© Springer-Verlag London 2015
Paul R. Barach, Jeffery P. Jacobs, Steven E. Lipshultz and Peter C. Laussen (eds.)Pediatric and Congenital Cardiac Care10.1007/978-1-4471-6566-8_1919. Lessons Learned from the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary and the English Safe and Sustainable Cardiac Review
(1)
Paediatric Cardiothoracic Surgery, University College London, Gresham College, London, UK
(2)
The Great Ormond Street Hospital for Children NHS Foundation Trust, London, WC1N 3JH, UK
Abstract
This chapter discusses the consequences of an episode in Bristol, UK in the 1980s and 1990s, in which there was an unacceptably high mortality in children undergoing open heart surgery. A major public inquiry followed and amongst many other recommendations, it was suggested that UK cardiac surgical services should be concentrated in a smaller number of centers. Subsequent service reviews came to the same conclusion. It did not happen. Eventually, a process called Safe and Sustainable Cardiac Surgery was established by the Department of Health, building on agreement of all centers to attempt once again to reduce the number of centers, using a standards-based approach. This chapter outlines, from the personal perspective of one lead care center involved, the process, its complexity, the scale of investment, the massive public consultation and, the final analysis that led to its ultimate failure. It contains salutary lessons for all those involved in pediatric cardiac service reform.
Keywords
Pediatric cardiac surgeryService reformHealth service managementBristolSafe and SustainableThe author was a member of both the Safe and Sustainable Cardiac Surgery Standards Group and the Steering Group
Introduction
There is a classic golfing quote, attributed to many, but mostly Gary Player who, when speaking to a journalist after a low score round beset by many lipped putts, said “the more I practice, the luckier I get!”. Cardiac surgeons know that is largely true for them, as it is for anyone carrying out a practical skill. The more you do the better you get. This principle underpinned a recent review of surgery for congenital heart defects in England,1 called ‘Safe & Sustainable Children’s Cardiac Services’ [1]. The aim of this review was to reorganize services in England to deliver care through a smaller number of bigger centers, themselves at the center of a rational geographic network of peripheral units staffed by general pediatricians with cardiology training. Each unit should have enough cases to ensure expertise of surgeons, and enough surgeons to provide cross cover and long term, sustainable staffing. The process of the review was standards based, complex and time-consuming for all involved. It also proved to be the biggest public consultation in the history of the National Health Service (NHS). It had the support of all the Royal Colleges, national patients groups, the Commissioners (the purchasers in the NHS model) and initially all the cardiac units in the UK. Many senior NHS managers experienced in health service change regarded Safe and Sustainable as the best process they had seen for achieving large scale service reconfiguration. Despite all this support, the process failed under a waterfall of litigation, process challenge, mixed publicity, ‘nimby’ism, and bad timing, occurring in the middle of the biggest reorganization of the NHS in its history.
I have to own up to being personally bruised by these events. I have striven over years to pursue excellence in cardiac care, and that was the underlying driver behind our involvement in this review. I am sorry that it did not proceed immediately, and hope that quality will not suffer. Yet another review has been commissioned and I hope that it does not lie in the political long grass since service redesign should be the very benefit of a state run health system, free at the point of delivery. This chapter summarizes the history of the process and lists some of the lessons learned.
Background
As in most countries throughout the 1950–1970s, pediatric cardiac surgery sprang up in places where there existed talented risk-taking surgeons, innovative and brave cardiologists and a hospital management team keen to put their institution on the map. They were usually sited in reasonably large pediatric hospitals or in single-organ specialist units. They were rarely designed from the bottom up as a networked service. It was a classic alpha-male environment with a work-all-hours ethic and highly competitive between institutions and especially between surgeons. New operations were being developed, and the age at which they could be performed fell rapidly as new technology developed, and results from pioneering units became known. Each surgeon, and each unit, became ‘tested’ by their willingness to adopt and their ability to deliver these new operations. By the mid-1980s the transition to neonatal surgery was firmly established and there were preliminary attempts at reporting of results through voluntary registries. Then came Bristol.
Bristol
Bristol is a large city in the west of England with a proud history, a good University and a well-established children’s hospital. In 1975, it had a small cardiac center, doing just over 100 cases per year when Mr. James Wisheart was appointed as a pediatric cardiac surgeon. The regional management team invested in the service and by 1985 the unit was performing 435 cases per year. That expansion required another surgeon to be hired, and Janardan Dhasmana was appointed as a junior colleague, and soon (1988) introduced the arterial switch procedure, by now the operation by which units were judged. He carried out 38 switches in all, with 20 deaths, way above the mortality rate anywhere else.
