Joint lead solicitor to the 300 members of Bristol Heart Children Action Group at the Bristol Inquiry, instructed in over 100 litigation cases arising from Wisheart or Dhasmana operations at Bristol in the years 1982 – 1995
The lack of action in the face of all the media reports was extraordinary. Private Eye first exposed the huge problems at the unit in 1992 with the “the Killing Fields” and “Departure Lounge” headlines in 1992, 9 years before the Kennedy report. There were then no reports until 3 years later with Matthew Hill’s BBC Close Up West regional news programme in April 1995 and the Daily Telegraph “hospital took 6 years to act over baby deaths” report of 1 May 1995. These were followed by the seminal Channel 4 Dispatches documentary of 28 March 1996 and Bristol-born William Rees-Mogg’s lead article in The Times 1 April 1996 “Why did they allow so many to die?”
It was hard to believe that heart surgery had been allowed to continue at the unit in spite of the lurid headlines in the media and the concerns expressed by an experienced consultant anaesthetist after his arrival in 1988 and that it took so long for anything to be done.
Perhaps this went to the very heart of the problem. The public has or certainly at that time in the early 90s had supreme confidence and trust in doctors. Despite the publicity, parents of children about to undergo surgery in April 1995 believed what they were told when calling the hospital to find out what was happening after watching the BBC Bristol programme and accepted the reassurance “it’s only a problem with one type of operation.” Parents trusted the word of the doctors and surgeons at Bristol when they quoted – in what were invariably optimistic terms – the likely survival prospects before their children underwent surgery. They still believed them when told how very ill their child had been and how the surgery had been much more complicated than anticipated when informed that their child had died. They thought the surgical team had done its best and parents in turn believed they had done their best for their children.
Tragically, parents had not been given the truth. The concealment of the unit’s record and unwillingness to accept that children should be referred to alternative, safer units was motivated by a combination of surgical pride and jealousy and a fear that if patient numbers fell, which they inevitably would if parents had been given the truth, the unit would lose the £1 – 2 m additional annual funding it had been receiving since it became a supra-regional centre.
Apart from suspicions or sixth senses confirmed in hindsight no parent at the time of the operations had any inkling of the problems at the unit. What occurred amounted to a betrayal of trust not only by the surgeons but also by all those at Bristol and elsewhere who knew of the appalling death rates. The Bristol Scandal had the most far-reaching consequences for healthcare in this country and the families who suffered so grievously. Parents of a sick child in need of life-saving surgery had to deal with the cards they had been dealt. Bristol offered hope but in fact delivered worse.
What Bristol did show is that sitting on this kind of problem and allowing it to carry on – as all those who knew what was happening but prevented action being taken did – stores up problems that are going to get worse. These problems will unravel over many years and have the most far-reaching consequences not only for patients and their families but also for the entire health service and public confidence in our doctors. We must not forget the massive financial cost of these events and the litigation arising from it. We can’t afford another Bristol.
Against the background of the current, long overdue Safe & Sustainable review of paediatric cardiac services and proposals to reduce the numbers of units to create centres of excellence – a major recommendation of the Kennedy Report which was credited with achieving a sea-change in attitudes within the medical profession – I am worried that despite all the checks and balances that were supposed to be in place, another Bristol could still occur. There are reports now that certain units have been under-performing and that this state of affairs has existed for some time.
My concern is that the current Safe & Sustainable review of paediatric cardiac units was only recently able to require the suspension of operations at the John Radcliffe Hospital in Oxford over which there have been worrying issues on many levels since the time of the Kennedy report. If the 3 other units under scrutiny are known to have been producing adverse outcomes over a lengthy period of time – otherwise why would they be earmarked for closure – this is completely unacceptable and grossly unfair to the families who have placed their trust in these units in the past or whose children are still to undergo surgery.
There is still concern that a number of the crucial recommendations made by Sir Ian Kennedy in 2001 have at worst not been implemented and at best have taken an inordinate amount of time to be put into effect.
In October 2010 the Daily Telegraph reported that 76 babies may have died needlessly under the current regime at other units.
As with Bristol in the pre-GMC (1998) era, establishing the true position is difficult. If recent press reports are correct and the units now under scrutiny continue operating when the authorities know their results are inferior to comparable units then those with power to intervene should take stock and call a halt to high risk procedures at the very least, exactly as Bristol should have done in the early to mid 1990s. It was their insistence on continuing to operate in the face of appalling results that formed the basis of the GMC charges against the 2 surgeons and Dr Roylance at Bristol.
We know that expertise is overstretched in paediatric heart surgery but it is crucial that funds are available to see this programme through. Saving lives and creating safe conditions for surgical and medical teams to work together in the interests of protecting patients must be the priority. Otherwise this makes a mockery of the government’s aim and the central recommendation of the Kennedy report of placing the patient at the centre of everything in the NHS.
