current services is extremely tight. In Glasgow,<br />
where the Clinical Directorate has taken over the delivery of local blood banking, space is<br />
very tight and this will not be resolved until the relocation of P&T to the <strong>National</strong> Centre<br />
releasing sufficient space for expanded clinical activity.<br />
In Dundee, there are pre-existing space constraints, which will become even more pressing<br />
if the implementation of universal apheresis platelets is mandated as this will impact<br />
adversely on available space for delivery of therapeutic apheresis and venesection.<br />
Initiatives such as the relocation of P&T from the Gartnavel facility and potential relocation<br />
of donor centres from hospital sites in Dundee, Aberdeen and Inverness will change the<br />
footprint <strong>SNBTS</strong> requires in these premises. As mentioned, discussions are ongoing with<br />
regional Health Boards to explore areas of complementarity between their property<br />
strategies and NSS in order to maximise the productive use of NHS facilities.<br />
Finally, there is a need to plan for the likelihood of blood component stockholding depots<br />
(likely to be within existing regional centres) distributed away from the <strong>National</strong> Centre and<br />
these requirements will become clearer after the location of the site is known.<br />
3.2.3.4 Co-location with other Functions<br />
The development of the national site offers the opportunity to review our working practices<br />
in a number of functions.<br />
(a) Donor Administration and Support<br />
Following the donor services review in 2003, donor administration functions and processes<br />
were standardised with minimal regional variation in practice or policy. However, the<br />
development of the <strong>National</strong> Centre offers the opportunity to review these functions to<br />
consider how best these should be delivered in the future. This process will be conducted<br />
in Partnership and will consider:<br />
• Which functions are best co-located with processing and testing?<br />
• Which functions need to be delivered locally?<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 33 of 62
• Whether there are efficiencies and service benefits arising from co-location at the<br />
<strong>National</strong> Centre?<br />
• Whether there are new functions that could be conducted locally to improve our<br />
community liaison and grass roots donor recruitment and retention activities?<br />
It is proposed that this work be undertaken during 2009. An implementation schedule to<br />
allow these changes to be phased in in advance of the national site becoming available will<br />
also be proposed during 2009.<br />
(b) Medical Care of <strong>Blood</strong> Donors<br />
Donor services is nationally led and medical care of donors follows national protocols and<br />
policy in the delivery of care for blood donors. It is anticipated that the medical<br />
establishment will undergo significant turnover due to retirement of key personnel and it is<br />
anticipated that it will be difficult to recruit suitable replacements. A plan to address this<br />
and to redesign this critically important area will be progressed during 2009. The proposed<br />
approach mirrors that outlined for donor administration and support.<br />
(c) <strong>National</strong> Microbiological Reference Unit (NMRU)<br />
Currently, the NMRU provides a highly responsive and high quality confirmatory and<br />
reference service for virus marker testing of blood and tissue donors. It also provides such<br />
a service under contract for the Northern Ireland <strong>Blood</strong> <strong>Transfusion</strong> <strong>Service</strong>.<br />
NMRU will benefit from being located within the <strong>National</strong> Centre where all testing and donor<br />
samples will be held.<br />
(d) Interaction with R&D<br />
<strong>Blood</strong> products and components has been a ‘Theme Group’ within R&D since the last<br />
reorganisation many years ago. With the closure of PFC, research into plasma products<br />
will cease and attention will focus on delivering high impact science that benefits patients<br />
and supporting developments aimed at improving blood component quality and safety.<br />
Much of this latter work is more operational in nature and many of the protocols are now<br />
well established and fairly routine.<br />
Experience with the development of prion filters has clearly illustrated the need to have<br />
highly experienced production staff to ensure that the development of technical<br />
specifications meet operational needs. There is much merit in having multidisciplinary staff<br />
working closer together to take developments from the validation stage into routine<br />
operations. The new <strong>National</strong> Centre will have small pilot plant facilities to ensure that new<br />
processes can be trialled near to the main plant without disrupting manufacturing<br />
operations or being carried out in unsuitable R&D labs. Details will be worked up in<br />
Partnership as part of the OBC development.<br />
(e) Environmental and Quality Monitoring Tests<br />
Currently this testing is shared between quality and P&T teams with different arrangements<br />
in place in Glasgow and Edinburgh. This has previously attracted comment from the<br />
MHRA and this will be resolved as we prepare to move into a <strong>National</strong> Centre. Details will<br />
be worked up in Partnership as part of the OBC development.<br />
(f) Integrated Working with Tissues<br />
One potential benefit of co-locating P&T and the Tissues Directorate is the opportunity to<br />
consider bringing all manufacturing activities under a unified management structure. This<br />
could have major benefits in terms of improving cover for key activities that require<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 34 of 62
24/7/365 support, making out of hours rosters much more robust and sustainable. Details<br />
will be explored in Partnership as part of the OBC development.<br />
(g) Co-location with other NSS Divisions<br />
If a suitable location is chosen for the <strong>National</strong> Centre, consideration will be given to the colocation<br />
of Counter Fraud <strong>Service</strong>s from Earlston House, Health Facilities Scotland from<br />
Kirkhill Business Park and Practitioner <strong>Service</strong>s Division from Bain Square.<br />
3.2.3.5 Lean and Compliant<br />
It is almost 10 years since the last major rationalisation and reorganisation of the <strong>SNBTS</strong><br />
manufacturing activities when the number of P&T units was reduced from five to two. The<br />
remaining P&T site within the Lauriston facility was reconfigured, and the new unit at the<br />
Gartnavel facility designed to meet the operational demands at that time. There is little<br />
doubt that this facilitated the implementation of some major developments in a more<br />
effective and efficient manner. Since then, <strong>SNBTS</strong> has implemented a number of other<br />
developments within the constraints of existing restricted space, laboratory workflows and<br />
layouts, staffing levels/skills mixes and working hours/shift patterns. Processes have<br />
changed or been adapted to accommodate new technology, respond to quality incidents or<br />
to correct non-conformances identified by internal and/or external regulatory audits.<br />
The move to a new <strong>National</strong> Centre will provide the opportunity to review and modernise<br />
current working practices and those likely to be introduced in the near future as well as<br />
ensuring they are designed for purpose. For example, there is ample evidence that<br />
process improvement strategies based on ‘Lean’ solutions can reduce cost and waste,<br />
dramatically reduce processing times and free up valuable staff to undertake more<br />
productive work. The underlying ‘Lean’ principle is to create flow and eliminate waste in all<br />
its forms and requires a fundamental change in working practices and the thinking behind<br />
them.<br />
Similarly our quality systems have evolved to address ever-increasing regulatory demands<br />
from the MHRA and HTA and to address quality incidents, systems failures and audit<br />
reports – both internal and external. Although significant effort has gone into the redesign of<br />
the Quality Management System, some elements of compliance have been achieved by the<br />
deployment of significant additional resource across all of our sites. Although <strong>SNBTS</strong> does<br />
achieve high levels of quality and compliance, there is little doubt that significant<br />
improvements could be made to how this is achieved.<br />
The design of the new <strong>National</strong> Centre will include process improvement strategies such as<br />
‘Lean’ and will completely modernise all aspects of how we work.<br />
3.2.3.6 Logistics<br />
<strong>SNBTS</strong> will apply the lessons learned in modernising blood component logistics to all<br />
activities. These developments will provide a real challenge to the transport team who will<br />
derive significant benefit from being physically and managerially integrated with<br />
manufacturing.<br />
In industries such as electronics that are dependent on efficient manufacturing and supply<br />
chain management, strategies such as Kan-Ban (automatic stock replenishment) and<br />
vendor managed inventory (VMI) have been deployed to improve efficiency (VMI stocks are<br />
held close to the point of use, owned by the 'vendor' (<strong>SNBTS</strong>) and replenished or moved<br />
around the supply chain by the 'vendor').<br />
<strong>SNBTS</strong> will make extensive use of these and other supply chain techniques to modernise<br />
this key part of our operation and support the delivery of an enhanced and more efficient<br />
logistics service. In turn, this will allow efficiency improvements in NHSScotland’s hospital<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 35 of 62
lood banks and the <strong>SNBTS</strong> supply chain e.g. <strong>SNBTS</strong> will reduce the number of<br />
emergency deliveries to reduce risks for patients by encouraging more appropriate blood<br />
stock management practices in hospitals,<br />
<strong>SNBTS</strong> will take the opportunity to fundamentally review the entire manufacturing and<br />
logistics operation, e.g. combine the inbound logistics of collected blood with the delivery of<br />
finished components thereby reducing journeys and our carbon footprint.<br />
3.2.3.7 Impact on staff of the creation of a <strong>National</strong> Centre for <strong>SNBTS</strong><br />
The creation of a <strong>National</strong> Centre is of critical importance to future proof the provision of<br />
Scotland’s blood and tissue supplies. The <strong>Strategy</strong> has described the major blood safety<br />
initiatives that we expect to be introduced over the next five years, including the estimated<br />
increased staffing resource that will be needed to deliver them. However, creating a single,<br />
