Annex A > Chapter 30 - Concerns 1995 and after > Concerns 1995 > February
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February
94 Dr Doyle wrote to Dr Roylance on 3 February 1995:
`... I and my colleagues are content for the Trust to act in the way agreed during our recent telephone conversation based on the advice offered by the President of the British Cardiac Society. It was agreed that at least two, and preferably three, outside advisors should be invited to look into the situation and offer advice. I was pleased to hear [that] Marc de Leval has already agreed to help.' [107]
95 Rachel Ferris, General Manager of the Directorate of Cardiothoracic Services at the BRI from 1994, stated in her written evidence to the Inquiry:
`My impression in late 1994 early 1995 was that the Chief Executive, ... Dr John Roylance responded dismissively to the concerns raised with him. He appeared to protect Mr Wisheart, even to the extent of allowing him to organise the Marc de Leval visit himself which I believe was inappropriate.' [108]
96 Professor Angelini in his written evidence to the Inquiry stated:
`... this culture of keeping everything under control remained, and Mr Wisheart was, I believe, put in charge of organising the external enquiry on his own practice.' [109]
97 Dr Roylance, when asked by Counsel to the Inquiry who organised the visit, told the Inquiry:
`Primarily, the visitors. I gave them full authority to ask for anything and guaranteed the Trust would provide them. I sent them off, I am fairly sure, with this manager as a sort of guide so they did not get lost.' [110]
98 Mr Wisheart stated that his part in the inquiry was:
`... limited to the initial approach to Mr de Leval and Dr Hunter, acting on the advice of the President of the British Cardiac Society ... Mrs Ferris ... describes how she arranged the venue, the programme and the people who should attend ... .' [111]
99 Mrs Ferris was responsible for making the logistical arrangements necessary for Professor de Leval and Dr Hunter to visit Bristol. She told the Inquiry that `... it was all arranged in a rush.' [112]
100 Mr McKinlay, Chairman, UBHT, from July 1994 to November 1996, commented on the arrangements for the conduct of the review in the following exchange:
`I actually thought at the time there would be a button you could press in the National Health Service which was marked "investigation" and the procedures would follow and I thought that something fairly normal would be put in place. I did not interfere with how the inquiry would be set up.
`Q. You thought that somewhere in the Health Service there would be an investigative unit, something of that sort?
`A. Not necessarily an investigative unit. I think I knew enough then that that was possibly unlikely. But there would be an accepted procedure.' [113]
101 Dr Hunter and Professor de Leval spent one day visiting Bristol. Professor de Leval stated:
`We were urged to visit UBHT as soon as possible and to issue a report without delay. I made it clear that I had booked one week's holiday from 11.2.95 and that if the visit to UBHT had to take place before I went away I could come only on 10.2.95. This was found to be acceptable.' [114]
102 Dr Hunter told the Inquiry:
`... basically if we were going to be able to do anything significant in the time which we were being given ... it is a continuing problem that I have just been through in another centre recently, where you are asked for very important decisions and to do very detailed examination of facts in a very short time. I think the sort of gun that was pointed at our heads was that it was critical and crucial to know whether the surgery should continue, or whether the decision had to be made that it should be referred elsewhere before Mr Pawade arrived.' [115]
103 The experts' remit was recorded in the first version of their report as follows:
`To advise the Trust on the best action to take following recent recommendations received by the Department of Health to stop complex neonatal and infant open-heart surgery.
`To make recommendations on the future of the paediatric cardiac services in the Trust.' [116]
104 In the second version of the report, the reference to the DoH's recommendations was omitted. In this version of the report, the remit of the review was expressed as:
`To advise the Trust on the best action to take to resolve conflicting professional advice in the field of paediatric cardiac surgery in general and, in particular, complex neonatal and infant open-heart surgery'. [117]
105 Dr Hunter's contemporaneous notes of the visit recorded that:
`Dr Roylance offered carte blanche in the investigation and stated his concerns about the service and also about professional loyalty in some members of staff involved in the dispute.' [118]
He told the Inquiry that Dr Roylance `... was very general in saying he wanted us to have free access to whatever information we wished ... .' [119]
106 Dr Roylance, in his written evidence to the Inquiry, stated that he `... wanted Mr de Leval and Dr Hunter to be completely frank (and blunt, if necessary) in their report ... .' [120]
107 Dr Roylance told the Inquiry that when speaking to Dr Hunter and Professor de Leval at the outset, he told them that there were:
`... three things [he needed] to know: first of all, is it right that the appointment of the paediatric cardiac surgeon is a proper solution to the problem? ... Secondly, is moving up the hill [to the BRHSC] proper? Thirdly, what should the Trust, the service, do between the time of them reporting and the arrival of Ash Pawade?' [121]
108 Professor de Leval recalled Dr Roylance's alluding to:
`... the difficulty of Mr Wisheart's position being on the one hand investigated in this particular problem, and at the same time, being Medical Director. ... He explained to us that there had been complaints about the results of cardiac surgery and that he wanted to have an outside opinion ... and asked again that [the] report be issued with the shortest possible delay ... .' [122]
109 Mrs Ferris stated that she accompanied Professor de Leval around the Trust on the day of his visit. She stated that Professor de Leval took the opportunity of asking her whether she thought there were any problems with paediatric cardiac surgery, to which she replied that she did not think so. She was asked about this reply by Counsel to the Inquiry:
`Q. ... did you think there were any problems with paediatric cardiac surgery as at 10th February 1995?
