Strategic Framework for Kidney Care in Cheshire and Merseyside:

Cheshire and Merseyside Kidney Care Network Strategic Framework for Kidney Care in Cheshire and Merseyside: 2008 2013 July 2008 FINAL VERSION Approved by Cheshire & Merseyside DoCs 19 th September 2008

CONTENTS Foreword Executive Summary The Next Five Years: A Patients Perspective Renal Facilities in Cheshire and Merseyside 2008 Page i ii iv v SECTION 1 SECTION 2 1.1 Guiding Principles and Scope of the Framework 1 1.2 What is kidney failure? 2 1.3 What services are involved in renal care? 3 1.3.1 Renal service descriptions 5 1.4 Principles of commissioning 6 1.5 National drivers, guidelines and policies 7 1.6 Renal National Service Framework 8 1.7 Local drivers 9 1.7.1 Chronic Kidney Disease (CKD) and General Nephrology 9 1.7.2 Transplantation 10 1.7.3 Acute Kidney Injury (Acute Renal failure) 11 1.7.4 Dialysis access surgery 11 1.7.5 Dialysis 11 1.7.6 Active Renal Supportive Care 12 1.8 Health needs assessment and demography 12 1.8.1 Demography 14 1.8.2 Patient Acceptance (Incidence) and Prevalence rates 15 1.9 Current renal facilities 16 1.10 Patient and carer involvement in planning Renal Services 17 1.11 Monitoring of the service 18 2.1 Chronic kidney disease (CKD) and general nephrology 19 2.1.1 Anaemia management 20 2.1.2 Outpatient services 20 2.1.3 Psychological and social support 20 2.1.4 General Nephrology 21 2.2 Transplantation 23 2.2.1 Transplant waiting list 24 2.2.2 Organ donation rates and registered donors 24 2.2.3 Innovations in transplantation 25 2.2.4 The transplantation laboratory 25 2.2.5 Post transplant care 26 2.2.6 Transplantation demand forecast 26 2.3 Acute Kidney Injury (acute renal failure) 27 2.4 Dialysis Access Surgery 29 2.4.1 Establishing and maintaining dialysis access 29 2.5 Dialysis 31 2.5.1 Development of home haemodialysis and peritoneal dialysis services 31

SECTION 3 2.5.2 Expansion of haemodialysis capacity 32 2.5.3 Innovations in dialysis 32 2.5.4 Services for patients with blood borne viruses (BBVs) 33 2.5.5 Renal transport 34 2.5.6 Dialysis demand forecast 34 2.5.7 Rationale for future capacity planning 35 2.5.8 Haemodialysis capacity plan (2008-2013) 38 2.5.9 Satellite dialysis unit developments beyond April 2008 39 2.6 Active Renal Supportive care (conservative management, palliative care and end of life care) 41 3.1 The next steps 43 3.2 Summary 44 3.3 Key reference documents 46 3.4 Acknowledgements 48 3.5 Glossary of terms 49 Page SECTION 4: APPENDICES 1 Kidney Care Network: Terms of reference and membership 51 2 Renal NSF Part 1 Standards and Markers of Good Practice 55 3 Renal NSF Part 2 Quality Requirements and Markers of Good Practice 57 4 Renal Services descriptions for non renal specialists 59 5 National initiatives and key strategies impacting on renal services 61 6 Further information and resources 64

FOREWORD Renal dialysis and transplantation services across Cheshire and Merseyside have been developing over the past few years in response to inevitable pressures facing the service. These pressures include an increasingly older renal patient population with more comorbidities, such as diabetes and coronary heart disease, and the need to enhance the choices available to renal patients in the care they receive. Equity of access and consistency in quality are two of the key drivers in this document. The Renal National Service Framework (NSF) 1 provides a clear guide on standards and is therefore the basis for all service developments across Cheshire and Merseyside and the North West Strategic Health Authority. This Strategic Framework for Kidney Care in Cheshire and Merseyside is a five year plan that builds on the existing strategy and uses the NSF Standards in reviewing local service delivery and in developing a clear improvement plan to take the service through to the end of the NSF implementation timescales. The Cheshire and Merseyside Kidney Care Network (Appendix 1) has a clear vision for renal care. A fundamental aspect of this is the commitment to place the patient and their carers at the centre of all service planning, in order that the quality of care will be focussed on patient outcome. This Strategic Framework outlines the key issues facing renal services and identifies actions for addressing these concerns. It is recognised that all health care sectors need to be involved to provide a high quality pathway of renal care; in primary care where early diagnosis, management and prompt referral to secondary or tertiary care impacts on outcome; in secondary and tertiary care where the joint management of chronic kidney disease, co-morbidities, and all aspects of established renal disease are crucially important in providing good quality of care; and finally end of life care which requires close collaboration across the healthcare sectors, and the involvement of other agencies. The Framework is population based for each provider, and includes in and out flows to and from the area to account for patients who receive their care in a location other than that in which they live. Work with healthcare professionals and patients in Cheshire and Merseyside will be undertaken as part of the process of implementation. The Framework includes core principles for the commissioning of renal services; the projected growth in the number of patients on renal replacement therapy programmes based on a health needs assessment; and the planning assumptions which will deliver those programmes necessary to provide a quality service for patients. The Kidney Care Network is totally committed to improving patient care and fully supports the aspiration of making the provision of renal care in the North West a world class service. This document aims to outline clearly the national requirements for renal services together with the local response required to meet these standards. On behalf of the Cheshire and Merseyside Renal Network, we look forward to working with the North West Specialised Commissioning Team, local Primary Care Trusts (PCTs), providers of primary, secondary and tertiary care and patient representatives, to ensure local services are responsive, effective and above all provide the best possible care for people with kidney disease. Helen Bellairs Chair Kidney Care Network i