In 1988, Steve Bolsin was appointed as an anesthesiologist and immediately noticed that operations were taking very much longer than he was used to during his training in London. He became worried about the quality of the surgical results. And this was not helped in the years 1990–1994 when James Wisheart had a mortality rate of 9/15 AVSD repairs, prompting Bolsin to write to the Clinical Director of the hospital, John Roylance, later to be replaced by James Wisheart himself. Steve Bolsin kept his own audit of outcomes.
I should add here that I was approached by Bristol in 1990 to apply for the Chair of Cardiac Surgery and to develop the pediatric practice. I turned down the offer, stating in writing that the way the unit was organized (multi-site, patchy cover, adult cardiac juniors covering pediatrics, ECHO on another site) was ineffective, inefficient and potentially dangerous.
Bolsin’s story reached the press, via the satirical magazine Private Eye whose MD column is written by a GP, Dr. Phil Hammond [2]. Finally various official bodies, including the Royal College of Surgeons, reviewed the unit, but the College decided not to withdraw the license to carry out surgery, and its president was quoted in a later BBC documentary as suggesting the surgeons ‘needed to get more practice’. In 1993 Bolsin’s audit was completed and despite a limited circulation, revealed a mortality rate considerably higher than was expected from the voluntary national register that the UK cardiac surgeons kept.
Dhasmana stopped doing switches that year, but was persuaded to do another on Joshua Loveday in 1995. Joshua died on the table. It emerged that a senior NHS official, Peter Doyle, had advised the hospital not to let the procedure go ahead because of previous poor results. An external review by Professor Marc de Leval (Great Ormond Street and University College London) and Stewart Hunter (a senior cardiologist from Newcastle-upon-Tyne) concluded that Bristol was a high risk unit and that there were excessive deaths. A patients’ group called the Bristol Action Group was established to campaign both to learn more and improve services to other children.
In 1996, Bolsin felt his position untenable and he emigrated to Australia. Wisheart stepped down as medical director, stopped operating and retired in 1997. The General Medical Council (GMC) launched an investigation and the BBC broadcast a damning documentary in its Panorama series [3]. The GMC struck Roylance and Wisheart off the register, and suspended Dhasmana. In 1999, a huge public inquiry began, chaired by Sir Ian Kennedy, a prominent lawyer with a specialist interest in health ethics.
His extensive, thorough and damning Inquiry made 198 recommendations for change, too many to cover here, but it is worth giving you some quotes from his press release; they form the core of why Safe and Sustainable developed:-
Sir Ian said Bristol was a hospital that had “over-reached itself”, where clinicians only had “limited experience” at the time it became a regional center.
“Clinicians were ambitious to expand – the ambitions were too ambitious.”
“The management of the hospital was flawed – too much power was in too few hands.”
“There was a club culture where it was hard to raise matters of concern and harder to get anything done.”
And he said wider problems in the NHS were also to blame.
“There were no agreed national standards as to what amounted to good quality care for paediatric cardiac surgery – no agreed measure or benchmark.”
“Bristol was awash with data … [but] there was confusion in the NHS from top to bottom as to where responsibility lay for monitoring the quality of paediatric cardiac surgery.”
NHS Inquiries are frequent and fraught with implementation difficulties [4]. However, Sir Ian’s view, expressed clearly in his report, was that there were too many centers in the UK, that complex surgery should be done in centers of excellence and that the whole process of care should be both standards-based and thoroughly monitored. Safe and Sustainable was thus ‘unfinished business.’
Safe and Sustainable
The Bristol scandal highlighted appalling lapses in the care of children with congenital heart defects. In 2001, Kennedy explained the need for children to have heart surgery in fewer specialist centers. His report concluded:
…standards should stipulate the minimum number of procedures which must be performed in a hospital over a given period of time in order to have the best opportunity of achieving good outcomes for children. Paediatric cardiac surgery must not be undertaken in hospitals which do not meet the minimum number of procedures. Considerations of ease of access to a hospital should not be taken into account in determining whether PCS should be undertaken at that hospital.
In 2003, a review group led by the late lamented Professor James Monro, then President of the Society of Cardiothoracic Surgeons, recommended that surgical centers should do no fewer than 300 open heart procedures per year. That would have meant that at the time, about half the centers should have closed. Action was not taken by government Ministers at the time who, no doubt mindful of the political storm inherent in moving hospital services (regardless of the strength of professional consensus), justified their inaction on the grounds that the review had not unearthed concrete evidence of unsafe practice in any particular unit.