`A. I really think my answer at that stage would be, "I do not really know, but perhaps possibly I think there may be something to this". That was the view I was starting to form, and really around that visit, so when I said "No, I do not think so", I was not being absolutely straight with him.
`Q. If in fact you thought that the true answer was, "I do not really know but there might be", to say "I do not think so" gave a false impression to Mr de Leval of your true feeling?
`A. Yes, it did, and I obviously regret having given him the false impression. I was very worried that this had been presented to me as something that came about as a result of troublemaking and I think at the same sort of time, when I was advised about this, although we were having external advisers coming in, there was this sense that I had that this was something we did not want to be dealt with outside of the Trust.' [123]
110 Mrs Ferris also stated that she saw Dr Roylance on the day of the visit. She recalled that she:
`... walked over to Trust Headquarters with [him]. He made some comment that he "should not really have let James organise the day", but thought "it might be good for him". He gave the impression of treating the whole day very casually.' [124]
111 Dr Roylance denied making such a comment to Mrs Ferris:
`... that is quite wrong ... I would not have discussed, with her, the review ... . I certainly would not have said to her that it might be good for him.' [125]
112 Mrs Ferris in her written evidence to the Inquiry stated:
`I recall, probably towards the end of February [or] the beginning of March 1995 (but I cannot be precise about the date), Mr Wisheart asked me to come into his office, to discuss his figures. I felt intimidated by this request and during the meeting itself. Mr Wisheart gave the impression that he had heard I had been asking questions, and wanted to put me right. I could tell that Mr Wisheart was angry because he was so quiet and controlled. He spoke slowly. I felt I was being "warned off" and that Mr Wisheart felt I had no role in a discussion of clinical outcomes.' [126]
113 Mr Wisheart was questioned by Counsel to the Inquiry about the meeting in the following exchange:
`Q. ... Did a meeting to that effect happen?
`A. It may have done, I do not have a precise recollection of the details of such a meeting; I have a vague recollection that we had such a conversation, that is all.
`Q. Mrs Ferris gives a description here of you wanting to put her right and her description of your being angry because you were quiet and controlled and feeling that she had been warned off; do you recognise yourself in that?
`A. I was quite confused by that sentence, I was not really sure how much was fact, how much was interpretation and how much was accurate.' [127]
114 Dr Hunter and Professor de Leval stated that they met many of those involved in paediatric cardiac surgery for interview and discussion. They stated that the cardiac surgeons produced the detailed results of the neonatal Switch; and mortality data relating to closed-heart surgery during the period 1990 to March 1994 and, in respect of open-heart surgery, from January 1992 to January 1995. [128] Dr Bolsin stated in his written evidence to the Inquiry that, when he met them, he provided Dr Hunter and Professor de Leval with the `best evidence' he had, which included:
`1. The Bolsin/Black data collection and analysis.
`2. The most complete record for the arterial switch available.
`3. My data on neonatal and non-neonatal arterial switch record.
`4. The unit's data from the annual report of 1990-91.' [129]
115 Dr Hunter stated that the fact that two sets of data covering different periods of time were produced was confusing. [130]
116 Dr Bolsin stated in his written evidence to the Inquiry that he faced a `tirade of hostile questions' [131] from Professor de Leval in relation to the data he presented. He was asked about this in the following exchange:
`Q. You talk about a "tirade of hostile questions" from Mr de Leval?
