CHD Consultation: Further Questions and Answers
NHS England has provided information addressing questions that have continued to be raised during the Congenital Heart Disease (CHD) Consultation.
To find out more about these questions including ‘Why 125 operations per surgeon, and what is the evidence for this?’ as well as a further 23 questions relating to the consultation, please see further information below.
‘Further questions and answers
NHS England has already published answers to 41 questions that have frequently been asked during the consultation. Here we seek to address questions that have continued to be raised, noting that in many cases this information is already freely available in one of the documents we have previously published.
1. Why 125 operations per surgeon, and what is the evidence for this?
We set out the evidence base for the key standards in the paper presented to the board at the time the standards were agreed. This was also summarised in the consultation document. The requirement that each surgeon should undertake at least 125 operations each year was based on the clear and consistent recommendation of the specialist congenital heart surgeons. This will enable surgeons to maintain their skills and will ensure the best possible outcomes for patients. Surgical volumes are particularly important in this specialty because of the wide range of different operations congenital cardiac surgeons are called upon to perform.
2. Currently none of the centres meet all the standards. Can centres continue if they meet the standards?
We have addressed this question in the previous Q&A document. If hospitals can show they can consistently meet the standards in the future to provide sustainable services they can continue to operate a CHD service. Robust and sustainable plans will need to be provided for all CHD services.
3. Why is Glenfield being judged on standards based on previous years, and not being allowed to meet standards within previously agreed timescales?
Our assessment of UHL against the standards follows the timetable set out in the standards. This requires that level 1 CHD centres have three surgeons each doing 125 operations per year by April 2016 and four surgeons each doing 125 operations per year by April 2021 (and if they do not already have a level of activity commensurate with meeting this requirement, then they need to have a robust and sustainable plan to do so). There has been no change to these requirements.
4. Why are some centres being supported more than others to reach the standards?
NHS England has worked with all centres that do not meet all of the standards to agree a plan to meet those standards. We have been in regular contact with all centres, particularly those where change has been proposed. We are not providing a higher level of support to some centres than others. The exception to this is Manchester where we have needed to support the development of interim arrangements for safely providing high quality care for adult CHD patients following the suspension of the service by CMFT.
5. You are proposing not to decommission L1 services at Newcastle because of their transplant service. How is this any different from Leicester’s ECMO service?
We have addressed this question in the consultation document and our impact assessment documents. Newcastle upon Tyne Hospitals NHS Foundation Trust has a unique, strategic position in the NHS in England in delivering care for CHD patients with advanced heart failure, including heart transplantation and bridge to transplant. The hospital trust is one of only two providing paediatric heart transplantation for the UK (the other is Great Ormond Street Hospital for Children NHS Foundation Trust in London). Advanced heart failure amongst people with CHD is increasing as a result of increased life expectancy, and treatment for people with this condition is dependent on CHD surgeons. Adult CHD patients with end stage heart failure have limited access to heart transplantation, and the unit in Newcastle is recognised as delivering more care to this group than other transplant centres nationally. This service is intimately connected to the CHD service and can only be delivered at a hospital providing Level 1 surgical services. No other provider currently has this capability so, while in principle it would be possible to commission these services from an alternative provider, the learning curve would be long and initially outcomes would not be as good. The surgeons who perform CHD operations are the same surgeons carrying out heart transplants. If CHD surgery were moved elsewhere, the transplantation service could not be replaced in the short term without a negative effect on patients. For this reason, we are proposing to retain CHD services at Newcastle upon Tyne Hospitals NHS Foundation Trust. This does not mean that change at Newcastle upon Tyne Hospitals NHS Foundation Trust is not expected to happen in the longer-term. The hospital trust is required to meet the standards in the same way as all of the other Level 1 surgical centres.