EXECUTIVE SUMMARY Overview Chronic Kidney Disease (CKD) is common, harmful and treatable. Using research statistics, there are potentially more than 650,000 people within the catchment population of Cheshire and Merseyside renal services living with some form of renal impairment. This also means there is the potential to delay progression of renal disease in more than 450,000 people by managing their disease in primary care to prevent development of established renal disease. The Renal National Service Framework (NSF) 1 is a ten year plan going through to 2014 and provides a clear guide on standards. This Strategic Framework for Kidney Care in Cheshire and Merseyside is a five year plan and uses the NSF Standards in reviewing local service delivery and in developing a clear improvement plan to take the service through to near the end of the NSF implementation timescales. This Strategic Framework for kidney Care in Cheshire and Merseyside includes core principles for the commissioning of renal services; the projected growth in the number of patients on renal replacement therapy programmes based on a health needs assessment; and the planning assumptions which will deliver those programmes necessary to provide a quality service for patients. Patients and their carers are the focus of this document and they remain at the centre of planning renal services in Cheshire and Merseyside. Kidney Function and Disease Progression Kidneys have five main functions. Removing toxic waste from the blood and excess water from the body: helping to control blood pressure and the manufacture of red blood cells: and helping to keep bones strong and healthy by maintaining the balance of calcium and phosphate. With kidney damage all these functions are either temporarily or permanently compromised. Most people may only start to feel unwell when their kidney function is reduced to less than 30% of normal levels. By 15% the point they begin to be very symptomatic, much of the damage done to the kidneys is irreversible. The only options available to patients with established renal disease are dialysis, either peritoneal dialysis or haemodialysis, transplantation, or active renal supportive care (palliative care / conservative management and end of life care). Key issues facing local services The number of patients in Cheshire and Merseyside requiring dialysis is projected to increase by more than 300 in the next 5 years. The local challenges will involve provision of quality care for these patients by ensuring the timely opening of the planned new dialysis units, increasing patient choice, increasing the number of transplants and liaising with primary care to identify patients earlier in their disease pathway. ii

Key Priorities for Action The importance of strengthening links with primary care to manage effectively the projected increase in the number of renal patients is unmistakably recognised. Transplantation is the best form of renal replacement therapy for those patients who are clinically suitable. The case for increasing the number of transplants is indisputable. Local implementation of the recommendations from Organs for Transplant: A Report from the Organ Donation Taskforce 2 will be critical to the success of increasing the number of transplants and they are fully supported by this Strategic Framework. Further work will be essential to ensure there is capacity to cope with the projected increase in the number of transplants and for the local followup of transplanted patients. Accreditation of the Transplantation Laboratory Service must be achieved without delay. A significant number of patients are receiving suboptimal haemodialysis care due to constraints on the existing facilities. Plans are in place to provide 53 more haemodialysis station to address this quality of care issue. It will be essential to ensure progress of these plans and to monitor future requirements. There is a need to progress high quality peritoneal dialysis and home haemodialysis as options for patient choice. Reliable and effective patient transport for renal haemodialysis patients is essential to their overall well being. Work will be done to improve current systems. It is essential to develop active renal supportive care for patients with established renal disease who choose not to receive dialysis (which may include some patients whose transplanted organs are failing), or for those patients currently receiving treatment who wish to stop and for those for whom it is no longer clinically appropriate. The Next Steps Work with healthcare professionals and patients in Cheshire and Merseyside will be undertaken as part of the process of implementing the recommendations from this document. An agreed programme of reviews on different aspects of the service will be developed, to ensure progress is being made and that the plans being implemented are bringing the desired improvement. Data collection systems will be established to constantly monitor developments and national statistics and information will be examined on a regular basis to check progress. There will be regular reporting to the Directors of Commissioning and the North West Specialised Commissioning Group. iii