<strong>National</strong> Centre will bring significant opportunities and challenges for staff and these will<br />
potentially impact all staff whose workload will relocate to the <strong>National</strong> Centre (see 3.2.1).<br />
These issues are discussed more fully in the workforce plan (see Section 4) but staff should<br />
be reassured that the NSS Organisational Change Policy will govern all changes.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 36 of 62
3.3 SUSTAINABLE TISSUE SERVICES<br />
3.3.1 Introduction<br />
Products prepared from bone, tissues and cells are relatively new therapeutic agents. Our<br />
experience in preparing biological materials as medicinal products makes <strong>SNBTS</strong> ideally<br />
placed to supply these preparations to the NHS in Scotland. This work has become<br />
established in the Tissue <strong>Service</strong>s Directorate of <strong>SNBTS</strong> with close links to the Clinical<br />
Directorate, and the consolidation and development of these products is a significant<br />
feature of the <strong>SNBTS</strong> <strong>Strategy</strong>. Bone, tissues and cells are all regulated by the HTA and<br />
these products are increasingly grouped together, not only for operational reasons, but also<br />
to facilitate regulatory compliance.<br />
The range and number of tissues procured has increased significantly over the past few<br />
years and it is likely that this will increase further driven by clinical development and<br />
demand. An example of this is the recent establishment of skin banking and the<br />
establishment of a pancreatic islet cell processing programme. It is likely that significant<br />
safety measures applicable to blood will also be similarly applicable to tissues. Measures<br />
taken in the context of prion diseases is imminent and some pilot work on splenic testing is<br />
already planned (to ensure that tissues harvested from deceased donors lack evidence of<br />
abnormal prions).<br />
Close collaboration already exists between the Tissue <strong>Service</strong>s Directorate and its NHSBT<br />
counterpart. This will be formalised wherever possible to maximise synergies and will be<br />
particularly useful in the processing of specialist products. Collaborations like this will result<br />
in tissues being available more quickly and cost effectively than if <strong>SNBTS</strong> undertook this<br />
work solely in house.<br />
3.3.2 Keeping Tissues and Cells Safe<br />
3.3.2.1 Anticipated Mandatory Safety Measures for Tissues and Cells<br />
Testing regimes and safety measures applicable to blood are in the main also applied to<br />
tissues. Therefore, any mandatory safety measures that will be applied to blood will, in all<br />
probability, be applied to tissues and cells. Uniquely however, bone washing for the<br />
removal of marrow is anticipated to become a mandatory measure in the near future and a<br />
UK protocol has been developed by <strong>SNBTS</strong> and NHSBT Tissue <strong>Service</strong>s. It is anticipated<br />
that bone washing will be mandated by SGHD on advice from SaBTO during 2009/10. It is<br />
planned that this work would be sub contracted to NHSBT at a projected annual cost of<br />
£150k to be funded through the safety bid process described previously.<br />
3.3.2.2 Multi Organ Donors<br />
It is anticipated that a prion blood test will be available for blood donors in the next few<br />
years. It is anticipated this will also be applied to organ and tissue donors. However, it may<br />
be possible to routinely test for prions histopathologically in sections of tissues and pilot<br />
work is being planned to assess the feasibility of testing specific tissues (e.g. spleen, optic<br />
nerve) for abnormal prions. In the first instance this work will be carried out only on<br />
deceased tissue donors, currently it is not possible to obtain a test result prior to organs<br />
being transplanted.<br />
3.3.3 Donor Recruitment<br />
3.3.3.1 Referrals from Organ Transplant Co-ordinators<br />
The recent recommendations of the Organ Donation Task Force are driven by a<br />
requirement to increase organ donation by 50% in five years. One of the major<br />
recommendations is the unified management of all transplant co-ordinators in the UK by<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 37 of 62
NHSBT. <strong>SNBTS</strong> has an excellent working relationship with the transplant co-ordinators, to<br />
the extent that 40% of <strong>SNBTS</strong> tissue donations are derived from multi organ donors<br />
referred by transplant co-ordinators. Transplant Co-ordinators also formally support<br />
<strong>SNBTS</strong> on call rotas and a formal SLA will be required to maintain this due to recent<br />
developments in NHSBT.<br />
3.3.3.2 Designated Requesters<br />
The procurement of tissues is derived mainly from deceased donors - heart beating (most<br />
often multi organ donors) and non-heart beating donors. The main sites where the latter<br />
potential donors can be identified are in A & E departments. The most cost effective way to<br />
achieve this is by training senior hospital nurses as designated requesters. This will<br />
enable them to identify potential donors and approach their families for onward referral to<br />
our nurses. This programme has started and will be further developed.<br />
3.3.3.3 The Bone Programme<br />
<strong>SNBTS</strong> has a well-established bone programme with bone being exclusively derived from<br />
patients undergoing hip surgery. This programme will continue for the foreseeable future.<br />
However, should vCJD testing for deceased donors become operationally feasible,<br />
particularly if this is before routine blood testing, then obtaining all bone from deceased<br />
donors will be evaluated. This will have a major impact on the bone programme and will<br />
need a 2-3 year lead time to implement fully.<br />
3.3.4 Tissue Retrieval<br />
3.3.4.1 Dedicated Mortuaries<br />
As part of the condition of our licences, it is important that tissues are retrieved in a<br />
controlled environment i.e. a dedicated mortuary controlled by <strong>SNBTS</strong> including<br />
environmental monitoring. Mortuaries suitable for use by <strong>SNBTS</strong> have been identified in<br />
Glasgow and Edinburgh.<br />
3.3.4.2 Retrieval Teams<br />
In order to improve the sustainability of our services it is important that <strong>SNBTS</strong> improves<br />
the way tissues are retrieved. This has been significantly facilitated by the recently enacted<br />
Human Tissues Act, which allows tissues to be retrieved by trained non-medical staff.<br />
Although we receive significant support from pathologists and Anatomical Pathology<br />
Technicians (APT) at the moment, there are instances where tissues that were potentially<br />
obtainable were not collected for a variety of reasons. Two retrieval models are being<br />
evaluated. Firstly, <strong>SNBTS</strong> retrieval teams will be employed to retrieve in our mortuaries in<br />
Edinburgh and Glasgow. Secondly, APT’s will be contracted to carry out this task,<br />
enhancing their role and ensuring their availability. It may be that a mixture of models will<br />
be used, depending on the level of support received from pathologists.<br />
Proposed source of Funding: NSS/<strong>SNBTS</strong>.<br />
TABLE SHOWS IN YEAR MOVEMENT<br />
Establish Tissue Retrieval Teams 2009/10 2010/11 2011/12 2012/13 2013/14<br />
Dedicated Tissue retrieval teams<br />
2 WTE to ensure sustained<br />
procurement of tissues for <strong>Scottish</strong><br />
patients.<br />
Funding bid submitted 2009.<br />
Initiative<br />
Staff<br />
Impact<br />
Prepare bid<br />
+2 WTE<br />
bid<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
£ Impact £80k bid<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 38 of 62
3.3.4.3 Pathologists<br />
Pathologists currently provide retrieval support through semi formal arrangements at the<br />
discretion of individual pathologists. In the West of Scotland, a semi-formal rota of<br />
pathologists are available to cover tissue retrievals; the support in the East is mainly via the<br />
forensic pathologists. The latter situation is more tenuous, particularly in view of their<br />
workload and other staffing issues. Discussions are taking place to ascertain whether it is<br />
possible to have a formal commitment to support the programme.<br />
3.3.5 Processing and Storage of Tissues and Cells<br />
Due to the volumes of some of the tissues and cells processed, it will be more efficient to<br />
do so in one site under an all embracing quality system to ensure regulatory compliance. In<br />
many instances appropriate process validation to enable a uniform approach has already<br />
been carried out and the infrastructure already exists for such processing. The advantage<br />
is tissues and cells are available for clinical use quicker and in a more cost effective<br />
manner. Such a mechanism is already in place for skin and should bone processing<br />
become a requirement, a similar collaboration with NHSBT will be requested.<br />
3.3.6 Cellular Products<br />
3.3.6.1 Haematopoietic/Cord <strong>Blood</strong> Stem Cells<br />
The Tissue <strong>Service</strong>s Directorate currently process and bank peripheral blood<br />
haematopoetic stem cells (HSC) for patients in Lothian. This service was transferred from<br />
the Western General Hospital to <strong>SNBTS</strong> a few years ago and the necessary infrastructure<br />
and expertise to run this service to the required standards is in place. The proposed move<br />
of HSC processing and banking to the new national site and the establishment of national<br />
cell banking facilities will provide an opportunity to raise quality, efficiency and regulatory<br />
compliance whilst retaining the clinical interface in our clinical centres. There are models<br />
where HSC are remotely processed and banked prior to reinfusion into patients locally.<br />
Once the location of the <strong>National</strong> Centre is known an option appraisal will be carried out in<br />
consultation with clinicians and other interested parties to determine the best model for<br />
Scotland.<br />
3.3.6.2 Pancreatic Islet Cells<br />
The NSS <strong>National</strong> <strong>Service</strong>s Division has recently funded the Edinburgh Clinical Transplant<br />
Unit to establish a <strong>Scottish</strong> islet cell transplantation programme. Initially, islet cell<br />
processing and transplantation will cover the needs of <strong>Scottish</strong> patients, however, it is likely<br />
that in the medium term we will become one of three islet cell transplantation units in the<br />
UK and part of the UK allocation process. This facility is currently being developed in<br />
redundant clean rooms in Ellen’s Glen Road and would relocate to the new <strong>National</strong><br />
Centre.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 39 of 62
Proposed source of Funding: NSS/<strong>SNBTS</strong>.<br />
TABLE SHOWS IN YEAR MOVEMENT<br />
Establish Islet Cell Transplantation programme 2009/10 2010/11 2011/12 2012/13 2013/14<br />