UHL provides cardiac and respiratory ECMO for children and is at the present the only provider commissioned to offer mobile ECMO (which allows children to be transferred between hospitals on ECMO). It also provides cardiac and respiratory ECMO for adults. If our proposals were to be implemented, Leicester would no longer be able to provide cardiac or respiratory ECMO for children or mobile ECMO for children. Taken together this would affect around 55 children a year. It would no longer provide cardiac ECMO for adults with CHD. We would expect that Leicester could continue to provide adult respiratory ECMO, in a similar way to other hospitals where services are supported by adult cardiac surgery services (not congenital cardiac). Unlike paediatric heart transplant most aspects of ECMO are provided from a number of other hospitals across the country. NHS England will work with the other hospitals, where increased paediatric cardiac and adult congenital surgery would be expected, if our proposals are implemented, (Birmingham Children’s Hospital, Great Ormond Street, Leeds General Infirmary and St Thomas’ – Evelina Hospital) to undertake the necessary planning and preparation to manage any increase in paediatric cardiac ECMO capacity that would be needed for CHD patients. The Paediatric Critical Care & Specialised Surgery for Children Service Review will consider the overall appropriate model of children’s ECMO provision and the appropriate number of providers, the case for minimum activity levels and the appropriate number of mobile ECMO providers. We will re-commission appropriate levels of children’s respiratory ECMO and mobile ECMO from an appropriate number of providers in the light of the recommendations of that review.
6. Children with CHD from across the East Midlands currently travel to Glenfield Hospital for treatment – this is already some distance from some parts of the region and a risk when they need to be treated quickly. How will the additional travel affect the outcomes for patients when they need specialist intervention as quickly as possible?
We have addressed this question in the previous Q&A document. Our clinical advisors (doctors from centres providing CHD care) tell us that true emergencies in CHD are – thankfully – very rare. Thanks to advances in antenatal diagnosis, most congenital heart defects are detected in the womb, which enables the mother to give birth either at, or close to, an appropriate hospital providing CHD surgery for children. Even in those cases where CHD is only spotted during, or after delivery, surgery will often be planned over a period of days. If infants need to be moved from one hospital to another for emergency care, then ambulance services, local hospitals and specialist retrieval transport teams are able to ensure that patients are stabilised before and during transfer, so the risks of long journeys are negligible. Access and proximity to care is an understandable concern. We have heard that the distance travelled for surgery is less important than travelling for ongoing care. We are working to strengthen local care so that as much care as possible can be delivered closer to home. We will also consider whether some hospitals should continue to provide specialist medical care for CHD patients even if surgery and interventional cardiology move elsewhere. We acknowledge that travel will be difficult for some people, especially those who live in more remote areas, with limited public transport options. We have had to balance this with the need to ensure that all patients with CHD have access to high quality care, which meets the required standards. We want to ensure that access to these important services is fair and equitable, and that no patient receives sub-standard care, simply because of where they live. We anticipate that longer journeys to a surgical centre will only be required for an outpatient appointment before and after surgery, and for the surgery itself. This means that most of the care received by people with CHD can be at a Level 2 hospital. This is why we are working to strengthen local care as much as possible, to ensure that patients, and their families/carers are only required to travel further afield when absolutely necessary. The standards address a number of areas that patients and families told us could be improved to make life more manageable when a patient is in hospital. This includes things like access to free wifi, overnight accommodation and facilities for meal preparation.
7. Are you doing this to save money?
We have addressed this question in the consultation document and in the previous Q&A document. This is not about saving money. You will already know that money is tight in the NHS, and the NHS has to live within its means. While implementing most of the standards will cost little, or nothing, we expect the overall amount of money spent on CHD care to increase in the future, as more and more people are – thankfully – living longer with CHD.
8. If the proposed changes to congenital heart services are agreed, over what time frame does NHS England expect them to be implemented, and how can patients and their families be reassured that there would be no risk to their care?
Detailed practical preparation for making any changes to level 1 surgical CHD services would only begin once a decision is made by the NHS England Board following the outcome of public consultation. We have already spoken to those hospitals which we expect would need to provide care for more patients if our proposals are implemented. They have looked at what they would need to do to increase the number of patients they care for and have assured us that they understand what is required and would be able to do what is needed to take on the extra patients. If a decision to move services is made, work would begin to turn those ‘agreements in principle’ into firm plans. Clinicians at all the affected centres will be involved in developing plans for how the service would work in the future. The involvement of any centres that would no longer provide level 1 services is key to the success of planning and managing the change because they have the detailed knowledge of their patients and the care they have been providing. Part of this process will be to identify and manage any risks. We would work to ensure that:
• the process is carried out carefully and thoroughly;
• there is a strong link between the plans of those hospitals that would cease to provide level 1 services and those hospitals that would expand their provision;
• that no change happens until there is enough capacity at the new hospital, including overnight accommodation and other facilities for families;
• that staff and patient representatives from the hospitals concerned are included in the planning process;
• there is frequent and clear communication so that everyone knows what to expect and how it will affect them; and
• there is no fall in service quality or rise in waiting times.