`A. No, no, it was just this very early bit and when I went through my explanation that the bit that seemed to have got him worked up was actually not my data, that was data produced within the unit by Mr Wisheart, he suddenly changed, he changed his whole effect completely.' [132]
117 Dr Hunter stated in his written evidence to the Inquiry:
`Those who initiated the auditing activities gave the impression that they were intent on policing the surgical activities rather than working together to see a solution. The figures presented by Dr Bolsin were incomplete and failed to give a total view of the problem. There was in general a lack of understanding of the problems of paediatric cardiac surgery.' [133]
118 Professor de Leval told the Inquiry:
`What I recollect is that during the meeting there was a sense of conflict which was present there and I think the way Dr Bolsin presented his data or the calendar of events was conflictural. Obviously it is difficult to blame someone, to adopt that attitude knowing what he had done for several years to try to solve the problem.' [134]
119 Dr Hunter's notes record discussions with Mr Dhasmana and Mr Wisheart. [135] They indicate that discussion took place about the impending move of the paediatric cardiac surgery department to the BRHSC and the arrival of the new surgeon, Mr Pawade. There was also discussion of the Switch programme at Bristol and the results which had been achieved.
120 Dr Hunter and Professor de Leval stated that they also interviewed the cardiologists Dr Martin and Dr Hayes (Dr Joffe was on holiday at the time), although it was not clear from their notes whether they saw the cardiologists at the same time as they saw Mr Wisheart and Mr Dhasmana, or whether they were seen separately. Dr Hunter told the Inquiry that he thought that they were seen separately but added that the Inquiry may have information to the contrary. [136] Dr Martin also was not sure:
`My general feeling was that we had met separately, but whether that is correct or not, I do not know.' [137]
121 Dr Hunter told the Inquiry that, having spoken to the cardiologists, he formed the view that there was:
`... a general support for the attempts by Mr Dhasmana and concern that he was having problems with the switch. ... I think they were generally supportive of their colleagues and worried about the effect of surgery, obviously, and where they should go from there.' [138]
122 Professor de Leval and Dr Hunter saw various other staff over the course of the day.
123 Professor de Leval stated that Dr Stephen Pryn, consultant intensivist, felt the:
`... surgical results were suboptimal but deplored the lack of hard data to prove it.' [139]
`... It frustrated me that people were having these grumbling conversations without any data to go with it, and the night before the meeting with Marc de Leval was the first time I had seen those results ... I was frustrated that we could not move the unit forwards in a constructive way.' [140]
125 Professor de Leval stated that Sister Fiona Thomas, the Clinical Nurse Manager, expressed concerns to him and Dr Hunter about the post-operative care of patients who had undergone paediatric cardiac surgery, and told them that there were `considerable conflicts between surgeons and anaesthetists and a lack of expertise for children.' [141]
126 Professor de Leval told the Inquiry that he formed the impression from talking to Sister Thomas that:
`... the decision-making [in intensive care] was highly disorganised ... There was a complete lack of cohesion in the management of those patients. Nobody knew who was in charge of the patients.' [142]
127 Both of the visiting experts stated that they found Dr Monk, the Clinical Director of Anaesthesia, to be `... one of the most lucid and logical of the people they met during the visit.' [143] Professor de Leval told the Inquiry that he was impressed by Dr Monk's overall view of the problem, which went wider than the conduct of surgery to cover the overall management of the patient. [144]
128 Dr Hunter told the Inquiry that he thought that Professor Angelini's attitude would `... not have made the department a happier place to work in, and would not have been conducive to healing and improving matters.' [145] Professor de Leval commented that Professor Angelini:
`... had reached a stage of being rather aggressive vis-à-vis the other two surgeons ... . I felt that he was rather hostile and aggressive ... .' [146]
129 Professor de Leval accepted that Professor Angelini's attitude could have been `just an indication of desperation' on his part. [147]
130 At the end of the day's visit an open meeting was held. Mr Wisheart told the Inquiry:
`... The only comment I can make is that that was the meeting at which it emerged for the first time, to me, that Dr Bolsin had undertaken an audit, and that he had given it to Dr Hunter and Mr de Leval, and I am not always good at concealing my feelings, and it is quite possible that my body language was visible on that occasion. I mean, I was absolutely shocked; profoundly shocked.
`A. Well, I expect so.' [148]
131 Professor de Leval and Dr Hunter set out a number of preliminary conclusions arising from their visit, including:
`... A major review of post-operative care was needed. The chain of command in the existing intensive care unit was hopelessly vague. ... Better communication and trust between the various parts of the service was essential to solve the problems existing and to heal the serious divisions that had arisen. ... A monthly morbidity and mortality conference attended by all parties where results, policies and practices would be openly discussed within the department ... The critical factor in solving the overall problem was the appointment and imminent arrival (April 1995) of a new surgeon with a proven track record in a major centre.' [149]
132 Professor de Leval was asked about the methods he and Dr Hunter had used in the following exchange:
`Q. How confident are you, or how happy are you, with the method of investigation that you were obliged to adopt as a means of reaching a conclusion upon the adequacy of care at the Unit?'