Establish Islet Cell Transplantation<br />
programme<br />
Initiative<br />
Prepare bid<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Funding bid submitted 2009.<br />
Staff<br />
Impact<br />
+3 WTE<br />
bid<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
£ Impact £165k bid<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
3.3.6.3 New Cellular therapy and regenerative medicine<br />
Scotland continues to experience some of the worst morbidity and mortality rates relating to<br />
neoplastic and degenerative disorders. Building on its experience in providing tissues and<br />
haematopoietic stem cells for transplantation, <strong>SNBTS</strong> has been at the forefront in<br />
supporting the research and development of new cellular therapies including an<br />
international T cell immunotherapy bank for EBV-driven post-transplant lymphoproliferative<br />
disease, adult stem cell therapies for heart, musculoskeletal and liver disease and the<br />
generation of pluripotential embryonic stem cells at cGMP grade.<br />
The new <strong>SNBTS</strong> <strong>National</strong> Centre will partner with the new University of Edinburgh Medical<br />
Research Council Centre for Regenerative Medicine in helping to position Scotland in the<br />
vanguard of this highly competitive international field to the benefit of the health and<br />
wellbeing of the people of Scotland.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 40 of 62
3.4 SERVICES FOR PATIENTS<br />
3.4.1 Introduction<br />
The <strong>SNBTS</strong> Clinical Directorate delivers front line medical care for patients in Scotland over<br />
a range of specialties including hospital blood banking, reference immunohaematology,<br />
histocompatibility and immunogenetics (H&I), clinical apheresis and stem cell services.<br />
This embodies the theme ‘<strong>Service</strong>s for Patient’.<br />
3.4.2 Supporting Better Health Better Care<br />
3.4.2.1 Develop a Coherent <strong>National</strong> Management Structure<br />
Currently, the Clinical Directorate is managed on a regional basis, which leads to<br />
replication of management duties and acts as a barrier to single system national working.<br />
An Associate Medical Director will be appointed from the existing Clinical Directors to<br />
create formal national leadership for the Clinical Directorate and to formally deputise for the<br />
<strong>SNBTS</strong> <strong>National</strong> Medical and Scientific Director. The intent is to develop a managed<br />
clinical network with an emphasis on national functional leadership and coherence of<br />
specialist services, balanced by the flexibility in accommodating local clinical requirements<br />
where required i.e. the approach is directly aligned with BHBC.<br />
From the existing Regional based staff, <strong>National</strong> Clinical Directors and senior managers will<br />
be appointed to lead the specialist services outlined below. The plan envisages that<br />
freeing the BMS3 staff from routine out of hours shift rosters will improve management<br />
continuity and communication and allow improved focus on quality, efficiency and<br />
regulatory compliance, service improvement and implementation of corporate initiatives.<br />
3.4.2.2 Single System Working<br />
The historical regional organisation of the Clinical Directorate has led to diversity in<br />
operating procedures and practices and some differences in the quality or extent of service<br />
offered between Centres. It is important that our customers, clinicians and patients enjoy<br />
access to a similar high quality comprehensive service wherever they are in the country<br />
(again this is fully aligned with the principles of BHBC and Delivering for Health which<br />
placed the reduction of health inequalities at the centre of NHSScotland business).<br />
This theme captures five strategic benefits:<br />
• Continuous quality improvement - good practice and new developments can be rolled<br />
out to all Centres, lessons learnt through complaints, incidents or regulatory inspection<br />
in one Centre can be applied to all.<br />
• Enhanced regulatory compliance - with compliance now required for multiple regulatory<br />
and accreditation bodies (e.g. MHRA, HTA, Clinical Pathology Accreditation (UK) Ltd.<br />
(CPA), European Federation for Immunogenetics (EFI), Joint Accreditation Committee-<br />
ISCT & EBMT (JACIE) and NHS Quality Improvement Scotland (QIS), a single<br />
operational and quality system is increasingly sought by inspectors and allows the<br />
correction of non-compliances in one centre to be applied across all.<br />
• Improved efficiency - management tasks such as procurement of new equipment and<br />
reagents, validation, change control and quality management documentation can be<br />
managed once and rolled out to all centres rather than reinvented five times.<br />
• Equality of access - patients and clinicians supported by every centre experience similar<br />
quality and availability of local service and access to national specialisation.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 41 of 62
• Fair and equitable terms and conditions for staff - supporting and embedding the<br />
principles underpinning Agenda for Change.<br />
Considerable progress has been made towards single system working over the past two<br />
years. This progress will be embedded by a national management structure, single<br />
operational and quality management systems within individual specialist services.<br />
Proposed source of Funding: NSS/<strong>SNBTS</strong><br />
TABLE SHOWS IN YEAR MOVEMENT<br />
Supporting Better Health Better Care 2009/10 2010/11 2011/12 2012/13 2013/14<br />
Improve management Structure<br />
BMS 3 staff off shift, increase in<br />
BMS 1 staff to provide shift cover.<br />
Funding bid to be submitted 2010.<br />
Improve<br />
M’anageme<br />
nt<br />
Prepare bid<br />
Funding bid<br />
submitted<br />
Business as<br />
Usual<br />
Business as<br />
Usual<br />
Business as<br />
Usual<br />
Staff Impact<br />
Negotiate<br />
change<br />
+ 5 WTE<br />
Business as<br />
Usual<br />
Business as<br />
Usual<br />
Business as<br />
Usual<br />
£ Impact<br />
Negotiate<br />
change<br />
£181k Rev<br />
Business as<br />
Usual<br />
Business as<br />
Usual<br />
Business as<br />
Usual<br />
3.4.3 Specialist <strong>Service</strong>s<br />
3.4.3.1 Hospital <strong>Blood</strong> Banking, Antenatal and Reference Immunohaematology<br />
<strong>SNBTS</strong> blood banks prepare almost half of all blood components transfused in Scotland.<br />
Continued provision of these, along with antenatal and regional reference<br />
immunohaematology provides the platform of experience and expertise which <strong>SNBTS</strong><br />
leverages in support for non-specialist hospital blood banks and identifying interventions to<br />
improve the quality of the clinical transfusion process. The <strong>SNBTS</strong> Strategic intent is to<br />
keep urgent reference and testing work that needs to be close to the patient in hospitals<br />
where it can be deployed most effectively.<br />
The <strong>Scottish</strong> Government has placed particular emphasis on patient safety through the ‘Six<br />
Dimensions of Quality’ and has charged <strong>SNBTS</strong> with supporting the rest of NHSScotland in<br />
maintaining compliance with the BSQR. However, there are a number of challenges,<br />
including sustainability of BMS and medical 24/7 rotas, increasing direct patient workload<br />
and increasing indirect workload due to quality and regulatory requirements principally CPA<br />
and MHRA. Significant progress has been made towards single system working through<br />
implementation of the ‘Traceline’ clinical laboratory computer application. Further work will<br />
be carried out to extend this application to other hospital blood banks (where appropriate)<br />
and provide links to other hospital laboratory information management systems. This will<br />
enable, for example, ward order communications and contribute to the delivery of the e-<br />
Health agenda. This work will be embedded through a national Clinical Director for blood<br />
banking and immunohaematology and appropriate restructuring of the medical and BMS<br />
management structures. Additional staff will be required to maintain blood bank shift rotas<br />
in the face of year on year increases in workload and in compliance with the EU Working<br />
Time Directive.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 42 of 62
Proposed source of Funding: NSS/<strong>SNBTS</strong><br />
TABLE SHOWS IN YEAR MOVEMENT<br />
Delivering Specialist <strong>Service</strong>s 2009/10 2010/11 2011/12 2012/13 2013/14<br />
Increase staff to maintain service<br />
delivery<br />
Increased establishment on each 5<br />
Clinical Directorate sites by 1x BMS 1<br />
per year.<br />
Cope with increasing workload.<br />
<br />
Establishment<br />
Staff<br />
Impact<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
+1 BMS1 +1 BMS1 +1 BMS1 +1 BMS1 +1 BMS1<br />
£ Impact £36k £36k £36k £36k £36k<br />
3.4.3.2 Histocompatibility and Immunogenetics, and Immunology<br />
Considerable progress has been made in the modernisation of H&I services over the past<br />
12 months. This includes redistribution of work between the centres in the East of Scotland,<br />
consolidation of solid-organ transplant work in Edinburgh, platelet and granulocyte<br />
immunohaematology in Aberdeen and disease association and transfusion related H&I<br />
from Edinburgh to Dundee.<br />
BMS out of hours services have been consolidated in Edinburgh in support of the solid<br />
organ transplant service and two H&I Consultant Clinical Scientists appointed.<br />
The overarching aim is to support a high quality, comprehensive service across Scotland.<br />
This will include a national Clinical Director for H&I and Immunology for the services<br />
delivered by <strong>SNBTS</strong>, better local integration between <strong>SNBTS</strong> and NHS Greater Glasgow<br />
and Clyde (GG&C) H&I laboratories and national collaboration between <strong>SNBTS</strong> and GGC<br />
on issues such as Consultant cross-cover, common practices and standards, and<br />
procurement.<br />
Operational targets include EFI accreditation and replacement of the current H&I IT<br />
systems with a common, up-to-date platform. There is a requirement for greater support for<br />
allogeneic haematopoietic stem cell transplantation and Scotland’s cellular therapies<br />
research and development programme. In addition, the Organ Transplant Taskforce has<br />
recommended a 50% increase in solid organ transplantation over the next 5 years and this<br />
has been supported by SGHD. Clearly, this change will require additional resource in the<br />
form of reagents, consumables and staff. It is estimated that 2 additional staff will be<br />
required in 2009/10 and again in 2011/12 and is envisaged that the increase in funding will<br />
be met from an increase in the current cross charge arrangements to reflect the higher<br />
activity levels. Consideration has been given to H&I support for blood testing and<br />