Patients and their families have told us that changes to where their care is provided and to the staff providing their care can be unsettling, so we would ask the hospitals involved to look carefully at how this process is managed if our proposals are implemented. We think the pattern set out in the standards for transition from children’s to adult services may be helpful as this offers an opportunity to visit the new centre and meet the new staff in advance of the change happening. We would also ask them to maximise continuity in care so that as much as possible can remain familiar. We would ask for special attention to be paid to people with learning disabilities and their families because we know that change can be particularly difficult for this group. If our proposals are implemented, we do not expect that changes of location in individual patient treatment will happen straight away. We know that recruiting medical consultants typically takes six to nine months and this will be an important factor in how long any changes take.
9. You can’t un-cook a sausage, you can’t un-close a surgical CHD service. When it’s gone it’s gone. What if the proposed changes do not realise the hoped benefits or more importantly the units ear-marked for expansion fail to deliver on their plans?
If the board decides to make any changes to the CHD service, NHS England will support the implementation of those changes with national oversight and programme management. The proposed implementation programme board will identify and manage risks and escalate these if necessary. Our regional teams will work closely with the affected hospitals. This will include working closely with providers to support the development of:
• Locally appropriate care model including consideration of the role of level 2 care
• Capacity planning and development
• Transition planning
• Implementation of ‘staff affected by change’ policies across affected organisations including action to minimise redundancies; there will be no reduction in the number of specialist staff required to deliver services
• Workforce planning and development
• Staff communication plans
• Patient communication plans In this way we will be able to monitor and manage implementation and take early corrective action if the changes were not to be delivered to plan or the expected benefits were not being realised.
10. What has been done to increase the number of patients referred to Glenfield rather than them being sent to other centres. How many potential patients are we losing and why? Are these referrals solely down to the preferences of the consultants doing the referrals? Are patients actually even being offered Glenfield as a choice?
Our analysis suggests that 26% of adults and 47% of children with CHD who live in UHL’s notional catchment (based on car journey times) were actually admitted elsewhere.
These numbers must be considered approximate as different analyses and different datasets would give different numbers. The overall point is that a significant number of patients that might come to UHL do not do so. We addressed this issue in the previous Q&A document. There is a mix of reasons why people attend different centres, including reputation, geography, patient choice and the recommendation of the referring clinician. Any changes to patient flows would need to be agreed between the hospitals concerned, the referring doctors, and representatives of the patients affected. We support patients being offered choice, and this is reinforced by the standards. As commissioners, we do not propose to mandate changes to patient flows: referral pathways are most appropriately decided between doctors and their patients.
11. Why does NHS England not actively support the on-going positive work between Leicester, Northampton, and Peterborough hospitals to explore what actions would be required for the assumptions regarding patient referral in the UHL growth plan to be delivered. This would negate the need to decommission services and pose much less risk and disruption to the patients from the East Midlands.
UHL has submitted a plan to increase surgical activity which includes developing relationships with hospitals in Peterborough, Northampton and others. NHS England is considering this plan.
12. Why has NHSE not discussed the over forty page growth plan from the Glenfield?
NHS England has committed to providing feedback to UHL about its growth plan, and will do so shortly once it has completed its consideration of the plan.
13. This process started after the first Bristol scandal; in 2014 another review of the Bristol service commenced; again related to outcomes and parental concerns… you then announced that you were minded to close Leicester in the same week that the more recent Bristol review was published. Why are you closing our centre hundreds of miles away to address an issue in Bristol?
Our process is not addressing an issue in Bristol. The link with the original Bristol enquiry is set out in our consultation document.