`A. I think that the report was carefully written. I think that the report indicated its weaknesses and the report mentioned the fact that the investigation should go well beyond the surgeons but through the systems. I think that was in the initial report. So I do not think that the report was misleading or that the report did not achieve what it had to do; I believe that the report provided some information which could have been useful for the Chief Executive to investigate further, to try to have a better understanding of what was happening and what had to be done.' [150]
133 Professor de Leval told the Inquiry that he recognised that reports were:
`... as robust or as weak as the data we received to make the report. We certainly agreed that there was a problem. We commented on ways to alleviate some of those problems and make recommendations for the future based on the decision that the Trust had already made when we visited them. But I think that the strengths or weaknesses of the report is parallel or relates to the strengths or weaknesses of the data we had.' [151]
134 Professor de Leval stated in his written evidence to the Inquiry that there was:
`... no evidence that the data collection had been validated. We did not have any form of risk stratification and we did not have the figures of the other UK units for comparison. With hindsight one could argue that it was unwise to produce a report based on such weak data.' [152]
135 Professor de Leval told the Inquiry:
`I think that the lack of a statistician is a deficiency of the report. There is more than that. I think that first of all the data we were presented with were deficient themselves, and I think that a statistician is as good as the data you provide to the statistician. I think that the deficiency was the weakness of the data and the pressure of time which just made it impossible to have good data. I do not disagree that a statistician would have been much more demanding than we were to produce a report, and any competent statistician would have simply refused to comment on this ... .' [153]
136 Professor de Leval explained:
`It was quite clear from Dr Bolsin's interview and from the head of anaesthesiology [Dr Monk], that they had great difficulties to obtain the results. It was, I think, clear also that when they met in 1993, the surgeons made a statement which was not supported by data and that a number of the people we had seen on that particular day in February had been presented with the surgical results for the first time, so there was an obvious reticence from the surgeons ... .' [154]
137 Professor Angelini stated in his written evidence to the Inquiry:
`I never received from Mr Dhasmana or Mr Wisheart specific data relating to their individual surgical performance. The first time I was provided with a full picture of results was literally half an hour before I was invited to speak to Mr de Leval and Dr Hunter on their visit to Bristol. ... I had no way of verifying whether the data were correct ... .' [155]
138 Commenting on Professor Angelini's observation, Mr Dhasmana told the Inquiry:
`... he would have seen it [the data] for the year 1993/94. ... The copy of annual unit returns to the Society's Annual Cardiac Register was regularly circulated to him along with other consultant members of staff. He never asked me for the surgeon specific figures and also never showed me the data provided by Dr Bolsin.' [156]
139 Dr Martin told the Inquiry:
`I did not get the impression that they [Mr Dhasmana and Mr Wisheart] were reluctant to reveal their figures ... My perception was that the surgeons were analysing their own results. [157]
140 Dr Joffe, when asked by Counsel to the Inquiry about the comment in the Hunter/de Leval report that the surgeons were reticent in producing their results, told the Inquiry: `It was not [the cardiologists'] experience. We always had access to those results ... .' [158]
141 Dr Hunter told the Inquiry that he remembered `a number of people saying to us that they had not been aware of the surgical data until literally a few days before, or shortly before' [159] his and Professor de Leval's visit.
142 Mr Wisheart stated in his written evidence to the Inquiry that the more detailed material was not provided to other clinicians until shortly before the arrival of Dr Hunter and Professor de Leval because:
`In less than two weeks and in addition to our regular commitments we had to (1) prepare the summarised results for 1992-95 and (2) complete a data sheet for each of 450 open-heart procedures carried out during those years.' [160]
143 Dr Monk, who had been aware of Dr Bolsin's audit from September 1993, [161] told the Inquiry about attempts to establish its meaning:
`The final meeting ... was just preceding the de Leval/Hunter external audit. Even at that stage we had still not sat down with Dr Bolsin and said: "What about this data?" We held that meeting and he did not come. So even when I went in to see de Leval and Hunter, we still did not have a joint opinion amongst the Cardiac anaesthetists of what the data actually meant, nor, as a group, what we should be doing about it.' [162]
The first version of the Hunter/de Leval report
144 The full text of the first version of the Hunter/de Leval report was as follows:
`VISIT OF CARDIAC SERVICES DIRECTORATE OF THE UNITED BRISTOL HEALTH CARE NHS TRUST. FRIDAY, 10 FEBRUARY 1995
`To advise the Trust on the best action to take following recent recommendations received by the Department of Health to stop complex neonatal and infant open-heart surgery.
`To make recommendations on the future of the paediatric cardiac services in the Trust.