processing and If the anticipated instruction is given to implement the procurement of all<br />
platelets by apheresis, there will be a significant additional body of H&I work. It is<br />
anticipated that this would be funded by Government as set out below.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 43 of 62
Proposed source of Funding: SGHD<br />
TABLE SHOWS IN YEAR MOVEMENT<br />
Implement mandatory safety measures as required by<br />
Government (currently under consideration)<br />
2009/10 2010/11 2011/12 2012/13 2013/14<br />
Implement Universal Apheresis<br />
Platelets<br />
Projected 2009-12, impacts include<br />
additional lab staff and test kits for<br />
increased H&I testing.<br />
100%<br />
Apheresis<br />
Staff<br />
Impact<br />
Funding bid<br />
submitted<br />
Implement<br />
Implement<br />
+2 WTE Implement Implement<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
£ Impact<br />
£195k Rev<br />
£186k NR<br />
bid<br />
Implement<br />
£36k rev<br />
£303k NR<br />
bid<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
The immunology laboratory service in Edinburgh will be led by a Clinical Scientist following<br />
the retirement of the current Consultant Immunologist. Better local collaboration is being<br />
discussed with the Clinical Consultant Immunologist and immunology laboratory service in<br />
Aberdeen, opening the prospect of developing a managed clinical network in this speciality<br />
across Scotland. Such a network would facilitate maintenance of quality and CPA<br />
standards, procurement, training and clinical advice. Recruitment and retention of specialist<br />
staff remains a key objective.<br />
Proposed source of Funding: NSS/<strong>SNBTS</strong>.<br />
TABLE SHOWS IN YEAR MOVEMENT<br />
Delivering Specialist <strong>Service</strong>s 2009/10 2010/11 2011/12 2012/13 2013/14<br />
Delivering H&I and Immunology<br />
<strong>Service</strong>s in line with new standards<br />
These services had previously been<br />
unable to secure funding to meet<br />
emerging new standards. Some funding<br />
released 2008/09, this represents phase<br />
II.<br />
<br />
Establishment<br />
Staff<br />
Impact<br />
Implement<br />
+2 trainee<br />
Clinical<br />
Scientists<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
£ Impact £85k<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
3.4.3.3 Clinical Apheresis and Stem Cell <strong>Service</strong>s<br />
Four centres provide clinical apheresis services on a 24/7 basis including therapeutic<br />
apheresis, stem cell collection and venesection. Progress has been made towards single<br />
system working around standards for stem cell collection through the NHSScotland<br />
<strong>Scottish</strong> Advisory Network for Therapeutic Apheresis <strong>Service</strong>s (SANTAS) group. This will<br />
be consolidated through a national Clinical Director, senior nurse and management<br />
structure.<br />
Continued 24/7 local provision is contingent upon enhanced staff numbers, common<br />
standards of practice and training, procurement of a new suite of apheresis machines and<br />
compliance with enhanced regulatory requirements.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 44 of 62
Haematopoietic stem cell (HSC) processing and storage is provided by Aberdeen and<br />
Dundee clinical centres, the Tissue Directorate in Edinburgh and NHS GGC. The Glasgow<br />
clinical centre is also engaged in the establishment of the <strong>Scottish</strong> Cord <strong>Blood</strong> Bank.<br />
<strong>SNBTS</strong> R&D cellular therapies group also has an interest in this service and has been<br />
involved in the establishment of Roslin Cells and the new GMP facilities at the <strong>Scottish</strong><br />
Centre for Regenerative Medicine. The creation of a tissue and cell processing facility<br />
within the <strong>National</strong> Centre would provide an opportunity for the centralisation of all HSC<br />
and cord cell banking from other <strong>SNBTS</strong> sites leaving the clinical interface in our clinical<br />
centres. There are models where HSC are remotely processed and banked prior to<br />
reinfusion into patients locally. Once the location of the <strong>National</strong> Centre is known, an<br />
option appraisal will be carried out in consultation with clinicians and other interested<br />
parties to determine the best model for Scotland.<br />
Proposed source of Funding: NSS/<strong>SNBTS</strong>.<br />
TABLE SHOWS IN YEAR MOVEMENT<br />
Delivering Specialist <strong>Service</strong>s 2009/10 2010/11 2011/12 2012/13 2013/14<br />
Clinical Apheresis and Stem Cell<br />
<strong>Service</strong>s<br />
These services are currently delivered by<br />
a combination of Supply Chain and<br />
Clinical Directorate Nursing staff,<br />
additional resource is needed to<br />
consolidate service delivery.<br />
Requirement to replace equipment<br />
<br />
Establishment<br />
Staff<br />
Impact<br />
£ Impact<br />
Edinburgh Glasgow Aberdeen<br />
Possible<br />
relocation<br />
of Donor<br />
<strong>Service</strong>s<br />
(Dundee)<br />
+1 Nurse +1 Nurse +1 Nurse +3 Nurses<br />
£36k<br />
£200k Cap<br />
£36k<br />
£200k Cap<br />
£36k<br />
£200K Cap<br />
£112k<br />
£200k Cap<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
£200k Cap<br />
3.4.3.4 Support for the Clinical <strong>Transfusion</strong> Process<br />
The BBTP initiatives have seen considerable enhancement in the quality of the clinical<br />
transfusion process across Scotland. Developments include, educational materials, training<br />
programmes, audit, support of the development of NHS QIS standards and peer review,<br />
support for clinical incident reporting and management, traceability, clinical blood wastage<br />
and hospital transfusion committees. This work needs to be embedded within the overall<br />
mission of the Clinical Directorate both to consolidate progress and achieve sustainability in<br />
the longer term. However, flexibility will also need to be retained to support local Health<br />
Board agendas. Continued work by the BBTP clinical effectiveness team with the R&D<br />
Directorate, NHSScotland and University colleagues, will be required to further develop the<br />
evidence base for the clinical effectiveness and safety of blood components.<br />
Proposed source of Funding: NSS/<strong>SNBTS</strong> .<br />
TABLE SHOWS IN YEAR MOVEMENT<br />
Delivering Specialist <strong>Service</strong>s 2009/10 2010/11 2011/12 2012/13 2013/14<br />
Support for the Clinical <strong>Transfusion</strong><br />
Process<br />
This post reflects the need to commit<br />
resource to continuously improving the<br />
delivery of the Clinical transfusion<br />
process.<br />
<br />
Establishment<br />
Staff<br />
Impact<br />
Bid<br />
submitted<br />
+1 Nurse<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
£ Impact £50k<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
Business<br />
as Usual<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 45 of 62
3.4.4 Local Delivery Supported by <strong>National</strong> Specialisation<br />
3.4.4.1 Sustainability of Local <strong>Service</strong>s<br />
The ageing demography of medical, scientific and nursing staff within <strong>SNBTS</strong> predicts a<br />
significant loss of experienced staff over the next 5-10 years. In addition, out of hours rotas<br />
in most centres and across most professional groups are under pressure in terms of<br />
compliance with the EU Working Time Directive and proposed AfC unsocial hours terms<br />
and conditions. It is unlikely going forward that the Clinical Directorate will be able to<br />
continue to support a multiplicity of stand-alone 24/7 local services. The approach to<br />
sustainability has a number of strands:<br />
• Continued provision of local services where rapid turnaround is required - for example,<br />
hospital blood banking, antenatal red cell immunohaematology and clinical apheresis.<br />
• Better integration with other local services – for example it may be possible to provide<br />
cross-medical coverage of blood bank and apheresis with local haematology<br />
colleagues. Cross-disciplinary working with colleagues may also be possible in<br />
support of some nursing and biomedical science rotas, though key specialist expertise<br />
needs to be protected from dilution.<br />
• <strong>National</strong> support for specialist functions - for example, specialist H&I and<br />
immunohaematology advice provided by a national rota.<br />
• Proactive strengthening of the workforce - through recruitment of additional staff to top<br />
up fragile rotas and enable succession planning.<br />
• <strong>National</strong> provision of highly specialist functions - to allow critical mass to be built in<br />
specialist facilities and staffing.<br />
• Structured training - to provide the new generation of professionals to support the<br />
<strong>Service</strong> and enhance career development opportunities.<br />
Single system working and national integration of specialist functions should support<br />
continued provision of local services. The funding requested to modernise and build<br />
resilience into the delivery of specialist services will also play a key role in improving and<br />
sustaining the provision of local services for Health Boards and the patients they serve.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 46 of 62
3.5 ORGANISATION FIT FOR THE FUTURE<br />
3.5.1 Introduction<br />
The ‘Organisation Fit for the Future’ theme in the <strong>SNBTS</strong> <strong>Strategy</strong> is concerned with those<br />
functions that support front line delivery. In an organisation like <strong>SNBTS</strong>, which is driven by<br />
the collection of a raw material (blood or tissue) and processing it to a product for issue, the<br />
distinction between front line and support is often blurred, especially in areas such as<br />
logistics, IT and quality. For this reason, some of the support functions and their impact on<br />
the <strong>Service</strong> are contained in previous sections of this document.<br />
Each of the support functions is committed to delivering a quality, professional service that<br />
is focussed on operational business needs and priorities yet is flexible enough and<br />
adaptable to accommodate changing requirements. However, it is imperative that there is<br />
a robust mechanism for service planning and prioritisation of business requirements to<br />
enable the support functions to deliver a focussed, value added service and avoid the<br />
adoption of solutions that are fragmented, crisis-driven and sub-optimal in the long term.<br />
3.5.2 Supporting Effective, Efficient and Safe <strong>Transfusion</strong> Practice<br />
The Better <strong>Blood</strong> <strong>Transfusion</strong> Programme and Effective Use of <strong>Blood</strong> (EUB) initiatives have<br />
significantly improved the quality of the clinical transfusion processes across Scotland and<br />
in the process reduced the demand for blood. In order to maintain these advances, the<br />