Publication of NHS England’s proposals in the summer of 2016 represented the latest milestone in a very long journey, stretching back 16 years, to the publication of the report of a public inquiry into concerns about the care of children receiving complex cardiac surgery at Bristol Royal Infirmary. This was followed by the Safe and Sustainable review, launched by the Department of Health, in 2008. This review set out recommendations for a CHD service based on networks; with clinical standards for all hospitals designated to provide heart surgery for children, and a reduction in the number of NHS hospitals in England providing that heart surgery. Ultimately, these recommendations were not implemented, following intervention with the Secretary of State.
We know, from talking to stakeholders, that the failure to implement the recommendations of previous reviews has created uncertainty for patients and staff, and concerns raised during these reviews have remained. However, despite the fact that previous reviews have not resulted in a coordinated programme of change, progress has been made.
The long history of repeated reviews of CHD services has created uncertainty within the specialty, damaging relationships between hospitals; harming recruitment and retention of specialist staff; and reducing the resilience of services. Continued uncertainty affects recruitment and retention of congenital heart disease surgeons, a group in short supply and subject to international demand. The 2014 report on CHD services at Leeds Teaching Hospitals NHS Trust recommended that NHS England should act to dispel the “almost morbid sense of spectatorship and foreboding that hangs over these services”. Clear resolution is now needed to bring the stability the service needs to move forward.
When NHS England took on responsibility for the commissioning of CHD services in 2013, we were aware of the impact that previous reviews had had, as described above, and were told by patients, families, doctors and nurses alike, that the best way to deal with these issues was through the development of service standards, setting out how a good CHD service should be set up, organised and run.
We worked with the different groups of stakeholders for more than two years, as part of the New Congenital Heart Disease Review, to create a set of quality and service standards that covered the entire patient pathway, from diagnosis, through treatment, and on into care at home and end of life care, to make sure that every child, young person and adult with CHD, in every part of the country, would receive the same high standard of treatment. We believe that implementation of these standards is the only way to ensure that patients are able to access care delivered to the same high standards, regardless of where they are treated. Patients, families and their representatives told us early on that, while it was a good thing to have standards, they only really mattered if we ensured that they were met.
Otherwise, they were a waste of time. That message is really important and has influenced our thinking throughout this process.
14. NHS England says that these proposals are designed to ‘reduce variation in access and quality, by implementing a set of nationally-agreed standards, governing a truly national service. However, how does planning to close the centre which is most accessible to its region, has the shortest waiting list nationally and the most potential current capacity, with some of the best outcomes in the country, fit with this?
We set out our aims in the consultation document. These are:
• securing best possible outcomes for all patients – not just reducing the number of deaths, but reducing disability caused by disease, and improving people’s quality of life;
• tackling variation, so that services are consistent in meeting standards, each of them offering 24/7 care, seven days a week, as part of a nationally resilient service;
• improving patient experience, including provision of better information for patients, plus more consideration of access and support for families when they are away from home.
We believe that implementation of the standards is the only way to ensure that patients are able to access care delivered to the same high standards, regardless of where they are treated. Currently UHL does not meet all the standards and at the time of the assessment did not have a robust and sustainable plan to do so within the required timeframe. UHL has now submitted a plan to increase surgical activity and NHS England is considering this plan.
15. The BBC has claimed: ‘NHS England said the trust’s congenital heart disease (CHD) services, based at the Freeman Hospital, must be on the same site as paediatrics, currently at the Royal Victoria Infirmary (RVI). Local managers say moving either would mean building work costing up to £100m.’ How can that cost be justified?
The Newcastle Trust is considering a variety of options for achieving co-location of its paediatric cardiac work with its other paediatric services that are delivered from the Great North Children’s Hospital. No firm plans or costings have yet been agreed by the Trust or shared with NHS England so these figures should not be regarded as reliable. The Trust will need to consider the costs of any planned change, the source of funds and its affordability. NHS England will assess Newcastle’s plans in the same way that it has assessed those of other hospitals.
16. How much would it cost to move surgery to Birmingham from the Glenfield and build extra capacity?
We cannot give a definitive answer to this question until detailed plans have been prepared, and this will not be until the board has made its decision. However, we have addressed the issue of costs in the consultation document and the impact assessments, looking particularly at the cost of possible redundancies and the capital costs (the costs of new building).