Concerns persisted; in 2006 a national workshop of experts chaired by Professor Roger Boyle (a cardiologist and national cardiac ‘Tsar’) and Dr. Sheila Shribman (who held a similar role for pediatrics) concluded that the current configuration of services was unsustainable. All the surgical units sent representatives to this meeting to discuss rationalization, and they agreed that the number of units should be reduced, probably to about 7 from the 11 that were then open. Each unit was challenged with the argument that the consequence of rationalization might be that their own unit would be scheduled for closure. They all agreed on the need for change.
In 2007, the Royal College of Surgeons of England called for the concentration of surgical expertise into fewer, larger specialist centers [5]. A year later, Professor Sir Bruce Keogh, NHS medical director and himself a cardiac surgeon, instigated the Safe and Sustainable (S&S) review, which began in 2008. His frank public warning was that failure to re-organize pediatric cardiac services this time round would be “a stain on the soul of the specialty”.
It was a response to the long-standing concerns of NHS clinicians, their professional associations, national parent groups and NHS commissioners about the sustainability of the service configuration then extant. Surgeons were thought to be spread too thinly across surgical centers (31 congenital cardiac surgeons spread over 11 surgical centers), leading to concerns around lack of 24/7 cover in smaller centers and the potential for sudden closure or suspension of smaller centers because of illness, burn out or diminished performance.
Sir Bruce had at the front of his mind the warnings made by the two previous reviews in 2000 and 2003 about the risk of something going wrong again in one of the English units. The case for change seemed unarguable when the pediatric congenital surgical service in Oxford (the smallest unit in England) was suddenly suspended in March 2010 after a number of deaths of babies following heart surgery. The NHS has very good experience of concentrating highly specialized services in the interests of quality and excellence; in our field these were ECMO (3 units), transplantation (2), tracheal surgery (1) and pulmonary hypertension (1). These units were producing world-leading results at low cost, concentrating expertise and delivering research output. The argument seemed clear.
The S&S review was managed by the National Specialised Commissioning Team (NSC Team), on behalf of the 10 Specialised Commissioning Groups (SCGs) in England and their constituent Primary Care Trusts.2
Governance Arrangements
It may seem boring to cover the governance arrangements, but this was bound to be a controversial piece of work, and great care was taken to ensure appropriate governance and attempt to get both top down and bottom up support, as well as strong political and professional leadership and lay involvement. The lessons we learned need to take into account the immense consideration that was put into this phase of the project.
Steering Group
A Steering Group was convened in January 2009, chaired by Dr Patricia Hamilton CBE, Director of Medical Education for England and Immediate Past President of the Royal College of Paediatrics and Child Health. The Steering Group comprised representatives of relevant professional and lay associations. The role of the Steering Group was advisory and it had no role in decision making:
Develop and communicate the clinical ‘Case for Change’
Consider the available research evidence around the relationship between larger surgical centers and clinical outcomes
Develop designation criteria that surgical centers must meet in the future
Develop a proposed model of care for regional pediatric cardiology networks
Oversee stakeholder engagement and communication
Endorse the process for the assessment of the current surgical centers
There was much debate early in the meetings of the Steering Group about whether it was right to consider pediatric cardiac surgery in isolation from adult congenital surgery. There was disagreement on the group about this and it was referred ‘upwards’, and the group was given clear guidance from the Department of Health that it should limit its scope to pediatrics. Thus, the scope of the S&S review excluded the designation of surgical services for adults with congenital heart disease, for which a separate designation process would be led later by individual SCGs once the pediatric review had concluded. However, the S&S review and the pediatric clinical standards gave prominence to the importance of transition to adult services.
Standards Group
Also in 2009, a pediatric cardiac surgery standards group was established, chaired by Mr. William Brawn, then President of the British Congenital Cardiac Association. Once again, this group had wide membership from professional organizations (cardiology, surgery, intensive care, adult CHD etc.), as well as commissioners. This group met regularly to define and publish standards of care and service to achieve excellence. In other words, the minimum standards a unit must have in order to be designated by the NHS as a suitable provider of care. The group consulted widely on the draft standards, including with the surgical units themselves. The finished standards are too detailed to present here, but are available at http://www.specialisedservices.nhs.uk/document/paediatric-cardiac-surgery-standards. They are clear and comprehensive and were widely supported as an outcome of public consultation.