initiatives made by BBT/EUB in, for example, the development of educational materials,<br />
training programmes, clinical blood audit and support for hospital transfusion committees,<br />
will become an integral part of the work of the Clinical Directorate.<br />
3.5.3 Ensuring Resilience and Compliance with cGMP and Clinical Standards<br />
The key regulatory objective is to ensure that all <strong>SNBTS</strong> operations remain compliant with<br />
all relevant legislation. In the last few years, the regulatory expectations placed on <strong>SNBTS</strong><br />
have increased and this has been reflected in a wider range of regulatory inspections by<br />
various inspection bodies, e.g. MHRA, HTA, CPA and in future this will be expanded to<br />
include JACIE (a body concerned with standards for Stem Cells). Not only is the range of<br />
regulatory requirements increasing, the intensity of inspection is also increasing. In<br />
response to this increase of regulatory demands, the role of the Quality Directorate has<br />
broadened and expanded. The greater expectations placed on our Quality professionals<br />
has resulted in an increase in our establishment from 60 to 70.5 WTE.<br />
3.5.3.1 Expansion of Expertise<br />
Through the Workforce Plan, attention will be given to expanding and developing the skills<br />
mix in the current Quality Directorate team to ensure that there is a broad awareness of<br />
practice in the pharmaceutical industry and the operation of an effective, modern Quality<br />
Management System (QMS). Where required, external expertise and consultancy will be<br />
used to ensure that our QMS is state-of- the-art.<br />
3.5.3.2 Provision of Quality Support<br />
Currently, QMS support is largely provided on a geographical basis, with some support from<br />
the head office team. The intention is to move to provision of quality management on a<br />
functional basis by appointing senior quality managers as support for each of the main<br />
functional directorates (Supply Chain and Clinical). This will prepare the organisation for the<br />
implications of the planned Property <strong>Strategy</strong>, when the manufacturing and clinical functions<br />
will be located in separate buildings, which are geographically distinct.<br />
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In addition to the provision of widespread quality support within <strong>SNBTS</strong>, there will be closer<br />
links with other parts of NSS (e.g. facilities, IM&T and procurement). This will ensure that<br />
QMS support is provided and delivered to those parts of the wider NSS organisation which<br />
provide <strong>SNBTS</strong> with key services and therefore are subject to regulatory scrutiny.<br />
3.5.3.3 Development of Quality Support to NHSScotland<br />
<strong>SNBTS</strong> is already delivering a significant service to non-<strong>SNBTS</strong> blood banks in support of<br />
their requirement to comply with the UK BSQR. This new requirement commenced in 2005<br />
and is imposing great demands on Hospital <strong>Blood</strong> banks who have no previous experience<br />
of formal regulatory scrutiny. <strong>SNBTS</strong> has arranged audits of the QMS operated in some<br />
blood banks and have assisted blood banks in preparing for MHRA inspections. This<br />
process will continue and expand, with closer partnerships being formed with relevant<br />
hospital and laboratory management throughout Scotland.<br />
3.5.4 Investing in High Impact Science that Benefits Patients<br />
The Culyer review of Research in the NHS commenced in 1995 and in Scotland was taken<br />
forward through the Chief Scientists Office. It was recognised then that <strong>SNBTS</strong> conducted<br />
Research and Development of products and processes that required integration and were<br />
important to the delivery of blood safety and should not be left to a reliance on the grant<br />
funding mechanism. <strong>SNBTS</strong> forward planning for the Research and Development<br />
Directorate calls for investing in high impact science. This applies to both the delivery of<br />
direct service needs and in high impact areas that are currently relevant to <strong>SNBTS</strong> and<br />
attracting high levels of Grant Support. <strong>SNBTS</strong> uses grant support to leverage its Science<br />
base. Up to half of all <strong>SNBTS</strong> research funding comes from externally awarded grants,<br />
often on three year cycles, and this will continue. The intent is to focus the work of this<br />
directorate in two main theme groups in support of clinical delivery (including tissues and<br />
cells) and processing and testing (including donation). This approach was set out in the<br />
latest R&D four-year plan, which was agreed with our external Research Advisory Group in<br />
January 2008.<br />
Work in support of clinical delivery will continue to focus on regenerative medicine and<br />
tissue services, making use of <strong>SNBTS</strong> skills in GMP and cell/tissue therapy to assess and<br />
deliver novel therapies such as islet cell transplantation for treatment of diabetes or cell<br />
therapy for the treatment of post-transplantation virus infections. <strong>SNBTS</strong> has recently<br />
received funding from the Welcome Trust to attempt to develop blood cells in culture, which<br />
if successful, would revolutionise transfusion practice. Work undertaken will also ensure<br />
that our diagnostic services remain state-of-the art (e.g. pre-natal assays of blood groups on<br />
mothers’ blood samples to enable more cost effective prevention of haemolytic disease of<br />
the new born).<br />
Work in support of processing and testing will ensure that <strong>SNBTS</strong> maintains a strong<br />
presence in the development of assays designed to ensure the safety of blood (virus<br />
confirmatory assays, development of vCJD confirmatory assays), as well as processing<br />
developments intended to improve the safety or utility of blood and tissue components.<br />
To achieve this, requires an appropriately skilled workforce working on projects relevant to<br />
the organisation with sufficient resource and links to other research groups to ensure the<br />
work will have high impact.<br />
This impact is demonstrably beneficial to other aspects of the NHS Scotland and Scotland’s<br />
economy. R&D works closely with <strong>Scottish</strong> Higher Educational Institutes to secure external<br />
grant and commercial funding in areas of mutual interest. By taking this collaborative<br />
approach, <strong>SNBTS</strong> is remarkably successful for its size - recent examples include<br />
involvement in the new MRC Centre for Regenerative Medicine in Edinburgh, the Paul<br />
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O'Gorman Leukaemia Research Centre in Glasgow and funding from the Welcome Trust,<br />
the European Union and <strong>Scottish</strong> Enterprise, inter alia, for work on novel cell- and immunotherapies.<br />
Skills arising form such joint working have supported innovative companies in Scotland<br />
such as BioScot, Alba BioScience and Roslin Cells and have also facilitated educational<br />
initiatives aimed at maintaining the skills of the <strong>Scottish</strong> workforce such as a BSc course at<br />
Strathclyde University, MSc course at Edinburgh University and training of medical students<br />
in Glasgow, Edinburgh and Aberdeen. Finally, <strong>SNBTS</strong> has generated considerable income<br />
from the licensing of intellectual property and technology arising from its R&D programme.<br />
3.5.4.1 Developments and Benefits<br />
The move to two theme groups will provide focussed, high quality support: in the following<br />
areas:<br />
Clinical & Tissues<br />
• Developing, trialling and providing existing and novel cell and tissue therapies within<br />
GMP facilities;<br />
• Cell and tissue matching and;<br />
• Assessing and validating new diagnostic screening and confirmatory assays.<br />
Processing and Testing<br />
• Assessing options in terms of component pathogen reduction;<br />
• Ensuring methods for the removal and assay of prions are assessed;<br />
• Undertaking basic research and providing reference facilities to ensure that methods for<br />
screening for emerging and existing transfusion transmitted infections are available<br />
when needed and that the epidemiology of infections of concern is understood;<br />
• Supplying library and teaching support to enable life long learning and;<br />
• Supporting further training initiatives such as the Edinburgh University MSc.<br />
3.5.4.2 Location of R&D Activities<br />
The cell therapy group will remain in academic centres of excellence in Glasgow and<br />
Edinburgh and potentially in Aberdeen, although support for tissues and GMP cell therapy<br />
development will require a presence of some of this group alongside the proposed new<br />
<strong>National</strong> Centre.<br />
For component development and virus reference work, proximity to the new <strong>National</strong><br />
Centre is required. Basic research would ideally be carried out close to academic groups<br />
with similar interests, however as <strong>SNBTS</strong> has been unsuccessful in identifying suitable<br />
sites close to any relevant academic groups, the preferred option is also to co-locate these<br />
parts of R&D in the new <strong>National</strong> Centre. Academic links will be maintained by developing<br />
joint working through provision of sponsorship for joint studentships. Hence, three of the<br />
current theme groups will come together on one site to support processing and testing<br />
activities.<br />
The other current theme group is immunohaematology, whose work falls into two current<br />
areas of activity; reference work on red cells and white cell diagnostic work (which could<br />
either remain in R&D or become a reference laboratory for the Clinical Directorate, possibly<br />
in Aberdeen) and developing alternative therapies and diagnostics for clinical conditions<br />
that make use of the resource of transfusion services. This includes the work on peptide<br />
analogs of blood groups for use in tolerising patients that otherwise might develop<br />
antibodies and use of such analogs as an alternative to red cells in diagnostic assays for<br />
such antibodies. This work could either form the basis of a ‘spin out’ commercialisation or<br />
be incorporated into the P&T theme group.<br />
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3.5.4.3 Staffing<br />
The age profile of the current R&D staff is such that a number of retirals at senior level are<br />
expected over the next five years. Mitigating actions to deal with this envisage clear and<br />
robust succession planning; increasing career enhancement, training and development<br />
opportunities available for staff; developing current mid-grade staff as leaders of the future<br />
and recruitment of new students and post-doctoral fellows.<br />
3.5.5 e-Health and Improving <strong>Service</strong> Performance<br />
Over the last three years much effort and investment has gone into the stabilisation of<br />