Although there have been great strides in the publication of mortality data for paediatric as well as adult cardiac units it is still not possible to establish the morbidity record of a unit – its non-fatal failures including cases in which children survive surgery but suffer brain damage and other injury as occurred at Bristol in the pre-1995/1996 era. These victims of the Bristol tragedy became the forgotten families who were left to look after injured children with little help from the State.
I first became involved in the BRI cases in 1996, before the GMC disciplinary hearings in 1998. Wisheart and Dhasmana had left and new surgeon Ash Pawade had been recruited from Melbourne turned the unit round. The unit had gained its rightful place among the best in the country: mortality rates were among lowest and morbidity as a result of surgery was as it should be – virtually non-existent.
I didn’t know of any parent who had seen the Private Eye stories in 1992. It was incredible that operations were still being carried out by the two surgeons after Matthew Hill’s BBC Close Up West regional news programme in April 1995 and the Daily Telegraph “hospital took 6 years to act over baby deaths” headline of 1 May 1995 coinciding with Ash Pawade’s arrival at the unit. Yet tragically families in Wales remained in the dark even after the Channel 4 Dispatches documentary in March 1996 because this was not screened in their region during the day.
After seeing TV and press coverage of the events many bereaved parents had written to the Trust’s new Chief Executive Hugh Ross to seek explanations. Was their child’s operation one that had gone wrong and could the other life of their child been saved if operated on as a safer unit? Did the concerns reported in the press only relate to the arterial switch? Which surgeon was the problem? Parents wanted to know if their child had died or suffered brain damage as a result of incompetence. They were desperate to know if they as parents could have done anything differently. Should they have asked more probing questions at the time?
Parents who came to me had accepted the explanations of the doctors when their children had lost their lives after undergoing surgery. They had believed them when told how very ill their child had been and how the operation had turned out to be much more complex than the surgeons had anticipated.
Parents had placed their trust and had complete faith in the two surgeons and cardiologists who had diagnosed their childrens’ conditions and had lined them up for their life-saving surgery. The written explanations they had received from the Trust afterwards were written in sympathetic, compassionate tones but as the new Chief Executive was relying on medical and surgical staff still at the hospital for his information, these letters were of little use and I do not recall any letter accepting that the surgeons or cardiologists had been to blame. In reality these were not complaints: parents were seeking information and explanations. It should not be left for lawyers to have to explain to grieving parents what really happened to their child but in many cases this was how they learned the truth. Patients often seek answers and many situations are not “complaint” territory. This emphasises the importance of a duty of candour to which I refer later.
In the cases where children had lost their lives, parents clung to the hope that their child’s operation was not one of those that had been carried out negligently. I had clients who were embarking on their cases on a quest to find the truth and in a complete departure from my normal experience, in many cases told me they hoped the experts we instructed to analyse the records of each operation would be unable to find any negligence. Parents of children who had survived surgery but suffered brain damage and other injury, and had significant care and other needs, on the other hand, were left with no alternative but to sue for compensation. They were to be offered no financial help unless they brought claims.
To investigate all the liability and consent issues we had to force the United Bristol Healthcare NHS Trust to produce internal documents and in September 1996 we secured a High Court pre-action discovery order. We returned to Court a year later after protracted argument and only limited compliance by the Trust. We were aware of the Bolsin data and the unit’s annual returns to the UK Cardiac Surgical Register but needed to establish the true morbidity as well as mortality record of the unit and who knew what and when within the hospital and the Trust. We knew, for example, the surgeons had maintained logs of all their operations. James Wisheart’s log was only released after he referred to it in his evidence to the GMC in 1998. No morbidity data was ever disclosed.
Professor Kennedy collected 900,000 pieces of evidence and heard or took written evidence from 577 witnesses covering the 12 year period coinciding with the years over which the unit enjoyed supra-regional status. Much of this material was published by the Inquiry and entered the public domain and could be used in the subsequent litigation. The Bristol Trust said they had not prepared an inventory of all the documents they provided to the Inquiry. Even now the Bristol Trust has not disclosed in the litigation documents that it made available to the Inquiry but which were not published and did therefore not enter the public domain.
We thought the GMC had been hasty in setting up its disciplinary investigation in 1998 ahead of what should have been a wide-ranging public inquiry. The GMC Preliminary Proceedings Committee (PPC) had decided that disciplinary charges would only be brought against James Wisheart, Janardan Dhasmana and Dr John Roylance, the Chief Executive of the Trust (a qualified doctor and therefore subject to the GMC disciplinary powers) and formulated the charges to be heard by the Professional Conduct Committee (PCC).
There was a suspicion that setting up the GMC’s imperfect investigation – the longest hearing they had ever held at that time into what was talked of even then as the biggest scandal to hit the NHS – was the only way of bringing the Wisheart-Dhasmana era to a close.