THE NEXT FIVE YEARS: A PATIENTS PERSPECTIVE On behalf of the patients, families and carers whom we represent, we welcome this opportunity to express our thoughts about the future direction of the renal service in the North West. For more than a decade, (starting with the reorganisation of renal services in Greater Manchester, right through to the ongoing ISTC programme to increase haemodialysis capacity in Cheshire & Merseyside), we have had real, as opposed to rhetorical, patient involvement in planning and monitoring the regional renal service. Such involvement carries with it a responsibility on our part to act in a committed and professional manner, and it automatically raises expectations in the patient community, (sometimes unrealistically) as to what can be achieved. Whilst recognising the realities of limited available resources, be they financial, workforce or otherwise, we believe strongly that we should set challenging targets for the next five years, and examine different and innovative ways of delivering the service. It should never be forgotten that the overall strategy will be judged by patients on their individual experience of what is provided, especially when it affects their quality of life. Being a renal patient is much more than a clinical experience; it impacts on all aspects of the lives of not only the patients themselves, but also their immediate family and those who care for them. Hours wasted waiting for transport, an inability to access the full range of multidisciplinary staff, a lack of spare capacity to enable patients to dialyse away from home for employment, family, or holiday purposes, and so on, matter as much as clinical excellence to those directly affected. From a patients perspective there is nothing to disagree with in the contents of this strategy document. Given its endpoint almost coincides with the date by which the implementation of all the standards and markers of good practice contained in the renal National Service Framework should be met, we believe that ensuring such implementation is achieved must be a priority. Linked to that, increased capacity to be able to offer all suitable modalities of treatment to all patients throughout the region has to be accomplished. That should include developing the availability of treatments such as daily haemodialysis, implementing the recommendations contained in the recent Organ Donor Task Force report 2, building on the primary care renal Quality Outcomes Framework (QOF) to reduce further the number of patients crash landing into the system, and providing comprehensive and appropriate end of life care for patients and their loved ones. We do not doubt the enormity of the challenge we face, but take heart from the very real progress made in recent years, and will do what we can to help meet and overcome the difficulties that lie ahead. Dennis Crane North Region Advocacy Officer National Kidney Federation iv

v

SECTION 1 Section 1 sets out the background to the document explaining about renal disease, the current position both nationally and locally, the drivers for improvement in renal care and the involvement of patients and carers in the planning and delivery of the service. 1.1 GUIDING PRINCIPLES AND SCOPE OF THE FRAMEWORK The guiding principles in developing renal and transplant care across Cheshire and Merseyside and the North West are that: patients and their carers will be the focus, and be at the centre, of all service planning. there will be equity of access to services for all patients. wherever possible, and appropriate, services will be developed close to the patient s home. patients will have choices in the care they receive unless clinically contraindicated, and such choices may change over time due to changing circumstances. there will be equitable standards of care provided by all renal service providers. the standards and markers of good practice outlined within the Renal National Service Framework 1, together with other relevant guidance, (eg Operating Framework 2008/09, NICE guidelines) will form the basis of all future plans for the service. the care provided for patients will be holistic, personalised, effective and safe. This Framework is based upon the catchment population of the Cheshire and Merseyside adult renal service providers as detailed in section 1.8.1. Some Central and Eastern Cheshire residents receive their care through the Greater Manchester Renal Network and the strategic developments for that area are addressed in a separate document. The performance monitoring and review of equity of access to renal care will be undertaken by the North West Specialised Commissioning Team on behalf of the PCTs. This Framework does however highlight the needs of the inflow population into Cheshire and Merseyside including patients from the West Lancashire area, the Isle of Man and parts of North Wales. The Framework is a five year plan, taking the service through to the end of the timescales for implementation of the standards, quality requirements and markers of good practice in the Renal National Service Framework 1 (NSF), and sets out the key planning assumptions for the recommendations made and will be reviewed on an annual basis in the light of actual service changes and other relevant factors. Renal services for children will be addressed within the North West Paediatric Partnership Board and are therefore not detailed within this document. However, the transition of children into the adult service crosses both areas of work and is covered in the Renal NSF 1. A forthcoming report from two Renal Action Learning Sets will deal with this topic and recommendations are made at the end of this document with regard to liaison between paediatric and adult renal services. 1