critical applications used by <strong>SNBTS</strong>. Due to the age of some of the technology and systems<br />
involved, they will not sustain business requirements into the future consequently they will<br />
be renewed in line with the Corporate IM&T <strong>Strategy</strong>.<br />
3.5.5.1 From Stability to Sustainability<br />
<strong>SNBTS</strong> plans to move forward with the implementation of modern systems on modern<br />
platforms, allowing flexibility to introduce business change with less effort in terms of<br />
resources required than is currently possible. This <strong>Strategy</strong> is fully aligned with the NSS<br />
corporate IM&T <strong>Strategy</strong>, built on the principles of consistent technologies, modern systems<br />
and joined up information. This will provide an agile IT environment that can support<br />
change and provide stable and sustainable systems in the organisation that are fit for the<br />
future and will facilitate involvement of <strong>SNBTS</strong> in a range of e-health initiatives.<br />
3.5.5.2 Enabling Improvements in <strong>Service</strong> Delivery<br />
(a) Provide safe and secure IT systems in support of efficient blood and tissue management.<br />
Information technology supports efficient blood and tissue management, being integrated<br />
into many of the service developments and initiatives within the <strong>Strategy</strong>, e.g. blood<br />
express, donor relationship management, traceability and quality management systems.<br />
The overarching Core System Replacement Programme (CSRP) incorporates multiple<br />
related projects that will improve technical platforms aligned to the broader NHSScotland e-<br />
health infrastructure strategy, supporting systems to provide additional business<br />
functionality across all areas of the <strong>Service</strong>. <strong>SNBTS</strong> will engage with the wider<br />
NHSScotland to explore the benefits and opportunities that would arise from a wider<br />
implementation of the Traceline Clinical <strong>Blood</strong> Banking system and to what extent<br />
interoperability with other hospital systems could be exploited to enhance patient safety and<br />
exchange information. Technical solutions to support the standardisation and streamlining<br />
of the interface between <strong>SNBTS</strong> and its customers in the areas of manufacturing and<br />
testing, ordering of blood, issue and inventory management and control will be sought.<br />
These solutions will reduce costs, waste and increase efficiency for <strong>SNBTS</strong> and<br />
NHSScotland.<br />
(b) Provide efficient and effective IT tools for the management of donors<br />
Closely related to and with dependencies on the CSRP, it is planned to provide efficient<br />
and effective IT tools that will support improvements in donor relationship and session<br />
management including, developments in user interactive technologies e.g. home DSR,<br />
health checks, session selection and registration, session planning and queue<br />
management.<br />
(c) Interaction with NSS Corporate business systems<br />
Another major area for development is information services. The current operational<br />
systems hold a vast amount of data on donor, patient and blood usage that could provide<br />
valuable information on to help predict future services requirements. These data also have<br />
the potential to show how current processes are performing and where improvements can<br />
be made. The <strong>SNBTS</strong> <strong>National</strong> Information <strong>Service</strong>s Department aim to support the<br />
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availability of such data to provide information management solutions including e.g.<br />
‘Account for <strong>Blood</strong>’ and ‘Corporate Data Warehouse’, to support and inform service<br />
decisions and benefit patients in Scotland.<br />
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4. MANAGING CHANGE IN THE WORKFORCE<br />
4.1 INTRODUCTION<br />
<strong>SNBTS</strong> has developed this Strategic Development Plan to ensure it can continue to meet<br />
the transfusion needs of patients in Scotland with high quality products and services and in<br />
full compliance with all regulatory and accreditation requirements. It has been developed in<br />
Partnership, refined following extensive engagement, consultation with staff and<br />
stakeholders, and sets out the route map by which we will introduce new safety measures<br />
and modernise the organisation over the next five years.<br />
<strong>SNBTS</strong> recognises that staff are its biggest asset and absolutely key to delivering our<br />
strategic aims. As will be clear from this document, we have identified multiple changes<br />
that will impact on staff:<br />
• Increasing numbers of staff to deliver new blood and tissue safety initiatives;<br />
• Increasing numbers of staff to cope with significant increases in workload;<br />
• Increasing numbers of staff to deliver improvements in test/process quality;<br />
• Increased development needs for staff to deliver new or expanded services/ roles and<br />
develop their potential;<br />
• Potential changes to staff reporting lines;<br />
• Introduction of working to nationally agreed protocols;<br />
• Delivery of rationalised specialist services;<br />
• Potential changes to working hours and other terms and conditions;<br />
• Agenda for Change on-call and unsocial hours arrangements;<br />
• Changing policy around registration of healthcare workers;<br />
• Changes to place of work; and<br />
• Reduction in staff required as a result of consolidation and more efficient ways of<br />
working.<br />
We have set out what we believe is an extremely ambitious and challenging agenda and<br />
will take every opportunity to facilitate its delivery by working in partnership with staff side<br />
and with our staff.<br />
4.2 WORKFORCE PLANNING<br />
4.2.1 Governing Principles<br />
The <strong>Strategy</strong> represents a major change programme, which will be progressed in<br />
Partnership within the full range of NSS and NHSScotland policies including:<br />
• Staff Governance Standard.<br />
• Better Health Better Care.<br />
• NHS Organisational Change Policy.<br />
• NSS Policies and Procedures.<br />
• NHS and NSS Training and Development Strategies.<br />
• NSS Workforce <strong>Strategy</strong>.<br />
• Diversity and Discrimination Act.<br />
• NSS Nursing <strong>Strategy</strong>.<br />
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Making use of the following resources and guidance:<br />
• Personal development planning and delivery via e-KSF;<br />
• NSS Learning Centre;<br />
• NSS Leadership Development programme and Leadership Academy.<br />
<strong>SNBTS</strong> will ensure there are effective Partnership structures in place with sufficient time<br />
and resource available for managers, trades union representatives and staff to deliver<br />
successful outcomes. <strong>SNBTS</strong> will also need considerable support from NSS Corporate<br />
<strong>Service</strong>s (especially HR, OD and Estates) to deliver the <strong>Strategy</strong>.<br />
4.2.2 Analysis of Current Workforce<br />
High-level analysis shows that in 2008, the workforce was 68% female and 32% male.<br />
With regard to age distribution, the high level breakdown is shown below. Additional detail<br />
is awaited from NSS OD, however, the high level analysis shows that >55% of the <strong>SNBTS</strong><br />
workforce is > 45 years old, some 20% is >55 years old and only 19% is
4.2.3 Recruitment Challenges<br />
Challenges are already being experienced in the recruitment of medical, nursing and<br />
biomedical scientist (BMS) roles. It is likely that <strong>SNBTS</strong> will replace some medical roles<br />
with nurse consultant and consultant clinical scientists. Nurse led apheresis will become<br />
normal practice, releasing medical staff to use their skills to better effect. Consideration will<br />
be given to the use of non-BMS Science graduates in processing and testing roles.<br />
4.2.4 Future Workforce Needs<br />
Workforce changes that can be predicted, have been set out in the strategic themes. Other<br />
changes will only become clear after pilot exercises have been completed and outcomes<br />
reviewed. Where strategy implementation necessitates new roles, skills and/or<br />
responsibilities, the key skills and competencies will be developed to ensure operational<br />
requirements can be delivered in a way that provides value for money and development<br />
opportunities for staff.<br />
4.2.5 Future Operational Needs<br />
The <strong>Strategy</strong> describes the major operational and strategic changes <strong>SNBTS</strong> will deliver<br />
over the next five years. These will improve process, service and product safety, build in<br />
regulatory compliance, renew our estate and modernise the <strong>Service</strong>. This will affect almost<br />
all <strong>SNBTS</strong> staff and the Workforce Plan will ensure that all staff have the opportunity to<br />
maximise the contribution they can make to deliver this agenda.<br />
In executing the <strong>Strategy</strong>, the challenge of delivering effective and compliant business as<br />
usual operations, mandated blood safety measures, service improvements, preparing for<br />
the commissioning and validation of the <strong>National</strong> Centre and, ultimately, relocating will place<br />
a significant burden on staff. The Workforce Plan will address how that burden can be<br />
minimised by providing timely and appropriate development opportunities for staff and<br />
increasing the contribution individuals can make to our organisation. Clearly, this will<br />
dovetail with activity and workforce demographics and will include:<br />
• Career Transition Opportunities - where staff will have access to training and<br />
development opportunities that will broaden their skill base into different areas;<br />
• Enhancing our Leadership Capacity - identifying leadership opportunities arising from<br />
our <strong>Strategy</strong> and anticipated business/workforce changes and encouraging staff to seek<br />
leadership development. This will include the development of a robust succession plan;<br />
• Training and Development - <strong>SNBTS</strong> will ensure that through e-KSF processes, all<br />
staff receive the training and development they need to support their personal<br />
development and deliver this <strong>Strategy</strong>;<br />
• OD and Support During Change - it is envisaged that a range of support mechanisms<br />
and services will be offered to staff through the Workforce Support Programme and OD<br />
Plans;<br />
• Healthy Working Lives - ensure that support and opportunities are provided to enable<br />
individuals to maximise their contribution whilst optimising their well being;<br />
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• Diversity and Equality - ensure there is no discrimination and actions are taken to<br />