A number of families were concerned at the narrow remit of the GMC investigation and questioned why charges had not been brought against the cardiologists and anaesthetists at the unit who had worked alongside the two surgeons and would have been aware of the surgeons’ record. There was also concern that the surgeons had been charged in relation to their results for only one type of operation each, arterial switch and AV Canal, when it was known that their mortality rates were significantly higher than other units in a number of other operations including Fallot’s Tetralogy and Truncus Arteriosus. In fact for the Truncus Arteriosus operation 9 of the last 11 children under 12 months Mr Wisheart had operated on had died and both survivors sustained significant brain damage. Morbidity and the incidence of brain damage and other non-fatal injury in children undergoing surgery was not to be on the GMC’s agenda. This was unacceptable to those parents left to care for seriously disabled children.
We did all we could to challenge the actions of the GMC in restricting their investigation with this narrow remit and we applied to the High Court for a Judicial Review in the hope of compelling the GMC to widen the scope of the disciplinary investigation. I found a sympathetic barrister willing to share my desire to run this on a pro-bono basis after we were refused legal aid and failed in our appeal to the then Legal Aid Board. The 2 day High Court hearing at 11am of our application failed because we were unable to show that the GMC had acted unreasonably in framing the charges and limiting the scope of the hearing as it had done. The GMC hearing went ahead with its narrow remit and with the parents of brain damaged children feeling increasingly ignored and isolated. These “forgotten families” were less vocal in the parents’ action group and they felt marginalised by the GMC proceedings and the Public Inquiry.
The GMC ruling at the conclusion of the hearing was that all 3 doctors had been guilty of serious professional misconduct and Wisheart and Roylance should be struck off the medical register was never appealed by the Defendants.
Following our appointment as joint lead solicitors for the Bristol Heart Children Action group at the time of their campaign for a public inquiry we faced the difficult task of balancing the interests of a large group of families linked only by their innocent involvement in what turned out to be an appalling, avoidable tragedy. Parents of brain damaged children felt they had been ignored and this was not helped by the fact that the opening stages of the Inquiry were taken up by the issue of organ retention that had arisen on the eve of the hearings.
There was the added factor that the 80 – 100 members belonging to the Surgeons’ Support Group, many of whom attended the hearings, on occasions treated us with hostility.
Parents in the SSG were in total support of the surgeons who they believed had saved the lives of their children. I respected that view, obviously, but felt this showed a lack of sensitivity towards the unlucky families who were grieving for the children they had lost or who they were having to care for because they had sustained brain damage and other injury.
The NHSLA was unwilling to set up a no-fault compensation scheme in the wake of the Inquiry report published in July 2001. There was no alternative but to litigate claims. Large numbers of offers for £20,000 plus costs arrived from the Trust before and after the Inquiry hearings in settlement of fatal cases – without any explanation to the distraught parents or indication of why they had chosen to settle their cases but not others. The statutory bereavement payment for deaths before 1991 was limited to £7500 for each family, £10,000 post-1991. Unless parents could produce documented evidence of psychiatric injury resulting from the circumstances in which they had learned of the death of their child this was more than we stood to recover at trial.
We investigated whether the fact that the Trust stood to lose £1 – 2 m annual funding if it lost its status as a supra-regional centre and the way in which the true position at the unit has been concealed from patients and their families could be relied on to support claims for aggravated or exemplary damages (the equivalent of punitive damages in the US) but this proved difficult to pursue under the law as it currently stands.
Nothing was ever proposed by the Trust for parents caring for children who had survived surgery but sustained injury during Wisheart or Dhasmana operations.
Following publication of the report in July 2001 we wrote to the Trust in every case inviting them to admit liability so that we could resolve fatal claims and assess the care and other needs of children who had survived with injury and get interim funds to their families. The Trust declined.
The Trust’s line has always been that as custodians of public funds they had a duty to settle only those cases that were deemed (by them) to have merit. We knew from that point we would have to fight cases on their individual facts and investigate and obtain expert evidence in every case.
A number of parents had suffered severe psychological harm as a result of the death of their children and the circumstances by which they learned of the true position at Bristol. One set of parents lost 3 babies. Bert Loveday whose son Joshua had lost his life in the pivotal operation of January 1995, later committed suicide in prison after taking part in a robbery as his life disintegrated with the unfolding of events at Bristol. There were 2 more suicides linked to Bristol.
Offers of £20,000 to settle fatal cases came with costs sanctions if parents refused to accept within 21 days. Most felt unable to continue and accepted. Others fought on and agreed to attend psychiatric examinations. Apart from one case in which a child had survived with massive brain damage but died 5 years later the highest settlement we achieved in a fatal claim was for £100,000 plus costs. Although settlements of the fatal cases were all concluded within 2 or 3 years of the Inquiry report, latterly with admissions of liability and written apologies, parents of brain damaged children had to fight on. This was despite the fact that those negligent operations related to the very same surgeons who had been disciplined by the GMC and the same unit that had been severally censured in the Inquiry report.