Trusts are paid for CHD services through tariff, which ensures that the money received is linked to patient activity. It is likely that there will be some economies of scale for providers linked with providing a higher volume of activity. As such the trusts which would gain activity under these proposals are confident of being able to fund this expansion through the income which would be associated with this extra activity.
While NHS England considers it probable that most at risk staff will be redeployed and that therefore the costs of redundancy will be mitigated, we estimate that the costs of redundancies at UHL could be up to £1m. This estimate is highly sensitive to the degree to which staff can be redeployed.
University Hospitals Birmingham indicated that they would need to source £4M capital funds to accommodate additional activity. It is expected that they would be able to source the capital funding from existing allocations and/or charitable funds.
17. How much will it cost to co locate CHD services from Glenfield to the LRI if the decision is to let surgery remain in Leicester? Where do these funds come from? How long before the extra capacity is built?
NHS England has not yet seen firm plans or costings for this change. The Trust will need to consider the costs of any planned change, the source of funds and its affordability. NHS England will assess Leicester’s plans in the same way that it has assessed those of other hospitals.
18. What reassurances can NHSE give that moving this (ECMO) will not destabilise the entire national system and put both children and adults at serious risk?
The CHD review has assessed the potential impact of the proposed changes on ECMO services. As part of this process NHS England has gained an assurance that the ECMO capacity required for CHD patients can be re-provided at the centres where those patients would be likely to go if the proposals are implemented.
The CHD review is working very closely with the Paediatric Critical Care & Specialised Surgery for Children Service Review which will consider the overall the appropriate model of children’s ECMO provision and the appropriate number of providers, the case for minimum activity levels and the appropriate number of mobile ECMO providers. NHS England would re-commission appropriate levels of children’s respiratory ECMO and mobile ECMO from an appropriate number of providers in the light of the recommendations of that review.
19. How can NHSE reassure the public that taking two PICU units out of the system will not put children at risk or cause far longer waiting lists for operations as a matter of course, again putting vulnerable children at risk?
The CHD review has assessed the potential impact of the proposed changes on paediatric intensive care (PIC) services. As part of this process NHS England has gained an assurance that the PIC capacity required for CHD patients can be re-provided at the centres where those patients would be likely to go if the proposals are implemented.
The CHD review is working very closely with the Paediatric Critical Care & Specialised Surgery for Children Service Review which will deal with any wider implications for changes in PIC consequent upon the proposed CHD changes as it considers the required capacity and distribution of PICU across the country as a whole.
20. Why are NHSE persisting with these proposals when there is no discernible benefit to any patients or their families, and where there is ample proof that this is actually a dangerous venture that will damage both patients and the service nationwide?
We discussed the expected benefits of implementing the standards in our consultation document. We believe that implementation of the standards is the only way to ensure that patients are able to access care delivered to the same high standards, regardless of where they are treated.
Implementation of all the standards is important, but two areas have been discussed more than the others – the surgical standards and the interdependency requirements.
Congenital cardiac surgeons must work in teams of at least four surgeons by 2021, each of whom must be the primary operator in a minimum of 125 congenital heart operations per year. This will enable surgeons to maintain their skills and will ensure the best possible outcomes for patients. Surgeons agree that the number of operations done by each surgeon is more important than the number of surgeons in a team.
Professor David Anderson, President of the British Congenital Cardiac Association said: ‘125 really is a minimum number. It equates to three operations a week, per surgeon. Practice makes perfect, and 125 operations a year is considered the minimum to ensure that a newly appointed consultant surgeon acquires the skills they need across the differing surgical techniques. Some of the operations we do only come up once or twice a year, so ideally you would be doing at least four operations per surgeon each week, as that would result in 170-200 operations a year. A surgeon doing too many, or too few, operations is not good. Either way can result in a poor performance when it matters, either through fatigue or a loss of skills. Individuals will, of course, vary in capability, but we must set a minimum standard in order to ensure that a surgeon has an acceptable level of skill refined and maintained through regular practice. Centres need to oversee the distribution of the work fairly, taking account of any specialist skills, to ensure that all surgeons have the opportunity to work at optimum levels.’