`Following a welcome meeting by the Chief Executive, Dr Roylance, who briefly outlined the problem, we met first the two paediatric cardiac surgeons, Mr Dhasmana and Mr Wisheart, who were then joined by two of the paediatric cardiologists, Dr Martin and Dr Hayes. We then met Dr Bolsin, consultant anaesthetist, Dr Monk, clinical director of anaesthesia, Sister Thomas, clinical nurse manager, and Professor Angelini, Professor of department of cardiac surgery. After lunch we met Dr Hughes, clinical director, and Mr Barrington, general manager, of the Bristol Children's Hospital, and then we met Dr Brynn [sic], consultant anaesthetist. The visit was closed by a general meeting that attempted to put forward a satisfactory proposal for the immediate future.
`CURRENT PAEDIATRIC CARDIAC SERVICES
`Paediatric cardiac services are currently provided on the two sites, the Bristol Children's Hospital and the Royal Infirmary. The paediatric cardiology services are in the Children's Hospital where closed-heart surgery is performed. Open-heart surgery is carried out at the Royal Infirmary. The operations are done by two surgeons, Mr Wisheart and Mr Dhasmana. The latter seems to have taken over the greater bulk of the paediatric practice. Anaesthesia is provided by three anaesthetists working on both sites. The postoperative care in the Children's Hospital is done by the surgeons, supported by paediatricians, cardiologists and anaesthetists. The junior staff on site is a paediatric SHO. At the Royal Infirmary the postoperative management is dealt with by the cardiac surgical team (adult) and the anaesthetic team. The person on site on a 24-hour basis is a surgical SHO. During the daytime there are currently two or three anaesthetic sessions which are dedicated to postoperative care. The paediatric cardiologists help with the postoperative management of the children at the Royal Infirmary. The overall postoperative management at the Royal Infirmary appears to be highly disorganised with conflicting decisions between the surgical senior registrar and the SHO who do rounds at 8.00 am, the anaesthetists who see the patients at 9.00 am, and the intensivists who work three days a week.
`BACKGROUND OF CURRENT PROBLEM
`From 1989 concerns about the surgical results of the paediatric cardiac surgeons have been raised by members of the anaesthetic department. Dr Bolsin undertook an audit of the paediatric cardiac surgical results from 1990-1992. The auditing showed: (1) that the results of the arterial Switch operation were poor; (2) the results of Bristol for more classical conditions, such as tetralogy of Fallot, AV canal and VSD, were worse than the national average; and (3) that one surgeon had results statistically worse than the other one.
`In 1993 one paediatric cardiac surgeon went to the Children's Hospital in Birmingham to improve his technique on the Switch operation.
`Professor Angelini, who joined the Trust in 1992, was informed as well as Professor Farndon (Professor of Surgery) of the results of the audit. A joint meeting between the cardiac surgeons, the paediatric cardiologists and the cardiac anaesthetists was called and the surgeons reassured their colleagues that the results were improving.
`Several members of staff who were interviewed during the visit confirmed that the surgeons failed to report and update their results until the day before our visit. Meanwhile, the results of the neonatal arterial Switch failed to improve and sometime in 1994 four cardiac anaesthetists agreed that they could no longer anaesthetise patients for a neonatal arterial Switch.
`On 19 July 1994 Dr P Doyle (Senior Medical Officer, DoH) visited Bristol and was shown the results of the audit (we assume that those were the 1990-1992 results). Three alternatives were proposed by Dr Doyle: inform the Secretary of State, ask Mr John Parker as President of the Cardiac Society to conduct an inquiry, or ask the President of the Royal College of Surgeons to conduct an inquiry. We understand that Mr John Parker was contacted to deal with the matter.
`On 24 July 1994 Professor Angelini and Professor Farndon informed the UBHT Chairman of the problem with paediatric cardiac surgery.
`This calendar of events was obtained in part from the interviews but mainly from a detailed report written by Dr Bolsin.
`In January 1995 a non-infant Switch was put on the surgical schedule. The wisdom of operating on this patient was discussed by a committee with representatives of all parties involved and an agreement was reached to proceed with the operation. The patient unfortunately did not survive and this allegedly led to the letter received from the Department of Health, advising to stop open-heart surgery for neonates and complex infants (we have not seen the letter from the Department of Health).
`The Trust has taken a number of positive steps to improve the paediatric cardiac services. They can be summarised as follows:
`From next October all paediatric cardiac services will be provided at the Children's Hospital where an operating theatre will be dedicated to cardiac work. The intensive care unit will expand from five to twelve beds. Professor Peter Fleming will run the paediatric intensive care unit and provision for a round-the-clock service will be made.
`Mr Ash Pawade has been appointed as paediatric cardiac surgeon and he is expected to take up his post within the next two or three months with the intention of putting him in charge of neonatal and complex paediatric cardiac surgery.