ensure there is equality across all areas of recruitment, retention, promotion, training,<br />
capability, grievances and discipline;<br />
• Organisational Change - NSS has a clear and comprehensive policy on organisational<br />
change, which will be used to guide implementation. This provides clear guidance on<br />
issues such as - recruitment of staff into new roles; identification of posts continuing<br />
under business continuity; relocation of staff to new places of work; identification of<br />
training and development requirements; and redeployment of staff into other areas of<br />
<strong>SNBTS</strong>/NSS.<br />
4.3 WORKFORCE PROJECTION<br />
The indicative anticipated impact on staff numbers across <strong>SNBTS</strong> of the developments<br />
proposed in the <strong>Strategy</strong> related to service modernisation and mandatory safety measures<br />
are shown below as increases (+) or decreases (-) in Whole Time Equivalents.<br />
Current 2009/10 wte 2010/11 wte 2011/12 wte 2012/13 wte 2013/14 wte Total<br />
Function wte Head Mod Safe Mod Safe Mod Safe Mod Safe Mod Safe wte<br />
Count<br />
Donor <strong>Service</strong>s 302 482 +3.5 +14 +26.5 -2.5 -4 339.5<br />
Processing & Testing 159.5 162 +8.5 +27 +4 +33 -48 184<br />
Logistics 44.5 46 44.5<br />
Clinical Directorate 222 251 +5 +2 +9 +1 +4 +4 +1 248<br />
(inc BBTP)<br />
Tissue <strong>Service</strong>s 32.5 35 +7 +1 40.5<br />
Quality (Inc Engineering) 67 71 -4 63<br />
R&D (Inc PTU) 54.5 56 -1 -1 -2 -2 48.5<br />
Head Office 12.5 14 12.5<br />
Finance & Procurement 27.5 28 27.5<br />
NISD 16 16 +2 +2 20<br />
Total 938 1161 +17.5 +25.5 +10 +54.5 +3 +1.5 +2 +29 -53 0 1028<br />
Notes<br />
i) Staff figures will be validated as part of the establishment of a Workforce Plan.<br />
ii)<br />
The reductions in numbers shown in 2013/14 arise from moving into a new <strong>National</strong><br />
Centre. These will be considered and agreed in Partnership as this plan and the<br />
<strong>SNBTS</strong> Property <strong>Strategy</strong> are developed.<br />
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5. FINANCIAL SUMMARY<br />
5.1 FUNDING THE BLOOD SUPPLY<br />
Resources will play a fundamental part of the strategy implementation as new technology is<br />
introduced and significant organisational change is undertaken to deliver longer-term<br />
efficiencies and continue to meet changing patient needs. Our challenge for the future is to<br />
ensure the provision of <strong>SNBTS</strong> services, maintaining and enhancing safety and quality of<br />
products and services, whilst at the same time achieving financial sustainability.<br />
5.1.1 Current Position<br />
<strong>SNBTS</strong> has had the lowest cost per unit of blood in the UK. However, the unit cost of red<br />
cells has, in common with other UK services, risen significantly over the last five years,<br />
mainly as a result of the introduction of mandatory, often expensive, blood safety<br />
requirements. As far as possible, <strong>SNBTS</strong> is committed to mitigating future rises in the cost<br />
of red cells through the development of more cost efficient and ‘lean’ working practices, and<br />
improved cost effective procurement, whilst ensuring the continuity and safety of the supply<br />
of blood and tissues.<br />
5.1.2 Future Pressures<br />
<strong>SNBTS</strong> is facing an unprecedented set of challenges now and over the near term that will<br />
require robust long term financial and service planning. As a division of NSS and in<br />
common with territorial Health Boards, we can expect to receive smaller funding increases<br />
over the next three years, whilst at the same time, will be expected to deliver increased,<br />
cash releasing efficiency savings. Over the period of this <strong>Strategy</strong> there are a number of<br />
safety and quality initiatives which will continue to tighten supply and increase the cost<br />
base, and when taken with Government spending and efficiency programmes, present<br />
significant challenge to securing funding to facilitate the timely introduction of safety<br />
measures.<br />
(a) Anticipated mandatory blood safety measures<br />
Known blood safety measures pending instruction to proceed, include the move to 100%<br />
apheresis platelets, pathogen reduction of platelets, prion filtration of red cells and the<br />
introduction of a vCJD test. The anticipated indicative full annual cost of these safety<br />
measures amount to almost £18m. In order to ensure and enable deployment of these and<br />
future safety measures, <strong>SNBTS</strong> needs to undertake a programme of modernisation, some<br />
aspects of which have already commenced and have received funding support from NSS<br />
reserves. Further developments will be required over the course of this <strong>Strategy</strong> to<br />
facilitate business as usual and the modernisation agenda and these are expected to<br />
continue to be funded through NSS uplift. It is envisaged that where mandated blood and<br />
safety measures cannot reasonably be funded by NSS, they will be funded directly by<br />
SGHD.<br />
(b) Cross Charging<br />
Most blood services in the developed world operate on a cost recovery system to fund the<br />
blood supply. The cross-charging mechanisms in use by other blood services vary in their<br />
complexity but mostly operate on a unit price basis, which develops the link between<br />
funding and levels of blood usage. It is <strong>SNBTS</strong>’ desire to consider such an approach and<br />
develop a flexible financial mechanism, such that it clearly links activity to cost. To this end,<br />
during the <strong>Strategy</strong> process <strong>SNBTS</strong> will engage with stakeholders to explore and evaluate<br />
options for an appropriate cross charging model for blood components, tissues, cells and<br />
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services as a way of funding strategic developments in <strong>SNBTS</strong> and enable the rapid<br />
introduction of safety measures.<br />
5.2 SUMMARY FORECAST<br />
The financial forecast has been built up incorporating known commitments and well<br />
advanced development proposals. However, in the absence of detail, it does not yet<br />
include the fully profiled financial impact of all strategic developments. In particular, the<br />
financial impact of the introduction of pathogen reduction for red cells has been excluded at<br />
present and whilst it is not anticipated to impact until 2013/14 at the earliest, the costs will<br />
be significant.<br />
At present the model presented is a framework on which to build the more detailed financial<br />
impact resulting from the strategy development work, as it crystallises and as business<br />
cases are developed.<br />
In line with planning guidance, the table below outlines a breakeven position based on the<br />
assumption that 2% savings per annum will be deliverable and that SGHD will normally<br />
fund these new safety measures which may be mandated over the period of the <strong>Strategy</strong>,<br />
but could not reasonably be funded within the NSS funding envelope. It is assumed that<br />
as far as possible, NSS resources will support modernisation and development of the<br />
<strong>Service</strong>.<br />
REVENUE PLAN 2009/10 2010/11 2011/12 2012/13 2013/14<br />
£000 £000 £000 £000 £000<br />
EXPENDITURE<br />
Modernisation/Business as Usual<br />
Pay 38,578 39,352 40,392 41,968 43,229<br />
Non-Pay 20,814 19,873 20,668 21,666 22,661<br />
Capital Charges 4,408 4,408 4,408 4,408 4,408<br />
Savings Plan (943) (1,984) (3,056) (4,167) (5,318)<br />
Total NSS Funded 62,857 61,649 62,412 63,876 64,980<br />
Anticipated Mandatory Safety Measures<br />
Pay 1,112 3,178 4,287 4,287 4,287<br />
Non-Pay 3,448 11,956 13,953 13,650 13,650<br />
Total SGHD Funded 4,560 15,134 18,240 17,937 17,937<br />
Total Expenditure 67,417 76,783 80,652 81,812 82,917<br />
INCOME/FUNDING SOURCES<br />
Baseline incl inflation uplift 54,169 53,618 55,528 57,563 59,664<br />
Savings Plan (943) (1,984) (3,056) (4,167) (5,318)<br />
Capital Charges 4,408 4,408 4,408 4,408 4,408<br />
Additional Allocation - NSS 1,642 2,026 1,951 2,490 2,645<br />
NHS SLA Income 2,618 2,618 2,618 2,618 2,618<br />
Third Party Income 964 964 964 964 964<br />
Total NSS Income 62,857 61,649 62,412 63,876 64,980<br />
Total SGHD Income 4,560 15,134 18,240 17,937 17,937<br />
Total Income 67,417 76,783 80,652 81,812 82,917<br />
Surplus/(Deficit) 0 0 0 0 0<br />
The elements of funding required from NSS to resource modernisation and business as<br />
usual is further analysed in the review of the baseline.<br />
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5.3 BASELINE ANALYSIS – REVIEW OF FUNDING REQUIREMENT<br />
A breakdown of the baseline is tabulated below showing, on a cumulative basis, the<br />
additional uplift required to fund inflation and deliver both anticipated blood safety<br />
measures and business as usual objectives (excluding the impact of a consolidated<br />
national site and pathogen reduction of red cells).<br />
2008/09 2009/10 2010/11 2011/12 2012/13 2013/14<br />
£000 £000 £000 £000 £000 £000<br />
Baseline 49,174 50,667 50,667 50,667 50,667 50,667<br />
FYE 08/09 developments 1,493<br />
One-off commitments 2,119 - - - -<br />
Inflation 1,383 2,951 4,861 6,896 8,997<br />
Additional Allocations<br />
NSS Reserves - Modernisation 1,642 2,026 1,951 2,490 2,645<br />
SGHD - Safety Measures 4,560 15,134 18,240 17,937 17,937<br />
Revised Baseline 50,667 60,371 70,777 75,718 77,990 80,245<br />
Movement 9,704 10,406 4,941 2,271 2,256<br />
%Uplift 19.2% 17.2% 7.0% 3.0% 2.9%<br />
CAGR 9.6%<br />
NSS Impact<br />
NSS Funded Baseline 50,667 55,811 55,643 57,479 60,053 62,309<br />
Movement 5,144 - 167 1,835 2,574 2,256<br />
%Uplift 10.2% -0.3% 3.3% 4.5% 3.8%<br />
CAGR 4.2%<br />
Over the period of the plan the increase on 2008/09 baseline is £29.6m, which equates to a<br />
Compound Annual Growth Rate (CAGR) of 9.6%. This assumes that costs of<br />
modernisation to enable the implementation of future safety measures will be funded<br />
through NSS uplift, whereas the full costs of safety measures will normally be funded by<br />
SGHD where these could not reasonably be funded within the NSS funding envelope. The<br />
impact on NSS of funding developments, business as usual and inflation is an increased<br />
recurring revenue requirement of £11.6m by 2013/14, an equivalent CAGR of 4.2%.<br />
5.4 BREAKDOWN OF ADDITIONAL ALLOCATIONS<br />
Anticipated Mandatory Safety Measures<br />
2009/10<br />
£000<br />
2010/11<br />
£000<br />
2011/12<br />
£000<br />
2012/13<br />
£000<br />
2013/14<br />
£000<br />
Move to Universal Apheresis Platelets 1,562 1,783 3,139 2,836 2,836<br />
Pathogen Inactivation of Platelets 343 1,370 1,370 1,370 1,370<br />
Prion Filtration of Red Cells 2,525 10,100 10,100 10,100 10,100<br />
vCJD Test - 1,750 3,500 3,500 3,500<br />
Pathogen Inactivation of Red Cells<br />
NYK<br />
Total 4,429 15,003 18,109 17,806 17,806<br />
Distinction Awards 131 131 131 131 131<br />
SGHD Funding Requirement 4,560 15,134 18,240 17,937 17,937<br />