1.2 WHAT IS KIDNEY FAILURE? Kidney failure can occur for several reasons some patients develop kidney failure from hypertension, diabetes, autoimmune or genetic abnormalities; some from early damage to the kidneys in childhood; and others due to sudden damage, perhaps as a result of trauma, but in many cases the cause is not known. Figure 1 identifies the primary renal diagnosis in new patients across England and Wales in 2005 (Source: UK Renal Registry 3 ). Figure 1: Percentage distribution of primary renal diagnosis in 2005 incident cohort Polycystic kidney 6.1% Hypertension 4.8% Reno-vascular Disease 7.6% Other 15.2% Diabetes 19.8% Unknown Aetiology 28.0% Glomerulonephritis 10.3% Pyelonephritis 8.2% Unknown Aetiology Glomerulonephritis Pyelonephritis Diabetes Reno-vascular Disease Hypertension Polycystic kidney Other Kidneys have five main functions. They are responsible for removing toxic waste from the blood and excess water from the body, both via urine. The kidneys also help to control blood pressure: help to control the manufacture of red blood cells by making erythropoietin (EPO): and help to keep bones strong and healthy by maintaining the balance of calcium and phosphate. With kidney damage all these functions are either temporarily or permanently compromised. Patients with progressive renal disease may feel perfectly well for months or years without knowing they have any problems. However, relatively simple urine analysis and laboratory tests would indicate that their kidney function was deteriorating with a decrease in, for example, their egfr (estimated Glomerular Filtration Rate). Referral based on the stage of chronic kidney disease (CKD) is now thought to be most appropriate. These stages are shown in the table below using egfr as the clinical indicator of kidney disease: Table 1: UK Prevalence of Chronic Kidney Disease (CKD) Stage egfr (ml / min) UK prevalence from NeoErica study* 1 >90 (normal GFR) 3.31% 2 60-89 (mild impairment) 14.43% 3 30-59 (moderate 7.39% impairment) 4 15-29 (severe 0.29% impairment) 5 <15 (established renal failure) 0.04% n.b. 5 indicating end stage renal disease. *Ref: PE Stevens et al 4 egfr = estimated Glomerular Filtration Rate this indicates how well the kidneys are functioning with Stage Most people may only start to feel unwell when their kidney function is reduced to less than 30% of normal levels. By 15% the point they begin to be very symptomatic, much of the damage done to the kidneys is irreversible. 2

The only options available to patients with established renal disease are dialysis and transplantation, (jointly referred to as renal replacement therapy) or active renal supportive care (palliative care / conservative management and end of life care). Using the percentage figures from Table1 and the catchment population figures from Table 4 (p17), there are potentially more than 650,000 people within the Cheshire and Merseyside catchment population of renal services living with some form of renal impairment. This also means there is the potential to delay progression of renal disease in more than 450,000 people by managing their disease in primary care to prevent development of established renal disease. Others patients will, regrettably, have a continued decline in kidney function until further treatment options will need to be considered. Figure 2 illustrates prevalence of patients nationally with CKD stage 3-5 by age group and highlights that renal disease is most common amongst older people many of whom will have co-morbidities. It is also known that CKD is approximately four times more prevalent in the Asian and Afro-Caribbean populations. Figure 2: Prevalence of CKD 3-5 in UK from NeoErica study 50 45 40 35 30 Percentage of population 25 20 Males w ith CKD 3-5 Females w ith CKD 3-5 15 10 5 0 18-24 25-34 35-44 45-54 55-64 65-74 75-84 85+ Overall Age groups 1.3 WHAT SERVICES ARE INVOLVED IN RENAL CARE? Renal care spans many professional groups and healthcare sectors, with different members of the multi-professional team treating various stages of the patient journey. At primary care level, GPs, dieticians, nurses and other professionals have a crucial role to play in screening for early stages of Chronic Kidney Disease (CKD). Primary care staff are also crucial in identifying those patients at risk of renal disease as early as possible and, where appropriate, referring them into specialist nephrology services for diagnosis. The recent Department of Health initiative to screen people between the ages of 40 74 for vascular disease will concurrently highlight those at risk of renal disease (see section 1.8). Secondary care also enables patients to be cared for in their District General Hospitals. Some elements of chronic kidney disease management such as blood pressure control and cardio vascular risk factor management can be undertaken mainly in primary care. Other 3

complications of CKD such as anaemia, bone disease and acidosis and also preparation for dialysis or transplantation will occur in the secondary care sector. Issues such as end of life care may be shared across both primary and secondary health and social care and voluntary, (e.g. hospice care), sectors. Links with other clinical specialities such as diabetes and cardiac services are also essential in the provision of holistic care. In specialist renal services, a wide range of professionals are involved in providing care including medical staff, nurses, pharmacists, dieticians, renal technicians, managers, social workers, occupational therapists, physiotherapists and psychologists. Figure 3, adapted from the Renal NSF 1, illustrates the renal patient pathway through services and outlines the options available to patients once they reach established renal failure and require renal replacement therapy (dialysis or transplantation). Figure 3: The care pathway for renal replacement therapy Patient Important at all stages of the care pathway: Unplanned or emergency presentation Planned referral from primary care Planned referral from other specialty (eg cardiology, elderly, diabetes) Quality of life Nephrology assessment and review Shared information Pre- renal replacement therapy programme with multidisciplinary review Choice for patients Renal replacement therapy treatment choices Continuing education Peritoneal access surgery Vascular access surgery Preemptive transplant Clinical care Nutritional support Medicines management Peritoneal or Haemodialysis Transplantation Treatment with respect and dignity Active renal supportive care and end of life care Failing transplant Psychological and social support for patients and carers 4

