Ten months to the day that the Bristol Royal Infirmary inquiry heard its first witness, Tracey Clarke, talk about the death of her daughter Melissa, its oral evidence sessions are drawing to a close. From tomorrow, its high-tech hearing rooms will close to the public and staff will prepare for phase two.
A more complex picture has built up than emerged from the General Medical Council investigation 18 months ago, which led to two doctors being struck off and one disciplined.
Then, there was anguished speculation about how operations that killed small babies could have been allowed to go on for so long. Now a key question is how Bristol could have been chosen as a specialist centre for such operations in the first place (see box, above).
Bristol Royal Infirmary emerges from the oral sessions as an institution under pressure. Trust finance director Graham Nix described a constant battle to meet demand for cardiac surgery, in which adult cases dominated. In 1982, it was agreed to increase the total number of open-heart cases from 275 to 600, with regional funding.
But despite substantial investment, long waiting lists remained. This did little to increase referrals to Bristol, leading to fears that the city would have to shoulder a disproportionate share of the cost of expanding its service while receiving almost no growth money.
The 600 operations target was not achieved until 1990. Regional demand was then 1,400 operations a year and the infirmary was operating at full capacity.
It faced a problem with paediatric heart surgery cases blocking intensive care beds until they could be transferred 'up the hill' to the Bristol Children's Hospital.
In the end, it was demand for yet more adult cardiac operations that ended split-site working.
Against this background, a cardiac surgery working party in 1989 found that waiting lists for priority paediatric cases were four to five months. The optimum period would have been four to six weeks. It also found that clinicians were working excessive hours.
And the split site caused constant worries. The inquiry heard concerns about the quality of nursing for children at the infirmary. Children had to be transferred 'up the hill' within days of surgery. A nurse noted against one case: 'Arrived unannounced as usual.'
Despite the vast resources at its disposal - it will cost about£15m - the inquiry has not come up with an exact figure for how many of the babies could have been saved.
A group of experts trawled data sources in search of an answer, but their preliminary report came no closer than saying there were between 30 and 35 'excess deaths' out of almost 70, depending on the source and comparison used.
But a review of 80 casenotes selected from 1,800 children who had open or closed-heart surgery at the hospital over 12 years showed that 'where the care was less than adequate, surgery does not figure very highly'.
Delays were identified in 21 cases examined. 'Less than adequate' postoperative care was identified after 19 procedures.
Even the case of Melissa Clarke makes the point. She suffered respiratory failure in intensive care after 'mechanical problems in ventilation' meant 'satisfactory oxygenation' was only achieved 'after several hours'.
Nevertheless, the statistical analysis shows that Bristol had much worse results in three operations - to correct atrial ventricular septal defects, atrial septal defects, and the transposition of the great arteries (switch operations).
So who did know?
Trust chief executive Dr John Roylance admitted in the early weeks of the inquiry that even in 1995 audit was 'non-existent'. Concerns would thus have to reach managers by other routes.
The 13 clinical directorates had substantial freedom, and Dr Roylance insisted repeatedly that managers could not judge clinicians.
Witnesses, including Rachel Ferris, general manager of cardiac services for 10 years, said a 'culture of fear' pervaded the organisation, even though Dr Roylance insisted he spent most of his time 'talking to people'.
Current chief executive Hugh Ross said an organisation designed to respond as quickly as possible to concerns 'probably would not' look like United Bristol Healthcare trust 'several years ago'.
Whistleblower Dr Stephen Bolsin started collecting data about operations at the start of the 1990s and showed his figures to a number of colleagues.
Professor John Vann Jones said he saw the figures in late 1993, shortly after he became clinical director of cardiac services. He said he spotted clear flaws in one set of data, but there was a 'diffusion' of information around the hospital until, by 1994, 'debate was everywhere'.
He insisted it would not have been appropriate for him to stop medical director James Wisheart or surgeon Janardan Dhasmana operating. He said former chief executive Dr John Roylance could have set up an investigation.
But he and other clinicians could not say for certain that Dr Roylance knew about the problems.
Dr Bolsin said he wrote to Dr Roylance in 1990 about trust status and mortality rates in paediatric cardiac surgery. Dr Roylance said he did not investigate death rates because 'we were discussing trust status, not figures within paediatric cardiac surgery'.
Dr Bolsin also told the inquiry that 'flak' over the letter from Mr Wisheart and Dean Hart, chair of the hospital's medical committee, meant he never gave his data to the surgeons or Dr Roylance. Mr Hart and Mr Wisheart said they did not remember these meetings.