`The anaesthetic department will provide four paediatric cardiac anaesthetists. The fourth post will be created after the forthcoming retirement of a senior paediatric anaesthetist.
`PERCEPTIONS COLLECTED DURING THE VISIT
`1. Although well intentioned, the auditing activities of the surgical results by the anaesthetic department was lacking the collaborative attitude that such a delicate endeavour would have required.
`2. The surgeons' reticence to produce and analyse their own results has obviously contributed to tension and eventually conflict between the department of cardiac surgery and the department of anaesthetics.
`3. The channel that was followed by those concerned about the problem that led to the Department of Health before professional bodies is unfortunate. Admittedly, Dr Doyle has rectified this situation in suggesting to approach the Cardiac Society or the Royal College of Surgeons.
`4. The members of the anaesthetic department were unanimous in claiming that not only the mortality but the morbidity was excessive. Mortality figures will be discussed later. There was no hard data on morbidity.
`5. The tension which has arisen from this long saga has created an atmosphere of distrust and lack of confidence, which have made the working conditions for the surgeons nearly untenable.
`Two sets of data were displayed during the meeting. The data produced by Dr Bolsin were the results of the 1990-1992 audit which compared the results of Bristol with the national average performance of 1991. They concluded that the results of tetralogy of Fallot (all ages), ventricular septal defect (all ages) and atrioventricular canals (under one year) were significantly worse in Bristol than the rest of the UK. Leaving aside the neonatal arterial Switch operation, "the data for other procedures do not show any statistically significant differences"(Dr Bolsin's report). Dr Bolsin also produced the results of the arterial Switch operation up to July 1994: there were thirty-three arterial Switch operations with a mortality of 66% (eight out of twelve) under one month of age, and 42% (nine out of twenty-one) over the age of one month. He also summarises the results of AV canals operated by Mr Wisheart between 1992 and 1994.
`The second set of data received from the cardiac surgeons included a detailed report of the results of the neonatal arterial Switch operation, the results of closed heart surgery from 1990 to March 1994 and the results of open-heart surgery from January 1992 to January 1995.
`There were nine deaths out of thirteen neonatal arterial Switches: one patient had an undiagnosed coarctation of the aorta, two patients had the whole coronary system arising from the same sinus, one of them with an intramural pathway: neither of those patients survived. Two patients had a circumflex coronary artery arising from sinus 2 (known to be a risk factor in a multi-institutional study); one of these patients died.
`The results of closed heart surgery are excellent with a mortality of 5.3% for patients under one year of age and a mortality of 2.8% for patients over the age of one year.
`For the results of open-heart surgery from January 1992 to January 1995, we have extracted the results of tetralogy of Fallot, VSD and AV canal to compare them with the 1990-1992 results produced by Dr Bolsin and we individualised the two surgeons (Consultant 1 and Consultant 2) (Fig 1, 2 & 3).
`Consultant 1 has a mortality of 0% for ventricular septal defects, 13.5% for tetralogy of Fallot and 87% for AV canals.
`Consultant 2 has a mortality of 0% for ventricular septal defects, 0% for tetralogy of Fallot and 8.6% for AV canals.
`The current results of the other UK units are not available to us. There is little doubt that Consultant 2 would certainly compare very favourably with the best UK institutions. Consultant 1 would be amongst the higher risk surgeons.
`WEAKNESSES AND DEFICIENCIES OF THE ANALYSIS
`1. We assume that the mortality figures relate to the hospital mortality, though we have not specified this.
`2. There is no recommended standard against which the performance of a unit can be compared. This emphasises the great need for a proper audit of the performance of each UK unit dealing with paediatric cardiac surgery. The use of the average UK results may be misleading. If one postulates, for example, that two or three larger units have better results than two or three smaller units, the poor results of the latter will be hidden, so to speak, by the average figures.
`3. It is therefore not possible to make any objective and fair recommendations to a unit without knowing what the performance of every single unit in the UK is, so as to set up a standard.
`4. Performance assessment should also take into consideration morbidity. Dr Bolsin's report includes an attempt to compare the performance of the two surgeons in looking at bypass time, extubation time, ITU time and hospital time for tetralogy of Fallot and AV canals. Here again, those data suffer the lack of standard to which they should be compared.
`CONCLUSIONS AND RECOMMENDATIONS
`The following has to be taken in the context of the above described deficiencies of this report.
`1. On the basis of the mortality figures presented to us, there is a significant improvement between the 1990-1992 results and the 1992-1995 results.
`2. The results of the neonatal arterial Switch operation should improve. It is not possible to determine the cause of these poor results. To blame surgical skill as the sole reason would be shortsighted. It is most likely a multifactorial and multidisciplinary problem.