UK surgeons agree that teams of four surgeons are ideal. This position was supported by the IRP in their recommendations: ‘Patients should receive congenital heart surgery and interventional cardiology from teams with at least four full-time consultant congenital heart surgeons and appropriate numbers of other specialist staff to sustain a comprehensive range of interventions, round the clock care, training and research.’
The benefits of larger teams include reduced pressure on individual surgeons compared to working in smaller teams, with the vulnerability of such services to the absence of one member of the team. Larger teams are also more able to subspecialise to handle rare, complex and innovative procedures. The combination of professional, annual and study leave will mean that members of 3 surgeon teams will spend almost half the year working a 1:2 on call. The Royal College of Surgeons, the Royal College of Anaesthetists, the Royal College of Paediatrics & Child Health and the Royal College of Nursing all told our Clinical Advisory Panel that this was not acceptable. Professor Norman Williams (then president of the Royal College of Surgeons) advised that the pressures this placed on individual surgeons could potentially jeopardise patient safety.
The standards require that specialist children’s cardiac services are only delivered in settings where a wider range of other specialist children’s services are also present on the same hospital site. This determines what medical care is available by the bedside for a child in a critical condition, which is important because many children with CHD have multiple medical needs. However, while this responsiveness is one important element behind the co-location requirement, it is not the only one.
NHS England’s clinical advisers consider that co-location with specialised paediatric services is also important because it allows much closer working relationships to develop between paediatric cardiology specialists and the wider specialised paediatrics team. Delivering these services effectively requires the input of the wider paediatric multidisciplinary team, and the interaction between these teams on a daily basis, when co-located, was considered by NHS England’s clinical advisers to be of significant benefit to patients. This way of working brings paediatric cardiac care into line with expectations in other specialist children’s services, because most other specialist paediatric services have moved to a paediatric environment, including liver transplantation; bone marrow transplant; stem cell/cancer therapy; and gastroenterology.
This follows the accepted international norm and is why the standard requires colocation on the same hospital site, not just the ability to get to bedside within 30 minutes of call. NHS England’s clinical advisers have said that in their view it was not safe to care for children with complex conditions and co-morbidities (a high proportion of whom will need input from other specialties) in settings where other paediatric services were not on site. Having all tertiary specialties on one site means neither the child nor the specialist has to travel with the potential compromises involved in the care environment, access to the full team and equipment and timeliness of advice and intervention.
21. Who took the decision to propose that UHL should no longer be commissioned to provide level 1 CHD services?
At this stage no decisions have been taken. NHS England’s proposals are under consultation.
The judgement that NHS England was minded to cease commissioning level 1 services from University Hospitals Leicester, subject to an appropriate service change process, was reached by the Director of Specialised Commissioning at the time, having been briefed on the findings of the national panel by the chair of that panel, Will Huxter. In doing so, he was taking forward a course of action agreed by the Specialised Services Commissioning Committee (SSCC).
22. When will a decision be taken?
Decisions will be taken at a meeting of the Board of NHS England, held in public. We are, of course, still in the formal consultation period. NHS England will make its decisions once it is ready to do so, having reviewed the consultation responses. We want to take the decision as soon as possible, understanding the importance of ending uncertainty for everyone involved with this specialty but it is vitally important that our Board has all the information it needs. We hope that the Board will be in a position to take a final decision no later the start of 2018 but earlier if at all possible.
23. Why will the East Midlands be the only region in England not served by a Congenital Heart Centre?
If the proposals are implemented, East Midlands will be one of a number of regions that do not contain a Congenital Heart Centre, and whose patients will be served by centres located outside the region. These include:
Cumbria and the lakes
The south east
The south west peninsula
In addition there is no level 1 centre in Wales or Northern Ireland and only one to serve all of Scotland.
NHS England Board Paper – New Congenital Heart Disease Review: Final Report
Proposals to implement standards for congenital heart disease services for children and adults in England – Consultation Document
NHS England Congenital Heart Disease Provider Impact Assessment 2017
Childrens and Adults CHD Engagement Q&As