Outside the hospital, witnesses divided about who was responsible for picking up concerns. Dr Norman Pryde Halliday, former medical secretary of the supra-regional services advisory group, said it was clearly not that group. Before the Conservatives' NHS reforms, he said, responsibility lay with health authorities.
After the reforms there was 'some ambiguity', but responsibility probably lay with the Department of Health unit in charge of trusts. The services advisory group, Dr Halliday said, was simply a funding mechanism.
But Sir Kenneth Calman, former chief medical officer for England, said responsibility did lie with the advisory group. So did Catherine Hawkins, former regional general manger of South West regional HA, who described Bristol as a 'rumbling appendix', but said she never had enough evidence to act.
The advisory group itself had no mechanism for collecting outcome data. Dr Halliday said it took advice from medical royal colleges and the Society for Cardiothoracic Surgeons, which kept a register and 'would know what was happening'.
He denied strongly that Sir Terence English, former president of the Royal College of Surgeons, had warned him in 1992 that outcomes at Bristol were so poor it should be de-designated.
He acknowledged that Sir Terence had asked for a report on all the centres to be withdrawn, ahead of a services advisory group meeting that decided to de-designate all UK neonatal and infant cardiac services because of a proliferation of units doing the operations. But he said Sir Terence never said why, and he had 'more than enough to do than to be asking Sir Terence to explain his very unusual behaviour'.
On 19 July 1994, Peter Doyle, a senior medical officer at the DoH, attended a meeting in Bristol and on a taxi-ride back to the station was handed a sealed enve lope by Dr Bolsin .
He did not open it, but wrote to professor of cardiothoracic surgery Gianni Angelini saying the concerns should be investigated.
He received an unprompted letter from Dr Roylance confirming 'the trust board's awareness of this problem'. But Dr Roylance said he only wrote to prompt the DoH to deal with him directly.
He said he assumed that the 'particular surgical procedure' referred to by Dr Doyle was the neonatal switch, which had ceased the previous October.
A pledge to monitor the situation meant ensuring promises to appoint a paediatric cardiac specialist and end split-site working were kept. He did not talk to Professor Angelini - which might have clarified whether any other problems were be ing referred to.
In the end, the turmoil in Bristol came to a head over the decision to perform a switch operation on an older baby, Joshua Loveday.
Clinicians met to debate the issue the evening before the operation, while Dr Bolsin and Professor Angelini contacted Dr Doyle, who spoke to Dr Roylance about it.
Asked whether he was given unambiguous advice to stop the operation, and whether he could have done so, Dr Roylance said he could have suspended a consultant but did not believe he had the authority to interfere in clinical judgements. In addition, he said it was 'made clear' to him that the operation was urgent.
Joshua Loveday subsequently died.
And Dr Doyle stepped in to arrange an independent inquiry.
Sir Graham Hart, director of operations at the NHS management board from 1985 to 1989 and then permanent secretary at the DoH from 1992 to 1997, said the department and the health secretary could 'never, as it were, sit at the centre of the web and monitor in detail exactly what is going on'.
The 'mainstay' of quality would have to be 'the doctors - and the professional staff who work with them' and 'the trusts and so forth'. There was a 'shared respons ib i l ity ' .
This prompted a furious response from a member of the public, who shouted: 'What you are saying is, it is not you.'
Inquiry chair Professor Ian Kennedy was more elegant. 'One of the features of our taking evidence is that no matter whom we have spoken to. . . they have always found someone else to be responsible.
'Hearing from you on the point of view of the department, saying 'ultimately it is back to the doctor', has effectively squared the circle of our difficulty.'
The second phase
The Bristol Royal Infirmary inquiry will move into its second phase in the new year, examining issues that will allow it to meet its remit to 'make recommendations which could help to secure high-quality care across the NHS'. As a first step, three seminars are planned, two dealing with management issues - 'the factors which determine the performance of organisations' and 'professional and managerial cultures and their impact on quality of service'. Both will be in London, the first in January and the second a month later, and will be open to the public. Phase two will be completed by April, with an inquiry report expected next autumn.
www.bristol-inquiry.org.uk
Why was Bristol chosen as a specialist centre?
Dr Norman Pryde Halliday, former medical secretary of the supra-regional services advisory group, told the inquiry in April that nine centres were designated for neonatal and infant cardiac surgery in 1984. Bristol was one, though it only performed three such operations that year. Its claim was essentially 'geographical'.
The services advisory group hoped referrals would increase, leading to better outcomes. But cases continued to go to London and other centres, while Wales lobbied for its own unit.
Dr Halliday said he could not tell why referrals did not pick up, but insisted he never heard that the problem was poor outcomes.
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