`3. Leaving aside the neonatal arterial Switch repairs, based on the mortality figures produced for 1992-1995, the results produced by Consultant 2 are, we believe, comparable to the results of the so-called low risk institutions (although the hard data for the UK are not available).
`4. We understand that Consultant 1 has decided to concentrate his activities on adult cardiac surgery when the new appointee starts.
`5. We believe that it would be a great mistake to ask the new appointee to do all neonatal and complex cardiac surgery using Mr Dhasmana as a "spare wheel". We would recommend that both surgeons help each other for the most complex pathologies. For this Mr Dhasmana should be relieved from part of his duties in adult cardiac surgery. The Trust may have therefore to consider appointing another adult cardiac surgeon should their workload justify it. This might be the case as the move of the paediatric cardiac surgery to the Children's Hospital will create more facilities at the Royal Infirmary.
`6. There is a great need for improving communications between the various departments. We would strongly recommend to organise multidisciplinary audit meetings (at least monthly). We would also recommend joint cardiac conferences, attended by the cardiologists, the anaesthetists, the intensivists and the surgeons weekly to discuss cases which have been investigated and those who are on the operating schedule for the following week.
`7. An atmosphere of cooperation and understanding between the various departments is essential, so as to alleviate the tension, the distrust and the present untenable atmosphere which without any doubt jeopardise the outcome of the patients.
`8. We believe that it would be inappropriate to do neonatal arterial Switch operations before the new appointee takes up his post. From the mortality figures presented to us, we have no reason to believe that Mr Dhasmana should not continue to carry on operating on the other conditions. This, however, would be possible only if he receives the full support he deserves from his colleagues. This requires a change of attitude to alleviate the stressful conditions under which he has had to work in the recent past.
`9. It is hoped that the new appointee will be more successful with the arterial Switch repair and that when the failure rate has returned to low values Mr Dhasmana will start afresh with the operation.' [163]
UBHT 0052 0263 - 0269 ; first version of the Hunter/de Leval report145 Mrs Ferris told the Inquiry that she thought that the comment about post-operative care being `disorganised' was fair. [164]
146 Mr Wisheart told the Inquiry that this conclusion was based solely on information given to the visiting experts by Fiona Thomas and was not therefore a conclusion `based on canvassing a broad spectrum of opinion'. [165]
147 Dr Roylance stated in his written evidence to the Inquiry that he gave the visiting experts his assurance that the report was confidential to him. [166] Dr Roylance told the Inquiry that the reason for the confidentiality of the report was that:
`... it was not refined, it was blunt, it was clear and it was helpful to me ... and to make sure there were no punches that were pulled, I promised them they could say whatever they liked and it would remain confidential to me and I would act on their advice.' [167]
148 Dr Roylance told the Inquiry that a further reason was because Dr Hunter and Professor de Leval were `to a certain extent, dealing on hunch and impression.' [168]
149 Professor de Leval stated in his written evidence to the Inquiry that the report was not written for public consumption: `... [The] report contained a number of statements which, in my opinion, could not be in the public domain without further investigation.' [169]
`The report was produced as a confidential document to the Chief Executive ... I think that if I had known that the document was going to be part of the public domain, I would have been more careful in the wording of the document. I think that it is totally unfair to say that a surgeon is a high risk surgeon with that type of data, and I think that it was irresponsible to say that with the data we had.' [170]
151 Dr Hunter discussed the status of the first version of the report in the following exchange:
`Q. [The report] has been described as being variously "confidential" or "a draft". What did you understand it to be?
`A. I understood it was a confidential report which was for the UBHT.
`Q. And by "confidential", who did you understand it would be circulated to?
`A. I assumed that that would be up to the UBHT. We were asked by the UBHT, by Mr Wisheart on its behalf, to do the report, and therefore our remit was to send it to them.
`Q. Did you understand that the first report that you had sent through was, as it were, a working draft that other people might comment on and ask you to revise, or a final version that -
`A. I thought that it was a draft.