Our approach in the ongoing brain damage cases was first, to obtain the medical records and then obtain expert opinion on those records and the parents’ accounts of the pre-operative conversations with the surgical and medical staff. We instructed experts in the fields of paediatric cardiac surgery, paediatric cardiology, anaesthesia/intensive care and paediatric neurology to advise on the liability and causation issues. The burden to prove negligence fell on each Claimant and we had to establish that the child’s neurological or other damage could have been avoided with the appropriate level of care to be expected of a specialist paediatric cardiac unit judged by the standards of the day.
We have relied in each case on the GMC and Inquiry findings to support our allegations of system and “corporate” failure. Despite the £15m cost to the tax payer and the finding that the service provided by the unit had been substandard over the entire period, with failures from top to bottom, and that patients had received surgery “on a number of criteria, less than adequate”, the Inquiry has been of surprisingly limited value in the litigation. The Trust argues that the Inquiry had made no case-specific findings of negligence and it had not been the Inquiry’s function to apportion blame or investigate individual cases.
In the early days of my involvement finding experts who had not been involved in the GMC proceedings or given evidence to the Public Inquiry or had connections with Bristol willing to take on these cases and prepare medico-legal reports proved difficult. The Bristol factor seemed to make them uncomfortable even after the public inquiry identified failings at all levels at the Trust. Many potential experts declined instructions because they knew one or other of the surgeons and I sensed a belief among other doctors that the 2 surgeons, particularly Mr Dhasmana, had been made scapegoats for the wider failings in the Trust.
The surgeons’ practice of quoting national rather than Bristol’s actual mortality data was a common feature of all of the cases and as a result, parents were deprived of the opportunity of securing treatment for their children at hospitals with a superior safety record. Such was the level of trust placed in the surgeons that grieving parents did not question why they had been quoted 80-90% survival rate before surgery or how the surgeons had arrived at this assessment.
The consent argument we advanced was that if parents had known how bad the results were at Bristol they would not have consented to these operations. Pointing to the superior safety record of other units at that time we maintain that on the balance of probabilities the risk of neurological damage would have been significantly lower and the child would not have suffered brain damage if operations had been carried out elsewhere.
This is an argument the NHS will risk facing now if they allow operations to continue at poorly performing units earmarked for closure under the current review.
In the post-Bristol era parents must be given a reasonable amount of information without prompting so they can understand the risk factors. They should be informed not only of the surgeon’s record in the procedure but also that of the unit and they should be made aware of how these compare with the national average.
Because of the way in which the GMC framed the disciplinary charges and how the GMC hearings were reported by the press the public believed that only 29 children had died during the Wisheart-Dhasmana era. The insistence of the press to report that up to 35 children had died as a consequence of care found by the Public Inquiry experts to be less than adequate over the period covered by the Inquiry was a major irritation to the families and this is still the statistic we read today when journalists refer to the Bristol scandal. In fact the true figure was much higher and we estimated that 170 children might have survived if operated on at other units.
We do not know the precise number of operations carried out at Bristol, or the number of deaths arising from those operations, over the years covered by the Inquiry. The most accurate figures had to be gleaned from the units’ returns to the UK Cardiac Surgical Register which showed that in the years 1985 to 1995 Bristol undertook 1322 open-heart operations with 179 deaths and a total of 2142 operations with the inclusion of closed-heart procedures and an overall figure of 224 for fatalities within one month of surgery.
Although a panel of eminent experts was appointed by the Inquiry the records of only 80 individual operations were scrutinised under their Clinical Case Note Review procedure. The inquiry’s statistical experts estimated the number of “excess deaths” at Bristol during 1991 to 1995 at 32.8 and 64.3 over the entire period examined by the inquiry. The CCNR extrapolated from the sample of cases 80 that of 1829 cases under consideration around 535 (29.3%) would have featured “less than adequate” care. It was concluded that in 101 of these cases (5.5%) care of a more acceptable standard “would reasonably be expected to have made a difference to outcome”.
BRAIN DAMAGE: THE LACK OF MORBIDITY DATA
The data examined under the Inquiry’s CCNR procedure ignored the incidence of brain damage, yet within the Action Group we knew of around 25 – 30 children who had survived surgery but suffered injury of some kind over the 13 years 82 – 95. There may have been more whose parents belonged to the 80 – 100 strong Surgeons’ Support Group at the Inquiry.
No figures have ever been produced by the Bristol Trust showing the incidence of brain damage and other serious non-fatal injury over the period. This was despite diligent efforts on my part and discovery applications against the Trust in October 1996 and October 1997 to compel them to disclose original data that either recorded the incidence of brain damage and neurological intervention or which enabled us to calculate the incidence. We knew this would have major implications for the consent arguments that we were running.
The parents struggling to look after children who had suffered brain damage and other disability after undergoing surgery carried out by Wisheart or Dhasmana became the forgotten families. There were to be no offers to settle these claims. The brutal fact is that whereas fatal cases can be bought off cheaply by a Defendant, brain damage cases are expensive to settle because of the injury to the child and the child’s continuing care and other needs
To give an idea of the numbers involved, the legal team represented in round terms 300 parents from 150 families belonging to the Bristol Heart Children Action Group at the Inquiry and approximately 30 of those families (10% of the whole) consisted of parents of children who had survived surgery but had suffered a variety of injuries, mainly neurological. The injuries from the estimated 25-30 children ranged at one end of the scale from catastrophic brain damage in which children needed round-the-clock care for the rest of their lives to those whose neurological injury was more subtle, producing learning difficulties, behavioural and psychological problems including loss of inhibition which combined to produce devastating long-term consequences for the child and his family.