Decision Making
Somebody had to make some tough decisions though and at the time it was clear that – in law – the only bodies which had legal powers for consulting on proposed changes to the number of units and for eventual decision making were the 152 Primary Care Trusts in England who commissioned secondary healthcare services. In July 2010, the Secretary of State endorsed a recommendation made by the National Specialised Commissioning Group (December 2009) to establish a joint committee of PCTs with delegated powers for consultation and decision-making. Each PCT Board in England accepted this recommendation via formal resolution after discussion at one of their own board meetings (this in itself conveys a sense of the scale of this program).
The joint committee of PCTs (JCPCT) comprised the Chair (or PCT Chief Executive Nominee) of each SCG in England and the Director of National Specialised Commissioning. They were thus very senior NHS managers, highly experienced in matters of service reconfiguration and implementing service change. It was chaired by Sir Neil McKay the Chief Executive of the East of England Strategic Health Authority – an experienced NHS career manager (this region does not have a pediatric cardiac surgical service within its borders, and so he was ‘neutral’). It should also be remembered that Wales, Scotland and Northern Ireland, whilst in Britain, are devolved administrations so this review only covered England. Thus, representatives of the devolved administrations were present at the meetings.
However, there were as an important caveat to the arrangements for decision making that proved incredibly problematic to the smooth running of the review process, and arguably proved to be fatal to its success. Democracy is a complex and untidy business.
Whilst in law it was clear that only the JCPCT had legal authority to make a “final” decision in the first instance, other legislation enabled local Health and Overview Scrutiny Committees (of which there are hundreds in England at local Council level) to challenge the decision by way of referral to the Secretary of State for Health. These committees have a very local focus, and it was apparent from the start that no committee (made up of elected councilors with no particular expertise in health matters) would dare incur the wrath of the local electorate by supporting the closure of its own local heart unit. A challenge by a scrutiny committee was therefore inevitable at some point, and it was thus an “open secret” from the start of the process that the final decision would ultimately rest with the Secretary of State for Health himself – as it did in 2003 with the disregarded Monro report.
The likely success of a challenge to the JCPCT’s decision by this route depended on the relevant scrutiny committee being able to demonstrate that the decision making process had been flawed – hardly an incentive for local politicians and local campaign groups to engage positively with the review team to achieve a good process. It also meant that campaigners realized early on that the way to influence government Ministers was to make the review a very public and controversial issue – and the various ensuing campaigns of mis-information and propaganda were quite extraordinary, resulting in a number of Ministerial debates in the House of Commons and House of Lords. In these debates government Ministers were always very careful to note the professional consensus on the need for change, but never actually gave a commitment to make changes. Instead, the role of the JCPCT as decision-maker was emphasized, along with a nod-and-a-wink to the likely role of the Secretary of State for Health once the JCPCT’s eventual decision had been challenged.
In April 2010, the extensive professional and lay support was crystallized in a document called ‘The Need for Change’ [6]. This need can be summarized as follows:-
Children’s heart surgery was becoming increasingly complex
Services had developed on an ad hoc basis; there was a need for a planned approach for England and Wales
Surgical expertise (31 surgeons) was spread too thinly over 11 surgical centers
Some centers were reliant on one or two surgeons and could not deliver a safe 24 h emergency service
Smaller centers are vulnerable to sudden and unplanned closure
Current arrangements were inequitable as there was too much variation in the expertise available from centers
Fewer surgical centers were needed to ensure that surgical and medical teams were seeing a sufficient number of children to maintain and develop their specialist skills
Available research evidence identified a relationship between higher-volume surgical centers and better clinical outcomes
Having a larger and varied caseload would mean that larger centers are best placed to recruit and retain new surgeons and plan for the future
The delivery of non-surgical cardiology care for children in local hospitals was inconsistent; strong leadership was thought to be required from surgical centers to develop expertise through regional and local networks
Increasing the national pool of surgeons was not considered the answer, as this would result in individual surgeons performing fewer surgical procedures and increase the risk of occasional surgical practice
The benefits of the proposed change were predicted to be as follows:-
Better results in the surgical centers with fewer deaths and complications following surgery
Better, more accessible diagnostic services and follow up treatment delivered within regional and local networks
Reduced waiting times and cancelled operations
Improved communication between parents and all of the services in the network that see their child
Better training for surgeons and their teams to ensure the sustainability of the service
A trained workforce expert in the care and treatment of children and young people with congenital heart disease
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