Early identification of kidney disease can greatly increase the success of managing the disease and slowing (or even stopping) the progression to established renal disease. The introduction of CKD into the Quality Outcomes Framework (QOF) in 2006 has facilitated the identification and management of CKD patients in primary care. Many patients with CKD will not develop progressive renal failure and may never be referred to a renal unit. Established renal disease is a long term condition like diabetes, and many patients within renal services also have other medical conditions. The challenge in this framework is not only to identify renal specific issues but also to address the need for synergy with other key service areas, particularly coronary heart disease and diabetes care. This interaction may include the linking of IT systems and registers, shared care plans, an integrated workforce and clinical targets. In addition, there is a direct link with non NHS agencies such as social services, transport providers, hospices etc, who provide essential services to renal patients throughout the care pathway. One way to improve the synergy and interaction between other service areas and non NHS agencies would be to consider migrating the renal care pathway into the Map of Medicine www.mapofmedicine.com. The map is a web-based visual representation of evidencebased patient care journeys currently covering 28 medical specialties and 390 pathways. As healthcare provision becomes much more specialised the need to plan and then benchmark clinical practice against national standards whilst incorporating local intricacies is key. The Map provides a visual framework for clinical knowledge that can be customised to meet local needs. All NHS staff in England and Wales can now access the Map of Medicine s national care pathways and quickly view the latest evidence, including NICE guidelines. Currently nephrologists in Wales, for example, are using the map as a way of delivering clinical information to primary care in order to reduce the number of people presenting to secondary care with late stages of chronic kidney disease. The Map of Medicine clinical pathways have now been made available to patients via the NHS Choices website www.nhs.uk/pages 1.3.1 Renal Service Descriptions For those patients who do progress to CKD stage 5, they will need renal replacement therapy (RRT) in the form of dialysis (either peritoneal dialysis or haemodialysis) or transplantation. Some patients will choose not to have RRT and these patients will need active renal supportive care and eventually end of life palliative care. Transplantation is the best form of RRT for those patients who are clinically suitable (approximately 40%), and a pre-emptive transplant (ie, one carried out before dialysis is required) is considered the optimum. Organs can be donated from a living or deceased donor. It is important to recognise that transplants may fail, even after many years, and these patients will need to return to dialysis. Patients may receive a kidney or, for some patients with diabetes, a kidney and pancreas. Pancreatic transplants will cure diabetes which may be the cause of the renal failure. By doing a simultaneous kidney and pancreas transplant both the diabetes and the renal disease can be treated. Dialysis can be provided either as peritoneal dialysis (PD) or haemodialysis. 5

Peritoneal dialysis is carried out through a catheter inserted into the patient s peritoneal cavity and can be in the form of continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD). Both of these forms of treatment can be performed by the patient at home and involve draining bags of special fluid into and out of the peritoneal cavity. These exchanges of bags are carried out 3-4 times a day in the case of CAPD or 3-4 times overnight for APD using a machine whilst the patient is asleep. Automated peritoneal dialysis can be organised as an assisted process (AAPD) for patients who do not have the dexterity to manipulate the machine. Haemodialysis purifies the blood outside the body by passing it through a filter called the dialyser. The dialyser is fitted to a machine which pumps the patient s blood through the filter and controls the whole process. A haemodialysis session will normally last for 3-5 hours and in most cases takes place 3 times a week. Patients who are clinically stable can dialyse in a satellite dialysis unit away from the renal centre, usually closer to where they live, or at home. Those patients who require extra care will need to dialyse in the renal centre. Dialysis access surgery is needed by both PD and haemodialysis patients in preparation for treatment. This will involve insertion of the catheter for PD or formation of a fistula for haemodialysis. Both of these procedures need to be performed in a timely fashion negating the requirement for any temporary access which increases morbidity and chances of infection. Active renal supportive care, previously referred to as conservative management, palliative care and end of life care, will be needed by patients who choose not to have RRT, or who cannot continue it for clinical reasons. It is important to stress that this does not mean no treatment but supportive treatment and will mostly be carried out in primary care with close liaison between renal staff and primary care staff. The crucial factor in the care pathway is that patients should be allowed to make an informed choice of treatment that can be reviewed at any time. 1.4 PRINCIPLES OF COMMISSIONING The development of commissioners as leaders of change has been progressing over a number of years. The core components of commissioning are illustrated in Figure 4: The National Review of Commissioning Arrangements for Specialised Services (Carter Report) 5 May 2006, looked at Figure 4: Core components of commissioning ways to improve the commissioning of specialised services to make the arrangements more robust and consistent and to ensure a good fit with the wider NHS system reform programme, the new organisational infrastructure for commissioning by the NHS and the changing role of the Department of Health (DH). 6