Inexplicably – but this can only have been motivated by the fear that parents would take their children to other, safer hospitals if they were given the true position – parents were invariably given survival rates that were hopelessly optimistic and which clearly were not going to be achieved at Bristol. Parents were given no information at all in relation to the risk of brain damage.
The incidence of brain damage during this period and right up to the present has always been a major issue for me. If a member of my family required cardiac surgery I would certainly want to know a unit’s morbidity as well as it’s mortality rates.
It is clear from the literature that brain damage can occur in the best units and with the best surgeons, even if the most meticulous steps are taken to avoid it. The literature is clear that total circulatory arrest when the body is cooled, the heart stopped and the child put on bypass to conduct open heart cardiac surgery, involves a risk of neurological injury. Neurological damage can be a major and often disabling complication of paediatric heart surgery or of the underlying congenital heart condition itself. We couldn’t pretend otherwise but neither can the Trust argue plausibly with all of the evidence against them from the GMC and the findings and evidence heard by the public inquiry that children at Bristol who have suffered brain damage fall into this non-negligent category.
An inevitable consequence of sitting on a problem like this and failing to act is that every patient who has suffered an adverse outcome will be convinced this resulted from negligence. Why should parents accept the word of the Bristol Trust when their former Chief Executive Dr John Roylance was struck off by the GMC for failing to intervene and, effectively, turning a blind eye to the surgeons’ incompetence? James Wisheart was Medical Director of the Trust as well as the leading cardiac surgeon so he must have known what was going on. The Trust, in this situation, is going to find it difficult to defend itself even if it convinced itself that the medical or surgical team were not negligent on a particular occasion. Settling and admitting liability in swathes of cases where children have died in operations involving the same surgeons committing the same errors in the same operations creates a credibility problem for the Trust in defending the brain damage cases.
Our investigations show that the “non-negligent” incidence of neurological damage runs at about (if not significantly less than) 1% and when it does occur, say, as a consequence of the time spent on bypass, the damage will tend to be of a subtle nature. Parents should be warned of this risk but even if it does materialise they need to feel reassured that this is an unavoidable hazard of a highly complex surgical procedure.
The collection of meaningful data at Bristol over the 11 year period 1984 to 1995 covered by the public inquiry was inadequate, making it difficult to establish the true position, and at worst, enabling the unit to conceal its adverse record. Any child who survived for 30 days post-surgery counted as a statistical success. We tried to force the Bristol Trust to disclose their rates for the incidence of brain damage and other injury but this information was never made available and they were unable to disclose, for example, a log of occasions when paediatric neurologists were called in from Bristol Children’s Hospital or Frenchay.
The literature suggests that where there is a high mortality rate more complications occur and the incidence of brain damage and other non-fatal injury will also be high. The fact that we knew of up to 25 or 30 families caring for such children suggests that morbidity rates at Bristol were dangerously high over this period and beyond all limits that would be acceptable at other centres. The fact that this crucial information was not given to parents when they were asked to consent to their children undergoing surgery was a serious failure of the Bristol unit. Although not tested in court, because only one brain damage case (involving surgery in 1985/86) has been taken to trial, we allege in these cases that operating on a child after concealing this information, depriving parents of the choice of whether or not to proceed with surgery or to proceed at another hospital with a superior safety record, amounts to the tort of battery for which damages can be claimed.
Although cardiac units have led the field in publishing mortality rates in the post-Bristol era there is still no consistent reporting of morbidity (non-fatal failure) rates. Other than cardiology assessments and treatment in the intervening years neurological follow up for any of these patients seems to have been non-existent. Other than the Royal Brompton who have made strides in the collection of morbidity data despite all the technical difficulties little is known of the procedures at other units and I am not sure of current practice nationally. I don’t see how there can be meaningful monitoring of outcomes if the progress of these children is not tracked. If as was reported in January 2006 the Brompton has had a formal protocol for reporting and investigating neurological injury in place for some years, so early clinical signs of possible neurological damage are subject to much fuller investigation, why can’t this practice be adopted elsewhere?
THE CURRENT SAFE AND SUSTAINABLE REVIEW OF PAEDIATRIC CARDIAC SERVICES
The drive to concentrate expertise nationally and create centres of excellence for this complex, and high risk specialism was a major recommendation of the Kennedy report in 2001. All the experts have supported the proposals to reduce the numbers of paediatric cardiac units but 10 years on it is difficult to see why the current Safe and Sustainable review has taken such a very long time to reach its current point.