`A. That "this is what we intend to say and we would like to hear your comments". That is what I have done on other reports.' [171]
152 Dr Roylance went on annual leave on 24 February 1995. Mr Graham Nix was acting Chief Executive in his absence. Mr Nix, in his written evidence to the Inquiry, recalled:
`Within a few days of Dr Roylance going on leave, the Trust began to be approached by people from outside the Trust asking for information, which tended to suggest that the fact of there being a report available and to some extent its contents were already in the public domain ... My own first involvement was I believe some time during the week of 27 February 1995 when the faxed report became known to me following Press interest.' [172]
153 Mr Nix stated that he consulted Mr McKinlay (Chairman, UBHT) about the appropriate response to be made by the UBHT. [173] Mr McKinlay stated that Dr Roylance had told the Board on 24 February 1995 that:
`Mr Wisheart would review the contents of the report with Dr [Professor] Vann Jones and Dr Hyam Joffe and would have discussions with Dr Winyard, who was Medical Director of the NHS Executive.' [174]
154 Mr McKinlay, in a letter to Ms Rennie Fritchie, Chair of the South & West Regional Health Authority (S&WRHA) dated 3 March 1995, wrote:
`To protect Mr Wisheart, I have requested him not to deal with the media queries and to leave the internal action in the hands of Gabriel Laszlo [Chairman, Hospital Medical Committee].' [175]
`The report was immediately considered by Dr Laszlo, as Chairman of the Hospital Medical Committee [HMC], Dr Joffe, Consultant Paediatric Cardiologist, Dr Monk as Clinical Director of the Directorate of Anaesthesia and Dr [Professor] John Vann Jones as Clinical Director of the Directorate of Cardiac Services. This led to a report of their combined views dated 3 March 1995, which was produced to assist Mr McKinlay and myself.' [176]
156 The report of the HMC concluded:
`No data are presented to show how [Mr Wisheart] is ranked nationally. In the tables provided, there is no significant difference between the mortality figures of the two surgeons. The total number of deaths in 1992-5 was very similar; the team which operated on the smaller number of children had a non-significantly higher mortality. A total of only four fewer deaths would have yielded equal percentages. There were four excess deaths in the "miscellaneous" group among patients with very unusual diagnoses not all of whom had operations.' [177]
157 Mr McKinlay wrote to Ms Fritchie confirming the UBHT's intention to act on the report's recommendations and stating that: `... While disagreeing with several of the comments made in the report we accept the recommendations.' [178]
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Footnotes
[107] UBHT 0061 0286; letter dated 3 February 1995
[108] WIT 0089 0105 Mrs Ferris
[109] WIT 0073 0018 Professor Angelini
[111] WIT 0089 0114 Mr Wisheart
[114] WIT 0319 0001 Professor de Leval
[115] T60 p.127-8; Dr Hunter. Mr Ashwinikumar Pawade, consultant paediatric cardiac surgeon, BRHSC (1 May 1995- )
[116] UBHT 0052 0263; first version of the Hunter/de Leval report
[117] UBHT 0061 0378; revised draft of the Hunter/de Leval report; (the differences in the two versions of the remit are considered later in this chapter)
[118] WIT 0319 0013; Dr Hunter's notes
[120] WIT 0108 0130 Dr Roylance
[122] T60 p.17-20 Professor de Leval
[124] WIT 0089 0099 Mrs Ferris
[126] WIT 0089 0100 Mrs Ferris
[128] WIT 0322 0005 Dr Hunter, WIT 0319 0002 Professor de Leval
[129] WIT 0080 0127 Dr Bolsin
[130] WIT 0322 0005 Dr Hunter
[131] WIT 0080 0127 Dr Bolsin
[133] WIT 0322 0006 Dr Hunter
[134] T60 p.30 Professor de Leval
[135] WIT 0319 0014 - 0015 ; Dr Hunter's note
[136] T60 p.139-40; the Inquiry did not have information to the contrary
[139] WIT 0319 0003 Professor de Leval
[141] WIT 0319 0003 Professor de Leval
[142] T60 p.39 Professor de Leval
[143] WIT 0319 0017; Dr Hunter's note
[144] T60 p.44 Professor de Leval
[146] T60 p.111 Professor de Leval
[147] T60 p.111 Professor de Leval
[149] WIT 0322 0006 - 0007 Dr Hunter
[150] T60 p.28-9 Professor de Leval
[151] T60 p.96 Professor de Leval
[152] WIT 0319 0002 Professor de Leval
[153] T60 p.5-6 Professor de Leval
[154] T60 p.59 Professor de Leval
[155] WIT 0073 0010 Professor Angelini
[156] WIT 0073 0059 - 0060 Mr Dhasmana
[160] WIT 0073 0097 Mr Wisheart
[161] WIT 0105 0020 Dr Monk
[163] UBHT 0052 0263 - 0269 ; first version of the Hunter/de Leval report (emphasis in original); see Chapter 3 for an explanation of clinical terms
[166] WIT 0108 0131 Dr Roylance
[169] WIT 0319 0001 Professor de Leval
[170] T60 p.84 Professor de Leval
[172] WIT 0106 0071 Mr Nix
[173] WIT 0106 0072 Mr Nix
[174] WIT 0102 0030 Mr McKinlay
[175] UBHT 0052 0260; letter dated 3 March 1995
[176] WIT 0106 0072 Mr Nix
[177] UBHT 0061 0371; HMC report
[178] UBHT 0052 0260; letter dated 3 March 1995