The Report made 32 recommendations including the establishing of a National Specialised Commissioning Group (formerly NSCAG) and 10 Specialised Commissioning Groups coterminous with the SHAs and supported by dedicated specialised commissioning teams (SCTs). The North West Specialised Commissioning Team (NWSCT) has delegated authority to act on behalf of 24 North West PCTs and commissions all 35+ specialised services including renal and transplant care. The NWSCT has a lead commissioner for renal services who will play an active role on the Kidney Care Network Group. The NWSCT will also be working closely with PCT commissioners in developing effective commissioning strategies across the patient pathway particularly focussed on vascular risk assessment and early kidney disease management. 1.5 NATIONAL DRIVERS, GUIDELINES AND POLICIES Over the past few years, the profile of renal services has been raised significantly and renal care is designated as one of eight national priorities within specialised services. Renal care is a relatively young discipline and only began to be provided as a mainstream service in the late 1960s. Since this time, significant advances have been made in the care that can be offered. As long ago as 1991, a National Renal Review was commissioned and this highlighted the fact that there were major gaps in renal service provision. It was noted that there was a significant shortfall in renal services and those services which did exist were patchy and uneven. Referral of patients was often late in their renal disease thereby reducing the options for treatment. There was also little patient choice in the modality of care received or in the location and timing of dialysis. Disappointingly, these issues are still relevant today. The findings of the National Renal Review, together with an ever-increasing number of patients presenting with established renal disease, have resulted in several key national initiatives being developed. These are described in Appendix 5 together with other key strategies, policies and guidelines which will impact upon renal services. Of particular importance is the Renal National Service Framework 1 (see 1.6 below), The Operating Framework for the NHS in England 2008/09 and the Report from the Organ Donor Taskforce 2008 2. The Operating Framework for 2008/09 states in commissioning for world-class health services, Specialised Commissioning Groups (SCGs) should pay particular attention to areas where significant increases in demand are likely to lead to pressure on services. For example, demand for renal replacement therapy (dialysis and transplantation) is projected to rise by around 5% per year until at least 2030. SCGs will wish to consider options for expanding the provision of satellite dialysis centres and offering more people the option of home dialysis as well as expanding main acute dialysis units. We know that demand for haemodialysis (as opposed to overall renal replacement therapy) is increasing at the even higher rate of 6-8% per annum. 7

The Report from the Organ Donor Taskforce 2 is discussed in more detail in section 2.2 but it makes 14 recommendations that are fully supported by this document and the Kidney Care Network. The Cheshire and Merseyside Kidney Care Network also recognises the importance of the new report from the North West Strategic Health Authority Healthier Horizons for the North West 6. The publication of this report in May 2008 marked the beginning of a three month period of discussion and engagement regarding the report s recommendations and commitments. The Cheshire and Merseyside Kidney Care Network fully supports the report and there is nothing in this Framework that conflicts with Healthier Horizons for the North West. 1.6 RENAL NATIONAL SERVICE FRAMEWORK 1 Renal services have become the focus of national attention in recent years with the publication of the Renal National Service Framework 1 (NSF). The NSF was published in two parts in January 2004 and February 2005. The Standards, Quality Requirements and Markers of Good Practice are detailed in Appendices 2 and 3. Part One of the NSF sets five standards and identifies 30 Markers of Good Practice and deals with Dialysis and Transplantation. Part One of the NSF had five actions to be achieved by 2006. Table 2 shows the current position with regards to these five actions in Cheshire and Merseyside. Table 2: Actions required from Part One of the NSF and current status for Cheshire and Merseyside Action to be achieved Use national data to support planning and to identify local priorities including the needs of black and minority ethnic (BME) groups. Continue to expand haemodialysis capacity Join the UK Renal Registry (RR) of the Renal Association and take part in national comparative audit. Implement NICE appraisal: assessment for home haemodialysis Implement NICE appraisal: immunosuppressive therapy Current position This Strategy uses national (e.g. Renal Registry, ONS) and local data to plan future services and accounts for the needs of BME groups Capacity has expanded over recent years and is an on going process. The renal centres in the conurbation submit data to the RR but this is not complete. Home haemodialysis is provided in the area and forms part of this planning document. The transplant unit has implemented the NICE guidelines. Part Two of the NSF sets out four Quality Requirements and 27 Markers of Good Practice dealing with chronic kidney disease, acute renal failure and end of life care (Appendix 3). Whilst the second part of the NSF does not have any specific actions to be achieved, the Quality Requirements and Markers of Good Practice are used in this document for planning purposes. 8