Both surgeons at Bristol, Mr Wisheart and Mr Dhasmana, had undertaken adult as well as paediatric cardiac surgery from a split site. The need for these operations to be carried out in the future by teams rather than individuals was to be fundamental.
In the wake of the Kennedy report a review group headed by the President of the Society of Cardiac Surgeons recommended that paediatric cardiac units should be performing a minimum of 300 operations annually. If implemented, concerns were expressed that this would result in half the units nationally closing because they did not meet these criteria.
In December 2003, 2 years post-Kennedy, the National Review of Paediatric Cardiac Services, set up in January 2001 to consider the findings of the inquiries into cardiac services at the Royal Brompton as well as Bristol, found that all units were providing a high standard of care but recommended publication of annual data on survival rates and highlighted the need for a quality service where “clinical practice should be evaluated in a systematic way, ensuring that key lessons are identified and disseminated, and that clear and supportive lines of accountability are in place”.
In 2007 The Royal College of Surgeons called for fewer but larger centres – the centres of excellence idea.
In 2008 Professor Sir Bruce Keogh NHS Medical Director initiated the current S&S review.
In 2010 the S&S steering group proposed new national standards by which 400 operations annually would be a mandatory requirement and 500 the recommended level for each unit that survived a cull of the existing 11 centres across the country (10 after Oxford is taken out of the picture). They regarded the 31 current paediatric cardiac surgeons as a sufficient number to provide the right level of service nationally but felt they were spread too thinly over too many units. Specialist units in the future should have a minimum 4 specialist paediatric cardiac surgeons working together.
Dr Leslie Hamilton, a former paediatric cardiac surgery, told Channel 4 News at the time that experts across the country were in consensus that the size of units needed to be revised. “Everyone is in agreement that we will be able to provide a better quality of care and a sustainable care through to the future if we have bigger units,” he said. “There is a professional consensus on that. We’ve kept the politicians informed and I know the politicians are supportive of the review process.
“The current national review that’s being undertaken by the national specialist commissioning group has come up with standards of a minimum of four surgeons with 400 but preferably 500 operations in a team in larger centres and that would equate to about five to seven centres in England and Wales.”
Dr Hamilton said the minimum would “provide cover sickness, for holidays for sustainability, in terms of planning the next generations of surgeons, mentoring – all sorts of reasons. We feel four is the minimum number of provide service 24 hours a day seven days a week”.
The current review is long overdue, if not dangerously late. The proposals to reduce the number of units from 11 to 7 or 8 announced in February have been put out to public consultation. Units earmarked for closure include those at Leicester Leeds and the Brompton, the latter proposal reflecting the stated intention to have 2 rather than 3 units in London. With the proposals now mired in political controversy and Brompton’s judicial review pending and challenges expected from other units it could be 2013 before the Kennedy recommendations are implemented.
With echoes of the time it took for the Bristol events to unravel before the GMC finally intervened in 1998 – if the data on which the headline is based is correct and has been interpreted correctly – the Daily Telegraph report of 19 September 2010 on the “76 needless child deaths at heart units” adds to the concern that despite all the checks and balances that were supposed to be in place, another Bristol could occur – if it has not already.
My concern is that the review has only recently been in a position to require the suspension of operations at the John Radcliffe Hospital in Oxford over which there have been concerns since the time of the Bristol Inquiry. If the 3 other units earmarked for closure are known to have been producing adverse outcomes over a lengthy period of time, this is unacceptable and grossly unfair to the families who have placed their trust in these units.
From what I am sure have been genuine patient safety considerations on the part of those involved in the review and the need to avoid another Bristol – with the cost in human lives and the financial cost to the NHS of claims for compensation – the debate has now entered the political arena. MPs and doctors don’t want to see their local units close. Neither do many of their constituents but do they really understand the issues involved? Saving lives and giving children with life threatening conditions the best possible chance of survival at a centre of excellence must over-ride the otherwise understandable desire to have a unit serving the local area. The surgical treatment of congenital heart disease in babies and young children is such a rapidly developing science that surgeons must be constantly evaluating their own performance and keeping themselves up to date with new procedures and techniques. In this field, what is acceptable practice one year can become outdated the next. Local factors must not be allowed to outweigh patient safety.
The results have to be scrutinised in the light of the disclosures published in the Telegraph but with the difficulty of meeting the Review’s criteria it would surely be wrong to close any unit that delivers safe care. I am no politician but so what if London runs 3 rather than 2 specialist high-performing units? Parents will go anywhere if it gives their child the best chance of survival.
Failing to act and close units despite known failings, if indeed there are found to be failings, is going to store up problems. As well as the danger to patients presented by any hiatus in care there will be an obvious litigation risk to the NHS and cost to the taxpayer potentially much greater than the cost of closing units and rationalising the service.
Patients and their families need to know the true position even if this can be difficult to establish or understand. Trusts with units earmarked for closure will cling to their status. The fear is that bad results will be obscured by the kind of arguments we saw at Bristol in the Wisheart/Dhasmana era – that data has not been categorised correctly according to types of operation or not properly risk adjusted and does not reflect the mix of cases at each unit.