Modernisation - Business As Usual<br />
Enough <strong>Blood</strong> for Patients 679 655 660 1,008 1,104<br />
Facilities for the Future 241 198 198 198 198<br />
Sustainable Tissue <strong>Service</strong>s 26 38 50 74 98<br />
<strong>Service</strong>s for Patients 465 705 774 911 945<br />
Organisation Fit for the Future 230 430 270 300 300<br />
NSS Funding Requirement 1,642 2,026 1,951 2,490 2,645<br />
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5.5 CAPITAL INVESTMENT<br />
Over the period of this <strong>Strategy</strong> there is a need for modest capital investment to support<br />
modernisation objectives and maintain rolling equipment replacement and renewal<br />
programmes. However, significant investment of an estimated £35m is required towards<br />
the end of the plan to deliver the proposed new <strong>National</strong> Centre for <strong>SNBTS</strong>. Whilst there<br />
are interim revenue costs to perform planned maintenance of the current estate, the option<br />
appraisal for the new <strong>National</strong> Centre demonstrates the potential to achieve recurring<br />
savings in property related revenue costs, estimated at around £0.5m, once the site is fully<br />
operational. This is largely due to efficiencies leveraged on hard FM, primarily energy<br />
costs, coupled with the release of existing costs upon the sale of Ellen’s Glen Road and<br />
transfer to Health Boards of surplus property.<br />
Note: Costs for the New <strong>National</strong> Centre will be phased over the life of the construction works and<br />
Capital Investment Plan 2009/10 2010/11 2011/12 2012/13 2013/14<br />
£000 £000 £000 £000 £000<br />
New <strong>National</strong> Centre 940 35,150<br />
Anticipated Mandatory Safety Measures 605 466<br />
Total SGHD 605 - 1,406 35,150 -<br />
Modernisation 750 187 90<br />
Rolling Replacement/Maintenance 1,368 1,388 1,007 704 810<br />
Total NSS 2,118 1,575 1,097 704 810<br />
Total 2,723 1,575 2,503 35,854 810<br />
treated as an asset under construction until the building is completed and the asset is capitalised<br />
which is expected towards the end of 2012/13.<br />
5.6 KEY FINANCIAL ASSUMPTIONS AND RISKS<br />
• Assumes funding will transfer for plasma products and any residual cost pressures will<br />
be met by NSS outwith <strong>SNBTS</strong> core budget.<br />
• Inflation uplift has been applied at a rate of 2.45% in respect of pay and 2.75% for nonpay<br />
in accordance with current planning guidance.<br />
• Over the next three years uplift expected to be 3.15% with further 2% savings target<br />
available for reinvestment.<br />
• The new national site is assumed cost neutral on revenue over the period of this plan<br />
with resource savings anticipated once fully operational.<br />
• The costs for prion filtration are in respect of 100% of red cells with implementation<br />
forecast for the last quarter of 2009/10 but may be sooner as, once instructed, we will<br />
be expected to implement rapidly. Filters account for £8.7m of the £10.1m and the<br />
price is based on current estimated UK volumes. If not all of the UK introduces at 100%<br />
level, this will likely impact on the filter price and potentially increase the financial<br />
exposure by c£6m for Scotland to introduce universal prion filtration in isolation.<br />
Costings are based on the need to filter 240,000 red cell units.<br />
• The scale up of apheresis platelet issues to 100% has been included at current<br />
estimates based on achievement via a staging post of 80% and assumes a new fixed<br />
site centre in 2011/12. Costs incorporated in 2009/10 are phased based on a<br />
commencement date around July 2009.<br />
• Estimated consumable costs for pathogen reduction of platelets assume a reduction on<br />
list price once through tender processes. If this were not achievable the annual costs<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 59 of 62
would rise to £1.7m (this includes savings arising from discontinuation of platelet<br />
irradiation, BacTAlert and CMV test). Assumed introduction in last quarter of 2009/10<br />
but this is subject to variation dependent on an instruction to implement.<br />
• Assumption that will introduce vCJD testing as soon as feasible, for the purposes of this<br />
plan estimated mid 2010 but possibly sooner. Costs shown are a broad estimate for<br />
the test costs themselves (£2m) with a more robust staffing resource plan (£1.5m). It is<br />
highly likely that staffing costs will reduce by £0.5m to £0.6m after 2 years due to less<br />
lookback activity, fewer confirmatory tests and less donor counselling at sessions.<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 60 of 62
6. EQUALITY & DIVERSITY<br />
Within the overall NSS Equality and Diversity Policies, <strong>SNBTS</strong> aims to be a leading<br />
organisation for promoting equal opportunities, as well as meeting the equality duties<br />
required by legislation. The <strong>Strategy</strong> will be impact-assessed using the NSS Equality &<br />
Diversity Impact Assessment procedure, in order to determine what actions are needed to<br />
ensure that there is no discrimination across the six strands of Equality and Diversity (Age,<br />
Disability, Faith/Belief, Gender, Race and Sexual Orientation).<br />
The <strong>Strategy</strong> will also be determined through full consultation and inclusion with all<br />
communities in Scotland who are served by <strong>SNBTS</strong>’s operations.<br />
7. RISKS<br />
The <strong>Strategy</strong> Project Team has identified the risks to the delivery of the <strong>Strategy</strong> and has<br />
agreed the mitigating actions that will be used to manage the risks. These are located in<br />
the Project Risk Register, which is held within the Project Library.<br />
The key risks are summarised below:<br />
Key Risk Issues Risk<br />
Score<br />
Mitigating Actions<br />
Revised<br />
Score<br />
Failure to maintain<br />
sufficient supplies of<br />
<strong>Blood</strong> and Tissues<br />
to meet the needs of<br />
patients in Scotland.<br />
Need to rebuild the active<br />
blood donor base to cope<br />
with public lifestyle and<br />
attitudinal changes and the<br />
adverse impact of vCJD test.<br />
12<br />
AMBER<br />
Deploying integrated Publicity and<br />
Marketing Campaign. Decline halted<br />
rebuild underway.<br />
Undertake research into the impact of<br />
vCJD test on donors.<br />
Closely monitor test developments<br />
Develop confirmatory assay<br />
Make better use of the donor’s gift<br />
6<br />
GREEN<br />
Need to modernise the<br />
<strong>Blood</strong> Collection Programme<br />
to better meet the needs of<br />
donors.<br />
12<br />
AMBER<br />
A number of partnership working groups<br />
are developing options for change that will<br />
allow us to Transform the donation<br />
experience to make it more accessible and<br />
rewarding.<br />
6<br />
GREEN<br />
Need to deliver increased<br />
tissue donation via the<br />
cadaveric programme.<br />
12<br />
AMBER<br />
Increased liaison with pathologists<br />
Develop Tissue <strong>Service</strong>s retrieval teams<br />
6<br />
GREEN<br />
Failure to Keep<br />
<strong>Blood</strong> and Tissue<br />
Supplies Safe.<br />
Need to ensure effective<br />
surveillance systems are in<br />
place to identify candidate<br />
blood and tissue safety<br />
measures.<br />
12<br />
AMBER<br />
Active contribution to SaBTO and UKBTS<br />
JPAC.<br />
Active contribution to evaluation of new<br />
blood and tissue safety measures.<br />
Develop implementation plans and identify<br />
associated funding requirements.<br />
Implement new <strong>Blood</strong> and Tissue safety<br />
measures as instructed.<br />
Maintain compliance with continually<br />
developing QMS.<br />
6<br />
GREEN<br />
Failure to maintain<br />
MHRA and/ or HTA<br />
licenses<br />
Premises currently used for<br />
Processing, Testing and<br />
storage of <strong>Blood</strong> and<br />
Tissues do not meet<br />
ESTATECODE standards<br />
and will not meet future<br />
regulatory requirements.<br />
Implementation of new<br />
safety measures will<br />
16<br />
RED<br />
Create a compelling Business Case that<br />
sets out the business imperatives for the<br />
creation of new, future proofed<br />
accommodation and describes the<br />
resulting opportunities for increased<br />
efficiency.<br />
Secure the support of regulators that new<br />
tests and processes can be satisfactorily<br />
accommodated within existing space on a<br />
6<br />
GREEN<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 61 of 62
exacerbate this position.<br />
temporary basis.<br />
Failure to secure<br />
funding to support<br />
the Business<br />
<strong>Strategy</strong> and its<br />
associated Property<br />
requirements.<br />
Against an extremely<br />
challenging financial<br />
situation, this plan proposes<br />
additional revenue funds of<br />
£18m for blood and tissue<br />
safety (SGHD), and £35m<br />
capital from CIG (SGHD).<br />
16<br />
RED<br />
SGHD will determine whether mandatory<br />
blood and tissue safety measures are<br />
implemented.<br />
<strong>SNBTS</strong> will endeavour to keep service<br />
modernisation costs to a minimum but<br />
NSS/ <strong>SNBTS</strong> will need to determine<br />
funding priorities.<br />
Create a compelling business case for the<br />
Property needs of the <strong>Strategy</strong><br />
12<br />
AMBER<br />
Failure to implement<br />
the Plan because of<br />
conflicts with other<br />
business critical<br />
initiatives<br />
<strong>SNBTS</strong> faces multiple<br />
challenges:<br />
• Maintaining licenses and<br />
BAU<br />
• Implementing new safety<br />
measures, systems and<br />
services<br />
• Implementing Corporate<br />
initiatives<br />
• Developing plans to<br />
deliver the <strong>Strategy</strong><br />
• Developing the workforce<br />
to deliver the strategy<br />
16<br />
RED<br />
Rigorously prioritise workload<br />
Continuously monitor performance<br />
Develop a comprehensive Workforce Plan<br />
Enhance partnership working<br />
Use Corporate NSS Support<br />
However if too many safety initiatives are<br />
required for overlapping implementation,<br />
delays to the modernisation and service<br />
improvement are inevitable as meeting<br />
current needs and implementing safety<br />
measures will take priority<br />
12<br />
AMBER<br />
8. COMMUNICATIONS STRATEGY<br />
As significant structural and operational changes will be progressed in Partnership, it is<br />
important that <strong>SNBTS</strong> is focussed on both staff needs as well as stakeholder<br />
communications. There is also continued media interest in the organisation, therefore a<br />
proactive and positive approach to building relationships with media contacts must continue<br />
to be a priority for <strong>SNBTS</strong>, particularly during the life of the <strong>Strategy</strong>.<br />
Appendix I sets out the <strong>Strategy</strong> Communication Plan 2009 – 2014<br />
<strong>SNBTS</strong> Strategic Development Plan Version 2.0 Approved NSS Board 06 March 2009 Page 62 of 62