1.7 LOCAL DRIVERS Renal services within Cheshire and Merseyside have been one of the leaders in the development of renal satellite dialysis care. Effective relationships with private sector providers in the 1980s and 1990s have continued with the inclusion of Cheshire and Merseyside in the first national tender for independent sector provision of haemodialysis which was awarded to Fresenius Medical Care. This has meant that the provision of haemodialysis across the zone has been extensive and future plans are in place for new and refurbished units over the next two years. This has also meant that new patient acceptance rates are relatively good across Cheshire and Merseyside. The Transplant Unit takes patients from North Wales and the Isle of Man as well as from across Cheshire and Merseyside. Patients who need a pancreas transplant currently have to travel to Manchester, Birmingham or Oxford. The local drivers for improvements to the services are summarised below. 1.7.1 Chronic Kidney Disease (CKD) and General Nephrology A key theme running through the NSF is the importance of enhancing primary care in the early identification of renal patients, early referral to delay the progression of renal failure, and in the commissioning of integrated care across the patient pathway. Management of patients in primary care is at an early stage of development in Cheshire and Merseyside. Progressing this development will need education, training and closer liaison between primary and secondary care staff. There are insufficient specialist outpatient clinics in local District General Hospitals including transplant clinics and multi-professional low clearance clinics. Many patients have to travel into renal centres for outpatient appointments. The provision of psychological and social support to kidney patients and their carers is fundamental in a patient centred service. Patients often need access to advice on their benefit entitlement, support in psychological adjustment to their treatment options and regimes and help in taking control back in their lives whilst living with a chronic condition. Many patients suffer from depression and appropriate psychological support can greatly benefit them in managing their condition. Anaemia management (both the prescribing of iron and erythropoietin - EPO) is a key quality issue for renal patients who are often anaemic and is fundamental to the service. (The more familiar term, EPO, has been used in this document to represent all the Erythropoiesis Stimulating Agents now referred to as ESAs). Renal information systems must evolve and develop in line with the service expansion. In particular, it is a requirement of the NSF that units submit full data reports to the Renal Registry. Integrated IT systems enable comparative data to be collected but also facilitate the multi-professional way of working across the renal team. There is a need to ensure the Renal Registry submissions are accurate, reliable, timely and completed by all renal service providers and data used for monitoring and audit and comparison with national performance. The national Renal Services Information Implementation Strategy 7 was published in January 2004 and gives guidance on how the implementation of its recommendations will help deliver the NSF targets. 9

1.7.2 Transplantation Transplantation is the best form of renal replacement therapy for those patients who are clinically suitable. The procedure not only significantly increases the patients quality of life but is also highly cost effective. The case for increasing the number of transplants is indisputable. Raising the number of transplants can be achieved in a number of ways including the development of antibody incompatible transplants, a non-heart beating donor programme and increasing the number of live donor transplants. Expansion of the donor retrieval programme and increasing organ donation rates is essential if national targets are to be met and the number of transplants increased. Additional work is required to increase the number of registered organ donors across the whole of the North West. This work will need to address sensitive issues such as the high rates of relative refusals to organ donation and closer interaction with Intensive Care Unit (ICU) staff. Organs for Transplant: A Report from the Organ Donation Taskforce 2 deals with the points above and the recommendations from this report will be fully supported by this Cheshire and Merseyside Strategic Framework document. The Renal NSF 1 section on transplantation recommends that patients are placed on the transplant list at least six months before dialysis is due to commence. It also highlights the importance of giving patients information regarding transplantation in order for them to make informed choices and to ensure that the infrastructure of the service is sufficient to meet key quality standards. Tissue typing is a fundamental element of the transplant service as this ensures the transplant recipient receives the best-matched organ, thereby reducing the potential for organ rejection. Serious concerns have been raised regarding the transplantation laboratory service in Cheshire and Merseyside which is not accredited. This situation is not sustainable and the recent appointment of a consultant clinical scientist should be followed up to ensure accreditation is achieved without delay. Development of local transplant outpatient clinics closer to patients homes would ensure patients could be followed up on a regular basis, including a comprehensive annual review, which may in turn improve rates of compliance with the treatment regimen. Good IT links with the Transplant Centre would facilitate this expansion. The data from the UK Transplant Allocation Review has raised a number of points that are relevant to the transplant unit. The issues raised by the review, need to be followed up and monitored. Following the implementation of the Human Tissue Act, a national paired-donation scheme now exists. It is likely this will have an impact on the living donor programme, and has a major impact on the demands made on the transplantation laboratory. The transplant unit does not run a non heart-beating donor programme. This may be essential to increase the number of transplants undertaken if the new allocation scheme does not favour the Liverpool unit. 10

1.7.3 Acute Kidney Injury (Acute Renal Failure) Acute kidney injury is an abrupt decline in kidney function (within 48 hours) resulting from an injury causing a functional or structural change in the kidney. At present there is no specific therapy for AKI and the cornerstone of treatment is renal replacement therapy. 1.7.4 Dialysis Access Surgery Standard 3 in Part One of the Renal NSF 1 (Appendix 2) highlights the importance of good access surgery to support the dialysis programme. Haemodialysis patients who require vascular access should have this established six months before commencing dialysis and peritoneal dialysis patients have their catheters inserted four weeks before dialysis. A national dialysis access survey carried out by the UK Renal Registry 3 in 2005, showed that in reports from 62 of 72 renal centres only 31% of haemodialysis patients commenced treatment with definitive access. It is known that temporary access leads to increased morbidity and mortality, increased numbers of inpatient episodes, increased risk of infection and poorer outcomes. The Renal NSF 1 recommends that patients are prepared for dialysis for around one year. This requires patients to be prepared for dialysis access well in advance of the need for surgery in order to meet European standards for establishing permanent access prior to dialysis. The number of patients with arterio-venous fistulas should be around 80% and this is the case in a number of European countries (Germany 84%, Spain 82%). The UK has a rate of 66%. The rate in Cheshire and Merseyside is 90%. Vascular access surgery may be undertaken by vascular surgeons or transplant surgeons or for some procedures, by specialist nurses. If sufficient procedures are to be undertaken to meet future need, new ways of working may need to be considered. Once access is established, the maintenance of the fistula or catheter site through use of clinical surveillance and regular monitoring is crucial so that problems can be detected early and action taken to preserve the access. Interventional radiology is fundamental to this process and the necessary radiological expertise is essential at each renal centre. 1.7.5 Dialysis There is a need to ensure high quality hospital haemodialysis can be provided 3 times weekly, local to the patient where clinically appropriate, and at a regular time to suit the patient. Many patients are currently receiving sub-optimal care. The new expansion programme should alleviate this situation but will need constant monitoring over the five year period of this plan. There is a need to maintain high quality peritoneal dialysis and home haemodialysis as options for patient choice and expand services as required. 11