The Difficult Task of Establishing the Results of a Unit
As occurred with Bristol in the 90s there is still a problem of conflicting information on the units over which there are concerns and getting to the bottom of whether a unit is performing as it should
Oxford is a case in point. Paediatric cardiac surgery remains suspended at John Radcliffe Hospital, following an NHS inquiry in 2010 into four deaths in 10 weeks, including Nathalie Lo, who died at 23 days in November 2009 following surgery. In July 2010, the inquiry said there was no evidence of surgical failings in the particular case and did not suggest “any immediate safety concerns” but criticised the way the small unit was run, and said surgery should not be allowed to continue unless major changes were made to the unit. The inquiry said the figures showed improvement in the last two years of the period examined, from 2006 to 2008, The inquest into Nathalie Lo’s death could find no evidence that she had died because of her surgery – which, the inquest heard, was assessed by her cardiologist as having a 95 % prospect of survival. The other three deaths will not be subject to inquests.
The unit at Oxford has been under scrutiny and subject to a number of investigations ever since the Bristol Public Inquiry. There must be a reason why the review has recommended that no more paediatric cardiac surgery should be carried out at the hospital, concluding it was the least likely out of 11 centres in England to meet new quality standards.
The same NHS inquiry looked at the performance of the 10 other units in England.
The study was carried out by Professor David Spiegelhalter, from the University of Cambridge, who led the statistics team at the Bristol Inquiry. The findings were announced for John Radcliffe but not for the other 10 units. Professor Spiegelhalter has highlighted the difficulty of comparing mortality rates amongst children undergoing heart surgery at different hospitals and the need to look very carefully at the data and case mix for any hospital that appears to be a statistical outlier in risk terms. He analysed the number of deaths found to be above the norm for each procedure, and he then pooled the figures to show the number of excess deaths and death rates at each unit.
He said hospitals should probe the results carefully: “These are alerts, they raise questions. The trusts need to undertake further investigation to establish the reasons why.”
Professor Spiegelhalter’s research found that death rates were highest at the Glenfield Leicester with 65% more deaths than expected, then the John Radcliffe, Oxford with 50% “excess” deaths over the period 2000 – 2008, and Leeds General Infirmary 43% and Guy’s & St Thomas 29%.
These results are deeply disturbing particularly if the units with excess mortality have been able to continue without proper supervision. Some of the figures are so out of kilter compared to “the expected” that you have to ask how these hospitals involved have been allowed to continue and why this was not picked up earlier and made public. I would encourage the review to act swiftly if children are not to be exposed to an increased risk of death or injury if they are to undergo surgery in a unit earmarked for closure.
We know Professor Spiegelhalter urges caution over these figures. He warns that focussing on mortality rates does not give the full picture and that the term excess deaths is a blunt instrument and can be misunderstood; because congenital heart defects vary so greatly, calculating the expected risk is an imperfect art.
Leeds admitted to the press that they had encountered a problem in one type of operation Fallots Tetralogy in which their mortality was 5 times higher than other units.
The Oxford findings were published but the findings relating to the other 10 units were not released until the Sunday Telegraph obtained them through the Freedom of Information Act.
My take on this is that relying on mortality rates gives only part of the picture. What is crucial to ensure that the best standards are to be maintained is for procedures to be in place to identify poor surgical performance and detect deteriorating performance at an early stage. Measures can then be taken to address deficiencies before results fall outside acceptable limits and patients are exposed to increased risk.
THE FUTURE AND NEED FOR WHISTLEBLOWERS TO BE PROTECTED
Professor Kennedy in his Learning from Bristol report wanted to see the patient at the centre of everything in the NHS. Everybody hoped that lessons had actually been learned. His report has been credited with bringing about a sea-change in attitudes, putting an end to the club culture in the NHS. The concept of clinical governance emerged from Bristol and made way for a more transparent and accountable health service in which patients were to be partners in the decision-making process with doctors surrendering their dominance and becoming team players. Standards for clinical and hospital practice were to be set and monitored, and surgical outcomes published, with the aim of improving safety and standards of care. We were to get away from the old blame culture and doctors were to be free to identify shortcomings in their colleagues and admit to their own failings without fear of recrimination or reprisal as had been the case with Dr Steve Bolsin
What happened to Dr Bolsin is well known. The experience of Helen Stratton shows how stress can be placed on colleagues if action is not taken to address failings.
Helen Stratton the nursing support specialist whose job was to counsel parents about the surgery faced by their babies told the Inquiry how she felt powerless to blow the whistle over the unit’s high mortality rates. She said: “At times I felt I wanted to say to parents: ‘Let’s go back upstairs and go back to your GP and discuss going somewhere else…. I wanted to pick the baby up and run out, but I would never have done that” She told the Inquiry that she found James Wisheart “dismissive and patronising” of her job and she felt Janardan Dhasmana would take any expression of concern as a criticism.
The Joint Commission International report of 2008 commissioned by former health minister Lord Darzi to look into hospitals where poor standards of care had been exposed by external auditors found a ‘pervasive culture of which meant managers were sometimes afraid of disclosing details of poor performance and that regulation was ‘light-handed’. The report suggested more deaths might be prevented if a system of regulation that involved doctors reporting errors was used.
The principles of the Hippocratic Oath are often referred to as the first statement of a moral code of conduct for the medical profession. There is still widespread under-reporting of adverse errors
In order that doctors and surgeons can learn from their mistakes it is imperative for hospitals to have a robust reporting structure in place. Doctors must be assisted in dealing with the personal factors and stress that may otherwise prevent or discourage them from reporting failings.
We didn’t know at the time of the Bristol events and the public inquiry what form the changes we wanted to see introduced in the wake of the Inquiry would take. The parents were desperate to see that there would never be another Bristol. They did not wish to see a proliferation of managers and a further tier of administrators who may not understand the surgeons and medical staff who work in their units and what makes them tick.
I suspect most parents don’t want to be looking at mortality or morbidity data when their baby needs urgent life-saving surgery. They need to know they can trust their doctor or surgeon. Although having practised in this field for nearly 30 years I only see those cases where things have gone wrong for the patient I still think most of our doctors do a brilliant job. We need them to be able to do their job of treating us and saving lives but scandals like Bristol and more recently Mid Staffs abuse our trust
We can’t afford another Bristol, not just financially but in terms of deaths that might have been avoided, the wrecked lives and the damage to the lack of trust we hold in our doctors.
Published comparisons of the performance of different hospitals or surgeons are likely to remain of limited value, even with the best possible use of the available data relating to risk factors. There is no doubt that league tables based on mortality rates are simplistic and a blunt instrument for measuring quality. But this is the only system no one has come up with anything better
We know that publishing patient outcome data saves lives. But there seems to be a resistance to using hospital standardised mortality rates – as occurs in other countries – so that hospitals can improve their performance and lives can be saved.
We need a system in which a formal inquiry is needed if a unit’s death rates rise above certain control limits. The chances of the next patient surviving surgery should be calculated using the surgeon’s most recent results
The need for truth and integrity is the cornerstone of the relationship of trust and confidence between their doctor and patient
I doubt that any insurance company would have tolerated a Bristol situation continuing. It may be that the different way in which NHS Trusts is in indemnified against negligence claims makes it difficult to address this kind of problem. I am certainly not making a case for outsourcing paediatric cardiac care but if this had occurred in the insured private sector the Trust at Bristol would have faced a significant loading on its premiums or it might have discovered that insurance could not be obtained at all.
NEED FOR A DUTY OF CANDOUR
In the wake of the Bristol scandal and Public Inquiry the Chief Medical Officer demanded that doctors should admit to patients when an error in their surgery had occurred. I still have my doubts that this happens in every case. Instead, the patient is left to discover it for himself and then turn to the law to try and put it right.
So it becomes essential that a duty of candour should be expected of doctors and hospitals, to insist that they report untoward events. The duty of doctors to blow the whistle on the failings and incompetence of colleagues – with proper legal safeguards to protect them from dismissal or victimisation if they have cause to take action – should be part of this overall obligation. Otherwise any talk of placing the patient at the heart of everything the NHS does is nonsense.
The recent report from the Society for Cardiothoracic Surgery suggests that surgeons are still burying their mistakes. The authors argue that surgeons have resisted the introduction of measures to detect substandard practice among their colleagues through a “misplaced sense of collegiality” and that the lives of patients are being endangered as a result. This is depressingly familiar. The Bristol Inquiry had concluded ten years earlier that surgeons had closed ranks to protect their own colleagues. It would seem that not a great deal has changed over the past decade.
So what is the way forward? The Government argues that greater transparency – making more data available on the performance of individual surgeons – is the solution. This is sensible. Since the 2001 Bristol inquiry, the death rates for individual surgeons have been published and a traffic light system set up to highlight those with a high patient death rate. According to the Society’s report, there has been a 50% improvement in the overall risk-adjusted death rate for cardiac surgery. Professor David Taggart, president of the Society of Cardiothoracic Surgery, argued “nothing stimulates change like clear comparable and publicly accessible evidence”.
Caution is often expressed over the publication of mortality rates because of the fear that it might deter surgeons from taking on riskier patients. But as the report points out, there is no systematic evidence of patients being discriminated against in this way.
While greater transparency has to be regarded, it is not sufficient to solve the problem of surgeons closing ranks and resisting change. There is still evidence of a “club culture” within the medical profession which seems to tolerate poor practice from a minority through misguided sense of loyalty. It is crucial for doctors to know that they will have legal protection if they blow the whistle on substandard practices and performance by their colleagues. The limited protection afforded by the Public Interest Disclosure Act 1998 to whistleblowers who make ‘protected disclosures’ needs to be re- examined.