Renal facilities for patients with blood borne viruses need to be reviewed and developed in the light of the Dept of Health guidance 8. This guidance sets out recommendations for managing the care of infected renal patients, particularly those with Hepatitis B, Hepatitis C and HIV. Transport for haemodialysis patients to and from their treatment venues is a key consideration for the service. Implementing the recommendations from the Cheshire and Merseyside Transport Action Learning Set will form part of this strategic plan. 1.7.6 Active Renal Supportive Care The term active renal supportive care is used in this document to cover all aspects of conservative management, palliative care and end of life care. The term active renal supportive care for patients opting not to have, or who are not suitable for, or who have to withdraw from, dialysis therapies is considered more appropriate, as choosing not to have dialysis does not mean no treatment but active treatment in the form of anaemia management, biochemical management, dietary management etc. There is a need to develop this active renal supportive care for patients with established renal disease who choose not to receive dialysis (which may include some patients whose transplanted organs are failing), or for those patients currently receiving treatment who wish to stop and for those for whom it is no longer clinically appropriate. 1.8 HEALTH NEEDS ASSESSMENT AND DEMOGRAPHY The key factors affecting the incidence of renal disease are age and ethnicity. Additional factors include co-morbidities and, to some extent, socio-economic deprivation. In order to plan for the needs of this population, it is important to understand the underlying pathology and its progression, the effects of co-morbid and associated conditions, as well as the complex interactions of patients, care providers, and service constraints. Renal disease is strongly linked to vascular disease and diabetes. These two conditions play a major role in the development of renal disease, and in the long-term prognosis of patients with renal failure. Like kidney disease, coronary heart disease, diabetes and stroke are forms of circulatory disease that relate to some extent to blood vessels or vascular disease. In July 2006, the Department of Health (DH) Renal Team was integrated into the DH s Vascular Programme, ensuring stronger policy links with colleagues working on heart disease, stroke and diabetes to address a set of shared issues such as prevention, early detection and risk management. More recently (April 2008) it has been announced that approval has been given to transform the National Diabetes Support Team into the National Diabetes and Kidney Support Team. This is seen as an opportunity to create a structure of support mechanisms to implement kidney care improvement across England. In the report Putting prevention first vascular checks: risk assessment and management 9 The link between kidney disease and other vascular diseases is highlighted. The majority of patients with early chronic kidney disease (CKD) do not progress to established renal disease (ERD) but do have increased risk of cardiovascular disease. 12

Optimal management of the risk factors for cardiovascular disease also reduces the risk of progression from early CKD to ERD. Late referral to specialist renal services of patients with ERD requiring renal replacement therapy is known to be associated with significant costs and poor clinical outcomes. Guidelines have been developed jointly by the Royal College of Physicians and the Renal Association on the identification, management, and referral of patients with CKD. These guidelines have been issued to GPs in the form of an information leaflet (September 2007) and there is already evidence that more patients are being referred in good time. The Vascular Programme Renal Disease Diabetes Shared Vascular Agenda: prevention, screening, managing risk Heart Disease Stroke Treatment for established renal disease (ERD) by dialysis or transplantation is very expensive costing over 2% of the total NHS budget. The numbers of patients requiring renal replacement therapy (RRT) is rising and unlikely to reach steady state within the next 20 years. Any improvement in the cost effective treatment of early renal disease is therefore highly desirable. There has been a significant rise in the number of patients treated with RRT in England over the last 10 years. It is likely, however, that as this rate is still below that of many similar developed countries, there is a persistent unmet need for RRT in the UK as a result of an under-provision of renal services. Section 1.8.2, shows a number of areas of the North West including Cheshire and Merseyside have an under-provision compared with other areas of England. The impact of demographic change, particularly the ageing of the ethnic minority population who have higher rates of renal disease and the increase in Type 2 diabetes may have contributed to the rise and will continue to affect demand. The modalities of RRT therapy have changed due to falling numbers of deceased donor kidneys with consequent growth in dialysis, particularly haemodialysis in satellite units. 13